A new traditional Chinese medicine composition for preventing and treating metabolic syndrome, a preparation method and application thereof

Abstract

The application belongs to the technical field of traditional Chinese medicines, and particularly discloses a new traditional Chinese medicine composition for preventing and treating metabolic syndrome, a preparation method and application thereof. The traditional Chinese medicine composition comprises poria cocos, fructus aurantii, radix bupleuri, bulbus allii macrostemonis, fructus aurantii, fructus armeniacae, radix platycladi, viscum album, polyporus umbellatus, coix seed, earthworm, and licorice. The formula has significant curative effects on metabolic syndrome, hyperglycemia, dyslipidemia and hypertension. The traditional Chinese medicine in the formula is mild and sweet, and the adverse effects caused by excessive dryness and pungency are avoided. All the components in the formula are natural components without any hormone components, and are more easily absorbed by the human body, and do not cause burden on the liver and kidney. The formula mainly uses the method of regulating and transporting, and focuses on treating the spleen and eliminating phlegm, so that the formula can be flexibly added or subtracted according to different pathogenesis of patients, the efficacy can be enhanced by using the principle of regulating and smoothing the qi and meridians of the original formula, and the body's normal qi is not damaged.

Description

TECHNICAL FIELD

[0001] The application belongs to the technical field of traditional Chinese medicine, and specifically discloses a new traditional Chinese medicine composition for preventing and treating metabolic syndrome, a preparation method and application thereof. BACKGROUND

[0002] Metabolic syndrome (MS) is also called X syndrome and insulin resistance syndrome, which refers to a series of metabolic and physiological disorders related to insulin resistance (IR) and serving as risk factors of atherosclerosis and cardiovascular diseases, including central obesity, hyperinsulinemia, impaired glucose tolerance and diabetes, hypertension, dyslipidemia, non-alcoholic fatty liver, and microalbuminuria. The MS is further expanded to include hyperuricemia, blood coagulation and fibrinolysis abnormalities, endothelial dysfunction, pro-inflammatory state, neuroendocrine abnormalities, and hyperleptinemia. In recent years, the MS has become a hot spot of worldwide medical research.

[0003] MS patients are a high-risk group of cardiovascular and cerebrovascular diseases. At present, the prevention and treatment goal of metabolic syndrome in the clinic is to prevent the occurrence of cardiovascular diseases and type 2 diabetes, and to control and delay secondary organ damage caused by metabolic disorders. The clinical treatment of Western medicine mainly aims at each component such as diabetes or impaired glucose regulation, hypertension, lipid disorder and obesity, and the drug treatment such as the use of hypoglycemic drugs, antihypertensive drugs and lipid-lowering drugs. For patients who have been diagnosed with cardiovascular diseases, anti-platelet therapy needs to be increased, and for chronic complications such as diabetic nephropathy, diabetic neuropathy and peripheral arterial disease that occur with the growth of the disease course, the corresponding drugs need to be further increased. Under the guidance of the overall concept and treatment based on syndrome differentiation of traditional Chinese medicine, traditional Chinese medicine has certain effect in preventing and treating metabolic syndrome. According to the clinical symptoms, it can be classified into the categories of obesity, fatness, dampness obstruction, diabetes and dizziness in traditional Chinese medicine. Referring to the Metabolic Syndrome Disease Syndrome Combination Diagnosis and Treatment Guide, the guide recommends several traditional Chinese medicine prescriptions and Chinese patent medicines, which are various in types.

[0004] At present, the high-risk population of metabolic syndrome includes: ① persons over 40 years old; ② persons with one or two components of metabolic syndrome but not meeting the diagnostic criteria; ③ persons with cardiovascular diseases, non-alcoholic fatty liver, gout, polycystic ovary syndrome and various types of fat atrophy; ④ persons with obesity, type 2 diabetes, hypertension, dyslipidemia, especially multiple combinations or family history of metabolic syndrome; and ⑤ persons with family history of cardiovascular diseases. The previous clinical research shows that metabolic syndrome significantly increases the risk of atherosclerotic cardiovascular diseases, type 2 diabetes, gout and other metabolic diseases.

