CN103599343B - A kind of pharmaceutical composition for the treatment of diabetes and its production and use - Google Patents
A kind of pharmaceutical composition for the treatment of diabetes and its production and use Download PDFInfo
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Abstract
The invention provides a kind of pharmaceutical composition for the treatment of diabetes, it is the preparation be prepared from by the crude drug comprising following weight proportion: Rhizoma Coptidis 10-60 part, Radix Asparagi 10-60 part, Radix Rehmanniae 10-60 part, Fructus Mume 10-60 part, Radix Ginseng 5-20 part, Cortex Cinnamomi 2-12 part.Present invention also offers preparation method and the purposes of this pharmaceutical composition.The present invention's test shows, pharmaceutical composition compatibility of the present invention is precise and appropriate, effectively can reduce blood glucose, and its drug activity is significantly better than classical side Lian Meitang and Jiao Tai ball, for the clinical application for the treatment of diabetes provides new selection.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition for the treatment of diabetes and its production and use.
Background technology
Diabetes be by the various virulence factor such as inherited genetic factors, immunologic function disorder, infected by microbes and toxin thereof, free radical toxin, Nervous and Mental Factors act on body cause hypoinsulinism, insulin resistant etc. and cause a series of metabolism disorder syndrome such as sugar, protein, fat, water and eletrolytes, its pathomechanism is defect of insulin secretion or insulin action defect mainly.Main feature is that blood glucose is too high, glycosuria, polyuria, polydipsia, polyphagia, become thin, tired.Diabetes are mainly divided into four large classes, i.e. type 1 diabetes, type 2 diabetes mellitus, other specific type diabetes and gestational diabetes.In recent years, diabetes have become the third-largest disease of serious harm human health after tumor, cardiovascular and cerebrovascular disease.Whole world diabetics number cumulative year after year.Within 2008, China's diabetics has 4,300 ten thousand, annual increase about 1,200,000 people, and every day increases by about 3000 people, becomes global diabetics number first big country.Wherein, type 2 diabetes mellitus account for about 95% in diabetics.Therefore, strengthen and prevent and treat diabetes, particularly the dynamics of type 2 diabetes mellitus becomes the task of top priority.
At present, Drug therapy type 2 diabetes mellitus is main mainly with Western medicine.Mainly contain following a few class hypoglycemic medicine, as insulin secretion stimulators, it represents medicine is glimepiride, glibenclamide (yellow sulfonylurea); Biguanides, representing medicine is metformin; Euglycemic agent, representing medicine has troglitazone, rosiglitazone and pioglitazone (thiazolidinediones); Small intestinal alpha-glucosidase inhibitor, representing medicine has acarbose (acarbose); Aldose reductase inhibitor, representing medicine has tolrestat and epalrestat; Non-yellow ureide derivative Insulin-secreting agent, representing medicine is repaglinide, Nateglinide, etc.Western medicine type 2 diabetes mellitus, has the advantage effectively controlling post-prandial glycemia, but long-term taking, easily produce toleration, also can bring larger side effect to health.
Chinese medicine has certain advantage in treatment diabetes: toxic and side effects is little, is suitable for long-term taking; Medicine source is wide, not easily produces toleration.In recent years, the domestic single medicinal material having found to have hypoglycemic activity has just exceeded 60 kinds, also in succession have developed multiple blood sugar lowering Chinese patent medicine, such as, patent of invention 200710300014.5, denomination of invention: the Chinese patent medicine and the production technology thereof that are used for the treatment of diabetes, which disclose a kind of Chinese patent medicine for the treatment of diabetes, it is containing, for example lower raw material: Radix Ophiopogonis, Radix Asparagi, Radix Scrophulariae, Rhizoma Coptidis, Rhizoma Alismatis, Poria, Cortex Lycii, the Radix Astragali, Fructus Corni, Fructus Lycii, Radix Rehmanniae, Radix Rehmanniae Preparata, Radix Trichosanthis, Radix Ginseng, Cornu Cervi Pantotrichum, Bombyx Batryticatus, its energy enhancing body is to the sensitivity of insulin, reduce blood glucose, blood fat and conditioning internal organs, nourishing the liver and kidney.Number of patent application: 97100874.4, denomination of invention: the formula of kebixiao pill, kebixiao plaster and production method, the medicine of a kind for the treatment of of the inside combined with the outside treatment diabetes is also provided in this application, wherein, the prescription of medicine for external use comprises the 20 multi-flavor medical materials such as raw Carapax Trionycis, Fructus Schisandrae Chinensis, Cortex Lycii, Radix Rehmanniae Preparata, Radix Rehmanniae, Radix Asparagi, Radix Ophiopogonis, Fructus Mume, Radix Polygoni Multiflori, Radix Codonopsis, Rhizoma Coptidis, Radix Scrophulariae, the Radix Astragali, Poria, the Rhizoma Anemarrhenae, Rhizoma Alismatis, Radix Sophorae Flavescentis, Radix Puerariae, Rhizoma Dioscoreae, Herba Spirodelae grass, mussel powder, Pancreas Sus domestica gland.Lu Xiong etc. study discovery, the Rat Model of Type 2 Diabetes of safe ball (Rhizoma Coptidis: Cortex Cinnamomi=1:1) to the injection of high glucose and high fat forage feed associating low dosage streptozotocin is handed over to have the effect of blood sugar lowering and serum triglycerides, but body weight, insulin level are not made significant difference, its mechanism may (Lu Xiong relevant to improving insulin sensitivity, Deng, hand over the experimentation of safe ball blood sugar reducing function, Liaoning Journal of Traditional Chinese Medicine, 34 volume 9 phases in 2007).
