CN101695533A - Chinese medicinal composition for decreasing blood glucose - Google Patents

Chinese medicinal composition for decreasing blood glucose Download PDF

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Publication number
CN101695533A
CN101695533A CN200910236534A CN200910236534A CN101695533A CN 101695533 A CN101695533 A CN 101695533A CN 200910236534 A CN200910236534 A CN 200910236534A CN 200910236534 A CN200910236534 A CN 200910236534A CN 101695533 A CN101695533 A CN 101695533A
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chinese
medicine
silkworm
weight
crude drug
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杜树山
姜良铎
沈圣民
张海鸣
曹杰
张文生
史培军
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Beijing Normal University
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Beijing Normal University
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Abstract

The invention relates to a Chinese medicinal composition for decreasing blood glucose, which comprises the following components in part by weight: 2 to 8 parts of Diopatra, 2 to 8 parts of cortex lyci radicis, 1 to 4 parts of Coptis chinensis, 1 to 4 parts of silkworm sand and 1 to 4 parts of radix puerariae. The medicinal components are medicament extracts which are Chinese medicament raw powders or Chinese medicament equivalent to a dose. The Chinese medicinal composition can be used for treating the diabetes.

Description

A kind of Chinese medicine composition of assistant hypoglycemic
Technical field
The present invention relates to a kind of Chinese medicine composition, specifically, is a kind of Chinese medicine composition that is used for the treatment of diseases such as quenching one's thirst, and the component of said composition can be directly to be ground into Chinese crude drug that powder is used as medicine and/or the Chinese medicine extract that obtains through extraction.
Background technology
Diabetes (quenching one's thirst) are a kind of chronic progressive external endocrine regulation diseases, are divided into I type and II type, and wherein whole world type ii diabetes accounts for 85% of sum, and China then is more than 95%, also do not effect a radical cure this sick specific drug and therapy at present both at home and abroad.This shows that Chinese patent medicine is still very weak comparatively speaking in the treatment market of quenching one's thirst, thus market in urgent need develop a kind of determined curative effect and significantly, the Chinese medicine medicine of sophisticated technologies, treatment diabetes that drug quality is stable.
Summary of the invention
The inventor comes from theory of Chinese medical science, adopts clearind deficient heat, the born fluid rule of treatment, sums up experience in many ways, carries through the clinical practice empirical and forms definite effect.The present invention is a Chinese medicine composition, is to extract the pure Chinese medicinal preparation that makes by Chinese medicines such as silkworm nest, Cortex Lycii, Rhizoma Coptidis, silkworm excrement, Radix Puerariae process, have assistant hypoglycemic and cure mainly diabetes, and determined curative effect, safe and effective.
The object of the present invention is to provide a kind of Chinese medicine composition and comprise the medicine of said composition, this medicine can be treated disease such as quench one's thirst.
The present invention also aims to provide the preparation method of above-mentioned composition and medicine,, can obtain being used for the treatment of evident in efficacy, the sophisticated technologies of diseases such as quenching one's thirst, stay-in-grade pharmaceutical composition by this method.
The present invention also aims to provide aforementioned pharmaceutical compositions to be used for the treatment of the purposes of diseases such as cough with asthma.
In order to achieve the above object, the invention provides a kind of Chinese medicine composition, said composition comprises following parts by weight of Chinese traditional medicine component: silkworm nest 2-8 part, Cortex Lycii 2-8 part, Rhizoma Coptidis 1-4 part, silkworm excrement 1-4 part, Radix Puerariae 1-4 part; Described Chinese medicinal components is above-mentioned Chinese crude drug fecula or be equivalent to the Chinese medicine extract of above-mentioned Chinese crude drug crude drug amount.
Above-mentioned serves as to calculate benchmark with silkworm nest 2-8 part, Cortex Lycii 2-8 part, Rhizoma Coptidis 1-4 part, silkworm excrement 1-4 part, Radix Puerariae 1-4 part all.
