CN102631526A - Chinese medicinal composition for treating diabetes mellitus - Google Patents
Chinese medicinal composition for treating diabetes mellitus Download PDFInfo
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Abstract
The invention discloses a Chinese medicinal composition for treating diabetes mellitus and a preparation thereof. The Chinese medicinal composition is prepared to form a certain preparation in the following steps: extracting and separating mulberry twig, mulberry leaf, dogwood, rhizoma anemarrhenae, prepared rehmannia and golden thread with 0 to 75 percent ethanol. The six medicaments are combined, so that the Chinese medicinal composition has the functions of tonifying kidney and consolidating vital energy, nourishing yin and gathering essence, clearing heat and purging intense heat, and reducing blood sugar and quenching thirst, and is used for treating light and moderate diabetes mellitus. Pharmacodynamic researches prove that: the medicinal composition can remarkably reduce the high blood sugar value of a streptozotocin and alloxan induced diabetes mellitus experimental diabetic model, and can remarkably reduce the sugar tolerance of a mice.
Description
Technical field
The invention belongs to medical technical field, relate to a kind of medicine or health food of treating diabetes, is the Chinese medicine composition that comprises Ramulus Mori, Folium Mori, Fructus Corni, the Rhizoma Anemarrhenae, Radix Rehmanniae Preparata, Rhizoma Coptidis specifically.
Background technology
Diabetes are the not normal property of a kind of common, multiple endocrine metabolism diseases, have the advantages that difficulty is effected a radical cure, complication is many, sickness rate is high.Because whole body hypoinsulinism or effect defective, or cause that owing to both exist simultaneously carbohydrate metabolism disturbance is main, comprise fat and protein metabolism disorder, clinical with hyperglycemia and polyuria, polyphagia, to become thin be characteristics.Because of its sickness rate, disability rate and mortality rate increase day by day, become the third-largest disease after cardiovascular diseases, tumor at present, Hesperian sickness rate is up to 2～5%, and China is 1.5～2.3%.Estimate that according to WHO by 2025, global maturity-onset diabetes patient's number will increase to 300,000,000, the expense of China's annual treatment diabetes up to 80,000,000,000 yuan about, diabetes will be serious public hygienic issues of China in following 50 years.Therefore, the research and development of treatment diabetes medicament have important society and economic implications.
For treatment of diabetes, doctor trained in Western medicine adopts sulphanylureas, glucosidase inhibitor class, biguanides, MEGLITINIDE class and Thiazolidine class more at present, and above-mentioned medicine side effect is big, is cost with other organs of infringement human body often; And problems such as later stage secondary failure are arranged.Diabetes spp is the traditional Chinese medical science " diabetes " category, and Chinese traditional treatment is should disease many from integral body, and determination of treatment based on pathogenesis obtained through differentiation of symptoms and signs has stable curative effect, characteristics that toxic and side effects is little, and to be that the advantage of Chinese medicine is sick plant diabetes.Though the Chinese patent medicine kind of treatment diabetes is many at present; But because of dialectical execute control, the difference of aspect such as composition of prescription, dosage form, processing technique; Curative effect is widely different, up to now, does not still have a kind of medicine fully up to expectations aspect curative effect, side reaction and prevent diabetes.Therefore, research and development good effect, few side effects and the modern preparation of blood sugar lowering Chinese medicine little, treating both the principal and secondary aspects of a disease have become the research focus.
Because the deficiency of YIN is scorching to be the total pathogenesis of diabetes, the deficiency of YIN is this, and is scorching for marking; Therefore; The present invention adopts Fructus Corni, Radix Rehmanniae Preparata, the Rhizoma Anemarrhenae, Rhizoma Coptidis, Ramulus Mori, Folium Mori composition of prescription, and said composition has nourishing kidney and consolidates, and tonifying YIN is held back essence; The effect that clearing away heat-fire, blood sugar lowering quench the thirst, it is remarkable to reduce experimental diabetic animal hyperglycemia drug effect.
Summary of the invention
The purpose of this invention is to provide a kind of Chinese medicine composition and preparation thereof that is used to treat diabetes.
