CN115381906A

CN115381906A - Traditional Chinese medicine composition for treating metabolic syndrome and preparation method and application thereof

Info

Publication number: CN115381906A
Application number: CN202211242731.8A
Authority: CN
Inventors: 安冬青; 汪建萍
Original assignee: Fourth Affiliated Hospital of Xinjiang Medical University
Current assignee: Fourth Affiliated Hospital of Xinjiang Medical University
Priority date: 2022-10-11
Filing date: 2022-10-11
Publication date: 2022-11-25
Anticipated expiration: 2042-10-11
Also published as: CN115381906B

Abstract

The invention belongs to the technical field of traditional Chinese medicines, and particularly discloses a traditional Chinese medicine composition for treating metabolic syndrome, and a preparation method and application thereof. The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 3 to 50 parts of angelica, 15 to 120 parts of desmodium, 25 to 50 parts of cogongrass rhizome, 3 to 50 parts of cassia occidentalis and 3 to 50 parts of fried hawthorn. The traditional Chinese medicine composition provided by the invention has a good treatment effect on metabolic syndrome with the syndromes of internal dampness and heat, qi stagnation and blood stasis, and adverse reactions such as liver and kidney injury, gastrointestinal discomfort and the like of patients do not occur.

Description

Traditional Chinese medicine composition for treating metabolic syndrome and preparation method and application thereof

Technical Field

The invention belongs to the technical field of traditional Chinese medicines, and particularly discloses a traditional Chinese medicine composition for treating metabolic syndrome, and a preparation method and application thereof.

Background

Metabolic Syndrome (MS), also known as syndrome X and insulin resistance syndrome, refers to a series of metabolic and physiological disorders related to Insulin Resistance (IR) as risk factors for atherosclerosis and cardiovascular diseases, including central obesity, hyperinsulinemia, impaired glucose tolerance and diabetes, hypertension, dyslipidemia, nonalcoholic fatty liver disease, microalbuminuria. Further expansion has been shown to include hyperuricemia, blood coagulation and fibrinolysis abnormalities, endothelial dysfunction, pre-inflammatory conditions, neuroendocrine abnormalities, hyperleptinemia, and the like. In recent years, MS has become a focus of world medical research.

Different organizations have a slight difference in MS definition internationally due to species differences and the like. The diagnosis standard of MS is established according to the characteristics and research results of Chinese population by the diabetes division of China medical society in 2017, namely the diagnosis can be carried out when 3 of the following 4 patients are met: (1) overweight or obese: the Body Mass Index (BMI) is more than or equal to 25.0; (2) hyperglycemia: fasting blood sugar is more than or equal to 6.1mmol/L, or blood sugar after sugar load is more than or equal to 7.8mmol/L, or the patient is diagnosed with diabetes and treated; (3) hypertension: systolic/diastolic blood pressure is not less than 140/90mm Hg (18.7/12.0 kPa) and/or hypertension has been diagnosed and treated; (4) blood lipid disorder: fasting triglyceride TG is more than or equal to 1.7mmoL/L or fasting blood HDL-C, male is less than 0.9mmoL/L, female is less than 1.0mmoL/L.

The current high risk group of metabolic syndrome includes: (1) those over the age of 40 years old; (2) those who have 1 or 2 metabolic syndrome components but do not meet diagnostic criteria; (3) patients with cardiovascular diseases, non-alcoholic fatty liver disease, gout, polycystic ovary syndrome and various lipoatrophy symptoms; (4) obesity, type 2 diabetes, hypertension, dyslipidemia, especially multiple combinations or a family history of metabolic syndrome; (5) there is a family history of cardiovascular disease. At present, the prevalence rate of metabolic syndrome in China reaches 14-16%, and the standardized prevalence rate is 9-12%. Early clinical studies show that metabolic syndrome significantly increases the risk of atherosclerotic cardiovascular diseases and metabolic diseases such as type 2 diabetes, gout, and the like. The total incidence and mortality of cardiovascular diseases and cerebral apoplexy in China exceed those of many developed countries, the vascular events are common in coronary heart disease in the west, and cerebrovascular diseases are more common in China. The metabolic syndrome can be said to be the first invisible killer which causes coronary heart disease and high stroke in the 21 st century and threatens human health and life safety. In conclusion, the current metabolic syndrome patients and high-risk groups thereof are huge in China, if the metabolic syndrome patients and the high-risk groups cannot be well controlled, the health and life safety of people are seriously threatened, and meanwhile, the nation needs to bear huge medical burden.

At present, the incidence of metabolic syndrome is in a clear rising trend due to the improvement of the living standard of substances and the relative weakness of self health care consciousness. The method aims at preventing the metabolic syndrome, advocates a healthy life style, pays attention to regular physical examination and discovers early treatment. For early patients, the traditional Chinese medicine adopts a four-diagnosis combined method to perform syndrome differentiation treatment, relieves symptoms, improves the body constitution of the patients on the whole and adjusts the metabolic imbalance of human bodies on the basis of improving the therapeutic life style so as to prevent or delay the occurrence and development of metabolic syndrome. The western medicine has a certain treatment effect on the treatment of the metabolic syndrome, but has considerable side effects and serious adverse reactions. At present, certain western medicines clinically used can cause metabolic disorder, for example, certain antihypertensive medicines can increase blood sugar and blood fat, lipid-lowering medicines can increase blood sugar and damage liver and kidney, and the medicines have large adverse reaction and can cause injury of multiple organs. The traditional Chinese medicine has relatively small adverse reaction, and the traditional Chinese medicine also has certain effect when being applied to the treatment of metabolic syndrome due to the characteristics of mild drug property, small side effect and the like.

