Title of Invention

DEVELOPMENT OF NOVEL HEREBAL FORMULATION USED AS AN ANTI-DIABETIC ON TRADITIONAL INDIGENOUS KNOWLEDGE

Abstract The invention provides a novel anti-diabetic herbal formulation comprises of Glycine max active fraction containing 7S globulin protein extract, Curcuma longa and Zingiber officinale Linn. Rhizome extract used in treatment of diabetes and diabetic related diseases.
Full Text A novel Anti-Diabetic herbal formulation
FIELD OF THE INVENTION
The invention provides a novel herbal preparation comprises of Glycine max active fraction containing 7S globulin protein extract, Curcuma longa and Zingiber officinale Linn. Rhizome extract used in treatment of diabetes. BACKGROUND AND PRIOR ART
Diabetic mellitus is a chronic condition that is diagnosed by a blood test and requires life long management (American Diabetic association, 2002). The more patients understand about the disease the better they are enabled to make good decisions on its management. Dietary therapy and exercise are critical both in preventing and managing diabetic mellitus and the results of the diabetic prevention program research group indicate that changes in life style reduced the incidence of diabetic by 58% (Knowler et al., 2002). In type 1 diabetic mellitus, where there is an absolute deficiency of insulin replacement forms a major component of treatment. In type 2 diabetic mellitus, insulin release from the pancreas is altered and may also be absolutely deficient in amount, and therefore its replacement also plays a part in management, especially when diabetic mellitus has been present for a long time. As the number of people with diabetes multiply world wide, the disease takes an ever-increasing proportion of national and international health care budgets. It is projected to become one of the world's main disablers within the next 25 years. It is very popularly known in medical history as "silent killer". Regions with greatest potential are Asia and Africa, where diabetes mellitus rates could rise to two to three-folds than the present rates. Apart from currently available therapeutic options, many herbal medicines have been recommended for the treatment of diabetes and diabetic related diseases (Sabu and Kuttan, 2002; Zhang and Tan 2000; Chitra et.al., 1998; Padma et.al., 2000; Osadebe et.al., 2004; Obatomei et.al., 1994; Oojewole and Adewunni 2004). Plant medicines are used throughout the world for a range of diabetic presentations.
The development of scientifically validated models of alloxan induced- diabetic is vital to the analysis of the functional consequences of pancreatic damage and to testing the recovery efficacy of potentially therapeutic drugs. The role of medicinal plants in increasing the secretion of insulin and acting as an anti-diabetic formulation in the form of tablet is still much underestimated. The retrieval hypothesis postulates
the alloxan agents disrupt the pancreas function as the effect of alloxan agents
diminish over time by the treatment of our present herbal formulation investigation
resulted in the reappearance of normal functioning of pancreas. Drugs like
glibenclamide, penformin-containing substances which has a stimulant activity on
diabetic. Accordingly, studies shown that the herbal formulation having the property
of improving the functioning of pancreas by alloxan induced diabetic and used in
treatment of diabetic as a tablet and acting as a strong anti-diabetic formulation.
OBJECT OF THE INVENTION
The main object of the present invention is to provide a novel herbal combination in
dosage form used as a anti-diabetic tablet, injection and formulation.
Another objective of the present invention is to prepare herbal dosage form that
improves in the treatment of diabetic mellitus.
Yet another object of the present invention is to prepare herbal dosage from in the
form of tablet for easy consumption.
SUMMARY OF THE INVENTION
Accordingly the present invention provides an herbal formulation useful in the
treatment of herbal dosage form from the soya bean milk used as a anti-diabetic. The
herbal formulation comprising of Glycine max active fraction containing 7 S globulin
fraction extract, Zingiber officinalis (rhizome) and curcumin (a phenolic antioxidant).
Glycine max (Soya bean) protein varies from light cream to white in colour. It is used
as nourishing food. It was shown that it produce a significant improvement in general
ability and behavioural pattern.
Glycine max Family:
Leguminosae
Botanical description: An annual with erect or climbing stem reach a height of one
half to six feet, densely clothed with leaves trifoliate, ovate-lanceolate, inconspicuous,
borne on auxiliary racemes, white or purple to red purple, normally self pollinated;
pods 3cm long in clusters of 3-5, densely hairy containing 3-4 seeds elliptical with
hilum, compressed, yellow, choclate or black. Soyabean is a native of south-eastern
Asia is considered, on the basis of genetical have originated from slender, prostste
plan. Soyabean is an important legume crop in Far East.
Medicinal uses: Soyabean ranks high among the leguminous crops of the world. It is
grown mainly as a food crop of the world. It is grown mainly as a food crop in China,
Japan and other country of East Asia. The seeds are consumed green, dry or sprouted,