The present invention treats the pharmaceutical composition of diabetes, comprises following Chinese medicinal raw materials in portion by weight: 2～8 parts of Fructus Corni, 2～8 parts of the Rhizoma Anemarrhenaes, 2～9 parts of Radix Rehmanniae Preparata, 1～3 part of Rhizoma Coptidis.
2～6 parts on all right further 2～6 parts of compatibility Ramulus Moris of the raw material of Chinese medicine of aforementioned pharmaceutical compositions and/or Folium Mori.
Preferably, said Chinese medicine composition is processed by following Chinese medicinal raw materials in portion by weight: 2～8 parts of Fructus Corni, 2～8 parts of the Rhizoma Anemarrhenaes, 2～9 parts of Radix Rehmanniae Preparata, 1～3 part of Rhizoma Coptidis, 2～6 parts on Folium Mori.
Also preferred, said Chinese medicine composition is processed by following Chinese medicinal raw materials in portion by weight: 2～8 parts of Fructus Corni, 2～8 parts of the Rhizoma Anemarrhenaes, 2～9 parts of Radix Rehmanniae Preparata, 1～3 part of Rhizoma Coptidis, 2～6 parts of Ramulus Moris.
Also preferred, said Chinese medicine composition is processed by following Chinese medicinal raw materials in portion by weight: 2～8 parts of Fructus Corni, 2～8 parts of the Rhizoma Anemarrhenaes, 2～9 parts of Radix Rehmanniae Preparata, 1～3 part of Rhizoma Coptidis, 2～6 parts on Folium Mori, 2～6 parts of Ramulus Moris.
Aforementioned pharmaceutical compositions is taken after can decocting, also can water or ethanol extraction after take.
The method for preparing of drug combination preparation of the present invention can adopt the conventional method of pharmaceutical field, uses conventional pharmaceutic adjuvant to carry out.For example adopt conventional method that carrier or adjuvant commonly used on extract and any one or more than one pharmaceutics mixed, process various peroral dosage forms then.Described carrier is excipient, filler, diluent, lubricant, wetting agent, disintegrating agent, surfactant, antiseptic, sweeting agent, aromatic etc. for example.Particularly, for example starch, dextrin, lactose, microcrystalline Cellulose, hydroxypropyl methylcellulose, Polyethylene Glycol, magnesium stearate, micropowder silica gel, glucose, mannitol, xylitol, glycine etc. of said carrier.
As required, pharmaceutical composition of the present invention can be made into the preparation that is suitable for oral medication, can be following arbitrary dosage form: tablet, capsule, granule, pill, oral liquid etc., preferred soft capsule, dispersible tablet, oral cavity disintegration tablet, drop pill.
Another object of the present invention is that a kind of preferred manufacturing procedure also is provided, and the method for preparing of the Chinese medicine composition of treatment diabetes promptly is provided, and this method comprises the steps:
In raw material of Chinese medicine, add 0～70% ethanol, extract 2～3 times, add 4～12 times of amount solvents at every turn; The each extraction 1～2 hour, extracting solution filters, and reclaims solvent and also concentrates, and drying is pulverized, as the raw material of composite preparation.
Another purpose of the present invention provides the application of this pharmaceutical composition in the treatment diabetes.
The present invention's flavour of a drug of writing out a prescription share, and have nourishing kidney and consolidate, and tonifying YIN is held back essence, the function that clearing away heat-fire, blood sugar lowering quench the thirst.The pharmacological research of the compositions that this side is extracted shows that said composition all has the specificity hypoglycemic activity to multiple diabetes experimental animal model, and can significantly reduce the animal carbohydrate tolerance.
The specific embodiment
For the present invention is carried out detailed description further, provide specific embodiment, but only the present invention is illustrated in conduct, rather than in order to limit scope of the present invention.
The granule dosage form of embodiment 1 pharmaceutical composition of the present invention
Adopt conventional preparation granule method, get 8 parts of Fructus Corni, 8 parts of the Rhizoma Anemarrhenaes, 9 parts of Radix Rehmanniae Preparata, 3 parts of Rhizoma Coptidis, 6 parts on Folium Mori, 6 parts of Ramulus Moris, soak after 0.5 hour and extract 2 times, amount of water is respectively 10 times, 8 times; Extracted 2 hours for the first time, extracted 1.5 hours for the second time, filter merging filtrate; Concentrate, dry, add right amount of auxiliary materials after pulverizing, mixing is granulated; Sieve, drying makes the drug combination preparation of granule dosage form.
