Title of Invention

" A PROCESS FOR THE PREPARATION OF A COMPOSITION USEFUL FOR TREATMENT IN CHRONIC RESPIRATORY DISORDERS"

Abstract A process for preparation of a composition useful for treatment in chronic respiratory disorders such as cold, cough, allergic, asthma, rhinitis, pharyngitis, laryngitis, whooping cough, sinusitis, throal infection comprising the steps of: (a) grinding and mixing Terminalia Chebula, Zingiber Officianale, Piper Nigrum, Piper Longum. Elettaria Cardamomum, Pogostemon Heynaeanus, Citrus Medica, Cypems Rostundus, Cinnamomum Zeylanicum, Eugenia Caryophyllaea, Molasses, Ghee, Mustard Oil in the ratio of 3-8 : 0.20-0.70 : 0.20-0.70 : 0.40- 0.9 ): 0.40-0.90 : 0.20-0.50 : 0.40-0.90 : 0.20-0.50 : 0.20-0.60 : 0.20-0.60 : 6-12 : 0.4) - 0.80 : 0.40 - 0.80 to form a powder; (b) mixing Emblica Officinalis, Tinospora Cordifolia, Plumbago Rosea, Adhatoda Vasica, Solanum Aculeatissimum, Casearia Esculertta, Clerodendron Serraturn, Kaempferia Galanga, Sida Retusa, Gmelina Arborea, Premna Integrifolia, Oroxylum Indicum, Steriospermum Tetragonum, Gmelina Asiatics, Tribulus Terrestris, Solanum Melongena, Desmodium Gangeticum, Pseudrathria Viscida, Solanum Melongena in the ratio of 1.5-4.5 : 1.5-4.5 : 1.5-4.5 : 1-3:1.5-4.5 : 0.5- 1.20 : 0.4-0.9 ; 0.1-0.25 : 0.15-0.40 : 0.10- 0.25 : 0.10- 0.25 : 0.10- 0.25 : 0.10- 0.25 : 0.10- 0.25 : 0.10- 0.25 : 0.10- 0.25 : 0.10- 0.25 : 0.10- 0.25 : 0.10- 0.25 and boiling in water for a period of 1 -10 hours to get a soupy form; (c) mixing and Grinding Swarnamashikam, Potassium Carbonate (Chavarkaram), Manayola, Rasasindhooram, Lohabhasmam, Abrahabhasmam in the ratio of 0.10- 0.40 : 0.10-0.40 : 0.10-0.40 : 0.10-0.40 : 0.10-0.40 : 0.10-0.40 to form a powder; (d) mixing the products obtained in the steps (a) & (b) and heating the mixture thus obtained in a strong steel jacketed vessel with continuous stirring till the mixture becomes a pasty form; (e) mixing the product obtained in step (d) with the powder obtained in step (c) while heating the product and continuously stirring the product; (i) allowing the mixture obtained in step (e) to cool for about 24 hours; (g) adding to the mixture obtained in step (f), honey in the ratio of 0.2-1.0 and stirring the mixture for about 30 minutes to obtain the desired product.
Full Text TECHNICAL FIELD
The present invention relates to a composition and more particularly to a process for preparation of the composition useful for treatment in chronic respiratory disorders such as cold, cough, allergic, asthma, migraine, piles, sinusitis, throat infection, fungi, bacteria and virus, seasonal allergic rhinitis, pharyngitis, laryngitis, whooping cough etc. The said composition is non-alcoholic and non-sedative in nature.
BACKGROUND OF INVENTION
During the last two decades there has been an increased occurrence of respiratory disorders amongst the children and the adults. The main reason for these disorders are smoke, dust, vehicular/ industrial pollution and humidity.
The houses and apartment buildings harbor their own allergens. While almost anything in dust can trigger an allergic reaction, the most important indoor allergens are pet dander, molds, cockroaches, and dust mites. Unlike seasonal allergies, indoor allergies may last all year long. They tend to be at their worst in the late summer, when dust mites, molds, and other insects are all at their peaks. The symptoms can actually be worse in the winter, though, when the windows are closed and we are shut in with the allergens. An allergic reaction is a reaction of the immune system to a foreign "invader," a substance that is not native to your body. Exposure to this invader, an allergen, triggers the reaction. It is the effects of the mediators on cells and tissues that cause the symptoms of an allergic reaction. When house dust particles come to rest in the linings of the eyes, nose, or airway of a susceptible person, an allergic reaction can occur. The usual symptoms of indoor allergic reactions are those of many other allergic reactions: Itchy stuffy nose, clear nasal discharge, Itchy watery swollen bloodshot eyes, Sneezing, Scratchy swollen throat.
Several studies have indicated that the prevalence rate of Asthma is increasing in many regions while the morbidity rate remains high. At present, the preventive therapy for asthma is mainly based on systemic corticosteroids administered by inhalation and oral route. The significant adverse effects were found with long-term use of hormone.
Similarly in Sinusitis, any infection of the nasal passages that cause it to swell can affect the opening to the sinuses. If the ostium (opening) is blocked, air and mucous secretions are collected and cause pressure on the sinus cavity walls. This is the main reason why we have pain during sinusitis. Sinusitis, in simple terms, means an inflammatory process in the nasal sinuses due to viral, bacterial, and fungal infections or allergic reactions. Sinuses are paired hollow cavities or air spaces in the head. They are within the bones of the skull that surround the nasal passage, hence they are also referred to as para nasal sinuses.
Similarly in case of migraines, contrary to public perception, migraine is not just a king-size regular headache. In fact, the cause of migraine pain is the opposite of ordinary tension headaches. Migraine is a neurological disorder. Migraine occurs when blood vessels in the head contract (which is the cause of tension headache pain) which occurs

