CN104056020A - Traditional Chinese medicine composition for treating metabolic syndrome - Google Patents
Traditional Chinese medicine composition for treating metabolic syndrome Download PDFInfo
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Abstract
The invention relates to a traditional Chinese medicine composition for treating the metabolic syndrome. The traditional Chinese medicine composition comprises, by weight, 3-8 parts of red ginseng, 10-15 parts of liriope spicata, 3-8 parts of panax notoginseng and 3-8 parts of rhizoma alismatis. The traditional Chinese medicine constituents are traditional Chinese medicinal material starchy flour or traditional Chinese medicine extracts equivalent to the crude traditional Chinese medicinal materials in amount. The traditional Chinese medicine composition can be used for treating the metabolic syndrome.
Description
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 the metabolism syndromes such as hyperglycemia, and the component of said composition can be to be directly ground into Chinese crude drug that powder is used as medicine and/or through extracting the Chinese medicine extract obtaining.
Background technology
Metabolism syndrome is the set of one group of cardiovascular connecting each other and diabetic risk factors, comprises obesity, insulin resistant, dyslipidemia, hypertension and can cause atherosclerotic high blood coagulation state.At present, the medicine for the treatment of metabolism syndrome mainly contains: antidiabetic drug metformin, Studies of The Insulin Sensitizer Thiazolidinediones medicine, HMG-COA reductase inhibitor (Pitavastatin) etc.But according to the report of existing experimentation, can't affirm the therapeutic effect of these medicines to metabolism syndrome and whether can reduce the danger of its cardiovascular disease, and these medicines there is the side effect that causes body weight increase and edema.Therefore market in urgent need develop a kind of determined curative effect and significantly, the Chinese medicine of drug quality is stable, toxic and side effects is little treatment metabolism syndrome.
Summary of the invention
The inventor comes from theory of Chinese medical science, sums up clinical experience for many years, carries and forms through clinical practice empirical.The present invention is Chinese medicine composition, is the pure Chinese medicinal preparation being made through extraction by Chinese medicines such as Radix Liriopes, Radix Notoginseng, Radix Ginseng Rubra, Rhizoma Alismatis, have and can improve and cure mainly the metabolism syndromes such as hyperglycemia, 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 the metabolism syndromes such as hyperglycemia.
The present invention also aims to provide the preparation method of above-mentioned composition and medicine, by the method, can obtain being used for the treatment of evident in efficacy, the sophisticated technologies of the metabolism syndromes such as hyperglycemia, stay-in-grade pharmaceutical composition.
The present invention also aims to provide aforementioned pharmaceutical compositions to be used for the treatment of the purposes of the metabolism syndromes such as hyperglycemia.
In order to achieve the above object, the invention provides a kind of Chinese medicine composition, said composition comprises the Chinese medicinal components of following weight portion: Radix Ginseng Rubra 3-8 part, Radix Liriopes 10-15 part, Radix Notoginseng 3-8 part, Rhizoma Alismatis 3-8 part; Above-mentioned Chinese crude drug fecula or be equivalent to the Chinese medicine extract of above-mentioned Chinese crude drug crude drug amount of described Chinese medicinal components.
Above-mentioned Chinese medicinal components comprises that Radix Ginseng Rubra, Radix Liriopes, Radix Notoginseng, Rhizoma Alismatis are the aqueous extract of this Chinese crude drug.
In a preferred embodiment of the invention, above-mentioned Chinese medicine composition is made up of the Chinese medicinal components of following weight portion: Radix Ginseng Rubra 4-6 part, Radix Liriopes 8-12 part, Radix Notoginseng 4-6 part, Rhizoma Alismatis 4-6 part; Above-mentioned Chinese crude drug fecula or be equivalent to the Chinese medicine extract of above-mentioned Chinese crude drug crude drug amount of described Chinese medicinal components.
In another preferred embodiment of the present invention, above-mentioned Chinese medicine composition is made up of the Chinese medicinal components of following weight portion: 6 parts of Radix Ginseng Rubra, 12 parts of Radix Liriopes, 6 parts of Radix Notoginseng, 6 parts of Rhizoma Alismatis; 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 present invention also provides a kind of medicine for the treatment of the metabolism syndromes such as hyperglycemia, comprising above-mentioned Chinese medicine composition and the acceptable adjuvant of pharmacy.
