Preparation method of traditional Chinese medicine for treating diabetes complicated with fatty liver

By combining traditional Chinese medicines such as Yang Erqi, Zishi, and Yanhuanglian according to the "monarch, minister, and envoy" to prepare traditional Chinese medicines for the treatment of diabetes and fatty liver, the problem of lack of special drugs for the treatment of diabetes and fatty liver in the existing technology was solved, and the effect of reducing blood sugar, reducing body quality and liver and kidney damage was achieved, while ensuring safety.

CN119607068APending Publication Date: 2025-03-14SHAANXI PROVINCIAL HOSPITAL OF CHINESE MEDICINE
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Patent Information

Application Number
CN202411810361.2
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2024-12-10
Publication Date
2025-03-14

AI Technical Summary

Technical Problem

The prior art lacks clear specific drugs for the treatment of diabetes and fatty liver. Commonly used drugs have major adverse reactions, and they are not cured by the symptoms.

Method used

A Chinese medicine preparation method is adopted to prepare traditional Chinese medicines such as elbow chrysanthemum, zishi, and yamcopene according to the compatibility theory of "monarch, minister, and envoy", and make traditional Chinese medicines for the treatment of diabetes and fatty liver. This Chinese medicine has the effects of promoting qi and dampness, protecting the liver and warming the kidneys, relieving phlegm and analgesic pain.

Benefits of technology

This traditional Chinese medicine can lower blood sugar, reduce body quality, reduce Chinese medicine syndrome scores, improve the efficacy of Chinese medicine syndrome, and reduce liver and kidney damage. The treatment effect is accurate, reliable, and has good safety.

✦ Generated by Eureka AI based on patent content.

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Abstract

The invention discloses a preparation method of a traditional Chinese medicine for treating diabetes complicated with fatty liver and relates to the technical field of traditional Chinese medicine preparation. The traditional Chinese medicine for treating diabetes complicated with fatty liver is prepared from the following raw materials in parts by weight: 8-15 parts of inula cappa, 10-16 parts of fructus catalpa, 6-12 parts of corydalis saxicola bunting, 6-10 parts of gypsophila elegans, 4-8 parts of equisetum arvense, 4-8 parts of hibiscus rosa-sinensis, 3-7 parts of laggera alata, 1-3 parts of rock ginseng, 2-6 parts of common vladimiria root, 1-5 parts of nauclea officinalis, 1-3 parts of hypericum japonicum and 3-7 parts of liquorice. The traditional Chinese medicine for treating diabetes mellitus complicated with fatty liver has the effects of reducing blood sugar, relieving body mass, reducing traditional Chinese medicine syndrome score, improving traditional Chinese medicine syndrome curative effect and relieving liver and kidney injury, and is definite and reliable in curative effect and good in safety.
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Description

Technical Field

[0001] The invention relates to the technical field of traditional Chinese medicine preparation, and in particular to a method for preparing a traditional Chinese medicine for diabetes combined with fatty liver. Background Art

[0002] There is an extremely complex two-way interactive relationship between diabetes and the liver. Diabetes can cause multiple liver damages, the most important of which is fatty liver. Diabetic patients have insulin resistance, which reduces the inhibitory effect of insulin on fat decomposition, increases the release of free fatty acids, and accelerates the uptake and synthesis of triglycerides (TG) by liver cells. At the same time, lipoprotein lipase activity is weakened, and TG degradation is reduced. Once TG formation exceeds the liver's ability to transport TG, liver fat will accumulate and fatty liver will form. The accumulation of liver fat affects sugar and lipid metabolism, forming a vicious cycle.

[0003] Studies in recent years have shown that the incidence of diabetes combined with fatty liver has generally shown a gradual upward trend, and the incidence of patients with type 2 diabetes combined with fatty liver can reach 20%-78%. Clinically, most patients have no obvious symptoms in the early stage of the disease, generally only showing mild elevation of transaminase and hepatomegaly, which is often easily ignored. Domestic studies have shown that about 10%-15% of patients can transform from simple fatty liver to liver fibrosis and cirrhosis, and 3% of patients may develop liver cancer or liver failure, and fatty liver can also induce or aggravate insulin resistance.

