Title of Invention	A COMPOSITION FOR TREATING AND PREVENTING SLEEP DISORDER
Abstract	The technical problem that the invention will tackle is to screen and study plants that have the function of treating sleep disorders and the parts of the plants that can treat sleep disorders. Since the mechanism or means that affects or regulates sleep involves many neurotransmitter systems, this invention screens and studies plant extracts that have synergetic effects on multiple mechanisms or means that affect or regulate sleep. In order to solve the above problem, the invention provides the following technical proposal: The application of Ampelopsis plants in manufacturing drugs and healthcare products that prevent or cure sleep disorders.

Title of Invention

A COMPOSITION FOR TREATING AND PREVENTING SLEEP DISORDER

Abstract

The technical problem that the invention will tackle is to screen and study plants that have the function of treating sleep disorders and the parts of the plants that can treat sleep disorders. Since the mechanism or means that affects or regulates sleep involves many neurotransmitter systems, this invention screens and studies plant extracts that have synergetic effects on multiple mechanisms or means that affect or regulate sleep. In order to solve the above problem, the invention provides the following technical proposal: The application of Ampelopsis plants in manufacturing drugs and healthcare products that prevent or cure sleep disorders.

Full Text	Technical Field The present invention relates to the usage of Ampelopsis plants and their extracts in manufacturing drugs and healthcare products. Background of the Invention Insomnia is a common sleep disorder that requires adequate attention and treatment. Each year, 35-49% of the adults suffer from insomnia. Man's sleep regulation center is located at the hypothalamus of the cerebral, where there are many hypothalamic neurotransmitters regulating the sleeping-awakening cycle (see: Mignot, E., Taheri, S., and Nishino, S., Sleeping with the hypothalamus: emerging therapeutic targets for sleep disorders. Nat.Neurosci. 2002, 5 Suppl: 1071-1075). The mechanism or means that affects or regulates - sleeping involves many neurotransmitter systems, for instance, γ- aminobutyric acid, adenosine(purin), dopamine, hypocretins system (also known as orexins; phenyl dihydroquinazolin), monoaminergic system (for instance, 5-hydroxyptamine, noradrenalin and histamine). ( Since drugs presently used for treating sleep disorders have different degrees of side effects, herbal medicines and other natural medicines that may help sleep are getting more and more attention. There are approximately 25 kinds of Ampelopsis plants around the world, including 17_in_china, which are widely distributed in such provinces and autonomous regions as Guangxi, Guangdong, Yun'nan, Guizhou, Hu'nan, Hubei, Jiangxi and Fujian, etc. Except common medicine [Ampelopsis japonica (Thunb.) Makino], the majority of Ampelopsis plants are folk Chinese herbal medicines, most of which, Ampelopsis grossedentata (Hand— Mazz)W. T. Wang, [ Ampelopsis cantoniensis(Hook.et Am.)Planch, Ampelopsis meliaefolia, Ampelopsis brevipedunculata(Uaxim. )Trautv, Ampelopsis megalophylla Diels et Gilg in particular, have functions such as promoting blood circulation, dissipating blood stasis, clearing heat and removing toxic substances, etc; Ampelopsis plants can prevent and cure icteric hepatitis, cold, wind heat, pharyngeal swelling and pain, wind-damp pain, calenture, getting drunken, etc. and pharmacological experiments have shown that main components of Ampelopsis plants have such functions as removing phlegm, reducing blood lipids, resisting inflammation, diuresis, and protecting the liver, etc. Summary of the Invention The technical problem that the invention will tackle is to screen and study plants that have the function of treating sleep disorders and the parts of the plants that can treat sleep disorders. Since the mechanism or means that affects or regulates sleep involves many neurotransmitter systems, this invention screens and studies plant extracts that have synergetic effects on multiple mechanisms or means that affect or regulate sleep. r In order to solve the above problem, the invention provides the following technical proposal: The application of Ampelopsis plants in manufacturing drugs and healthcare products that prevent or cure sleep disorders. The application of extracts of Ampelopsis plants in manufacturing drugs and healthcare products that prevent or cure sleep disorders. Said Ampelopsis plants include Ampelopsis grossedentata(Hand-Mazz)W, T, Wang, [Ampelopsis cantoniensis (Hook.et Am.)Planch], Ampelopsis meliaefolia, Ampelopsis brevipedunculata(Uaxim.)Trautv, Ampelopsis megalophylla Diels et Gilg, Ampelopsis bodinieri (Levl, et Vant.) Rehd, Ampelopsis brevipedunculat (Maxim.) Maxim ex Trautv, Ampelopsis brevipedunculat (Maxim.) Trautv. var. Hancei Rehd, Ampelopsis delavayana Planch, Ampelopsis japonica (Thunb) Makino, Ampelopsis aconitifolia Brnge, Ampelopsis aconitifolia Bge. var. glabra Diels et Grig, Ampelopsis brevipedunculata (Maxim.)Trautv. var. kulingensisRehd, Ampelopsis humulifolia Bge,_Ampelopsis heterophylla (Thunb.) Sieb. & Zucc, Ampelopsis chaffanjoni (Levi, et Vant.) Rehd . Said Ampelopsis plants and/ or extracts of Ampelopsis plants can be mixed with drug carriers or food carriers for manufacturing drugs and/or healthcare products that can prevent or cure sleep disorders. Said extracts of Ampelopsis plants include extracts obtained through extraction of Ampelopsis plants with water, low alcohols, low ketone or acetjc acid ethyl ester as solvents or random mixed solvents of these solvents; the low alcohols among the solvents used for extraction may be methanol ,ethanol or n-butyl alcohol and the low ketones maybe acetone; the extraction method may be self-immersion extraction, circumfluence extraction, ultrasonic extraction, circumfluence extraction and supercritical extraction. For instance, extract with the mixed solvent of ethanol: water (volume ratio: 90-10: 10: 90), preferably the mixed solvent of ethanol; water (volume ratio:70:30), extract with acetone /water (volume ratio: 50:50) by means of circumfluence or extract directly by soaking with water. Said extracts of Ampelopsis plants mainly contain protein, amino acid, amylose, inorganic nutrients, phenolic compounds and/or flavone, especially amino acid, amylose, phenolic compounds and/or flavone; Said extracts of Ampelopsis plants may mainly contain phenolic compounds and/or flavone. To be specific, so-called 'treating sleep disorders' mentioned in this invention means that the drugs or healthcare products can help sleep and be used in daily life to alleviate or improve various sleep disorders due to different causes. The dose of the plant of genus Ampelopsis of this invention, for instance, Ampelopsis grossedentata (Hand—Mazz)W . T. Wang, is 0.05-5000mg/kg/day by weight and the preferred dose is 0.05-2500mg/kg/day when preventing and curing sleep disorders. The dose of the extract of Ampelopsis plant of this invention, for instance, Ampelopsis grossedentata (Hand—Mazz)W . T. Wang, is 0.01-100mg/kg/day by weight and the preferred dose is 0.01-50 mg/kg/day when used for preventing and curing sleep disorders. Due to different types and extents of sleep disorders of different individuals and individual differences (age, gender, etc.), the dose of plants and their extracts of this invention is not limited to the above scope. The combination of this invention that prevents or cures sleep disorders is characterized as containing Ampelopsis plants and/or extracts or Ampelopsis plants. This invention includes healthcare products containing said combination that can prevent or cure sleep disorders, which are suitable for preventing and curing sleep disorders. This invention includes drugs containing said combination that can prevent or cure sleep disorders, which are suitable for preventing and curing sleep disorders. Said Ampelopsis plants include Ampelopsis grossedentata(Hand—Mazz)W . T. Wang, [Ampelopsis cantoniensis(Hook.et Am.)Planch] , Ampelopsis meliaefolia, Ampelopsis brevipedunculata(Uaxim.)Trautv, Ampelopsis megalophylla Diels et Gilg , Ampelopsis bodinieri (Levi, et Vant.) Rehd, Ampelopsis brevipedunculat (Maxim.) Maxim ex Trautv, Ampelopsis brevipedunculat (Maxim.) Trautv. var. Hancei Rehd, Ampelopsis delavayana Planch, Ampelopsis japonica (Thunb.) Makino, Ampelopsis aconitifolia Brnge, Ampelopsis aconitifolia Bge. var. glabra Diels et Grig, Ampelopsis brevipedunculata (Maxim.)Trautv. var. kulingensisRehd, Ampelopsis humulifolia Bge,_Ampelopsis heterophylla (Thunb.) Sieb^y & Zucc, Ampelopsis chaffanjoni (Levi, et Vant.) Rehd. Extracts of Ampelopsis plants involved in this invention include extracts obtained through I extraction of Ampelopsis plants with water, low alcohols, low ketones or acetic acid ethyl ( ester as solvents or random mixed solvents of these solvents; said low alcohols among the solvents used for extraction is methanol % ethanol or n-butyl alcohol and the low ketone is acetone; the extraction method is selected from self-immersion extraction, circumfluence extraction, ultrasonic extraction, circumfluence extraction and supercritical extraction. Extracts of Ampelopsis plants of this invention mainly contain protein, amino acid, amylose, inorganic nutrients, phenolic compounds and/or flavone, especially amino acid, amylose, phenolic compounds and/or flavone, or especially phenolic compounds and/or flavone. When manufacturing drugs or healthcare products that prevent or cure sleep disorders, the plant of genus Ampelopsiss and their extracts of this invention may be added with various mineral substances, preferably mineral substances that play the role of supplementing necessary elements and trace elements that are apt to be insufficient in the body of organisms. In addition, when manufacturing drugs or healthcare products that preventing or curing sleep disorders, the plant of genus Ampelopsiss and their extracts of this invention may be added with other natural drugs, amino acids and/or vitamins. Said natural drugs are free from special restrictions and shall preferably be Ganodorma lucidum, glutinous rehmannia, Chinese date, Schisandra chinensis (Turcz.) Baill, semen, ziziphi spinosae that are useful in stabilizing the spirit. In addition, lavender, Semen Biotae, radix polygalae, cortex albizziae, caulis polygoni multifiori, etc. that have sedative and relaxation effects may also be selected. There are no special requirements for the state of these plant drugs, which may be extract powder, essential oil extracted and herbal tea, etc. Also, there are no special requirements for the state of amino acid, which may be glutamine, troptophan, lysine, leucine, glutamic acid, isoleucine , and methionine,etc.And, there are no special requirements for vitamine, which, for instance, may be vitamine B6, vitamine Bl, vitamin B2, folacin, vitamine C and Vitamin E, etc. When manufacturing drugs or healthcare products that prevent or cure sleep disorders, the . plant of genus Ampelopsiss and their extracts of this invention may be added with other elements, for instance, aloe, royal jelly, spirulina, gingko leaf, bifid bacterium,etc. The plant of genus Ampelopsiss and their extracts of this invention may be manufactured into different forms of drugs or healthcare products; said healthcare products of the invention include healthcare foods manufactured by adding the plant of genus Ampelopsiss and their extracts of this invention into existing foods. There are no special requirements for drugs or healthcare products of this invention, which may contain only Ampelopsis plants or their extracts, which may be in any of the following forms: solution, mixed suspended liquid, power, solid moulding, etc., may be tablets, capsules, powders, granules in dose form and be used in combined with other drugs. Description of the drawings. Figure 1. Influence of Ampelopsis extracts on pentobarbital prolonged sleeping time in mice. Figure 2. Influence of ECBRC-T3 concentration on relaxation effect of Guinea pig. Examples Example 1 Manufacturing method 1: teek-300g of dry stem leaf ( Ampelopsis. Grosedentata [Hand.- Mazz.] W. T. Wang) , the stem leaf of which is known as tea vine (source: verified by Hou Yulin, the Chinese University of Hong Kong, was soaked them in water and extracted 3 times using the circumfluence extraction method, 45 minutes each time. The extract was filtered whilst hot and subsequently evaporated to a small volume and dried to obtain 92g of extracts (code: ECBRC- T1), representing a recovery rate of 30.7%. Through determination, the extract contained 81.2% of flavone, 1.1% of polyphenol components as well as small quantities of amino acid and amylose. Extraction method 2: 300g of dry stem leaf (A. grosedentata [Hand.-Mazz.] W. T. Wang, - was soaked in ethanol/water (V/V, 70:30) and extracted 3 times using the circumfluence method, 30 minutes each time. The extract was subsequently rotated and filtered whilst still hot (lower than 40°C) to remove ethanol, then freeze-dried to obtain 81g of powder-like extract (code: ECBRC-T2, representing a recovery rate of 27%. Through determination, the extract contained 90.3% of flavone, 1.3% of polyphenol components as well as small quantities of amino acid and amylose. Manufacturing method 3: 100g of extract of dry Ampelopsis plant (A. grosedentata [Hand.