The Tabules of embodiment 2 pharmaceutical compositions of the present invention
Adopt the conventional method for preparing tablet, get 6 parts of Fructus Corni, 6 parts of the Rhizoma Anemarrhenaes, 9 parts of Radix Rehmanniae Preparata, 2 parts of Rhizoma Coptidis, 5 parts on Folium Mori, 5 parts of Ramulus Moris, add 70% soak with ethanol and extract 2 times after 0.5 hour, amount of water is respectively 6 times, 4 times; Extracted 2 hours for the first time, extracted 1 hour for the second time, filter merging filtrate; Concentrate, dry, add right amount of auxiliary materials after pulverizing, mixing is granulated, and sieves; Drying, through further tabletting, drying promptly makes the drug combination preparation of Tabules with the granule that makes.
The capsule dosage form of embodiment 3 pharmaceutical compositions of the present invention
Adopt the conventional method for preparing capsule, get 4 parts of Fructus Corni, 4 parts of the Rhizoma Anemarrhenaes, 5 parts of Radix Rehmanniae Preparata, 1 part of Rhizoma Coptidis, 5 parts on Folium Mori, 5 parts of Ramulus Moris, add 60% soak with ethanol and extract 2 times after 0.5 hour, amount of water is respectively 7 times, 5 times; Extracted 2 hours for the first time, extracted 1 hour for the second time, filter merging filtrate; Concentrate, dry, add right amount of auxiliary materials after pulverizing, mixing is granulated, and sieves; Drying incapsulates shell with the granule that makes, and processes capsule, promptly makes the drug combination preparation of capsule formulation.
The drops of embodiment 4 present compositions
Preparation: adopt the technology of conventional preparation drop pill, get 2 parts of Fructus Corni, 2 parts of the Rhizoma Anemarrhenaes, 2 parts of Radix Rehmanniae Preparata, 1 part of Rhizoma Coptidis, 2 parts on Folium Mori, 2 parts of Ramulus Moris, add 50% soak with ethanol and extract 2 times after 0.5 hour; Amount of water is respectively 6 times, 4 times, extracts 2 hours for the first time, extracts 1 hour for the second time; Filter; Merging filtrate, concentrate, dry, add right amount of auxiliary materials after pulverizing, make the drop pill of this pharmaceutical composition.
The soft capsule dosage form of embodiment 5 present compositions
Preparation: adopt the technology of conventional preparation soft capsule, get 2 parts of Fructus Corni, 3 parts of the Rhizoma Anemarrhenaes, 4 parts of Radix Rehmanniae Preparata, 1 part of Rhizoma Coptidis, 3 parts on Folium Mori, 2 parts of Ramulus Moris, add 40% soak with ethanol and extract 2 times after 0.5 hour, amount of water is respectively 7 times, 5 times; Extracted 2 hours for the first time, extracted 1 hour for the second time, filter; Merging filtrate, concentrate, dry, add right amount of auxiliary materials, mixing after pulverizing; Make capsule casing material with gelatin, be pressed into soft capsule, make the soft capsule of this pharmaceutical composition.
The micropill dosage form of embodiment 6 present compositions
Preparation: adopt the technology of conventional preparation micropill, get 2 parts of Fructus Corni, 2 parts of the Rhizoma Anemarrhenaes, 2 parts of Radix Rehmanniae Preparata, 1.5 parts of Rhizoma Coptidis, 2 parts on Folium Mori, 2 parts of Ramulus Moris, add 30% soak with ethanol and extract 2 times after 0.5 hour; Amount of water is respectively 6 times, 4 times, extracts 2 hours for the first time, extracts 1 hour for the second time; Filter; Merging filtrate, concentrate, dry, add right amount of auxiliary materials after pulverizing, make the micropill of this pharmaceutical composition.