Therefore, it is necessary to develop new Chinese medicinal compositions for treating and preventing metabolic syndrome.

Disclosure of Invention

In view of the above technical problems, the present invention provides the following technical solutions:

the invention provides a traditional Chinese medicine composition for treating metabolic syndrome, which comprises the following raw materials in parts by weight: 3 to 50 parts of angelica, 15 to 120 parts of desmodium, 25 to 50 parts of cogongrass rhizome, 3 to 50 parts of cassia occidentalis and 3 to 50 parts of fried hawthorn.

Preferably, the traditional Chinese medicine composition consists of the following raw materials in parts by weight: 10 to 40 portions of angelica, 30 to 80 portions of lysimachia christinae hance, 30 to 40 portions of cogongrass rhizome, 10 to 40 portions of cassia occidentalis and 10 to 40 portions of fried hawthorn.

Preferably, the traditional Chinese medicine composition consists of the following raw materials in parts by weight: 25 to 35 portions of angelica, 50 to 80 portions of desmodium, 35 to 40 portions of cogongrass rhizome, 20 to 30 portions of cassia occidentalis and 20 to 30 portions of fried hawthorn.

Preferably, the traditional Chinese medicine composition consists of the following raw materials in parts by weight: 35 parts of angelica, 70 parts of longhairy antenoron herb, 40 parts of cogongrass rhizome, 25 parts of cassia occidentalis and 25 parts of fried hawthorn.

The invention also provides a preparation method of the traditional Chinese medicine composition, which comprises the following steps:

weighing angelica, desmodium, cogongrass rhizome, cassia occidentalis and fried hawthorn in parts by weight;

mixing the weighed medicinal materials, adding water for decoction, and collecting decoction to obtain the traditional Chinese medicine composition.

Preferably, the specific operation process of decocting with water is as follows: adding water which is 2-4 times of the total weight of the medicinal materials, decocting for 2-3 times, decocting for 15-30 min each time, and collecting decoction.

Preferably, water which is 2 to 4 times of the total weight of the medicinal materials is added to soak the medicinal materials for 30 to 60 minutes before decoction.

The invention provides application of the traditional Chinese medicine composition in preparing a medicine for treating damp-heat and blood stasis type metabolic syndrome.

Preferably, the metabolic syndrome comprises obesity, hyperglycemia, hypertension, dyslipidemia, hyperviscosity, hyperuricemia, fatty liver, or hyperinsulinemia.

The invention also provides a traditional Chinese medicine preparation for treating metabolic syndrome, which comprises the traditional Chinese medicine composition and pharmaceutically acceptable auxiliary materials or carriers.

