CN104056020B - A kind of Chinese medicine composition for treating metabolic syndrome - Google Patents
A kind of Chinese medicine composition for treating metabolic syndrome Download PDFInfo
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Abstract
A kind of Chinese medicine composition for treating metabolic syndrome.The present invention relates to the traditional Chinese medicinal components that a kind of said composition includes following parts by weight：38 parts of red ginseng, 10 15 parts of Radix Liriopes, 38 parts of pseudo-ginseng, 38 parts of rhizoma alismatis；The traditional Chinese medicinal components are above-mentioned Chinese medicine fecula or the Chinese medical extract equivalent to above-mentioned Chinese medicine crude drug amount；The Chinese medicine composition of the present invention can be used for treating metabolic syndrome.
Description
Technical field
It is a kind of to be used to treat the metabolic syndromes such as hyperglycaemia specifically the present invention relates to a kind of Chinese medicine composition
Chinese medicine composition, the component of said composition can be directly ground to Chinese medicine that powder is used as medicine and/or extracted obtain
Medicament extract.
Background technology
Metabolic syndrome is the set of one group of angiocarpy connected each other and diabetic risk factors, including fat, pancreas islet
Plain resistance, dyslipidemia, hypertension and the high blood coagulation state that atherosclerosis can be caused.At present, Metabolic syndrome is treated
The medicine of sign mainly has：Antidiabetic drug melbine, Studies of The Insulin Sensitizer Thiazolidinediones medicine, HMG-COA reduction enzyme levels
Agent (Pitavastatin) etc..But reported according to existing experimental study, treatment of these medicines to metabolic syndrome can't be affirmed
Effect and the danger that whether can reduce its angiocardiopathy, and these medicines have the side effect for causing increased weight and oedema.
Therefore treatment metabolic syndrome a kind of curative for effect and notable, that drug quality is stable, toxic side effect is small is developed in market in urgent need
Chinese medicine.
The content of the invention
The present inventor comes from theory of traditional Chinese medical science, summarizes clinical experience for many years, carries and forms by clinical practice empirical.The present invention
For Chinese medicine composition, it is the pure Chinese medicinal preparation as made from the Chinese medicines such as Radix Liriopes, pseudo-ginseng, red ginseng, rhizoma alismatis by Hydrolysis kinetics, has
It can improve and cure mainly the metabolic syndromes such as hyperglycaemia, and it is curative for effect, safely and effectively.
It is an object of the invention to provide a kind of Chinese medicine composition and the medicine including said composition, the medicine can treat
The metabolic syndromes such as hyperglycaemia.
The present invention also aims to provide the preparation method of above-mentioned composition and medicine, with it, can be used
In treat the metabolic syndrome such as hyperglycaemia the effect of significantly, sophisticated technologies, the pharmaceutical composition of steady quality.
The purposes for treating the metabolic syndromes such as hyperglycaemia the present invention also aims to provide aforementioned pharmaceutical compositions to be used for.
In order to achieve the above object, the invention provides a kind of Chinese medicine composition, said composition to include following parts by weight
Traditional Chinese medicinal components：Red ginseng 3-8 parts, Radix Liriopes 10-15 parts, pseudo-ginseng 3-8 parts, rhizoma alismatis 3-8 parts；The traditional Chinese medicinal components can be above-mentioned Chinese medicine
Material fecula or the Chinese medical extract equivalent to above-mentioned Chinese medicine crude drug amount.
Above-mentioned traditional Chinese medicinal components include the aqueous extract that red ginseng, Radix Liriopes, pseudo-ginseng, rhizoma alismatis are the Chinese medicine.
In a preferred embodiment of the invention, above-mentioned Chinese medicine composition is made up of the traditional Chinese medicinal components of following parts by weight：It is red
Join 4-6 parts, Radix Liriopes 8-12 parts, pseudo-ginseng 4-6 parts, rhizoma alismatis 4-6 parts；The traditional Chinese medicinal components can be above-mentioned Chinese medicine fecula or suitable
In the Chinese medical extract of above-mentioned Chinese medicine crude drug amount.