[0004] At present, Western medicine has no specific therapeutic drugs for the treatment of diabetes combined with fatty liver. Clinically, most of them use hypoglycemic, lipid-lowering and liver-protecting drugs in combination. Although they have certain curative effects, most of them have large adverse reactions, such as gastrointestinal reactions, hypoglycemia, liver and kidney damage and other side effects, which only treat the symptoms but not the root cause. Chinese herbal medicine has the characteristics of definite efficacy, high safety, no toxic side effects, and not easy to produce drug resistance. It has certain application and development prospects in the treatment of diabetes combined with fatty liver. Therefore, it is urgent to develop a combination of Chinese herbal medicines with definite efficacy and high safety for the treatment of diabetes combined with fatty liver. Summary of the invention

[0005] In view of the above problems, the present invention provides a method for preparing a traditional Chinese medicine for treating diabetes combined with fatty liver.

[0006] In order to achieve the above object, the technical solution adopted by the present invention is as follows: The invention provides a method for preparing a traditional Chinese medicine for treating diabetes combined with fatty liver. The traditional Chinese medicine for treating diabetes combined with fatty liver is prepared from the following raw materials in parts by weight: 8-15 parts of chrysanthemum argentea, 10-16 parts of zelkova chinensis, 6-12 parts of coptis chinensis, 6-10 parts of gypsophila paniculata, 4-8 parts of arvense, 4-8 parts of hibiscus, 3-7 parts of chrysanthemum argentea, 1-3 parts of ginseng, 2-6 parts of kaempferia lappa, 1-5 parts of galactorrhiza, 1-3 parts of lycopodiella ciliata, and 3-7 parts of liquorice. The method for preparing the traditional Chinese medicine for treating diabetes combined with fatty liver specifically comprises the following steps: S1: taking the above Chinese medicinal materials by weight, washing away the surface sediment, drying, sterilizing, and obtaining a drug mixture for later use; S2: adding clean water to the drug mixture, soaking, boiling and extracting to obtain a filtrate, repeating the extraction three times, combining the filtrates to obtain a mixed drug solution; concentrating the mixed drug solution by evaporation under reduced pressure to obtain a drug extract; S3: Mixing the drug extract with pharmaceutically acceptable drug excipients to prepare the traditional Chinese medicine.

[0007] Preferably, the Chinese medicine for treating diabetes and fatty liver is prepared from the following raw materials in parts by weight: 12 parts of chrysanthemum argentea, 14 parts of zelkova chinensis, 9 parts of coptis chinensis, 8 parts of gypsophila paniculata, 6 parts of equisetum arvense, 6 parts of hibiscus, 5 parts of chrysanthemum argentea, 2 parts of ginseng, 4 parts of chuanmuxiang, 3 parts of gallwood, 2 parts of ground ear grass, and 5 parts of liquorice. Preferably, in step S2, the mass ratio of the drug mixture to clean water is 1:6-10; the soaking time is 1-1.5 hours, and the extraction time is 1.5-2.5 hours.

[0008] Preferably, in step S2, the relative density of the drug extract is 1.30-1.34 g / mL.

[0009] Preferably, in step S3, the mass ratio of the drug extract to the pharmaceutically acceptable drug excipient is 1:0.3-0.5.

[0010] Preferably, in step S3, the dosage form of the Chinese medicine is tablets, pills, granules or capsules.

