Traditional Chinese medicine composition for treating dyslipidemia related diseases and application thereof

Abstract

The invention belongs to the technical field of traditional Chinese medicines, and relates to a traditional Chinese medicine composition for treating dyslipidemia related diseases and application thereof. The traditional Chinese medicine composition is prepared from at least the following raw material components in parts by weight: 3-10 parts of sea-buckthorn, 3-24 parts of rhizoma cyperi, 3-15 parts of pericarpium citri reticulatae, 3-30 parts of rhizoma pinellinae praeparata, 6-30 parts of poria cocos, 3-24 parts of rhizoma atractylodis, 3-12 parts of fructus amomi, 3-30 parts of medicated leaven, 5-60 parts of scorched hawthorn fruit, 3-30 parts of fried fructus gardeniae and 3-24 parts of ligusticum wallichii. The traditional Chinese medicine composition has the effects of relieving depression, eliminating phlegm and dissolving turbidity, is clinically used for treating dyslipidemia caused by qi depression and phlegm stagnation, has a remarkable lipid-lowering effect and has no adverse reaction. The raw materials are low in price and cost, and the preparation method is low in condition severity, easy to operate and diversified in processable dosage form.

Description

Technical Field

[0001] The present application belongs to the field of traditional Chinese medicine technology, and relates to a Chinese medicine composition for treating dyslipidemia-related diseases and its use. In particular, the present application relates to an efficient and safe Chinese medicine composition for treating qi stagnation and phlegm stagnation type dyslipidemia-related diseases and its use. Background Art

[0002] Dyslipidemia is one of the main risk factors for atherosclerotic cardiovascular disease (ASCVD). Monitoring of blood lipids has become a primary preventive measure for ASCVD, among which low-density lipoprotein cholesterol (LDL-C) and non-HDL cholesterol (non-HDL-C) are intervention targets for lipid-lowering. Triglycerides have been found to have a positive effect on reducing the risk of ASCVD. Although modern medicine has conducted a lot of research on this type of disease, and statins have become the first choice for treatment, existing research and clinical applications have shown that the adverse reactions and risks of statins in Chinese people are higher than those in Europe and the United States, and side effects such as myalgia, gastrointestinal reactions, and hepatotoxicity often occur.

[0003] In order to reduce or overcome the high risks faced by people using Western medicine to treat dyslipidemia, and to find better treatment drugs or treatment methods, traditional Chinese medicine has also conducted extensive and in-depth research in this field. Many researchers and practitioners in the field of traditional Chinese medicine have studied the treatment of dyslipidemia, and have also summarized the experience of famous doctors to evaluate the effectiveness and safety of traditional Chinese medicine treatment for dyslipidemia. It has been found that traditional Chinese medicine has particularly outstanding advantages in relieving symptoms and adverse reactions when treating such diseases.

[0004] At present, there is no unified understanding of the causes and mechanisms of diseases related to dyslipidemia among various Chinese medicine schools. However, in general, most studies are based on the theory of "blood stasis", sometimes combined with phlegm and dampness, and the treatment method is to activate blood circulation and remove blood stasis. Regarding the cause of the disease, in recent decades, people's dietary structure and lifestyle have undergone tremendous changes, usually excessive intake of fatty and sweet foods, insufficient exercise, high life pressure, and improper emotional adjustment. Excessive intake of fatty and sweet foods causes fat to accumulate in the stomach, and the spleen cannot transfer it in time, which turns into phlegm and turbidity in the stomach; or because modern people have high life pressure, improper emotional adjustment, and insufficient exercise, it is easy to cause liver qi stagnation, qi cannot flow into water, and it is easy to cause water stagnation, which will become phlegm and fluid over time, leading to the occurrence of dyslipidemia. Qi stagnation and phlegm obstruction have become the main pathogenic factors for dyslipidemia in today's society.

[0005] Although many Chinese herbal medicines have lipid-lowering effects, for example, hawthorn, cassia seed, lotus leaf, rhubarb, salvia miltiorrhiza, etc., these medicines have certain lipid-lowering effects when they are decocted alone or taken as tea. However, there is still a lack of effective drugs for patients with dyslipidemia of qi stagnation and phlegm obstruction syndrome in the existing Chinese medicine field. There is an urgent need for a Chinese medicine treatment method and drug that reduces the risk of treatment for Chinese people and is more suitable for the Chinese physique. Summary of the invention

[0006] In order to make up for the above-mentioned defects or shortcomings in the prior art, an object of the present invention application is to provide a traditional Chinese medicine composition for treating diseases related to dyslipidemia, which is prepared from at least the following raw material components: by weight, 3-10 parts of sea buckthorn, 3-24 parts of cyperus rotundus, 3-15 parts of tangerine peel, 3-30 parts of pinellia, 6-30 parts of poria, 3-24 parts of atractylodes, 3-12 parts of amomum, 3-30 parts of Shenqu, 5-60 parts of charred hawthorn, 3-24 parts of chuanxiong and 3-30 parts of stir-fried gardenia.

