CN107496603A - A kind of Chinese medicine composition for treating IGR and preparation method and application - Google Patents
A kind of Chinese medicine composition for treating IGR and preparation method and application Download PDFInfo
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Abstract
The present invention provides a kind of Chinese medicine composition, is prepared by the Chinese medicine of following mass parts for raw material：500 1000 parts of 600 1200 parts of hainan holly leaf, 600 1200 parts of potentilla discolor, 600 1200 parts of Guava Leaf, the root bark of white mulberry 900 1200,500 900 parts of the coptis and panax japonicus.Clinical test results show that composition prepared by the present invention has reduction fasting blood-glucose, postprandial blood sugar, reduces blood fat, improves the effect of insulin resistance, can obviously reduce the level of significance that IGR is converted into diabetes.
Description
Technical field
The invention belongs to food or pharmaceutical technology field, and in particular to a kind of Chinese medicine composition for treating IGR and
Its preparation method and application.
Background technology
IGR is prediabetes, is the abnormal metabolism states between euglycemia and diabetes, mainly
Including IFG (impaired fasting glucose, IFG) and Impaired Glucose Tolerance Treated (impaired glucose
tolerance,IGT).Prediabetes is most important risk of diabetes crowd, therefore it is prevention sugar to intervene prediabetes
Urinate the key of disease.The diabetes mellitus in China incidence of disease there are about 11.6% at present, and prediabetes there are about 50%, and China there are about 1.139 hundred million
Diabetic, pre-diabetic there are about 3.6 hundred million, diabetes turned into threaten one of China Public health it is great because
Element.Several extensive Intervention trials that prediabetes is carried out are studied both at home and abroad and shown, change lifestyles and acarbose,
The pharmaceutical interventions such as melbine can reduce diabetes incidence to a certain extent.But strengthen lifestyle modification and pharmaceutical intervention
Some side effects make patient be difficult to adhere to for a long time.
The content of the invention
It is an object of the invention to provide a kind of Chinese medicine composition for safely and effectively treating IGR and preparation method thereof.
Chinese medicine composition provided by the present invention, it is prepared by the Chinese medicine of following mass parts for raw material：Hainan holly leaf 600-
1200 parts, potentilla discolor 600-1200 parts, Guava Leaf 600-1200 parts, root bark of white mulberry 900-1200, coptis 500-900 parts and ring
Join 500-1000 parts.
Specifically, Chinese medicine composition provided by the present invention is prepared by the Chinese medicine of following mass parts for raw material：Mountain is green
Tea 600g, potentilla discolor 600g, Guava Leaf 600g, root bark of white mulberry 900g, coptis 500g and panax japonicus 500g.
Or, specifically, Chinese medicine composition provided by the present invention is prepared by the Chinese medicine of following mass parts for raw material：Mountain
Green tea 1200g, potentilla discolor 1200g, Guava Leaf 1200g, root bark of white mulberry 1200g, coptis 900g and panax japonicus 1000g.
Chinese medicine composition provided by the present invention is prepared by the method comprising the following steps：
1) hainan holly leaf, potentilla discolor, Guava Leaf, the root bark of white mulberry, the coptis and panax japonicus are ground into coarse powder respectively；
2) hainan holly leaf coarse powder is impregnated with 70% ethanol as solvent, diacolation, collects percolate, recovery ethanol is simultaneously dense
Contracting, obtains paste hainan holly leaf ethanol extract；
3) it is dense by potentilla discolor, Guava Leaf and panax japonicus mass concentration 60-80% ethanol solution heating and refluxing extraction
Contracting extract solution, obtain paste potentilla discolor, Guava Leaf and ring conopsea extraction；
4) root bark of white mulberry, the coptis are added water to cook, filtered, collected filtrate, concentrate the filtrate to clear cream shape, cooled down, add second
Alcohol, stir evenly, stand, supernatant concentration is reclaimed into ethanol, obtains the paste root bark of white mulberry, coptis extract；
5) above-mentioned three kinds of heavy paste extracts are mixed, dry, pulverize into fine powder, obtain Chinese medicine composition.