Medicine provided by the invention, its component comprises: Radix Ginseng Rubra 3-8 part, Radix Liriopes 10-15 part, Radix Notoginseng 3-8 part, Rhizoma Alismatis 3-8 part; Above-mentioned Chinese crude drug fecula or be equivalent to the Chinese medicine extract of above-mentioned Chinese crude drug crude drug amount of described Chinese medicinal components, and the acceptable adjuvant of pharmacy; 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.
Preferably Radix Ginseng Rubra, Radix Liriopes, Radix Notoginseng, Rhizoma Alismatis are the aqueous extract of this Chinese crude drug.
The medicine of above-mentioned treatment metabolism syndrome is preferably peroral dosage form, comprises the 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, a kind of medicine for the treatment of the metabolism syndromes such as hyperglycemia is provided, this medicine is granule or capsule, this medicine comprises Chinese medicine composition and the acceptable adjuvant of pharmacy, wherein, described Chinese medicine composition is the Chinese medicinal components that is equivalent to the weight portion of the crude drug amount of following Chinese crude drug: Radix Ginseng Rubra 3-8 part, Radix Liriopes 10-15 part, Radix Notoginseng 3-8 part, Rhizoma Alismatis 3-8 part; Radix Ginseng Rubra, Radix Liriopes, Radix Notoginseng, Rhizoma Alismatis are the aqueous extract of those Chinese crude drugs; The acceptable adjuvant of described pharmacy is arbitrary or its combination in the Icing Sugar that accounts for this drug weight 0.15-35%, microcrystalline Cellulose, starch, dextrin.
The present invention also provides a kind of prepare medicine for the treatment of the metabolism syndromes such as hyperglycemia method, and the method comprises: Radix Ginseng Rubra, Radix Liriopes, Radix Notoginseng, Rhizoma Alismatis are the aqueous extract of this Chinese crude drug, and it is that Radix Ginseng Rubra, Radix Liriopes, Radix Notoginseng, Rhizoma Alismatis decoct with water; The weight adding water is 1-20 times of this Chinese crude drug weight, decocting liquid filters, when filtrate is concentrated into 60 DEG C, relative density is 1.20～1.25, dry, pulverize, obtain extract powder, add arbitrary in the Icing Sugar, microcrystalline Cellulose, starch, dextrin that accounts for this drug weight 0.15-35% or its combination, mix, granulate, be dried, obtain this medicine of tablet, granule, capsule or powder preparation formulation.
Through experiment, the acceptable Optimization of Adjuvant of pharmacy that screening obtains is arbitrary in Icing Sugar, microcrystalline Cellulose, starch, dextrin or its combination, and more preferably microcrystalline Cellulose, starch or dextrin, most preferably be dextrin; The weight of the acceptable adjuvant of this pharmacy accounts for the 0.15-35% of this drug weight.
Compositions of the present invention and medicine have the effect of the multiple arteries and veins of benefiting QI for activating blood circulation, YIN nourishing and the production of body fluid promoting the turbid descending, cure mainly the metabolism syndromes such as hyperglycemia.The present invention, according to the feature of its medication, has first selected mixture, simple process, taking convenience, but clinical reflection and find the less stable of mixture in practice process; Inventor is again according to the medication feature of modern patient, preferably select the oral solid formulation of for example granule, in order to meet better modern health idea, more preferably tablet of medicine of the present invention, because each Chinese medicinal components of the present invention is to be used as medicine through the form of extracting the aqueous extract obtaining, after clothes, absorb fast, and easy and simple to handle, preparation stabilization, finished-product volume is few, taking convenience, low cost of manufacture.Through experimentation, preparation technology is easy, steady quality, controlled, preparation safety, effectively, clinical verification effect is also good, so in a preferred embodiment of the invention, the dosage form of medicine of the present invention is most preferably 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 comprehensive above-mentioned each taste medicine, clinical, productions, on the basis of By consulting literatures data, in conjunction with physicochemical property, the pharmacologically active of 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 preparation method of above-mentioned Chinese medicine composition comprises: the Chinese crude drug of Radix Ginseng Rubra, Radix Liriopes, Radix Notoginseng, Rhizoma Alismatis decocted with water three times, is respectively heat time heating time 2 hours, and 1 hour, 1 hour; The weight adding water is 1-20 times of this Chinese crude drug weight, is respectively 8 times, 6 times, and 6 times; Collecting decoction, can obtain Chinese medicine composition of the present invention.Also can obtain dried cream powder by dry this decocting liquid, be this solid-state Chinese medicine composition (or dried cream powder of title Chinese medicine composition).