whole or split. The green seed are used as vegetable; roasted and salted seeds are used in cakes and candies. The seeds are ground in to flour and used for bakery products. The fatty oil extracted from the seed is used for the industrial purposes. The soya been used as a whole been, or processed as a soya milk, tofu, tempesh, soya sauce. The increasing popularly of soya food in mainly used in prevention of chronic diseases continues to be a top priority for scientist around the world. Even the FDA has conformed that the food containing the soya protein may reduce the risk of coronary heart diseases. There has been increasing interest of soya been as an antioxidant effect (Wealth of India, 1992).
Phytochemistry: Soya been seeds contain protein 29.6-50.3, fat 13.5-24.2, fiber 2.84-2.67, carbohydrate 14.07-23.88. The decorticated bean contains about 12 % polysaccharides. It contains higher % of proteins than many other foodstuffs. Chief protein is a globulin, glycinine that accounts for 80-90% of the total protein of the seed. Besides the true proteins, it contains the following nitrogenous substances like adenine; arginine, glycine etc and total non-protein nitrogen varies from 2.8-6.8% of the total nitrogen. The average mineral composition of mature soya been is as Fe, K, Zn, I etc. it is a good source of beta amylase. It contains variety of pigments, isoflavones, glycosides etc.
Pharmacology: In human metabolism experiments soya been proteins comparable to other pulse protein, biological values digestibility coefficient. Soya been is valued in special diet and as an aid in reliving acidosis. The increasing popularly of soya food in mainly used in prevention of chronic diseases continues to be a top priority for scientist around the world. Even the FDA has conformed that the food containing the soya protein may reduce the risk of coronary heart diseases. Their has been increasing interest of soya been as an antioxidant effect and the particular the isoflavones. (Wealth of India, 1992)
CURCUMA LONGA Family:
Zingiberaceae
Botanical description: The genus Curcuma comprising about fifty species, distributed in tropical and subtropical regions of Asia, belongs to the tribe Hedychieae and consists of a rather homogenous group of rhizomatous perennials. Govindarajan (1980 Food Science and Nutrition, 14: 119-301 and 1982 Food Science and Nutrition, 17:1-258) published critical reviews on turmeric C. longa. The taxonomic status of Curcuma heyneana was discussed by Finnan et al (1988 Phytochem. 27: 3887-3891)
based on essential oil analysis. Tomlinson's (1969) work based on the anatomical evidence, which has much relevance in the classification of the order Zingiberales. Medicinal uses: Ethnobotanical details of some of the species of Curcuma has been reviewed and it was found that Curcuma is useful in the treatment of liver disorders and has a promising kind of broad spectrum hepatoprotective agent which is used in Indonesia (Lin et al., American J. Chin. Med., 1995 23:243-254). Curcuma longa was used predominantly for endoparasites, internal and external injuries and pregnancy related conditions in ethnic community of Trinidad and Tobago. Curcuma longa is used as dietary intake in Nepal (Signer and Scholz, JEthnopharmacol 1999, 67(1): 1-6).
Phytochemistry: Essential oils are complex mixtures of odorous and steam-volatile compounds that are deposited in the subcuticular space of glandular hair, cell organells, idioblasts, excretory cavities and canals or exceptionally in heartwoods. In other words, they are very complex, aromatic, volatile mixture containing many different compounds. The constituents of essential oils belong to numerous classes of chemical substances, such as hydrocarbons, alcohols, aldehydes, ketones, acids, esters, oxides and ether (Thappa et al, J. Essent. Oil Res., 1982, 11: 97-103). Essential oils largely comprises of terpenoid compounds, which constitute two or more isoprene units. Based on this, terpenoids are mainly classified into four groups viz. monoterpenes (with 2 isoprene units i.e. 10 carbon atoms) sesquiterpenes (with 15 carbon atoms), diterpenes (with 4 isoprine units i.e. 20 carbon atoms) and polyterpenes (with 5 or more isoprene units). These terpenoid compounds provide aroma and pungency to plants. The essential oil forms the basic raw materials for perfume and flavour making industries. They are also used in the cosmetics and pharmaceutical industries. Many natural essential oils are used in aromatherapy to cure and prevent illness due to their therapeutic properties and also because of their fragrance which can influence human thoughts and emotions. Many of the essential oils are reported to have antimicrobial, insect repellent and insecticidal properties. Pharmacological use: The genus Curcuma exhibits diverse pharmacological activities against cancer and tumorgensis. Anto et al, Mutation Res., 1996, 370:127-131, has reported the anticancer and antitumour properties of Curcuma longa. It was demonstrated that the inhibitory effect of curcumin on DNA and RNA synthesis in cultured HeLa cells. Dietary curcumin may inhibit azoxymethanol (40 M) induced colonic neoplasia in mice (Huang et al., Cancer Lett 1992, 64(2): 117-21). The