In above method step 2), the amount of alcohol of the dipping can be 5-8 times of medicinal material gross mass, the dipping when
Between can be 20-30 hours.
The condition of the diacolation is：Every kilogram of medicinal material carries out diacolation with 5~8ml per minute.
In above method step 3), the extraction is with 5-8 times that the amount of ethanol solution is medicinal material gross mass.
The extraction can be carried out repeatedly, concretely 3 times.
The time extracted every time can be 1-2 hours.
The operation of the concentrated extracting solution is：Obtained extract solution merging will be repeatedly extracted, ethanol is recovered under reduced pressure, is concentrated into
Relative density is 1.30-1.35 (70 DEG C) thick paste.
In above method step 4), the decoction can be carried out repeatedly, concretely 3 times.
The decoction water consumption is 8-12 times of medicinal material gross mass.
The temperature of the decoction is 100 DEG C, and the time decocted every time can be 1.5 hours.
It is described by filtrate concentration operation be：Concentrate the filtrate to the clear cream that relative density is 1.10-1.15 (75 DEG C).
The quality of the ethanol of addition is 2.5 times of clear cream quality.
The time of the standing can be 24 hours.
It is described by supernatant concentration reclaim ethanol operation be：It is 1.30-1.35 (75 by supernatant concentration to relative density
DEG C) thick paste.
In above method step 5), the drying is concretely dried under reduced pressure.
Present invention also offers the application of above-mentioned Chinese medicine composition.
The application of above-mentioned Chinese medicine composition provided by the present invention is application of the above-mentioned Chinese medicine composition in following medicines are prepared：
1) medicine of IGR is treated；
2) medicine of fasting blood-glucose is reduced；
3) medicine of postprandial blood sugar is reduced；
4) medicine of blood fat is reduced；
5) medicine of insulin resistance is improved；
6) medicine that IGR is converted into the level of significance of diabetes is reduced.
The present invention also protect it is a kind of be used to treating the medicine of IGR, reduce the medicine of fasting blood-glucose, reduce it is postprandial
The medicine of blood glucose, the medicine for reducing blood fat, the medicine for improving insulin resistance and/or reduction IGR are converted into diabetes
Level of significance medicine.
The medicine contains Chinese medicine composition provided by the present invention and pharmaceutically acceptable carrier.
The carrier include the conventional diluent of pharmaceutical field, excipient, filler, adhesive, wetting agent, disintegrant,
Sorbefacient, surfactant, absorption carrier, lubricant etc..
It is a variety of that tablet, pulvis, granule, capsule, oral liquid etc. can be made in medicine containing Chinese medicine composition of the present invention
Form.The medicine of above-mentioned various formulations can be prepared according to the conventional method of pharmaceutical field.
Illustrated exemplified by preparing granule.Dried Chinese medical extract is ground into fine powder, takes 500g, is added
The mixture of 500g soluble starches and dextrin (mass ratio 1：1), 10g steviosides mix, with the ethanol water that mass concentration is 80%
Solution is pelletized, and dries, whole grain, particle 1000g is made.It is distributed into 6g/ bags.Usage and dosage：Boiling water is taken after mixing it with water, once a bag, 3 times a day.
Above-mentioned fine powder meets regulation of 2010 editions pharmacopeia to fine powder：Referring to can be all by No. five sieve, and containing can pass through No. six
Powder of the sieve no less than 95%.
Clinical test results show that compound granular prepared by the present invention has reduction fasting blood-glucose, postprandial blood sugar, reduces blood
Fat, improve the effect of insulin resistance, can obviously reduce the level of significance that IGR is converted into diabetes.
Embodiment
Below by specific embodiment, the present invention will be described, but the invention is not limited in this.
Experimental method used in following embodiments is conventional method unless otherwise specified；Institute in following embodiments
Reagent, material etc., unless otherwise specified, commercially obtain.
Hainan holly leaf used, potentilla discolor, Guava Leaf, the root bark of white mulberry, the coptis, panax japonicus meet China in following embodiments
Pertinent regulations under each medicinal material item of pharmacopeia one text of version in 2010.Before feeding intake, by identification, ingredients material object and title phase
Symbol, quality meet standard.