Above-mentioned Chinese medicinal components silkworm nest, Cortex Lycii, Rhizoma Coptidis, silkworm excrement, Radix Puerariae is the aqueous extract of this Chinese crude drug.
In a preferred embodiment of the invention, above-mentioned Chinese medicine composition is made up of following parts by weight of Chinese traditional medicine component: silkworm nest 4-6 part, Cortex Lycii 4-6 part, Rhizoma Coptidis 4-6 part, silkworm excrement 2-4 part, Radix Puerariae 2-4 part; Described Chinese medicinal components is above-mentioned Chinese crude drug fecula or be equivalent to the Chinese medicine extract of above-mentioned Chinese crude drug crude drug amount.
In another preferred embodiment of the present invention, above-mentioned Chinese medicine composition is made up of following parts by weight of Chinese traditional medicine component: 3 parts in silkworm nest, 3 parts of Cortex Lycii, 2 parts of Rhizoma Coptidis, 2 parts of silkworm excrements, 2 parts of Radix Puerariaes; Described Chinese medicinal components can be above-mentioned Chinese crude drug fecula or the Chinese medicine extract that is equivalent to the crude drug amount of above-mentioned Chinese crude drug.
The medicine that the present invention also provides a kind of treatment to quench one's thirst is comprising above-mentioned Chinese medicine composition and pharmacy acceptable auxiliary.
Medicine provided by the invention, its component comprises: silkworm nest 2-8 part, Cortex Lycii 2-8 part, Rhizoma Coptidis 1-4 part, silkworm excrement 1-4 part, Radix Puerariae 1-4 part; Described Chinese medicinal components is above-mentioned Chinese crude drug fecula or be equivalent to the Chinese medicine extract of above-mentioned Chinese crude drug crude drug amount, and the pharmacy acceptable auxiliary; Above-mentioned Chinese medicinal components is Chinese medicine extract or the powder that is equivalent to the crude drug amount of above-mentioned Chinese crude drug.
Preferred silkworm nest, Cortex Lycii, Rhizoma Coptidis, silkworm excrement, Radix Puerariae are the aqueous extract of this Chinese crude drug.
The medicine that above-mentioned treatment is quenched one's thirst is preferably peroral dosage form, comprises dosage forms such as honeyed pill, condensed water honeyed pill, the watered pill, granule, capsule, tablet, powder, unguentum, oral liquid or syrup; This medicine is granule, capsule, tablet more preferably.
In a preferred embodiment of the invention, the medicine that provides a kind of treatment to quench one's thirst, this medicine is granule, capsule or tablet, this medicine comprises Chinese medicine composition and pharmacy acceptable auxiliary, wherein, described Chinese medicine composition is the parts by weight of Chinese traditional medicine component that is equivalent to the crude drug amount of following Chinese crude drug: silkworm nest 2-8 part, Cortex Lycii 2-8 part, Rhizoma Coptidis 1-4 part, silkworm excrement 1-4 part, Radix Puerariae 1-4 part; Silkworm nest, Cortex Lycii, Rhizoma Coptidis, silkworm excrement, Radix Puerariae are the aqueous extract of this Chinese crude drug; Described pharmacy acceptable auxiliary is arbitrary or its combination in the microcrystalline Cellulose that accounts for this drug weight 0.15-25%, starch, the dextrin.
The present invention also provides the method for preparing the medicine that a kind of treatment quenches one's thirst, and this method comprises: silkworm nest, Cortex Lycii, Rhizoma Coptidis, silkworm excrement, Radix Puerariae are the aqueous extract of this Chinese crude drug, and it is that silkworm nest, Cortex Lycii, Rhizoma Coptidis, silkworm excrement, Radix Puerariae decoct with water; The weight that adds water is 1-30 times of this Chinese crude drug weight, decocting liquid filters, relative density was 1.20~1.25 when filtrate was concentrated into 60 ℃, and drying is pulverized, get extract powder, add arbitrary or its combination in the microcrystalline Cellulose account for this drug weight 0.15-25%, starch, the dextrin, mixing is granulated, drying promptly obtains this medicine of granule, capsule or Tabules.
