WO2022021638A1

WO2022021638A1 - Traditional chinese medicinal composition for invigorating spleen and removing turbidity and application thereof

Info

Publication number: WO2022021638A1
Application number: PCT/CN2020/124366
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: 2020-07-29
Filing date: 2020-10-28
Publication date: 2022-02-03
Also published as: CN111729058A

Abstract

A traditional Chinese medicinal composition for invigorating the spleen and removing turbidity, which consists of the following components in parts by weight: 15-25 parts of Pueraria lobata, 12-18 parts of red sage, 15-25 parts of Rhizoma Atractylodis, 15-25 parts of Codonopsis pilosula, 25-35 parts of Phellodendron amurense, 8-12 parts of tangerine peel, 12-18 parts of Sichuan calamus, 12-18 parts of China root, 8-12 parts of Fructus aurantii immaturus, 15-25 parts of Atractylodes lancea, 25-35 parts of Anemarrhena asphodeloide, 8-12 parts of Curcuma aromatica, and 15-25 parts of seeds of trichosanthes seeds. The described composition has the effects of invigorating the spleen and removing phlegm and clearing heat and promoting fluid production, and can treat metabolic disorders such as diabetes and fatty liver.

Description

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

technical field

The invention relates to the field of traditional Chinese medicine formulations, in particular to a traditional Chinese medicine composition for strengthening the spleen and removing turbidity.

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; The body is thin due to nourishing the limbs; most of the modern diabetes patients are obese, obese people have more phlegm, excess phlegm-dampness, and excess dampness damages the spleen. The typical "Yin-deficiency-dry-heat-type diabetes mellitus" is rare. Things are not naturalized, the subtleties are not transported, and the viscera are not nourished.” Nourishing yin helps dampness and hinders the spleen, while clearing heat injures spleen yang and worsens phlegm-dampness. 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 "weakness of the spleen and stomach, lack of clear yang, dampness and turbidity, and stagnation of fire." The qi, blood and body fluids of the 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, some focus on nourishing yin and replenishing qi, promoting body fluid and quenching thirst, clearing heat and eliminating vexation, such as Yuquan Granule; ; Some focus on clearing heat and nourishing qi, such as Jinqi Jiangtang Tablets; some focus on removing turbidity and dampness, promoting blood circulation and calming pain, such as Jintangning Capsule; Ning Capsule, etc., there is no relevant research on the effects of the present invention for strengthening the spleen, dispelling dampness and resolving phlegm, clearing heat, promoting body fluid and quenching thirst, promoting blood circulation and relieving depression, and there is no such variety available on the market.

Type 2 diabetes (T2DM) and non-alcoholic fatty liver disease (NAFLD) have seriously endangered people's health. The prevalence of NAFLD in ordinary adults is 2% to 3%. Among patients with type 2 diabetes and hyperlipidemia, the prevalence of NAFLD is The rates were 28.0% to 55.0% and 27.9% to 92.0%, respectively. NAFLD is characterized by fat deposition in hepatocytes. Excessive alcohol consumption, drug-induced liver injury and viral liver disease are excluded. Excess lipid deposition in the liver can lead to adverse reactions such as insulin resistance, and the function of pancreatic β cells is successively damaged and gradually Development of diabetes, and multiple studies have shown that NAFLD is an independent risk factor for the risk of developing T2DM. Liver damage in patients with diabetes can initially cause changes in enzymes in the body, and fatty liver, liver fibrosis, etc. can also occur, which can seriously lead to liver cell necrosis and liver failure. It can be seen that diabetes and fatty liver are causal and affect each other. In the treatment of diabetic non-alcoholic fatty liver disease, western medicine often uses anti-inflammatory, liver-protecting, enzyme-lowering, and insulin-resistant hypoglycemic and hypolipidemic drugs. There are deficiencies. Traditional Chinese medicine research believes that T2DM combined with NAFLD is mainly related to phlegm-dampness, qi stagnation, qi stagnation, qi deficiency, blood stasis, and internal heat in the body. Therefore, the theories of traditional Chinese medicine such as holistic view, syndrome differentiation and treatment, and balance of yin and yang have significant advantages in the treatment of this disease. It can improve the overall function of the human body, and it can also use less or no western medicine, which not only eliminates pathogens but also strengthens the body.

Diabetic ketoacidosis is a common clinical complication of diabetes, which mainly refers to the hyperglycemia of patients with diabetes due to the influence of various external factors, which leads to hyperketosis, metabolic acidosis or electrolyte imbalance. situation. Diabetic ketoacidosis has the characteristics of rapid onset, severe disease, and high risk factor. Once a patient develops diabetic ketoacidosis, physicians need to take emergency measures to the patient immediately, otherwise the patient may be in danger. The main causes of diabetic ketoacidosis are infection, improper diet, uncontrolled diet and/or gastrointestinal diseases. Acute infection is the main factor of diabetic ketoacidosis, usually respiratory system infection, followed by urinary system infection and skin infection, which can be a complication of diabetic ketoacidosis and interact with diabetic ketoacidosis, form a vicious circle. According to clinical statistics, most patients are prone to acute infection in spring, which induces diabetic ketoacidosis; some hospitals may also easily lead to the occurrence of diabetic ketoacidosis by taking improper treatment measures for diabetic patients. Ketoacidosis can be divided into mild, moderate and severe conditions according to its degree. Mild: simple ketosis without acidosis; moderate: mild or moderate acidosis; severe: ketoacidosis Poisoning accompanied by coma, or without coma but CO2CP <10mmol/L, or even accompanied by coma symptoms. The clinical symptoms of diabetic ketoacidosis are also more diverse, such as large breathing, ketone odor, dehydration shock, disturbance of consciousness, and gastrointestinal abnormalities. Because diabetic ketoacidosis is an acute disease with high risk to patients, according to clinical statistics, 45% of diabetic patients die from diabetic ketoacidosis. It can be seen that diabetic ketoacidosis is a serious threat to diabetic patients, so effective and rapid treatment of this diabetic complication is very important to the life safety of patients.

