WO2022011880A1

WO2022011880A1 - Spleen strengthening traditional chinese medicine composition and application thereof

Info

Publication number: WO2022011880A1
Application number: PCT/CN2020/124362
Authority: WO
Inventors: 陈超; 吴邦泰; 许旭昀; 陈秋铭; 王叙煌; 陈子睿; 吴典伟; 谢希; 林玺; 林俊和
Original assignee: 汕头市中医医院
Priority date: 2020-07-14
Filing date: 2020-10-28
Publication date: 2022-01-20
Also published as: CN111658701A

Abstract

A spleen strengthening traditional Chinese medicine (TCM) composition and an application thereof, the composition being calculated in parts by weight, and the formula thereof consisting of the following components: 15-25 parts of Pueraria lobata, 12-18 parts of red sage, 25-35 parts of Atractylodes macrocephala rhizome, 25-35 parts of false starwort, and 8-12 parts of Phellodendron amurense. Said TCM composition "treats diabetes from the spleen and stomach", has the function of strengthening the spleen and dredging the collaterals, clearing heat and promoting blood circulation, and is used for spleen deficiency and heat stagnation and polydipsia, polyuria, polyphagia, distension, and so on caused by vein stasis. Symptoms comprise dry mouth, polydipsia, polyuria, bitter taste, obesity, chest tightness, nausea, fatigue, loose stools, limb paralysis, and the like. People having a family history of diabetes, people at high risk of diabetes, and people suffering from pre-diabetes, early diabetes, impaired glucose tolerance, obesity, hyperlipidemia, hyperuricemia, and metabolic syndrome have significant effects after taking the composition.

Description

A kind of traditional Chinese medicine composition for strengthening spleen and application thereof

technical field

The invention relates to the field of traditional Chinese medicine formulations, in particular to a spleen-strengthening traditional Chinese medicine composition.

Background technique

Diabetes is a common and frequently-occurring disease in clinical practice. In 2010, Prof. Ning Guang's team surveyed the prevalence of diabetes and prediabetes among people over 18 years old in China, reaching 11.6% and 50.1%, respectively. The prevalence of diabetes in my country is increasing year by year, especially in recent years, the prevalence rate has risen sharply, the development trend is not optimistic, and the incidence has changed. Epidemiological data show that more than 80% of diabetics are obese in my country.

Diabetes, modern Chinese medicine mostly belongs to the category of "diabetes" in Chinese medicine. The related discussion of diabetes mellitus was first seen in the "Nei Jing", including "xiaoheng", "three eliminations", "diaphragm elimination", "xiaozhong" and other disease names. The explanation in "Shuowen Jiezi": "to disappear, to exhaust" means "to lose weight, dissipate, and consume". "Thirsty and desire" means "dry mouth and desire to drink". Literally, this disease name is a generalization of patients with similar symptoms. Ancient physicians formed various theories when discussing the pathogenesis of diabetes mellitus. Physicians of past dynasties have enriched and developed the pathogenesis of the disease, including the theory of yin deficiency and dryness, the theory of three eliminations, the theory of liver stagnation and qi stagnation, and the theory of blood stasis. Dispelling and other pathogenesis understanding. At present, it is generally believed that the basic pathogenesis of the lung, stomach and kidney with multiple responsibilities of the diseased viscera is "Yin deficiency is the foundation, dryness and heat are the standard", and the treatment focuses on "nourishing yin and clearing heat".

However, today's clinical findings are different from those in ancient times in terms of etiology, pathogenesis and pathogenesis, clinical manifestations, and even treatment methods. In the long-term clinical practice, the applicant found that modern diabetics drink water again and again but do not quench their thirst. The water they drink cannot be transformed into body fluid and urinate frequently; Nourishing the limbs and the body is thin; modern diabetes patients are mostly obese, obese people have more phlegm, phlegm-dampness is full, dampness damages the spleen, the typical "Yin deficiency and dry-heat diabetes" patients are rare, and nourishing yin helps dampness. Spleen, clearing heat will damage spleen-yang and phlegm-dampness will be worse. Therefore, no matter "yin deficiency" or "dry heat", they are only the "marks" of diabetes, and only the symptoms of diabetes are seen, while the root of the disease is ignored.

The pathogenesis of modern diabetes has evolved from "dry heat due to yin deficiency" to "weak spleen and stomach, lack of clear yang, dampness and turbidity, and stagnation of fire." The qi, blood, and body fluids of qi, blood and body fluids are blocked, and "diabetes" is caused by not following the normal path. It should be treated by "invigorating the spleen and stomach, raising the yang, removing dampness and turbidity, and reducing yin fire". As for the Chinese patent medicines for the treatment of early diabetes, most of them focus on nourishing qi, nourishing yin, clearing heat and promoting body fluid, such as Kelening Capsules, Xiaokekang Granules, Jiangtangshu Capsules, Jiangtangning Capsules, Shiwei Yuquan Capsules, etc. The present invention has similar related researches on the effects of invigorating the spleen and dredging collaterals, clearing heat and activating blood circulation, and there is no such variety available on the market.

The development of diabetes is divided into three stages, from front to back, high-risk groups, pre-diabetes and diabetes. Among them, impaired glucose tolerance refers to the condition that has not developed to the stage of diabetes, but the blood glucose level is higher than that of the normal population, and there is a tendency towards diabetes. The trend of development, it may become a diabetic patient at any time, and it is necessary to focus on prevention and treatment. There are many factors that induce the development of prediabetes to diabetes, most of which are considered to be closely related to hyperuricemia, which is manifested as prediabetes combined with hyperuricemia. Other studies have shown that hyperuricemia is an independent risk factor for prediabetes. If prediabetes is combined with hyperuricemia, it will accelerate its development towards diabetes. Therefore, it is not difficult to see that prediabetes and hyperuricemia are interrelated. It has been reported in the literature that with the increase of uric acid levels, the risk of developing type 2 diabetes also increases. Baseline hyperuricemia was found to be an independent predictor of type 2 diabetes in a study in Taiwan. Moreover, hyperuricemia is associated with an increased risk of nephropathy in diabetic patients. For the clinical treatment of abnormal glucose tolerance combined with hyperuricemia, hypoglycemia is the basic treatment. By lowering blood sugar, the blood sugar can be stabilized within the normal range, which is conducive to preventing the development of diabetes, but this basic measure is far from enough. , the problem of hyperuricemia is still unsolved. Hyperuricemia is an important cause of gout. The continuous increase in the level of uric acid leads to the continuous deposition of urate in the joints, which causes joint pain, dysfunction, seriously affects kidney function, and even threatens life safety. Benzbromarone is a common blood uric acid lowering drug. Its mechanism of action is as follows: it acts on the proximal convoluted tubule of the kidney, inhibits the reabsorption of uric acid, and accelerates the excretion of uric acid. Scientific and rational use can effectively improve the symptoms of hyperuricemia. Symptoms, but the effect of a single drug is not ideal, and it is easy to cause certain adverse reactions. Traditional Chinese medicine has formed its own unique thinking in the treatment of pre-diabetes complicated with hyperuricemia. It believes that the emergence of complications is related to factors such as diet, living habits, and exercise. Toxin is endogenous, and the principles of invigorating the spleen and removing turbidity, and dredging collaterals and dredging should be adhered to during treatment. In recent years, with the improvement of living standards, the number of pre-diabetic patients with impaired glucose tolerance combined with hyperuricemia and dyslipidemia has been increasing, and the concept of integrated traditional Chinese and Western medicine should be highly valued in the treatment of this disease. The effect of prediabetes combined with hyperuricemia is obvious.

With the development of my country's economy and society, the proportion of obese people is increasing year by year. Obesity is also an important cause of chronic diseases such as cardiovascular and cerebrovascular diseases, cancer, and diabetes. It is listed by the World Health Organization as one of the top ten diseases that threaten human health. Researchers have also found that obesity is involved in insulin resistance and vascular endothelial damage through the secretion of inflammatory factors, leading to the development of various chronic diseases (such as diabetes, coronary heart disease, and stroke), and ultimately affecting the lifespan of patients. Traditional Chinese medicine believes that the onset of simple obesity is mainly caused by spleen deficiency and heat, and blood stasis. Obesity and phlegm-damp are inextricably linked. And "the spleen is the source of phlegm." If the spleen is not elevated, the essence of water and grain will not be able to be distributed, hindered by the middle energizer, it will be transformed into phlegm-damp, accumulated in the body for a long time, and transformed into cream. Therefore, qi deficiency and dampness stagnation is the pathogenesis of obesity. The essential. Therefore, the method of strengthening the spleen and removing dampness is often used in clinical practice to improve the function of the spleen to govern the transportation and transformation, so that the water and grain essence can be transported and transformed regularly, so that the phlegm and turbidity will not endure, causing obesity. Huang Ping et al. (Huang Ping, Zhou Qing, Shang Hongtao. Investigation on TCM constitution characteristics and constitution types of obese people [J]. Western Traditional Chinese Medicine, 2016, 29(5):64.) A survey of TCM constitution in obese people found that obesity The patient's TCM syndrome differentiation is mainly based on deficiency, and most of them are qi deficiency, yang deficiency, or deficiency with excess. The diseased viscera mostly involves the spleen and kidney, and the pathological changes involve blood stasis and heat. The applicant also conducted an epidemiological survey on 150 obese patients in 2015. After statistics, it was found that clinically, spleen deficiency and stagnation of heat and blood stasis accounted for the largest proportion of obese patients. ) patients often have the symptoms of spleen deficiency, stagnation and heat, and blood stasis in the blood vessels at the same time. It can be seen that obesity is inseparable from the stagnation of spleen heat and blood stasis in the TCM dialectical classification. At present, the common weight loss drugs on the market have disadvantages such as high price, many adverse reactions, and insignificant weight loss effect. A large number of clinical data have confirmed that traditional Chinese medicine is a more effective method than Western medicine, has the advantages of less side effects and is not easy to rebound, and is worthy of widespread clinical application.

Modern medicine believes that the main cause of metabolic syndrome is bad lifestyle and habits, and central obesity and insulin resistance (IR) are the core pathogenesis of metabolic syndrome. At present, for the prevention and treatment of metabolic syndrome, the most basic intervention measures are firstly to change unhealthy lifestyles, and secondly to treat various abnormal metabolic components, such as lipid-lowering, hypoglycemic, and antihypertensive treatments. All effective drugs. Studies have shown that metformin can intervene in metabolic syndrome by reducing IR, regulating TG, delaying the progression of hypertension, suppressing appetite, and reducing body weight (Ding Huajun. Analysis of the intervention effect of metformin on metabolic syndrome [J]. Modern Practical Medicine, 2016, 28(2): 223-224.), but the clinical efficacy still has certain limitations. Metabolic syndrome can be classified into the category of "spleen deflation" and "elimination of spleen" in traditional Chinese medicine. The holistic treatment of traditional Chinese medicine has unique clinical advantages in the treatment of metabolic syndrome.

SUMMARY OF THE INVENTION

In order to solve the problems of the prior art, the purpose of the present invention is to provide a spleen-strengthening traditional Chinese medicine composition, which has a definite curative effect, has the functions of strengthening the spleen and dredging collaterals, clearing away heat and activating blood, and is used for quenching thirst caused by spleen deficiency due to stagnation of heat and blood stasis. , Xiaoping, Xiaoping, etc.

Another object of the present invention is to apply the above-mentioned spleen-strengthening traditional Chinese medicine composition to the preparation of medicines for the treatment of diabetes, impaired glucose tolerance, obesity, hyperlipidemia, hyperuricemia and metabolic syndrome.

The object of the invention is achieved in this way: a kind of Chinese medicine composition for strengthening the spleen, it is characterized in that: by weight, the formula is made up of the following components: 15-25 parts of Pueraria lobata, 12-18 parts of Salvia miltiorrhiza, 25-35 parts of Atractylodes Rhizoma , 25-35 copies of Taizishen, 8-12 copies of Treats.

Preferably, calculated in parts by weight, the formula consists of the following components: 18-22 parts of Pueraria lobata, 14-16 parts of Salvia miltiorrhiza, 28-32 parts of Atractylodes Rhizoma, 28-32 parts of Taizishen, and 9-11 parts of Treats.

Most preferably, calculated in parts by weight, the formula is composed of the following components: 20 parts of Pueraria lobata, 15 parts of Salvia miltiorrhiza, 30 parts of Atractylodes Rhizoma, 30 parts of Taizishen, and 10 parts of Treats.

The application of the spleen-strengthening traditional Chinese medicine composition in preparing medicines for treating diabetes, abnormal glucose tolerance, obesity, hyperlipidemia, hyperuricemia and metabolic syndrome.

The medicine is decoction, granule, tablet, capsule, oral liquid or pill.

The medicine is a preparation prepared by using the extracts of the components in the formula of the spleen-strengthening traditional Chinese medicine composition as an active ingredient and adding medicinal excipients.

The extract is a water extract.

Described diabetes, impaired glucose tolerance, obesity, hyperlipidemia, hyperuricemia, metabolic syndrome are spleen deficiency and heat, blood stasis type diabetes, impaired glucose tolerance, obesity, hyperlipidemia, hyperuricemia blood, metabolic syndrome.

The present invention is a formula for "treatment of diabetes from the spleen and stomach", which has the functions of strengthening the spleen and dredging collaterals, clearing heat and activating blood circulation, and is used for quenching thirst, phlegm, and phlegm caused by spleen deficiency, stagnation of heat and blood stasis, etc., and the symptoms are dry mouth. Polydipsia, polyuria, bitter mouth, body obesity, chest tightness, nausea, fatigue, loose stools, limb paralysis, etc.; family history of diabetes, high-risk group of diabetes, prediabetes, early diabetes, impaired glucose tolerance, obesity, high fat Hyperuricemia, hyperuricemia, metabolic syndrome and other symptoms above have obvious curative effect after taking it.

detailed description

The invention is a traditional Chinese medicine composition for strengthening the spleen. Calculated in parts by weight, the formula is composed of the following components: 15-25 parts of Pueraria lobata, 12-18 parts of Salvia miltiorrhiza, 25-35 parts of Atractylodes Rhizoma, 25-35 parts of Taizishen, and 8 parts of Cortex Phellodendri -12 servings. Preferably, calculated in parts by weight, the formula consists of the following components: 18-22 parts of Pueraria lobata, 14-16 parts of Salvia miltiorrhiza, 28-32 parts of Atractylodes Rhizoma, 28-32 parts of Taizishen, and 9-11 parts of Treats. Most preferably, calculated in parts by weight, the formula is composed of the following components: 20 parts of Pueraria lobata, 15 parts of Salvia miltiorrhiza, 30 parts of Atractylodes Rhizoma, 30 parts of Taizishen, and 10 parts of Treats.

The application of the spleen-strengthening traditional Chinese medicine composition in preparing medicines for treating diabetes, abnormal glucose tolerance, obesity, hyperlipidemia, hyperuricemia and metabolic syndrome. The medicament can be in oral dosage forms such as decoction, granule, tablet, capsule, oral liquid or pill. The medicine is a corresponding preparation prepared by using the extracts of the components in the formula of the spleen-strengthening traditional Chinese medicine composition as an active ingredient, and adding pharmaceutical excipients of corresponding dosage forms according to the existing general process. Preferably, the extract is a water extract.

The formula of the present invention comes from the theoretical system of the inventor's "Treatment of Diabetes from the Spleen and Stomach", and it is believed that the pathogenesis of diabetes is: "The spleen and stomach are out of balance, the things are not naturalized, the subtleties are not transported, and the organs are out of nourishment", so the treatment is to reconcile the spleen and stomach, attack and supplement both Shi is the core. The early stage of diabetes is mostly manifested as spleen deficiency, stagnation of heat, and blood stasis.

The symptoms of diabetes mellitus are mainly consumption of more food, dry mouth and more drinking. The metabolism, transportation and transformation of diet are most closely related to the spleen and stomach. So, how is water metabolized into the human body? "Plain Questions: The Differentiation of Meridians" says: "Drinking enters the stomach, escaping the essence and qi, and transporting it upward to the spleen, dispersing the spleen, returning to the lungs, regulating the water channels, and transporting the bladder downward. Under normal circumstances, food and water grains enter the human body, decompose through the stomach, metamorphose into the subtle substances, and transport and transform through the spleen to spread the subtle substances throughout the body to support the functional activities of the whole body. When the diet is disordered and the spleen and stomach are damaged, the disease will occur. It can be seen that as early as the "Neijing" period, it was clearly proposed that the onset of diabetes is either due to overeating fat, sweet and thick taste, internal injury to the spleen and stomach, or due to accumulation of heat in the stomach, which is fundamentally in the "spleen and stomach".

(1) The spleen and stomach are out of balance, and things are not naturalized. Over time, heat, stagnation, dampness, phlegm, turbidity, and blood stasis are generated.

Fatty, sweet and thick-flavored diet damages the spleen and stomach, and cannot be transported and transformed. Thirst.

Diabetes the thirst for a long time, fat, sweet and thick taste, the change of the cream, the internal injury to the spleen and stomach, the spleen deficiency, the phlegm-dampness is endogenous, and the hair is diabetes.

Emotional depression, liver qi discomfort, stagnation of blood and heat for a long time will also lead to the pathogenesis of thirst.

(2) If the spleen fails to function properly, the subtleties are not transported, and the viscera fails to nourish, the qi and blood will be deficient, and both yin and yang will be deficient over time.

The spleen and stomach are located in the middle coke, which transports and transforms water and valleys. If the spleen fails to function properly, the spleen cannot disperse the essence, the upper essence cannot be transferred to the lungs, and the lower essence cannot be transported to the bladder, and the viscera cannot be nourished. Damage to the spleen and stomach of the middle burner, passive blood biochemistry, deficiency of qi and blood, and lack of righteousness, not only cause diabetes, but also various syndromes. Dystrophy of blood vessels, disharmony of meridians and collaterals, showing signs of paralysis of limbs; deficiency of liver and kidney yin, inability to nourish ears and eyes, showing signs of dim vision, sudden blindness, deafness, etc. And sores and boils, carbuncle.

Combined with a large number of clinical practice, the present invention believes that the syndrome of deficiency and excess is common in the clinical diagnosis of diabetes, and the combination of deficiency and excess runs through the entire course of diabetes. Deficiency syndrome is mainly qi deficiency and yin deficiency. Generally speaking, in the early stage, it is mostly manifested as spleen deficiency and lung heat, spleen deficiency and stomach deficiency, spleen deficiency and liver stagnation. , and develop into a syndrome of yin and yang deficiency or spleen deficiency and collateral obstruction. Concurrent syndromes are mostly evidence, mainly stagnation, heat, dampness, phlegm, turbidity, and blood stasis, often caused by multiple evil qi intermingled with each other, or appearing in the entire course of diabetes, or more prominent at a certain stage. Therefore, reconciling the spleen and stomach, attacking and nourishing as the core treatment method, and nourishing the spleen and strengthening the core are the core. In the process of strengthening the righteousness, attention must be paid to exorcising evil spirits.

In the early stage of diabetes mellitus, only the spleen is deficient and the stomach is full, the veins are stagnant, the real evil has not become a trend, and the deficiency has not reached other viscera. The traditional Chinese medicine composition of the present invention is used for treatment. exact. In the prescription, Atractylodes atractylodes invigorates the spleen, replenishes qi and dries dampness, and is the king drug; it is used in combination with Taizishen to strengthen the power of invigorating the middle and replenishing qi, so that the central axis can be transported. It is a ministerial medicine; Huangbai clears heat and dries dampness and helps the spleen to purify and reduce yin-fire. Salvia miltiorrhiza is used as an adjuvant to promote blood circulation and remove blood stasis. The two are adjuvant drugs.

At the same time, modern pharmacological research has found that: Atractylodes macrocephala in the prescription can promote the recovery of damaged autonomic nerve function, adjust the balance of human viscera functions, regulate gastrointestinal motility, lower blood sugar, diuresis, and enhance resistance; Oxypyrimidine can induce blood sugar in diabetic mice, and at the same time can improve insulin resistance to a certain extent and improve the body's insulin sensitivity; Puerariae has a hypoglycemic effect, and the preparations of Puerariae and its extracts have been widely used in diabetes and its complications disease treatment. Cortex Phellodendri has various pharmacological effects, mainly including hypoglycemic, antibacterial, antifungal, antitussive, antihypertensive, anti-trichomoniasis, anti-hepatitis, anti-ulcer and immunosuppressive effects. Salvia miltiorrhiza contains a large amount of diterpene quinone pigment, tanshinone, danshensu, diylaldehyde and other substances, which have the functions of promoting blood circulation and removing blood stasis, reducing blood viscosity, etc.

Therefore, the present invention reconciles the spleen and stomach, attacks and supplements simultaneously, is well-matched, and has obvious characteristics of principles and methods. In the early stage of diabetes, only the spleen is deficient and the stomach is stagnant, the veins are stagnant, and the real evils have not yet become a trend, and the deficiency is safe for patients with other viscera. efficient. According to the data of the following clinical studies, the applicant proves that this prescription is effective, safe and reliable in the treatment of diabetes, especially in patients with diabetes due to spleen deficiency and heat, and collateral stasis.

The concept of traditional Chinese medicine treatment emphasizes "preventive treatment", and abnormal glucose tolerance is prediabetes, which means that there is a high risk of developing diabetes, so it is necessary to strengthen prevention and treatment. Traditional Chinese medicine believes that excessive drinking, addicted to eating green sorghum and thick flavor will make the spleen lose its health, and the spleen will be derelict. Diabetes the thirst for a long time, accumulates dampness and produces phlegm, phlegm-dampness flows into the body, internal resistance of phlegm-dampness affects the circulation of qi and blood, and chronic illness and more blood stasis, and blood stasis is endogenous, forming the pathological basis of phlegm-dampness and blood stasis. On the other hand, in patients with hyperuricemia, the normal diet is improper, which damages the spleen and stomach, causes dampness and turbidity to stagnate in the kidneys, accumulates in the kidneys and collaterals, turns heat over time, consumes qi and blood, and causes liver and kidney insufficiency, resulting in insufficient blood and essence. In addition, the liver qi is lost in regulation, the qi mechanism is not smooth, the kidney is lost to transpiration and gasification, and the turbid toxin of the metaplasia of essence and blood is lost due to the accumulation of stagnation and discharge, causing disease. The pathogenesis of hyperuricemia is the excessive production or decreased excretion of uric acid caused by metabolic disorders, so that the excessive uric acid stops in the body to form harmful substances, which is similar to "turbidity". The two diseases have the same similar etiology and pathogenesis, that is, the pathogenesis of spleen deficiency caused by diet and phlegm-dampness and blood stasis. It makes it possible to treat both different diseases at the same time.

Example 1 (decoction)

The formula consists of the following components: 20g of Pueraria lobata, 15g of Salvia miltiorrhiza, 30g of Atractylodes Rhizoma, 30g of Taizishen, and 10g of Treats. Add water and cook to a bowl.

Embodiment 2 (decoction)

The formula consists of the following components: 15g of Pueraria lobata, 12g of Salvia miltiorrhiza, 25g of Atractylodes Rhizoma, 25g of Taizishen, and 8g of Treats. Add water and cook to a bowl.

Embodiment 3 (decoction)

Each dose of the formula consists of the following components: 25g of Pueraria lobata, 18g of Salvia miltiorrhiza, 35g of Atractylodes Rhizoma, 35g of Taizishen, and 12g of Treats. Add water and cook to a bowl.

Example 4 (decoction)

The formula consists of the following components: 22g of Pueraria lobata, 14g of Salvia miltiorrhiza, 30g of Atractylodes Rhizoma, 32g of Taizishen, and 9g of Treats. Add water and cook to a bowl.

Example 5 (tablet)

Calculated in parts by weight, the formula is composed of the following components: 20 parts of Pueraria lobata, 15 parts of Salvia miltiorrhiza, 30 parts of Atractylodes Rhizoma, 30 parts of Taizishen, and 10 parts of Treats. Extract with water twice, add 8-10 times of water each time, decoct for 1-1.5 hours, combine the water extracts, concentrate and dry to obtain dry extract.

Take 20g of dry extract and grind it into fine powder, according to the tablet manufacturing process, add medicinal starch and micropowder silica gel, mix, granulate, dry and granulate, then add magnesium stearate, mix well, and press into 100 tablets, namely Get tablets. Each tablet weighs 0.3g.

Example 6 (capsule)

Take 20 g of the dry extract obtained in Example 5 and grind it into fine powder, according to the capsule manufacturing process, add medicinal starch and micropowder silica gel, mix, sieve, and put into capsules to make 100 capsules to obtain capsules. The content of each capsule weighs 0.2g.

Clinical comparative experiment

In order to objectively evaluate the clinical effectiveness and safety of the traditional Chinese medicine composition of the present invention, according to the requirements of the clinical research guidelines for new traditional Chinese medicines, clinical research is carried out on the medicine. The following studies were approved by the Ethics Committee of Shantou Hospital of Traditional Chinese Medicine, and all patients gave informed consent to this study.

1. Clinical research on the treatment of diabetes

1. General information and methods

1.1 Case source

A total of 60 eligible diabetic patients who were admitted to the outpatient clinic and inpatient ward of the Diabetes Department of Shantou Hospital of Traditional Chinese Medicine from January 2016 to January 2018 were randomly selected.

1.2 Case grouping

Among the diagnosed diabetic patients, the selected 60 patients were randomly divided into 2 groups according to the ratio of 1:1, namely the traditional Chinese medicine group and the control group (metformin group). The gender, age and other general data of the two groups were compared, and SPSS software was used to determine whether they were comparable (no significant difference P>0.05).

1.3 Diagnostic criteria for cases

1.3.1 Western medicine diagnostic criteria:

Adopted in 1999 by the United Nations Educational, Scientific and Cultural Organization (WHO) and the International Diabetes Association (IDF), which was approved by the Diabetes Association of the Chinese Medical Association in the same year, and recommended to be implemented in China. Those who meet one of the following conditions can be diagnosed as diabetes. ①Have typical symptoms, fasting blood sugar 7.0mmol/l or postprandial blood sugar ≥11.1mmol/l. ②No typical symptoms, only fasting blood glucose 7.0mmol/l or postprandial blood glucose 11.1mmol/l should be repeated again, and those who still reach the above values can be diagnosed as diabetes. ③ There are no typical symptoms, only fasting blood glucose 7.0mmol/l or postprandial blood glucose 11.1mmol/l, glucose tolerance test 2 hours blood glucose 11.1mmol/l can be diagnosed as diabetes.

1.3.2 TCM diagnostic criteria

Diabetes TCM diagnostic criteria: refer to the "Guidelines for Clinical Research on New Chinese Medicines for Diabetes Disease (Diabetes) Type 2" formulated by the Pharmacy Administration of the Ministry of Health of the People's Republic of China in 1993: Anyone with thirst and polydipsia, hunger and urination, and excessive urination. And sweet, the body gradually sees weight loss and other symptoms can be diagnosed.

1.4. Inclusion and exclusion criteria of cases

1.4.1 Inclusion criteria: Those who meet the above Western medicine diagnostic criteria for diabetes, have a short course of disease, and clinical manifestations such as dry mouth and polydipsia, polyuria, obesity, chest tightness and nausea, loose stools, limb paralysis, etc. Patients who have not yet reached other possessions, but have not yet reached a certain level of evil will be included.

1.4.2 Exclusion criteria: ① Although the blood sugar of the patient is higher than normal, the fasting blood sugar is less than 7.0 mmol/L (126 mg/dl) after diet control and increased activity, or the blood sugar 2 hours after meals is less than 11.1 mmol/L (200 mg/L). dl), glycated hemoglobin <6.8%. ② Patients under the age of 18 or over 60, pregnant or lactating women. ③ Patients with serious heart, liver, kidney and other complications, or combined with other serious primary diseases and mental illness. ④ Patients with diabetic ketosis and ketoacidosis within the past 1 month.

1.4.3 Elimination and dropout criteria: patients who meet the inclusion criteria and have been grouped, but have not received any treatment for various reasons, or who have not completed the treatment and control observations as required for various reasons, and who have incomplete efficacy observation records.

1.5 Research method: all patients began to treat and observe after 1 month of diet, exercise and lifestyle intervention, on the basis of diabetes education, adopt diabetic diet, and the treatment group orally took the decoction of the embodiment of the present invention (hereinafter referred to as spleen-strengthening Kefang), 1 dose a day; the control group took metformin 0.5, 3 times a day. Treatment time is 3 months.

1.6. Observation method

1.6.1 Observation indicators

1.6.1.1 Safety Evaluation Criteria

①General physical examination: blood pressure, respiration, pulse, body temperature. ② Routine examination of hematuria and stool.

1.6.1.2 Observation of curative effect

① Fasting and 2h postprandial blood glucose, glycosylated hemoglobin, and clinical symptoms and signs of traditional Chinese medicine were evaluated once before treatment and once after 3 months of treatment.

1.7 Efficacy evaluation criteria

Evaluation standard of TCM efficacy: Evaluate TCM efficacy by TCM symptom score scale: ①Significantly effective: TCM symptoms and signs have improved significantly, and the symptom score has been reduced by more than or equal to 70%; ②Effective: TCM symptoms and signs have improved, and the symptom score has been reduced more than or equal to 30%; ③ Ineffective: TCM symptoms and signs did not improve significantly, or even worsened, and the symptom score was reduced by less than 30%.

Referring to the "Guidelines for Clinical Research of New Chinese Medicines", the actual changes of relevant indicators such as glycosylated hemoglobin (HbAlc), fasting blood glucose (FBG), 2h postprandial blood glucose (2hPG), and evaluation of the efficacy of traditional Chinese medicine, clinical symptoms improvement and adverse reactions were observed. After the statistics, it was determined whether the clinical symptoms of the two groups after treatment were significantly different from those before treatment.

1.8 Statistical processing The statistical software SPSS 18.0 was used for statistical processing of the relevant data in this study. The measurement data were expressed as mean ± standard deviation, and t test was used; The difference is more significant and there is statistical significance.

2 results

2.1 Comparison of blood glucose between the two groups before and after treatment There was no significant difference in the 2-h postprandial blood glucose and fasting blood glucose between the two groups before treatment (P>0.05). The fasting blood glucose of the two groups decreased after treatment, and the difference between before and after treatment was statistically significant (P<0.05). There was statistical significance in the control group (P<0.05), see Table 1.

Table 1 Comparison of fasting blood glucose, 2h postprandial blood glucose and glycosylated hemoglobin between the two groups before and after treatment (n=30)

Note: ★Compared with before treatment, P<0.05; ●Compared with metformin group, P<0.05

2.2 Comparison of TCM symptom scores between the two groups After treatment, the TCM symptom efficacy evaluation of the patients in the Jianpi Shangke prescription group was significantly better than that in the metformin group, and the difference was statistically significant (P<0.05), as shown in Table 2.

Table 2 Comparison of TCM efficacy evaluation after treatment

Note: ★Compared with metformin group, P<0.05

2.3 Comparison of adverse reactions between the two groups: 1 case in the Jianpi Shangke prescription group developed upper abdominal pain and acid regurgitation after taking traditional Chinese medicine; intestinal reaction to complete the treatment. There were no acute complications such as abnormal liver and kidney function, diabetic ketoacidosis, hypoglycemia and coma in the two groups.

3. Conclusion

Diabetes belongs to the category of "diabetes" in traditional Chinese medicine, and ancient traditional Chinese medicine mostly treats it from "dryness and heat due to yin deficiency". However, the current clinical findings have changed in terms of etiology, pathogenesis and pathogenesis, clinical manifestations, and even treatment methods.

Clinical practice shows that Jianpi Shangke Prescription can treat patients with early diabetes, only the spleen is deficient and the stomach is full, the veins are stagnant, the real evil has not become a trend, and the deficiency has not reached other organs, not only the hypoglycemic effect is accurate, the use is safe, but also Compared with simple western medicine treatment, it has more advantages in improving the quality of life of patients and alleviating the symptoms caused by diabetes.

2. Clinical research on the treatment of obesity

1Clinical data

1.1 General information The 60 cases of simple obesity were all patients admitted to the Department of Traditional Chinese Medicine in our hospital from January 2016 to October 2019, and were randomly divided into an observation group and a control group, with 30 cases in each group. The average age in the observation group was (44.07±2.73) years, and the BMI was 28.36±3.32; the average age in the control group was (49.53±2.91) years, and the BMI was 28.82±4.44.

1.2 Diagnostic criteria

2.1 Western medicine diagnostic criteria: The diagnostic criteria for obesity adopts the "Guidelines for the Prevention and Control of Overweight and Obesity in Chinese Adults" issued by the Department of Disease Control of the Ministry of Health in April 2003, body mass index (BMI) = weight (kg)/height ² (m ² ); wherein a body mass index (BMI) ≥ 28 is defined as obesity.

1.2.2 TCM Syndrome Type Diagnosis Criteria According to "Simple Obesity Diagnosis and Efficacy Evaluation Criteria" (Wei Beihai, Jia Baopeng. Chinese Journal of Integrative Medicine, 1998, 18(5): 137), TCM syndrome differentiation was performed.

1.2.3 The inclusion criteria met the diagnostic criteria; the age was 16 to 60 years old, and no weight loss drugs other than those specified in the study were added during the observation period.

1.2.4 Exclusion criteria: Secondary obesity, pregnant and lactating women, patients with serious primary diseases such as cardiovascular and cerebrovascular, liver and kidney, those who are undergoing or have received other weight loss treatment in the past 1 month, and have not followed the prescribed course of treatment drug users.

2 methods

2.1 Treatment methods

2.1.1 The control group was given exercise therapy. Low-intensity, long-term aerobic exercise such as jogging and moderate-to-rapid walking (115-125 steps/min) should be the main focus; exercise 3-6 times a week, 40-90 min/time, and the distance should be 4-6 km. Should not be less than half an hour. Exercise should be gradual, and the load intensity is better if you feel a little tired but can persist. The best effect is to persist for 5 to 10 minutes after sweating. The course of treatment is 3 months.

2.1.2 Observation group ① Exercise treatment plan: the same as the control group. ②The spleen-invigorating formula of Example 1 is acceptable; 1 dose per day, decocted in water, and taken in the morning and evening. The course of treatment is 3 months.

2.2 Observation indicators and methods

2.2.1 Observe the changes in body weight, BMI, waist circumference, hip circumference, and waist-to-hip ratio before and after 3 months of treatment. Before lunch, excess clothing was removed when measuring body weight; 12. At the midpoint of the line connecting the lower edge of the rib, place the tape close to the skin without any pressure, and the measurement value is accurate to 1cm. The hip circumference is the horizontal circumference of the body measured around the most prominent point of the buttocks. The method is the same as the waist circumference measurement method.

2.2.2 Observe the change of symptom score before and after treatment. According to the "Diagnosis and Efficacy Evaluation Criteria for Simple Obesity", BMI, waist circumference and waist-hip ratio were rated as 1, 2, and 3 points for mild, moderate and severe symptoms, respectively. The changes of symptom scores before and after 3 months of treatment were observed.

2.2.3 Exercise intervention score According to the implementation of exercise intervention, exercise intervention score is given.

Scoring criteria: 1 point (execution rate 0%-20%); 2 points (execution rate 20%-40%); 3 points (execution rate 40%-60%); 4 points (execution rate 60%-80%) ;5 points (execution rate 80% to 100%)

2.2.4 Diet control score According to the implementation of exercise intervention, exercise intervention score was given.

Scoring criteria: 1 point (execution rate 0-20%); 2 points (execution rate 20%-40%); 3 points (execution rate 40%-60%); 4 points (execution rate 60%-80%); 5 points (80% to 100% execution rate)

2.3 Statistical methods The measurement data is expressed as (x±s), the comparison of experimental data between each group uses the t test of the mean of the two samples, and the rank data uses the rank sum test, and P<0.05 indicates a significant difference. The correlation between the indicators of the measurement data was analyzed by two-factor correlation, and the results were expressed as r values. SPSS17.0 analysis software was used.

3 Treatment results

3.1 The baseline conditions are shown in Table 3.

Table 3 Baseline situation of treatment group and control group

There were no significant differences in age, weight, BMI, waist-to-hip ratio, and symptom scores between the two groups before treatment, and there was no statistical difference in the scores of diet control and exercise intervention between the two groups during the course of treatment.

3.2 The comparison of body weight, BMI, waist-hip ratio and symptom score before and after treatment in the simple exercise intervention group is shown in Table 4.

Table 4 Comparison of body weight, BMI, waist-to-hip ratio, symptom score before and after treatment in the control group

★ indicates that there is a significant statistical difference compared with before treatment (P<0.05)

The statistical results showed that there was a significant statistical difference between the weight before treatment and the weight after treatment (P<0.05); the BMI before treatment and BMI after treatment had a significant statistical difference (P<0.05). It shows that the body weight is significantly reduced after exercise intervention, with an average of 1kg, and there is a significant statistical difference in symptom scores before and after, which means that exercise intervention is effective for weight loss.

3.3 The comparison of body weight, BMI, waist-hip ratio and symptom score before and after treatment in Jianpi Shangkefang combined with exercise intervention group is shown in Table 5.

Table 5 Comparison of body weight, BMI, waist-to-hip ratio, symptom score in the treatment group before and after treatment

★ means there is a significant statistical difference compared with before treatment (P<0.05). ★★ means there is a significant statistical difference compared with before treatment (P<0.01)

The statistical results showed that the weight before treatment and the weight after treatment were significantly different (P<0.05); the BMI before treatment and the BMI after treatment were significantly different (P<0.05); the symptom score before treatment and the symptom score after treatment were significantly different Statistical difference (P<0.05). Through analysis, it is not difficult to find that the weight loss of Jianpi Shangkefang combined with exercise intervention is more obvious, with an average of 2.5kg, which means that the weight loss effect is more obvious after traditional Chinese medicine combined with exercise intervention.

3.4 The comparison of body weight change, BMI change, waist-hip ratio change, diet control score, and exercise intervention score between the Jianpi Shangkefang combined with exercise intervention group and the simple exercise intervention group are shown in Table 6.

Table 6 Comparison of changes in body weight, BMI, waist-to-hip ratio before and after treatment group and control group

★ indicates that there is a significant statistical difference compared with the simple exercise intervention group (P<0.05)

The statistical results showed that there was a significant difference in body weight before and after treatment between the Jianpi Shangke prescription combined with exercise intervention group and the exercise intervention group alone (P<0.05). There was no significant difference in diet control score and exercise intervention score between Jianpi Shangkefang combined with exercise intervention group and simple exercise intervention group (P<0.05). It shows that under the condition of similar diet control and exercise intervention, the effect of Jianpi Shangkefang combined with exercise intervention on weight loss is better than that in the simple exercise intervention group.

The clinical efficacy of Jianpi Shangke recipe combined with exercise intervention in 30 obese patients and exercise intervention alone in 30 obese patients was observed respectively. and symptom scores were significantly decreased; and the effect of traditional Chinese medicine combined with exercise intervention was more significant than that of the simple exercise intervention group. This fully proves that Jianpi Shangke formula has a significant clinical effect on the treatment of obesity. Since Jianpi Shangke formula combined with exercise intervention, the symptom scores of patients were significantly reduced, and the decline was also higher than that of patients with simple exercise intervention. The weight loss effect of prescription is better than that of simple exercise intervention.

3. Clinical research on the treatment of metabolic syndrome (MS)

1.1 General information

1.1.1 Cases: Select 60 MS patients diagnosed in our hospital from October 2016 to October 2019 as the research objects, and divide them into an observation group and a control group according to the random number table method, with 30 cases in each. In the observation group, there were 19 males (63.3%) and 11 females (36.6%), with an average age of (39.41±9.33) years; 18 (60.0%) cases of abnormal blood glucose, 26 cases (86.6%) of abnormal blood lipids, and 19 cases of abnormal blood pressure ( 63.3%). In the control group, there were 17 males (56.6%) and 13 females (43.3%); the average age was (38.98±11.99) years; 23 (76.6%) were abnormal in blood glucose, 24 (80.0%) were abnormal in blood lipids, and 18 were abnormal in blood pressure ( 60%). There was no significant difference in general data between the two groups (P>0.05), which was comparable.

1.1.2 Western medicine diagnostic criteria: refer to the MS diagnostic criteria in CDS "China Guidelines for the Prevention and Treatment of Type 2 Diabetes" (2017 edition).

1.1.3 Diagnosis criteria for TCM syndrome types: spleen deficiency, stagnation of heat, and collateral stasis syndrome. The diagnosis of spleen deficiency syndrome, stomach heat syndrome, damp-heat accumulation in spleen syndrome, and blood stasis syndrome in the "Guiding Principles of Clinical Research on New Chinese Medicines" is formulated. The main manifestations are dry mouth and polydipsia. , polyuria, bitter mouth, body obesity, chest tightness, nausea, fatigue, loose stools, limb paralysis, etc., and the symptoms and tongue and pulse were quantitatively graded. Main symptoms: abdominal distention and stuffiness, thirst, elimination of grains and hunger, heavy limbs, red tongue and yellow coating. Secondary symptoms: low body heat, heavy head and body, lassitude and fatigue, sticky stool, constipation, yellow and red urine. Among them, if 3 of the main symptoms are met (the tongue image is necessary), or 2 of the main symptoms (the tongue image is necessary) plus 2 secondary symptoms, the syndrome can be diagnosed. According to the severity of TCM symptoms, moderate and mild symptoms, the main symptoms were scored as 6, 4, and 2, and the secondary symptoms were scored as 3, 2, and 1.

1.1.4 Inclusion criteria: ①Meet the above-mentioned diagnostic criteria of western medicine and traditional Chinese medicine; ②Age 18-65 years old; ③Blood pressure: systolic blood pressure (SBP)<180mmHg, diastolic blood pressure (DBP)<100mmHg; Those who have taken or have discontinued weight loss, hypoglycemic, hypolipidemic, hypotensive and other drugs and health care products with similar effects within 2 weeks.

1.1.5 Exclusion criteria: ① Type 1 diabetes mellitus or fasting blood glucose >11 mmol/L, or those who are receiving insulin therapy; ② Those with severe cardiovascular and cerebrovascular diseases; ③ Those with a history of drug allergy or allergic constitution; ④ Those who are planning to become pregnant, pregnant or breastfeeding ⑤ Psychiatric patients and patients with poor compliance.

1.2 Methods

Both groups of patients were given health education, diet control, strengthening exercise, smoking cessation and alcohol restriction and other lifestyle interventions. The control group was given oral metformin hydrochloride tablets (Gehuazhi) (manufacturer: Sino-US Shanghai Squibb Pharmaceutical Co., Ltd.; approval number: Guoyao Zhunzi H20023370), 0.5 g/time, 3 times/d. The observation group was given the spleen-invigorating formula of Example 1, 1 dose per day, decocted with water, and taken in the morning and evening. The course of treatment in both groups was 3 months.

1.3 Observation indicators

①Comparison of TCM symptom scores before and after treatment in the two groups. ②Compare the general indicators of the two groups before and after treatment, including body weight (W), waist circumference (WC), SBP, DBP. ③Compare the biochemical indexes and insulin resistance index (HOMA-IR), fasting blood glucose (FPG), fasting insulin (FINS), triglyceride (TG) and uric acid (UA) between the two groups before and after treatment. ④Comparison of safety indicators before and after treatment between the two groups, including blood routine, urine routine, stool routine + occult blood, serum creatinine (Cr), serum urea nitrogen (BUN), electrocardiogram, etc. ⑤Comparison of the occurrence of adverse reactions in the two groups of patients. Every 2 weeks, the outpatient clinic was revisited, and the observation indicators were checked by a special person to observe whether there were any adverse reactions.

1.4 Statistical methods

SPSS19.0 statistical software was used to process the data. The count data was expressed by n/%, and the χ2 test was used. The measurement data was expressed by x±s, and the t test was used.

2 results

2.1 Comparison of TCM symptom scores between the two groups of patients before and after treatment

Before treatment, there was no significant difference in the scores of main symptoms, secondary symptoms and total symptoms between the two groups (P>0.05). The observation group was lower than the control group, and the difference was statistically significant (P<0.05). See Table 7.

Table 7 Comparison of TCM symptom scores before and after treatment in the two groups of patients

Note: Compared with the same group before treatment, *P<0.05; compared with the observation group after treatment, #P<0.05.

2.2 Comparison of general indicators before and after treatment in the two groups of patients

Before treatment, there was no significant difference in W, WC, SBP and DBP between the two groups (P>0.05). , WC was lower than the control group, the difference was statistically significant (P<0.05). See Table 8.

Table 8 Comparison of general indicators before and after treatment in the two groups of patients

2.3 Comparison of biochemical indexes and HOMA-IR between the two groups before and after treatment

Before treatment, there was no significant difference in the levels of various biochemical indexes and HOMA-IR between the two groups (P>0.05). Statistical significance (P<0.05). See Table 9.

Table 9 Comparison of biochemical indexes and HOMA-IR between the two groups of patients before and after treatment

Note: Compared with the same group before treatment, *P<0.05.

2.4 Comparison of safety and adverse reactions between the two groups of patients before and after treatment

There were no obvious abnormalities in the safety indicators before and after treatment in the two groups. During the treatment, 1 patient in the observation group developed diarrhea, which resolved spontaneously after 2 days. In the control group, 1 case of mild nausea and 3 cases of diarrhea occurred, which gradually eased after 3 days.

Statistical results show that after treatment, spleen-invigorating Shangke can achieve or even some indicators are better than the therapeutic effect of metformin hydrochloride tablets.

4. Clinical research on the treatment of impaired glucose tolerance combined with hyperuricemia

1. Materials and methods

1.1 General information

A total of 68 patients with prediabetes combined with hyperuricemia who were treated in our hospital from January to December 2019 were selected for study, and they were divided into control group and observation group with 34 cases in each group according to the random table method. Control group: 20 males and 14 females; aged 26-50 years, mean age (44.49±4.12) years; disease duration 2-5 years, mean disease duration (3.12±0.65) years. Observation group: 19 males and 15 females; aged 28-48 years, mean age (43.82±4.25) years; course of disease 1-7 years, mean course of disease (4.31±2.70) years. This study was approved by the hospital ethics committee, and there was no significant difference in general data between the two groups (P>0.05), which was comparable.

Inclusion criteria: (1) Meet the clinical diagnostic criteria of impaired glucose tolerance and hyperuricemia (see Gao Feng. Observation of the curative effect of benzbromarone combined with low-purine diet on hyperuricemia elderly hypertensive patients with diabetes mellitus [J]. Treatment, 2017, 28(17): 70-71.); (2) Diagnosed by a combination of medical history, symptoms, laboratory tests, etc.; (3) Mental and cognitive are normal, and basic communication and communication can be completed; (4) Participate voluntarily and sign informed consent. Exclusion criteria: (1) patients with severe heart, liver and lung dysfunction; (2) patients diagnosed with diabetes; (3) patients with drug allergies used in this study; (4) patients during pregnancy or lactation; (5) patients with acute and chronic infections .

1.2 Methods

Both groups adopted routine hypoglycemic measures, such as oral hypoglycemic drugs, dietary guidance and exercise guidance, and patients were advised to develop good living habits. On this basis, patients in the control group were given oral benzbromarone capsules (Kunshan Longdeng Ruidi Pharmaceutical Co., Ltd., H20010790), 50 mg each time, once a day. On the basis of the control group, the observation group was treated with the Jianpi Shangke recipe of Example 1 in combination. 1 dose a day, add water to decoct to 200ml, and take twice in the morning and evening. 8 weeks was a course of treatment in both groups, and the effect was observed after 1 course of treatment.

1.3 Observation indicators

1.3.1 Determination of curative effect

The total effective rates of the two groups were compared. Judgment criteria: the reduction of blood uric acid is not less than 35% (or the level is lower than 300μmol/l), and the reduction of blood sugar level is at least 30%, which means marked effect; the reduction of blood uric acid is between 15% and 34%, and the blood sugar level is lower than that before treatment. 10%-29% indicates improvement; serum uric acid and blood sugar have no significant changes compared with those before treatment, and the condition even worsens as invalid. The total efficiency is the sum of the marked efficiency and the improvement rate.

1.3.2 Detection of blood uric acid and blood lipids

Serum uric acid, total cholesterol, and triglyceride levels were compared before and after treatment. Collect 5 ml of venous blood in the early morning on an empty stomach, store it in an EDTA anticoagulant tube, centrifuge at 3000 r/min for 10 min, store at -30 °C, and send it for inspection in time. Serum uric acid, fasting blood glucose, total cholesterol and triglycerides were detected by an automatic biochemical analyzer.

1.4 Statistical analysis

SPSS23.0 software was used for processing. measurement data using

, the t test was performed; the count data was represented by n(%), and the x2 test was performed. P<0.05 difference was statistically significant.

2. Results

2.1 Comparison of the total effective rate of treatment between the two groups

Compared with the control group, the observation group was significantly higher in the total effective rate of treatment, and the difference was statistically significant (P<0.05). As shown in Table 10.

Table 10 Comparison of the total effective rate of two groups of treatments [n (%)]

2.2 Comparison of blood uric acid, blood sugar and blood lipid levels between the two groups

In terms of serum uric acid, fasting blood glucose, total cholesterol and triglyceride levels, there was no significant difference between the two groups before treatment (P>0.05). The difference was statistically significant (P<0.05). As shown in Table 11.

Table 11 Comparison of blood uric acid and blood lipid levels between the two groups

Note: ^* means P<0.05 compared with before treatment.

The results of this study showed that the total effective rate of treatment in the observation group was higher than that in the control group (P<0.05), indicating that Jianpi Shangke Fang combined with benzbromarone had obvious therapeutic effect and could promote the improvement of symptoms and signs. In terms of serum uric acid, fasting blood glucose, total cholesterol and triglyceride after treatment, the observation group was significantly lower than the control group (P < 0.05), indicating that compared with single benzbromarone treatment, the combination of strengthening the spleen and spleen is still effective. The treatment of abnormal glucose tolerance combined with hyperuricemia is more effective, and it is more conducive to the reduction of blood uric acid, blood sugar and blood lipid levels, and has a significant effect.

Claims

A spleen-strengthening traditional Chinese medicine composition is characterized in that: calculated in parts by weight, the formula is composed of the following components: 15-25 parts of Pueraria Root, 12-18 parts of Salvia miltiorrhiza, 25-35 parts of Atractylodes Rhizoma, 25-35 parts of Taizishen, Treats 8-12 servings.
The traditional Chinese medicine composition for strengthening the spleen according to claim 1, is characterized in that: by weight, the formula is made up of the following components: 18-22 parts of Pueraria lobata, 14-16 parts of Salvia miltiorrhiza, 28-32 parts of Atractylodes Rhizoma 28-32 servings, Treats 9-11 servings.
The spleen-strengthening traditional Chinese medicine composition according to claim 1, is characterized in that: by weight, the formula is made up of the following components: 20 parts of Pueraria lobata, 15 parts of Salvia miltiorrhiza, 30 parts of Atractylodes Rhizoma, 30 parts of Taizishen, 10 parts of Treats .
Application of the spleen-strengthening traditional Chinese medicine composition according to any one of claims 1-3 in the preparation of medicines for the treatment of diabetes, impaired glucose tolerance, obesity, hyperlipidemia, hyperuricemia and metabolic syndrome.
Application according to claim 4, is characterized in that: described medicine is decoction, granule, tablet, capsule, oral liquid or pill.
The application according to claim 4, wherein the medicine is a preparation prepared by using the extract of the components in the formula of the spleen-strengthening traditional Chinese medicine composition as an active ingredient and adding medicinal excipients.
The application according to claim 6, wherein the extract is a water extract.
The application according to claim 4 is characterized in that: described diabetes, impaired glucose tolerance, obesity, hyperlipidemia, hyperuricemia, metabolic syndrome are spleen deficiency and stagnation of heat, blood stasis type diabetes, sugar Impaired tolerance, obesity, hyperlipidemia, hyperuricemia, metabolic syndrome.
The application according to claim 4, wherein the diabetes is early diabetes.