The present invention another preferred embodiment in, above-mentioned Chinese medicine composition by following parts by weight traditional Chinese medicinal components group
Into：6 parts of red ginseng, 12 parts of Radix Liriopes, 6 parts of pseudo-ginseng, 6 parts of rhizoma alismatis；The traditional Chinese medicinal components can be above-mentioned Chinese medicine fecula or quite
In the Chinese medical extract of the crude drug amount of above-mentioned Chinese medicine.
Present invention also offers a kind of medicine for treating the metabolic syndromes such as hyperglycaemia, including above-mentioned Chinese traditional medicine composition
Thing and pharmaceutically acceptable auxiliary material.
Medicine provided by the invention, its component include：Red ginseng 3-8 parts, Radix Liriopes 10-15 parts, pseudo-ginseng 3-8 parts, rhizoma alismatis 3-8
Part；The traditional Chinese medicinal components can be above-mentioned Chinese medicine fecula or the Chinese medical extract equivalent to above-mentioned Chinese medicine crude drug amount, and medicine
Learn acceptable auxiliary material；Above-mentioned traditional Chinese medicinal components are the Chinese medical extract or powder of the crude drug amount equivalent to above-mentioned Chinese medicine.
It is preferred that red ginseng, Radix Liriopes, pseudo-ginseng, rhizoma alismatis are the aqueous extract of the Chinese medicine.
The medicine of above-mentioned treatment metabolic syndrome is preferably peroral dosage form, including honeyed bolus, concentration water-honeyed pill, the water-bindered pill, particle
The formulations such as agent, capsule, tablet, powder, paste, oral liquid or syrup；The medicine is more preferably granule, capsule, piece
Agent.
In a preferred embodiment of the invention, there is provided a kind of medicine for treating the metabolic syndromes such as hyperglycaemia, the medicine
For granule or capsule, the medicine includes Chinese medicine composition and pharmaceutically acceptable auxiliary material, wherein, described Chinese medicine composition
For the traditional Chinese medicinal components of the parts by weight of the crude drug amount equivalent to following Chinese medicine：Red ginseng 3-8 parts, Radix Liriopes 10-15 parts, pseudo-ginseng 3-8
Part, rhizoma alismatis 3-8 parts；Red ginseng, Radix Liriopes, pseudo-ginseng, rhizoma alismatis are the aqueous extract of those Chinese medicines；Described is pharmaceutically acceptable
Auxiliary material is to account for any in drug weight 0.15-35% Icing Sugar, microcrystalline cellulose, starch, dextrin or its combination.
Present invention also offers a kind of method for the medicine for treating the metabolic syndromes such as hyperglycaemia is prepared, this method includes：
Red ginseng, Radix Liriopes, pseudo-ginseng, rhizoma alismatis are the aqueous extract of the Chinese medicine, and it is that red ginseng, Radix Liriopes, pseudo-ginseng, rhizoma alismatis add decocting
Boil；The weight for adding water is 1-20 times of the Chinese medicine weight, decocting liquid filtration, when filtrate is concentrated into 60 DEG C relative density for 1.20~
1.25, it dry, pulverize, obtain extract powder, add Icing Sugar, microcrystalline cellulose, starch, the dextrin for accounting for drug weight 0.15-35%
In any or its combination, mix, pelletize, dry, that is, obtain the medicine of tablet, granule, capsule or powder preparation formulation.
By experiment, the pharmaceutically acceptable auxiliary material for screening to obtain is preferably in Icing Sugar, microcrystalline cellulose, starch, dextrin
Any or its combination, more preferably microcrystalline cellulose, starch or dextrin, most preferably dextrin；The pharmaceutically acceptable auxiliary material
Weight accounts for the 0.15-35% of the drug weight.
There is the composition and medicine of the present invention the multiple arteries and veins of qi and activate blood circulation, nourishing Yin and promoting production of body fluid to drop turbid effect, cure mainly hyperglycaemia etc.