The oral cavity disintegration tablet of embodiment 7 present compositions
Preparation: adopt the technology of conventional preparation oral cavity disintegration tablet, get 2 parts of Fructus Corni, 2 parts of the Rhizoma Anemarrhenaes, 2 parts of Radix Rehmanniae Preparata, 1 part of Rhizoma Coptidis, 2 parts on Folium Mori, 2 parts of Ramulus Moris, add 50% soak with ethanol and extract 2 times after 0.5 hour; Amount of water is respectively 6 times, 4 times, extracts 2 hours for the first time, extracts 1 hour for the second time; Filter; Merging filtrate, concentrate, dry, add right amount of auxiliary materials after pulverizing, make the oral cavity disintegration tablet of this pharmaceutical composition.
The dispersible tablet of embodiment 8 present compositions
Preparation: adopt the technology of conventional preparation dispersible tablet, get 2 parts of Fructus Corni, 2 parts of the Rhizoma Anemarrhenaes, 2 parts of Radix Rehmanniae Preparata, 1 part of Rhizoma Coptidis, 2 parts on Folium Mori, 2 parts of Ramulus Moris, add 70% soak with ethanol and extract 2 times after 0.5 hour; Amount of water is respectively 6 times, 4 times, extracts 2 hours for the first time, extracts 1 hour for the second time; Filter; Merging filtrate, concentrate, dry, add right amount of auxiliary materials after pulverizing, make the dispersible tablet of this pharmaceutical composition.
The test of pesticide effectiveness of embodiment 9 present compositions
The purpose of this test is to observe the therapeutical effect of the present composition to the diabetes experimental animal model.Present composition A, B, C all adopt extractum, and the time spent is prepared desired concn with pure water, and other reagent chemicalses have streptozotocin, and (Streptozotcin STZ) and alloxan, is U.S. sigma chemical company product.Diformin tablet, the refined pharmaceutical Co. Ltd in Hunan, Hunan product.
Compositions A: get 4 parts of Fructus Corni, 4 parts of the Rhizoma Anemarrhenaes, 5 parts of Radix Rehmanniae Preparata, 1 part of Rhizoma Coptidis, 3 parts on Folium Mori, 3 parts of Ramulus Moris, soak after 0.5 hour and extract 2 times, amount of water is respectively 12 times, 10 times; Extracted 2 hours for the first time, extracted 1 hour for the second time, filter; Merging filtrate; Concentrate, drying gets compositions A dry extract after the pulverizing.
Compositions B: get 4 parts of Fructus Corni, 4 parts of the Rhizoma Anemarrhenaes, 5 parts of Radix Rehmanniae Preparata, 1 part of Rhizoma Coptidis, 3 parts on Folium Mori, add 50% soak with ethanol and extract 2 times after 0.5 hour, amount of water is respectively 8 times, 6 times; Extracted 2 hours for the first time, extracted 1 hour for the second time, filter; Merging filtrate; Concentrate, drying gets compositions B dry extract after the pulverizing.
Compositions C: get 4 parts of Fructus Corni, 4 parts of the Rhizoma Anemarrhenaes, 5 parts of Radix Rehmanniae Preparata, 1 part of Rhizoma Coptidis, 3 parts of Ramulus Moris, add 70% soak with ethanol and extract 2 times after 0.5 hour, amount of water is respectively 7 times, 5 times; Extracted 2 hours for the first time, extracted 1 hour for the second time, filter; Merging filtrate; Concentrate, drying gets compositions C dry extract after the pulverizing.
Laboratory animal: SPF level SD rat, 180～200g, male and female half and half are available from west, Shanghai pul-Bi Kai laboratory animal company limited, laboratory animal production licence number: SCXK (Shanghai) 2008-0016.SPF level kunming mice, 18～22g, male and female half and half reach the laboratory animal company limited available from Hunan Si Laike scape, production licence number SCXK (Hunan) 2009-0004.
This test data is checked between the result organizes with the t check analysis all with the EXCEL software processes.
1, STZ is caused the influence of rat diabetes model blood glucose
Fasting can't help water 14 hours before the modeling, tail vein injection STZ modeling, and modeling dosage is 50mg/kg, the administration volume is 1mL/kg.STZ is dissolved in that (pH=4.4) makes its solution that becomes 25mg/mL in the citrate buffer of freshly prepared 0.05mol/L, joins existing usefulness at present, and solution remains 4 ℃ during use, adopts tail vein injection at a slow speed, every rat about 60s inject time.
