CN100353948C - Prescription for treating type 2 diabetes and its preparing method - Google Patents
Prescription for treating type 2 diabetes and its preparing method Download PDFInfo
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- CN100353948C CN100353948C CNB2004100064368A CN200410006436A CN100353948C CN 100353948 C CN100353948 C CN 100353948C CN B2004100064368 A CNB2004100064368 A CN B2004100064368A CN 200410006436 A CN200410006436 A CN 200410006436A CN 100353948 C CN100353948 C CN 100353948C
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Abstract
The present invention discloses a formulation of health-care food or medicine for treating non-insulin dependent diabetes and a manufacturing method thereof. The present invention uses balsam pear, ginseng and fiveleaf gynostemma herb as main raw materials, the effective parts and the effective components of the raw materials are extracted by a modern biological engineering technique, and the advanced functionality nutrient health-care food and medicine are developed by a solid dispersion technique. The present invention adopts a buccal mode and avoids the damage of the effective components because of the stomach intestine, etc., and the present invention also increases the direct absorption of the oral mucosa capillary vessel for the effective components and simultaneously adds salivary secretion and a swallowing action. Therefore, gastrointestinal activities and physiological insulin secretion are reinforced by reflectivity, and the health-care food or medicine has very strong preventing and treating effect on non-insulin dependent diabetes. The present invention has the advantages of unique prescription and manufacturing method and significant treating effect.
Description
The present invention is a kind of new prevention and health product or the drug formulation and the manufacture method of treatment type ii diabetes.It is to be primary raw material with natural drugs such as main component Radix Ginseng, Herb Gynostemmae Pentaphylli and Fructus Momordicae charantiaes, through utilizing modern biotechnology to extract effective site and effective ingredient, the advanced functionality nutritional health food or the medicine that adopt solid dispersion technology to develop, effect with significant blood sugar lowering improves significantly and mitigation to type ii diabetes patient's clinical symptoms.
The diabetics of China has exceeded 30,000,000, along with aged tendency of population constantly increase and in low age bracket patient's emerge in multitude, this numeral just with year the ratio more than 10% increase.
The present invention contains the effective ingredient of natural plants such as Fructus Momordicae charantiae, Radix Ginseng, Herb Gynostemmae Pentaphylli, has the remarkable function of blood sugar lowering, blood lipid regulation, and type ii diabetes patient's clinical symptoms is improved significantly and mitigation.The present invention's product adopts sublingual administration more, avoided the destruction to effective ingredient such as stomach, liver, intestinal, and increased of the direct absorption of oral mucosa blood capillary to effective ingredient, simultaneously also increased salivation and swallowing act, thereby reflexive gastrointestinal activity and physiological insulin secretion have been strengthened.Because the increase of the bitter principle saliva stimulating glandular secretion in the used medical material, thereby alleviated the xerostomia and the thirsty symptom of diabetics preferably, the effect of medicine is further improved.
The diabetes patient because of insulin deficit in the body or relatively increase in demand cause sugar, protein and lipometabolic disorder, make and how to repair islet function, recover the normal secretion of insulin, become cure the disease basic.In the time of in the past with the chemicals blood sugar lowering, though some curative effect of medication are good, life-time service or excessively orally all can produce toxic and side effects or Drug resistance to important organs such as liver, kidneys descends health sensitivity and influences drug effect.
The present invention uses modern biotechnology, distinctive active substance in the extract at low temperature Fructus Momordicae charantiae.This material that is commonly called as the glucokinin sample can fully participate in the carbohydrate metabolism of diabetics, and blood sugar lowering, blood fat reduce the activity of liver gluconeogenesis enzyme, and glyconeogenesis is reduced, and blood glucose is synthetic to be reduced.
The sublingual lozenge that the present invention adopts the microencapsulation new technique to make, broken the backward way that traditional antidiabetic drug absorbs through the intestines and stomach, biological activity that can more effective reservation medicine, utilize the oral mucosa blood capillary that effective ingredient is directly absorbed, avoided the decomposition of gastric acid, liver enzyme, liver road antibacterial to destroy, bring into play drug effect to greatest extent, reached hypoglycemic effect.
The present invention at first is a kind of microcapsule formulation, is that the microcapsule of substrate is directly in blocks under drying regime with PEG6000, can reach to keep cyst membrane medical material good stability, Yi Rong, quick-acting purpose, helps buccal tablet digestion, slow release, performance drug effect.