Through experiment, the pharmacy acceptable auxiliary that screening obtains is preferably arbitrary or its combination in microcrystalline Cellulose, starch, the dextrin, and more preferably microcrystalline Cellulose, starch or dextrin most preferably are dextrin; The weight of this pharmacy acceptable auxiliary accounts for the 0.15-25% of this drug weight.
Compositions of the present invention and medicine have the effect that YIN nourishing and the production of body fluid promoting, pathogenic fire purging are quenched the thirst, and are used for the diabetes due to the deficiency of YIN, and disease is seen polydipsia, polyphagia, polyuria, the shortness of breath and fatigue of becoming thin.The present invention has at first selected mixture according to the characteristics of its medication, and technology is easy, taking convenience, but clinical response and find the less stable of mixture in the practice process; The inventor is again according to modern patient's medication characteristics, preferably select for example oral solid formulation of granule, in order to meet modern health idea better, medicine of the present invention is tablet more preferably, because of each Chinese medicinal components of the present invention is to be used as medicine with the form of the aqueous extract that obtains through extraction, therefore it is fast to obey post-absorption, and easy and simple to handle, preparation stabilization, finished-product volume reduces, cost is low, taking convenience.Through experimentation, preparation technology is easy, steady quality, controlled, preparation safety, effectively, the clinical verification effect is also good, so in a preferred embodiment of the invention, the dosage form of medicine of the present invention most preferably is defined as tablet.
The present invention also provides the preparation method of above-mentioned Chinese medicine composition, this preparation method is in many-sided factors such as the property of medicine of the comprehensive above-mentioned medicine of respectively distinguishing the flavor of, clinical, productions, consulting on the basis of documents and materials, physicochemical property, pharmacologically active in conjunction with the effective ingredient of each flavour of a drug, through repetition test research, the process route of the product of the present invention of design.
The preferred for preparation method of above-mentioned Chinese medicine composition comprises: the Chinese crude drug of silkworm nest, Cortex Lycii, Rhizoma Coptidis, silkworm excrement, Radix Puerariae decocted with water three times, was respectively heat time heating time 2 hours, and 1 hour, 1 hour; The weight that adds water is 1-30 times of this Chinese crude drug weight, is respectively 12 times, 10 times, and 8 times; Collecting decoction can obtain Chinese medicine composition of the present invention.Also this decocting liquid drying can be obtained dried cream powder, be this solid-state Chinese medicine composition (or dried cream powder of title Chinese medicine composition).
General Chinese crude drug is used with decoction clinically substantially, and the method that adopts decocting to boil just can extract it substantially, but owing to effective ingredient in the component of the present invention, does not therefore adopt alcohol precipitation process.Thereby guarantee the curative effect of preparation.
Extraction process of the present invention preferably obtains through Orthogonal Experiment and Design.
Through overtesting, investigate the factor that decocting boils that influences in many ways, select amount of water, extraction time, extraction time for to influence the main factor that decocting boils, and three reasonable level of corresponding selection are tested.Be to guarantee the controllability and the advance of product quality, to the main test data berberine hydrochloride of reflection product quality, paste-forming rate as investigating index.
With medicine of the present invention is that tablet is an example, and bound drug self-characteristic, preparations shaping standard and big Financial cost of producing need, and adopt wet granulation, add appropriate amount of auxiliary materials and make granule, and drying, tabletting, coating are promptly.
Test with the mixed accessories of single adjuvant, different cultivars, different proportion respectively, with adjuvant and 80g dried cream powder mixing, spray in right amount with 80% ethanol, wet granulation, 12 mesh sieves are granulated, 16 mesh sieve granulate, and drying is made granule.Find out the adjuvant kind and the consumption thereof of basic preparations shaping, select suitable pharmaceutical adjunct.According to result of the test, most preferably determine to select for use the preparation condition of dextrin as adjuvant, i.e. 80g dried cream powder adds dextrin 20g, mixing, spray an amount of with 80% ethanol, granulation, drying is made granule, promptly.