antimicrobial properties are well known and the result reported by many researchers pointed out the antibiotic activities of Curcuma. Banerjee and Nigam (J. Res. Ind. Med. Yoga Homoeo., 1978, 13: 63-70) reported the antibacterial and antifungal activity of various species of Curcuma. Molluscicidal property of C. longa was reported. The insecticidal property of different species of Curcuma. Curcumin showed anti-inflammatory effect in acute, subacute and chronic models of inflammation in mice and rat models. The oral ED50 in mice, against carrageenin-induced acute oedema was 100.2 mg/kg compared to 78 mg/kg of cortisone. Clinically curcumin did not produce any side effect up to 1600mg/kg/day for 4 weeks in phase-I trials in male volunteers. Phase-II clinical trials have been conducted in patients with rheumatoid arthritis and osteoarthritis. Curcumin inhibited rat liver microsomal delta 5 and delta 6 denaturizes (Shimizu et al., Lipids 1992, 27(7):509-12). Curcuma contains an active principle(s) other than curcuminoid, which can modify the metabolism of lipid and lipoproteins. Several reports suggest that curcumin as well as turmeric increase bile flow. Essential oils of turmeric have also been found to increase the bile flow. However, some investigators have found it to be ulcerogenic (Prasad et al. J. Physiol. Pharmocol, 1976, 20, 92). The gastric secretion was found to be reduced after 3 h in conscious rabbits by aqueous and methanolic extracts of turmeric (Sakai et al. Chem. Pharm. Bull. 1989, 37, 215). Curcumin and turmeric have been shown to protect liver against a variety of toxicants in vitro as well as in vivo. They include carbon tetrachloride, aflatoxin B-l, paracetamol iron, and cyclophosphamide in mouse, rat and duckling. Evidence for the hypocholesterolemic and hypolipidemic activities of curcumin has been provided when it was fed with diet to rats for 7 weeks at the concentration of 0.15% (Rao et al. 1970 J. Nutri. 100, 1307). Ethanolic extract of C. longa has been shown to have hypoglycemic activity in normal as well as alloxan -induced diabetics in rats. They have also isolated a lipopolysaccharide from the root of Curcumin, which is similar to bacterial lipopolysaccharides and is immunostimulant (Inagawa et al. Chem Pharm Bull 1992, 40, 1994). The wound healing property of turmeric was investigated long back and its local application was found to be effective (Gujral et al., J. Ind. Med. Association 22, 273 1958). A sum of approximately 26 compounds has been isolated from different Curcuma sp. having high antioxidant activity. Curcumin did not produce any toxicity either on single administration or on repeated oral administration over a period of 6 months in rat and monkey at doses up to 800 and 1800-mg/kg day, respectively. Curcumin administered
orally to patients suffering from chronic antieri or ureitis (CAU) at a dose of 375 mg three times a day for 12 weeks and all the patients who received curcumin alone improved (Lai et al, Phytother Res 13(4): 318-22, 1999).
Zingiber offlcinale Linn. Family: Zingiberaceae
Botanical description: An herbaceous rhizomatous perennial, reaching up to 90 cm in height under cultivation. Rhizomes are aromatic, thick lobed, pale yellowish, bearing simple alternate distiches narrow oblong lanceolate leaves. The herb develops several lateral shoots in clumps, which begin to dry when the plant matures. Leaves are long and 2-3 cm broad with sheathing bases, the blade gradually tapering to a point. Inflorescence solitary, lateral, radical, pendiculate oblong-cylindrical spikes. Flowers are rare, rather small, calyx superior, gamosepalous, three toothed; open splitting on one side, and corolla of three-sub equal oblong to lanceolate connate greenish segments. (The Wealth of India, NISCOM, D-23, C.S.I.R., New Delhi 1996).
Medicinal use: Ginger is carminative, pungent, stimulant, used widely for indigestion. It is chiefly used to cure diseases due to morbidity of kapha and vata. Ginger with limejuice and rock salt increases appetite and stimulates the secretion of gastric juices. It is said to be used for chronic bronchitis, cold, chest congestion, and cough, difficulty in breathing, dropsy, sore throat, throat ache, stomachache, vomiting and rheumatism. Zinger forms an important constituent of many pharmacopoeal ayurvedic formulations. (Misra B, Bhavaprakasha Nighantu, 5th ed., 1969, p. 14.; Sharma P, Dravyaguna vigyan, part 2, Chauukhamba Publications 1993, p. 331; Indian medicinal plant, a compendium of 500 sps., Part 5, orient Longman Publication, 1997, p. 431; Nadkarni, Indian Materia Medica, vol. 1, 1993, p. 1308; Yogaratnakra, Chauukhamba Publications 1993, p. 320-330; Bhavaprakasha with Vaidyotina commentary by Misra BS; Chikitsa Prakarana Madhyana Khadana-Chauukhamba Publications 1980, p. 683-701).
Phytochemistry: Ginger has been reported to contain usually 1-3 % of volatile oil, pungent principles, viz. gingerols and shogaols and about 6-8 lipids and others. Ginger oil contains zingiberene and bisaboline as major constituents along with other sesqui and mono terpines. Ginger oleoresin contains mainly the pungent principles gingerols and shogaols as well as zingeberine. Shogaols have recently been found twice as pungent as gingerols. (Kiuchi F, et. al., Chem. Pharm. Bull, 1982, 30, 754;waigner H, et al., Plant drug analysis, springer, 1996, 300; Akhila A and Tewari CROMAP,
1984,6(3), 143-146).
Pharmacology: It is used for common cold, due to pathogenic wind cold, characterized by
severe intolerance to cold, slight fever, headache, general ache, congestion and running nose.