[0011] There is no name for diabetes combined with fatty liver in traditional Chinese medicine. Chinese medicine scientists classify it as "diabetes mellitus" combined with "accumulation" or "flank pain" in traditional Chinese medicine based on its symptoms. Chinese medicine believes that diabetes combined with fatty liver is often caused by improper diet, especially overeating of fatty and greasy foods, which produces dampness and phlegm; or abnormal hunger and satiety damages the spleen and stomach, the spleen fails to function properly, water and dampness cannot be transformed, and dampness gathers to form phlegm, which enters the meridians, flows with the qi, and stagnates in the liver; or excessive emotions, anger and depression damage the liver, and worry damages the spleen. Over time, it will damage the internal organs, affect the qi, cause qi stagnation and blood stasis, and phlegm and blood stasis block the blood vessels of the liver, causing liver pain. The Chinese medicine for treating diabetes combined with fatty liver of the present invention is based on the theory of "monarch, minister, assistant and envoy" compatibility, with chrysanthemum, catalpa and coptis as monarch medicines, which have the effects of promoting qi and removing dampness, protecting the liver and warming the kidney; with cyperus, arvense, hibiscus and chrysanthemum as ministers, which have the effects of clearing heat, resolving phlegm, relieving pain, removing dampness and promoting blood circulation; with ginseng, Sichuan costus root, gallwood and ground ear grass as adjuvants, which have the effects of clearing heat and detoxifying, promoting qi and relieving pain; with liquorice as the envoy, which has the effects of tonifying the spleen and replenishing qi and harmonizing the medicinal properties. The pharmacological effects of each Chinese medicine raw material are as follows: Sheep's Ear Chrysanthemum: warm in nature, spicy, sweet and slightly bitter in taste, and has no meridian entry. It has the effects of dispelling wind and dampness, promoting qi and removing dampness, detoxifying and reducing swelling. It is mainly used to treat colds, coughs, rheumatic pain, hepatitis, mastitis, etc.

[0012] Ziziphus fruit: mild in nature, sweet in taste; non-toxic, enters the kidney meridian and bladder meridian, has the effect of protecting the liver and warming the kidney, and is used to treat edema, chronic nephritis, cystitis, ascites due to liver cirrhosis, etc.

[0013] Coptis chinensis: It is cool in nature and bitter in taste. It has the effects of clearing away dampness and heat, dispersing blood stasis and reducing swelling. It is used to treat sores, boils, hepatitis, cirrhosis, liver cancer, etc.

[0014] Glehnia littoralis: slightly cold in nature, sweet and spicy in taste, enters the liver meridian, has the effect of clearing heat and cooling blood, and is mainly used to treat yin deficiency, internal heat, consumptive disease, and bone steaming.

[0015] Equisetum arvense: It is mild in nature and bitter in taste. It enters the lung meridian, stomach meridian, and liver meridian. It has the effects of clearing heat, cooling blood, relieving cough, and diuresis. It also has the effects of protecting the liver, lowering blood lipids, diuresis, lowering blood pressure, anti-inflammatory, and analgesic.

[0016] Hibiscus flower: It is cold in nature, sweet in taste, and enters the heart meridian, lung meridian, liver meridian, and spleen meridian. It has the effects of clearing the lungs, resolving phlegm, cooling blood, and detoxifying. It is used to treat cough due to phlegm and fire, epistaxis, dysentery, and red and white turbidity. Apply an appropriate amount externally, mash it and apply it to the affected area. It is used to treat carbuncles, toxic sores, tinea versicolor, etc.

[0017] Hexalobium: It is slightly warm in nature, pungent and bitter in taste, and belongs to the bladder meridian, spleen meridian, and lung meridian. It has the effects of dispelling wind and dampness, promoting blood circulation and detoxifying. It is mainly used to treat colds and fever, rheumatism and pain, edema, diarrhea, amenorrhea, bruises, carbuncles, scrofula, eczema and itching, burns from water or fire, snake and insect bites, etc.

[0018] Rock ginseng: It is mild in nature and spicy in taste. It has the effects of promoting qi and relieving pain, and stopping diarrhea. It is mainly used to treat abdominal distension and pain, abdominal pain caused by diarrhea, toothache, etc.

[0019] Sichuan costusroot: warm in nature, pungent and bitter in taste, enters the spleen meridian, stomach meridian, large intestine meridian, and gallbladder meridian. It has the effect of promoting qi and relieving pain. It is used for distension and pain in the chest and flanks, abdomen, intestinal rumbling, diarrhea, tenesmus, etc.

[0020] Gallwood: It is cold in nature, bitter in taste, and belongs to the lung meridian and large intestine meridian. It has the effects of clearing away heat and detoxifying, reducing swelling and relieving pain. It is used to treat eczema, dysentery, pyrexia, lower limb ulcers, carbuncle abscess, eczema, etc.