- Mazz.] W. T. Wang) was dissolved in 200ml of acetone, heated & extracted using the circumfluence extraction method (45 °C). The extract was subsequently rotated and filtered whilst still hot to approximately 20ml, then diluted with 20-50 times of distilled water, keep it static at 4°C to separate and allow sufficient crystal formation after approximately 12-24 hours. Approximately 39g of crystals were recovered after drying (code: ECBRC-T3), representing a recovery rate of 39%. Through determination, the extract contained 98% of . flavone as well as polyphenol components, amino acid and amylose. Manufacturing method 4: teek 300g of dry stem leaf (A. cantoniensis (Hook, et Arn.) Planch; verified by Hou Yulin from the Chinese University of Hongkong), was extracted with acetone /water (V/V,50:50) using the circumfluenee method. The extract was filtered % whilst hot and subsequently evaporated to a small volume and dried to obtain 20g of extracts (code: ECBRC- T4). Through determination, the extract contained 53.94% of flavone as well as polyphenol, amino acids and amyloses. Manufacturing method 5: teek 300g of dry stem leaf (A. meliaefolia; verified by Hou Yulin from the Chinese University of Hong Kong), was soaked in methanoT/ water (V/V,90:i0), and extracted 3 times using the ultrasonic method, 60 minutes each time. The extract was filtered, rotated and then evaporated to remove the methanol, then dried to obtain 59g of extract (ECBRC-T5). Through determination, the extract contained 14.8% of flavone as well as polyphenol, amino acids and amylose. Manufacturing method 6:: teek 300g of dry stem leaf (A. brevipedunculat (Maxim); verified by Hou Yulin from the Chinese University of Hongkong), was soaked in acetic acid ethyl ester and extracted using the countercurrent method for 2 hours. The extract was filtered, rotated and then evaporated to remove the solvents, giving the concentrated water a solution - petroleum ether discoloration to get 36g of extracts (ECBRC- T6). Through determination, the extract contained 46.1% of flavone, 9.6% of polyphenol contents as well as a small quantities of amino acids and amyloses. Manufacturing method 7: teek 300g of dry stem leaf (A. megalophylla Diels et. Gilg; verified by Hou Yulin from the Chinese University of Hongkong), was soaked them in n-butyl alcohol and extracted 4 times using the circumfluenee extraction method. The extract was filtered whilst hot to remove the solvents, and subsequently treated with chloroform to get 44 g of extract (ECBRC-T7. Through determination, the extract contained 20.1% of flavone, 22.3% of polyphenol as well as amino acid and amylose. Manufacturing method 8: preparation method of vine tea powder. teek 300g of dry stem leaf (A. grosedentata [Hand.-Mazz.] W. T. Wang), was ground into 100 mesh of fine powder to be used. Example 2 C57/B6 mice were randomised into groups and orally administered; ECBRC- T2_ (30mg/kg), melatonin (30mg/kg), Radix Valerianae (140mg/kg) or vehicle (10ml/kg H2O), 30 min prior to low dose injection of sodium pentobarbital (30 mg/kg, i/p.). The animals were then placed on a heating pad (37°C) and their sleep latency to onset of sleep and the duration of sleep determined according to loss of righting reflex. Statistical analysis using one-way ANOVAR showed that each group to be significantly differenct (p4 in sleep time when compared with the vehicle control group and the increase in sleep time, in the high-to-low order, was melatonin (Sigma, batch number: 12K1471) , ECBRC- T2, Radix Valerianae (Roha Arzneimittel, batch number: 007420920. The result indicated that ECBRC- T2 had similar effect that helps sleep as melatonin.(see figure 1). Example 3 C57/B6 mice were randomised into groups and orally administered; ECBRC- T2 (30mg/kg), melatonin (30mg/kg), Radix Valerianae (140mg/kg) or vehicle (10ml/kg H2O), 30 min prior to low dose injection of sodium pentobarbital (16 mg/kg, i/p.). The animals were then placed on a heating pad (37°C) and their sleep latency to onset of sleep and the duration of sleep determined according to ioss of righting reflex. The experiment result showed that ECBRC- . T2 had sedative /hypnotic effect.(Table 1). Example 4 C57/B6 mice were randomised into groups and orally administered ECBRC-T1 s (10,50,100,500mg/kg), 30 min prior to low dose injection of sodium pentobarbital (16 mg/kg, i/p.). The animals were then placed on a heating pad (37°C) and their sleep latency to onset of sleep and the duration of sleep determined according to loss of righting reflex. ECBRC-T1 (10,50,100,500mg/kg) 30 minutes later. Placed the animals on 37°C hot plates and determined the latency of sleep start and the duration of sleep. The experiment result showed that ECBRC-T1 had the function of helping sleep and certain dosage-effect relationship( Table 2). Example 5 C57/B6 mice were randomised into groups and orally administered with different dosages of ECBRC- T3 and melatonin (sigma, batch number: 12K1471), 30 min prior to low dose injection of sodium pentobarbital (16 mg/kg, i/p.). The animals were then placed on a heating pad (37°C) and their sleep latency to onset of sleep and the duration of sleep determined according to loss of righting reflex. The result showed that ECBRC-T3 could extend the sleep time of mice in a dosage-dependent manner and increased with the melatonin group synchronously.(Table 3). Example 6 Remote sensing determination of mice activities. Telemetric activity and temperature monitors were surgically implanted sub-coetaneously into male C57/B6 mice under ketamie (Alfasan, batch number: 112319) and xyalsine (Alfasan, batch number: 073210) (75 / 10 mg/kg, i.p.) anaesthesia to remotely record activity Correct placement was determined using X-ray radiography. Following a 2 week recovery and acclimatization period, the mice were orally treated with either test compounds, positive controls or vehicle; ECBRC- T3, zopiclone (Tocris,batch number: 1094 and An Shen Bu Nao Ye (Sedative and Brain-invigorating Fluid) (Jilin Aodong Yanbian Pharmaceutical Co.,Ltd, batch number: 030659) respectively. Six hours following drug administration, the sleep time of mice of the ECBRC- T3 (20mg/kg, p.o) group was significantly extended (table 4) as were mice treated with zopiclone (20mg/kg, p.o group (table 5), when compared to vehicle control. The result indicated that ECBRC- T3 (20mg/kg, p.o.) could generate similar degree of sedative-hypnotic effect as zopiclone (20mg/kg, p.o.) . Example 7 Isolated organ test Guinea pig aorta was harvested from adult male guinea pigs following euthanisation via cervical dislocation. Aortic rings were suspended in carbonated Krebs solution (37°C) containing 3 uM indomethacin (to prevent endogenous prostacyclin production) at a resting tension of 1 g. Care was taken not to remove or damage the endothelial lining of the ring so as not disrupt any nitric oxide dependant relaxation. The tissue was then allowed to equilibrate for 1-2 hours, followed by pre-contraction with 40mM KC1. After washout. ECBRC-T3 was assessed for contractility by adding directly to the aorta at resting tension, whereas relaxant effect was assessed by pre-contracting the aorta with phenylepherine (1 uM) followed cumulatively adding the ECBRC-T3 to the bath. Results demonstrated that ECBRC- T3 had no contractile effect on aortic smooth muscle. However, following pre-contraction with phenylepherine, ECBRC-AG-Act was able to concentration dependently relax guinea pig aorta with an effective concentration of approximately 600 uM (see figure 2) Example 8 Sub-acute toxicity test In accordance with OECD guidelines, half lethal dose is no longer regarded as an acceptable method for determining the toxicity of drugs. Rather, it is replaced by giving high dose in a single time or multiple doses within 24 hours. The experiments and results are given below: Administered SD rats (8 weeks of age, half female and half male), 5 rats per group, vine tea extract (method 2, ECBRC-T2) (2000mg/kg/24hrs) or distilled water (10ml/kg/24hrs) by intragastic administration. Administered drugs at a single dose then observed daily for 14 consecutive days for toxicity. Then, performed the euthanasia operation and performed toxicological section inspection. The result showed that compared with the control group, weight increase, food intake, skin/hair color & brightness of the rats showed no significant difference, indexes of its organs such as heart, lung, liver, spleen, genital organs, adrenal gland, pituitary gland etc. showed no significant difference, its hematological indicators such as white cell count, red cell count, platelet, hemoglobin and hematocrit, etc. showed no significant difference and its bio-chemical indicators such as total bilirubin, SGOT, SGPT, urea, creatinine, sodium ion, potassium ion, chloride ion and carbon dioxide, etc. also showed no significant differences. The result indicated that when given vine tea extract (EC3RC-T2) 2000mg/kg/24hrs as a high single oral dose SD rats had no any acute toxicity and death, so its half lethal dose was greater than 2000mg/kg (approximately 200 times that of adult human dose). Example 9 Phase I clinical test. A preliminary clinical test (phase I clinical test) was carried out in Zhengzhou University: 29 healthy volunteers, to whom insomnia had never occurred, were in good health during the testing period. And then, they were given a 3-day encephalogram test at form 11:30 pm each night to 6:30 am the next morning for 7 hours a day. Baseline test and environmental adaptability investigation were performed on the first night and placebo (200mg of wheat starch ) or 200mg of vine tea extract (method2, ECBRC-T2) were given on the second and third nights respectively. The study adopts double blind design to eliminate any influence of placebo or observation error. The average baseline value was used for matching t test, the result of which indicated that compared with placebo; the vine tea extract could significantly increase NREM sleeping time by 6% while reducing sleep waiting time by 3%. Considering wide variance in the baseline values of the recipient, although the analysis had statistical significance, it could not reflect the response of an individual recipient to drug treatment accurately. Further data analysis indicated that among all the samples , 91% of recipient had positive response to drug treatment, namely, could either reduce sleep waiting time, or increased NREM sleeping time, or both. According to self-comparison and analysis, - 71% of the recipient improved their sleep waiting time, which was decreased by 53.8p4.7% on average; 83% of the recipient improved their NREM sleeping time, which increased by 24.2p6.1% on average. This detailed analysis indicated that the vine tea extract had sedative /hypnotic effect over human body. (see Table 6) NREMS in the table meant non-rapid eye movement sleep, also known as orthodox sleep or slow wave sleep, while REMS means rapid eye movement sleep, also known as paradoxical sleep or fast wave sleep. Example 10 Preliminary clinical test: 4 people suffering from insomnia without other physiological diseases took lg of vine tea powder (example 1, manufacturing method 8) with hot water continuously for one month each night before going to bed. As a result, 4 patients were sleepy and could fall asleep within 30 minutes each day after taking the vine tea powder with extended sleeping time during the night and felt in good spirit on the next day. Statistical data indicated that the vine tea powder had the effect of helping sleep and increasing sound sleep over the human body. We Claim: 1. A composition for treating and preventing sleep disorders comprising selective flavones, extract of the plant of genus Ampelopsis in amounts of atleast 80% in combination with compatible other extracts of said Ampelopsis plant. 2. A composition for treating and preventing sleep disorders as claimed in claim 1 wherein said compatible other extracts of the genus Ampelopsis plant comprises selectively anyone or more of protein, amino acid, amylose, inorganic nutrients, phenol compounds. 3. A composition as claimed in claim 1 wherein the plant of genus Ampelopsis comprises Ampelopsis grossedentata, Ampelopsis meliaefolia, Ampelopsis brevipedunculat trautv, Ampelopsis megalophtlla Diels et Gilg, Ampelopsis bodinieri Rehd, Ampelopsis brevipedunculat Maxim ex trautv, Ampelopsis brevipedunculat Trautv. Var. Hancei Rehd, Ampelopsis delavayana Planch, Ampelopsis Japonica makino, Ampelopsis aconitifolia Brnge, Ampelopsis aconitifolia Bge. Var. glabra Diels et grig, Ampelopsis brevipedunculata trautv. Var. kulingensis rehd, Ampelopsis humulifolia bge, Ampelopsis heterophylla Sieb. And zucc, Ampelopsis chaffanjoni Rehd. 4. A composition as claimed in claim 3 wherein the extracts from the plant of genus Ampelopsis includes extracts of dry stem leaf of the said plant by solvents including water, low alcohol preferably methanol, ethanol, n-butyl alcohol, low ketone preferably acetone, or acetic acid ethyl ester or extracts by the random mix of said solvents. 5. A composition as claimed in claim 1 comprising drug carriers or food carriers. 6. A composition as claimed in claim 1 comprising a healthcare product comprising mineral substances, trace elements, vitamins and amino acids. 7. A composition as claimed in claim 1 comprising a drug for treating sleep disorder comprising various mineral substances, trace elements, vitamins and amino acids and natural drugs preferably ganodarma lucidum, glutinous rehmannia, Chinese date, Schisandra chineses (Turcz) Baill, semen, ziziphi spinosae to stabilize the extract, and lavender, semen biotae, radix polygalae, cortex albizziae, caulis polygoni multiflori to provide further sedative and relaxative effect wherein the said natural drug are present preferably in the form of powdered extract, essential oil, extracted herbal tea and the like. 8. A composition as claimed in claim 1 wherein said flavone extract for treating and preventing sleep disorders comprising the flavone as active sourced from selective plant of genus Ampelopsis having flavones atleast 80% is obtained involving method of extraction of the said synergistic combination of flavone, and anyone or more of amino acid and amylose from the plant of genus Ampelopsis comprising the extraction method selected from self-immersion extraction, circumfluence extraction, ultrasonic extraction, and supercritical extraction. The technical problem that the invention will tackle is to screen and study plants that have the function of treating sleep disorders and the parts of the plants that can treat sleep disorders. Since the mechanism or means that affects or regulates sleep involves many neurotransmitter systems, this invention screens and studies plant extracts that have synergetic effects on multiple mechanisms or means that affect or regulate sleep. In order to solve the above problem, the invention provides the following technical proposal: The application of Ampelopsis plants in manufacturing drugs and healthcare products that prevent or cure sleep disorders.