Antihistaminic activity has been studied in ginger. Zingiber officinale was indicated in
allergic conditions in traditional text. However they were following crude methods. Toyoda J,
Chem. Abst, 1969, 71, 33425; Yogaratnakra, Chauukhamba Publications 1993, p. 320-330;
Bhavaprakasha with Vaidyotina commentary by Misra B. S; Chikitsa Prakarana Madhyana
Khanda- Chauukhamba Publications 1980, p. 683-701).
BRIEF DESCRIPTION OF THE TABLES
Table I: Effect of formulation (Fl) Glycine max {soya bean) active fraction containing
7S globulin fraction on alloxan induced diabetic rats.
Table II: Effect of formulation (F2) containing Glycine max (soya bean) active fraction
containing 7S globulin fraction with Curcuma longa extract on alloxan
induced diabetic rats.
Table III: Effect of formulation (F3) containing Glycine max (soya bean) active fraction
containing 7S globulin fraction, Curcuma longa with Zingiber officinalis on
alloxan induced diabetic rats.
Table IV: Effect of formulation (F4) with out Glycine max {soya bean) active fraction
containing 7S globulin fraction on alloxan induced diabetic rats.
Table V: Effect of formulation (F3) containing Glycine max (soya bean) active
fraction containing 7S globulin fraction, Curcuma longa, Zingiber officinale
on relative mean ± SEM organ weights of rats (n=6).
Table VI: Effect of formulation (F3) containing Glycine max (soya bean) active fraction
containing 7S globulin fraction, Curcuma longa and Zingiber officinale on
Glucose tolerance test in rats. Detailed description of the present invention
Accordingly, the present invention provides a novel anti-diabetic herbal formulation comprising an extract of Glycine max in the range of 2-5 wt% along with extract(s) of Curcuma longa in the range of 1-3 wt% and/or Zingiber officinale in the range of 1-3.5 wt% along with pharmaceutically acceptable carrier(s) which are selected from proteins in the range of 80.6 - 90.7 wt %, amino acids in the range of 1.0 - 19.0 wt %, fibre in the range of 2.845 - 6.27 wt %, phosphorus in the range of 0.55 - 0.75 wt %, fat in the range of 13.5 -24.2 wt % and carbohydrates in the range of 14.3 -23.5 wt %.
In another embodiment of the present invention the novelty of the invention is a said herbal formulation having the property of anti-diabetic and used in treatment of diabetic mellitus as a tablet and as a formulation.
Further, in another embodiment of the invention, an herbal anti-diabetic synergistic formulation(s) containing extracts of plant in pharmacologically effective form. In another embodiment of the invention, herbal formulation(s) the plants selected from the genus Glycine max (2-5 wt %).
In another embodiment of the invention, the 7S globulin fraction of Glycine max seed. In another embodiment of the invention, the plants selected from the genus Curcuma longa(\-3 wt%).
In another embodiment of the invention, the plants selected from the genus Zingiber officinale(l-3.5\vt%).
In another embodiment of the invention, the composition as a soft/ hard gelatin capsule of oral dosage forms.
In another embodiment of the invention, the extract of Glycine max is of active fraction containing 7 S globulin fraction extracts, Zingiber officinalis and Curcuma longa is of rhizome extracts.
In another embodiment of the invention, the formulation having the property of improving the anti-diabetic property and used in treatment of type II diabetes and type I diabetes.
In another embodiment of the invention, the formulation is used as anti- oxidant, cooling, oleaginous, astringent, nerves relaxant properties and anti-diabetic property. In another embodiment of the invention, the formulation is use to treat diabetic related diseases, blood purifier, anti-periodic and externally applied sprain and wound. In another embodiment of the invention, the said formulation is used as a tonic. In another embodiment of the invention, the said formulation is use as an anti-parasitic for many skin affections.
In another embodiment of the invention, the said formulation is use as antacid, carminative.
In another embodiment of the invention, the said formulation is use as cholerectic action.
In another embodiment of the invention, the said formulation is use as anti-arthritis. In another embodiment of the invention, the said formulation further comprises the specific gravity 0.992 - 1.505.
In another embodiment of the invention, the formulation further comprises the
refractive index of 1.5463 -1. 6914.
In another embodiment of the invention, the formulation used in cakes and candies.
In another embodiment of the invention, the said formulation further comprises
proteins, 80.6 - 90.7%.
In another embodiment of the invention, the formulation further comprises Amino
acids 1.0- 19.0%
In another embodiment of the invention, the said formulation further comprises the
fibre 2.845 - 6.27%.
In another embodiment of the invention, the formulation further comprises the
phosphorus, 0.69%
In another embodiment of the invention, the formulation further comprises fat, 13.5 -
24.2%.
In another embodiment of the invention, the formulation further comprises
carbohydrates, 14.3 -23.5%.
In another embodiment of the invention, the suspension at a dose of 50 to 200 mg/kg
did not show any abnormality of general condition in treatment as anti-diabetic
activity.
In another embodiment of the invention, the suspension at a dose of 50 to 200 mg/kg