Measured rat fasting blood-glucose in 72 hours after the modeling, be higher than 16.65mmol/L and be regarded as the standard diabetes rat model.Then be grouped into 5 groups: model control group, positive drug control group, compositions A group, compositions B group and compositions C group by the blood glucose stratified random.Other adds the blank group, and experiment is divided into 6 groups, every group of 8 rats, male and female half and half.Each treated animal is administered once every day, administration volume 10mL/kg, and blank control group and model group give isopyknic distilled water.Successive administration 21 days.The result sees table 1.
Table 1 present composition causes the influence (n=8,
mmol/L) of blood glucose in diabetic rats to STZ
Annotate: model group and blank control group compare, * P≤0.05, * * P≤0.01; With the model group ratio,
#P≤0.05,
##P≤0.01
Can know that from table 1 compare with blank control group, each time point blood glucose value of model group animal significantly raises (P＜0.01), and the modeling success is described.Compare with model group, compositions A, B, C treated animal different time points blood glucose value behind medicine all has obvious reduction (P＜0.01).
2, alloxan is caused the influence of blood glucose in diabetic mice
Except that 10 of blank group mices, with 300 of healthy kunming mices, 24 hours lumbar injection alloxan of fasting 200mg/kg, choose after the 5th day blood glucose greater than the mice of 11.1mmol/L as model mice.Model mice is divided into 5 groups: model control group, positive drug control group, compositions A group, compositions B group, compositions C group, 10 every group.Other adds the blank group, and it is 6 groups that experiment is divided into.Be administered once every day, administration volume 20mL/k successive administration 15 days, and blank control group and model group give isopyknic distilled water.After the last administration 1 hour, the rathole socket of the eye was got blood from childhood, measured blood glucose value.The result sees table 2.
Table 2 present composition causes the influence (n=10,
mmol/L) of blood glucose in diabetic mice to alloxan
Annotate: model group and blank control group compare, * P≤0.05, * * P≤0.01; With the model group ratio,
#P≤0.05,
##P≤0.01
Can know that from table 2 compare with blank control group, the model group blood glucose value significantly raises (P＜0.01), and the modeling success is described.Compare with model group, the present composition all has reduction (P＜0.01 or P＜0.05) in various degree.
3, to the influence of mice carbohydrate tolerance
With 60 of healthy kunming mices, be divided into 6 groups at random, 10 every group, male and female half and half.Be respectively the blank group, model control group, positive drug control group, compositions A group, compositions B group and compositions C group.Measure a fasting glucose before the administration.Every day gastric infusion once; Continuous 7 days; Fasting was prohibited water 2 hours in 12 hours before the last administration, and all the other respectively organized the glucose solution 2.0g/kg (being equivalent to 8mL/kg) of equal lumbar injection 25% except that the blank group in 2 hours after the last administration; The blank group gives the distilled water of equivalent, gives behind the glucose solution 30,60,120, each group of 240min all cuts the tail blood sampling and measure blood glucose value and record.The result sees table 3.
Table 3 the present invention is to the influence (n=10,
mmol/L) of mice carbohydrate tolerance
Annotate: model group and blank control group compare, * P≤0.05, * * P≤0.01; With the model group ratio,
#P≤0.05,
##P≤0.01
Can know from table 3, compare, all significantly risings (P＜0.01) of different time points blood glucose value behind the model group medicine pneumoretroperitoneum injectable dextrose monohydrate with blank control group.Compare with model group, present composition B, compositions C 30min behind injectable dextrose monohydrate all has obvious decline (P＜0.05); Compositions A 30min, 60min time point blood glucose value behind injectable dextrose monohydrate significantly reduce (P＜0.01 or P＜0.05).
Pharmacological tests shows that pharmaceutical composition of the present invention has significant reduction effect, and can obviously reduce the mice carbohydrate tolerance streptozotocin, the inductive animal hyperglycemia of alloxan.
