WO2006048696A1 - Anti-diabetic herbal formulation comprising glycine max - Google Patents
Anti-diabetic herbal formulation comprising glycine max Download PDFInfo
- Publication number
- WO2006048696A1 WO2006048696A1 PCT/IB2004/003585 IB2004003585W WO2006048696A1 WO 2006048696 A1 WO2006048696 A1 WO 2006048696A1 IB 2004003585 W IB2004003585 W IB 2004003585W WO 2006048696 A1 WO2006048696 A1 WO 2006048696A1
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- WIPO (PCT)
- Prior art keywords
- formulation
- extract
- glycine max
- diabetic
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- 210000000056 organ Anatomy 0.000 description 1
- 210000003463 organelle Anatomy 0.000 description 1
- 201000008482 osteoarthritis Diseases 0.000 description 1
- 230000004203 pancreatic function Effects 0.000 description 1
- 229960005489 paracetamol Drugs 0.000 description 1
- 230000003071 parasitic effect Effects 0.000 description 1
- 230000001717 pathogenic effect Effects 0.000 description 1
- 239000002304 perfume Substances 0.000 description 1
- 238000009521 phase II clinical trial Methods 0.000 description 1
- 239000002530 phenolic antioxidant Substances 0.000 description 1
- 239000000049 pigment Substances 0.000 description 1
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- 230000035935 pregnancy Effects 0.000 description 1
- 230000008569 process Effects 0.000 description 1
- 235000021251 pulses Nutrition 0.000 description 1
- 235000019633 pungent taste Nutrition 0.000 description 1
- KKOXKGNSUHTUBV-UHFFFAOYSA-N racemic zingiberene Natural products CC(C)=CCCC(C)C1CC=C(C)C=C1 KKOXKGNSUHTUBV-UHFFFAOYSA-N 0.000 description 1
- 238000011552 rat model Methods 0.000 description 1
- 239000002994 raw material Substances 0.000 description 1
- 238000011084 recovery Methods 0.000 description 1
- 238000011160 research Methods 0.000 description 1
- 230000029058 respiratory gaseous exchange Effects 0.000 description 1
- 230000000717 retained effect Effects 0.000 description 1
- 238000012552 review Methods 0.000 description 1
- 206010039073 rheumatoid arthritis Diseases 0.000 description 1
- 235000015067 sauces Nutrition 0.000 description 1
- 210000002966 serum Anatomy 0.000 description 1
- 235000013322 soy milk Nutrition 0.000 description 1
- 230000002195 synergetic effect Effects 0.000 description 1
- 150000003505 terpenes Chemical class 0.000 description 1
- 238000012360 testing method Methods 0.000 description 1
- 229940126585 therapeutic drug Drugs 0.000 description 1
- 238000002560 therapeutic procedure Methods 0.000 description 1
- 230000001256 tonic effect Effects 0.000 description 1
- 231100000167 toxic agent Toxicity 0.000 description 1
- 239000003440 toxic substance Substances 0.000 description 1
- 230000001988 toxicity Effects 0.000 description 1
- 231100000419 toxicity Toxicity 0.000 description 1
- 230000001562 ulcerogenic effect Effects 0.000 description 1
- 235000013311 vegetables Nutrition 0.000 description 1
- 229930003231 vitamin Natural products 0.000 description 1
- 235000013343 vitamin Nutrition 0.000 description 1
- 239000011782 vitamin Substances 0.000 description 1
- 229940088594 vitamin Drugs 0.000 description 1
- 230000008673 vomiting Effects 0.000 description 1
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/906—Zingiberaceae (Ginger family)
- A61K36/9066—Curcuma, e.g. common turmeric, East Indian arrowroot or mango ginger
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/906—Zingiberaceae (Ginger family)
- A61K36/9068—Zingiber, e.g. garden ginger
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
- A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
Definitions
- 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.
- 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.
- 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.
- Yet another object of the present invention is to prepare herbal dosage from in the form of tablet for easy consumption.
- 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.
- 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.
- soya has conformed that the food containing the soya protein may reduce the risk of coronary heart diseases.
- soya 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.
- soya 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.
- 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.
- the taxonomic status of Curcuma heyneana was discussed by Firman 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.