on anti-diabetic showed significant and dose dependent activity.
In another embodiment of the invention, the suspension at a dose of 50 to 200 mg/kg
showed significant and dose dependent antioxidant activity.
In another embodiment of the invention, the liquid dosage form of Glycine max at a
dose of 50- 200 mg/kg showed an 11.91- 26.65% protection in diabetes.
In another embodiment of the invention, the liquid dosage form of Glycine max at a
dose of 50- 200 mg/kg shown a 28.77% glucose tolerance.
In another embodiment of the invention, the suspension form of Glycine max at a dose
of 50- 200 mg/kg shown a 19.5- 45.53% protection in diabetes dose dependently with
the combination of Glycine max with Curcuma longa.
In another embodiment of the invention, the suspension form of Glycine max at a dose
of 50- 200 mg/kg shown a 29.8- 55.0% protection in diabetes dose dependently with
the combination of Glycine max, Curcuma longa with Zingiber officinalis.
The invention thus meets the need for a new process in which the optimal proportions
of vitamins, amino acids, long chain fatty acids and active therapeutic marker
compounds are retained in the product and underlies the efficacy of the compound as anti diabetic.
Further in another embodiment of present invention the Glycine max (soya bean) seed fraction containing 7S globulin -like protein (Komatsu and Hiranc, 1991) according to the invention can be incorporated into a variety of food products, including, without limitation, butter, cakes, candies, ice cream and mayonnaise-chocolate products, preparation of jaggery, water based brinks such as wines and mineral waters. The inventive oil is also suitable for encapsulation in gelatine shells to form soft gels/capsules. Regardless of the particular form in which the inventive oil is prepared, the daily dosage of the fraction to experimental animals fall within the ranges set forth above. Depending on the concentration of the inventive protein fraction in the above form, the total amount of the food product per serving or encapsulated will also vary the desired therapeutic activity. Examples
The invention is further illustrated by the following non-limiting examples. Formulation 1 (Fl)
Glycine max (Soya bean) 3wt. %
Lactose 66.7g
Starch lOg
Water q.s. to make 100 ml
Dry mature seed of Glycine max (Soya bean) are washed in purified distilled water of pyrogen free, and were immersed in hot water (30-60° c) for 2-3 hr. the seeds released 7 S globulin were used along with the extract that obtained after squeezed in a silicon cloth to get a white exudates.
Mix the plant constituents and filter the solution and add specified quantity of starch and heat until the starch dissolves and then cool and make up the volume with required amount of water to make 100 ml.
The formulation is useful to a anti-diabetic. Accordingly, the investigation deals with the oral dosage form have been described in detail giving the formula of the ingredients along with the method and mode of usage of the standardized formulation. Formulation 2 (F2)
Glycine max (Soya bean) 3wt. %
Curcuma longa l.Swt. %
Lactose 2.5%
Starch 0.5%
Water q.s. to make 100 ml
Dry mature seed of Glycine max (Soya bean) are washed in purified distilled water of pyrogen free, and were immersed in hot water (30-60° c) for 2-3 hr. the seeds released 7 S globulin were used along with the extract that obtained after squeezed in a silicon cloth to get a white exudates. The Curcuma longa were collected and dried in shade. The dried material (IKg) is then powdered and extracted with water for 5 days. At the end of this, the solvent is decanted and filtered if necessary to remove the plant debris. The extract is then concentrated under vacuum at less than 50 °C. Then the extract is lyophilized to obtain the extract in powder form.
Mix the plant extracts and dissolve them water, filter the solution and add specified quantity of starch and heat the until the starch dissolves and then cool and make up the volume with required amount of water to make 100 ml. The formulation is useful to a anti-diabetic. Accordingly, the investigation deals with the oral dosage form have been described in detail giving the formula of the ingredients along with the method and mode of usage of the standardized formulation. Formulation 3 (F3)
Glycine max (Soya bean) 3wt. %
Curcuma longa 1.5%
Zingiber officinale 1.5%
Lactose 45.7g
Starch lOg
Water q.s. to make 100 ml
Dry mature seed of Glycine max (Soya bean) are washed in purified distilled water of pyrogen free, and were immersed in hot water (30-60° c) for 2-3 hr. the seeds released 7 S globulin were used along with the extract that obtained after squeezed in a silicon cloth to get a white exudates. The Curcuma longa and Zingiber officinale were collected and dried in shade. The dried material (IKg) is then powdered and extracted with water for 5 days. At the end of this, the solvent is decanted and filtered if necessary to remove the plant debris. The extract is then concentrated under vacuum at less than 50°C. Then the extract is lyophilized to obtain the extract in powder form. Mix the plant extracts and dissolve them water, filter the solution and add specified quantity of starch and heat the until the starch dissolves and then cool and make up the volume with required amount of water to make 100 ml.