Modern medicine believes that the main causes of metabolic syndrome are poor 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 categories of “spleen and spleen” 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 traditional Chinese medicine composition for strengthening the spleen and removing turbidity, which has a definite curative effect, has the functions of strengthening the spleen and removing phlegm, clearing away heat and producing body fluid, and is used for the treatment of spleen deficiency due to stomach stagnation and spleen deficiency due to stagnant heat. Metabolic disorders are safe and effective.

Another object of the present invention is to apply the above-mentioned Chinese medicinal composition for strengthening the spleen and removing turbidity in the preparation of medicines for treating metabolic disorders.

The object of the invention is achieved in this way: a kind of traditional Chinese medicine composition for strengthening the spleen and dispelling turbidity, is characterized in that: calculated in parts by weight, the formula is made up of the following components: 15-25 parts of pueraria, 12-18 parts of Salvia miltiorrhiza, 15- 25 parts, Codonopsis 15-25 parts, Treats 25-35 parts, Chenpi 8-12 parts, Chuanchangpu 12-18 parts, Poria 12-18 parts, Citrus aurantium 8-12 parts, Atractylodes japonica 15-25 parts, Anemarrhena 25 parts -35 servings, 8-12 servings of turmeric, 15-25 servings of Gualou Ren.

Preferably, calculated in parts by weight, the formula is composed of the following components: 18-22 parts of Pueraria lobata, 14-16 parts of Salvia miltiorrhiza, 18-22 parts of Atractylodes Rhizoma, 18-22 parts of Codonopsis Radix, 28-32 parts of Treats, 9-11 parts of dried tangerine peel parts, 14-16 parts of Chuanchangpu, 14-16 parts of Poria, 9-11 parts of Citrus aurantium, 18-22 parts of Atractylodes, 28-32 parts of Anemarrhena, 9-11 parts of Turmeric, 18-22 parts of Gualouren.

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, 20 parts of Atractylodes Rhizoma, 20 parts of Codonopsis Radix, 30 parts of Treats, 10 parts of dried tangerine peel, 15 parts of Chuanchangpu, 15 parts of Poria, 10 Citrus aurantium, 20 Atractylodes, 30 Zhimu, 10 Turmeric, 20 Gualouren.

The application of the traditional Chinese medicine composition for strengthening the spleen and removing turbidity in the preparation of medicines for treating metabolic disorders.

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 traditional Chinese medicine composition for strengthening the spleen and removing turbidity as active ingredients, and adding medicinal excipients.

The extract is a water extract.

The metabolic disorders are diabetes, diabetic ketosis, ketoacidosis, fatty liver, and metabolic syndrome.

The metabolic disorder diseases are diabetes mellitus, diabetic ketosis, ketoacidosis, fatty liver, and metabolic syndrome of spleen deficiency and stomach deficiency and spleen deficiency and stagnation of heat.

The present invention is a prescription for "treatment of diabetes from the spleen and stomach". Polyuria, obesity, chest tightness and nausea, fullness under the heart, water and grains not disappearing, excessive phlegm, heavy limbs, heavy head, dizziness, loose stools or constipation, etc. , the pulse is slippery and weak; diabetes and diabetic ketosis, ketoacidosis, fatty liver, metabolic syndrome and other metabolic disorders have obvious curative effect after taking it.

detailed description

The invention is a traditional Chinese medicine composition for strengthening the spleen and removing turbidity. Calculated in parts by weight, the formula is composed of 15-25 parts of Pueraria lobata, 12-18 parts of Salvia miltiorrhiza, 15-25 parts of Atractylodes Rhizoma, 15-25 parts of Codonopsis Radix, and 25 parts of Cortex Phellodendri. -35 parts, 8-12 parts of dried tangerine peel, 12-18 parts of Chuanchangpu, 12-18 parts of Poria, 8-12 parts of Citrus aurantium, 15-25 parts of Atractylodes, 25-35 parts of Zhimu, 8-12 parts of Turmeric, Gualou Ren 15-25 servings. Preferably, calculated in parts by weight, the formula is composed of the following components: 18-22 parts of Pueraria lobata, 14-16 parts of Salvia miltiorrhiza, 18-22 parts of Atractylodes Rhizoma, 18-22 parts of Codonopsis Radix, 28-32 parts of Treats, 9-11 parts of dried tangerine peel parts, 14-16 parts of Chuanchangpu, 14-16 parts of Poria, 9-11 parts of Citrus aurantium, 18-22 parts of Atractylodes, 28-32 parts of Anemarrhena, 9-11 parts of Turmeric, 18-22 parts of Gualouren. 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, 20 parts of Atractylodes Rhizoma, 20 parts of Codonopsis Radix, 30 parts of Treats, 10 parts of dried tangerine peel, 15 parts of Chuanchangpu, 15 parts of Poria, 10 Citrus aurantium, 20 Atractylodes, 30 Zhimu, 10 Turmeric, 20 Gualouren.