during the aura phase of the headache. Some medical professionals think there may be some swelling of the meninges (the thin layer of tissue that covers the brain) involved, Migraineurs may have an insufficiency of the neurotransmitter serotonin, which can make them particularly vulnerable to an attack if it gets too low. Serotonin is also involved in regulating the digestive system, and migraine sufferers may find themselves prone to digestive difficulties.
U.S. Patent No. 6,193,995 describes herbal mixture for the treatment of nasal congestion that comprises of plurality of herbs thoroughly mixed together and combined with an adhesive. This type of herbal bandage made of a mixture of white pepper, dried ginger, rhizome and cinnamon twig powder with adhesive. The present invention differs from the above patent because the patent abstract is a topical dosage form and it is for the treatment of nasal congestion where as present invention is an oral syrup formulation for treating cough from different etiologies and related symptoms.
U.S. Patent No. 6,287,567 describes a method of making an herbal drink and an apparatus developed for relieving symptoms of fatigue, congestion, fever and asthma. The drink is formed by straining water through a combination of equal portions of rosehip, goldenseai, comfrey leaf, bee pollen, spearmint, chickweed, comfrey root chamomile flower, catnip, mullein, pennyroyal, eucalyptus, and licorice root. The therapy does not address severe conditions such as bronchial asthma, chronic obstructive pulmonary disease, bronchitis, and other respiratory disorders and also the product is not cost-effective since it involves special apparatus for administration of the medicament.
U.S. Pat. No. 6,197,306 describes herbal composition mainly for the treatment of chronic obstructive pulmonary disease (COPD) and respiratory disorders and a process for preparing the same. The composition comprises of Bryonia, Ipecacuanha, Drosera, and Antimony Potassium Tartrate. The product preparation involves use of pharmaceutically hazardous organic solvents for extraction process.
Thus there is a need to provide a composition having an improved therapeutic efficacy for the treatment of various types of cough and respiratory disorders.
In view of forgoing shortcomings inherent in the known types of herbal compositions as mentioned in the prior art, there is a need to provide a composition having an improved therapeutic efficacy for the treatment of various types of cough and respiratory disorders wherein the same can be utilized for relieving cough from different etiology and also related symptoms.
There is a further is a need to provide a composition, which is devoid of use of pharmaceutically unacceptable organic solvents and which does not contain codeine or any other sedative agent which causes side effects like dizziness, delirium, etc. Still further, there is a need to provide a composition which does not freeze, at subzero temperatures thus preserving the medicinal properties of the herbs and thereby making it more efficacious.
SUMMARY OF THE INVENTION
Thus according to the present invention there is provided a process for preparation of a composition having an improved therapeutic efficacy for the treatment of various types of cough and respiratory disorders and which is devoid of use of pharmaceutically unacceptable organic solvents and which does not contain codeine or any other sedative agent which causes side effects like dizziness, delirium, etc.
DETAILED DESCRIPTION OF THE INVENTION.
Thus according to this embodiment of this invention, there is provided a process for preparation of a composition comprising a mixture of different herbs selected from the following:
1. Terminalia Chebula
2. Emblica Officinalis
3. Tinospora Cordifolia
4. Plumbago Rosea
5. Adhatoda Vasica
6. Solanum Aculeatissimum
7. Casearia Esculenta
8. Clerodendron Serratum
9. Kaempferia Galanga
10. SidaRetusa
11. Gmelina Arborea
12. Premna Integrifo lia
13. Oroxylum Indicum
14. Steriospermum Tetragonum
15. Gmelina Asiatica
16. Tribulus Terrestris
17. Solanum Melongena
18. Desmodium Gangeticum
19. Pseudrathria Viscida
20. Solanum Melongena
21. Zingiber Officianale
22. Piper Nigrum
23. Piper Longum
24. Elettaria Cardamomum
25. Pogostemon Heynaeanus
26. Citrus Medica
27. Cyperus Rostundus
28. Swarnamashikam
29. Potassium Carbonate (Chavarkaram)
30. Manayola
31. Rasasindhooram
32. Lohabhasmam
3 3. Abrahabhasmam
34. Gurh
35. Ghee
36. Mustard Oil
37. Honey
38. Cinnamomum Zeylanicum
39. Eugenia Caryophyllaea