Summary of the invention
The object of the present invention is to provide a kind of pharmaceutical composition for the treatment of diabetes and its production and use.
The invention provides a kind of pharmaceutical composition for the treatment of diabetes, it is the preparation be prepared from by the crude drug comprising following weight proportion:
Rhizoma Coptidis 10-60 part, Radix Asparagi 10-60 part, Radix Rehmanniae 10-60 part, Fructus Mume 10-60 part, Radix Ginseng 5-20 part, Cortex Cinnamomi 2-12 part.
Further, it is the preparation be prepared from by the crude drug comprising following weight proportion:
Rhizoma Coptidis 30 parts, Cortex Cinnamomi 6 parts, Radix Ginseng 15 parts, Radix Asparagi 30 parts, Radix Rehmanniae 30 parts, Fructus Mume 30 parts.
Further, it is the preparation be prepared from by the crude drug of following weight proportion:
Rhizoma Coptidis 25-35 part, Cortex Cinnamomi 4-8 part, Radix Ginseng 12-18 part, Radix Asparagi 25-35 part, Radix Rehmanniae 25-35 part, Fructus Mume 25-35 part.
Preferably, it is the preparation be prepared from by the crude drug of following weight proportion:
Rhizoma Coptidis 30 parts, Cortex Cinnamomi 6 parts, Radix Ginseng 15 parts, Radix Asparagi 30 parts, Radix Rehmanniae 30 parts, Fructus Mume 30 parts.
Further, described Radix Rehmanniae is selected from Radix Rehmanniae.
In this pharmaceutical composition, Rhizoma Coptidis, bitter cold blood sugar lowering is monarch drug; Fructus Mume, sour in the mouth, blood sugar lowering promotes the production of body fluid; The Radix Rehmanniae, clearing away heat and cooling blood YIN nourishing and the production of body fluid promoting; Radix Asparagi, YIN nourishing and the production of body fluid promoting; Be ministerial drug altogether; Radix Ginseng, protection islet cells, strongly invigorating primordial QI; Cortex Cinnamomi, warming and recuperating the gate of life, the nature and flavor of restriction Rhizoma Coptidis bitter cold; Share with Rhizoma Coptidis, restoring normal coordination between the heart and kidney is adjuvant drug altogether.After above-mentioned each medicine compatibility, played synergism, drug action significantly strengthens.
Present invention also offers said medicine at the hypoglycemic medicine of preparation or/and purposes in health product.
Further, described medicine is or/and health product are that treatment or the medicine that prevents diabetes are or/and health product.
Further, described diabetes are type 2 diabetes mellitus.
The present invention's test shows, pharmaceutical composition compatibility of the present invention is precise and appropriate, effectively can reduce blood glucose, and its drug activity is significantly better than classical side Lian Meitang and Jiao Tai ball, for the clinical application for the treatment of diabetes provides new selection.
Detailed description of the invention
The preparation of embodiment 1 pharmaceutical composition of the present invention
Get Rhizoma Coptidis 30g, Cortex Cinnamomi 6g, Radix Ginseng 15g, Radix Asparagi 30g, Radix Rehmanniae 30g, Fructus Mume 30g; Add 8 times amount soak by water 3 times, each 0.5h, merge decocting liquid, filter, after filtrate is concentrated, add suitable soluble starch, granulate.
The preparation of embodiment 2 pharmaceutical composition of the present invention
Get Rhizoma Coptidis 30g, Cortex Cinnamomi 6g, Radix Ginseng 15g, Radix Asparagi 30g, Radix Rehmanniae 30g, Fructus Mume 30g; Add 8 times amount soak by water 3 times, each 0.5h, merge decocting liquid, filter, filtrate is concentrated, after drying, add appropriate microcrystalline Cellulose, mixing, encapsulated.
