Traditional Chinese medicine composition for treating obesity type 2 diabetes and preparation method thereof

Abstract

The invention discloses a traditional Chinese medicine composition for treating obesity type 2 diabetes and a preparation method thereof, and relates to the technical field of traditional Chinese medicine preparation. The traditional Chinese medicine composition comprises the following raw materials in parts by weight: 12-18 parts of astragalus membranaceus, 8-12 parts of rehmannia, 6-10 parts of rhizoma alismatis, 4-8 parts of Chinese ladiestresses root, 8-12 parts of raw oyster, 3-5 parts of euonymus alatus, 4-8 parts of semen aesculi, 3-5 parts of rhizoma atractylodis, 4-8 parts of radices trichosanthis, 3-5 parts of kadsura longepedunculata, 4-8 parts of raw malt and 2-4 parts of raw liquorice. The traditional Chinese medicine composition for treating obesity type 2 diabetes is reasonable in formula, has the effects of reducing blood sugar and losing weight, has a comprehensive treatment effect on obesity type 2 diabetes, and is good in curative effect, safe and free of toxic and side effects.

Description

Technical Field

[0001] The present invention relates to the technical field of Chinese medicine preparation, and in particular to a Chinese medicine composition for treating obese type 2 diabetes and a preparation method thereof. Background Art

[0002] In recent years, the number of patients with type 2 diabetes and obesity has increased year by year. When type 2 diabetes coexists with obesity, it is obese type 2 diabetes. Obesity is not only an important factor leading to the onset of type 2 diabetes, but also an important factor inducing diabetic complications. The pathological mechanism of obese type 2 diabetes is complex, and the key lies in insulin resistance (IR) and hyperglycemia caused by lipotoxicity caused by excess fat. Both the American and European Associations for the Study of Diabetes have made controlling patient weight an important guideline for the treatment of obese type 2 diabetes.

[0003] At present, Western medicine treatment for obese type 2 diabetes is relatively uniform and has the characteristics of rapid onset of action. When choosing hypoglycemic drugs, first consider drugs that are conducive to weight loss or do not increase weight. The first choice of treatment drug in clinical practice is metformin, but patients often experience various adverse reactions such as bloating, fatigue, and abdominal discomfort in the early stages of medication. Long-term use of metformin may lead to insufficient vitamin B intake in the body and cause lactic acidosis. In addition to obvious adverse reactions, Western medicine also has disadvantages such as poor patient tolerance and compliance, and relatively expensive medical expenses.

[0004] The rational use of Chinese herbal medicine to treat diseases can achieve the effect of treating both the symptoms and the root causes, and Chinese herbal medicine has the characteristics of high safety, no toxic side effects, not easy to produce drug resistance, and low price. Traditional Chinese medicine believes that the occurrence of obese type 2 diabetes is related to insufficient endowment, improper diet, emotional imbalance, etc. The core of the pathogenesis is the obstruction of the middle jiao and the stagnation of qi, which in turn generates pathological factors such as pathogenic heat, phlegm and dampness, and blood stasis, which damages the positive energy and yin fluid, leading to complex pathological characteristics of both deficiency and excess. In terms of treatment, there are few existing Chinese medicine formulas for the treatment of obese type 2 diabetes, and there are also disputes about the formulation and efficacy of each Chinese medicine. Based on this, it is very meaningful to develop a Chinese medicine formula with a reasonable formula and good efficacy for the treatment of obese type 2 diabetes. Summary of the invention

[0005] In view of the above problems, the present invention provides a Chinese medicine composition for treating obese type 2 diabetes and a preparation method thereof.

[0006] In order to achieve the above object, the technical solution adopted by the present invention is as follows: The invention provides a traditional Chinese medicine composition for treating obese type 2 diabetes. The raw material formula and weight proportions of the traditional Chinese medicine composition are: 12-18 parts of astragalus, 8-12 parts of rehmannia, 6-10 parts of oriental rhizome, 4-8 parts of panlongqi, 8-12 parts of raw oyster, 3-5 parts of euphorbia obesa, 4-8 parts of sauerkraut seeds, 3-5 parts of atractylodes, 4-8 parts of trichosanthes, 3-5 parts of schisandra chinensis, 4-8 parts of raw malt and 2-4 parts of raw liquorice.