In the long-term clinical treatment process of metabolic syndrome and hyperuricemia, the inventor finds that the patients with internal dampness-heat resistance, qi stagnation and blood stasis are mostly addicted to be fatty and sweet, and are willing to drink wine, and the spleen fails to transport and transform, dampness turbidity is generated internally, water dampness is stagnated, stagnation is caused by stagnation and heat is transformed, the pathogenesis of dampness-heat is presented, the channels are flowed and infused, the circulation of qi and blood is not smooth, and the blood stasis is stopped internally, so the invention is drawn up by taking the damp-heat with stasis (internal dampness-heat resistance, qi stagnation and blood stasis) as the key point of syndrome differentiation and taking heat clearing and dampness removing, blood circulation activating and blood stasis (dampness-removing and blood stasis method) as the main treatment principle. The Chinese medicinal composition provided by the invention has the advantages that the Chinese angelica in the formula has sweet and pungent taste and warm nature, enters liver, heart and spleen channels, has the effects of enriching blood and activating blood, warming channels and freeing Bi, and can be used for treating rheumatic arthralgia. The book Xin Xiu Ben Cao (newly revised materia Medica) carries the treatment of damp arthralgia. The famous physicians Bie Lu carries the herb of pungent, warm and non-toxic. Warming the middle energizer, alleviating pain, removing obstruction in the blood, treating apoplexy, no sweating, damp arthralgia, nausea, deficiency and coldness of the vital energy, tonifying five zang organs and generating muscles. The book Jingyue quan recorded that can dispel pain, relax bowels, benefit tendons and bones, treat spasm, paralysis, dryness and astringency. In the recipe, the Chinese angelica is a monarch drug because it can tonify qi and nourish blood, support healthy energy, promote blood circulation to remove blood stasis, warm meridians and remove arthralgia. The lysimachia christinae hance is sweet and salty in taste and slightly cold in nature, belongs to liver, gallbladder, kidney and bladder channels, has the effects of inducing diuresis for treating stranguria, clearing heat and removing toxicity, and dissipating blood stasis and dispersing swelling, so that the effect of inducing diuresis for removing damp evil qi, clearing heat due to cold nature, gathering blood and promoting blood circulation along the wild part of the liver channels is achieved, the effect of dissipating blood stasis is achieved, and the lysimachia christinae hance is used as a ministerial drug for assisting the effects of inducing diuresis for clearing heat and dissipating blood stasis. "Baicao mirror" year: jin Qian Cao is indicated for traumatic injury. The "materia medica seeking origin" says: dispel wind-damp and relieve bone pain. The monarch drug for relaxing tendons and activating collaterals and stopping traumatic injury and flash injury is soaked in wine. The lysimachia christinae hance in the formula has the effects of clearing liver and gallbladder fire and removing lower-jiao damp-heat, the cogongrass rhizome has sweet taste and cold nature, enters lung, stomach and bladder channels, has the functions of inducing diuresis, clearing heat, cooling blood and stopping bleeding, has cold-nature settlement, has the functions of clearing heat, promoting diuresis, eliminating turbid pathogen and promoting diuresis, and also can clear away heat from the lung and stomach, induce diuresis for treating stranguria, promote the production of body fluid and quench thirst, so the cogongrass rhizome is taken as a ministerial drug. The book Jing: deficiency due to fatigue, invigorating spleen and replenishing qi, removing blood stasis, blood retention, cold and heat, and promoting urination. The bibliography: five stranguria, removing heat in intestines and stomach, quenching thirst and strengthening tendons. The cassia seed is bitter, sweet, salty and slightly cold in nature, enters liver, kidney and large intestine channels, has the functions of promoting diuresis, relaxing bowels, reducing lipid, clearing liver and improving eyesight, has the laxative effect, has the effects of assisting monarch and minister to dispel dampness and dissolving turbidity, is used as an adjuvant, clears liver fire, suppresses liver yang, moistens intestines and relaxes bowels, combines three medicaments of desmodium, lalang grass rhizome and cassia seed to ensure that damp-heat evil comes out from lower jiao to achieve the effects of clearing heat and dispelling dampness, and the bitter and cold medicament is easy to injure spleen and stomach, so the hawthorn is used for tonifying spleen and stomach, promoting qi circulation and dissipating blood stasis, harmonizing qi activity, eliminating evil without damaging vital qi, and giving consideration to both the pathogenic factor and the vital qi. The title of Mediterranean treaty: the action of purging pathogenic water. The record of Western medicine of the full intentions of medicine: haw, if combined with herbs of sweet flavor, can resolve blood stasis without damaging new blood and dispel qi without damaging healthy qi, is of good balance. The stir-fried hawthorn is sour and sweet in taste and warm in nature, has the effects of promoting the circulation of qi, removing blood stasis, helping digestion and removing food retention, and regulates the cold and cool property of the medicines and the qi and blood, so that the qi and blood flow together, the blood stasis is removed without damaging new blood, and the qi stagnation is removed without damaging healthy qi, thereby being used as a guiding drug. The medicines are matched to play the effects of clearing heat, promoting diuresis, promoting blood circulation and removing blood stasis, and are used for treating damp-heat internal resistance, qi stagnation and blood stasis syndrome metabolic syndrome (obesity, hyperglycemia, hypertension, dyslipidemia, hyperviscosity, hyperuricemia, high fatty liver incidence, hyperinsulinemia and the like).

Compared with the prior art, the invention has the beneficial effects that:

the traditional Chinese medicine composition provided by the invention has a good treatment effect on metabolic syndromes (including obesity, hyperglycemia, hypertension, dyslipidemia, hyperviscosity, high fatty liver incidence, hyperinsulinemia and the like) with the syndromes of internal dampness-heat resistance and qi stagnation and blood stasis; simultaneously, the medicine can reduce the uric acid level of patients with hyperuricemia, has better effect on metabolic syndrome and hyperuricemia, and does not have adverse reactions such as liver and kidney injury, gastrointestinal discomfort and the like.

Drawings

FIG. 1 shows the results of uric acid level measurements for each group; compared with the control group, the compound of the formula, ^*** P<0.001; in comparison to the set of models, ^### P<0.001；

FIG. 2 shows the results of detection of interleukins 1. About.beta. For each group; compared with the control group, the compound of the formula, ^*** P<0.001; in comparison to the set of models, ^### P<0.001；

FIG. 3 shows the results of detection of interleukin 6 in each group; compared with the control group, the compound of the formula, ^*** P<0.001; in comparison to the set of models, ^### P<0.001；

FIG. 4 is the change in creatinine content for each group; compared with the control group， ^*** P<0.001; compared with model group ^### P<0.001。

Detailed Description

The principles and features of this invention are described below in conjunction with the following drawings, which are set forth by way of illustration only and are not intended to limit the scope of the invention.

Example 1

A traditional Chinese medicine composition for treating metabolic syndrome comprises the following raw materials: 3g of angelica, 15g of desmodium, 25g of cogongrass rhizome, 3g of cassia occidentalis and 3g of fried hawthorn.

Example 2

A traditional Chinese medicine composition for treating metabolic syndrome is composed of the following raw materials: 50g of angelica, 120g of desmodium, 50g of cogongrass rhizome, 50g of cassia occidentalis and 50g of fried hawthorn.

Example 3

A traditional Chinese medicine composition for treating metabolic syndrome comprises the following raw materials: 10g of angelica, 30g of desmodium, 30g of cogongrass rhizome, 10g of cassia occidentalis and 10g of fried hawthorn.

Example 4

A traditional Chinese medicine composition for treating metabolic syndrome is composed of the following raw materials: 40g of angelica, 80g of desmodium, 40g of cogongrass rhizome, 40g of cassia occidentalis and 40g of fried hawthorn.