Embodiment 1, prepare Chinese native medicine compound prescription pellet for treating IGR
1. prescription
Hainan holly leaf 600g potentilla discolor 600g Guava Leafs 600g
Root bark of white mulberry 900g panax japonicus 500g coptiss 500g
2. preparation method
The taste of the above 6, is ground into coarse powder.Hainan holly leaf is impregnated with 70% ethanol as solvent, and amount of alcohol is the total matter of medicinal material
5-8 times of amount, for dipping after 24 hours, every kilogram of medicinal material carries out diacolation with 5~8ml per minute, collects 6 times of percolate, recovery
Ethanol is simultaneously concentrated into paste；Potentilla discolor, Guava Leaf and the taste of panax japonicus 3 are heated to reflux with the ethanol solution of mass concentration 70%
Extraction 3 times, each alcohol adding amount are 6 times of medicinal material gross mass, and extraction 1.5 hours, merge extract solution, ethanol is recovered under reduced pressure every time,
It is concentrated into the thick paste that relative density is 1.30-1.35 (70 DEG C)；The root bark of white mulberry, the taste medicine of the coptis 2 add water to cook 3 times, and amount of water is medicine
10 times of material gross mass, extract 1.5 hours every time, the temperature of decoction is 100 DEG C, collecting decoction, filtration, and filtrate is concentrated into relatively
Density is 1.10-1.15 (75 DEG C) clear cream, lets cool, adds the ethanol of 2.5 times of quality of clear cream, stir evenly, and stands 24 hours, takes
Supernatant reclaims ethanol, is concentrated into the thick paste that relative density is 1.30-1.35 (75 DEG C)；Above-mentioned 3 kinds of thick pastes are mixed, decompression is dry
It is dry, fine powder is ground into, obtains Chinese medical extract powder.
The above-mentioned Chinese medical extract powder of 500g is taken to add the mixture (1 of 500g soluble starches and dextrin：1, mass ratio), 10g
Stevioside, mix, pelletized with the ethanol water that mass concentration is 80%, dry, whole grain, 1000g is made.Formulation：Granule, 6g/ bags.
The clinical effectiveness experiment of embodiment 2, Chinese native medicine compound prescription pellet for treating IGR
First, research object
1. subject source：150 IGR subjects suffer from from Beijing University of Traditional Chinese Medicine Subsidiary Dongfang Hospital's outpatient service
Person, Fang Zhuan communities examination patient and Beijing Hospital of Traditional Chinese Medicine of Capital University of Medical Sciences out-patient.
2. diagnostic criteria：The standard formulated using WHO in 1999：IFG (IFG) diagnostic criteria：Fasting blood-glucose
>=6.1mmol/L but<7.0mmol/L, 2 hours blood glucose after oral 75g dextrose tolerance tests (OGTT) clothes are sugared<7.8mmol/L.
Impaired Glucose Tolerance Treated (IGT) diagnostic criteria：Fasting blood-glucose<7.0mmol/L, 2 after oral 75g dextrose tolerance tests (OGTT) clothes are sugared
Hour blood glucose >=7.8mmol/L, but<11.1mmol/L.
3. inclusive criteria：A. above-mentioned diagnostic criteria is met；B. the age is between 35-70 year；C. body mass index is in 20-35Kg/m2。
4. exclusion standard：A. cardiovascular event person occurred at no distant date；B. previously in 3 months using glucocorticoid, β by
Body blocking agent, thiazide diuretic, nicotinic acid class medicine；C. serum creatinine >=130umol/L；D. liver transaminases are increased to normally
More than 2 times persons of range limit；E. more than moderate or the non-rectifier of severe hypertension, endocrine system disease；F. fasting plasma glycerine three
Lipid level>6.0mmol/L.
2nd, Double-blind randomized clinical trial
1. random packet：With simple randomization table method, 2 groups (Chinese native medicine compound prescription pellet group, placebos) are randomly divided into, every group each
75, totally 150.Establishment is randomly assigned card, is sealed with envelope, is taken care of by special messenger.