The application of the spleen-invigorating and turbid-resolving traditional Chinese medicine composition in the preparation of medicines for treating metabolic disorders, especially diabetes, diabetic ketosis, ketoacidosis, fatty liver or metabolic syndrome due to spleen deficiency and stomach deficiency, spleen deficiency and stagnation of heat. The medicines are oral dosage forms such as decoctions, granules, tablets, capsules, oral liquids or pills. The medicine is a preparation prepared by using the extracts of the components in the formula of the traditional Chinese medicine composition for strengthening the spleen and removing turbidity as active ingredients, and adding medicinal excipients. 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". It is believed that the pathogenesis of diabetes is: "the spleen and stomach are out of balance, things are not naturalized, the essence is not transported, and the organs are out of nourishment". With attacking and supplementing as the core, the spleen-invigorating and turbid-resolving prescription of the present invention is established, which is effective in strengthening the spleen and resolving phlegm, clearing away heat and producing body fluid, and is safe and effective in treating diabetes caused by spleen deficiency and stomach stagnation and spleen deficiency and heat.

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 clinical practice, the present invention believes that the syndrome of deficiency and excess is common in the clinic 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.

Aiming at the disease characteristics of spleen deficiency and stomach stagnation and spleen deficiency and stagnation of heat in the early stage of modern diabetic patients, the traditional Chinese medicine composition of the present invention has a certain and exact curative effect on diabetes and complications. In the prescription, Atractylodes atractylodes, invigorating the spleen, nourishing qi and drying dampness, is the king drug; it is combined with Codonopsis pilosula to strengthen the power of tonifying and nourishing qi, so that the central axis can be transported, and Phellodendron rhizome is used to clear heat and dry dampness to help the spleen to purify and reduce yin-fire. Chen Yao; supplemented with tangerine peel to invigorate the spleen and regulate Qi, Poria to invigorate the spleen and dispel dampness, Atractylodes Rhizoma to invigorate the spleen and remove dampness, Citrus aurantium to regulate Qi and eliminate accumulation, resolve phlegm and remove sputum, Chuanchangpu resolves dampness and appetizers, regulates Qi and removes phlegm and removes turbidity. Dampness and phlegm are used as adjuvants, Pueraria lobata promotes clearing yang to clear the spleen and collaterals, relieves heat to produce body fluid and quenches thirst, Anemarrhena clears heat and purifies fire, nourishes yin and moistens dryness and is also the adjuvant of Cortex Phellodendri; Entering the lung and liver meridians, clearing heat and cooling blood, regulating qi and relieving stagnation, melon seeds enter the lung meridian and moisten the lungs and resolve phlegm. The whole formula ascends and descends in harmony, and combines the functions of invigorating the spleen, dispelling dampness and resolving phlegm, clearing heat, producing body fluid and quenching thirst, promoting blood circulation and relieving stagnation.

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. Codonopsis polysaccharide can reduce blood sugar in alloxan-induced diabetic mice, and at the same time can improve insulin resistance to a certain extent, and improve the body's insulin sensitivity; Phellodendron chinensis has various pharmacological effects, mainly including hypoglycemic, antibacterial, antifungal, and antitussive. , antihypertensive, anti-trichomoniasis, anti-hepatitis, anti-ulcer and immunosuppressive effects. The antioxidant and anti-inflammatory effects of tangerine peel can achieve the effects of regulating blood lipids, antithrombosis, and anti-atherosclerosis. Poria has anti-tumor, liver protection, diuretic, anti-aging, anti-inflammatory, hypolipidemic, and immune-enhancing effects. Atractylodes can reduce High blood sugar, high blood uric acid, high blood pressure and protection of myocardium. Citrus aurantium has pharmacological effects such as regulating gastrointestinal motility, regulating uterine function, boosting blood pressure, strengthening the heart, antioxidant, antibacterial, analgesic, and antithrombotic. Tumor, lipid-lowering, anti-inflammatory, Pueraria lobata has the effect of lowering blood sugar, and the preparations of Pueraria lobata and its extracts have been widely used in the treatment of diabetes and its complications. Anemarrhena has antitumor, anticoagulant, antithrombotic, hypoglycemic, hypolipidemic, antidepressant, and hypotensive effects. Salvia 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. , anti-inflammatory, improve blood rheology, reduce hyperlipidemia, anti-free radical damage and other effects, Gualou Ren has pharmacological effects such as improving cardiovascular disease, anti-inflammatory, anti-tumor, hypoglycemic and diarrhea.

Therefore, the present invention reconciles the spleen and stomach, attacks and supplements simultaneously, is well-matched, and has obvious characteristics of principles and methods. The applicant has proved through the data of the following clinical research that this prescription treats diabetes, especially early stage diabetes patients with spleen deficiency and stomach deficiency and spleen deficiency stagnation and heat type diabetes. The formula has obvious hypoglycemic effect, few adverse reactions, and is safe and reliable.

Example 1 (decoction)

The formula consists of the following components: Pueraria 20g, Salvia 15g, Atractylodes 20g, Codonopsis 20g, Phellodendron 30g, Chenpi 10g, Chuanchangpu 15g, Poria 15g, Citrus aurantium 10g, Atractylodes 20g, Anemarrhena 30g, Radix Radix 10g, Gua Louren 20g. Add water and cook to a bowl.

Embodiment 2 (decoction)

The formula consists of the following components: Pueraria 15g, Salvia 12g, Atractylodes 15g, Codonopsis 15g, Phellodendron 25g, Chenpi 8g, Chuanchangpu 12g, Poria 12g, Citrus aurantium 8g, Atractylodes 15g, Anemarrhena 25g, Turmeric 8g, Gualouren 15g. Add water and cook to a bowl.

Embodiment 3 (decoction)

Each dose of the formula consists of the following components: Pueraria 20g, Salvia 14g, Atractylodes 18g, Codonopsis 20g, Phellodendron 30g, Chenpi 11g, Chuanchangpu 16g, Poria 16g, Citrus citrus 9g, Atractylodes 18g, Anemarrhena 28g, turmeric 11g, melon Beetroot 20g. Add water and cook to a bowl.