Example 5

A traditional Chinese medicine composition for treating metabolic syndrome comprises the following raw materials: 25g of angelica, 50g of desmodium, 35g of cogongrass rhizome, 20g of cassia occidentalis and 20g of fried hawthorn.

Example 6

A traditional Chinese medicine composition for treating metabolic syndrome comprises the following raw materials: 35g of angelica, 80g of desmodium, 40g of cogongrass rhizome, 30g of cassia occidentalis and 30g of fried hawthorn.

Example 7

A traditional Chinese medicine composition for treating metabolic syndrome comprises the following raw materials: 35g of angelica, 70g of desmodium, 40g of cogongrass rhizome, 25g of cassia occidentalis and 25g of fried hawthorn.

The traditional Chinese medicine compositions provided by the above embodiments 1 to 7 are all prepared according to the following method:

weighing radix Angelicae sinensis, herba Lysimachiae Christinae, lalang grass rhizome, semen Cassiae and parched fructus crataegi;

mixing the weighed medicinal materials, adding water in an amount which is 4 times the total weight of the medicinal materials, soaking for 30min, decocting the medicinal liquid for 30min with slow fire after the medicinal liquid is boiled, and filtering out the medicinal liquid for later use; adding 3 times of water into the filter residue, boiling the liquid medicine, decocting with slow fire for 20 minutes, and combining the two times of the liquid medicine to obtain the Chinese medicinal preparation.

Example 8

A traditional Chinese medicine composition for treating metabolic syndrome, which is different from the preparation method of the embodiment 7, and specifically comprises the following steps:

mixing the weighed medicinal materials, adding water in an amount which is 2 times of the total weight of the medicinal materials, soaking for 60min, decocting the medicinal liquid for 20 min with slow fire after the medicinal liquid is boiled, and filtering out the medicinal liquid for later use; adding 2 times of water into the filter residue, boiling the liquid medicine, decocting for 15 minutes with slow fire, and combining the two times of the liquid medicine to obtain the Chinese medicinal preparation.

Since the effects of the Chinese medicinal compositions provided in examples 1 to 8 are substantially the same, the effects will be described below by taking the Chinese medicinal composition provided in example 7 as an example.

1. Pharmacodynamic experiment

1. Modeling

Balb/c mice of 4-6 weeks old are selected and adaptively fed for 7 days, and then 10 mice in each group are respectively given a molding medicament (500 mg/kg xanthine +1000mg/kg potassium oxonate) for 14 days. The change of uric acid of different groups is detected by a uric acid kit (Nanjing construction), and statistical analysis is carried out by SPSS22.0 to determine whether the molding is successful.

2. Method of producing a composite material

Mice successfully modeled were divided into a model group, a low dose group in example 7, a medium dose group in example 7, a high dose group in example 7, and a positive control group, and drug intervention was performed for 14 days, and a blank control group was set for comparison. And detecting the uric acid, serum inflammatory factor and creatinine content of each group of mice.

Wherein the dosage of the low-dose group in example 7 is 1.25mg/kg, the dosage of the high-dose group in example 7 is 2.5mg/kg, the dosage of the high-dose group in example 7 is 5mg/kg, allopurinol in the positive group is 40mg/kg, and the blank control group and the model group are subjected to physiological saline intragastric administration for 14 days.

3. Statistical analysis

The experimental data are statistically analyzed by SPSS22.0 software, the quantitative data are expressed by mean +/-standard deviation, the statistical test of the difference is the matched t test, and the difference is shown to have statistical significance if P is less than 0.05.

4. Results

4.1, detection of uric acid level

The results showed that mice in the low dose group of example 7, the medium dose group of example 7, the high dose group of example 7 and the positive control group (allopurinol group) had significantly decreased uric acid level compared to the model group, as shown in fig. 1 and table 1.

TABLE 1 variation in uric acid values in the groups of mice

Grouping	Uric acid level (umol/L)
		Blank control group	58.00±24.49
Model set	248.00±135.76
		Positive control group	98.01±37.28
Example 7 Low dose group	116.33±17.51
		Dose groups of example 7	59.67±23.38
Example 7 high dose group	146.33±15.06

4.2 serum inflammatory factor detection

The inflammatory factors of the mice are detected, and the interleukin 1-beta of the mice are obviously reduced compared with a model group after the treatment of the high, medium and low dose groups of the embodiment 7, and the effect is better than that of a positive control group, which is shown in a figure 2 and a table 2.

The results of interleukin 6 detection show that the dose group in example 7 and the high dose group in example 7 are both significantly reduced, and the effect of the dose group in example 7 is better than that of the positive control group, as shown in fig. 3 and table 3.

TABLE 2 Interleukin 1-beta content variation in groups of mice

Grouping	Interleukin 1-beta content (pg/mL)
		Blank control group	96.97±37.44
Model set	217.41±15.93
		Positive control group	159.08±19.1
Example 7 Low dose group	138.8±14.62
		Dose groups of example 7	138.75±11.83
Example 7 high dose group	121.3±16.78

TABLE 3 Change in Interleukin 6 content in groups of mice

4.3 detecting the content of creatinine

The creatinine content of the mice tested in the example 7 is significantly reduced compared to the model group and the positive control group, as shown in fig. 4 and table 4.