2. prepared by trial drug：
Investigational agent Chinese native medicine compound prescription pellet and placebo are prepared by Beijing University of Traditional Chinese Medicine Subsidiary Dongfang Hospital Drug Manufacturing Room, and placebo is equal
It is its outward appearance, shape, in the same size using granule.
3. double blind controling test：Medication and comparison medicine will be tested by the group of study subject and its enter the sequence number thing studied
First mix Unified coding, unitizing.Test drug and be randomly assigned card by do not participate in directly clinical observation special messenger take care of.Press
Number order, enter by patient and sequentially get use when studying.Each one medicine bag of patient, loads random card in bag, during use
It should be grouped according to as defined in random card and medicine for treatment is carried out, it is impossible to make any change, to the end of clinical test, analysis is complete
Take off blind after finishing, cipher control person when taking off blind, clinical research director, data collection personnel, analysis personnel all should be on the scene.
3rd, medicine for treatment scheme
1. test drug
Every subject in take before the meal every time embodiment 1 preparation 6 grams of 6 grams of Chinese native medicine compound prescription pellet or placebo, three times a day.
2. Primary Care
1. all subjects receive after general Diabetes Mellitus Knowledge propaganda and education no longer fortified diet and motor education.
2. complicated hypertension person, select ACEI or ARB or calcium ion antagonist.
4th, observation index
1. health giving quality index：
1. oral 75g dextrose tolerance tests (OGTT)；
2. fasting blood-glucose (FPG), postprandial 2 hours blood glucose (2hPG)；Glucose oxidase method；
3. glycosylated hemoglobin (HbA1C) measure：Determined with DCA2000 diabetes specialized analyzer；
4. blood fat：T-CHOL (TC), triglyceride (TG), HDL (HDL), low-density lipoprotein (LDL)：
Full-automatic biochemical method；
5. Fasting plasma insulin (FINS) determines：Full-automatic chemiluminescence immunization；
6. insulin resistance index (IR)：Insulin resistance index (HOMA-IR=is calculated according to HOMA Model formula
FPG×FINS/22.5)；
7. body mass index (BMI), systolic pressure (SBP), diastolic pressure (DBP).
2. safety indexes：Blood routine, liver function, renal function, electrocardiogram,
Above index, OGTT, blood fat and insulin assay and safety indexes detect once every year, every 3 of remaining index
Moon detection is once.
5th, terminal target：
OGTT every year measure once, if the oral 75g dextrose tolerance tests of all subjects, 2 hours blood glucose after clothes sugar >=
11.1mmol/L person, OGTT experiments need to be repeated once again, if OGTT is tested twice, after clothes sugar 2 hours blood glucose >=
11.1mmol/L, then diabetes B is diagnosed as, subject reaches terminal target, terminates clinical test.
6th, statistical method
Enumeration data X2Examine, measurement data is checked with t, and ranked data are analyzed with Ridit or rank test.Statistical
Analysis is carried out with SAS6.02 statistical analysis systems.
7th, result
The comparison of general information when the 1st, visiting for the first time
2 groups of number of cases when visiting for the first time, the age, sex, FPG, 2hPG, blood pressure, body mass index (BMI), blood fat (TC, TG, HDL,
LDL) difference there are no significant (P>0.05).In follow-up observation in 1 year, 150 9 lost to follow-up, wherein (1 goes out placebo 5
State, 4 are lost to follow-up because moving), Chinese native medicine compound prescription pellet group 4 (3 are out of touch because moving, and 1 automatically exits from without cause specific).