General Chinese crude drug is clinically substantially with decoction application, and the method that adopts decocting to boil just can extract it substantially, but due to effective ingredient in component of the present invention, does not therefore adopt alcohol precipitation process.Thereby ensure the curative effect of preparation.
Extraction process of the present invention preferably obtains through Orthogonal Experiment and Design.
Through overtesting, in many ways investigate the factor that decocting boils that affects, selecting amount of water, extraction time, extraction time is to affect the main factor that decocting boils, and three reasonable level of corresponding selection are tested.For ensureing controllability and the advance of product quality, the main experimental data DT-13 to reflection product quality and paste-forming rate are as investigating index.
Taking medicine of the present invention be tablet as example, bound drug self-characteristic, preparations shaping standard and large Financial cost of producing need, and adopt wet granulation, add appropriate amount of auxiliary materials granulation, dry, tabletting, coating, to obtain final product.
Test with the mixed accessories of single adjuvant, different cultivars, different proportion respectively, adjuvant and 80g dried cream powder are mixed, spray with 80% appropriate amount of ethanol, wet granulation, 14 mesh sieves are granulated, and 16 mesh sieve granulate are dry, granulation, tabletting, coating.Find out adjuvant kind and the consumption thereof of basic preparations shaping, select suitable pharmaceutical adjunct.According to result of the test, most preferably determine and select the preparation condition of dextrin as adjuvant, 80g dried cream powder, adds dextrin 20g, mixes, and spray, with 80% appropriate amount of ethanol, is granulated, dry, granulation, tabletting, coating and get final product.
Make three batches of samples by prescription and technique, take above-mentioned dry cream 80g, add appropriate amount of auxiliary materials, mix, with 14 eye mesh screen wet granulations, with 16 eye mesh screen granulate, dry, obtain granule, tabletting, coating.Investigate tablet situation, respectively the tablet of three batches is carried out to preparation inspection, check friability, disintegration, the weight differential of tablet.Obtain following 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, the dried cream powder that said method is made adds adjuvant, and for example dextrin or also interpolation or other binding agent, fully mix, and dry, pulverize, and incapsulates, and to obtain final product.
The Chinese crude drug adopting in compositions of the present invention is the medical material that version pharmacopeia in 2010 is recorded, and through qualification, indices all meets pharmacopeia regulation.
The inspection of arsenic salt and heavy metal in medicine of the present invention: press one of Chinese Pharmacopoeia version in 2010, specify under annex IXE, IXF item, heavy metal and arsenic salt to this product 3 batch samples checks, result is in prescribed limit.
Health examination in medicine of the present invention: through health examination, meet pharmacopeia Hygienic Standard.
The present invention also provides above-mentioned Chinese medicine composition to treat the application in the metabolism syndromes such as hyperglycemia in preparation.
And the present invention also provides above-mentioned medicine to treat the application in the metabolism syndromes such as hyperglycemia in preparation.
Medicine of the present invention is taking tablet as example.
The Chinese medicine preparation that the present invention's (Radix Notoginseng Rhizoma Zingiberis Recens drink) is made up of Radix Liriopes etc., the clinical metabolism syndromes such as hyperglycemia that are used for the treatment of.Do pharmacodynamic experiment by new drug requirement.
1, materials and methods
Reagent: Radix Notoginseng Rhizoma Zingiberis Recens decoction pieces, 0.50g/ sheet, is provided lot number: 20100401 by the Ministry of Education of Beijing Normal University resource medicine engineering research center; Alloxan (alloxan, ALx, Sigma company of the U.S.); Glucose enzyme process blood sugar detection test kit (the safe clinical reagent of Beijing Northization company limited); Insulin, glucagon radioimmunological kit (French CIS company); Glibenclamide (Qinhuangdao Xinghua pharmaceutical factory provides, and lot number is 090528).