In the first step, the herbs such as Terminalia Chebula, Zingiber Officianale, Piper Nigrum, Piper Longum, Elettaria Cardamomum, Pogostemon Heynaeanus, Citrus Medica, Cyperus Rostundus, Cinnamomum Zeylanicum & Eugenia Caryophyllaea are taken in proportional ratio. The plant part which is to be used such as leaves, barks, stems etc. are graded and the extraneous material is removed manually, it is then shredded and cleaned thoroughly with water. It is then dried in the in sunlight or heated at about 30°- 50°C in a stainless steel jacketed vessel provided with a stirrer. The dried material is then powdered in a hammer mill and grinded thoroughly. This powder is then mixed with Molasses, Ghee and Mustard Oil in the vessel and then stirred thoroughly while heating continuously for about 4 hours. The mixture thus obtained is keep separately.
In the next step, the herbs such as Emblica Officinalis, Tinospora Cordifolia, Plumbago Rosea, Adhatoda Vasica, Solanum Aculeatissimum, Casearia Esculenta, Clerodendron Serratum, Kaempferia Galanga, Sida Retusa, Gmelina Arborea, Premna Integrifolia, Oroxylum Indicum, Steriospermum Tetragonum, melina Asiatica, Tribulus Terrestris, Solanum Melongena, Desmodium Gangeticum, Pseudrathria Viscida, Solanum Melongena are taken. The part of the plant which is to be used is graded and the extraneous material is removed manually and it is washed thoroughly. The material thus obtained is boiled in water for about 1-10 hrs depending upon the quantity to get a soupy form.
In the next step, herbs such as Swarnamakshikam, Potassium Carbonate (Chavarkarm), Manayola, Rasasindhooram, Lohabhasmam, Copper Pyrate, Abrahabhasmam in a proportional ratio. The useful part of the plant is graded and the extraneous material is removed manually, and the material thus obtained is thoroughly grinded in a hammer mill.
In the subsequent step, the mixture obtained from step 1 is mixed with the extract obtained from step 2. The mixture thus obtained is heated and stirred in a strong steel jacketed vessel until the content in the vessel becomes pasty form. Then the contents prepared in the step 3 is mixed with the content in the vessel and is again heated for some time. The contents thus obtained are allowed to cool for about 24 hours. After cooling the contents thus obtained are added with a predetermined amount of honey and the mixture thus obtained is stirred thoroughly for about 30 minutes thus making the final composition.
Thus according to the present invention there is provided a process for preparation of a composition useful for treatment in chronic respiratory disorders comprising the steps of:
(a) grinding and mixing the seed of Terminalia Chebula, the root of Zingiber
Officianale, the seed of Piper Nigrum, the seed of Piper Longum, the seed of
Elettaria Cardamomum, the leaf of Pogostemon Heynaeanus, the seed of Citrus
Medica, the root of Cyperus Rostundus, the bark of Cinnamomum Zeylanicum,
the seed of Eugenia Caryophyllaea, Molasses, Ghee, Mustard Oil in the ratio of 3-
8 : 0.20-0.70 : 0.20-0.70 : 0.40-0.90: 0.40-0.90 : 0.20-0.50 : 0.40-0.90 : 0.20-0.50
: 0.20-0.60 : 0.20-0.60 : 6-12 : 0.40 - 0.80 : 0.40 - 0.80 to form a powder;
(b) mixing the seed of Emblica Officinalis, the stem of Tinospora Cordifolia, the root
of Plumbago Rosea, the root of Adhatoda Vasica, the stem and root of Solanum
Aculeatissimum, the root of Casearia Esculenta, the root of Clerodendron
Serratum, the root of Kaempferia Galanga, the root of Sida Retusa, the root of
Gmelina Arborea, the root of Premna Integrifolia, the root of Oroxylum Indicum,
the root of Steriospermum Tetragonum, the root of Gmelina Asiatica, the seed of
Tribulus Terrestris, the root of Solanum Melongena, the root of Desmodium
Gangeticum, the root of Pseudrathria Viscida in the ratio of 1.5-4.5 : 1.5-4.5 :
1.5-4.5 : 1-3:1.5-4.5 : 0.5-1.20 : 0.4-0.9 : 0.1-0.25 : 0.15-0.40 : 0.10- 0.25 : 0.10-
0.25 : 0.10- 0.25 : 0.10- 0.25 : 0.10- 0.25 : 0.10- 0.25 : 0.10- 0.25 : 0.10- 0.25 :
0.10- 0.25 and boiling in water for a period of 1-10 hours to get a soupy form;
(c) mixing and grinding Swarnamashikam, Potassium Carbonate (Chavarkaram),
Manayola, Rasasindhooram, Lohabhasmam, Abrahabhasmam in the ratio of
0.10-0.40 : 0.10-0.40 : 0.10-0.40 : 0.10-0.40 : 0.10-0.40 : 0.10-0.40 to form a
powder;
(d) mixing the products obtained in the steps (a) & (b) and heating the mixture at
about 80°-100°C in a strong steel jacketed vessel with continuous stirring till the
mixture becomes a pasty form;
(e) mixing the product obtained in step (d) with the powder obtained in step (c) while
heating at about 70°-100°C and continuously stirring the mixture;
(f) allowing the mixture obtained in step (e) to cool for about 24 hours;
(g) adding honey to the mixture obtained in step (f), in the ratio of 0.2-1.0 and stirring
the mixture for about 30 minutes to obtain the desired product.
In the study the inventors have found that such compositions are not mentioned anywhere in the traditional scriptures nor are available in the traditional knowledge of the medicines. Moreover the mking of the ingredients in a particular ratio has resulted in a synergestic composition which has shown surprising results as compared to the conventional or commonly used medicines.