Full Text

Technical Field
The present invention relates to the usage of Ampelopsis plants and their extracts in
manufacturing drugs and healthcare products.
Background of the Invention
Insomnia is a common sleep disorder that requires adequate attention and treatment. Each
year, 35-49% of the adults suffer from insomnia. Man's sleep regulation center is located at
the hypothalamus of the cerebral, where there are many hypothalamic neurotransmitters
regulating the sleeping-awakening cycle (see: Mignot, E., Taheri, S., and Nishino, S.,
Sleeping with the hypothalamus: emerging therapeutic targets for sleep disorders.
Nat.Neurosci. 2002, 5 Suppl: 1071-1075). The mechanism or means that affects or regulates -
sleeping involves many neurotransmitter systems, for instance, γ- aminobutyric acid,
adenosine(purin), dopamine, hypocretins system (also known as orexins; phenyl
dihydroquinazolin), monoaminergic system (for instance, 5-hydroxyptamine, noradrenalin
and histamine).
(
Since drugs presently used for treating sleep disorders have different degrees of side effects,
herbal medicines and other natural medicines that may help sleep are getting more and more
attention. There are approximately 25 kinds of Ampelopsis plants around the world, including
17_in_china, which are widely distributed in such provinces and autonomous regions as
Guangxi, Guangdong, Yun'nan, Guizhou, Hu'nan, Hubei, Jiangxi and Fujian, etc. Except
common medicine [Ampelopsis japonica (Thunb.) Makino], the majority of Ampelopsis
plants are folk Chinese herbal medicines, most of which, Ampelopsis grossedentata (Hand—
Mazz)W. T. Wang, [ Ampelopsis cantoniensis(Hook.et Am.)Planch, Ampelopsis
meliaefolia, Ampelopsis brevipedunculata(Uaxim. )Trautv, Ampelopsis megalophylla Diels
et Gilg in particular, have functions such as promoting blood circulation, dissipating blood
stasis, clearing heat and removing toxic substances, etc; Ampelopsis plants can prevent and
cure icteric hepatitis, cold, wind heat, pharyngeal swelling and pain, wind-damp pain,
calenture, getting drunken, etc. and pharmacological experiments have shown that main
components of Ampelopsis plants have such functions as removing phlegm, reducing blood
lipids, resisting inflammation, diuresis, and protecting the liver, etc.
Summary of the Invention
The technical problem that the invention will tackle is to screen and study plants that have the
function of treating sleep disorders and the parts of the plants that can treat sleep disorders.
Since the mechanism or means that affects or regulates sleep involves many neurotransmitter
systems, this invention screens and studies plant extracts that have synergetic effects on
multiple mechanisms or means that affect or regulate sleep. r
In order to solve the above problem, the invention provides the following technical proposal:

The application of Ampelopsis plants in manufacturing drugs and healthcare products that
prevent or cure sleep disorders.
The application of extracts of Ampelopsis plants in manufacturing drugs and healthcare
products that prevent or cure sleep disorders.
Said Ampelopsis plants include Ampelopsis grossedentata(Hand-Mazz)W, T, Wang,
[Ampelopsis cantoniensis (Hook.et Am.)Planch], Ampelopsis meliaefolia, Ampelopsis
brevipedunculata(Uaxim.)Trautv, Ampelopsis megalophylla Diels et Gilg, Ampelopsis
bodinieri (Levl, et Vant.) Rehd, Ampelopsis brevipedunculat (Maxim.) Maxim ex Trautv,
Ampelopsis brevipedunculat (Maxim.) Trautv. var. Hancei Rehd, Ampelopsis delavayana
Planch, Ampelopsis japonica (Thunb) Makino, Ampelopsis aconitifolia Brnge, Ampelopsis
aconitifolia Bge. var. glabra Diels et Grig, Ampelopsis brevipedunculata (Maxim.)Trautv.
var. kulingensisRehd, Ampelopsis humulifolia Bge,_Ampelopsis heterophylla (Thunb.) Sieb.
& Zucc, Ampelopsis chaffanjoni (Levi, et Vant.) Rehd .
Said Ampelopsis plants and/ or extracts of Ampelopsis plants can be mixed with drug carriers
or food carriers for manufacturing drugs and/or healthcare products that can prevent or cure
sleep disorders.
Said extracts of Ampelopsis plants include extracts obtained through extraction of
Ampelopsis plants with water, low alcohols, low ketone or acetjc acid ethyl ester as solvents
or random mixed solvents of these solvents; the low alcohols among the solvents used for
extraction may be methanol ,ethanol or n-butyl alcohol and the low ketones maybe acetone;
the extraction method may be self-immersion extraction, circumfluence extraction, ultrasonic
extraction, circumfluence extraction and supercritical extraction. For instance, extract with
the mixed solvent of ethanol: water (volume ratio: 90-10: 10: 90), preferably the mixed
solvent of ethanol; water (volume ratio:70:30), extract with acetone /water (volume ratio:
50:50) by means of circumfluence or extract directly by soaking with water.
Said extracts of Ampelopsis plants mainly contain protein, amino acid, amylose, inorganic
nutrients, phenolic compounds and/or flavone, especially amino acid, amylose, phenolic
compounds and/or flavone; Said extracts of Ampelopsis plants may mainly contain phenolic
compounds and/or flavone.
To be specific, so-called 'treating sleep disorders' mentioned in this invention means that the
drugs or healthcare products can help sleep and be used in daily life to alleviate or improve
various sleep disorders due to different causes.
The dose of the plant of genus Ampelopsis of this invention, for instance, Ampelopsis
grossedentata (Hand—Mazz)W . T. Wang, is 0.05-5000mg/kg/day by weight and the
preferred dose is 0.05-2500mg/kg/day when preventing and curing sleep disorders. The dose
of the extract of Ampelopsis plant of this invention, for instance, Ampelopsis grossedentata
(Hand—Mazz)W . T. Wang, is 0.01-100mg/kg/day by weight and the preferred dose is
0.01-50 mg/kg/day when used for preventing and curing sleep disorders. Due to different
types and extents of sleep disorders of different individuals and individual differences (age,
gender, etc.), the dose of plants and their extracts of this invention is not limited to the above