2nd, the comparison of follow-up year end 1 each group blood glucose and FPI
At the year end of follow-up 1, placebo FPG, 2hPG and HbA1c substantially rise (P when relatively visiting for the first time<0.05), Chinese medicinal granule
Group FPG, 2Hpg, HbA1c are decreased obviously (P when relatively visiting for the first time<0.05), and with placebo comparing difference there is conspicuousness (P<
0.05).Follow-up end, prompts Chinese medicinal granule group to play the role of substantially to reduce blood glucose.When each group Fasting insulin level is relatively visited for the first time without
Significant change (P>0.05).Refer to table 1
The comparison of table 1 follow-up, year end 1 each group blood glucose and FPI
△ shows and itself compares before and after treatment, P<0.05.▲ show compared with placebo, P<0.05
3rd, between follow-up year end 1 each group insulin resistance index comparison
The year end of follow-up 1, placebo insulin resistance index substantially rise (P when relatively visiting for the first time<0.05), Chinese medicinal granule group pancreas
Insulin resistance index is decreased obviously (P when relatively visiting for the first time<0.05), prompt：The effect that Chinese medicinal granule group improves insulin resistance is better than
Placebo.Refer to table 2.
The comparison of insulin resistance index between table 2 follow-up, year end 1 each group
△ shows and itself compares before and after treatment, P<0.05.
4th, the comparison of follow-up year end 1 each group blood fat
At the year end of follow-up 1, placebo TG, TC, LDL-c are without being decreased obviously (P>0.05), Chinese medicinal granule group TG, TC, LDL-c
(P is decreased obviously when relatively visiting for the first time<0.05), and with placebo comparing difference there is conspicuousness (P<0.05).Follow-up end, in prompting
Medicine particle group plays the role of substantially to reduce blood fat.Refer to table 3
Table 3 follow-up, year end 1 each group blood fat compares
△ shows and itself compares before and after treatment, P<0.05.▲ show compared with placebo, P<0.05
5th, after follow-up 1 year each group body mass index, blood pressure comparison
The year end of follow-up 1, each group BMI, blood pressure level, when visiting for the first time compared with there are no significant difference (P>0.05).
6th, follow-up year end 1 each group sugar tolerance lapses to
In follow-up year end 1 placebo 70, normal glucose tolerance (NGT) person 8,11.4% is accounted for, IGT (IGT)
Person 54, accounts for 77.2%, switchs to diabetes (DM) person 8, accounts for 11.4%.It is changed into DM person every year on average as 11.4%.
In follow-up year end 1 Chinese medicinal granule group 71, normal glucose tolerance person 16 accounts for 22.5%, IGT person 51,
71.8% is accounted for, is changed into DM person 4, accounts for 5.6%, is changed into DM person every year on average as 5.6%.2 types occur compared with placebo
Diabetes Relative Risk reduces by 50.14%.Refer to table 4.
The comparison that table 4 follow-up, year end 1 each group sugar tolerance lapses to
▲ show compared with placebo, P<0.05.
7th, adverse reaction
2 groups of patients checked blood routine and Liver and kidney function afterwards before the treatment, in normal range (NR), pretherapy and post-treatment nothing
Significant difference.In therapeutic process, 2 groups do not find any adverse reaction.
Clinical test results show：2 hours blood glucose (2hPG), HbAles after placebo fasting blood-glucose (FPG), OGTT
Albumen (HbA1c) and insulin resistance index (IR) have rising, and diabetes morbidity is 11.4% every year on average；Chinese medicine compound prescription
Particle group FPG, 2hPG, HbA1c and IR are remarkably decreased, and the incidence of disease of diabetes is 5.6% every year on average, compared with placebo
Generation diabetes B Relative Risk reduces by 50.14%.Show that Chinese native medicine compound prescription pellet prepared by embodiment 1 has reduction on an empty stomach
Blood glucose, postprandial blood sugar, blood fat is reduced, improve the effect of insulin resistance, can obviously reduce IGR and be converted into diabetes
Level of significance.