Metabolic syndrome.The present invention have selected mixture, simple process is convenient to take, but practice process first according to the characteristics of its medication
Middle clinical reflection and the less stable for finding mixture；Inventor preferably selects for example further according to the Medicinal Trait of modern patient
The oral solid formulation of granule, in order to conform better to the health idea in modern times, medicine of the invention more preferably tablet, Yin Ben
Each traditional Chinese medicinal components of invention are used as medicine in the form of extracted obtained aqueous extract, and fast and easy to operate, system is absorbed after clothes
Agent is stable, and finished-product volume is few, convenient to take, and manufacturing cost is low.Through experimental study, preparation technology is easy, steady quality, controllable,
Preparation safety, effective, clinical verification effect is also good, so, in a preferred embodiment of the invention, the formulation of medicine of the invention
Most preferably it is defined as tablet.
Present invention also offers the preparation method of above-mentioned Chinese medicine composition, the preparation method is in each taste medicine of summary
Many factors such as the property of medicine, clinic, production, on the basis of consulting literatures data, with reference to the reason of the active ingredient of each flavour of a drug
Change property, pharmacological activity, studied by repetition test, the process route of the product of the invention of design.
The preferred preparation method of above-mentioned Chinese medicine composition includes：The Chinese medicine of red ginseng, Radix Liriopes, pseudo-ginseng, rhizoma alismatis is added into water
Decoct three times, the heat time is respectively 2 hours, 1 hour, 1 hour；The weight for adding water is 1-20 times of the Chinese medicine weight, point
Wei not be 8 times, 6 times, 6 times；Collecting decoction, you can obtain the Chinese medicine composition of the present invention.Also the decocting liquid can be dried to obtain dry cream
The Chinese medicine composition (or dried cream powder of Chinese medicine composition) of powder, as solid-state.
Clinically substantially with decoction application, the method boiled using decocting just can be extracted it substantially general Chinese medicine
Come, but due to the characteristics of active ingredient, therefore not using alcohol precipitation process in the component of the present invention.So as to ensure the treatment of preparation
Effect.
The extraction process of the present invention preferably obtains by Orthogonal Experiment and Design.
Multi-party to investigate the factor that decocting is boiled that influences through overtesting, it is influence to select amount of water, extraction time, extraction time
The main factor that decocting is boiled, and three reasonable levels of corresponding selection are tested.To ensure the controllability and advance of product quality,
To reflect product quality main experimental data DT-13 and paste-forming rate as inspection target.
Exemplified by medicine by the present invention is tablet, with reference to medicine self-characteristic, preparations shaping standard and the warp produced greatly
Cost of helping needs, and using wet granulation, adds appropriate amount of auxiliary materials that particle is made, and dries, tabletting, coating, produces.
Tested respectively with the mixed accessories of single auxiliary material, different cultivars, different proportion, by auxiliary material and 80g dried cream powders
Mix, spray with 80% appropriate amount of ethanol, wet granulation, the granulation of 14 mesh sieves, 16 mesh sieve whole grains, dry, particle, tabletting, coating is made.
The auxiliary material kind and its dosage of basic preparation shaping are found out, selects suitable pharmaceutical adjunct.According to result of the test, most preferably really
Surely formulation conditions of the dextrin as auxiliary material, i.e. 80g dried cream powders are selected, add dextrin 20g, are mixed, are sprayed with 80% appropriate amount of ethanol, system
Grain, dry, particle is made, tabletting, is coated and produces.
Three batches of samples are made by prescription and technique, weigh above-mentioned dry cream 80g, add appropriate amount of auxiliary materials, are mixed, with 14 eye mesh screens
Wet granulation, with 16 eye mesh screen whole grains, dry, obtain particle, tabletting, coating.Tablet situation is investigated, the tablet of three batches is entered respectively
Row preparation inspection, check the friability of tablet, disintegration time limited, weight differential.The following following preparation work of the present invention is obtained
Skill.