[0021] Ground ivy: It is cool in nature, sweet and slightly bitter in taste, and enters the liver meridian, gallbladder meridian, and large intestine meridian. It has the effects of clearing away heat and dampness, detoxifying, dispersing blood stasis and reducing swelling, and relieving pain. It is mainly used to treat damp-heat jaundice, diarrhea, dysentery, intestinal abscess, lung abscess, carbuncle, furuncle, swelling and poison, papule, mouth ulcer, red and swollen eyes, snake bites, and traumatic injuries.

[0022] 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.

[0023] Compared with the prior art, the present invention has the following beneficial effects: In the present invention, by adopting traditional Chinese medicines with the effects of promoting qi and removing dampness, protecting the liver and warming the kidney, and resolving phlegm and relieving pain as raw materials, according to the traditional Chinese medicine compatibility theory of "monarch, minister, assistant and messenger", the traditional Chinese medicine for treating diabetes combined with fatty liver is prepared, and the drug compatibility is reasonable; the traditional Chinese medicine for treating diabetes combined with fatty liver of the present invention has the effects of lowering blood sugar, reducing body weight, reducing TCM syndrome scores, improving TCM syndrome efficacy and reducing liver and kidney damage, and the therapeutic efficacy is definite and reliable, and the safety is good. DETAILED DESCRIPTION

[0024] 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.

[0025] 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.

[0026] Example 1 The present embodiment provides a method for preparing a traditional Chinese medicine for treating diabetes and fatty liver. The traditional Chinese medicine for treating diabetes and fatty liver is prepared from the following raw materials in parts by weight: 8 parts of chrysanthemum officinale, 10 parts of catalpa chinensis, 6 parts of coptis chinensis, 6 parts of gypsophila paniculata, 4 parts of arvense, 4 parts of hibiscus, 3 parts of hexapoda chrysanthemum, 1 part of ginseng, 2 parts of chuanmuxiang, 1 part of gallwood, 1 part of ground ear grass, and 3 parts of liquorice; The Chinese medicine preparation method specifically comprises the following steps: S1: taking the above Chinese medicinal materials by weight, washing away the surface sediment, drying, sterilizing, and obtaining a drug mixture for later use; S2: Add 6 times the mass of clean water to the drug mixture, soak for 1 hour, boil and extract for 1.5 hours to obtain a filtrate, repeat the extraction 3 times, and combine the filtrates to obtain a mixed drug solution; evaporate and concentrate the mixed drug solution under reduced pressure to obtain a drug extract with a relative density of 1.30 g / mL; S3: Mixing the drug extract with pharmaceutically acceptable drug excipients in a mass ratio of 1:0.3 to prepare the above-mentioned Chinese medicine tablets.

[0027] Example 2 The present embodiment provides a method for preparing a traditional Chinese medicine for treating diabetes with fatty liver. The traditional Chinese medicine for treating diabetes with fatty liver is prepared from the following raw materials in parts by weight: 12 parts of chrysanthemum argentea, 14 parts of zelkova chinensis, 9 parts of coptis chinensis, 8 parts of gypsophila paniculata, 6 parts of arvense, 6 parts of hibiscus, 5 parts of chrysanthemum argentea, 2 parts of ginseng, 4 parts of chuanmuxiang, 3 parts of gallwood, 2 parts of ground ear grass, and 5 parts of liquorice; The Chinese medicine preparation method specifically comprises the following steps: S1: taking the above Chinese medicinal materials by weight, washing away the surface sediment, drying, sterilizing, and obtaining a drug mixture for later use; S2: Add 8 times the weight of clean water to the drug mixture, soak for 1.25 hours, boil and extract for 2 hours to obtain a filtrate, repeat the extraction 3 times, and combine the filtrates to obtain a mixed drug solution; evaporate and concentrate the mixed drug solution under reduced pressure to obtain a drug extract with a relative density of 1.32 g / mL; S3: Mixing the drug extract with a mass ratio of 1:0.4 with pharmaceutically acceptable drug excipients to prepare the above-mentioned Chinese medicine pills.