Embodiment 3, prepare Chinese native medicine compound prescription pellet for treating IGR
1. prescription
Hainan holly leaf 1200g potentilla discolor 1200g Guava Leafs 1200g
Root bark of white mulberry 1200g panax japonicus 1000g coptiss 900g
2. preparation method
The taste of the above 6, is ground into coarse powder.Hainan holly leaf is impregnated with 70% ethanol as solvent, and amount of alcohol is the total matter of medicinal material
5-8 times of amount, for dipping after 24 hours, every kilogram of medicinal material carries out diacolation with 5~8ml per minute, collects 6 times of percolate, recovery
Ethanol is simultaneously concentrated into paste；Potentilla discolor, Guava Leaf and the taste of panax japonicus 3 are heated to reflux with the ethanol solution of mass concentration 70%
Extraction 3 times, each alcohol adding amount are 6 times of medicinal material gross mass, and extraction 1.5 hours, merge extract solution, ethanol is recovered under reduced pressure every time,
It is concentrated into the thick paste that relative density is 1.30-1.35 (70 DEG C)；The root bark of white mulberry, the taste medicine of the coptis 2 add water to cook 3 times, and amount of water is medicine
10 times of material gross mass, extract 1.5 hours every time, the temperature of decoction is 100 DEG C, collecting decoction, filtration, and filtrate is concentrated into relatively
Density is 1.10-1.15 (75 DEG C) clear cream, lets cool, adds the ethanol of 2.5 times of quality of clear cream, stir evenly, and stands 24 hours, takes
Supernatant reclaims ethanol, is concentrated into the thick paste that relative density is 1.30-1.35 (75 DEG C)；Above-mentioned 3 kinds of thick pastes are mixed, decompression is dry
It is dry, fine powder is ground into, obtains Chinese medical extract powder.
1000g medicament extracts powder is taken to add the mixture (1 of 1000g soluble starches and dextrin：1, mass ratio), 20g
Stevioside mixes, and with the alcohol granulation that mass concentration is 80%, dries, whole grain, 2000g is made.Formulation：Granule, 6g/ bags.
The clinical effectiveness experiment of embodiment 4, Chinese native medicine compound prescription pellet for treating IGR
First, research object is the same as embodiment 2
1. subject source：220 IGR subjects suffer from from Beijing University of Traditional Chinese Medicine Subsidiary Dongfang Hospital's outpatient service
Person, Fang Zhuan communities, The Big Red Gate community examination patient and Beijing Hospital of Traditional Chinese Medicine of Capital University of Medical Sciences out-patient.
2. diagnostic criteria：With embodiment 2.
3. inclusive criteria：With embodiment 2.
4. exclusion standard：With embodiment 2.
2nd, Double-blind randomized clinical trial
1. random packet：With simple randomization table method, 2 groups (Chinese native medicine compound prescription pellet group, placebos) are randomly divided into, every group each
110, totally 220.Establishment is randomly assigned card, is sealed with envelope, is taken care of by special messenger.
2. prepared by trial drug：With embodiment 2.
3. double blind controling test：With embodiment 2.
3rd, medicine for treatment scheme
1. test drug
Every subject in take before the meal every time embodiment 3 preparation 6 grams of 6 grams of Chinese native medicine compound prescription pellet or placebo, daily
Three times.
2. Primary Care is the same as embodiment 2.
4th, observation index is the same as embodiment 2.
5th, terminal target is the same as embodiment 2.
6th, statistical method is the same as embodiment 2.
7th, result
The comparison of general information when the 1st, visiting for the first time
2 groups of number of cases when visiting for the first time, the age, sex, FPG, 2hPG, blood pressure, body mass index (BMI), blood fat (TC, TG, HDL,
LDL) difference there are no significant (P>0.05).In follow-up observation in 1 year, 220 10 lost to follow-up, wherein placebo 5 (1
Go abroad, 4 are lost to follow-up because moving), Chinese native medicine compound prescription pellet group 5 (3 are out of touch because moving, and 2 are gone abroad).
2nd, the comparison of follow-up year end 1 each group blood glucose and FPI
At the year end of follow-up 1, placebo FPG, 2hPG and HbA1c substantially rise (P when relatively visiting for the first time<0.05), Chinese medicinal granule
Group FPG, 2Hpg, HbA1c are decreased obviously (P when relatively visiting for the first time<0.05), and with placebo comparing difference there is conspicuousness (P<
0.05).Follow-up end, prompts Chinese medicinal granule group to play the role of substantially to reduce blood glucose.When each group Fasting insulin level is relatively visited for the first time without
Significant change (P>0.05).Refer to table 5.
The comparison of table 5 follow-up, year end 1 each group blood glucose and FPI
△ shows and itself compares before and after treatment, P<0.05.▲ show compared with placebo, P<0.05.