Animal: male rat, clean level, body weight 200 ± 20g, is provided by Beijing Vital River Experimental Animals Technology Co., Ltd., and the animal quality certification number is betrothed to for capital is moving: SOXK (capital) 2010-0012.Raising in center Animal House, is shielding environment, credit number: SYXK (capital) 2010-0009.Mouse feed is Beijing Australia of the section large and small Mus growth of clean level pellet that feed corporation,Ltd produces of pulling together, product license number: capital is moving is betrothed to (2010) No. 010.
Modeling and determination method of blood sugar: rat adaptability was fed after 1 week, be divided at random 2 groups by body weight.The 1st group 20 is Normal group (A group), and the 2nd group 80 is modeling group.When modeling, water 12h is can't help in rat fasting, 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 sunshine-duration 10h, raise, after 72h, form diabetes model, ad lib after injection.Rat tail vein is got blood, adopts determination of glucose oxidase blood sugar concentration (mmol/L).The 4th day survey fasting blood sugar after last injection ALX, after rat model fasting, blood glucose is (14.21 ± 1.68) mmol/L, after ad lib, blood glucose is (18.32 ± 1.06) mmol/L, with normal group comparison, there is significant difference, illustrate and adopt the standby diabetes model rat conformance with standard (blood glucose value > 11.1mmol/L person is modeling winner) of this legal system.
Grouping and processing: get 80 of rats of modeling success and be divided at random again 4 groups: model control group (B group, give distilled water), Radix Notoginseng Rhizoma Zingiberis Recens decoction pieces low dose group (C1 group, 200mg/kg), Radix Notoginseng Rhizoma Zingiberis Recens decoction pieces high dose group (C2 group, 400mg/kg), glibenclamide group (D group, 15mg/kg).Each group gavage amount is only 2mL/, 1 time/d, carries out altogether 14d.After off-test, put to death in two batches animal, detect respectively after fasting blood biochemistry index (blood glucose, insulin, glucagon) after (fasting, prohibit water 12h) and ad lib.
Statistical method: measurement data adopt X ± s represent, statistical data t check analysis, with P < 0.05 for there being statistical significance.
2, result
Fasting glucose, insulin, Plasma Glucagon Level after the rat fasting of each group and free fasting, in table 1.
The each group of table 1 rat fasting blood-glucose, insulin, Plasma Glucagon Level comparison (X ± s, n=20)
Note: compare * P < 0.05, * * P < 0.01 with A group; Compare △ P < 0.05, △ △ P < 0.01 with B group; Compare * P > 0.05 with D group.
Two dosage groups of Radix Notoginseng Rhizoma Zingiberis Recens decoction pieces all can significantly reduce blood glucose after rat model fasting and ad lib, and curative effect and glibenclamide be (P > 0.05) quite; And the insulin level after the fasting of elevation model Mus and after ad lib significantly, with high dose group the best, effect and glibenclamide be (P > 0.05) quite; Two dosage of Radix Notoginseng Rhizoma Zingiberis Recens decoction pieces all can reduce the glucagon after model mouse fasting.
Detailed description of the invention
For more clear explanation goal of the invention and technical scheme, be described in further detail by following embodiment.
Embodiment 1:
The prescription (weight portion) of compositions of the present invention:
6 parts of 6 portions of Rhizoma Alismatis of 12 portions of Radix Notoginseng of 6 parts of Radix Liriopes of Radix Ginseng Rubra
Preparation method:
Above flavour of a drug decoct with water three times, are respectively heat time heating time 2 hours, and 1 hour, 1 hour; The weight adding water is 1-20 times of this Chinese crude drug weight, is respectively 8 times, 6 times, and 6 times; Collecting decoction filters, and it is 1.20～1.25 (60 DEG C) that filtrate is concentrated into relative density, and spraying is dry, and (160 DEG C of intake air temperatures, 85 DEG C of air outlet temperature, inlet amount 50mL/min), obtains extract powder, is compositions.
Embodiment 2:
The prescription of compositions of the present invention:
6 parts of 6 portions of Rhizoma Alismatis of 12 portions of Radix Notoginseng of 6 parts of Radix Liriopes of Radix Ginseng Rubra
Preparation method: the preparation of compositions is with embodiment 1;
Tablet: add dextrin in compositions, mix, spray is with 80% alcohol granulation, dry, adds appropriate magnesium stearate, tabletting, coating, obtains tablet of the present invention.