Example 4 (decoction)

The formula consists of the following components: Pueraria 22g, Salvia 14g, Atractylodes 22g, Codonopsis 22g, Phellodendron 30g, Chenpi 11g, Chuanchangpu 14g, Poria 15g, Citrus aurantium 11g, Atractylodes 22g, Anemarrhena 32g, Turmeric 9g, Gualouren 22g. Add water and cook to a bowl.

Example 5 (tablet)

Calculated in parts by weight, the formula is composed of the following components: 25 parts of Pueraria lobata, 18 parts of Salvia miltiorrhiza, 25 parts of Atractylodes Rhizoma, 25 parts of Codonopsis Radix, 35 parts of Treats, 12 parts of dried tangerine peel, 18 parts of Chuanchangpu, 18 parts of Poria, 12 parts of Citrus aurantium, 25 shares of Atractylodes, 35 shares of Anemarrhena, 12 shares of Turmeric, 25 shares of Gualou Ren. 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

1Clinical data

1.1 General information Sixty-four outpatients and inpatients in the Diabetes Department of Shantou Hospital of Traditional Chinese Medicine from January 2016 to January 2018, who met the diagnostic criteria, were randomly divided into two groups. There were 32 cases in the treatment group, including 15 males and 17 females; the age was 41-62 years, with an average of (56.0±5.7) years; the duration of diabetes was 2-5 years, with an average of (2±2.9) years. The control group consisted of 32 cases, 18 males and 14 females; aged 44-63 years, mean (52.0±8.1) years; duration of diabetes mellitus 3-8 years, mean (6±2.6) years. There was no significant difference in general data between the two groups (P>0.05), which was comparable.

1.2 Diagnosis and dialectical criteria Western medicine diagnostic criteria: using the 1999 World Health Organization (WHO). TCM syndrome differentiation criteria: The diagnostic criteria were formulated with reference to the 2010 "Traditional Chinese Medicine Diagnosis and Treatment Program for 95 Diseases in 22 Specialties". Clinical symptoms include fullness under the heart, distention, nausea, nausea, hiccups, stagnation of water and grains, anorexia, loose stools, or bowel sounds, or excessive phlegm, body obesity, pale tongue, stasis of sublingual collaterals, and greasy coating. , the pulse string slippery weak. 1.3 Inclusion criteria (1) Meet the diagnostic criteria for type 2 diabetes; (2) The main syndrome of TCM syndrome differentiation belongs to patients with spleen deficiency and stomach stagnation, spleen deficiency and stagnation heat, and can be treated with this spleen-invigorating Huazhuo formula.

1.4 Exclusion criteria (1) Exclude hospitalized patients with myocarditis, pericardial disease, other organic heart disease, electrolyte imbalance and other heart diseases; (2) Combined renal artery stenosis, acute metabolic dysfunction, severe heart, liver, and brain complications Those who need emergency treatment; (3) Those who are not suitable for this treatment plan due to pregnancy, allergies, etc.; (4) Those who are older than 70 years old; (5) Those who have major changes in lifestyle during data collection, which may affect the analysis of research results patients; (6) non-cooperators.

2 methods

2.1 Treatment method Control group: diabetes health education, strict diet control, emotional stability, appropriate exercise, oral hypoglycemic drugs or routine insulin therapy, so that blood sugar is controlled at fasting <7.0mmol/L, 2h postprandial blood sugar <10.0mmol/L L. On this basis, the treatment group was given the spleen-invigorating and turbid formula of Example 1, decocted in water, 1 dose per day, decocted into 400 mL, 200 mL each time, warmed twice in the morning and evening, 4 weeks as a course of treatment, 2 Statistical treatment results after the course of treatment.

2.2 Observation indicators

2.2.1 Safety evaluation criteria General physical examination: blood pressure, respiration, pulse, body temperature. ② Routine examination of hematuria and stool.

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

2.3 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.

2.4 Statistical processing Statistical software SPSS 18.0 was used for statistical processing of relevant data in this study. Measurement data were expressed as mean ± standard deviation, and t-test was used; Chi-square test was used, and P<0.05 indicated a comparison of count data between groups. The difference is more significant and there is statistical significance.

3 results

3.1 Comparison of blood glucose and glycated hemoglobin between the two groups before and after treatment There was no significant difference in fasting blood glucose, 2h postprandial blood glucose and glycated hemoglobin between the two groups before treatment (P>0.05), which was comparable. The fasting blood glucose, 2h postprandial blood glucose and glycosylated hemoglobin of the two groups of patients decreased after treatment, and the difference between before and after treatment was statistically significant (P<0.05), indicating that both groups achieved a certain therapeutic effect, but after treatment There was no statistically significant difference between the two groups (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=32)

Note: ★Compared with before treatment, P<0.05; ●Compared with control group, P>0.05.

3.2 Comparison of TCM symptom scores between the two groups after treatment After treatment, the efficacy evaluation of TCM symptoms in the Jianpi Huazhuo prescription group was significantly better than that in the control group, and the difference was statistically significant (P<0.05), indicating that Jianpi Huazhuo prescription was improving The patient's symptoms have significant curative effect. See Table 2.

Table 2 Comparison of TCM efficacy evaluation between the two groups after treatment

Note: ★Compared with the control group, P<0.05.

3.3 Comparison of adverse reactions between the two groups: 3 patients in the Jianpi Huazhuo Recipe group developed belching, acid reflux and sore throat after taking Chinese medicine; 4 patients in the control group developed abdominal distension and diarrhea, which lasted from 5 to 10 days. Complete 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 in the early stage of diabetes, Jianpi Huazhuo Recipe only has spleen deficiency and stomach stagnation, spleen deficiency and stagnation and heat, and the actual evil has not become a trend, and the deficiency has not reached other viscera. Compared with simple western medicine treatment, it is more advantageous to improve the quality of life of patients and reduce the symptoms caused by diabetes. Clinical practice shows that Jianpi Huazhuo Recipe can treat patients with spleen deficiency and stomach stagnation, spleen deficiency and stagnation heat in the early stage of diabetes, manifested as dry mouth, polydipsia, polyuria, obesity, chest tightness, nausea, and loose stools. It is safe to use and has advantages over simple western medicine in improving the quality of life of patients and alleviating symptoms caused by diabetes.

2. Clinical study on the treatment of diabetes mellitus complicated with non-alcoholic fatty liver disease

1. Materials and methods

1.1 Inclusion and exclusion criteria

1.1.1 Inclusion criteria: According to the 2010 Chinese Guidelines for the Prevention and Treatment of Diabetes, patients with diabetes symptoms, fasting blood sugar greater than 7.0 mmol/L or blood sugar greater than 11.1 mmol/L at any time or OGTT2h blood sugar greater than 11.1 mmol/L. Refer to the Chinese Medical Association Hepatology Branch Fatty Liver and Alcoholic Liver Diseases Group in 2010 revised "China Non-Alcoholic Fatty Liver Disease Diagnosis and Treatment Guidelines"; meet the imaging diagnostic criteria of diffuse fatty liver.

The main clinical manifestations of TCM diagnosis are: dry mouth, or sticky or bitter mouth, distending pain in the liver area or feeling of distention in the flanks, abdominal distention and depression, depression and discomfort, abdominal and abdominal suffocation, obesity, tongue not red, moss White greasy or red tongue with yellow greasy coating, thin pulse, etc.

1.1.2 Exclusion criteria: ① Type 1 diabetes mellitus, gestational diabetes mellitus, secondary diabetes, etc., and acute and chronic complications of diabetes requiring insulin treatment; ② Patients with severe liver and kidney damage; unstable or severe angina pectoris, cardiac insufficiency (NYHA classification) Ⅲ/Ⅳ); ③ Suffering from malignant tumor and other chronic wasting diseases, hematological diseases, mental illness, autoimmune diseases, obvious digestion and absorption disorders, and acute cerebrovascular disease within the past 6 months; ④ Long-term heavy drinking, History of drug use; ⑤ Exclude viral hepatitis; use drugs that affect glucose metabolism, such as glucocorticoids.

1.2 General information 64 cases of diabetic non-alcoholic fatty liver patients diagnosed and treated in our hospital were selected and divided into control group (n=32) and treatment group (n=32) by random number method. In the control group, there were 18 males and 14 females; the age ranged from 36 to 68 years, with an average of (47.87±6.51) years; the course of T2DM was 2.5 to 20 years, with an average of (13.16±3.43) years; the course of NAFLD was 4 to 19 months, with an average of (10.30) years. ±2.39) months; Liver B-ultrasound showed that fatty liver was severe in 5 cases, moderate in 17 cases, and mild in 10 cases; the average BMI index was (24.57±2.07) kg/m ² . In the treatment group, there were 17 males and 15 females; the age ranged from 37 to 70 years, with an average of (48.02±6.39) years; the course of T2DM was 2.8 to 19 years, with an average of (13.44±3.62) years; the course of NAFLD was 4.5 to 20 months, with an average of (10.82) years. ±2.65) months; Liver B-ultrasound showed that fatty liver was severe in 6 cases, moderate in 17 cases, and mild in 9 cases; the average BMI was (24.73±2.40) kg/m ² ; there was no statistical difference in general data between the two groups of patients. Significance (P>0.05), see Table 3.

Table 3 Investigation and analysis of the general data of the two groups of patients

1.3 Methods After admission, both groups of patients were given routine treatment such as diet control, exercise, oral hypoglycemic drugs or insulin injection to control blood sugar. The control group was given fenofibrate (Shandong Hualu Pharmaceutical Co., Ltd., H37022101), once a day, 0.2 g each time. On the basis of the control group, the treatment group was treated with the Jianpi Huazhuo Recipe of Example 1. One dose a day, decocted into 400mL, 200mL each time, warmed twice in the morning and evening, and the two groups were treated for 6 months.

1.4 Observation indicators

1.4.1 The clinical effect is markedly effective: the clinical symptoms basically disappear, the fasting blood glucose is less than 7.0mmol/L, the indicators of liver function and blood lipid levels return to normal, and the liver imaging shows that the liver shape and echo return to normal; effective: the symptoms of Linchuan have been alleviated , fasting blood sugar decreased by more than 20%, various indicators of liver function and blood lipid levels improved by 50% to 75%, and liver imaging was improved; invalid: no significant improvement in clinical symptoms, no significant changes in various indicators and liver imaging ^{[10] ]} . Total effective rate=(marked effect+effective)/total number of cases×100%.

1.4.2 Liver imaging According to the NAFLD liver B-ultrasound grading standard in the "Guidelines for the Diagnosis and Treatment of Non-Alcoholic Fatty Liver Diseases", mild: fine light spots, clear blood vessels, near-field echo enhancement, and far-field echo mild attenuation; moderate: light The spot is dense, the blood vessels are not clear, the near-field echo is enhanced, and the far-field echo is significantly attenuated; severe: the light spot is dense, the blood vessel cannot be distinguished, the near-field echo is significantly enhanced, and the far-field echo is highly attenuated.

1.4.3 Index detection Fasting venous blood was collected from the two groups of patients before and after treatment, and serum was collected after centrifugation at 4000 r/min for 10 min. Blood glucose levels (FBG, 2hPG, HbAlc); blood lipid levels (TC, TG, LDL-C, HDL-C); liver enzyme levels (ALT, AST) were measured; adverse reactions during the treatment were recorded.

1.5 Statistical analysis SPSS 18.0 was used for statistical analysis, and measurement data were

The t test was used for comparison between groups, the count data was expressed as percentage, and the χ ² test was used between groups. P<0.05 indicated that the difference was statistically significant.

2 results

2.1 Comparison of clinical efficacy between the ^two groups The total clinical effective rate in the treatment group was 90.63%, and the total clinical effective rate in the control group was 68.75%.

Table 4 Comparison of clinical efficacy between two groups of patients [n(%)]

2.2 Comparison of blood glucose levels in the two groups After treatment, the levels of FBG, 2hPG, and HbAlc in the two groups were significantly decreased (P<0.05), and the treatment group was significantly lower than the control group (P<0.05), see Table 5.

Table 5 Comparison of blood glucose levels in the two groups of patients

Note: *P<0.05 compared with before treatment, **P<0.05 compared with control group.

2.3 Comparison of blood lipid levels in the two groups After treatment, the levels of TC, TG, and LDL-C in the two groups were significantly decreased (P<0.05), and the level of HDL-C was significantly increased (P<0.05), and the treatment group was better than the control group (P<0.05). <0.05), see Table 6.

Table 6 Comparison of blood lipid levels between the two groups of patients (mmol·L ^-1 ,

)

2.4 Comparison of liver enzyme levels in the two groups After treatment, the levels of glutamate pyruvate aminotransferase (ALT) and aspartate aminotransferase (AST) in the two groups were significantly decreased (P<0.05), and the treatment group was lower than the control group (P<0.05). <0.05), see Table 7.

Table 7 Comparison of liver enzyme levels between the two groups of patients (U·L ^-1 ,

)

Note: *P<0.05 before treatment, **P<0.05 compared with control group.

2.5 Comparison of the improvement of liver B-ultrasound grading between the two groups The improvement of liver B-ultrasound grading in the treatment group was significantly better than that in the control group, and the difference was statistically significant (χ ² =5.1892, P=0.0227), see Table 8.

Table 8 Comparison of improvement of liver B-ultrasound grading between two groups of patients [n(%)]

2.6 Adverse reactions During the treatment, there were no serious adverse reactions such as liver and kidney function damage and abnormal blood routine in the two groups, while 2 patients in the control group had mild gastrointestinal reactions, and there was no significant difference in adverse reactions between the two groups (P >0.05).

3 Discussion

The Jianpi Huazhuo Decoction has a significant effect on the treatment of T2DM and NAFLD, and the total effective rate of the treatment group increased to 93.75%. The research results showed that after treatment, the blood glucose level parameters FBG, 2hPG, and HbAlc were significantly decreased (P<0.05), and the blood lipid level parameter TC , TG, LDL-C, HDL-C were significantly improved (P<0.05), liver enzymes and liver imaging improved, indicating that this prescription has the effect of protecting liver, protecting liver, lowering blood sugar and blood lipid. The overall adjustment of this recipe, from strengthening the spleen and resolving phlegm, clearing away heat and producing body fluid, makes nourishing benefits without warming dryness, and strengthening the body without stagnation, making full use of the advantages of traditional Chinese medicine, mobilizing internal factors, and acting on multiple links in the onset of non-alcoholic fatty liver disease and diabetes. The two diseases are treated at the same time, and finally achieve the purpose of correcting endocrine disorders and the balance of glucose and lipid metabolism in the body. It can not only achieve the purpose of reducing the adverse reactions of simple western medicine treatment, but also increase the clinical efficacy, and at the same time, the prescription is simple and the medicinal materials are easy to obtain.

To sum up, Jianpi Huazhuo Decoction has a significant effect in the treatment of diabetes mellitus complicated with non-alcoholic fatty liver, can significantly reduce the blood sugar level of patients, and protect the liver function of patients, which is safe and effective.

3. Clinical research on diabetic ketoacidosis

1 Materials and methods

1.1 General information: 200 patients with diabetic ketoacidosis who were treated in our hospital from January 2016 to December 2019 were selected, and the blood glucose range of the patients was 15.6-34.1 mmol/L during treatment. The patients were randomly divided into the study group and the control group, 100 cases in each. There were 56 males and 44 females in the study group; the average age was (56.2±4.58) years old; all patients had various degrees of routine symptoms such as thirst, polydipsia, and polyuria. Among them, 42 patients had acute asthma, and 22 patients had acute asthma. Accompanied by abdominal pain, 10 patients had disturbance of consciousness, 2 patients had coma symptoms; carbon dioxide binding capacity (CO2CP) was 11-21 mmol/L; 28 patients had serum potassium concentration <3.3 mmol/L, and 42 patients had serum potassium concentration of 3.3 ~5.5mmol/L, 30 patients had serum potassium concentration >5.5mmol/L; serum sodium level of patients was 110-140mmol/L; blood urea nitrogen level of patients was 4.0-7.5mmol/L. There were 54 males and 46 females in the control group; the average age was (57.4±5.52) years old; all the patients had different degrees of routine symptoms such as thirst, polydipsia, and polyuria. Among them, 38 patients had acute asthma, and 20 patients had acute asthma. Accompanied by abdominal pain, 13 patients had disturbance of consciousness, 3 patients had coma symptoms; CO2CP was 10-20 mmol/L; 27 patients had serum potassium concentration <3.3 mmol/L, and 44 patients had blood potassium concentration of 3.3-5.5 mmol/L In 29 patients, the serum potassium concentration was >5.5mmol/L; the serum sodium level of the patients was 110-145mmol/L; the blood urea nitrogen level of the patients was 5.0-8.2mmol/L. There was no statistically significant difference in the general data of the two groups of patients (P>0.05), which was comparable.

1.2 Methods: The control group received routine emergency treatment, such as fluid infusion, potassium supplementation, pH correction, intravenous insulin infusion, etc., and the supplementation of sodium chloride injection was 12% of the patient's body weight. 50U insulin was dissolved in 500ml normal saline, and the patient was given continuous intravenous infusion of insulin 0.1U/(kg·h). After the patient's body function is restored, the metabolism is normal, and the urine ketone body production is reduced during the treatment, the insulin dose can be adjusted according to the specific situation of the patient. On the basis of the control group, the study group was combined with Example 1 Jianpi Huazhuo Recipe for oral treatment, decocted in water, decocted into 400 mL, 200 mL each time, and taken twice in the morning and evening. In the process of applying insulin, the two groups should always observe the patient's physical indicators and make corresponding adjustments, such as electrolytes, acid-base balance and so on. When the patient's serum potassium is reduced, the corresponding treatment measures of potassium supplementation should be timely carried out to ensure that the patient is in a relatively stable and safe environment. For routine rehydration, normal saline can be used for rehydration, and the rehydration volume is strictly controlled within 1000-2000ml.

1.3 Observation indicators and judgment criteria Observation and comparison of the therapeutic effects, fasting blood glucose, 2h postprandial blood glucose, blood ketone negative time, and urine ketone negative time were compared between the two groups. The reference for the efficacy judgment standard "Analysis of Emergency Nursing Points of Emergency Diabetic Ketoacidosis". Zhao Danfang. Diabetes New World, 2017, 20(11): 144-145., divided into markedly effective, effective and ineffective, total effective rate = markedly effective rate + efficient.

1.4 Statistical methods SPSS23.0 statistical software was used to process the data. Measurement data are expressed as mean ± standard deviation

Expressed by t test; count data expressed by rate (%), by χ2 test. P<0.05 indicates that the difference is statistically significant.

2 results

2.1 Comparison of the therapeutic effects of the two groups: 56 cases of patients in the control group were markedly effective, accounting for 56%; 25 cases were effective, accounting for 25%; 19 cases were ineffective, accounting for 19%; the total effective rate was 81%. In the study group, 83 cases were markedly effective, accounting for 83%; 13 cases were effective, accounting for 13%; 4 cases were ineffective, accounting for 4%; the total effective rate was 96%. The total effective rate of patients in the study group was significantly higher than that in the control group, and the difference was statistically significant (P<0.05). See Table 9.

Table 9 Comparison of treatment effects between two groups of patients (n, %)

Note: Compared with the control group, P<0.05

2. The fasting blood glucose, 2h postprandial blood glucose, blood ketone negative time, and urine ketone negative time were compared between the two groups. After treatment, the fasting blood glucose level of the patients in the study group was (5.12±1.79) mmol/L, and the 2h postprandial blood glucose level was ( 6.56±3.11) mmol/L, which were significantly lower than (7.45±2.37) and (9.23±3.14) mmol/L of the control group, and the differences were statistically significant (P<0.05); the blood ketones of the patients in the study group turned negative The time was (17.21±5.34) h, and the time for urine ketone to turn negative was (17.33±5.32) h, which were significantly shorter than (28.45±10.89) and (27.24±9.56) h in the control group, and the differences were statistically significant (P＜ 0.05). See Table 10.

Table 10 Comparison of fasting blood glucose, 2h postprandial blood glucose, time to negative for blood ketones, and time to negative for urinary ketones in the two groups of patients

Note: Compared with the control group, P<0.05

3 Discussion

Diabetic ketoacidosis belongs to the category of "diabetic thirst" syndrome in traditional Chinese medicine, and it develops on the basis of the pathogenesis of "spleen and stomach disorders, non-naturalization of things, subtle intransigence, and dystrophy of viscera". The patient may be due to lack of endowment, weak five internal organs, loss of healthy spleen; Emotional discomfort, causing Qi stagnation. On the basis of spleen deficiency, stagnation, heat, phlegm, dampness, and turbidity, and other factors such as exogenous seasonal evils, improper diet, fatigue and internal injury, emotional stimulation, mistreatment and mistreatment, etc., the toxin of heat is inflamed, disturbing the gods; or Fire burns the body, stagnant heat damages the yin, yin deficiency and yang hyperactivity; or the turbid toxin is stagnant, the upper Mongolia clears the orifice; even when the yin is exhausted, the yang is deprived, and the yin and yang are separated. The early stage of the disease is characterized by deficiency of the spleen and stomach, phlegm turbidity and heat knots, so the treatment should be "invigorating the spleen and stomach, raising the yang, removing dampness and turbidity, and reducing yin fire".

The results of this study showed that the total effective rate of patients in the control group was 81%, and the total effective rate of patients in the research group was 96%; the total effective rate of patients in the research group was significantly higher than that in the control group, and the difference was statistically significant (P<0.05). ). After treatment, the fasting blood glucose level of the study group was (5.12±1.79) mmol/L, and the 2h postprandial blood glucose level was (6.56±3.11) mmol/L, which were significantly lower than those of the control group (7.45±2.37), (9.23) ±3.14) mmol/L, the difference was statistically significant (P<0.05); the time of blood ketones turning negative was (17.21±5.34) h, and the time of urine ketone turning negative was (17.33±5.32) h, both of which were significant It was shorter than (28.45±10.89) and (27.24±9.56) h in the control group, and the difference was statistically significant (P<0.05).

Therefore, this Jianpi Huazhuo formula combined with insulin in the treatment of diabetic ketoacidosis can quickly help patients balance their metabolic conditions, correct their metabolic disorders in a timely manner, and control elevated blood sugar levels, so it can be widely promoted in clinical practice.

4. Clinical research on the treatment of metabolic syndrome

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 21 males (70.0%) and 9 females (30.0%), with an average age of (36.46±8.93) years; 19 (63.3%) cases of abnormal blood sugar, 27 cases (90.0%) of dyslipidemia, and 20 cases of abnormal blood pressure ( 66.6%). In the control 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 sugar, 26 cases (86.6%) of dyslipidemia, and 19 cases of abnormal blood pressure ( 63.3%). There was no significant difference in general data between the two groups (P>0.05), which was comparable. This study was approved by the ethics committee of our hospital, and all patients gave informed consent to this study.

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 of TCM syndrome types: The diagnosis of spleen deficiency and stomach deficiency and spleen deficiency and stagnation heat syndrome are formulated according to the "Guidelines for Clinical Research of New Chinese Medicines" for spleen deficiency syndrome, stomach heat syndrome and depression syndrome, mainly manifested as dry mouth, bitter taste, polydipsia, and polyuria. , Obesity, chest tightness, nausea, fullness under the heart, undisturbed water and grains, excessive phlegm, heavy limbs, heavy head, dizziness, loose stools or constipation, etc. Symptoms and tongue pulse were quantitatively graded. Main symptoms: body fat, chest tightness, nausea, fullness under the heart, stagnant water and grains, excessive phlegm, pale and fat tongue, stasis of collaterals under the tongue, white greasy coating, slippery and weak pulse. Secondary symptoms: heavy limbs, heavy head, dizziness, loose stools or constipation. Among them, if three 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 diagnosis of this syndrome can be made. According to the severity, moderate and mild severity of TCM 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 invigorating spleen Huazhuo recipe of Example 1, 1 dose per day, boiled in water to make 400 mL, 200 mL each time, and taken twice 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 once, and each observation index was detected by a special person to observe whether there was any adverse reaction.

1.4 Statistical methods

SPSS19.0 statistical software was used to process the data, the count data was expressed as n/%, and the χ2 test was used.

Indicated by t-test, with P<0.05 as the difference being statistically significant.

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 11.

Table 11 Comparison of TCM symptom scores before and after treatment between 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 12.

Table 12 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 13.

Table 13 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.

3 Discussion

Metabolic syndrome can be classified into the categories of "spleen deflation" and "diabetes" in traditional Chinese medicine. Its pathological characteristics are deficiency and excess, the disease location is mainly in the spleen and stomach. Treating with the methods of invigorating the spleen and removing phlegm, clearing heat and producing body fluid, this recipe can effectively improve the abnormal metabolic components of metabolic syndrome and insulin resistance.

Claims

A traditional Chinese medicine composition for strengthening the spleen and removing turbidity, characterized in that: 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, 15-25 parts of Atractylodes Rhizoma, and 15-25 parts of Codonopsis Radix , 25-35 parts of Cork, 8-12 parts of tangerine peel, 12-18 parts of Chuanchangpu, 12-18 parts of Poria, 8-12 parts of Citrus aurantium, 15-25 parts of Atractylodes, 25-35 parts of Zhimu, 8- 12 servings, 15-25 servings of Gualou Ren.
The traditional Chinese medicine composition for strengthening the spleen and removing turbidity according to claim 1, is characterized in that: calculated in parts by weight, the formula is made up of the following components: 18-22 parts of Pueraria lobata, 14-16 parts of Salvia miltiorrhiza, 18-22 parts of Atractylodes Rhizoma, Codonopsis 18-22 parts, Treats 28-32 parts, Chenpi 9-11 parts, Chuanchangpu 14-16 parts, Poria 14-16 parts, Citrus aurantium 9-11 parts, Atractylodes rhizome 18-22 parts, Anemarrhena 28-32 parts , 9-11 parts of turmeric, 18-22 parts of melon seeds.
The traditional Chinese medicine composition for strengthening the spleen and removing turbidity according to claim 1, is characterized in that: calculated in parts by weight, the formula is made up of the following components: 20 parts of Pueraria lobata, 15 parts of Salvia miltiorrhiza, 20 parts of Atractylodes Rhizoma, 20 parts of Codonopsis Radix, 30 parts of Cork Phellodendri parts, 10 parts of dried tangerine peel, 15 parts of Chuanchangpu, 15 parts of Poria, 10 parts of Citrus aurantium, 20 parts of Atractylodes, 30 parts of Anemarrhena, 10 parts of Turmeric, and 20 parts of Gualouren.
Application of the traditional Chinese medicine composition for strengthening the spleen and removing turbidity according to claim 1, 2 or 3 in the preparation of a medicine for treating metabolic disorders.
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, characterized in that: the medicine is a preparation prepared by using the extract of the components in the formula of the Chinese medicine composition for strengthening the spleen and removing turbidity 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, wherein the metabolic disorder is diabetes, diabetic ketosis, ketoacidosis, fatty liver and metabolic syndrome.
The application according to claim 4, characterized in that: the metabolic disorders are diabetes mellitus, diabetic ketosis, ketoacidosis, fatty liver, and metabolic syndrome due to spleen deficiency and stomach deficiency, spleen deficiency and stagnation of heat.
The application according to claim 8, wherein the diabetes is early diabetes.