From prescription, the present invention is original and different.Fructus Momordicae charantiae has to drive away summer heat and washs heat in the prescription, and the merit that makes eye bright, detoxifies is controlled calentura excessive thirst taking fluids profusely, heatstroke, dysentery, fervid pain, carbuncle erysipelas, malignant boil.The medical value of Fructus Momordicae charantiae has record more in motherland's medical science ancient books and records, as the existing hundreds of years history of typical integration of edible and medicinal herbs.Modern medicine study proves that Fructus Momordicae charantiae contains several amino acids, and its extract and Insulin receptor INSR, insulin antibody all have tangible association reaction, shows that it and islets of langerhans have common antigenicity and biological activity.Fructus Momordicae charantiae extract has similar ILA, but insulin level in the blood that do not raise.Medical circle scholar is seen in various academic journals about the research report of Fructus Momordicae charantiae blood sugar lowering, blood fat, and all kinds of tests all obtain compellent effective result.
Herb Gynostemmae Pentaphylli has remarkable cholesterol reducing (TCH); triglyceride (TG); low density lipoprotein, LDL (LDL); the effect of high density lipoprotein increasing (HDL); has the protection vascular endothelial cell simultaneously; stop the deposition of lipid in blood vessel wall; suppress hematoblastic coagulation and release; prevent microthrombusis; reduce blood viscosity; improve hemorheology; adjust blood pressure and to the protective effect of myocardial infarction and myocardial ischemia reperfusion injury; reduce irreversibility chamber due to the ischemia-reperfusion incidence rate of quivering; the effect of antagonism negativity muscular strength is comprehensive; the main medicine of systemic treatment arteriosclerosis and cardiovascular and cerebrovascular disease.Pharmacological research shows that gypenoside has blood sugar lowering, blood fat reducing, antioxidation.Gypenoside has significant blood sugar reducing function to the streptozotocin diabetes rat, and along with the prolongation of the course of treatment, hypoglycemic effect is better, and normal rat blood sugar is not had influence, and the prompting gypenoside has dual regulation to blood glucose.More meaningfully treatment back insulin level obviously reduces, and the prompting gypenoside has the reduction insulinemia, improves the effect of hyperinsulinism opposing, and prevention and treatment diabetes and complication are highly profitable.
Radix Ginseng is warm in nature, and sweet and slightly bitter taste has strongly invigorating primordial QI, promoting the production of body fluid to quench thirst, function such as calm the nerves, the disease of qi-blood-body fluid deficiency such as it is deficient to cure mainly impairment caused by overstrain, and prolonged deficiency is multiple.Have antiplatelet aggregation and fibrinolytic, can suppress thrombosis, arteriosclerosis; Make the normalization of utilizing of sugar by the ANOMALOUS VARIATIONS of correcting G-6-Pase and two kinds of enzymatic activitys of glucokinase, thereby play the obvious functions of blood sugar effect.
The present invention with the pure natural plant is the blood sugar lowering goods that raw material develops, and is without any side effects, and the patient can take separately as one sees fit or cooperates other hypoglycemic medicine to take according to the practical situation of self, is the new formulation for the treatment of both the principal and secondary aspects of a disease, determined curative effect.
The object of the present invention is to provide the novel medicine of a kind of taking convenience, evident in efficacy, treating both the principal and secondary aspects of a disease.
Another object of the present invention provides the advanced unique preparing process of this health food and medicine.
Solution of the present invention is: under the pathogenetic understanding and Therapeutic Principle guidance of motherland's traditional medicine to diabetes, use for reference the achievement and the advanced technology of domestic and international modern pharmacological research, from motherland's medicine treasure-house, filter out blood fat reducing, the elite of hypoglycemic representative Chinese crude drug and natural drug, by behind the theory of Chinese medical science prescription compatibility, it is carried out comprehensive qualitative and quantitative analysis, on this basis, extract, separation or its effective site of synthetic and effective ingredient also carry out scientific combination, adopt solid dispersion technology, it is little to produce dosage, quick-acting, pharmaceutical dosage form efficiently.
The present invention adopts solid dispersion technology earlier with effective site and the compound microcapsule that is prepared into of composition, thereby has improved surface area greatly, and its bioavailability is much higher than the medicine of general dosage form.Because particle is little, the solid dispersion dissolution velocity is fast, can be absorbed by cell rapidly to enter blood circulation, thereby reach efficient and quick-acting effects.
Medicine of the present invention is formed (consumption is a weight portion) by following component:
Fructus Momordicae charantiae extract 0.1-1.2 part Radix Ginseng total saponins 0.5-1.5 part
Herb Gynostemmae Pentaphylli total glycosides 1.5-4 part mannitol 30-50 part
Xylitol 30-50 part polyethylene glycol 6000 2-12 part
Citric acid 1-5 part aspartame 1-5 part
The method of above-mentioned component being made health food of the present invention or medicine is:
1, Fructus Momordicae charantiae extract, Radix Ginseng total saponins, Herb Gynostemmae Pentaphylli total glycosides are added polyethylene glycol 6000 and make microcapsule;
2, vacuum dehydrating at lower temperature (35-40 ℃);
3, cross 40 mesh sieves;
4, add mannitol, xylitol and polyethylene glycol 6000 mixing granulation;
5, vacuum dehydrating at lower temperature (35-40 ℃); 6, sieve; 7, preparation; 8, radiosterilization sterilization; 9, packing.