Claim :
1. A process for preparation of a composition useful for treatment in chronic respiratory disorders comprising the steps of:
(a) grinding and mixing the seed of Terminalia Chebula, the root of
Zingiber Officianale, the seed of Piper Nigrum, the seed of Piper
Longum, the seed of Elettaria Cardamomum, the leaf of Pogostemon
Heynaeanus, the seed of Citrus Medica, the root of Cyperus
Rostundus, the bark of Cinnamomum Zeylanicum, the seed of
Eugenia Caryophyllaea, Molasses, Ghee and Mustard Oil in the ratio
of 3-8 : 0.20-0.70 : 0.20-0.70 : 0.40-0.90: 0.40-0.90 : 0.20-0.50 :
0.40-0.90 : 0.20-0.50 : 0.20-0.60 : 0.20-0.60 : 6-12 : 0.40 - 0.80 :
0.40 - 0.80 to form a powder;
(b) mixing the seed of Emblica Officinalis, the stem of Tinospora
Cordifolia, the root of Plumbago Rosea, the root of Adhatoda
Vasica, the stem and root of Solanum Aculeatissimum, the root of
Casearia Esculenta, the root of Clerodendron Serratum, the root of
Kaempferia Galanga, the root of Sida Retusa, the root of Gmelina
Arborea, the root of Premna Integrifolia, the root of Oroxylum
indicum, the root of Steriospermum Tetragonum, the root of
Gmelina Asiatica, the seed of Tribulus Terrestris, the root of
Solanurn Melongena, the root of Desmodium Gangeticum, the root
of Pseudrathria Viscida in the ratio of 1.5-4.5 : 1.5-4.5 : 1.5-4.5 : 1-
3:1.5-4.5 : 0.5-1.20 : 0.4-0.9 : 0.1-0.25 : 0.15-0.40 : 0.10- 0.25 :
0.10- 0.25 : 0.10- 0.25 : 0.10- 0.25 : 0.10- 0.25 : 0.10- 0.25 : 0.10-
0.25 : 0.10- 0.25 : 0.10- 0.25 and boiling in water for a period of 1-
10 hours to get a soupy form;
(c) mixing and grinding Swarnamashikam, Potassium Carbonate
(Chavarkaram), Manayola, Rasasindhooram, Lohabhasmam,
Abrahabhasmam in the ratio of 0.10-0.40 : 0.10-0.40 : 0.10-0.40 :
0.10-0.40 : 0.10-0.40 : 0.10-0.40 to form a powder;
(d) mixing the products obtained in the steps (a) & (b) and heating the
mixture at 80°-100°C in a strong steel jacketed vessel with
continuous stirring till the mixture becomes a pasty form;
(e) mixing the product obtained in step (d) with the powder obtained in
step (c) while heating at 70°-100°C and continuously stirring the
mixture;
(f) allowing the mixture obtained in step (e) to cool for about 24 hours;