TABLE 4 Change in creatinine content in groups of mice

Grouping	Creatinine content (umol/L)
		Blank control group	10.59±3.99
Model set	27.91±7.72
		Positive control group	25.23±2.2
Example 7 Low dose group	9.98±7.03
		Dose groups of example 7	10.68±1.79
Example 7 high dose group	13.76±1.24

The results show that the traditional Chinese medicine composition provided by the invention can not only play a role in reducing uric acid in the process of treating hyperuricemia mice, but also can relieve inflammatory reaction of the mice caused by hyperuricemia without liver and kidney damage to the hyperuricemia mice.

2. Clinical trial

1. Study object

1.1 general data

170 cases of patients with damp-heat and blood stasis syndrome (damp-heat internal resistance, qi stagnation and blood stasis syndrome) which are identified in traditional Chinese medicine and accord with the diagnosis of metabolic syndrome are selected from a pre-established hyperuricemia patient survey database, and are randomly divided into two groups of 85 cases according to a random principle, wherein the treatment group is aged at the average age of 45.34 +/-7.11 and aged at the average course of 8.43 +/-4.12, and the patients with the complicating diseases of diabetes, hypertension, coronary heart disease and hyperlipidemia are 12, 28, 7 and 38 cases respectively. Mean age of control (44.78 ± 8.24) years; the average course of disease (8.26 + -3.57) years, 14, 24, 7, and 40 cases of complicated diabetes, hypertension, coronary heart disease, and hyperlipidemia. The two groups of general data are statistically processed, the P is more than 0.05, and the balance among the groups is better and has comparability.

1.2 diagnostic criteria

1.2.1 diagnostic criteria for Metabolic syndrome

Refer to the diabetes mellitus division of the Chinese medical society, china guidelines for the prevention and treatment of type 2 diabetes (2017 edition). The diagnosis standard of the metabolic syndrome in China is as follows: the diagnosis can be made by providing 3 or more of the following.

Abdominal obesity (i.e. central obesity): the waist circumference of the male is more than or equal to 90cm, and the waist circumference of the female is more than or equal to 85cm.

Overweight or obese: the Body Mass Index (BMI) is more than or equal to 25.0.

Hyperglycemia: the fasting blood sugar is more than or equal to 6.1mmol/L or the blood sugar after 2 hours of sugar load is more than or equal to 7.8mmol/L and/or the patient is diagnosed and treated with diabetes.

Hypertension: blood pressure of 130 mmHg or more/85 mmHg (1mmHg = 0.133kPa) and/or those confirmed as hypertension and treated.

Fasting Triacylglycerol (TG) is not less than 1.70mmol/L.

Fasting HDL-C is less than 1.04mmol/L.

Wherein, the waist circumference cut point of the central obesity adopts the standard established by 2013 national health and family planning Committee 'standards in the health industry of the people's republic of China-adult weight judgment (standard number WS/T428-2013).

1.2.2 diagnostic criteria for hyperuricemia

According to the standard of the health industry of the people's republic of China-the standard established by the hyperuricemia and gout patient diet guidance (WS/T560-2017): in the usual diet state, fasting blood was collected 2 times on different days and the blood uric acid level was measured by the uricase method, and the blood uric acid level was higher for men than 420. Mu. Mol/L or higher for women than 360. Mu. Mol/L.

1.2.3 Chinese medicine diagnostic Standard

Refer to the ' guidelines on clinical research of new drugs in traditional Chinese medicine ' published by 2012 edition and the master of Tiandeli Lu in traditional Chinese medicine ' and the ' terms of clinical diagnosis and treatment in traditional Chinese medicine ' published by the State administration of technology supervision. The main symptoms are: gastric and abdominal fullness, heaviness of the head and body, dizziness, heaviness of the body, dry throat, bitter taste, yellow and burning urine, red tongue with yellow and greasy coating. The secondary symptoms are as follows: halitosis, chest distress, hypochondriac distention, headache, insomnia, dry mouth without drinking, chest distress, nausea, numbness or tingling of limbs, pain in extremities and joints, and even stone in joints. And (3) thermogravimetry: excessive appetite, overeating, restlessness, insomnia, constipation, and slippery and rapid pulse; wet weight: poor appetite, vomiting without appetite, dry stool and soft pulse. Blood stasis weight: dark red tongue with petechia, ecchymosis, or sublingual stasis. The disease can be diagnosed as damp-heat with blood stasis (damp-heat internal resistance, qi stagnation and blood stasis) in two main symptoms and one secondary symptom.

1.3 inclusion and exclusion criteria

1.3.1, inclusion criteria

Selecting the patients who meet the diagnosis standard of the metabolic syndrome and the hyperuricemia and the traditional Chinese medicine symptoms which belong to damp-heat with blood stasis.

1.3.2, exclusion criteria

Removing serious primary diseases such as cardiovascular diseases, liver diseases, kidney diseases and the like; removing non-gouty stones, renal failure and other kidney diseases from the kidney; eliminating the drugs which can promote the excretion of uric acid such as dihydrocodex and pyrazinamide and the like which are taken recently; or patients with metabolism of biochemical indexes such as blood sugar, blood lipid, and uric acid due to drug, renal insufficiency, and hematopathy; patients who cannot take drugs on time or who cannot adhere to therapeutic lifestyle improvement; allergic constitution, planned pregnancy, pregnant or lactating women.

All subjects were controlled between 20 and 70 years of age, were asked to participate voluntarily and informed consent.

2. Observation index

2.1 general health examination

The height is measured by a height and weight meter which is corrected before and at different stages of the drug application of the tested population, and the weight and the waistline of the patient are measured.