[0007] Preferably, the raw material formula and weight proportions of the traditional Chinese medicine composition are: 15 parts of Astragalus, 10 parts of Rehmannia, 8 parts of Alisma, 5 parts of Panax Notoginseng, 10 parts of raw oyster, 4 parts of Euphorbia obesa, 5 parts of Sauvignon granatum, 4 parts of Atractylodes, 5 parts of Radix Trichosanthis, 4 parts of Schisandrae Chinensis, 5 parts of raw malt, and 3 parts of raw licorice.

[0008] The present invention also provides a method for preparing the above-mentioned Chinese medicine composition for treating obese type 2 diabetes, which specifically comprises the following steps: S1: Take astragalus, rehmannia, orientalis, Panlongqi, raw oyster, euphorbia pulex, salvia miltiorrhiza, atractylodes, radix trichosanthis, schisandra chinensis, raw malt, and raw licorice according to weight, rinse with clean water, dry, and mix to obtain a drug mixture for later use; S2: crushing and sieving the drug mixture, sterilizing, and obtaining drug powder; adding 75% ethanol aqueous solution to the drug powder, refluxing and extracting it three times in a water bath, filtering after the refluxing is completed to obtain a filtrate; evaporating and concentrating the filtrate under reduced pressure to obtain a drug thick paste; S3: Mixing the thick medicinal paste with pharmaceutically acceptable excipients to prepare the Chinese medicine composition.

[0009] Preferably, in step S2, the mass ratio of the drug powder to the 75% ethanol aqueous solution is 1:6-10.

[0010] Preferably, in step S2, the water bath temperature is 65-75° C. and each reflux time is 40 min.

[0011] Preferably, in step S2, the relative density of the thick drug paste is 1.30-1.35 g / mL.

[0012] Preferably, in step S3, the mass ratio of the drug paste to the pharmaceutically acceptable drug excipients is 1:0.2-0.4.

[0013] Preferably, in step S3, the dosage form of the Chinese medicine composition is tablets, pills or granules.

[0014] It targets the obstruction of the middle jiao (spleen, stomach, liver, etc.), stagnation of qi (difficult defecation, decreased appetite, abdominal distension and pain), thus generating pathological factors such as pathogenic heat, phlegm and dampness, and blood stasis, damaging the vital energy and yin fluid, and leading to complex pathological characteristics of both deficiency and excess. The Chinese medicine composition for treating obese type 2 diabetes of the present invention follows the theory of "monarch, minister, assistant and messenger" compatibility, with Astragalus and Rehmannia as monarch medicines, which have the effects of strengthening the spleen and replenishing qi, nourishing yin and clearing heat; with Alisma, Panlongqi, raw oyster, Ghost Arrow Feather, and Radix Trichosanthis as minister medicines, which have the effects of strengthening the spleen and promoting diuresis, promoting diuresis and eliminating dampness, clearing heat and activating blood circulation; with Sauerkraut seeds, Atractylodes, Schisandrae Chinensis, and raw malt as adjuvants, which have the effects of soothing the liver and regulating qi, strengthening the spleen and drying dampness, replenishing qi and nourishing yin; with raw licorice as a messenger, which has the effects of tonifying the spleen and replenishing qi and harmonizing the properties of the medicine. The pharmacological effects of each Chinese medicine raw material are as follows: Astragalus: sweet in taste, slightly warm in nature, enters the spleen and lung meridians, has the effects of strengthening the spleen and tonifying the middle, raising yang and lifting the sunken, benefiting the Wei and consolidating the exterior, promoting diuresis, expelling toxins and promoting tissue regeneration, and is used for spleen qi deficiency syndrome, lung qi deficiency syndrome, qi deficiency and spontaneous sweating syndrome, qi and blood deficiency, sores that are difficult to heal or ulcers that are difficult to heal, etc.

[0015] Rehmannia: sweet in taste, cold in nature, enters the heart, liver, and kidney meridians, has the effects of clearing heat and cooling blood, nourishing yin and promoting body fluid, and is used for heat entering the blood, warm toxins causing rashes, vomiting blood, epistaxis, yin damage caused by heat disease, red tongue and thirst, constipation caused by body fluid damage, and sore throat.