[0005] There is no exact traditional Chinese medicine for the treatment of metabolic syndrome at present, and Western medicine treats the symptoms but not the root cause. In China, the traditional Chinese medicines for treating the disease include:

[0006] Chinese patent CN 108066650 B discloses a traditional Chinese medicine composition with therapeutic effect on metabolic syndrome and its preparation method and application. The traditional Chinese medicine composition is prepared from 15-45 parts of radix pseudostellariae, 15-45 parts of radix ophiopogonis, 10-30 parts of radix salviae miltiorrhizae, 10-30 parts of sophora flower, 10-30 parts of honeysuckle flower, 10-30 parts of imperata cylindrical root, 10-30 parts of radix raphani. The medicine can correct the glucose and lipid metabolism disorder of patients with metabolic syndrome, and has the effects of reducing blood glucose, blood lipid and blood pressure, and improving insulin resistance. However, it does not elaborate on the phlegm-heat and blood stasis type according to TCM differentiation.

[0007] Chinese patent CN 115381906 B belongs to the technical field of traditional Chinese medicine, and specifically discloses a traditional Chinese medicine composition for treating metabolic syndrome and a preparation method and application thereof. The traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 3-50 parts of angelica, 15-120 parts of money grass, 25-50 parts of imperata cylindrical root, 3-50 parts of cassia senna, and 3-50 parts of roasted hawthorn. Only 5 kinds of medicinal materials are contained, and the dosage is not clear enough in terms of monarch, minister, assistant and guide. SUMMARY

[0008] Western medicine treatment of metabolic syndrome uses different drugs for different components, resulting in multiple types of drugs, long medication period, high risk of adverse reactions, the need for persistent monitoring of blood indicators, poor patient compliance, and difficulty in curing. According to the Metabolic Syndrome Disease Syndrome Combination Diagnosis and Treatment Guide, most of the recommendations are disease-specific prescriptions for different clinical manifestations of MS. The clinical manifestations of this disease are diverse, and the pathogenesis is complex, making it difficult to comprehensively regulate and slow to take effect.

[0009] Therefore, the present application provides a traditional Chinese medicine composition, and the specific technical solutions are as follows:

[0010] A traditional Chinese medicine composition with therapeutic effect on metabolic syndrome is prepared from the following raw medicinal materials in parts by weight: 10-53 parts of poria cocos, 6-25 parts of fructus aurantii immaturus, 4-21 parts of radix bupleuri, 5-25 parts of bulbus allii macrostemonis, 4-21 parts of fructus aurantii, 4-21 parts of armeniacae semen, 5-26 parts of platycladi caulis, 7-44 parts of lonicerae japonicae flos, 6-32 parts of kujimyces, 12-63 parts of coicis semen, 4-21 parts of radix ophiopogonis, and 2-8 parts of radix glycyrrhizae.

[0011] Further, in the embodiments of the present application, the traditional Chinese medicine composition is prepared from the following raw medicinal materials in parts by weight: 10-24 parts of poria cocos, 6-12 parts of fructus aurantii immaturus, 4-9 parts of radix bupleuri, 5-12 parts of bulbus allii macrostemonis, 4-9 parts of fructus aurantii, 4-9 parts of armeniacae semen, 5-12 parts of platycladi caulis, 7-18 parts of lonicerae japonicae flos, 6-15 parts of kujimyces, 12-30 parts of coicis semen, 4-9 parts of radix ophiopogonis, and 2-3 parts of radix glycyrrhizae.

[0012] Further, in the most preferred embodiment of the present application, the traditional Chinese medicine composition is made from the following raw materials in the following weight proportions: 24 parts by weight of Poria cocos, 12 parts by weight of Fructus aurantii, 9 parts by weight of Rhizoma Pinelliae praeparatum, 12 parts by weight of Bulbus Allii Macrostemonis, 9 parts by weight of Fructus Aurantii Immaturus, 9 parts by weight of Semen Armeniacae Amarum, 12 parts by weight of Radix Platycodi, 18 parts by weight of Spatholobus suberectus, 15 parts by weight of Kujin, 30 parts by weight of Radix et Rhizoma Glycyrrhizae, 9 parts by weight of Pheretima, and 3 parts by weight of Radix Glycyrrhizae.