The formulation is useful to a anti-diabetic. Accordingly, the investigation deals with the oral dosage form have been described in detail giving the formula of the ingredients along with the method and mode of usage of the standardized formulation. Formulation 4 (F4)
Curcuma longa 1.5%
Zingiber qfficinale 2.5%
Lactose 20g
Starch lOg
Water q.s. to make 100 ml
The Curcuma longa and Zingiber qfficinale were collected and dried in shade. The dried material (IKg) is then powdered and extracted with water for 5 days. At the end of this, the solvent is decanted and filtered if necessary to remove the plant debris. The extract is then concentrated under vacuum at less than 50°C. Then the extract is lyophilized to obtain the extract in powder form. Mix the plant extracts and dissolve them water, filter the solution and add specified quantity of starch and heat the until the starch dissolves and then cool and make up the volume with required amount of water to make 100 ml.
The formulation is useful to a anti-diabetic. Accordingly, the investigation deals with the oral dosage form have been described in detail giving the formula of the ingredients along with the method and mode of usage of the standardized formulation. Alloxan-induced hyperglycemia
Hyperglycemia was induced by a single intraperitoneal injection of 120 mg/kg of alloxan monohydrate in sterile saline. After five days of alloxan injection, the diabetic rats (glucose level >350mg/dl) were separated and divided into different groups of six animals each. Blood samples were collected from the tail vein just prior to and 1 and 3h after Glycine max (soya bean) administration. And same procedure repeated for effect of formulation with and with out Glycine max (soya bean) protein on alloxan-induced rats. (Venkatesh et al, 2003) Effect formulation on glucose tolerance in rats
Fasted rats were divided into four groups of six rats each. Groups of rats were treated with the formulation and after 30 min of the rats of all groups were orally treated 2g/kg of glucose. Blood samples were collected from the tail vein just prior to glucose administration and at 30 and 90 min after glucose loading. Serum was separated and
blood glucose levels were measured immediately by glucose oxidase method. (Venkatesh et al, 2003) Table I:

(Table Removed)
Values are mean ± S.D. for six rats;
P a Fl- Formulation containing only Glycine max
The results of the present study of table-I shows that there is a significant decrease in
blood glucose level at lOOmg/kg and 200 mg/kg of containing only Glycine max
(Soya bean) active fraction containing 7S globulin fraction in alloxan induced
diabetes at 3h and percentage protection ranged 11.91-26.65 percentage in controlling
the diabetes.
Table II:

(Table Removed)
Values are mean ± S.D. for six rats;
Pa The results of the present study of table-II shows that there is a significant decrease in blood glucose level at a dose range 50-100 mg/kg showed significant results and the
percentage protection ranged 19.5-45.53 percent in lowering the increased level of blood glucose level. Table III:

(Table Removed)
Values are mean ± S.D. for six rats;
Pa The results of the present study of table-Ill shows a significant decrease in blood glucose level at Ih at a dose 200mg/kg and the percentage protection in controlling the increased level of blood glucose were significant at dose range 50-200mg/kg at 3h and percentage protection ranged 29.8-55.0 percent. Table IV:
(Table Removed)
Values are mean ± S.D. for six rats; P a F4- Formulation contains Curcuma longa and Zingiber officinale without Soya bean active fraction containing 7S globulin fraction.
The results of the present study of table-IV showed the probable significant effect (P Table V:

F3- Formulation containing Glycine max (soya bean) active fraction containing 7S
(Table Removed)
globulin fraction, Curcuma longa, Zingiber officinale.
Note: No mortality/ gross abnormality were observed in the animals during the
treatment of formulation F3.
Table VI:

(Table Removed)
Values are mean ± S.D. for six rats;
P a Aganval et al., Indian Journal of Experimental Biology, 38, pp994-998, 2000. Asres K, Indian Drugs, 30,pp 189-190,1993. Barik et al, Indian Journal of Chemistry, 20B, pp 938-939, 1981. Bean et al, Journal of Natural Product, 48, pp 500, 1985.
Chitra P, Sajithlal GB, Chandrakasan G. Influence of Aloevera on the healing of dermal wounds in diabetic rats. J. Ethanopharmacol. 1998; 59: 195- 201. Chopra RN et al, Glossary of Indian Medicinal Plants, 1956. Chopra RN et al, Indian journal of medical research, 29, pp769, 1941.
Chottopadhyay RR, Indian Journal Of Experimental Biology, 31,pp893, 1993. Holmann et al, Textbook of Diabetics, pp467-469, 1991, Joy KL, Kuttan R, Journal of Ethnopharmacology, 67(2), pp 143, 1999. Kameshwara Rao et al, manphar vaidhya partika, l,pp 33, 1997. Kamiya et al, Phytochemistry, 57, pp 297-301, 2001. Kirthikar KR and Basu BD, Indian Medicinal plants, 1, 1981.
Obatomi DK, Bikomo EO, Temple VJ. Anti diabetic properties of the African mistletoe in STZ induced diabetic rats. J. Ethanopharmacol. 1994; 43(1): 13- 17. Osadebe PO, Okide GB, Akabogu 1C. Study on anti diabetic activities of crude methanolic extracts of Lorathus micranthus (Linn) sourced from five different host trees. J. of Ethanopharmacol. 2004; 95(2-3): 133-138.
Padma P, Khosa RL, Chansouria JPN. Lipid peroxidation during healing of cutaneous wounds in albino rats. Ind. J. of Natural Products. 2000; 18(2): 16-19. Pari L, Journal of Ethnopharmacology, 68(1), pp 321, 1999. Romesh P, Yuvarajan CR, Journal of Natural Product, 58, pp!242-1243, 1995. Sabu MC, Kuttan R. Anti diabetic activity of medicinal plants and its relationship with their anti oxidant property. J. Ethanopharmacol. 2002; 81(2): 155-160. Saraswati Bai N, Bull. Cent. Res. Inst, 3, pp89-107, 1954. Satake et al, Chem. Pharma Bull, 47, pp!444-1447, 1999.
Setsuko Komatsu and Hisashi Hiranc, Federation of European Biochemical sciences 294(3)210-212, 1991.
Singh et al, Indian Journal of Pharmaceutical Sciences, 46, pp!48-149, 1984. Subramanyan, Current Science, 14, pp204, 1945. Thorpe, Chemurg Dig, 10 (2), pp 11, 1951. Trease and Evan, Textbook of Pharmacognosy, 1983. Trinder P, Ann Clinical Biochem., 6, pp24-27, 1969. US Patent 6,592,896 July, 2003 Rosen bloom US Patent 6,596,313 July, 2003 Rosen bloom US Patent 6,632,459 October, 2003 Graus, et. al. US Patent 6,649,185 November, 2003 Solanki Valiathan MS, current science, 75, ppl 120-1122, 1998. Venkatesh et al, Fitoterapia, 74, pp.274-279, 2003. Venkatesh et al, Pharmaceutical Biology, 41, 2003.
Zhang XF, Tan B.K. Anti hyperglycaemic and anti oxidant properties of Androgaphis paniculata in normal and diabetic rats. Clin. Exp. Pharmacol. Physiol. 2000; 27 (5-6): 358-363.