- 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 (Eigner and Scholz, / Ethnopharmacol 1999, 67(1): 1-6).
- Essential oils are complex mixtures of odorous and steam- volatile compounds that are deposited in the subcuticular space of glandular hair, cell organelle, 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.
- 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.
- Curcuma exhibits diverse pharmacological activities against cancer and tumorgensis.
- Curcumin inhibited rat liver microsomal delta 5 and delta 6 denaturizes (Shimizu et ah, Lipids 1992, 27(7):509-12). Curcuma contains an active principle(s) other than curcuminoid, which can modify the metabolism of lipid and lipoproteins.
- 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).
- 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-I, 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 /. Nut ⁇ . 100, 1307).
- Ethanolic extract of C. longa has been shown to have hypoglycemic activity in normal as well as alloxan - induced diabeties in rats. They have also isolated a lipopoly saccharide 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., /. Ind. Med. Association 22, 2731958). 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 officinale Linn. Family: Zingiberaceae
- Rhizomes 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.
- 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.
- 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).
- 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 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.
- formulation (F3) containing Glycine max (soya bean) active fraction containing 7S globulin fraction, Curcuma longa and Zingiber officinale on Glucose tolerance test in rats.
- the present invention provides a novel of the invention of an herbal formulation(s) obtained from decoction of two most potent plants having the property of anti-diabetic and used in treatment of diabetes mellitus as a tablet, injection and as a liquid formulation(s).
- 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.
- an herbal anti-diabetic synergistic formulation(s) containing extracts of plant in pharmacologically effective form.
- herbal formulation(s) the plants selected from the genus Glycine max (2-5 wt %).
- the 7S globulin fraction of Glycine max seed is another embodiment of the invention.
- the plants selected from the genus selected from the genus
- Curcuma longa (1-3 wt %).
- the plants selected from the genus selected from the genus
- composition as a soft/ hard gelatin capsule of oral dosage forms.
- the extract of Glycine max is of active fraction containing 7 S globulin fraction extracts, Zingiber officinalis and Curcuma longa is of rhizome extracts.
- the formulation having the property of improving the anti-diabetic property and used in treatment of type II diabetes and type I diabetes.
- the formulation is used as anti- oxidant, cooling, oleaginous, astringent, nerves relaxant properties and anti-diabetic property.
- the formulation is use to treat diabetic related diseases, blood purifier, anti-periodic and externally applied sprain and wound.
- the said formulation is used as a tonic.
- the said formulation is use as an anti ⁇ parasitic for many skin affections.
- the said formulation is use as antacid, carminative.
- the said formulation is use as cholerectic action.
- the said formulation is use as anti- arthritis.
- the said formulation further comprises the specific gravity 0.992 - 1.505.
- the formulation further comprises the refractive index of 1.5463 -1. 6914.
- the said formulation further comprises proteins, 80.6 - 90.7%.
- the formulation further comprises Amino acids 1.0 - 19.0%
- the said formulation further comprises the fibre 2.845 - 6.27%.
- the formulation further comprises the phosphorus, 0.69%
- the formulation further comprises fat,
- the formulation further comprises carbohydrates, 14.3 -23.5%.
- 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.
- the suspension at a dose of 50 to 200 mg/kg on anti-diabetic showed significant and dose dependent activity.
- the suspension at a dose of 50 to 200 mg/kg showed significant and dose dependent antioxidant activity.
- liquid dosage form of Glycine max at a dose of 50- 200 mg/kg showed an 11.91- 26.65% protection in diabetes.
- liquid dosage form of Glycine max at a dose of 50- 200 mg/kg shown a 28.77% glucose tolerance.
- the suspension form of Glycine max at a dose of 50- 200 mg/kg shown a 19.5- 45.53% protection in diabetes dose dependency with the combination of Glycine max with Curcuma longa.
- 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 Glycine max (soya bean) seed fraction containing 7S globulin -like protein 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
- Glycine max (Soya bean) 3wt. % Curcuma longa 1.5wt. %
- 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.
- 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.