scope.
The combination of this invention that prevents or cures sleep disorders is characterized as
containing Ampelopsis plants and/or extracts or Ampelopsis plants. This invention includes
healthcare products containing said combination that can prevent or cure sleep disorders,
which are suitable for preventing and curing sleep disorders. This invention includes drugs
containing said combination that can prevent or cure sleep disorders, which are suitable for
preventing and curing sleep disorders.
Said Ampelopsis plants include Ampelopsis grossedentata(Hand—Mazz)W . T. Wang,
[Ampelopsis cantoniensis(Hook.et Am.)Planch] , Ampelopsis meliaefolia, Ampelopsis
brevipedunculata(Uaxim.)Trautv, Ampelopsis megalophylla Diels et Gilg , Ampelopsis
bodinieri (Levi, et Vant.) Rehd, Ampelopsis brevipedunculat (Maxim.) Maxim ex Trautv,
Ampelopsis brevipedunculat (Maxim.) Trautv. var. Hancei Rehd, Ampelopsis delavayana
Planch, Ampelopsis japonica (Thunb.) Makino, Ampelopsis aconitifolia Brnge, Ampelopsis
aconitifolia Bge. var. glabra Diels et Grig, Ampelopsis brevipedunculata (Maxim.)Trautv.
var. kulingensisRehd, Ampelopsis humulifolia Bge,_Ampelopsis heterophylla (Thunb.) Sieb^y
& Zucc, Ampelopsis chaffanjoni (Levi, et Vant.) Rehd.
Extracts of Ampelopsis plants involved in this invention include extracts obtained through I
extraction of Ampelopsis plants with water, low alcohols, low ketones or acetic acid ethyl (
ester as solvents or random mixed solvents of these solvents; said low alcohols among the
solvents used for extraction is methanol % ethanol or n-butyl alcohol and the low ketone is
acetone; the extraction method is selected from self-immersion extraction, circumfluence
extraction, ultrasonic extraction, circumfluence extraction and supercritical extraction.
Extracts of Ampelopsis plants of this invention mainly contain protein, amino acid, amylose,
inorganic nutrients, phenolic compounds and/or flavone, especially amino acid, amylose,
phenolic compounds and/or flavone, or especially phenolic compounds and/or flavone.
When manufacturing drugs or healthcare products that prevent or cure sleep disorders, the
plant of genus Ampelopsiss and their extracts of this invention may be added with various
mineral substances, preferably mineral substances that play the role of supplementing
necessary elements and trace elements that are apt to be insufficient in the body of organisms.
In addition, when manufacturing drugs or healthcare products that preventing or curing sleep
disorders, the plant of genus Ampelopsiss and their extracts of this invention may be added
with other natural drugs, amino acids and/or vitamins. Said natural drugs are free from
special restrictions and shall preferably be Ganodorma lucidum, glutinous rehmannia,
Chinese date, Schisandra chinensis (Turcz.) Baill, semen, ziziphi spinosae that are useful in
stabilizing the spirit. In addition, lavender, Semen Biotae, radix polygalae, cortex albizziae,
caulis polygoni multifiori, etc. that have sedative and relaxation effects may also be selected.
There are no special requirements for the state of these plant drugs, which may be extract
powder, essential oil extracted and herbal tea, etc. Also, there are no special requirements for
the state of amino acid, which may be glutamine, troptophan, lysine, leucine, glutamic acid,
isoleucine , and methionine,etc.And, there are no special requirements for vitamine, which,
for instance, may be vitamine B6, vitamine Bl, vitamin B2, folacin, vitamine C and Vitamin

E, etc.
When manufacturing drugs or healthcare products that prevent or cure sleep disorders, the .
plant of genus Ampelopsiss and their extracts of this invention may be added with other
elements, for instance, aloe, royal jelly, spirulina, gingko leaf, bifid bacterium,etc.
The plant of genus Ampelopsiss and their extracts of this invention may be manufactured into
different forms of drugs or healthcare products; said healthcare products of the invention
include healthcare foods manufactured by adding the plant of genus Ampelopsiss and their
extracts of this invention into existing foods.
There are no special requirements for drugs or healthcare products of this invention, which
may contain only Ampelopsis plants or their extracts, which may be in any of the following
forms: solution, mixed suspended liquid, power, solid moulding, etc., may be tablets,
capsules, powders, granules in dose form and be used in combined with other drugs.
Description of the drawings.
Figure 1. Influence of Ampelopsis extracts on pentobarbital prolonged sleeping time in mice.
Figure 2. Influence of ECBRC-T3 concentration on relaxation effect of Guinea pig.
Examples
Example 1
Manufacturing method 1: teek-300g of dry stem leaf ( Ampelopsis. Grosedentata [Hand.-
Mazz.] W. T. Wang) , the stem leaf of which is known as tea vine (source: verified by Hou
Yulin, the Chinese University of Hong Kong, was soaked them in water and extracted 3 times
using the circumfluence extraction method, 45 minutes each time. The extract was filtered
whilst hot and subsequently evaporated to a small volume and dried to obtain 92g of extracts
(code: ECBRC- T1), representing a recovery rate of 30.7%. Through determination, the
extract contained 81.2% of flavone, 1.1% of polyphenol components as well as small
quantities of amino acid and amylose.
Extraction method 2: 300g of dry stem leaf (A. grosedentata [Hand.-Mazz.] W. T. Wang, -
was soaked in ethanol/water (V/V, 70:30) and extracted 3 times using the circumfluence
method, 30 minutes each time. The extract was subsequently rotated and filtered whilst still
hot (lower than 40°C) to remove ethanol, then freeze-dried to obtain 81g of powder-like
extract (code: ECBRC-T2, representing a recovery rate of 27%. Through determination, the
extract contained 90.3% of flavone, 1.3% of polyphenol components as well as small
quantities of amino acid and amylose.
Manufacturing method 3: 100g of extract of dry Ampelopsis plant (A. grosedentata [Hand.-
Mazz.] W. T. Wang) was dissolved in 200ml of acetone, heated & extracted using the
circumfluence extraction method (45 °C). The extract was subsequently rotated and filtered
whilst still hot to approximately 20ml, then diluted with 20-50 times of distilled water, keep it
static at 4°C to separate and allow sufficient crystal formation after approximately 12-24
hours. Approximately 39g of crystals were recovered after drying (code: ECBRC-T3),
representing a recovery rate of 39%. Through determination, the extract contained 98% of .