Illustrate:
(1) Fructus Momordicae charantiae extract of the presently claimed invention is light blue or pale yellow powder.
(2) Radix Ginseng total saponins of the presently claimed invention is a pale yellow powder, free from extraneous odour, and purity is 75%-95%.
(3) Herb Gynostemmae Pentaphylli total glycosides of the presently claimed invention is the khaki powder, free from extraneous odour, purity 75%-95%.
(4) mannitol of the presently claimed invention should meet the pertinent regulations under 2000 editions two 89 pages of mannitol items of Pharmacopoeia of People's Republic of China.
(5) xylitol of the presently claimed invention should meet the pertinent regulations under the GB13509-1992 item.
(6) polyethylene glycol 6000 of the presently claimed invention should meet " pharmacopeia " standard.
With 0.35,0.70, the health food of 1.05g/kg body weight dosage or medicine irritate and fed mice 30 days, 1. can reduce the post-prandial glycemia of normal mouse; When giving glucose 0.5h, the blood glucose value of low, middle dosage group mice is starkly lower than the solvent control group and significant difference p＜0.05 is arranged, and high dose group has utmost point significant difference p＜0.01; When giving glucose 2h, the blood glucose value of low dose group mice obviously is reduced to the solvent control group and significant difference p＜0.05 is arranged, and middle and high dosage group has utmost point significant difference p＜0.01.2. can strengthen the glucose load carbohydrate tolerance of normal mouse; Low dose group and solvent control group compare, and 0.5h and 0h blood glucose difference reduce obvious and significant difference p＜0.05 is arranged; And middle and high dosage group and solvent control group are relatively, and utmost point significant difference p＜0.01 is all arranged.3 can reduce the post-prandial glycemia of diabetic mice.After giving glucose 0.5h, the blood glucose value of middle and high dosage group mice is starkly lower than the solvent control group and significant difference p＜0.05 is arranged.4. can strengthen the glucose load carbohydrate tolerance of diabetic mice.In dosage group and solvent control group relatively, 0.5h and 0h blood glucose difference reduce obviously and significant difference p＜0.05 are arranged, and high dose group has utmost point significant difference p＜0.01 is extremely significantly arranged.5. can reduce the fasting glucose of diabetic mice; The fasting blood sugar of middle and high dosage treated animal and solvent control group relatively all have utmost point significant difference p＜0.01.More than these goods of prompting have certain blood sugar regulation effect.
Health food " Tang An sublingual lozenge " with the present invention's development is ratified (authentication code: the strong word G20040009 of state's food) in Nikkei State Food and Drug Administration registration January 9 in 2004.Before being batch, in accordance with regulations human body has been carried out the test-meal observation, conclusion is as follows: adopt the double blind control method, 60 routine type ii diabetes patients balancedly are divided into two groups by the kind of taking medicine, blood glucose, blood lipid level etc., every group 30 example, be divided into matched group and observation group at random, edible respectively placebo and Tang An sublingual lozenge, every day three times, each two.Viewing duration is adhered to diet control, and former treatment Rezulin species mediating recipe amount is constant.After one month, the result shows that the Tang An sublingual lozenge can obviously improve the cardinal symptom of diabetics, can reduce on an empty stomach and post-prandial glycemia and glucose in urine, and can reduce serum cholesterol and triglyceride, rising serum high-density LP-cholesterol.Do not influence secretion of insulin and release.Its hypoglycemic obvious effective rate is 21%, and total effective rate is 76.6%, apparently higher than matched group (7,2%).Hemogram and hepatic and renal function do not have significant change before and after the test, illustrate that the Tang An sublingual lozenge is to the healthy no obvious damage of experimenter.This shows that the Tang An sublingual lozenge has the effect of blood sugar lowering and blood lipid regulation.
Claims (8)
1, the health food or the medicine of a kind of prevention and treatment type ii diabetes is characterized in that it is to be made by the following weight proportion raw material:
Ginsenoside: 0.5-1.5 part gypenoside: 1.5-4 part
Fructus Momordicae charantiae extract: 0.1-1.2 part mannitol: 30-50 part
Xylitol: 30-50 part aspartame: 1-5 part
Citric acid: 1-5 part Polyethylene Glycol: 2-12 part.