Make three batches of samples by prescription and technology, take by weighing above-mentioned dried cream 80g, add appropriate amount of auxiliary materials, mixing with 14 eye mesh screen wet granulations, with 16 eye mesh screen granulate, drying, gets granule, tabletting, coating.Investigate the tablet situation, respectively three batches tablet is carried out the preparation inspection, check friability, disintegration, the weight differential of tablet.Obtained following preparation technology of the present invention.
According to this area routine techniques, compositions of the present invention also can be made into oral liquid, honeyed pill, water-honeyed pill, the watered pill, paste pill, wax pill, concentrated pill, its processing step is routine operation, and visual medical material situation difference takes the circumstances into consideration to change process conditions, and it is conventionally known to one of skill in the art.
If medicine of the present invention is capsule, then the dried cream powder made of said method adds adjuvant, dextrin or also add or other binding agent for example, and abundant mixing, drying is pulverized, and incapsulates, promptly.
The Chinese crude drug that is adopted in the compositions of the present invention is the medical material that version pharmacopeia in 2005 is recorded, and through identifying, every index all meets the pharmacopeia regulation.
The inspection of arsenic salt and heavy metal in the medicine of the present invention: press one one of Chinese Pharmacopoeia version in 2005, appendix IXE, IXF item be regulation down, the arsenic salt and the heavy metal of this product 3 batch samples is checked the result is in prescribed limit.
Health examination in the medicine of the present invention:, meet pharmacopeia hygiology standard through health examination.
The present invention also provides the application in the preparation treatment such as quenches one's thirst at disease of above-mentioned Chinese medicine composition.
And the present invention also provides the application in the preparation treatment such as quenches one's thirst at disease of above-mentioned medicine.
Medicine of the present invention is example with the tablet.
The Chinese medicine preparation that the present invention (yellow ground metformin) is made up of Cortex Lycii etc., clinical being used for the treatment of quenches one's thirst.Done pharmacodynamic experiment by the new drug requirement.
1 materials and methods
1.1 material
Reagent: yellow ground metformin (self-control); Alloxan (alloxan, ALx, U.S. Sigma company); Glucose enzyme process blood sugar detection test kit (the safe clinical reagent company limited of Beijing northization); Insulin, glucagon radioimmunological kit (French CIS company); Glibenclamide (Xing Hua pharmaceutical factory in Qinhuangdao provides, and lot number is 060428).
Animal: 120 of male rats, cleaning level, body weight 190240g is provided by Beijing Vital River Experimental Animals Technology Co., Ltd., and the animal quality certification number moves for the capital is betrothed to: SOXK (capital) 2007-0001.
1.2 modeling and determination method of blood sugar
After the rat adaptability fed for 1 week, be divided into 2 groups at random by body weight.The 1st group 20 is normal control group (A group), and the 2nd group 100 are the modeling group.Water 12h is can't help in the rat fasting during modeling, lumbar injection ALX, now with the current, be made into 2% injection administration with normal saline, 1 time/d, 2d continuously, dosage is respectively 120mg/kg and 100mg/kg, and under the sun-drenched condition more than the sunshine-duration 10h, raise, form diabetes model behind the 72h, injection back ad lib.Rat tail vein is got blood, adopts determination of glucose oxidase blood sugar concentration (mmol/L).Surveyed fasting blood sugar in the 4th day behind the last injection ALX, blood glucose value>11.1mmol/L person is the modeling winner.
1.3 grouping and processing
Get 80 of rats of modeling success and be divided into 4 groups more at random: model control group (the B group gives distilled water), yellow ground metformin low dose group (the C1 group, 180mg/kg), yellow ground metformin high dose group (the C2 group, 360mg/kg), the glibenclamide group (the D group, 15mg/kg).Each group is irritated the stomach amount and only is 2mL/, 1 time/d, carries out 14d altogether.After the off-test, put to death animal in two batches, detect fasting respectively after blood biochemistry index (blood glucose, insulin, glucagon) behind (fasting, prohibit water 12h) and the ad lib.