3rd, between follow-up year end 1 each group insulin resistance index comparison
The year end of follow-up 1, placebo insulin resistance index substantially rise (P when relatively visiting for the first time<0.05), Chinese medicinal granule group pancreas
Insulin resistance index is decreased obviously (P when relatively visiting for the first time<0.05), prompt：The effect that Chinese medicinal granule group improves insulin resistance is better than
Placebo.Refer to table 6.
The comparison of insulin resistance index between table 6 follow-up, year end 1 each group
△ shows and itself compares before and after treatment, P<0.05.
4th, the comparison of follow-up year end 1 each group blood fat
At the year end of follow-up 1, placebo TG, TC, LDL-c are without being decreased obviously (P>0.05), Chinese medicinal granule group TG, TC, LDL-c
(P is decreased obviously when relatively visiting for the first time<0.05), and with placebo comparing difference there is conspicuousness (P<0.05).Follow-up end, in prompting
Medicine particle group plays the role of substantially to reduce blood fat.Refer to table 7
Table 7 follow-up, year end 1 each group blood fat compares
△ shows and itself compares before and after treatment, P<0.05.▲ show compared with placebo, P<0.05
5. follow-up year end 1 each group body mass index (BMI), blood pressure
The year end of follow-up 1, each group BMI, blood pressure level, when visiting for the first time compared with there are no significant difference (P>0.05).
6. follow-up year end 1 each group sugar tolerance lapses to
In follow-up year end 1 placebo 105, sugar tolerance switchs to NGT (NGT) person 15, accounts for 15%, still for
IGT person 77, accounts for 74%, switchs to diabetes (DM) person 13, accounts for 13%.Annual DM average attack rates are 13%.
In follow-up year end 1 Chinese medicinal granule group 105, sugar tolerance switchs to normal person 24, accounts for 23%, is still IGT person 75,
72% is accounted for, is changed into DM person 6, accounts for 6%, is changed into DM every year on average as 6%.Diabetes B phase occurs compared with placebo
50.4% is reduced to level of significance.Refer to table 8.
The comparison that table 8 follow-up, year end 2 each group sugar tolerance lapses to
▲ show compared with placebo, P<0.05.
7th, adverse reaction
2 groups of patients checked blood routine and Liver and kidney function afterwards before the treatment, in normal range (NR), pretherapy and post-treatment nothing
Significant difference.In therapeutic process, 2 groups do not find any adverse reaction.
Clinical test results show：Chinese native medicine compound prescription pellet has reduction fasting blood-glucose, postprandial blood sugar, reduces blood fat, improves
The effect of insulin resistance, it can obviously reduce the level of significance that IGR is converted into diabetes.
Claims (9)
1. a kind of Chinese medicine composition, it is prepared by the Chinese medicine of following mass parts for raw material：Hainan holly leaf 600-1200 parts, potentilla discolor
600-1200 parts, Guava Leaf 600-1200 parts, root bark of white mulberry 900-1200, coptis 500-900 parts and panax japonicus 500-1000 parts.
2. Chinese medicine composition according to claim 1, it is characterised in that：The Chinese medicine composition is by following mass parts
Medicine is prepared for raw material：Hainan holly leaf 600g, potentilla discolor 600g, Guava Leaf 600g, root bark of white mulberry 900g, coptis 500g and ring
Join 500g.
3. Chinese medicine composition according to claim 1, it is characterised in that：The Chinese medicine composition is by following mass parts
Medicine is prepared for raw material：Hainan holly leaf 1200g, potentilla discolor 1200g, Guava Leaf 1200g, root bark of white mulberry 1200g, coptis 900g and
Panax japonicus 1000g.
4. the method for the Chinese medicine composition any one of claim 1-3 is prepared, including：
1) hainan holly leaf, potentilla discolor, Guava Leaf, the root bark of white mulberry, the coptis and panax japonicus are ground into coarse powder respectively；
2) hainan holly leaf coarse powder is impregnated with 70% ethanol as solvent, diacolation, collects percolate, reclaimed ethanol and concentrate, obtain
To paste hainan holly leaf ethanol extract；
3) potentilla discolor, Guava Leaf and panax japonicus mass concentration 60-80% ethanol solution heating and refluxing extraction, concentration are carried
Liquid is taken, obtains paste potentilla discolor, Guava Leaf and ring conopsea extraction；
4) root bark of white mulberry, the coptis are added water to cook, filtered, collected filtrate, concentrate the filtrate to clear cream shape, cooled down, added ethanol, stir
It is even, stand, supernatant concentration is reclaimed into ethanol, obtains paste root bark of white mulberry coptis extract；
5) above-mentioned three kinds of heavy paste extracts are mixed, dry, pulverize into fine powder, obtain Chinese medicine composition.
5. according to the method for claim 4, it is characterised in that：In step 2), the amount of alcohol of the dipping is that medicinal material is total
5-8 times of quality, the time of the dipping is 20-30 hours；
The condition of the diacolation is：Every kilogram of medicinal material carries out diacolation with 5~8ml per minute.
6. the method according to claim 4 or 5, it is characterised in that：In step 3), the extraction is with the amount of ethanol solution
5-8 times of medicinal material gross mass；
The extraction carries out multiple；
The time extracted every time is 1-2 hours.
7. according to the method any one of claim 4-6, it is characterised in that：In step 4), described decoct is carried out repeatedly；
The decoction water consumption is 8-12 times of medicinal material gross mass；
The temperature of the decoction is 100 DEG C, and the time decocted every time is 1.5 hours；
The quality of the ethanol of addition is 2.5 times of clear cream quality；
The time of the standing is 24 hours.
8. application of the Chinese medicine composition in following medicines are prepared any one of claim 1-3：
1) medicine of IGR is treated；
2) medicine of fasting blood-glucose is reduced；
3) medicine of postprandial blood sugar is reduced；
4) medicine of blood fat is reduced；
5) medicine of insulin resistance is improved；
6) medicine that IGR is converted into the level of significance of diabetes is reduced.
9. a kind of be used to treat the medicine of IGR, the medicine for reducing the medicine of fasting blood-glucose, reducing postprandial blood sugar, reduce
The medicine of blood fat, the medicine for improving insulin resistance and/or reduction IGR are converted into the medicine of the level of significance of diabetes,
Contain the Chinese medicine composition and pharmaceutically acceptable carrier described in claim 1.
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| JPH01121221A (en) * | 1987-11-02 | 1989-05-12 | Toyo Pharma- Kk | Aldose reductase inhibitor |
| CN101322757A (en) * | 2008-07-28 | 2008-12-17 | 北京润德康医药技术有限公司 | Medicament composition for treating diabetes and method for preparing the same |
| CN102441064A (en) * | 2011-12-27 | 2012-05-09 | 西南大学 | Traditional Chinese medicine composition for treating diabetes and preparation thereof |
| CN102552578A (en) * | 2012-01-20 | 2012-07-11 | 首都医科大学 | Traditional Chinese medicine extract for treating impaired glucose tolerance and preparation method thereof |
| CN103099865A (en) * | 2013-03-05 | 2013-05-15 | 湖南希尔天然药业有限公司 | Traditional Chinese medicine composition and preparation method and application thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPH01121221A (en) * | 1987-11-02 | 1989-05-12 | Toyo Pharma- Kk | Aldose reductase inhibitor |
| CN101322757A (en) * | 2008-07-28 | 2008-12-17 | 北京润德康医药技术有限公司 | Medicament composition for treating diabetes and method for preparing the same |
| CN102441064A (en) * | 2011-12-27 | 2012-05-09 | 西南大学 | Traditional Chinese medicine composition for treating diabetes and preparation thereof |
| CN102552578A (en) * | 2012-01-20 | 2012-07-11 | 首都医科大学 | Traditional Chinese medicine extract for treating impaired glucose tolerance and preparation method thereof |
| CN103099865A (en) * | 2013-03-05 | 2013-05-15 | 湖南希尔天然药业有限公司 | Traditional Chinese medicine composition and preparation method and application thereof |
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Application publication date: 20171222 |