Claims (14)
1. a Chinese medicine composition that is used to treat diabetes is characterized in that: comprise following Chinese medicinal raw materials in portion by weight: 2～8 parts of Fructus Corni, 2～8 parts of the Rhizoma Anemarrhenaes, 2～9 parts of Radix Rehmanniae Preparata, 1～3 part of Rhizoma Coptidis.
2. the Chinese medicine composition that is used to treat diabetes according to claim 1 is characterized in that: 2～6 parts of further compatibility Ramulus Moris and/or Folium Mori are 2～6 parts in the raw material of Chinese medicine.
3. according to each described Chinese medicine composition that is used to treat diabetes of claim 1-2, it is characterized in that processing: 2～8 parts of Fructus Corni, 2～8 parts of the Rhizoma Anemarrhenaes, 2～9 parts of Radix Rehmanniae Preparata, 1～3 part of Rhizoma Coptidis, 2～6 parts of Ramulus Moris by following Chinese medicinal raw materials in portion by weight.
4. according to each described Chinese medicine composition that is used to treat diabetes of claim 1-2, it is characterized in that processing: 2～8 parts of Fructus Corni, 2～8 parts of the Rhizoma Anemarrhenaes, 2～9 parts of Radix Rehmanniae Preparata, 1～3 part of Rhizoma Coptidis, 2～6 parts on Folium Mori by following Chinese medicinal raw materials in portion by weight.
5. according to each described Chinese medicine composition that is used to treat diabetes of claim 1-2, it is characterized in that: process: 2～8 parts of Fructus Corni, 2～8 parts of the Rhizoma Anemarrhenaes, 2～9 parts of Radix Rehmanniae Preparata, 1～3 part of Rhizoma Coptidis, 2～6 parts on Folium Mori, 2～6 parts of Ramulus Moris by following Chinese medicinal raw materials in portion by weight.
6. according to each described Chinese medicine composition that is used to treat diabetes of claim 1-2, it is characterized in that: said composition is processed acceptable forms clinically.
7. according to each described Chinese medicine composition that is used to treat diabetes of claim 1-2, it is characterized in that: said composition is processed tablet, capsule, granule, pill, oral liquid.
8. according to each described Chinese medicine composition that is used to treat diabetes of claim 1-2, it is characterized in that: said composition is processed soft capsule, dispersible tablet, oral cavity disintegration tablet, drop pill.
9. according to each described Chinese medicine composition that is used to treat diabetes of claim 1-2, it is characterized in that: with adding 0～70% ethanol in the crude drug, extract 2～3 times, add 4～12 times of amount solvents at every turn; The each extraction 1～2 hour, extracting solution filters, and reclaims solvent and concentrate preparation promptly to get.
10. according to each described method for preparing that is used to treat the Chinese medicine composition of diabetes of claim 1-2, it is characterized in that: with adding 0～70% ethanol in the crude drug, extract 2～3 times, add 4～12 times of amount solvents at every turn; The each extraction 1～2 hour, extracting solution filters, and reclaims solvent and concentrates preparation.
11. method for preparing according to claim 10 is characterized in that adding 0～70% ethanol, extracts 2 times, adds 4～10 times of amount solvents at every turn; The each extraction 1～2 hour, extracting solution filters, and reclaims solvent and concentrates preparation.
12. method for preparing according to claim 10 is characterized in that adding 0～70% ethanol, extracts 2 times, adds the solvent that 6-10 doubly measures for the first time, extracts 2 hours, adds the solvent that 4-8 doubly measures for the second time, extracts 1 hour; Extracting solution filters, and reclaims solvent and concentrates preparation.
13., it is characterized in that adding 70% ethanol extraction according to each described method for preparing of claim 11-12.
14. treat the medicine of diabetes and/or the application in the health food in preparation according to each described Chinese medicine composition of claim 1-2.
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| CN103110825B (en) * | 2013-02-19 | 2014-08-20 | 青岛正大海尔制药有限公司 | Medicinal composition for treating diabetes and preparation method thereof |
| CN103735719A (en) * | 2014-01-12 | 2014-04-23 | 万世凤 | Method for preparing compound coptis root capsule |
| CN113679778A (en) * | 2021-09-28 | 2021-11-23 | 安发（福建）生物科技有限公司 | Traditional Chinese medicine composition for reducing blood sugar and preparation method thereof |
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