[0028] Example 3 The present embodiment provides a method for preparing a traditional Chinese medicine for treating diabetes and fatty liver. The traditional Chinese medicine for treating diabetes and fatty liver is prepared from the following raw materials in parts by weight: 15 parts of chrysanthemum argentea, 16 parts of catalpa chinensis, 12 parts of coptis chinensis, 10 parts of gypsophila paniculata, 8 parts of arvense, 8 parts of hibiscus, 7 parts of chrysanthemum argentea, 3 parts of ginseng, 6 parts of chuanmuxiang, 5 parts of gallwood, 3 parts of ground ear grass, and 7 parts of liquorice; The Chinese medicine preparation method specifically comprises the following steps: S1: taking the above Chinese medicinal materials by weight, washing away the surface sediment, drying, sterilizing, and obtaining a drug mixture for later use; S2: Add 10 times the mass of clean water to the drug mixture, soak for 1.5 hours, boil and extract for 2.5 hours to obtain a filtrate, repeat the extraction three times, and combine the filtrates to obtain a mixed drug solution; evaporate and concentrate the mixed drug solution under reduced pressure to obtain a drug extract with a relative density of 1.34 g / mL; S3: Mixing the drug extract with pharmaceutically acceptable drug excipients in a mass ratio of 1:0.5 to prepare the above-mentioned granular Chinese medicine.

[0029] Example 4 The difference from Example 2 is that the traditional Chinese medicine is a capsule.

[0030] A clinical trial was conducted using the Chinese medicine for treating diabetes combined with fatty liver of Example 4. The following is the specific process and experimental results of the clinical trial: 1. Diagnostic criteria: 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 ≥ 7.0mmol / L and (or) 2h postprandial blood glucose ≥ 11.1mmol / L. Diagnostic criteria for non-alcoholic fatty liver disease (NAFLD): refer to the diagnostic criteria of the "Guidelines for the Prevention and Treatment of Non-alcoholic Fatty Liver Disease" (2018 edition).

[0031] 2. Inclusion criteria: ① Meet the diagnostic criteria for diabetes combined with fatty liver; ② Age 18-60 years old, regardless of gender; ③ Those who sign the informed consent form and agree to receive this treatment are included in the selection.

[0032] 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.

[0033] 4. Experimental subjects: Patients with diabetes and fatty liver who visited Shaanxi Provincial Hospital of Traditional Chinese Medicine from 2020 to 2022 were screened according to the inclusion and exclusion criteria, and 153 qualified cases were screened. According to the principle of open and parallel control, the patients were randomly divided into two groups: 78 cases in the treatment group and 75 cases in the control group. There was no statistical difference in the clinical data such as age, gender, and disease course of the two groups of experimental subjects, and they were comparable.

[0034] 5. Treatment (intervention) methods: (1) Control group: Metformin hydrochloride enteric-coated tablets (Shengjitang, Guizhou Shengjitang Pharmaceutical Co., Ltd.), 0.25 g / time, 3 times a day, orally taken half an hour before meals.

[0035] (2) Treatment group: The subjects were given the Chinese medicine capsule for treating diabetes combined with fatty liver prepared in Example 4, 10 g per day, taken twice a day, morning and evening, half an hour before meals.

[0036] The two groups of patients were given intervention treatment according to the above method, with a treatment course of 3 months.

[0037] 6. Indicator monitoring (1) The fasting blood glucose, 2-hour postprandial blood glucose, waist circumference, and BMI values ​​of the patients were measured on days 0, 14, 30, 60, and 90. The 2-hour postprandial blood glucose value was uniformly defined as taking 75 g of anhydrous glucose dissolved in 200 mL of water, which the patient was required to drink within 5 minutes. The blood glucose value was measured 2 hours after the patient drank the first sip of the sugar water.

[0038] (2) TCM syndrome scoring: This was developed with reference to the TCM Diagnosis and Treatment Program for 95 Diseases in 22 Specialties (Combined Edition). The scoring criteria for each major symptom are: 0 for none, 2 for mild, 4 for moderate, and 6 for severe; the scoring criteria for each minor symptom are: 0 for none, 1 for mild, 2 for moderate, and 3 for severe. Records were taken once before and after treatment.