According to this area routine techniques, composition of the invention may be made as oral liquid, honeyed bolus, water-honeyed pill, the water-bindered pill, paste
Ball, wax-wrapped pill, condensed pill, its processing step are routine operation, and visual medicinal material situation is different to take the circumstances into consideration to change process conditions, and it is this
Well known to art personnel.
If the present invention medicine be capsule, made of the above method dried cream powder add auxiliary material, such as dextrin or and also
Addition or other adhesives, fully mix, dry, pulverize, load capsule, produce.
Chinese medicine employed in the composition of the present invention is the medicinal material that version pharmacopeia in 2010 is recorded, identified, respectively
Item index meets States Pharmacopoeia specifications.
The inspection of arsenic and heavy metal in medicine of the present invention：By Chinese Pharmacopoeia version one in 2010, under annex IXE, IXF item
Regulation, is checked the heavy metal and arsenic of 3 batches of samples of this product, as a result in prescribed limit.
Health examination in medicine of the present invention：Through health examination, meet pharmacopeia Hygienic Standard.
Present invention also offers application of the above-mentioned Chinese medicine composition in the metabolic syndromes such as treatment hyperglycaemia are prepared.
And the application present invention also offers above-mentioned medicine in the metabolic syndromes such as treatment hyperglycaemia are prepared.
The medicine of the present invention is by taking tablet as an example.
The Chinese medicine preparation that (Radix Notoginseng wheat drink) of the invention is made up of Radix Liriopes etc., it is clinically used for treating the metabolism such as hyperglycaemia
Syndrome.Pharmacodynamic experiment has been done by new drug requirement.
1st, materials and methods
Reagent：Radix Notoginseng wheat medicine materical crude slice, 0.50g/ pieces, carried by the Ministry of Education of Beijing Normal University resource medicine engineering research center
For lot number：20100401；Alloxan (alloxan, ALx, Sigma Co., USA)；Glucose enzyme process blood sugar detection kit
(the safe clinical reagent Co., Ltd of Beijing Northization)；Insulin, hyperglycemic factor radioimmunological kit (French CIS companies)；Lattice arrange
This urea (Qinhuangdao Xinghua pharmaceutical factory provides, lot number 090528).
Animal：Male rat, cleaning grade, 200 ± 20g of body weight, by Beijing Vital River Experimental Animals Technology Co., Ltd.
There is provided, animal quality certification number, which is that capital is dynamic, is betrothed to：SOXK (capital) 2010-0012.Raise in central animals room, be shielding environment, permitted
Can the number of card：SYXK (capital) 2010-0009.Mouse feed be Beijing Australia of section pull together feed corporation,Ltd production cleaning grade it is large and small
Mouse grows pellet, product license number：Capital is dynamic to be betrothed to (2010) No. 010.
Modeling and determination method of blood sugar：After rat adaptability is fed 1 week, 2 groups are randomly divided into by body weight.1st group 20
For Normal group (A groups), the 2nd group 80 are modeling group.Rat Fast can't help water 12h during modeling, and ALX is injected intraperitoneally, now matches somebody with somebody
It is current, 2% parenteral solution is made into physiological saline and is administered, 1 time/d, continuous 2d, dosage is respectively 120mg/kg and 100mg/kg,
And raised under conditions of sunny more than sunshine-duration 10h, diabetes model is formed after 72h, is freely entered after injection
Food.Rat tail vein takes blood, using determination of glucose oxidase blood sugar concentration (mmol/L).The 4th day after final injection ALX
Survey fasting blood sugar, blood glucose be (14.21 ± 1.68) mmol/L after rat model fasting, after ad lib blood glucose be (18.32 ±
1.06) mmol/L, compared with normal group, there is significant difference, illustrate to meet mark using diabetic model rats prepared by this method
Accurate (blood glucose value ＞ 11.1mmol/L persons are modeling winner).