Waist circumference measurement: the subject stands upright when the waist circumference is measured, and the middle points of the lower edge of the waist rib and the upper edge of the hip bone of the subject are horizontally measured by using a flexible ruler. After resting for 30min with a desk sphygmomanometer calibrated by a metering bureau, the right arm blood pressure is measured in a sitting position for 3 times continuously, and the average value is taken.

2.2, measurement of blood uric acid concentration and blood Biochemical index

2ml of venous blood is collected before administration and at different stages of administration of a human subject after fasting for 12 hours, the blood uric acid concentration (SUA) is detected by a Hitachi 7060 full-automatic biochemical analyzer at 3500 rpm/min x 15min on the day, and blood routine, urine routine, stool routine, biochemical indexes (liver function, kidney function, blood sugar and blood fat), blood uric acid, blood coagulation function, glycosylated hemoglobin and other biochemical indexes are measured.

2.3 Chinese medicine symptom integration of patients before and after treatment

The traditional Chinese medicine syndrome integration is utilized according to the traditional Chinese medicine disease diagnosis curative effect standard to verify the curative effect and the safety of the traditional Chinese medicine composition on patients.

The traditional Chinese medicine syndrome curative effect judgment standard is as follows:

refer to Xudilua "quantitative diagnosis of Chinese medicine" and Zhengxian Yu "clinical research guiding principle of new Chinese medicine".

Clinical cure: the integral of symptom and physical sign disappearance or basic disappearance syndrome is reduced by > 95 percent;

the effect is shown: symptoms and physical signs are obviously improved, and the integral of the symptoms is reduced by more than or equal to 70 percent;

the method has the following advantages: symptoms and physical signs are improved, and the integral of the symptoms is reduced by more than or equal to 30 percent;

and (4) invalidation: symptoms and signs are not obviously improved or even aggravated, and the syndrome score is reduced by less than 30.

3. Observation method

3.1 two groups of treatment methods

Control group: according to the 2020 Chinese guideline for preventing cardiovascular metabolic diseases, the improvement of sexual life style (including low-fat and low-purine diet, ensuring aerobic exercise for more than 2h every day, and water intake > 2000 ml/d) is adopted.

Treatment groups: the traditional Chinese medicine composition provided by the embodiment 7 of the invention is provided on the basis of the intervention method of the control group. The packaging is provided by a herbal medicine room of a traditional Chinese medicine institute in the Uygur autonomous region of Xinjiang, cold water is added before decoction, the traditional Chinese medicine decoction pieces are soaked for 60 minutes, the water amount is 4 times of that of the first decoction, the first decoction time is that the liquid medicine is boiled and then decocted for 30 minutes by slow fire, and the liquid medicine is filtered for later use. The second decoction is added with 3 times of water, the decoction time is 20 minutes after the liquid medicine is boiled and the slow fire is carried out, the filtered liquid medicine is mixed with the liquid medicine left for one time (about 400 to 600 milliliters), and the liquid medicine is taken warmly after meals for two times. The composition is administered 1 dose daily for 12 weeks.

The treatment course of each group is 4 weeks for 1 treatment course, and 3 treatment courses are continuously observed.

3.2 Observation of therapeutic Effect

3.2.1, observation index

(1) The degree of the symptoms, signs, tongue condition and pulse condition of the traditional Chinese medicine is expressed by a scoring method, and the symptoms and the pulse condition are observed and recorded for 1 time before and after treatment respectively. The syndrome curative effect is determined by calculating the curative effect integral by using a nimodipine method.

(2) Body mass index, blood pressure, blood uric acid (SUA), glycated hemoglobin, triglycerides (TG), total Cholesterol (TC), and low-density lipoprotein (LDL) were measured in the patient before treatment, 1 month after treatment, and 3 months after treatment, respectively.

The above indexes are measured before and after treatment.

(3) The biochemical indexes (including ALT, AST, ALP, GT, BUN and CR) related to the liver and kidney functions of the patient are respectively measured before and after the treatment of the whole treatment course.

3.2.2 criteria for disease efficacy

The effect is shown: the observation index after treatment is reduced by more than or equal to 35 percent compared with the observation index before treatment;

the method has the following advantages: the observed index after treatment is reduced by more than or equal to 20 percent but less than 35 percent compared with the observed index before treatment;

and (4) invalidation: the observed index after treatment is reduced by less than 20 percent compared with the observed index before treatment.

Note: the blood observation index decline rate calculation formula: [ (pretreatment value to treatment value)/pretreatment value ] x 100%.

3.2.3 criteria for determining the curative effects of the syndromes

Clinical recovery, namely, the clinical symptoms and physical signs of the traditional Chinese medicine disappear or basically disappear, and the syndrome integral is reduced by more than or equal to 95 percent;

the effect is shown: the clinical symptoms and physical signs of the traditional Chinese medicine are obviously improved, and the syndrome integral is reduced by more than or equal to 70 percent;

the method has the following advantages: the clinical symptoms and physical signs of the traditional Chinese medicine are obviously improved, and the syndrome integral is reduced by more than or equal to 30 percent;

the traditional Chinese medicine has no obvious improvement or even aggravation of clinical symptoms and physical signs of the traditional Chinese medicine, and the syndrome integral is reduced by less than 30 percent.

Note that the calculation formula (nimodipine method) is [ (integration before treatment-integration after treatment)/integration before treatment ]. Times.100%.

3.2.4 statistical methods

Statistical scoring is performed by adopting SPSS22.0 statistical softwareAverage + -SD for analyzing and measuring data

The indexes before and after treatment are compared by adopting one-factor variance analysis, and grade data is checked by using rank sum.

4. Results

4.1.2 Effect on the clinical symptoms and signs of traditional Chinese medicine

The invention randomly selects 170 cases to be included, wherein 85 cases are in a treatment group, and 85 cases are in a control group. The observation of the curative effect of the traditional Chinese medicine diseases shows that: the treatment group has 37 effective cases, 44 effective cases and 4 ineffective cases, and the total effective rate is 95.29 percent; the control group has 22 effective cases, 35 effective cases and 28 ineffective cases, and the total effective rate is 67.06%. See table 5.

TABLE 5 comparison of the therapeutic effects of the two groups of diseases (examples)

Note that, compared with the control group, ^* P＜0.05。

two groups of traditional Chinese medicine syndrome curative effect comparison (see table 6)

TABLE 6 two groups of the syndromes of traditional Chinese medicine for efficacy comparison (example)

The curative effects of the traditional Chinese medicine syndromes are compared, the total effective rate of the treatment group reaches 90.59 percent, and the total effective rate of the control group is 60.0 percent, which shows that the formula is obviously superior to the control group in the aspect of improving the traditional Chinese medicine syndromes.

The results show that the curative effect of the group is obviously better than that of a control group (P is less than 0.01) in the aspect of improving the Chinese medicine symptoms.

4.2, detecting blood uric acid, triglyceride, total cholesterol, low-density lipoprotein, glycosylated hemoglobin, blood pressure, body mass index and related safety indexes of metabolic syndrome (meeting obesity, hyperglycemia, hypertension and hyperlipidemia) and hyperuricemia patients (only 40 patients are selected to carry out the detection of biochemical indexes and related safety indexes for patent application due to limited expenditure at present).

4.2.1 effects on metabolic syndrome (consistent with obesity, hyperglycemia, hypertension, hyperlipidemia) and blood uric acid of patients with hyperuricemia

The blood uric acid (SUA) tests before, 1 month after and three months after treatment were performed on 40 patients with metabolic syndrome (consistent with obesity, hyperglycemia, hypertension, hyperlipidemia) and hyperuricemia who were included in the test.

The results showed that the patient before treatment had an SUA of 485.19. + -. 93.66. Mu. Mol/L, the blood uric acid level decreased to 383.56. + -. 81.42. Mu. Mol/L after 1 month of treatment, the blood uric acid level decreased to 324.96. + -. 72.81. Mu. Mol/L after 3 months of treatment, the blood uric acid level of the patients in the treatment group decreased somewhat after the treatment, and the decrease tendency after 3 months of treatment group was greater than that in the 1 month group (P < 0.05). A comparison of Serum Uric Acid (SUA) before and after treatment is shown in table 7.

TABLE 7 SUV comparison before and after treatment: (

μmol/L)

Note: p is less than 0.01 before and one month after treatment; comparing before and after treatment groups, wherein P is less than 0.01 before treatment and P is less than 3 months after treatment; the significant difference P <0.01,f =38 compared between the groups.

4.2.2 effects on the Metabolic syndrome (consistent with overweight, hyperglycemia, hypertension, hyperlipidemia) and Triglycerides (TG), total Cholesterol (TC), low Density Lipoprotein (LDL) in hyperuricemic patients

By three months of treatment, TG of patients in a treatment group is reduced to 1.69 +/-0.79 mmol/L after 1 month and 1.18 +/-0.38 mmol/L after 3 months from the original 2.36 +/-1.52 mmol/L. The TC is reduced to 3.86 +/-0.95 mmol/L after 1 month and to 3.56 +/-0.87 mmol/L after 3 months from the original 4.47 +/-0.82 mmol/L. LDL is reduced to 2.26 +/-0.50 mmol/L in the group 1 month after treatment and 2.05 +/-0.61 mmol/L after 3 months of treatment from the original 2.49 +/-0.57 mmol/L. The differences of TC, TG and LDL in the groups 1 month after treatment and 3 months after treatment are obviously lower than those before treatment, and the differences are significant (P is less than 0.01). It is clear that the reduction of TC, TG and LDL is obviously better after treatment than before treatment. (see Table 8)

TABLE 8 comparison of TG, TC, and LDL before and after treatment: (

μmol/L)

Note: p is less than 0.01 before treatment compared with 1 month after treatment and 3 months after treatment (TC, TG, LDL groups: F values =13.61, 11.06, 6.25 respectively; P is less than 0.01 before treatment compared with 1 month after treatment, and P is less than 0.01 before treatment compared with 3 months after treatment.

4.2.3 effects on the BMI of patients with Metabolic syndrome (consistent with overweight, hyperglycemia, hypertension, hyperlipidemia) and hyperuricemia

Through three months of treatment, the BMI of the patients in the treatment group is reduced from the original BMI of 27.47 +/-2.38, 26.89 +/-2.04 after 1 month and 26.33 +/-1.94 after 3 months. BMI in the group 1 month after treatment and the group 3 months after treatment are obviously lower than that before treatment, and the difference is significant (P is less than 0.05). It follows that post-treatment is superior to pre-treatment in reducing body weight. (see Table 9)

TABLE 9 comparison of BMI before and after treatment

Note: p <0.05 (P =0.049, F = 2.87) between pre-treatment and post-treatment 3 months after 1 month treatment

4.2.4 improvement of blood pressure

By three-month treatment, the Systolic Blood Pressure (SBP) of the patients in the treatment group is reduced to 138.05 +/-6.31 mmHg after 1 month of treatment and to 131.88 +/-4.89 mmHg after three months of treatment from the original 146.70 +/-6.83 mmHg. The diastolic pressure (DBP) of the patients in the treatment group is reduced to 82.23 +/-4.80 mmHg after 1 month of treatment and is reduced to 80.00 +/-5.19 mmHg after three months of treatment from the original 88.30 +/-6.98 mmHg. Compared with the groups 1 month after treatment and 3 months after treatment, the difference is significant (P is less than 0.01). (see Table 10)

TABLE 10 comparison of SBP, DBP before and after treatment (mmHg)

Note: compared with the group 1 month after treatment and the group 3 months after treatment, the difference has significance (P is less than 0.01) (the F values of SBP and DBP are respectively 60.29 and 22.44); the decrease was more significant in the group 3 months after treatment compared to before treatment, from which it can be seen that the group 3 months after treatment was significantly superior to before treatment in terms of lowering blood pressure.

4.2.5 improvement of blood sugar (glycated hemoglobin)

By three-month treatment, the glycosylated hemoglobin of the patients in the treatment group is reduced to 7.32 +/-1.26% after 1 month of treatment and 6.7 +/-1.18% after 3 months of treatment from the original 7.83 +/-1.22%. Compared with the intermediate glycated hemoglobin (HbA 1 c) before and after treatment, although the glycated hemoglobin (HbA 1 c) after treatment was reduced, the difference between groups was not significant (P < 0.05), and thus, it was found that the glycated hemoglobin after treatment was slightly lower than that before treatment, but had no statistical significance. See table 11.

TABLE 11 comparison of glycated hemoglobin before and after treatment

Note: glycated hemoglobin is an average blood glucose level of 3 months, with no statistical difference P >0.05 (P = 0.46), possibly associated with a small sample size or with a not long enough dosing time, requiring further expansion of the sample size and extension of the dosing time for future effects.

4.2.6 evaluation of safety

The invention compares the related biochemical indexes of liver and kidney functions of 40 patients who accord with overweight, hyperglycemia, hypertension, hyperlipidemia and hyperuricemia before and after taking the medicine, finds that ALT, AST, ALP, GT, BUN and CR have no obvious change before taking the medicine, after 1 month and 3 months of taking the medicine, and the difference has no statistical significance (P is more than 0.05), which indicates that the liver and kidney functions of the patients have no obvious damage effect when taking the medicine provided by the invention. Meanwhile, the routine of urine, routine of stool and blood coagulation function of the patient are not abnormal.

The above description is only for the purpose of illustrating the preferred embodiments of the present invention and is not to be construed as limiting the invention, and any modifications, equivalents, improvements and the like that fall within the spirit and principle of the present invention are intended to be included therein.

Claims

1. The traditional Chinese medicine composition for treating metabolic syndrome is characterized by comprising the following raw materials in parts by weight: 3 to 50 parts of angelica, 15 to 120 parts of desmodium, 25 to 50 parts of cogongrass rhizome, 3 to 50 parts of cassia occidentalis and 3 to 50 parts of fried hawthorn.

2. The traditional Chinese medicine composition according to claim 1, which is prepared from the following raw materials in parts by weight: 10 to 40 portions of angelica, 30 to 80 portions of lysimachia christinae hance, 30 to 40 portions of cogongrass rhizome, 10 to 40 portions of cassia occidentalis and 10 to 40 portions of fried hawthorn.

3. The traditional Chinese medicine composition according to claim 1, which is prepared from the following raw materials in parts by weight: 25 to 35 portions of angelica, 50 to 80 portions of desmodium, 35 to 40 portions of cogongrass rhizome, 20 to 30 portions of cassia occidentalis and 20 to 30 portions of fried hawthorn.

4. The traditional Chinese medicine composition according to claim 1, which is prepared from the following raw materials in parts by weight: 35 parts of angelica, 70 parts of desmodium, 40 parts of cogongrass rhizome, 25 parts of cassia occidentalis and 25 parts of fried hawthorn.

5. A method for preparing the traditional Chinese medicine composition of any one of claims 1 to 4, which is characterized by comprising the following steps:

6. The preparation method of the traditional Chinese medicine composition according to claim 5, wherein the specific operation process of decocting with water is as follows: adding water which is 2-4 times of the total weight of the medicinal materials, decocting for 2-3 times, decocting for 15-30 min each time, and collecting decoction.

7. The method for preparing a Chinese medicinal composition according to claim 6, wherein water in an amount of 2-4 times the total weight of the herbs is added before decocting for 30-60 min.

8. Use of the Chinese medicinal composition of any one of claims 1 to 4 in the preparation of a medicament for treating damp-heat and blood stasis type metabolic syndrome.

9. The use according to claim 8, wherein the metabolic syndrome comprises obesity, hyperglycemia, hypertension, dyslipidemia, hyperviscosity, hyperuricemia, hyperlipidemic liver or hyperinsulinemia.

10. A Chinese medicinal preparation for treating metabolic syndrome, which is characterized by comprising the Chinese medicinal composition of any one of claims 1 to 4 and pharmaceutically acceptable auxiliary materials or carriers.