flavone as well as polyphenol components, amino acid and amylose.
Manufacturing method 4: teek 300g of dry stem leaf (A. cantoniensis (Hook, et Arn.) Planch;
verified by Hou Yulin from the Chinese University of Hongkong), was extracted with
acetone /water (V/V,50:50) using the circumfluenee method. The extract was filtered %
whilst hot and subsequently evaporated to a small volume and dried to obtain 20g of extracts
(code: ECBRC- T4). Through determination, the extract contained 53.94% of flavone as well
as polyphenol, amino acids and amyloses.
Manufacturing method 5: teek 300g of dry stem leaf (A. meliaefolia; verified by Hou Yulin
from the Chinese University of Hong Kong), was soaked in methanoT/ water (V/V,90:i0),
and extracted 3 times using the ultrasonic method, 60 minutes each time. The extract was
filtered, rotated and then evaporated to remove the methanol, then dried to obtain 59g of
extract (ECBRC-T5). Through determination, the extract contained 14.8% of flavone as well
as polyphenol, amino acids and amylose.
Manufacturing method 6:: teek 300g of dry stem leaf (A. brevipedunculat (Maxim); verified
by Hou Yulin from the Chinese University of Hongkong), was soaked in acetic acid ethyl
ester and extracted using the countercurrent method for 2 hours. The extract was filtered,
rotated and then evaporated to remove the solvents, giving the concentrated water a solution -
petroleum ether discoloration to get 36g of extracts (ECBRC- T6). Through determination,
the extract contained 46.1% of flavone, 9.6% of polyphenol contents as well as a small
quantities of amino acids and amyloses.
Manufacturing method 7: teek 300g of dry stem leaf (A. megalophylla Diels et. Gilg; verified
by Hou Yulin from the Chinese University of Hongkong), was soaked them in n-butyl
alcohol and extracted 4 times using the circumfluenee extraction method. The extract was
filtered whilst hot to remove the solvents, and subsequently treated with chloroform to get 44
g of extract (ECBRC-T7. Through determination, the extract contained 20.1% of flavone,
22.3% of polyphenol as well as amino acid and amylose.
Manufacturing method 8: preparation method of vine tea powder.
teek 300g of dry stem leaf (A. grosedentata [Hand.-Mazz.] W. T. Wang), was ground into
100 mesh of fine powder to be used.
Example 2
C57/B6 mice were randomised into groups and orally administered; ECBRC- T2_ (30mg/kg),
melatonin (30mg/kg), Radix Valerianae (140mg/kg) or vehicle (10ml/kg H2O), 30 min prior
to low dose injection of sodium pentobarbital (30 mg/kg, i/p.). The animals were then placed
on a heating pad (37°C) and their sleep latency to onset of sleep and the duration of sleep
determined according to loss of righting reflex. Statistical analysis using one-way ANOVAR
showed that each group to be significantly differenct (p4 in sleep time when
compared with the vehicle control group and the increase in sleep time, in the high-to-low
order, was melatonin (Sigma, batch number: 12K1471) , ECBRC- T2, Radix Valerianae
(Roha Arzneimittel, batch number: 007420920. The result indicated that ECBRC- T2 had
similar effect that helps sleep as melatonin.(see figure 1).

Example 3
C57/B6 mice were randomised into groups and orally administered; ECBRC- T2 (30mg/kg),
melatonin (30mg/kg), Radix Valerianae (140mg/kg) or vehicle (10ml/kg H2O), 30 min prior
to low dose injection of sodium pentobarbital (16 mg/kg, i/p.). The animals were then placed
on a heating pad (37°C) and their sleep latency to onset of sleep and the duration of sleep
determined according to ioss of righting reflex. The experiment result showed that ECBRC- .
T2 had sedative /hypnotic effect.(Table 1).

Example 4
C57/B6 mice were randomised into groups and orally administered ECBRC-T1 s
(10,50,100,500mg/kg), 30 min prior to low dose injection of sodium pentobarbital (16 mg/kg,
i/p.). The animals were then placed on a heating pad (37°C) and their sleep latency to onset of
sleep and the duration of sleep determined according to loss of righting reflex. ECBRC-T1
(10,50,100,500mg/kg) 30 minutes later. Placed the animals on 37°C hot plates and
determined the latency of sleep start and the duration of sleep. The experiment result showed
that ECBRC-T1 had the function of helping sleep and certain dosage-effect
relationship( Table 2).

Example 5
C57/B6 mice were randomised into groups and orally administered with different dosages of
ECBRC- T3 and melatonin (sigma, batch number: 12K1471), 30 min prior to low dose
injection of sodium pentobarbital (16 mg/kg, i/p.). The animals were then placed on a heating

pad (37°C) and their sleep latency to onset of sleep and the duration of sleep determined
according to loss of righting reflex. The result showed that ECBRC-T3 could extend the sleep
time of mice in a dosage-dependent manner and increased with the melatonin group
synchronously.(Table 3).

Example 6
Remote sensing determination of mice activities.
Telemetric activity and temperature monitors were surgically implanted sub-coetaneously
into male C57/B6 mice under ketamie (Alfasan, batch number: 112319) and xyalsine
(Alfasan, batch number: 073210) (75 / 10 mg/kg, i.p.) anaesthesia to remotely record activity
Correct placement was determined using X-ray radiography. Following a 2 week recovery
and acclimatization period, the mice were orally treated with either test compounds, positive
controls or vehicle; ECBRC- T3, zopiclone (Tocris,batch number: 1094 and An Shen Bu
Nao Ye (Sedative and Brain-invigorating Fluid) (Jilin Aodong Yanbian Pharmaceutical
Co.,Ltd, batch number: 030659) respectively. Six hours following drug administration, the
sleep time of mice of the ECBRC- T3 (20mg/kg, p.o) group was significantly extended
(table 4) as were mice treated with zopiclone (20mg/kg, p.o group (table 5), when compared
to vehicle control. The result indicated that ECBRC- T3 (20mg/kg, p.o.) could generate
similar degree of sedative-hypnotic effect as zopiclone (20mg/kg, p.o.) .

Example 7
Isolated organ test
Guinea pig aorta was harvested from adult male guinea pigs following euthanisation via
cervical dislocation. Aortic rings were suspended in carbonated Krebs solution (37°C)
containing 3 uM indomethacin (to prevent endogenous prostacyclin production) at a resting
tension of 1 g. Care was taken not to remove or damage the endothelial lining of the ring so
as not disrupt any nitric oxide dependant relaxation. The tissue was then allowed to
equilibrate for 1-2 hours, followed by pre-contraction with 40mM KC1. After washout.
ECBRC-T3 was assessed for contractility by adding directly to the aorta at resting tension,
whereas relaxant effect was assessed by pre-contracting the aorta with phenylepherine (1 uM)
followed cumulatively adding the ECBRC-T3 to the bath. Results demonstrated that ECBRC-
T3 had no contractile effect on aortic smooth muscle. However, following pre-contraction
with phenylepherine, ECBRC-AG-Act was able to concentration dependently relax guinea
pig aorta with an effective concentration of approximately 600 uM (see figure 2)
Example 8
Sub-acute toxicity test
In accordance with OECD guidelines, half lethal dose is no longer regarded as an acceptable
method for determining the toxicity of drugs. Rather, it is replaced by giving high dose in a
single time or multiple doses within 24 hours. The experiments and results are given below:
Administered SD rats (8 weeks of age, half female and half male), 5 rats per group, vine tea
extract (method 2, ECBRC-T2) (2000mg/kg/24hrs) or distilled water (10ml/kg/24hrs) by
intragastic administration. Administered drugs at a single dose then observed daily for 14
consecutive days for toxicity. Then, performed the euthanasia operation and performed
toxicological section inspection. The result showed that compared with the control group,
weight increase, food intake, skin/hair color & brightness of the rats showed no significant
difference, indexes of its organs such as heart, lung, liver, spleen, genital organs, adrenal
gland, pituitary gland etc. showed no significant difference, its hematological indicators such
as white cell count, red cell count, platelet, hemoglobin and hematocrit, etc. showed no
significant difference and its bio-chemical indicators such as total bilirubin, SGOT, SGPT,
urea, creatinine, sodium ion, potassium ion, chloride ion and carbon dioxide, etc. also showed
no significant differences.