The preparation of embodiment 3 pharmaceutical composition of the present invention
Get Rhizoma Coptidis 35g, Cortex Cinnamomi 4g, Radix Ginseng 12g, Radix Asparagi 25g, Radix Rehmanniae 25g, Fructus Mume 25g, add 80%v/v alcohol reflux 2 times, alcohol extract is for subsequent use; Medicinal residues add 8 times amount soak by water 2 times, merge decocting liquid; Alcohol extract merges with decocting liquid after reclaiming ethanol, after concentrated, adds suitable soluble starch, granulates, obtains granule.
The preparation of embodiment 4 pharmaceutical composition of the present invention
Get Rhizoma Coptidis 25g, Cortex Cinnamomi 8g, Radix Ginseng 18g, Radix Asparagi 35g, Radix Rehmanniae 35g, Fructus Mume 35g, beat powder, sieve, add appropriate microcrystalline Cellulose, namely mixing, encapsulatedly obtain capsule.
Beneficial effect of the present invention is illustrated below by way of test example.
The therapeutical effect of test example 1 diabetes
1, trial drug
Rhizoma Coptidis group: get Rhizoma Coptidis single medical material appropriate
Fructus Mume group: get Fructus Mume single medical material appropriate
Hand over safe ball group: Rhizoma Coptidis: Cortex Cinnamomi=30:30
Lian Meitang group: Coptis Teeta Wall: Fructus Mume: Radix Ophiopogonis: the Radix Rehmanniae: Colla Corii Asini=30:45:45:45:30
Rhizoma Coptidis+Fructus Mume group: Rhizoma Coptidis: Fructus Mume=30:30
The Radix Rehmanniae+Radix Asparagi+Rhizoma Coptidis+Fructus Mume group, the Radix Rehmanniae: Radix Asparagi: Rhizoma Coptidis: Fructus Mume=30:30:30:30
The Radix Rehmanniae+Radix Asparagi+Rhizoma Coptidis+Fructus Mume+Radix Ginseng+Cortex Cinnamomi group, the Radix Rehmanniae: Radix Asparagi: Rhizoma Coptidis: Fructus Mume=30:30:30:30:15:6
Above-mentioned each group of medical material, adds 8 times of soak by water 3 times respectively, merges decocting liquid, after concentrating in right amount, for subsequent use, is trial drug.
2, test method
Experiment divides 8 groups, often organizes 12 Wistar rats, adopts lumbar injection STZ55mg/Kg modeling.Except model group, all treatment rats equal Chinese medicine gavage 8 weeks (W), each Chinese drug-treated group dosage is this dosage of 20mg/Kg(and calculates with crude drug in whole).Detect fasting glucose (FPG) and 2h-plasma glucose (2hPG).
3, result of the test
See table.
Table 1
Statistic software SPSS 16.0, statistical method: single factor test variance ratio is comparatively.Statistical result:
Rhizoma Coptidis+Fructus Mume group compares with Rhizoma Coptidis group, P<0.05;
Rhizoma Coptidis+Fructus Mume group compares with Fructus Mume group, P<0.01;
Rhizoma Coptidis+Fructus Mume group compares with Lian Meitang group, P>0.05;
The Radix Rehmanniae+Radix Asparagi+Rhizoma Coptidis+Fructus Mume group compares with Rhizoma Coptidis group, P<0.01;
The Radix Rehmanniae+Radix Asparagi+Rhizoma Coptidis+Fructus Mume group compares with Fructus Mume group, P<0.01;
The Radix Rehmanniae+Radix Asparagi+Rhizoma Coptidis+Fructus Mume group compares with Lian Meitang, P<0.05;
The Radix Rehmanniae+Radix Asparagi+Rhizoma Coptidis+Fructus Mume group compares with the safe ball group of friendship, P>0.05;
The Radix Rehmanniae+Radix Asparagi+Rhizoma Coptidis+Fructus Mume+Radix Ginseng+Cortex Cinnamomi group compares with Lian Meitang group, P<0.05;
The Radix Rehmanniae+Radix Asparagi+Rhizoma Coptidis+Fructus Mume+Radix Ginseng+Cortex Cinnamomi group compares with the safe ball group of friendship, P<0.05;
The Radix Rehmanniae+Radix Asparagi+Rhizoma Coptidis+Fructus Mume+Radix Ginseng+Cortex Cinnamomi group compares with Rhizoma Coptidis group, P<0.01;
The Radix Rehmanniae+Radix Asparagi+Rhizoma Coptidis+Fructus Mume+Radix Ginseng+Cortex Cinnamomi group compares with Fructus Mume group, P<0.01;
Model group compares P<0.01 with each group.