[0039] (3) Criteria for judging the efficacy of TCM syndrome: refer to the TCM Diagnosis and Treatment Program for 95 Diseases in 22 Specialties (Combined Edition) and evaluate the efficacy based on the changes in TCM syndrome scores before and after treatment. Clinical cure: clinical symptoms and signs disappear or basically disappear, and the TCM syndrome score decreases by ≥90%; marked effect: clinical symptoms and signs are significantly improved, and the TCM syndrome score decreases by ≥70%; effective: clinical symptoms and signs are improved, and the TCM syndrome score decreases by ≥30%; ineffective: clinical symptoms and signs are not significantly improved, or even worsen, and the TCM syndrome score decreases by less than 30%.

[0040] (4) Liver and kidney function tests: Liver function (ALT, AST) and kidney function (UREA, CREA) were tested once before and after treatment.

[0041] 7. 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.

[0042] 8. Results (1) Comparison of blood sugar The comparison results of fasting blood glucose values ​​and 2-hour postprandial blood glucose values ​​of patients before and after treatment are shown in Table 1.

[0043] Table 1

[0044] Note: *For comparison with day 0, P < 0.05; # Compared with the control group, P<0.05.

[0045] As can be seen from Table 1, the fasting blood glucose values ​​of the patients in the treatment group after treatment (14d, 30d, 60d, 90d) were significantly lower than those before the start of treatment (0d), and the 2h postprandial blood glucose values ​​of the patients in the treatment group after treatment (30d, 60d, 90d) were significantly lower than those before the start of treatment (0d). At the same time, the fasting blood glucose values ​​and 2h postprandial blood glucose values ​​of the patients in the treatment group detected on the 60th and 90th days were significantly lower than those in the control group, indicating that the traditional Chinese medicine for treating diabetes combined with fatty liver in this embodiment has the effect of lowering the blood glucose of patients.

[0046] Comparison of waist circumference and BMI values The comparison results of waist circumference and BMI values ​​of patients before and after treatment are shown in Table 2.

[0047] Table 2

[0048] Note: * For comparison with day 0, P < 0.05; # Compared with the control group, P<0.05.

[0049] As can be seen from Table 2, the waist circumference and BMI values ​​of the patients in the treatment group after treatment (14d, 30d, 60d, 90d) were significantly lower than those before the start of treatment (0d). At the same time, the waist circumference of the patients in the treatment group detected on the 60th and 90th days was significantly lower than that in the control group, indicating that the Chinese medicine of this embodiment has the effect of reducing the body weight of the patients.

[0050] (3) Comparison of TCM syndrome scores The comparison results of TCM syndrome scores of patients before and after treatment are shown in Table 3.

[0051] Table 3

[0052] Note: * For comparison with day 0, P < 0.05; # Compared with the control group, P<0.05.

[0053] As can be seen from Table 3, the TCM syndrome score of the patients in the treatment group after treatment (90d) was significantly lower than that before treatment (0d). At the same time, the TCM syndrome score of the patients in the treatment group after treatment (90d) was significantly lower than that of the control group, indicating that the Chinese medicine in this embodiment has the effect of reducing the TCM syndrome score.

[0054] (4) TCM syndrome efficacy The results of the comparison of the efficacy of TCM syndromes in patients after treatment are shown in Table 4.

[0055] Table 4

[0056] As shown in Table 4, the total effective rate of the treatment group was 92.31% (5.13%+33.33%+53.85%), and the total effective rate of the control group was 77.33% (1.33%+25.33%+50.67%). This indicates that the TCM syndrome efficacy of the Chinese medicine for treating diabetes combined with fatty liver in this embodiment is better than that of the control group.

[0057] (5) Comparison of liver and kidney function The comparison results of liver and kidney function of patients before and after treatment are shown in Table 5.

[0058] Table 5

[0059] Note: * For comparison with day 0, P < 0.05; # Compared with the control group, P<0.05.