[0013] A second object of the present application is to provide a preparation method of the medicine having the effect of treating metabolic syndrome, comprising the following steps:

[0014] The Poria cocos, Fructus aurantii, Rhizoma Pinelliae praeparatum, Radix Platycodi, Semen Armeniacae Amarum, Bulbus Allii Macrostemonis, Fructus Aurantii Immaturus, Spatholobus suberectus, Kujin, Radix et Rhizoma Glycyrrhizae, Pheretima, and Radix Glycyrrhizae are taken in the weight proportions, and the traditional Chinese medicine decoction pieces are soaked for 30-40 minutes before decoction. The decoction is prepared with normal water, and each dose of medicine is decocted twice, with 500 ml of water added each time, and decocted for 15-20 minutes. The filtrate is concentrated to 100 ml, and the combined decoction is obtained.

[0015] For the purpose of taking, transportation, commercialization, or other reasons, the extract of the traditional Chinese medicine composition and the pharmaceutically acceptable carrier are prepared into oral liquid, granules, capsules, or tablets.

[0016] Further, the preparation of the clinically acceptable dosage form of the present application comprises the following steps:

[0017] (1) The Poria cocos, Fructus aurantii, Rhizoma Pinelliae praeparatum, Radix Platycodi, Semen Armeniacae Amarum, Bulbus Allii Macrostemonis, Fructus Aurantii Immaturus, Spatholobus suberectus, Kujin, Radix et Rhizoma Glycyrrhizae, Pheretima, and Radix Glycyrrhizae are taken in the weight proportions, and the traditional Chinese medicine decoction pieces are soaked for 30-40 minutes before decoction. The decoction is prepared with normal water, and each dose of medicine is decocted twice, with 500 ml of water added each time, and decocted for 15-20 minutes. The filtrate is concentrated to 100 ml, and the combined decoction is obtained.

[0018] (2) The concentrated liquid of step (1) is concentrated into extract and mixed with conventional excipients to prepare oral liquid, granules, capsules, or tablets.

[0019] For the purpose of use, it is found through pharmacological and pharmacodynamic experiments that the traditional Chinese medicine composition has the effects of treating and preventing metabolic syndrome of phlegm and blood stasis, treating and preventing metabolic syndrome combined with diabetes, treating and preventing metabolic syndrome combined with hyperlipidemia, treating and preventing metabolic syndrome combined with hypertension, and treating and preventing metabolic syndrome combined with uric acid.

[0020] The application has a complete monarch, minister, and assistant, and discusses the mechanism as follows: the origin of phlegm is water, and the movement of phlegm is dampness. Spleen deficiency and internal generation of phlegm dampness are the core pathogenesis of metabolic syndrome. Based on the theory of "transporting and transforming the middle energizer and regulating the triple energizer", the recipe uses tuckahoe as a phlegm treatment drug, which enters the lung and spleen meridians, strengthens the spleen to treat the root, and penetrates dampness to control the movement. The monarch drug is mild in flavor and has the effect of descending with ascending. When the damp phlegm is formed, it blocks the qi movement. The orange red is bitter, warm and dry, which can regulate qi and remove stagnation, dry dampness and phlegm. It is used to treat phlegm by treating qi first, and phlegm disappears when qi is smooth. The clear pinellia is pungent, warm and dry, which can dry dampness and phlegm, descend adverse qi and harmonize the stomach, and disperse and resolve phlegm. It is combined with the orange red to remove phlegm and fluid in the middle energizer, and is combined with tuckahoe to reflect the theory of "dry dampness and penetrate dampness to prevent the generation of phlegm" by Zhu Danxi. The pinellia is pungent and dispersing, which can ventilate lung qi, remove phlegm and pus, clear the throat, lift water, open the chest and diaphragm, carry the medicine upward, and reach the upper energizer. The apricot kernel enters the lung and large intestine, and has the effects of bitter and descending qi, removing phlegm and resolving phlegm, moistening the intestine and defecating. It is combined with the pinellia to ascend and descend, and is connected from top to bottom. The allium is pungent and warm, which can open the chest and remove phlegm, and is the best to resolve phlegm. The bitter orange is pungent and bitter, which can break qi and remove phlegm, regulate qi and resolve distension, and is good at stopping qi stagnation pain. It is combined with the allium to coordinate yin and yang, remove stagnation and resolve phlegm. The six drugs are all minister drugs. When the disease is prolonged and delayed, the spleen yang is damaged, the qi and blood essence are not generated, the kidney qi is damaged, and the euonymus alatus can supplement the kidney qi and generate yin and yang, and maintain the whole body. The poria cocos is specially used in the lower energizer, and is used in the kidney and bladder meridians. The alpinia oxyphylla is used in the spleen, stomach, lung and large intestine meridians, and can dry dampness and clear gold, and drain water and remove dampness. The three drugs can generate gold and water, and the spleen is healthy and light when the dampness is removed, and the lung is strong and the qi is improved when the gold is clear.