[0016] Alisma: Sweet, light, cold in nature, enters the kidney and bladder meridians, has the effects of promoting diuresis and dispelling dampness, purging heat, clearing turbidity and reducing lipids. It is used for urinary problems, edema, diarrhea, oliguria, phlegm and dizziness, hot stranguria and pain, and hyperlipidemia.

[0017] Panlongqi: It is mild in nature, astringent and slightly bitter in taste. It enters the spleen meridian, liver meridian, bladder meridian and lung meridian. It has the effects of tonifying the spleen and stomach, astringing and strengthening the intestines, removing dampness and promoting diuresis, and activating blood circulation. It is mainly used to treat acute and chronic gastroenteritis, edema, metrorrhagia, leucorrhea, gonorrhea, dysentery, impetigo, baldness, and scabies.

[0018] Raw oysters: salty and moist in taste, cool in nature, enter the liver and kidney meridians, and have the effects of astringing yin, suppressing yang, stopping sweating, astringing essence, resolving phlegm, and softening hard masses. They are used for palpitations, insomnia, dizziness, tinnitus, scrofula, phlegm nodules, lumps, spontaneous sweating, night sweats, spermatorrhea, metrorrhagia, stomachache and heartburn.

[0019] Ghost Arrow Feather: bitter and pungent in taste, cold in nature, enters the liver and spleen meridians, has the effects of breaking blood and dredging menstruation, detoxifying and reducing swelling, and killing insects. It is used for lumps and masses, heart and abdominal pain, amenorrhea, dysmenorrhea, metrorrhagia, postpartum abdominal pain due to blood stasis, retained lochia, hernia, pain in the joints, sores, bruises, abdominal pain due to worm accumulation, burns, and snake bites.

[0020] Sala seeds: warm in nature, sweet in taste, and enter the liver meridian and stomach meridian. It is warm in nature, sweet in taste, and enters the liver meridian and stomach meridian. It has the effects of regulating qi, relieving fullness, harmonizing the stomach and relieving pain. It is used to treat chest and abdominal distension, epigastric pain, and has the effects of reducing swelling, anti-inflammatory, and lowering cholesterol.

[0021] Atractylodes: It tastes pungent and bitter, and is warm in nature. It enters the spleen, stomach, and liver meridians. It has the effects of drying dampness and strengthening the spleen, dispelling wind and cold, and improving eyesight. It is used for dampness blocking the middle burner, abdominal distension, diarrhea, edema, beriberi, rheumatism, colds, night blindness, and blurred vision.

[0022] Radix Trichosanthis: It tastes sweet and slightly bitter, is slightly cold in nature, and enters the lung and stomach meridians. It has the effects of clearing away heat and purging fire, promoting fluid and quenching thirst, reducing swelling and discharging pus. It is used for thirst caused by febrile diseases, dry cough due to lung heat, internal heat and thirst, and sores and swelling.

[0023] Schisandra chinensis: sour and sweet in taste, warm in nature, enters the lung, heart and kidney meridians, has the effects of astringing, invigorating Qi and promoting body fluid, nourishing the kidney and calming the mind, and is used for long-term cough and asthma, nocturnal emission and spermatorrhea, enuresis and frequent urination, long-term diarrhea, spontaneous sweating and night sweats, thirst due to loss of body fluid, internal heat and polydipsia, palpitations and insomnia.

[0024] Raw malt: sweet in taste, neutral in nature, enters the spleen and stomach meridians, has the effects of promoting qi and digestion, strengthening the spleen and appetizing, reducing milk and relieving bloating, and is used for indigestion, abdominal distension and pain, spleen deficiency and poor appetite, milk and sweat accumulation, breast distension and pain, and weaning in women.

[0025] Raw licorice: It is mild in nature, sweet in taste, and enters the heart meridian, stomach meridian, spleen meridian, and lung meridian. It has the effects of tonifying the spleen and replenishing qi, and harmonizing the properties of medicines.