[0060] As shown in Table 5, the ALT, AST, UREA, and CREA values ​​of the patients in the treatment group after treatment (90 days) were significantly lower than those before the start of treatment (0 days). At the same time, the ALT and AST values ​​of the patients in the treatment group after treatment (90 days) were significantly lower than those in the control group, indicating that the Chinese medicine of this embodiment has the effect of alleviating liver and kidney damage in patients. In addition, after treatment, the liver and kidney functions of the patients were within the normal range, the vital signs of the patients were stable, and no adverse reactions occurred, indicating that the Chinese medicine of this embodiment has good safety.

[0061] In some embodiments of the present invention, clinical trials were conducted using the Chinese medicine for treating diabetes combined with fatty liver of Examples 1-3, and the same experimental results as those of the Chinese medicine of Example 4 were obtained (having the efficacy of lowering patients' blood sugar, reducing patients' body weight, reducing TCM syndrome scores, improving TCM syndrome efficacy, and reducing patients' liver and kidney damage).

[0062] In summary, the traditional Chinese medicine for treating diabetes combined with fatty liver in this embodiment has the effects of lowering blood sugar, reducing body weight, reducing TCM syndrome scores, improving TCM syndrome efficacy and alleviating liver and kidney damage. The therapeutic efficacy is definite and reliable, and the safety is good.

[0063] 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 method for preparing a traditional Chinese medicine for diabetes combined with fatty liver, characterized in that: The Chinese medicine for treating diabetes combined with fatty liver is prepared from the following raw materials in parts by weight: 8-15 parts of chrysanthemum argentea, 10-16 parts of zizyphus chinensis, 6-12 parts of coptis chinensis, 6-10 parts of gypsophila paniculata, 4-8 parts of arvense, 4-8 parts of hibiscus, 3-7 parts of chrysanthemum argentea, 1-3 parts of ginseng, 2-6 parts of kaempferia lappa, 1-5 parts of scutellaria baicalensis, 1-3 parts of lycopodiella ciliata, and 3-7 parts of liquorice; The method for preparing the traditional Chinese medicine for treating diabetes combined with fatty liver specifically comprises the following steps: S1: taking the above Chinese medicinal materials by weight, washing away the surface sediment, drying, sterilizing, and obtaining a drug mixture for later use; S2: adding clean water to the drug mixture, soaking, boiling and extracting to obtain a filtrate, repeating the extraction three times, combining the filtrates to obtain a mixed drug solution; evaporating and concentrating the mixed drug solution under reduced pressure to obtain a drug extract; S3: Mixing the drug extract with pharmaceutically acceptable drug excipients to prepare the traditional Chinese medicine.

2. The method for preparing a traditional Chinese medicine for treating diabetes combined with fatty liver according to claim 1, characterized in that: The traditional Chinese medicine for diabetes combined with fatty liver is prepared from the following raw materials in parts by weight: 12 parts of chrysanthemum morifolium, 14 parts of zelkova chinensis, 9 parts of coptis chinensis, 8 parts of gypsophila paniculata, 6 parts of arvense, 6 parts of hibiscus, 5 parts of hexapoda chrysanthemum, 2 parts of ginseng, 4 parts of kaempferia lappa, 3 parts of scutellaria baicalensis, 2 parts of ground ear grass, and 5 parts of liquorice.

3. The method for preparing a traditional Chinese medicine for treating diabetes combined with fatty liver according to claim 1, characterized in that: In step S2, the mass ratio of the drug mixture to clean water is 1:6-10; the soaking time is 1-1.5 hours, and the extraction time is 1.5-2.5 hours.

4. The method for preparing a traditional Chinese medicine for treating diabetes combined with fatty liver according to claim 1, characterized in that: In step S2, the relative density of the drug extract is 1.30-1.34 g / mL.

5. The method for preparing a traditional Chinese medicine for treating diabetes combined with fatty liver according to claim 1, characterized in that: In the step S3, the mass ratio of the drug extract to the pharmaceutically acceptable drug excipient is 1:0.3-0.

5.

6. The method for preparing a traditional Chinese medicine for diabetes combined with fatty liver according to claim 1, characterized in that: In step S3, the dosage form of the Chinese medicine is tablets, pills, granules or capsules.