1.4 statistical method
Measurement data adopts X ± s to represent, statistical data t check analysis, with P<0.05 for statistical significance is arranged.
2 results
In this test, 100 rat modelings finish dead 10 of back, survive 90, wherein 85 present polydipsia, polyphagia, polyuria, become thin, diabetes signs such as weight loss, chaeta are loose, activity minimizing.Blood glucose is (14.21 ± 1.68) mmol/L after the rat model fasting, and blood glucose is (1832 ± 1.06) mmol/L behind the ad lib, compares with normal group, and significant difference is arranged, and the diabetes model rat conformance with standard that adopts this method preparation is described.Each organizes fasting glucose after rat fasting and the free fasting, insulin, glucagon level.See Table 1.
Table 1 respectively organize rat fasting blood-glucose, insulin, glucagon level relatively (X ± s, n=20)
Figure G2009102365343D0000071
Annotate: compare * P<0.05, * * P<0.01 with the A group; Compare △ P<0.05, △ △ P<0.01 with the B group; Compare * P>0.05 with the D group.
Two dosage groups of yellow ground metformin all can significantly reduce blood glucose behind rat model fasting and the ad lib, curative effect and glibenclamide be (P>0.05) quite, and reach the insulin level behind the ad lib significantly after the fasting of elevation model Mus, with high dose group the best, effect and glibenclamide be (P>0,05) quite; Metformin two dosage in yellow ground all can reduce the glucagon after the model mouse fasting.
The specific embodiment
For more clear explanation goal of the invention and technical scheme, be described in further detail by following embodiment.
Embodiment 1:
The prescription of compositions of the present invention (weight portion):
3 parts in silkworm nest, 3 parts of Cortex Lycii, 2 parts of Rhizoma Coptidis, 2 parts of silkworm excrements, 2 parts of Radix Puerariaes.
Preparation method:
Above flavour of a drug decoct with water three times, were respectively heat time heating time 2 hours, and 1 hour, 1 hour; The weight that adds water is 1-30 times of this Chinese crude drug weight, is respectively 12 times, 10 times, and 8 times; Collecting decoction filters, and it is 1.20~1.25 (60 ℃) that filtrate is concentrated into relative density, spray drying, and (160 ℃ of intake air temperatures, 85 ℃ of air outlet temperature, inlet amount 50ml/min) gets extract powder, is compositions.
Embodiment 2:
Prescription: 3 parts in silkworm nest, 3 parts of Cortex Lycii, 2 parts of Rhizoma Coptidis, 2 parts of silkworm excrements, 2 parts of Radix Puerariaes.
Preparation method: preparation of compositions is with embodiment 1;
Capsule: in compositions, add dextrin, mixing, spray is with 80% alcohol granulation, and drying adds lubricants such as magnesium stearate, and is encapsulated, promptly gets capsule of the present invention.
The result shows: present composition capsule meets the relevant every regulation under the capsule item.
Embodiment 3:
Prescription: 3 parts in silkworm nest, 3 parts of Cortex Lycii, 2 parts of Rhizoma Coptidis, 2 parts of silkworm excrements, 2 parts of Radix Puerariaes.
Preparation method: preparation of compositions is with embodiment 1;
Tablet: in compositions, add dextrin, mixing, spray is with 80% alcohol granulation, and drying adds lubricants such as magnesium stearate, tabletting, coating promptly gets tablet of the present invention.
The result shows: present composition tablet meets the relevant every regulation under the tablet item.
More than described the preferred embodiment for the present invention, so it is not in order to limit the present invention.Those skilled in the art can not depart from the improvement and the variation of category of the present invention and spirit to embodiment disclosed herein.

Claims (9)

1. Chinese medicine composition, said composition comprises following parts by weight of Chinese traditional medicine component: silkworm nest 2-8 part, Cortex Lycii 2-8 part, Rhizoma Coptidis 1-4 part, silkworm excrement 1-4 part, Radix Puerariae 1-4 part; Described Chinese medicinal components is above-mentioned Chinese crude drug fecula or the Chinese medicine extract that is equivalent to above-mentioned Chinese crude drug crude drug amount.