[0021] The recipe is based on the theory of "transporting and transforming the middle energizer and regulating the triple energizer", and focuses on strengthening the spleen, removing phlegm, ventilating lung qi, and tonifying the kidney and dredging the collaterals to transport and transform the middle energizer and regulate the qi movement of the triple energizer. The main pathogenesis of metabolic syndrome patients is phlegm dampness blocking the middle energizer, and the recipe has good effects of removing phlegm, transporting the middle energizer and regulating the triple energizer. The recipe is in line with the compatibility principle of traditional Chinese medicine, and has small dosage, safety, no toxicity, no compatibility contraindication, no dietary contraindication, convenient dosage form, exact curative effect, and is suitable for long-term use of patients. One treatment cycle is 14 days, and generally 4 treatment courses are taken.

[0022] Compared with the prior art, the traditional Chinese medicine composition has the following advantages:

[0023] The formula of the present application has remarkable curative effect on metabolic syndrome, including hyperglycemia, dyslipidemia and hypertension; the medicinal herbs in the formula of the present application are mild and gentle, avoiding the adverse effects caused by excessive dryness and pungency; all the components in the formula of the present application are natural components without any hormone components, and are more easily absorbed by human bodies, and do not cause burden to liver and kidney; the formula of the present application mainly regulates the spleen and eliminates phlegm, and thus can be flexibly added or subtracted according to different pathogenesis of patients, and can enhance the efficacy according to the principle of regulating qi and meridians, and does not damage the healthy qi of the body. BRIEF DESCRIPTION OF DRAWINGS

[0024] Figure 1 : Compared with the model group, comparative examples 1-2 and 4, and compared with comparative example 3, examples 1-3 have significant difference, and comparative example 3 has no significant difference with example 1.

[0025] Figure 2 : Compared with the model group and comparative example 4, examples 1-3 have significant difference, and have no significant difference with other groups.

[0026] Figure 3 : Compared with the model group and comparative example 4, examples 1-3 have significant difference at the 4th week, and have no significant difference with other groups.

[0027] Figure 4 : Except for HDL-C, the model group has significant difference with the blank group, which indicates that the modeling is successful. For the detection of TC, TG and LDL-C, examples 1-3 are significantly better than comparative examples 1-4.

[0028] Figure 5 : At the 4th and 8th weeks, the BMI index of males in the treatment group and the observation group has significant difference.

[0029] Figure 6 : The change of BMI index of females in the treatment group and the observation group has no significant difference.

[0030] Figure 7 : The fasting blood glucose of the treatment group and the observation group has no significant difference.

[0031] Figure 8 : The blood pressure of the treatment group and the observation group has no significant difference.

[0032] Figure 9 : The triglyceride of the treatment group and the observation group has significant difference.

[0033] Figure 10 : The uric acid of males in the treatment group and the observation group has significant difference.

[0034] Figure 11 There is a significant difference between the uric acid of the treatment group and the observation group. DETAILED DESCRIPTION

[0035] It should be noted that the drugs selected in the pharmacodynamic test of the present application are the drugs obtained by the representative formula and preparation method of the present application. The tests and results involved in the drugs obtained by other formulas and preparation methods included in the present application are limited in length and are not listed one by one.

[0036] Example 1: A traditional Chinese medicine composition for treating metabolic syndrome, which composition and preparation process are as follows:

[0037]

[0038] The preparation process is as follows:

[0039] Before decoction, the traditional Chinese medicine decoction pieces of the above weight parts are soaked for 30-40 minutes, and the water quality is normal. Each dose of medicine is decocted twice, 500ml of water is added each time, decocted for 15-20 minutes, and the filtrate is concentrated to 100ml. The filtrates are combined.

[0040] Example 2: A traditional Chinese medicine composition for treating metabolic syndrome, which composition and preparation process are as follows:

[0041]

[0042] The preparation process is the same as example 1.

[0043] Example 3: A traditional Chinese medicine composition for treating metabolic syndrome, which composition and preparation process are as follows:

[0044]

[0045] The preparation process is the same as example 1.

[0046] Example 4: A traditional Chinese medicine composition for treating metabolic syndrome, which composition and preparation process are as follows:

[0047]

[0048] Preparation process: Before decoction, the traditional Chinese medicine decoction pieces of the above weight parts are soaked for 30-40 minutes, and the water quality is normal. Each dose of medicine is decocted twice, 500ml of water is added each time, decocted for 15-20 minutes, and the filtrate is concentrated to 100ml. The filtrates are combined, the filtrate is concentrated to obtain an extract, then cyclodextrin is added and mixed uniformly, the whole is granulated, dried, and granules are prepared.

[0049] Example 5: A traditional Chinese medicine composition for treating metabolic syndrome, which composition and preparation process are as follows:

[0050]

[0051] Preparation process: before decocting, the above-mentioned Chinese medicine decoction pieces are soaked for 30-40 minutes, and the water is boiled to make medicine, each dose of medicine is decocted twice, 500 ml of water is added each time, decocted for 15-20 minutes, the filtrate is concentrated to 100 ml, the filtrate is combined, the filtrate is concentrated to extract, then cyclodextrin is added and mixed uniformly, the whole grain is added, the adhesive is added, the tablet is pressed, and the tablet is prepared.

[0052] Example 6: A traditional Chinese medicine composition for treating metabolic syndrome, which composition and preparation process are as follows:

[0053]

[0054] Preparation process: before decocting, the above-mentioned Chinese medicine decoction pieces are soaked for 30-40 minutes, and the water is boiled to make medicine, each dose of medicine is decocted twice, 500 ml of water is added each time, decocted for 15-20 minutes, the filtrate is concentrated to 100 ml, the filtrate is combined, the filtrate is concentrated to extract, then cyclodextrin is added and mixed uniformly, the whole grain is added, the adhesive is added, the tablet is pressed, and the tablet is prepared.

[0055] Comparative example 1: A traditional Chinese medicine composition for treating metabolic syndrome, which composition and preparation process are as follows:

[0056]

[0057] Preparation process is:

[0058] Before decocting, the above-mentioned Chinese medicine decoction pieces are soaked for 30-40 minutes, and the water is boiled to make medicine, each dose of medicine is decocted twice, 500 ml of water is added each time, decocted for 15-20 minutes, the filtrate is concentrated to 100 ml, and the filtrate is combined.

[0059] Comparative example 2: A traditional Chinese medicine composition for treating metabolic syndrome, which composition and preparation process are as follows:

[0060]

[0061] Preparation process is:

[0062] Before decocting, the above-mentioned Chinese medicine decoction pieces are soaked for 30-40 minutes, and the water is boiled to make medicine, each dose of medicine is decocted twice, 500 ml of water is added each time, decocted for 15-20 minutes, the filtrate is concentrated to 100 ml, and the filtrate is combined.

[0063] Comparative example 3: Liu Junzi decoction

[0064] Radix ginseng (9 grams) Atractylodes (9 grams) Poria cocos (9 grams) Radix glycyrrhizae (6 grams) Pericarpium citri reticulatae (3 grams) Pinellia ternata (4.5 grams) is boiled into a decoction by a conventional method.

[0065] Comparative Example 4: a traditional Chinese medicine composition for treating metabolic syndrome, which consists of and is prepared by the following process:

[0066]

[0067] The preparation process is the same as Example 1.

[0068] I. Pharmacological experiment: effects of different decoctions on metabolic syndrome model rats

[0069] 1.1 Materials and reagents

[0070] SD male rats, 8-10 weeks old, body weight 280-320 g, SPF level, certificate number: SYXK (Lu) 20230031 Shandong University of Traditional Chinese Medicine Affiliated Hospital, approved by the experimental animal ethics committee.

[0071] 1.2 Construction of rat metabolic syndrome model and grouping of administration

[0072] The animals were raised in a standard controlled environment with a temperature of 22-24°C, humidity of 55%, good ventilation, and a light / dark cycle of 12 h. The purpose of this study was to investigate the effects of long-term intake of the decoctions of Examples 1-3 on glucose and lipid metabolism disorders and blood pressure.