[0026] Compared with the prior art, the present invention has the following beneficial effects: In the present invention, by adopting Chinese medicines with the effects of invigorating qi and nourishing yin, strengthening the spleen and removing dampness, soothing the liver and relieving depression, and promoting blood circulation and diuresis as raw materials, according to the Chinese medicine compatibility theory of "monarch, minister, assistant and messenger", a Chinese medicine composition for treating obese type 2 diabetes is prepared, and the formula is reasonable; the Chinese medicine composition for treating obese type 2 diabetes of the present invention has the effects of lowering blood sugar and losing weight, has a comprehensive therapeutic effect on obese type 2 diabetes, has good efficacy, and is safe and has no toxic side effects. DETAILED DESCRIPTION

[0027] In order to make the purpose and advantages of the present invention more clearly understood, the present invention is further described in detail below in conjunction with the embodiments. It should be understood that the specific embodiments described herein are only used to explain the present invention and are not used to limit the present invention.

[0028] The instruments, reagents, materials, etc. involved in the following examples, unless otherwise specified, are all conventional instruments, reagents, materials, etc. in the prior art and can be obtained through regular commercial channels. The experimental methods, detection methods, etc. involved in the following examples, unless otherwise specified, are all conventional experimental methods, detection methods, etc. in the prior art.

[0029] Example 1 The present embodiment provides a traditional Chinese medicine composition for treating obese type 2 diabetes. The raw material formula and weight proportions of the traditional Chinese medicine composition are: 12 parts of astragalus, 8 parts of rehmannia, 6 parts of oriental rhizome, 4 parts of panax notoginseng, 8 parts of raw oyster, 3 parts of euphorbia obesa, 4 parts of sauerkraut seeds, 3 parts of atractylodes, 4 parts of trichosanthes, 3 parts of schisandra chinensis, 4 parts of raw malt, and 2 parts of raw licorice.

[0030] The preparation method of the above-mentioned Chinese medicine composition for treating obese type 2 diabetes specifically comprises the following steps: S1: Take astragalus, rehmannia, orientalis, Panlongqi, raw oyster, euphorbia pulex, salvia miltiorrhiza, atractylodes, radix trichosanthis, schisandra chinensis, raw malt, and raw licorice according to weight, rinse with clean water, dry, and mix to obtain a drug mixture for later use; S2: The drug mixture was crushed and passed through a 60-mesh sieve, sterilized, and obtained drug powder; 6 times the mass of 75% ethanol aqueous solution was added to the drug powder, and refluxed and extracted three times in a 65°C water bath, each reflux time was 40 minutes, and after the reflux was completed, a filtrate was obtained by filtration; the filtrate was evaporated and concentrated under reduced pressure to obtain a drug paste with a relative density of 1.30 g / mL; S3: Mixing the thick medicinal paste with pharmaceutically acceptable excipients in a mass ratio of 1:0.2 to prepare a Chinese medicine composition in the form of tablets.

[0031] Example 2 The present embodiment provides a traditional Chinese medicine composition for treating obese type 2 diabetes. The raw material formula and weight proportions of the traditional Chinese medicine composition are: 15 parts of astragalus, 10 parts of rehmannia, 8 parts of oriental rhizome, 5 parts of panax notoginseng, 10 parts of raw oyster, 4 parts of euphorbia obesa, 5 parts of sauerkraut seeds, 4 parts of atractylodes, 5 parts of trichosanthes, 4 parts of schisandra chinensis, 5 parts of raw malt, and 3 parts of raw licorice.

[0032] The preparation method of the above-mentioned Chinese medicine composition for treating obese type 2 diabetes specifically comprises the following steps: S1: Take astragalus, rehmannia, orientalis, Panlongqi, raw oyster, euphorbia pulex, salvia miltiorrhiza, atractylodes, radix trichosanthis, schisandra chinensis, raw malt, and raw licorice according to weight, rinse with clean water, dry, and mix to obtain a drug mixture for later use; S2: The drug mixture was crushed through a 60-mesh sieve and sterilized to obtain drug powder; 8 times the mass of 75% ethanol aqueous solution was added to the drug powder, and refluxed and extracted three times in a 70°C water bath, each reflux time was 40 minutes, and after the reflux was completed, a filtrate was obtained by filtration; the filtrate was evaporated and concentrated under reduced pressure to obtain a drug paste with a relative density of 1.32 g / mL; S3: Mixing the drug paste with pharmaceutically acceptable excipients in a mass ratio of 1:0.3 to prepare a Chinese medicine composition in the form of pills.