(g) adding honey to the mixture obtained in step (f), in the ratio of 0.2:1.0 and stirring the mixture for about 30 minutes to obtain the renewed composition.
2. A process as claimed in claim 1 wherein the boiling in step (b) is carried out at
70-100°C.
3. A process as claimed in claim 1 or 2 wherein the leaves, roots, stem, barks used
are first cleaned in water and then dried at a temperature between 30°-40° C.
4. A process for preparation of a composition useful for treatment in chronic
respiratory disorders substantially as herein described.

Documents:

903-del-2004-abstract.pdf

903-del-2004-claims.pdf

903-del-2004-Correspondence-Others-(17-01-2011).pdf

903-del-2004-correspondence-others.pdf

903-del-2004-correspondence-po.pdf

903-del-2004-description (complete).pdf

903-del-2004-form-1.pdf

903-del-2004-Form-15-(17-01-2011).pdf

903-del-2004-form-19.pdf

903-del-2004-form-2.pdf

903-del-2004-form-3.pdf


Patent Number 210085
Indian Patent Application Number 903/DEL/2004
PG Journal Number 13/2009
Publication Date 27-Mar-2009
Grant Date 18-Sep-2007
Date of Filing 19-May-2004
Name of Patentee MAROZHUKAYIL JOSEPH JOSE
Applicant Address 65-C POCKET J & K, DILSHAD GARDEN, DELHI-110095.
Inventors:
# Inventor's Name Inventor's Address
1 MAROZHUKAYIL JOSEPH JOSE 65-C POCKET J & K, DILSHAD GARDEN, DELHI-110095.
2 MAROZHUKAYIL JOSEPH JOSE 65-C POCKET J & K, DILSHAD GARDEN, DELHI-110095.
PCT International Classification Number A61K 35/78
PCT International Application Number N/A
PCT International Filing date
PCT Conventions:
# PCT Application Number Date of Convention Priority Country
1 NA