[0073] After 1 week of adaptive feeding, 72 rats were randomly divided into 9 groups, and the experimental design was as follows: blank control group (hereinafter referred to as blank group, n=8), metabolic syndrome model group (hereinafter referred to as model group, n=8), Example 1 group (n=8), Example 2 group (n=8), Example 3 group (n=8), Comparative Example 1 group (n=8), Comparative Example 2 group (n=8), Comparative Example 3 group (n=8), and Comparative Example 4 group (n=8).

[0074] Administration method: intragastrically administered 1.5 mL / 100 g of each example decoction, and the blank group and model group were intragastrically administered 0.9% normal saline 1.5 mL / 100 g once a day at 9 am.

[0075] Modeling: 10% (volume fraction) fructose solution was used to replace drinking water for the model group and each example group of rats to drink freely, and a metabolic syndrome model was established for 10 weeks. Body weight and fasting blood glucose were measured every 2 weeks, and the experiment was completed after 10 weeks. After 10 weeks, the model group of rats were obese, slow-moving, depressed, and irritable, indicating that the modeling was successful. The activity of the Example 1-3 groups was strong, the mental state was good, and they were not easily agitated, indicating that the composition of the present application could significantly improve the morphological and mental state changes caused by fructose in rats.

[0076] 1.3 Data statistics

[0077] Data are expressed as mean ± SD, and graphs were made using GraphPad Prism 9 software.

[0078] 1.4 Body weight, waist circumference, blood glucose, blood lipid

[0079] Body weight and waist circumference: body weight was measured every 2 weeks, and the details are shown in Table 1. Figure 1 Figure 1 It can be seen that, in Example 1 and Comparative Example 1-4, significant changes in body weight occurred at weeks 6, 8, and 10 (p < 0.05); since the waist circumference of the rats did not change much, it was found that the changes in each group were not too large in the first 8 weeks (p > 0.05), and the waist circumference data of each group were statistically analyzed at week 10, as shown in Table 2. Figure 2

[0080] Blood glucose measurement: fasting blood glucose was measured every 2 weeks, and significant changes occurred at weeks 4, 6, 8, and 10 (p < 0.05); specifically, the present example had a significant effect of lowering blood glucose compared to the comparative example or the model group.

[0081] Blood lipid: blood lipid detection included the detection of four indicators: TC, TG, LDL-C, and HDL-C. Figure 4 As can be seen from a-d, the content of HDL-C did not change much, but as can be seen from the tables of TC, TG, and LDL-C, Examples 1-3 were significantly better than Comparative Examples 1-4.

[0082] Second, clinical diagnosis of the pharmaceutical composition of the present application

[0083] 2.1 Clinical source

[0084] In this study, 128 patients with metabolic syndrome and phlegm and blood stasis syndrome who met the criteria from July 2021 to July 2022 in the outpatient or inpatient department of the Affiliated Hospital of Shandong University of Traditional Chinese Medicine were randomly divided into two groups, with a male to female ratio of 1:1, specifically the treatment group and the observation group, and the general data of the two groups were statistically processed, with good balance between groups, and there was no significant difference in gender, age (over 40 years old), and disease condition between groups (P > 0.05).

[0085] 2.2 Dosing regimen

[0086] Observation group: Liu Junzi Decoction (Radix Ginseng (9 g) Rhizoma Atractylodis Macrocephalae (9 g) Poria Cocos (9 g) Radix Glycyrrhizae (6 g) Pericarpium Citri Reticulatae (3 g) Rhizoma Pinelliae (4.5 g)), one dose per day, 14 days as a course of treatment, and 4 consecutive courses of treatment were observed.

[0087] Treatment group: the decoction of Example 1 of the present application, one dose per day, 14 days as a course of treatment, and 4 consecutive courses of treatment. ​​

[0088] 2.3 Diagnostic inclusion criteria

[0089] 2.3.1 Western medicine diagnostic criteria:

[0090] (1) Metabolic syndrome according to the current Chinese diagnostic criteria According to the 2020 edition of the Chinese guidelines for the prevention and treatment of type 2 diabetes mellitus:

[0091] ① Abdominal obesity (i.e. central obesity): waist circumference ≥ 90 cm in men and ≥ 85 cm in women.

[0092] ② Hyperglycemia: fasting blood glucose ≥ 6.1 mmol / L or 2-hour post-load blood glucose ≥ 7.8 mmol / L and / or those who have been diagnosed with diabetes and are being treated.

[0093] ③ Hypertension: blood pressure ≥ 130 / 85 mmHg (1 mmHg = 0.133 kPa) and / or those who have been confirmed as hypertensive and are being treated.

[0094] ④ Fasting triglycerides ≥ 1.70 mmol / L.

[0095] ⑤ Fasting HDL-C < 1.04 mmol / L.

[0096] ⑥ Uric acid: normal value of serum uric acid in men is 150-420 μmol / L; normal value of serum uric acid in women is 89-357 μmol / L

[0097] The above criteria need to be met for 3 or more to be the diagnostic criteria for MS.

[0098] 2.3.2 Chinese medicine diagnostic criteria

[0099] Reference 2012 edition of "Guidelines for Clinical Research of New Drugs of Traditional Chinese Medicine" and "Internal Medicine of Traditional Chinese Medicine" edited by Tian Delu, "Clinical Diagnosis and Treatment Terms of Traditional Chinese Medicine"

[0100] Main symptoms: phlegm and blood stasis are mutually obstructed, with local mass stabbing pain, or limb numbness, dry mouth, flaccid, and fatigue. Chest tightness with much phlegm, or phlegm with dark blood clots, dark tongue or spots, greasy fur, and stringy and astringent pulse are common symptoms.

[0101] Secondary symptoms: dizziness, bad breath, headache, insomnia, and joint pain in extremities.

[0102] Two main symptoms and one secondary symptom are required to diagnose phlegm and blood stasis.

[0103] Those who meet the criteria of "2.3.1" and "2.3.2" Chinese medicine are included in this trial.

[0104] 2.4 Exclusion criteria

[0105] (1) Combined with other diabetic complications (such as diabetic peripheral neuropathy, diabetic nephropathy diagnosis, etc.);

[0106] (2) Current presence of severe primary disease or comorbidities;

[0107] (3) Mental or psychological abnormalities that cannot be treated;

[0108] (4) Patients with allergic or non-acceptance of Chinese medicine ingredients;

[0109] (5) Pregnant or planned pregnancy women;

[0110] (6) Lack of medical records for diagnosis and treatment;

[0111] (7) TCM treatment is not obvious.

[0112] Excluded from the patient population by one of the above.

[0113] 2.5 Western medicine disease efficacy criteria

[0114] Cure: the observation index after treatment decreased by ≥35% compared to before;

[0115] Marked effect: the observation index after treatment decreased by ≥20% but <35% compared to before;

[0116] Effective: the observation index after treatment decreased by ≥10 but <20% compared to before,

[0117] Ineffective: the observation index after treatment decreased by <10 compared to before.

[0118] Note: The blood observation index drop rate calculation formula is: [(pre-treatment value ~ post-treatment value) / pre-treatment value] x 100%.

[0119] 2.6 TCM syndrome efficacy criteria

[0120] Cure: TCM clinical symptoms and signs disappear or basically disappear, and syndrome score reduction ≥95%;

[0121] Marked effect: TCM clinical symptoms and signs improved significantly, and syndrome score reduction ≥70%;

[0122] Effective: TCM clinical symptoms and signs have improved significantly, and syndrome score reduction ≥30%;

[0123] Ineffective: TCM clinical symptoms and signs have not improved significantly, or even worsened, and syndrome score reduction is less than 30%.

[0124] Note: The calculation formula (Nimodipine method) is: [(pre-treatment score ~ post-treatment score) / pre-treatment score] x 100%.

[0125] 2.7 Physical and chemical index detection

[0126] The TCM symptoms, signs, tongue and pulse manifestations are expressed by scoring method, and are observed and recorded once before treatment, 4 weeks and 8 weeks after treatment, and the curative effect of syndromes is calculated by using the nimodipine method to calculate the curative effect integral.

[0127] The body mass index, blood pressure, blood glucose (detecting the fasting blood glucose of each patient), and fasting blood lipid of the patients are measured before treatment, 4 weeks after treatment and 8 weeks after treatment.

[0128] 2.8 Result analysis

[0129] Table 1 Western medicine disease curative effect result

[0130]

[0131] As shown in Table 1, the cure rate of the treatment group is 34.36%, and the effective rate is 95.31%; while the cure rate of the observation group is 21.86%, and the effective rate is 71.88%, the prescription of Example 1 of the application can significantly improve the physical and chemical indicators such as blood glucose and blood lipid, although the Liujunzi Decoction has certain effect, but the treatment effect is lower than that of Example 1 of the application.