The result indicated that when given vine tea extract (EC3RC-T2) 2000mg/kg/24hrs as a
high single oral dose SD rats had no any acute toxicity and death, so its half lethal dose was
greater than 2000mg/kg (approximately 200 times that of adult human dose).
Example 9
Phase I clinical test.
A preliminary clinical test (phase I clinical test) was carried out in Zhengzhou University: 29
healthy volunteers, to whom insomnia had never occurred, were in good health during the
testing period. And then, they were given a 3-day encephalogram test at form 11:30 pm each
night to 6:30 am the next morning for 7 hours a day. Baseline test and environmental
adaptability investigation were performed on the first night and placebo (200mg of wheat
starch ) or 200mg of vine tea extract (method2, ECBRC-T2) were given on the second
and third nights respectively. The study adopts double blind design to eliminate any
influence of placebo or observation error. The average baseline value was used for matching
t test, the result of which indicated that compared with placebo; the vine tea extract could
significantly increase NREM sleeping time by 6% while reducing sleep waiting time by 3%.
Considering wide variance in the baseline values of the recipient, although the analysis had
statistical significance, it could not reflect the response of an individual recipient to drug
treatment accurately. Further data analysis indicated that among all the samples , 91% of
recipient had positive response to drug treatment, namely, could either reduce sleep waiting
time, or increased NREM sleeping time, or both. According to self-comparison and analysis, -
71% of the recipient improved their sleep waiting time, which was decreased by 53.8p4.7%
on average; 83% of the recipient improved their NREM sleeping time, which increased by
24.2p6.1% on average. This detailed analysis indicated that the vine tea extract had sedative
/hypnotic effect over human body. (see Table 6)
NREMS in the table meant non-rapid eye movement sleep, also known as orthodox sleep or
slow wave sleep, while REMS means rapid eye movement sleep, also known as paradoxical
sleep or fast wave sleep.

Example 10
Preliminary clinical test:
4 people suffering from insomnia without other physiological diseases took lg of vine tea
powder (example 1, manufacturing method 8) with hot water continuously for one month

each night before going to bed. As a result, 4 patients were sleepy and could fall asleep
within 30 minutes each day after taking the vine tea powder with extended sleeping
time during the night and felt in good spirit on the next day. Statistical data indicated
that the vine tea powder had the effect of helping sleep and increasing sound sleep over
the human body.

We Claim:
1. A composition for treating and preventing sleep disorders comprising selective
flavones, extract of the plant of genus Ampelopsis in amounts of atleast 80% in
combination with compatible other extracts of said Ampelopsis plant.
2. A composition for treating and preventing sleep disorders as claimed in claim 1
wherein said compatible other extracts of the genus Ampelopsis plant comprises
selectively anyone or more of protein, amino acid, amylose, inorganic nutrients,
phenol compounds.
3. A composition as claimed in claim 1 wherein the plant of genus Ampelopsis
comprises Ampelopsis grossedentata, Ampelopsis meliaefolia, Ampelopsis
brevipedunculat trautv, Ampelopsis megalophtlla Diels et Gilg, Ampelopsis bodinieri
Rehd, Ampelopsis brevipedunculat Maxim ex trautv, Ampelopsis brevipedunculat
Trautv. Var. Hancei Rehd, Ampelopsis delavayana Planch, Ampelopsis Japonica
makino, Ampelopsis aconitifolia Brnge, Ampelopsis aconitifolia Bge. Var. glabra Diels
et grig, Ampelopsis brevipedunculata trautv. Var. kulingensis rehd, Ampelopsis
humulifolia bge, Ampelopsis heterophylla Sieb. And zucc, Ampelopsis chaffanjoni
Rehd.
4. A composition as claimed in claim 3 wherein the extracts from the plant of genus
Ampelopsis includes extracts of dry stem leaf of the said plant by solvents including
water, low alcohol preferably methanol, ethanol, n-butyl alcohol, low ketone
preferably acetone, or acetic acid ethyl ester or extracts by the random mix of said
solvents.
5. A composition as claimed in claim 1 comprising drug carriers or food carriers.
6. A composition as claimed in claim 1 comprising a healthcare product comprising
mineral substances, trace elements, vitamins and amino acids.
7. A composition as claimed in claim 1 comprising a drug for treating sleep disorder
comprising various mineral substances, trace elements, vitamins and amino acids
and natural drugs preferably ganodarma lucidum, glutinous rehmannia, Chinese

date, Schisandra chineses (Turcz) Baill, semen, ziziphi spinosae to stabilize the
extract, and lavender, semen biotae, radix polygalae, cortex albizziae, caulis
polygoni multiflori to provide further sedative and relaxative effect wherein the said
natural drug are present preferably in the form of powdered extract, essential oil,
extracted herbal tea and the like.
8. A composition as claimed in claim 1 wherein said flavone extract for treating and
preventing sleep disorders comprising the flavone as active sourced from selective
plant of genus Ampelopsis having flavones atleast 80% is obtained involving method
of extraction of the said synergistic combination of flavone, and anyone or more of
amino acid and amylose from the plant of genus Ampelopsis comprising the
extraction method selected from self-immersion extraction, circumfluence extraction,
ultrasonic extraction, and supercritical extraction.

The technical problem that the invention will tackle is to screen and study plants that have
the function of treating sleep disorders and the parts of the plants that can treat sleep
disorders. Since the mechanism or means that affects or regulates sleep involves many
neurotransmitter systems, this invention screens and studies plant extracts that have
synergetic effects on multiple mechanisms or means that affect or regulate sleep.
In order to solve the above problem, the invention provides the following technical
proposal:
The application of Ampelopsis plants in manufacturing drugs and healthcare products that
prevent or cure sleep disorders.

A COMPOSITION FOR TREATING AND PREVENTING SLEEP DISORDER

Documents:

Inventors:

PCT Conventions: