CN107496603A - A kind of Chinese medicine composition for treating IGR and preparation method and application - Google Patents

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

A traditional Chinese medicine composition for treating impaired sugar regulation and its preparation method and application

technical field

The invention belongs to the technical field of food or medicine, and in particular relates to a traditional Chinese medicine composition for treating impaired sugar regulation and its preparation method and application.

Background technique

Impaired glucose regulation, namely prediabetes, is an abnormal metabolic state between normoglycemia and diabetes, mainly including impaired fasting glucose (IFG) and impaired glucose tolerance (IGT). Prediabetes is the most important diabetes risk group, so intervening in prediabetes is the key to prevent diabetes. At present, the incidence of diabetes in China is about 11.6%, and pre-diabetes is about 50%. There are about 113.9 million diabetic patients in China, and about 360 million pre-diabetic patients. Diabetes has become a major factor threatening the public health of China. Several large-scale intervention trials on prediabetes at home and abroad have shown that lifestyle changes and drug interventions such as acarbose and metformin can reduce the incidence of diabetes to a certain extent. However, certain side effects of intensive lifestyle intervention and drug intervention make it difficult for patients to persist for a long time.

Contents of the invention

The object of the present invention is to provide a safe and effective traditional Chinese medicine composition for treating impaired glucose regulation and a preparation method thereof.

The traditional Chinese medicine composition provided by the present invention is prepared from the following traditional Chinese medicines in parts by mass: 600-1200 parts of camellia green tea, 600-1200 parts of Herba Verbacula, 600-1200 parts of guava leaves, 900-1200 parts of Morus alba 1200, 500-900 copies of coptis and 500-1000 copies of bamboo ginseng.

Specifically, the traditional Chinese medicine composition provided by the present invention is prepared from the following traditional Chinese medicines in parts by mass: 600g of Camellia japonica, 600g of Herba Vernis, 600g of guava leaves, 900g of Cortex Mori, 500g of Coptis chinensis and 500g of Panax ginseng .

Or, specifically, the traditional Chinese medicine composition provided by the present invention is prepared from the following traditional Chinese medicines in parts by mass: 1200g of Camellia japonica, 1200g of Herba Verbacula, 1200g of guava leaves, 1200g of Cortex Mori, 900g of Coptidis Rhizoma and bamboo See 1000g.

The traditional Chinese medicine composition provided by the present invention is prepared according to the method comprising the following steps:

1) Pulverize camellia green tea, white grass, guava leaves, Morus alba, Coptis chinensis and bamboo joint ginseng into coarse powder respectively;

2) using 70% ethanol as a solvent to impregnate the camellia coarse powder, percolate, collect the percolation liquid, recycle the ethanol and concentrate to obtain a thick paste-like camellia ethanol extract;

3) Heat and reflux the extracts of Herba Herba, guava leaves and Panax ginseng with an ethanol solution with a mass concentration of 60-80%, and concentrate the extract to obtain thick paste-like extracts of Herba Herba, Guava leaves and Panax ginseng;

4) Decoct Morus alba and Coptis chinensis with water, filter, collect the filtrate, concentrate the filtrate to a clear paste, cool, add ethanol, stir well, let stand, concentrate the supernatant to recover ethanol, and obtain a thick paste of mulberry White bark and Coptis chinensis extract;

5) Mix the above three kinds of thick paste extracts, dry and pulverize into fine powder to obtain the traditional Chinese medicine composition.

In step 2) of the above method, the amount of ethanol used for impregnation may be 5-8 times the total mass of medicinal materials, and the impregnation time may be 20-30 hours.

The percolation condition is as follows: 5-8 ml per minute per kilogram of medicinal material is used for percolation.

In step 3) of the above method, the amount of the ethanol solution for extraction is 5-8 times of the total mass of medicinal materials.

The extraction can be performed multiple times, specifically 3 times.

The time for each extraction can be 1-2 hours.

The operation of concentrating the extract is as follows: combining the extracts obtained by multiple extractions, recovering ethanol under reduced pressure, and concentrating to a thick paste with a relative density of 1.30-1.35 (70° C.).

In step 4) of the above method, the decocting can be performed multiple times, specifically 3 times.

The decocting water consumption is 8-12 times of the total mass of medicinal materials.

The temperature of the decocting is 100° C., and the time of each decocting can be 1.5 hours.

The operation of concentrating the filtrate is as follows: concentrating the filtrate to a clear paste with a relative density of 1.10-1.15 (75° C.).

The quality of the ethanol that adds is 2.5 times of clear ointment quality.

The standing time can be 24 hours.

The operation of concentrating the supernatant to recover ethanol is as follows: concentrating the supernatant to a thick paste with a relative density of 1.30-1.35 (75° C.).

In step 5) of the above method, the drying may specifically be drying under reduced pressure.

The present invention also provides the application of the above-mentioned traditional Chinese medicine composition.

The application of the above-mentioned Chinese medicine composition provided by the present invention is the application of the above-mentioned Chinese medicine composition in the preparation of the following medicines:

1) Drugs for the treatment of impaired glucose regulation;

2) Drugs that lower fasting blood sugar;

3) Drugs that lower postprandial blood sugar;

4) Drugs for lowering blood lipids;

5) Drugs that improve insulin resistance;

6) Drugs that reduce the risk of impaired glucose regulation turning into diabetes.

The present invention also protects a drug for treating impaired glucose regulation, a drug for lowering fasting blood sugar, a drug for lowering postprandial blood sugar, a drug for lowering blood lipids, a drug for improving insulin resistance and/or reducing the transformation of impaired sugar regulation into diabetes dangerous drug.

The medicine contains the traditional Chinese medicine composition provided by the invention and a pharmaceutically acceptable carrier.

The carrier includes conventional diluents, excipients, fillers, binders, wetting agents, disintegrants, absorption promoters, surfactants, adsorption carriers, lubricants and the like in the pharmaceutical field.

The medicine containing the traditional Chinese medicine composition of the present invention can be made into various forms such as tablet, powder, granule, capsule, oral liquid and the like. The above-mentioned medicines in various dosage forms can be prepared according to conventional methods in the field of pharmacy.

Take the preparation of granules as an example for illustration. Grind the dried Chinese medicine extract into a fine powder, take 500g, add 500g of a mixture of soluble starch and dextrin (mass ratio 1:1), mix with 10g of stevioside, and granulate with an aqueous ethanol solution with a mass concentration of 80%. Dry and granulate to make 1000g of granules. Packed into 6g/bag. Usage and dosage: Take after boiling water, 1 bag each time, 3 times a day.

The above-mentioned fine powder meets the requirements of the 2010 Pharmacopoeia for fine powder: it refers to the powder that can pass through the No. 5 sieve and contains no less than 95% of the powder that can pass through the No. 6 sieve.

Clinical test results show that the compound granule prepared by the invention has the effects of reducing fasting blood sugar, postprandial blood sugar, lowering blood fat, and improving insulin resistance, and can significantly reduce the risk rate of impaired sugar regulation transforming into diabetes.

detailed description

The present invention will be described below through specific examples, but the present invention is not limited thereto.

The experimental methods used in the following examples are conventional methods unless otherwise specified; the reagents and materials used in the following examples can be obtained from commercial sources unless otherwise specified.

The camellia, baicalensis, guava leaves, Morus alba, Coptis chinensis, and bamboo ginseng used in the following examples all conform to the relevant regulations under the main text of the Chinese Pharmacopoeia 2010 edition. Before feeding, through identification, the real medicinal materials of each flavor are consistent with the names, and the quality meets the standards.

Example 1. Preparation of traditional Chinese medicine compound granules for the treatment of impaired glucose regulation

1. Prescription

Mountain green tea 600g, white grass 600g, guava leaves 600g

Mulberry bark 900g Bamboo ginseng 500g Coptis 500g

2. Preparation method

The above 6 flavors were all crushed into coarse powder. The mountain green tea is impregnated with 70% ethanol as a solvent, and the amount of ethanol is 5-8 times of the total mass of the medicinal materials. After 24 hours of immersion, perkg of medicinal materials is percolated at 5-8 ml per minute, and 6 times of percolation liquid is collected and recycled. Ethanol and concentrated to a thick paste; the 3 flavors of Herba Vermilion, Guava Leaf and Bamboo Ginseng were heated and refluxed for 3 times with an ethanol solution with a mass concentration of 70%, and the amount of alcohol added each time was 6 times the total mass of the medicinal materials. Extract for 1.5 hours, combine the extracts, recover ethanol under reduced pressure, and concentrate to a thick paste with a relative density of 1.30-1.35 (70°C); decoct the two herbs of Morus alba and Coptis chinensis with water for 3 times, and the amount of water added is 1/2 of the total mass of the medicinal materials. 10 times, extracting for 1.5 hours each time, decocting at 100°C, combining the decoctions, filtering, concentrating the filtrate to a clear paste with a relative density of 1.10-1.15 (75°C), letting it cool, and then adding 2.5 times the clear paste quality ethanol, stir well, let it stand for 24 hours, take the supernatant to recover ethanol, concentrate to a thick paste with a relative density of 1.30-1.35 (75°C); mix the above three kinds of thick paste, dry under reduced pressure, and pulverize into fine powder to obtain Chinese medicine extract powder.

Take 500g of the above-mentioned traditional Chinese medicine extract powder, add 500g of a mixture of soluble starch and dextrin (1:1, mass ratio), 10g of stevioside, mix well, granulate with an ethanol aqueous solution with a mass concentration of 80%, dry, granulate, and prepare into 1000g. Dosage form: granules, 6g/bag.

Example 2. Clinical effect test of traditional Chinese medicine compound granules for the treatment of impaired glucose regulation

1. Research object

1. Source of subjects: 150 subjects with impaired glucose regulation came from outpatients of Dongfang Hospital of Beijing University of Traditional Chinese Medicine, screening patients in Fangzhuang community and outpatients of Beijing Hospital of Traditional Chinese Medicine of Capital Medical University.

2. Diagnostic criteria: Adopt the criteria established by WHO in 1999: Impaired Fasting Glucose (IFG) Diagnostic criteria: fasting blood glucose ≥ 6.1mmol/L but < 7.0mmol/L, oral 75g glucose tolerance test (OGTT) 2 hours after taking sugar Blood sugar <7.8mmol/L. Impaired glucose tolerance (IGT) diagnostic criteria: fasting blood glucose <7.0mmol/L, blood glucose ≥7.8mmol/L but <11.1mmol/L 2 hours after oral glucose tolerance test (OGTT) 75g glucose tolerance test (OGTT).

3. Inclusion criteria: A. Meet the above diagnostic criteria; B. Age between 35-70 years old; C. Body mass index between 20-35Kg/m ² .

4. Exclusion criteria: A. recent cardiovascular events; B. use of glucocorticoids, β-receptor blockers, thiazide diuretics, and niacin within the past 3 months; C. serum creatinine ≥130umol/L; D. Hepatic transaminase elevated to more than 2 times the upper limit of the normal range; E. Moderate or severe hypertension, endocrine disease uncorrected; F. Fasting plasma triglyceride level > 6.0mmol/L.

2. Randomized double-blind controlled trial

1. Random grouping: using simple random table method, randomly divided into 2 groups (Chinese medicine compound granule group, placebo group), 75 cases in each group, 150 cases in total. Prepare the random distribution card, seal it in an envelope, and keep it by a special person.

2. Test drug preparation:

The test drug Chinese medicine compound granules and the placebo were prepared by the preparation room of Dongfang Hospital, Beijing University of Chinese Medicine, and the placebos were all granules with the same appearance, shape and size.

3. Double-blind controlled trial: The test drug and the control drug are mixed and coded in advance according to the group of the subjects and the serial number of the study, and packaged in a unified way. Test drugs and random distribution cards are kept by special personnel who do not directly participate in clinical observation. According to the sequence of numbers and the order in which patients enter the study, they will be collected and used. Each patient has a medicine bag, and the random card is put in the bag. When using it, it should be carried out according to the grouping and treatment prescribed by the random card, and no changes can be made. After the clinical trial is over and the data analysis is completed, the blind is unblinded. When unblinding, the password is controlled. , the person in charge of clinical research, data collectors, and data analysts should all be present.

3. Treatment plan

1. Test drugs

Each subject took 6 grams of traditional Chinese medicine compound granules prepared in Example 1 or 6 grams of placebo before each meal, three times a day.

2. Basic treatment

① All subjects received general diabetes knowledge education and did not strengthen diet and exercise education.

②For patients with hypertension, choose ACEI or ARB, or calcium ion antagonists.

4. Observation indicators

1. Curative effect index:

① Oral 75g glucose tolerance test (OGTT);

② Fasting blood glucose (FPG), 2-hour postprandial blood glucose (2hPG); glucose oxidase method;

③ Determination of glycosylated hemoglobin (HbA _1C ): Measured with DCA2000 diabetes analyzer;

④ Blood lipids: total cholesterol (TC), triglyceride (TG), high-density lipoprotein (HDL), low-density lipoprotein (LDL): automatic biochemical method;

⑤ Determination of fasting plasma insulin (FINS): automatic chemiluminescence immunoassay;

⑥Insulin resistance index (IR): Calculate the insulin resistance index according to the HOMA Model formula (HOMA-IR=FPG×FINS/22.5);

⑦ body mass index (BMI), systolic blood pressure (SBP), diastolic blood pressure (DBP).

2. Safety indicators: blood routine, liver function, kidney function, electrocardiogram,

The above indicators, OGTT, blood lipid and insulin determination and safety indicators are tested once a year, and other indicators are tested every 3 months.

5. End goal:

OGTT is measured once a year. If all subjects take a 75g oral glucose tolerance test and their blood glucose ≥ 11.1mmol/L 2 hours after taking sugar, they need to repeat the OGTT test again. 11.1mmol/L, type 2 diabetes is diagnosed, and the subject reaches the end point, and the clinical trial is terminated.

6. Statistical methods

Enumeration data were analyzed by X ² test, measurement data by t test, and rank data by Ridit analysis or rank sum test. Statistical analysis was carried out with SAS6.02 statistical analysis system.

7. Results

1. Comparison of general information during the first visit

There was no significant difference between the two groups in the number of cases, age, sex, FPG, 2hPG, blood pressure, body mass index (BMI), blood lipids (TC, TG, HDL, LDL) at the initial visit (P>0.05). During the 1-year follow-up observation, 9 cases out of 150 cases were lost to follow-up, including 5 cases in the placebo group (1 case went abroad, 4 cases were lost due to relocation), 4 cases in the Chinese medicine compound granule group (3 cases lost contact due to relocation, 1 case did not). Automatic withdrawal for special reasons).

2. Comparison of blood glucose and fasting insulin in each group at the end of 1 year follow-up

At the end of 1-year follow-up, FPG, 2hPG and HbA1c in the placebo group were significantly higher than those at the initial visit (P<0.05), and FPG, 2Hpg and HbA1c in the Chinese medicine granule group were significantly lower than those at the initial visit (P<0.05). There was significant difference between groups (P<0.05). At the end of the follow-up, it was suggested that the traditional Chinese medicine granule group had a significant effect on lowering blood sugar. There was no significant change in the fasting insulin levels in each group compared with the initial visit (P>0.05). See Table 1 for details

Table 1 Comparison of blood glucose and fasting insulin in each group at the end of 1 year follow-up

△ indicates self-comparison before and after treatment, P<0.05. ▲Compared with the placebo group, P<0.05

3. Comparison of insulin resistance index between groups at the end of 1 year follow-up

At the end of 1 year of follow-up, the insulin resistance index of the placebo group was significantly increased (P<0.05) compared with the initial visit, and the insulin resistance index of the Chinese medicine granule group was significantly lower than that of the initial visit (P<0.05), suggesting that the traditional Chinese medicine granule group can improve insulin resistance. superior to the placebo group. See Table 2 for details.

Table 2 Comparison of insulin resistance index among groups at the end of 1-year follow-up

△ indicates self-comparison before and after treatment, P<0.05.

4. Comparison of blood lipids in each group at the end of 1 year follow-up

At the end of the 1-year follow-up, TG, TC, and LDL-c in the placebo group had no significant decrease (P>0.05), while TG, TC, and LDL-c in the Chinese medicine granule group decreased significantly (P<0.05) compared with those at the initial visit, and compared with the placebo group. There was significant difference between groups (P<0.05). At the end of the follow-up, it was suggested that the Chinese medicine granule group had a significant effect on lowering blood lipids. See Table 3 for details

Table 3 Comparison of blood lipids in each group at the end of 1 year follow-up

△ indicates self-comparison before and after treatment, P<0.05. ▲Compared with the placebo group, P<0.05

5. Comparison of body mass index and blood pressure in each group after 1 year of follow-up

At the end of the 1-year follow-up, there were no significant differences in BMI and blood pressure levels in each group compared with those at the initial visit (P>0.05).

6. Glucose tolerance outcome of each group at the end of 1 year follow-up

Among the 70 cases in the placebo group at the end of 1 year follow-up, 8 cases were with normal glucose tolerance (NGT), accounting for 11.4%, 54 cases were with abnormal glucose tolerance (IGT), accounting for 77.2%, and 8 cases were converted to diabetes mellitus (DM), accounting for 11.4%. %. The average annual conversion to DM was 11.4%.

Among the 71 cases in the TCM granule group at the end of 1 year follow-up, 16 cases had normal glucose tolerance, accounting for 22.5%, 51 cases had abnormal glucose tolerance, accounting for 71.8%, and 4 cases transformed into DM, accounting for 5.6%. 5.6%. Compared with placebo, the relative risk rate of type 2 diabetes was reduced by 50.14%. See Table 4 for details.

Table 4 Comparison of glucose tolerance outcomes in each group at the end of 1 year follow-up

▲shows that compared with the placebo group, P<0.05.

7. Adverse reactions

The blood routine and liver and kidney functions of patients in both groups were checked before and after treatment, all of which were within the normal range, and there was no significant difference before and after treatment. During the treatment, no adverse reactions were found in the two groups.

The results of clinical trials showed that the fasting blood glucose (FPG), 2-hour blood glucose after OGTT (2hPG), glycosylated hemoglobin (HbA1c) and insulin resistance index (IR) all increased in the placebo group, and the average annual incidence of diabetes was 11.4%. FPG, 2hPG, HbA1c and IR in the granule group decreased significantly, the average annual incidence of diabetes was 5.6%, and the relative risk of type 2 diabetes was reduced by 50.14% compared with the placebo group. It shows that the traditional Chinese medicine compound granule prepared in Example 1 has the effects of lowering fasting blood sugar, postprandial blood sugar, lowering blood lipids, and improving insulin resistance, and can significantly reduce the risk rate of impaired sugar regulation turning into diabetes.

Example 3. Preparation of traditional Chinese medicine compound granules for the treatment of impaired glucose regulation

1. Prescription

Mountain green tea 1200g Turn white grass 1200g Guava leaves 1200g

Mulberry bark 1200g Bamboo ginseng 1000g Coptis 900g

2. Preparation method

The above 6 flavors were all crushed into coarse powder. The mountain green tea is impregnated with 70% ethanol as a solvent, and the amount of ethanol is 5-8 times of the total mass of the medicinal materials. After 24 hours of immersion, perkg of medicinal materials is percolated at 5-8 ml per minute, and 6 times of percolation liquid is collected and recycled. Ethanol and concentrated to a thick paste; the 3 flavors of Herba Vermilion, Guava Leaf and Bamboo Ginseng were heated and refluxed for 3 times with an ethanol solution with a mass concentration of 70%, and the amount of alcohol added each time was 6 times the total mass of the medicinal materials. Extract for 1.5 hours, combine the extracts, recover ethanol under reduced pressure, and concentrate to a thick paste with a relative density of 1.30-1.35 (70°C); decoct the two herbs of Morus alba and Coptis chinensis with water for 3 times, and the amount of water added is 1/2 of the total mass of the medicinal materials. 10 times, extracting for 1.5 hours each time, decocting at 100°C, combining the decoctions, filtering, concentrating the filtrate to a clear paste with a relative density of 1.10-1.15 (75°C), letting it cool, and then adding 2.5 times the clear paste quality ethanol, stir well, let it stand for 24 hours, take the supernatant to recover ethanol, concentrate to a thick paste with a relative density of 1.30-1.35 (75°C); mix the above three kinds of thick paste, dry under reduced pressure, and pulverize into fine powder to obtain Chinese medicine extract powder.

Take 1000g of the medicinal extract powder, add 1000g of a mixture of soluble starch and dextrin (1:1, mass ratio), and 20g of stevioside, mix well, granulate with ethanol with a mass concentration of 80%, dry, and granulate to make 2000g. Dosage form: granules, 6g/bag.

Example 4. Clinical effect test of traditional Chinese medicine compound granules for the treatment of impaired glucose regulation

One, research object is the same as embodiment 2

1. Source of subjects: 220 subjects with impaired glucose regulation came from outpatients of Dongfang Hospital of Beijing University of Traditional Chinese Medicine, screening patients of Fangzhuang Community and Dahongmen Community, and outpatients of Beijing Hospital of Traditional Chinese Medicine of Capital Medical University.

2. Diagnostic criteria: with embodiment 2.

3. Inclusion criteria: the same as in Example 2.

4. Exclusion criteria: the same as in Example 2.

2. Randomized double-blind controlled trial

1. Random grouping: using simple random table method, randomly divided into 2 groups (Chinese medicine compound granule group, placebo group), 110 cases in each group, 220 cases in total. Prepare the random distribution card, seal it in an envelope, and keep it by a special person.

2. Test drug preparation: the same as in Example 2.

3. Double-blind controlled test: same as Example 2.

3. Treatment plan

1. Test drugs

Each subject took 6 grams of traditional Chinese medicine compound granules prepared in Example 3 or 6 grams of placebo before each meal, three times a day.

2. Basic treatment is the same as in Example 2.

Four, observation index is with embodiment 2.

Five, the end goal is the same as embodiment 2.

6. The statistical method is the same as in Example 2.

7. Results

1. Comparison of general information during the first visit

There was no significant difference between the two groups in the number of cases, age, sex, FPG, 2hPG, blood pressure, body mass index (BMI), blood lipids (TC, TG, HDL, LDL) at the initial visit (P>0.05). During the 1-year follow-up observation, 220 cases lost 10 cases, including 5 cases in the placebo group (1 case went abroad, 4 cases lost due to relocation), 5 cases in the Chinese medicine compound granule group (3 cases lost contact due to relocation, 2 cases went abroad ).

2. Comparison of blood glucose and fasting insulin in each group at the end of 1 year follow-up

At the end of 1-year follow-up, FPG, 2hPG and HbA1c in the placebo group were significantly higher than those at the initial visit (P<0.05), and FPG, 2Hpg and HbA1c in the Chinese medicine granule group were significantly lower than those at the initial visit (P<0.05). There was significant difference between groups (P<0.05). At the end of the follow-up, it was suggested that the traditional Chinese medicine granule group had a significant effect on lowering blood sugar. There was no significant change in the fasting insulin levels in each group compared with the initial visit (P>0.05). See Table 5 for details.

Table 5 Comparison of blood glucose and fasting insulin in each group at the end of 1 year follow-up

△ indicates self-comparison before and after treatment, P<0.05. ▲shows that compared with the placebo group, P<0.05.

3. Comparison of insulin resistance index between groups at the end of 1 year follow-up

At the end of 1 year of follow-up, the insulin resistance index of the placebo group was significantly increased (P<0.05) compared with the initial visit, and the insulin resistance index of the Chinese medicine granule group was significantly lower than that of the initial visit (P<0.05), suggesting that the traditional Chinese medicine granule group can improve insulin resistance. superior to the placebo group. See Table 6 for details.

Table 6 Comparison of insulin resistance index between groups at the end of 1-year follow-up

△ indicates self-comparison before and after treatment, P<0.05.

4. Comparison of blood lipids in each group at the end of 1 year follow-up

At the end of the 1-year follow-up, TG, TC, and LDL-c in the placebo group had no significant decrease (P>0.05), while TG, TC, and LDL-c in the Chinese medicine granule group decreased significantly (P<0.05) compared with those at the initial visit, and compared with the placebo group. There was significant difference between groups (P<0.05). At the end of the follow-up, it was suggested that the Chinese medicine granule group had a significant effect on lowering blood lipids. See Table 7 for details

Table 7 Comparison of blood lipids in each group at the end of 1 year follow-up

△ indicates self-comparison before and after treatment, P<0.05. ▲Compared with the placebo group, P<0.05

5. Changes in body mass index (BMI) and blood pressure of each group at the end of 1 year follow-up

At the end of the 1-year follow-up, there were no significant differences in BMI and blood pressure levels in each group compared with those at the initial visit (P>0.05).

6. Glucose tolerance outcome of each group at the end of 1 year follow-up

Among the 105 cases in the placebo group at the end of the 1-year follow-up, 15 cases were converted to normal glucose tolerance (NGT), accounting for 15%, 77 cases were still IGT, accounting for 74%, and 13 cases were converted to diabetes mellitus (DM). 13%. The average annual incidence of DM is 13%.

At the end of 1 year follow-up, among the 105 cases in the TCM granule group, 24 cases (23%) had normal glucose tolerance, 75 cases (72%) were still IGT, and 6 cases (6%) had changed to DM. 6%. Compared with placebo, the relative risk of developing type 2 diabetes was reduced by 50.4%. See Table 8 for details.

Table 8 Comparison of glucose tolerance outcomes in each group at the end of 2 years of follow-up

▲shows that compared with the placebo group, P<0.05.

7. Adverse reactions

The blood routine and liver and kidney functions of patients in both groups were checked before and after treatment, all of which were within the normal range, and there was no significant difference before and after treatment. During the treatment, no adverse reactions were found in the two groups.

The results of clinical trials show that Chinese medicine compound granules can lower fasting blood sugar, postprandial blood sugar, lower blood lipids, and improve insulin resistance, and can significantly reduce the risk of impaired sugar regulation turning 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.