[0132] Table 2 TCM syndrome disease curative effect result

[0133]

[0134] As shown in Table 2, the cure rate of the treatment group is 29.69%, and the effective rate is 93.75%; while the cure rate of the observation group is 12.5%, and the effective rate is 68.75%, from the TCM syndromes, it can be seen that the prescription of Example 1 of the application can significantly relieve the pricking pain, or limb numbness, dry mouth, flaccid, fatigue, and chest tightness, phlegm, dizziness, halitosis, headache, insomnia, and joint pain at the extremities.

Claims

1. A traditional Chinese medicine composition for treating metabolic syndrome, characterized in that, The traditional Chinese medicine composition is made from the following raw materials in parts by weight: Poria cocos 10-53 parts by weight, Citrus reticulata peel 6-25 parts by weight, Pinellia ternata 4-21 parts by weight, Allium macrostemon 5-25 parts by weight, Citrus aurantium 4-21 parts by weight, Prunus armeniaca 4-21 parts by weight, Platycodon grandiflorus 5-26 parts by weight, Loranthus parasiticus 7-44 parts by weight, Polyporus umbellatus 6-32 parts by weight, Coix lacryma-jobi 12-63 parts by weight, Pheretima aspergillum 4-21 parts by weight, Glycyrrhiza uralensis 2-8 parts by weight.

2. The traditional Chinese medicine composition for treating metabolic syndrome according to claim 1, characterized in that, The traditional Chinese medicine composition is made from the following raw materials in parts by weight: Poria cocos 10-24 parts by weight, Citrus reticulata peel 6-12 parts by weight, Pinellia ternata 4-9 parts by weight, Allium macrostemon 5-12 parts by weight, Citrus aurantium 4-9 parts by weight, Prunus armeniaca 4-9 parts by weight, Platycodon grandiflorus 5-12 parts by weight, Loranthus parasiticus 7-18 parts by weight, Polyporus umbellatus 6-15 parts by weight, Coix lacryma-jobi 12-30 parts by weight, Pheretima aspergillum 4-9 parts by weight, Glycyrrhiza uralensis 2-3 parts by weight.

3. The traditional Chinese medicine composition for treating metabolic syndrome according to claim 2, characterized in that, The traditional Chinese medicine composition is made from the following raw materials in parts by weight: Poria cocos 24 parts by weight, Citrus reticulata peel 12 parts by weight, Pinellia ternata 9 parts by weight, Allium macrostemon 12 parts by weight, Citrus aurantium 9 parts by weight, Prunus armeniaca 9 parts by weight, Platycodon grandiflorus 12 parts by weight, Loranthus parasiticus 18 parts by weight, Polyporus umbellatus 15 parts by weight, Coix lacryma-jobi 30 parts by weight, Pheretima aspergillum 9 parts by weight, Glycyrrhiza uralensis 3 parts by weight.

4. A method for preparing the traditional Chinese medicine composition with therapeutic effect on metabolic syndrome according to any one of claims 1-3, characterized in that, The preparation method includes the following steps: According to any one of claims 1 to 3, take the following ingredients in the specified weight proportions: Poria cocos, Citrus reticulata peel, Pinellia ternata, Platycodon grandiflorus, Prunus armeniaca, Allium macrostemon, Citrus aurantium, Loranthus parasiticus, Polyporus umbellatus, Coix lacryma-jobi, Pheretima aspergillum, and Glycyrrhiza uralensis. Before decocting, soak the above-mentioned ingredients in the specified weight proportions for 30-40 minutes. Decoction is prepared with normal water quality. Each dose is decocted twice, with 500ml of water added each time. The decoction is prepared for 15-20 minutes, and the filtrate is concentrated to 100ml to obtain the decoction.

5. The use of the traditional Chinese medicine composition with therapeutic effect on metabolic syndrome as described in any one of claims 1 to 3 in the preparation of a drug for treating metabolic syndrome with phlegm and blood stasis syndrome.

6. The use of the traditional Chinese medicine composition with therapeutic effect on metabolic syndrome as described in any one of claims 1 to 3 in the preparation of a drug for treating metabolic syndrome complicated with diabetes.

7. The use of the traditional Chinese medicine composition with therapeutic effect on metabolic syndrome as described in any one of claims 1 to 3 in the preparation of a drug for treating metabolic syndrome complicated with hyperlipidemia.

Images