2. Chinese medicine composition as claimed in claim 1, wherein, in the described Chinese medicinal components, silkworm nest, Cortex Lycii, Rhizoma Coptidis, silkworm excrement, Radix Puerariae are the aqueous extract of those Chinese crude drugs.
3. Chinese medicine composition as claimed in claim 1, wherein, described Chinese medicine composition is made up of following parts by weight of Chinese traditional medicine component: silkworm nest 2-8 part, Cortex Lycii 2-8 part, Rhizoma Coptidis 1-4 part, silkworm excrement 1-4 part, Radix Puerariae 1-4 part; Described silkworm nest, Cortex Lycii, Rhizoma Coptidis, silkworm excrement, Radix Puerariae are the aqueous extract of those Chinese crude drugs.
4. medicine that treatment is quenched one's thirst, it comprises each described Chinese medicine composition of claim 1-3 and pharmacy acceptable auxiliary, this medicine is an oral formulations.
5. medicine as claimed in claim 4, wherein, described oral formulations is granule, capsule, tablet or powder, described pharmacy acceptable auxiliary is arbitrary or its combination in microcrystalline Cellulose, starch, the dextrin; The weight of described pharmacy acceptable auxiliary accounts for the 0.15-25% of this drug weight.
6. medicine that treatment is quenched one's thirst, comprise Chinese medicine composition and pharmacy acceptable auxiliary, wherein, this Chinese medicine composition is the parts by weight of Chinese traditional medicine component that is equivalent to the crude drug amount of following Chinese crude drug: silkworm nest 2-8 part, Cortex Lycii 2-8 part, Rhizoma Coptidis 1-4 part, silkworm excrement 1-4 part, Radix Puerariae 1-4 part; Silkworm nest, Cortex Lycii, Rhizoma Coptidis, silkworm excrement, Radix Puerariae are the aqueous extract of those Chinese crude drugs in the described Chinese medicinal components; This pharmacy acceptable auxiliary is arbitrary or its combination in the microcrystalline Cellulose that accounts for this drug weight 0.15-25%, starch, the dextrin.
7. the preparation method of the described medicine of claim 3, wherein, this method comprises: the Chinese crude drug of silkworm nest, Cortex Lycii, Rhizoma Coptidis, silkworm excrement, Radix Puerariae decocts with water; The weight that adds water is 1-30 times of this Chinese crude drug weight, and decocting liquid filters, and relative density was 1.20~1.25 when filtrate was concentrated into 60 ℃, and drying gets extract powder, adds the pharmacy acceptable auxiliary, mixing, and granulation, drying promptly obtains this medicine.
8. the preparation method of the described treatment of claim 7 medicine of quenching one's thirst, this method comprises: the Chinese crude drug of silkworm nest, Cortex Lycii, Rhizoma Coptidis, silkworm excrement, Radix Puerariae decocts with water; The weight that adds water is 1-30 times of this Chinese crude drug weight, decocting liquid filters, relative density was 1.20~1.25 when filtrate was concentrated into 60 ℃, and drying is pulverized, get extract powder, add arbitrary or its combination in the microcrystalline Cellulose account for this drug weight 0.15-25%, starch, the dextrin, mixing, spray alcohol granulation, drying promptly obtains this medicine.
9. the application of the described Chinese medicine composition of claim 1 in the medicine that the preparation treatment is quenched one's thirst.
CN200910236534A 2009-10-30 2009-10-30 Chinese medicinal composition for decreasing blood glucose Pending CN101695533A (en)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102406755A (en) * 2011-11-01 2012-04-11 北京师范大学 Chinese medicinal composition for assisting reduction of blood sugar

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102406755A (en) * 2011-11-01 2012-04-11 北京师范大学 Chinese medicinal composition for assisting reduction of blood sugar

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