We Claim:
1. A novel anti-diabetic herbal formulation comprising an extract of Glycine max in the range of 2-5 wt% along with extract(s) of Curcuma longa in the range of 1-3 wt% and/or Zingiber officinale in the range of 1-3.5 wt% along with pharmaceutically acceptable carrier(s) which are selected from proteins in the range of 80.6 - 90.7 wt %, amino acids in the range of 1.0 - 19.0 wt %, fibre in the range of 2.845 - 6.27 wt %, phosphorus in the range of 0.55 - 0.75 wt %, fat in the range of 13.5 - 24.2 wt % and carbohydrates in the range of 14.3 -23.5 wt%.
2. A formulation as claimed in claim 1, wherein the Glycine max extract is seed extract.
3. A formulation as claimed in claim 1, wherein the Zingiber officinalis extract is rhizome extracts.

Documents:

1286-delnp-2005-Abstract-(26-03-2010).pdf

1286-delnp-2005-abstract.pdf

1286-delnp-2005-Claims-(26-03-2010).pdf

1286-delnp-2005-claims.pdf

1286-delnp-2005-Correspondence-Others-(26-03-2010).pdf

1286-delnp-2005-correspondence-others.pdf

1286-delnp-2005-Description (Complete)-(26-03-2010).pdf

1286-delnp-2005-description (complete).pdf

1286-delnp-2005-Form-1-(26-03-2010).pdf

1286-delnp-2005-form-1.pdf

1286-delnp-2005-form-18.pdf

1286-delnp-2005-form-2.pdf

1286-delnp-2005-Form-3-(26-03-2010).pdf

1286-delnp-2005-form-3.pdf

1286-delnp-2005-form-5.pdf

1286-delnp-2005-Petition 137-(26-03-2010).pdf


Patent Number 240358
Indian Patent Application Number 1286/DELNP/2005
PG Journal Number 20/2010
Publication Date 14-May-2010
Grant Date 05-May-2010
Date of Filing 31-Mar-2005
Name of Patentee COUNCIL OF SCIENTIFIC & INDUSTRIAL RESEARCH
Applicant Address ANUSANDHAN BHAWAN, RAFI MARG, NEW DELHI-110 001, INDIA
Inventors:
# Inventor's Name Inventor's Address
1 CHANDANA VENKATESWARA RAO NBRI, LUCKNOW.INDIA
2 AJAY KUMAR SINGH RAWAT NBRI, LUCKNOW.INDIA
3 VIJAY KUMAR NBRI, LUCKNOW.INDIA
4 MANJU PATAK NBRI, LUCKNOW.INDIA
5 PALPU PUSHPANGADAN NBRI, LUCKNOW.INDIA
PCT International Classification Number A61K 36/9068
PCT International Application Number PCT/IB04/03585
PCT International Filing date 2004-11-03
PCT Conventions:
# PCT Application Number Date of Convention Priority Country
1 PCT/IB04/03585 2004-11-03 PCT