2, the health food or the medicine of prevention according to claim 1 and treatment type ii diabetes is characterized in that wherein the weight proportion of each component is:
Ginsenoside: 0.8-1.2 part gypenoside: 2-3 part
Fructus Momordicae charantiae extract: 0.3-1 part mannitol: 35-45 part
Xylitol: 35-45 part aspartame: 2-4 part
Citric acid: 2-4 part Polyethylene Glycol: 4-10 part.
3, the health food or the medicine of prevention according to claim 1 and treatment type ii diabetes is characterized in that wherein the weight proportion of each component is:
Ginsenoside: 1.0 parts of gypenosides: 2.6 parts
Fructus Momordicae charantiae extract: 0.4 portion of mannitol: 42 parts
Xylitol: 40 parts of aspartames: 3 parts
Citric acid: 3 parts of Polyethylene Glycol: 8 parts.
4, the health food or the medicine of prevention according to claim 1 and treatment type ii diabetes is characterized in that said health food or medicine are that any health food or medicine are learned upward said dosage form.
5, a kind of making according to any described prevention of claim 1 to 4 and the health food of treatment type ii diabetes or the method for medicine is characterized in that:
(1) Radix Ginseng is extracted its total Saponin, and be dried to powder;
(2) Herb Gynostemmae Pentaphylli is extracted its total Saponin, and be dried to powder;
(3) Fructus Momordicae charantiae is extracted its effective site, and be dried to powder; Or Fructus Momordicae charantiae fine straining postlyophilization become powder;
(4) choose mannitol, xylitol, Polyethylene Glycol and aspartame, citric acid by pharmacopeia and ministry standard;
Adopt solid dispersion technology to be made into several formulations above-mentioned effective site and active ingredient.
6, the health food or the medicine manufacture method of a kind of prevention according to claim 5 and treatment type ii diabetes is characterized in that: utilize solid dispersion technology that three kinds of effective sites and effective ingredient are made microcapsule with Polyethylene Glycol, play slow releasing function.
7, the health food or the medicine manufacture method of a kind of prevention according to claim 5 and treatment type ii diabetes, it is characterized in that: various compositions fully stir, in order to dry granulation.
8, the health food or the medicine manufacture method of a kind of prevention according to claim 5 and treatment type ii diabetes is characterized in that: can reduce technological process on the basis of dry granulation, directly make granule, dress up capsule, be pressed into tablet.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2004100064368A CN100353948C (en) | 2004-03-08 | 2004-03-08 | Prescription for treating type 2 diabetes and its preparing method |
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| Application Number | Priority Date | Filing Date | Title |
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| CNB2004100064368A CN100353948C (en) | 2004-03-08 | 2004-03-08 | Prescription for treating type 2 diabetes and its preparing method |
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| CN1666751A CN1666751A (en) | 2005-09-14 |
| CN100353948C true CN100353948C (en) | 2007-12-12 |
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Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN105250508A (en) * | 2015-10-13 | 2016-01-20 | 六枝祥晖民族民间中医药开发研究所 | Medicine for treating diabetes and preparation method thereof |
| CN111067094B (en) * | 2019-11-28 | 2022-08-30 | 广东省农业科学院蚕业与农产品加工研究所 | Non-bitter gourd triterpene composition for inhibiting gluconeogenesis and application thereof |
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Non-Patent Citations (3)
| Title |
|---|
| 中药及其复方制剂治疗II型糖尿病的研究概况 王梅芳等.中成药，第23卷第4期 2001 * |
| 中药活性成分的降血糖作用及其治疗II型糖尿病研究进展 吴忠忱.中国中药杂志，第23卷第2期 1998 * |
| 中药片剂有效成分溶出速率存在的问题分析及对策思路 刘华钢.中成药，第22卷第6期 2000 * |
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Addressee: Sun Minfu Document name: Written notice of preliminary examination of application for patent for invention |
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Assignee: YANTAI KANGDAER PHARMACEUTICAL CO., LTD. Assignor: Sun Minfu Contract fulfillment period: 2008.11.25 to 2013.11.25 Contract record no.: 2008990001286 Denomination of invention: Prescription for treating type 2 diabetes and its preparing method Granted publication date: 20071212 License type: Exclusive license Record date: 20081127 |
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Free format text: EXCLUSIVE LICENSE; TIME LIMIT OF IMPLEMENTING CONTACT: 2008.11.25 TO 2013.11.25; CHANGE OF CONTRACT Name of requester: YINTAI KANGDAER PHARMACEUTICAL CO., LTD. Effective date: 20081127 |
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Address after: 100102, Beijing, Chaoyang District, Wangjing Kai Yang Road, No. 4 light building, 16 floor Patentee after: Sun Minfu Address before: 264006 No. 32, Yantai Development Zone, Yantai, Shandong, Zhujianglu Road Patentee before: Sun Minfu |
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Granted publication date: 20071212 Termination date: 20140308 |