Packet and processing：Modeling success rat 80 is taken only to be divided into 4 groups at random again：(B groups, give and distill model control group
Water), Radix Notoginseng wheat medicine materical crude slice low dose group (C1 groups, 200mg/kg), Radix Notoginseng wheat medicine materical crude slice high dose group (C2 groups, 400mg/kg),
Glibenclamide group (D groups, 15mg/kg).Each group gavage amount is 2mL/, 1 time/d, carries out 14d altogether.After off-test, it is divided to two
Batch animal is put to death, detect after fasting blood biochemistry index (blood glucose, insulin, pancreas after (fasting, prohibit water 12h) and ad lib respectively
Glucagons).
Statistical method：Measurement data is represented using X ± s, statistics t check analyses, is to have statistics with P ＜ 0.05
Learn meaning.
2nd, result
Fasting blood-glucose, insulin, Plasma Glucagon Level after each group Rat Fast and free fasting, are shown in Table 1.
The each group rat fasting blood-glucose of table 1, insulin, Plasma Glucagon Level compare (X ± s, n=20)
Note：Compared with A groups, * P ＜ 0.05, * * P ＜ 0.01；Compared with B groups, △ P ＜ 0.05, △ △ P ＜ 0.01；With D groups
Compare, * P ＞ 0.05.
Two dosage groups of Radix Notoginseng wheat medicine materical crude slice can significantly reduce blood glucose after rat model fasting and ad lib, curative effect
(P ＞ 0.05) suitable with glibenclamide；And can significantly after the fasting of elevation model mouse and after ad lib insulin level, with
High dose group is optimal, and effect is suitable with glibenclamide (P ＞ 0.05)；Two dosage of Radix Notoginseng wheat medicine materical crude slice can reduce model mouse taboo
Hyperglycemic factor after food.
Embodiment
For apparent explanation goal of the invention and technical scheme, it is described in further detail by following embodiments.
Embodiment 1：
The prescription (parts by weight) of the composition of the present invention：
6 portions of red ginseng, 12 portions of Radix Liriopes, 6 portions of pseudo-ginseng, 6 parts of rhizoma alismatis
Preparation method：
Above flavour of a drug add water to cook three times, and the heat time is respectively 2 hours, 1 hour, 1 hour；The weight for adding water is in this
1-20 times of medicinal material weight, respectively 8 times, 6 times, 6 times；Collecting decoction filters, filtrate be concentrated into relative density for 1.20~
1.25 (60 DEG C), spray drying, (160 DEG C of intake air temperature, 85 DEG C of air outlet temperature, inlet amount 50mL/min), obtain extract powder,
As composition.
Embodiment 2：
The prescription of the composition of the present invention：
6 portions of red ginseng, 12 portions of Radix Liriopes, 6 portions of pseudo-ginseng, 6 parts of rhizoma alismatis
Preparation method：The preparation of composition is the same as embodiment 1；
Tablet：Dextrin is added in the composition, is mixed, and is sprayed with 80% alcohol granulation, is dried, add appropriate magnesium stearate,
Tabletting, coating, produces Tablets.
As a result show：Present composition tablet meets relevant every regulation under tablet item.
The preferred embodiment for the present invention is the foregoing described, so it is not limited to the present invention.Those skilled in the art couple
Embodiment disclosed herein can carry out improvement and the change without departing from scope and spirit.
Claims (9)
1. a kind of Chinese medicine composition for treating hyperglycaemia, is made up of the traditional Chinese medicinal components of following parts by weight：Red ginseng 3-8 parts, Radix Liriopes
10-15 parts, pseudo-ginseng 3-8 parts, rhizoma alismatis 3-8 parts；The traditional Chinese medicinal components are above-mentioned Chinese medicine fecula or given birth to equivalent to above-mentioned Chinese medicine
The Chinese medical extract of dose.
2. Chinese medicine composition as claimed in claim 1, wherein, in described traditional Chinese medicinal components, red ginseng, Radix Liriopes, pseudo-ginseng, rhizoma alismatis
It is the aqueous extract of the Chinese medicine.
3. Chinese medicine composition as claimed in claim 1, wherein, described Chinese medicine composition by following parts by weight traditional Chinese medicinal components
Composition：Red ginseng 3-8 parts, Radix Liriopes 10-15 parts, pseudo-ginseng 3-8 parts, rhizoma alismatis 3-8 parts；The Chinese medical extract is the Chinese medicine
Aqueous extract.