[0033] Example 3 The present embodiment provides a traditional Chinese medicine composition for treating obese type 2 diabetes. The raw material formula and weight proportions of the traditional Chinese medicine composition are: 18 parts of astragalus, 12 parts of rehmannia, 10 parts of oriental rhizome, 8 parts of panax notoginseng, 12 parts of raw oyster, 5 parts of euphorbia obesa, 8 parts of sauerkraut seeds, 5 parts of atractylodes, 8 parts of trichosanthes, 5 parts of schisandra chinensis, 8 parts of raw malt, and 4 parts of raw licorice.

[0034] The preparation method of the above-mentioned Chinese medicine composition for treating obese type 2 diabetes specifically comprises the following steps: S1: Take astragalus, rehmannia, orientalis, Panlongqi, raw oyster, euphorbia pulex, salvia miltiorrhiza, atractylodes, radix trichosanthis, schisandra chinensis, raw malt, and raw licorice according to weight, rinse with clean water, dry, and mix to obtain a drug mixture for later use; S2: The drug mixture was crushed through a 60-mesh sieve and sterilized to obtain drug powder; 10 times the weight of 75% ethanol aqueous solution was added to the drug powder, and refluxed and extracted three times in a 75°C water bath, each reflux time was 40 minutes, and after the reflux was completed, a filtrate was obtained by filtration; the filtrate was evaporated and concentrated under reduced pressure to obtain a drug paste with a relative density of 1.35 g / mL; S3: Mixing the drug paste with pharmaceutically acceptable drug excipients in a mass ratio of 1:0.4 to prepare a granular Chinese medicine composition.

[0035] A clinical trial was conducted using the Chinese medicine composition for treating obese type 2 diabetes of Example 2. The specific process and test results of the clinical trial are as follows: 1. Diagnostic criteria: (1) Diagnostic criteria for obesity: refer to the diagnostic criteria published by the Chinese Medical Association, BMI ≥ 28 kg / m 2 (2) Diagnostic criteria for type 2 diabetes mellitus (T2DM): refer to the Guidelines for the Prevention and Treatment of Type 2 Diabetes in China (2020 edition), fasting blood glucose ≥ 7.0 mmol / L and (or) 2h postprandial blood glucose ≥ 11.1 mmol / L.

[0036] 2. Inclusion criteria: ① Meet the diagnostic criteria for obesity T2DM; ② Aged 18-60 years old, regardless of gender; ③ Those who sign the informed consent form and agree to receive this treatment are included.

[0037] 3. Exclusion criteria: ① patients whose condition is in the acute exacerbation stage or with complications; ② pregnant or lactating women; ③ those who are allergic to this drug; ④ those who do not meet the above inclusion criteria.

[0038] 4. Experimental subjects: Obese T2DM patients who visited Shaanxi Provincial Hospital of Traditional Chinese Medicine from 2021 to 2024 were screened according to the inclusion and exclusion criteria, and 178 qualified cases were screened. According to the principle of open and parallel control, the patients were randomly divided into two groups: 90 cases in the treatment group and 88 cases in the control group. There was no statistical difference in age and clinical data of the two groups of experimental subjects, and they were comparable.

[0039] 5. Treatment (intervention) methods: (1) Control group: Metformin sustained-release tablets (Yuedaning, Yuekang Pharmaceutical Group Co., Ltd.), 1.0 g / time, once a day, orally before dinner.

[0040] (2) Treatment group: The subjects were given the Chinese medicine composition for treating obese type 2 diabetes prepared in Example 2, 15 g per day, divided into 3 doses, orally taken half an hour before meals.

[0041] The two groups of patients were treated with intervention therapy according to the above method for 3 months. The fasting blood glucose, 2-hour postprandial blood glucose, glycosylated hemoglobin, body weight, and BMI values ​​of the patients were tested on the 0th, 14th, 30th, 60th, and 90th days, respectively. All index tests were performed in our hospital; the 2-hour postprandial blood glucose value was uniformly defined as taking 75g of anhydrous glucose dissolved in 200mL of water, requiring the patient to drink it within 5 minutes, and the blood glucose value was counted 2 hours after the patient drank the first sip of sugar water.