- IV F2 (200mg/kg) 372.54 ⁇ 19.08 315.61 ⁇ 16.54 255.99 ⁇ 14.65 C Values are mean ⁇ S.D. for six rats;
- IV F3 (200mg/kg) 365.20 ⁇ 17.99 215.61 ⁇ 15.64* 166.99 ⁇ 13.65 C Values are mean ⁇ S.D. for six rats;
- IV F4 (200mg/kg) 365.24 + 18.02 348.15 ⁇ 16.29 304.29 ⁇ 14.61* Values are mean ⁇ S.D. for six rats;
- F4- Formulation contains Curcuma longa and Zingiber officinale without Soya bean active fraction containing 7S globulin fraction.
- Osadebe PO Okide GB, Akabogu IC. Study on anti diabetic activities of crude methanolic extracts of Lorathus mkranthus (Linn) sourced from five different host trees. J. of Ethanopharmacol.2004; 95(2-3): 133- 138.
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Citations (4)
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CN1397293A (en) * | 2001-07-23 | 2003-02-19 | 李春澍 | Pumpkin powder |
US20030035851A1 (en) * | 2001-02-08 | 2003-02-20 | Sophie Chen | Anti-cancer agents and method of use thereof |
US20030147979A1 (en) * | 2001-10-23 | 2003-08-07 | Tatsumasa Mae | Ligand for peroxisome proliferator-activated receptor |
US20030185913A1 (en) * | 2002-03-26 | 2003-10-02 | Palpu Pushpangadan | Herbal health protective and promotive nutraceutical formulation for diabetics and process for preparing the same |
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Publication number | Priority date | Publication date | Assignee | Title |
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US20030035851A1 (en) * | 2001-02-08 | 2003-02-20 | Sophie Chen | Anti-cancer agents and method of use thereof |
CN1397293A (en) * | 2001-07-23 | 2003-02-19 | 李春澍 | Pumpkin powder |
US20030147979A1 (en) * | 2001-10-23 | 2003-08-07 | Tatsumasa Mae | Ligand for peroxisome proliferator-activated receptor |
US20030185913A1 (en) * | 2002-03-26 | 2003-10-02 | Palpu Pushpangadan | Herbal health protective and promotive nutraceutical formulation for diabetics and process for preparing the same |
Non-Patent Citations (7)
Title |
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BIOSCIENCE, BIOTECHNOLOGY, AND BIOCHEMISTRY. FEB 2004, vol. 68, no. 2, February 2004 (2004-02-01), pages 352 - 359, ISSN: 0916-8451 * |
CROP SCIENCE, vol. 41, no. 6, November 2001 (2001-11-01), pages 1985 - 1987, ISSN: 0011-183X * |
DATABASE BIOSIS [online] BIOSCIENCES INFORMATION SERVICE, PHILADELPHIA, PA, US; November 2001 (2001-11-01), STREETER JOHN G: "Simple partial purification of D-pinitol from soybean leaves", XP002335004, Database accession no. PREV200200433075 * |
DATABASE MEDLINE [online] US NATIONAL LIBRARY OF MEDICINE (NLM), BETHESDA, MD, US; February 2004 (2004-02-01), MORIYAMA TATSUYA ET AL: "Soybean beta-conglycinin diet suppresses serum triglyceride levels in normal and genetically obese mice by induction of beta-oxidation, downregulation of fatty acid synthase, and inhibition of triglyceride absorption.", XP002335003, Database accession no. NLM14981298 * |
DATABASE WPI Section Ch Week 200366, Derwent World Patents Index; Class B04, AN 2003-690274, XP002335035 * |
EIGNER D ET AL: "Ferula asa-foetida and Curcuma longa in traditional medical treatment and diet in Nepal", JOURNAL OF ETHNOPHARMACOLOGY, vol. 67, no. 1, October 1999 (1999-10-01), pages 1 - 6, XP002335002, ISSN: 0378-8741 * |
VEDAVANAM K ET AL: "Antioxidant action and potential antidiabetic properties of an isoflevonoid-containing soyabean phytochemical extract spe", PHYTOTHERAPY RESEARCH, JOHN WILEY & SONS LTD. CHICHESTER, GB, vol. 13, no. 7, 1999, pages 601 - 608, XP002973175, ISSN: 0951-418X * |
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