4. a kind of medicine for treating hyperglycaemia, it, which includes Chinese medicine composition described in claim any one of 1-3 and pharmacy, to connect
The auxiliary material received, the medicine are oral formulations.
5. medicine as claimed in claim 4, wherein, described oral formulations be oral liquid, granule, capsule, tablet or
Powder, described pharmaceutically acceptable auxiliary material is any in Icing Sugar, microcrystalline cellulose, starch, dextrin or its combination；Described medicine
The weight for learning acceptable auxiliary material accounts for the 0.15-35% of the drug weight.
6. a kind of medicine for treating hyperglycaemia, including Chinese medicine composition and pharmaceutically acceptable auxiliary material, wherein, the Chinese medicine composition
For the traditional Chinese medicinal components of the parts by weight of the crude drug amount equivalent to following Chinese medicine：Red ginseng 3-8 parts, Radix Liriopes 10-15 parts, pseudo-ginseng 3-8
Part, rhizoma alismatis 3-8 parts；Red ginseng, Radix Liriopes, pseudo-ginseng, rhizoma alismatis are the aqueous extract of the Chinese medicine in the traditional Chinese medicinal components；The pharmacy
Acceptable auxiliary material is to account for any in drug weight 0.15-35% Icing Sugar, microcrystalline cellulose, starch, dextrin or its combination.
7. the preparation method of the medicine described in claim 4, wherein, this method includes：Red ginseng, Radix Liriopes, pseudo-ginseng, rhizoma alismatis add water
Decoct；The weight for adding water is 1-20 times of the Chinese medicine weight, and decocting liquid filtration, relative density is 1.20 when filtrate is concentrated into 60 DEG C
~1.25, dry, obtain extract powder, add pharmaceutically acceptable auxiliary material, mix, pelletize, dry, that is, obtain the medicine.
8. the preparation method of the medicine of the treatment hyperglycaemia described in claim 7, this method include：Red ginseng, Radix Liriopes, pseudo-ginseng,
The Chinese medicine of rhizoma alismatis adds water to cook；The weight for adding water is 1-20 times of the Chinese medicine weight, and decocting liquid filters, and filtrate is concentrated into 60 DEG C
When relative density be 1.20~1.25, dry, obtain extract powder, add Icing Sugar, the microcrystalline cellulose for accounting for drug weight 0.15-35%
Any or its combination, mixes, pelletizes, dry, that is, obtain the medicine in element, starch, dextrin.
9. application of the Chinese medicine composition in the medicine for preparing treatment hyperglycaemia described in claim 1.
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1330930A (en) * | 2000-06-28 | 2002-01-16 | 秦中凯 | Medicine for treating cardiovascular disease |
| CN1357368A (en) * | 2001-12-25 | 2002-07-10 | 岳小鸥 | Health beverage |
| CN101979050A (en) * | 2010-11-04 | 2011-02-23 | 北京绿源求证科技发展有限责任公司 | Traditional Chinese medicine for treating diabetic peripheral neuropathy |
-
2014
- 2014-06-27 CN CN201410308750.5A patent/CN104056020B/en not_active Expired - Fee Related
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1330930A (en) * | 2000-06-28 | 2002-01-16 | 秦中凯 | Medicine for treating cardiovascular disease |
| CN1357368A (en) * | 2001-12-25 | 2002-07-10 | 岳小鸥 | Health beverage |
| CN101979050A (en) * | 2010-11-04 | 2011-02-23 | 北京绿源求证科技发展有限责任公司 | Traditional Chinese medicine for treating diabetic peripheral neuropathy |
Non-Patent Citations (2)
| Title |
|---|
| 中医治疗代谢综合征研究进展;耿春丽;《山东中医杂志》;20140531;第33卷(第5期);第411-414页 * |
| 代谢综合征中医药研究概况;顾震宇、王旭;《中医杂志》;20070331;第48卷(第3期);第275页第4部分第1、3段 * |
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