[0042] 6. Statistical analysis The experimental data were analyzed and processed using SPSS 22.0 software and expressed as mean ± standard deviation. The measurement data were analyzed using t test and the count data were analyzed using X-test. 2 Inspection and rank data were analyzed using Ridit.

[0043] 7. Results (1) Fasting blood sugar The comparison results of fasting blood glucose levels of patients before and after treatment are shown in Table 1.

[0044] Table 1

[0045] Note: * For comparison with day 0, P < 0.05; # Compared with the control group, P<0.05.

[0046] As can be seen from Table 1, the fasting blood glucose values ​​of the patients in the treatment group detected on the 30th, 60th and 90th days were significantly lower than those before the start of treatment (0d). At the same time, the fasting blood glucose values ​​of the patients in the treatment group detected on the 60th and 90th days were significantly lower than those of the patients in the control group during the same period, indicating that the Chinese medicine composition for treating obese type 2 diabetes in this embodiment has the effect of reducing the fasting blood glucose of obese T2DM patients.

[0047] (2) Blood sugar 2 hours after meal The comparison results of blood glucose levels 2 hours after meal of patients before and after treatment are shown in Table 2.

[0048] Table 2

[0049] Note: * For comparison with day 0, P < 0.05; # Compared with the control group, P<0.05.

[0050] As can be seen from Table 2, the 2-h blood glucose values ​​of the patients in the treatment group detected on the 30th, 60th and 90th days were significantly lower than those before the start of treatment (0d). At the same time, the 2-h blood glucose values ​​of the patients in the treatment group detected on the 14th, 30th, 60th and 90th days were significantly lower than the 2-h blood glucose values ​​of the patients in the control group during the same period, indicating that the Chinese medicine composition for treating obese type 2 diabetes in this embodiment has the effect of reducing the 2-h blood glucose level of obese T2DM patients after a meal.

[0051] Based on the above results, it is shown that the Chinese medicine composition for treating obese type 2 diabetes of this embodiment has the effect of lowering the blood sugar level of obese T2DM patients.

[0052] (3) Glycated hemoglobin The comparison results of glycosylated hemoglobin values ​​of patients before and after treatment are shown in Table 3.

[0053] Table 3

[0054] Note: * For comparison with day 0, P < 0.05; # Compared with the control group, P<0.05.

[0055] As can be seen from Table 3, the glycated hemoglobin values ​​of the patients in the treatment group detected on the 60th and 90th days were significantly lower than those before the start of treatment (0d). At the same time, the glycated hemoglobin values ​​of the patients in the treatment group detected on the 30th, 60th and 90th days were significantly lower than those of the patients in the control group during the same period, indicating that the Chinese medicine composition for treating obese type 2 diabetes of this embodiment has the effect of reducing the glycated hemoglobin value of obese T2DM patients, and further illustrates that the Chinese medicine composition for treating obese type 2 diabetes of this embodiment can reduce the average blood sugar level of obese T2DM patients within 3 months.

[0056] weight (4) The comparison results of patients’ body weight before and after treatment are shown in Table 4.

[0057] Table 4

[0058] Note: * For comparison with day 0, P < 0.05; # Compared with the control group, P<0.05.

[0059] As can be seen from Table 4, the weight values ​​of patients in the treatment group detected on the 60th and 90th days were significantly lower than those before the start of treatment (0d). At the same time, the weight values ​​of patients in the treatment group detected on the 60th and 90th days were significantly lower than those of patients in the control group during the same period, indicating that the Chinese medicine composition for treating obese type 2 diabetes in this embodiment has the effect of reducing the weight of obese T2DM patients.

[0060] BMI value (5) The comparison results of BMI values ​​of patients before and after treatment are shown in Table 5.

[0061] Table 5

[0062] Note: * For comparison with day 0, P < 0.05; # Compared with the control group, P<0.05.

[0063] As can be seen from Table 5, the BMI value of the patients in the treatment group detected on the 90th day was significantly lower than that before the start of treatment (0d). At the same time, the BMI values ​​of the patients in the treatment group detected on the 60th and 90th days were significantly lower than the BMI values ​​of the patients in the control group during the same period, indicating that the Chinese medicine composition for treating obese type 2 diabetes in this embodiment has the effect of reducing the weight of obese T2DM patients and lowering the BMI value.