Result shows: present composition tablet meets the relevant every regulation under 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 improvement and the variation of category of the present invention and spirit to embodiment disclosed herein.
Claims (9)
1. a Chinese medicine composition, said composition comprises the Chinese medicinal components of following weight portion: Radix Ginseng Rubra 3-8 part, Radix Liriopes 10-15 part, Radix Notoginseng 3-8 part, Rhizoma Alismatis 3-8 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 described Chinese medicinal components, Radix Ginseng Rubra, Radix Liriopes, Radix Notoginseng, Rhizoma Alismatis 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 the Chinese medicinal components of following weight portion: Radix Ginseng Rubra 3-8 part, Radix Liriopes 10-15 part, Radix Notoginseng 3-8 part, Rhizoma Alismatis 3-8 part; Described Radix Ginseng Rubra, Radix Liriopes, Radix Notoginseng, Rhizoma Alismatis are the aqueous extract of those Chinese crude drugs.
4. treat a medicine for the metabolism syndromes such as hyperglycemia, it comprises Chinese medicine composition and the acceptable adjuvant of pharmacy described in claim 1-3 any one, and this medicine is oral formulations.
5. medicine as claimed in claim 4, wherein, described oral formulations is oral liquid, granule, capsule, tablet or powder, the acceptable adjuvant of described pharmacy is arbitrary in Icing Sugar, microcrystalline Cellulose, starch, dextrin or its combination; The weight of the described acceptable adjuvant of pharmacy accounts for the 0.15-35% of this drug weight.
6. treat the medicine of the metabolism syndromes such as hyperglycemia for one kind, comprise the acceptable adjuvant of Chinese medicine composition and pharmacy, wherein, this Chinese medicine composition is the Chinese medicinal components that is equivalent to the weight portion of the crude drug amount of following Chinese crude drug: Radix Ginseng Rubra 3-8 part, Radix Liriopes 10-15 part, Radix Notoginseng 3-8 part, Rhizoma Alismatis 3-8 part; In described Chinese medicinal components, Radix Ginseng Rubra, Radix Liriopes, Radix Notoginseng, Rhizoma Alismatis are the aqueous extract of those Chinese crude drugs; The acceptable adjuvant of this pharmacy is arbitrary or its combination in the Icing Sugar that accounts for this drug weight 0.15-35%, microcrystalline Cellulose, starch, dextrin.
7. the preparation method of medicine claimed in claim 4, wherein, the method comprises: Radix Ginseng Rubra, Radix Liriopes, Radix Notoginseng, Rhizoma Alismatis decoct with water; The weight adding water is 1-20 times of this Chinese crude drug weight, and decocting liquid filters, and when filtrate is concentrated into 60 DEG C, relative density is 1.20～1.25, dry, obtains extract powder, adds the acceptable adjuvant of pharmacy, mixes, and granulates, dry, obtains this medicine.
8. the preparation method of the medicine of the metabolism syndrome such as treatment hyperglycemia claimed in claim 7, the method comprises: the Chinese crude drug of Radix Ginseng Rubra, Radix Liriopes, Radix Notoginseng, Rhizoma Alismatis decocts with water; The weight adding water is 1-20 times of this Chinese crude drug weight, decocting liquid filters, when filtrate is concentrated into 60 DEG C, relative density is 1.20～1.25, dry, obtain extract powder, add arbitrary or its combination in the Icing Sugar, microcrystalline Cellulose, starch, dextrin that accounts for this drug weight 0.15-35%, mix, granulate, dry, obtain this medicine.
9. the application of Chinese medicine composition claimed in claim 1 in the medicine of the metabolism syndromes such as preparation treatment hyperglycemia.
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| CN108042554A (en) * | 2017-10-27 | 2018-05-18 | 陈思禹 | Application of the ophiopogonin D on treatment metabolic syndrome drug is prepared |
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| CN1330930A (en) * | 2000-06-28 | 2002-01-16 | 秦中凯 | Medicine for treating cardiovascular disease |
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| CN1330930A (en) * | 2000-06-28 | 2002-01-16 | 秦中凯 | Medicine for treating cardiovascular disease |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN108042554A (en) * | 2017-10-27 | 2018-05-18 | 陈思禹 | Application of the ophiopogonin D on treatment metabolic syndrome drug is prepared |
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