From the above results:
(1) in the present invention by after Rhizoma Coptidis and Fructus Mume conbined usage, its blood sugar reducing function is obviously better than Rhizoma Coptidis, Fructus Mume is alone, has played synergistic function after showing both compatibilities; Meanwhile, compared with classics side Lian Meitang, Rhizoma Coptidis Fructus Mume group of the present invention obviously reduces flavour of a drug, and changes the compatibility consumption of Rhizoma Coptidis and Fructus Mume, and its drug activity is suitable with Lian Meitang.
(2), after Rhizoma Coptidis, Fructus Mume and the Radix Rehmanniae, Radix Asparagi compatibility use by the present invention, its blood sugar reducing function is obviously better than single medicine, shows that above-mentioned compatibility has played synergistic function; Meanwhile, compared with classics side Lian Meitang, its 2h-plasma glucose value is lower, and compares between group and have statistical significance (p<0.05), illustrates that present composition drug action is stronger.
(3), after Rhizoma Coptidis, Fructus Mume and the Radix Rehmanniae, Radix Asparagi, Radix Ginseng, Cortex Cinnamomi compatibility use by the present invention, its blood sugar reducing function is obviously better than classical side Lian Meitang and Jiao Tai ball, and after showing said medicine compatibility, played synergism, drug action significantly strengthens.
The present invention's test shows, pharmaceutical composition compatibility of the present invention is precise and appropriate, effectively can reduce blood glucose, and its drug activity is significantly better than classical side Lian Meitang and Jiao Tai ball, for the clinical application for the treatment of diabetes provides new selection.
Claims (8)
1. treat a pharmaceutical composition for diabetes, it is characterized in that: it is the preparation be prepared from by the crude drug of following weight proportion:
Rhizoma Coptidis 25-35 part, Cortex Cinnamomi 4-8 part, Radix Ginseng 12-18 part, Radix Asparagi 25-35 part, Radix Rehmanniae 25-35 part, Fructus Mume 25-35 part.
2. pharmaceutical composition according to claim 1, is characterized in that: it is the preparation be prepared from by the crude drug of following weight proportion:
Rhizoma Coptidis 30 parts, Cortex Cinnamomi 6 parts, Radix Ginseng 15 parts, Radix Asparagi 30 parts, Radix Rehmanniae 30 parts, Fructus Mume 30 parts.
3. pharmaceutical composition according to claim 1 and 2, is characterized in that: described Radix Rehmanniae is selected from Radix Rehmanniae.
4. pharmaceutical composition according to claim 1 and 2, is characterized in that: described preparation is oral formulations.
5. the preparation method of pharmaceutical composition described in claim 1-4 any one, is characterized in that: it comprises following operating procedure:
(1) each crude drug is taken by weight ratio;
(2) each crude drug directly pulverized or add water or/and after ethanol extraction, adding adjuvant conventional in pharmacy or health product or complementary composition, be prepared into conventional preparation.
6. the pharmaceutical composition described in claim 1-4 any one at the hypoglycemic medicine of preparation or/and purposes in health product.
7. purposes according to claim 6, is characterized in that: described medicine is or/and health product are that treatment or the medicine that prevents diabetes are or/and health product.
8. purposes according to claim 6, is characterized in that: described diabetes are type 2 diabetes mellitus.
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| CN106214787B (en) * | 2016-09-20 | 2019-10-29 | 中国中医科学院西苑医院 | A kind of Chinese medicine composition for treating diabetes and preparation method thereof and purposes |
| CN106421342A (en) * | 2016-10-20 | 2017-02-22 | 湖北三峡神农生物科技有限公司 | Pill composition with rhizoma anemarrhenae and coptis chinensis as well as effect of reducing blood sugar or blood lipid and detection method thereof |
| CN114712454A (en) * | 2022-03-11 | 2022-07-08 | 广州中医药大学科技产业园有限公司 | Application of pharmaceutical composition in preparation of medicines for treating cardiovascular diseases |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101856458A (en) * | 2010-06-10 | 2010-10-13 | 成都市翻鑫家科技有限公司 | Chinese medicament for treating diabetes mellitus |
| CN102441064A (en) * | 2011-12-27 | 2012-05-09 | 西南大学 | Traditional Chinese medicine composition for treating diabetes and preparation thereof |
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Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101856458A (en) * | 2010-06-10 | 2010-10-13 | 成都市翻鑫家科技有限公司 | Chinese medicament for treating diabetes mellitus |
| CN102441064A (en) * | 2011-12-27 | 2012-05-09 | 西南大学 | Traditional Chinese medicine composition for treating diabetes and preparation thereof |
Non-Patent Citations (2)
| Title |
|---|
| 养阴法在消渴病各阶段治疗中的应用;张龙等;《辽宁中医药大学学报》;20120331;第14卷(第3期);148-150 * |
| 黄连为主药系列经方在糖尿病辩证中的运用;仝小林;《中医杂志》;20130228;第54卷(第3期);209-211 * |
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