[0064] In some embodiments of the present invention, clinical trials were conducted using the Chinese medicine compositions for treating obese type 2 diabetes of Examples 1 and 3, and the same experimental results as those of the Chinese medicine composition of Example 2 were obtained (having the efficacy of lowering blood sugar levels in obese T2DM patients, lowering average blood sugar levels, reducing body weight, and lowering BMI values).

[0065] Safety and toxic side effect monitoring: During the study period, no abnormalities in the safety indicators (liver and kidney function, blood routine, etc.) related to the use of the Chinese medicine composition for treating obese type 2 diabetes of Examples 1-3 were found before and after the clinical experimental treatment. Follow-up visits were conducted for 6 months to 1 year, and no side effects were observed in the patients taking the medicine, indicating that the Chinese medicine composition is safe and has no toxic side effects.

[0066] Based on the above results, it can be seen that the Chinese medicine composition for treating obese type 2 diabetes of Examples 1-3 has the effects of lowering blood sugar, reducing body weight, and reducing BMI value, has a comprehensive therapeutic effect on obese type 2 diabetes, has good efficacy, is safe and has no toxic side effects.

[0067] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

Claims

1. A Chinese medicine composition for treating obese type 2 diabetes, characterized in that: The raw material formula and weight proportions of the traditional Chinese medicine composition are: 12-18 parts of astragalus, 8-12 parts of rehmannia, 6-10 parts of oriental rhizome, 4-8 parts of panax notoginseng, 8-12 parts of raw oyster, 3-5 parts of euphorbia obesa, 4-8 parts of sauerkraut seeds, 3-5 parts of atractylodes, 4-8 parts of trichosanthes, 3-5 parts of schisandra chinensis, 4-8 parts of raw malt and 2-4 parts of raw licorice.

2. A Chinese medicine composition for treating obese type 2 diabetes according to claim 1, characterized in that: The raw material formula and weight proportions of the Chinese medicine composition are: 15 parts of Astragalus, 10 parts of Rehmannia, 8 parts of Alisma, 5 parts of Panax Notoginseng, 10 parts of raw oyster, 4 parts of Euphorbia obesa, 5 parts of Salacia chinensis, 4 parts of Atractylodes, 5 parts of Radix Trichosanthis, 4 parts of Schisandrae Chinensis, 5 parts of raw malt, and 3 parts of raw liquorice.

3. A method for preparing a Chinese medicine composition for treating obese type 2 diabetes as claimed in any one of claims 1 to 2, characterized in that: The specific steps include: S1: Take astragalus, rehmannia, orientalis, Panlongqi, raw oyster, euphorbia pulex, salvia miltiorrhiza, atractylodes, radix trichosanthis, schisandra chinensis, raw malt, and raw licorice according to weight, rinse with clean water, dry, and mix to obtain a drug mixture for later use; S2: crushing and sieving the drug mixture, sterilizing, and obtaining drug powder; adding 75% ethanol aqueous solution to the drug powder, refluxing and extracting it three times in a water bath, filtering after the refluxing is completed to obtain a filtrate; evaporating and concentrating the filtrate under reduced pressure to obtain a drug thick paste; S3: Mixing the thick medicinal paste with pharmaceutically acceptable excipients to prepare the Chinese medicine composition.

4. A method for preparing a Chinese medicine composition for treating obese type 2 diabetes according to claim 3, characterized in that: In step S2, the mass ratio of the drug powder to the 75% ethanol aqueous solution is 1:6-10.

5. A method for preparing a Chinese medicine composition for treating obese type 2 diabetes according to claim 3, characterized in that: In step S2, the water bath temperature is 65-75° C. and each reflux time is 40 min.

6. A method for preparing a Chinese medicine composition for treating obese type 2 diabetes according to claim 3, characterized in that: In the step S2, the relative density of the thick drug paste is 1.30-1.35 g / mL.

7. A method for preparing a Chinese medicine composition for treating obese type 2 diabetes according to claim 3, characterized in that: In the step S3, the mass ratio of the drug paste to the pharmaceutically acceptable drug excipients is 1:0.2-0.

4.

8. A method for preparing a Chinese medicine composition for treating obese type 2 diabetes according to claim 3, characterized in that: In step S3, the dosage form of the Chinese medicine composition is tablets, pills or granules.

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