[0007] Preferably, the Chinese medicine composition is prepared from the following multiple raw material components: 5-10 parts of seabuckthorn, 5-20 parts of cyperus rotundus, 8-12 parts of tangerine peel, 5-26 parts of pinellia, 8-16 parts of poria, 8-18 parts of atractylodes, 3-10 parts of amomum, 10-20 parts of Shenqu, 10-50 parts of charred hawthorn, 6-18 parts of chuanxiong and 8-20 parts of stir-fried gardenia.

[0008] Optimally, the Chinese medicine composition is prepared from the following raw material components: 10 parts of seabuckthorn, 10 parts of cyperus rotundus, 8 parts of dried orange peel, 9 parts of pinellia tuber, 10 parts of tuckahoe, 10 parts of atractylodes, 5 parts of amomum, 15 parts of Shenqu, 15 parts of charred hawthorn, 9 parts of chuanxiong and 10 parts of stir-fried gardenia.

[0009] Furthermore, the Chinese medicine composition is a water-soluble extract of the multiple raw material components.

[0010] Furthermore, the Chinese medicine composition also includes a pharmaceutically acceptable carrier. The Chinese medicine composition can be processed into a variety of dosage forms, including decoctions, powders, pills, pastes, syrups, medicinal teas, granules or capsules.

[0011] Another object of the present invention is to provide a method for preparing a Chinese medicine composition for treating dyslipidemia, wherein the method comprises at least the following steps:

[0012] Step 1: weigh at least the following initial raw material components according to the following weight proportions: 3-10 parts of seabuckthorn, 3-24 parts of cyperus rotundus, 3-15 parts of dried orange peel, 3-30 parts of pinellia tuber, 6-30 parts of tuckahoe, 3-24 parts of atractylodes, 3-12 parts of amomum villosum, 3-30 parts of Shenqu, 5-60 parts of charred hawthorn, 3-24 parts of chuanxiong and 3-30 parts of stir-fried gardenia;

[0013] Step 2: adding water, mixing the mixture in a weight ratio of 6-12:1 between water and the total amount of the above-mentioned raw material components, heating the mixture at at least 80° C. to 100° C. for 0.5-1 hour, filtering the mixture, setting the first filter residue aside, and collecting the first filtrate;

[0014] Step 3: extracting the filter residue with water at least once, mixing the filter residue with a weight ratio of water to the total weight of the initial raw material components of 1-5:1, heating the filter residue at least 80° C. to 100° C. for 0.5-1 hour, filtering the filter residue to obtain a second filter residue, and collecting a second filtrate;

[0015] Step 4: The first filtrate and the second filtrate are combined to obtain an extract containing a Chinese medicine composition for treating dyslipidemia.

[0016] Further, the method further comprises repeating step 3 to collect a third filtrate, wherein water is added to the second filter residue for extraction, mixed in a weight ratio of 1-5:1 between water and the total weight of the initial raw material components, heated at least 80°C to 100°C for 0.5-1 hour, filtered, and the third filtrate is collected.

[0017] Preferably, in the method, the initial raw material components are weighed according to the following weight portions: 5-10 parts of seabuckthorn, 5-20 parts of cyperus rotundus, 8-12 parts of tangerine peel, 5-26 parts of pinellia, 8-16 parts of poria, 8-18 parts of atractylodes, 3-10 parts of amomum, 10-20 parts of Shenqu, 10-50 parts of charred hawthorn, 6-18 parts of chuanxiong and 8-20 parts of stir-fried gardenia.

[0018] Optimally, the method comprises weighing the following initial raw material components in parts by weight: 10 parts of seabuckthorn, 10 parts of cyperus rotundus, 8 parts of dried orange peel, 9 parts of pinellia tuber, 10 parts of tuckahoe, 10 parts of atractylodes, 5 parts of amomum villosum, 15 parts of Shenqu, 15 parts of charred hawthorn, 9 parts of ligusticum chuanxiong and 10 parts of stir-fried gardenia.

[0019] Furthermore, in the method, the extract of the Chinese medicine composition can be taken directly.

[0020] Furthermore, in the method, the first filtrate, the second filtrate and the third filtrate all contain active extracts of various raw materials, which can be used to prepare the dosage form required for the traditional Chinese medicine composition for treating diseases related to dyslipidemia.

[0021] Furthermore, the method also includes combining a pharmaceutically acceptable carrier to process the Chinese medicine composition extract into a variety of dosage forms, including decoctions, powders, pills, pastes, syrups, medicinal teas, granules or capsules.

[0022] Another object of the present invention is to provide a use of any of the above-mentioned Chinese medicine compositions in the preparation of drugs for treating or regulating diseases related to dyslipidemia of qi stagnation and phlegm obstruction type.

[0023] Beneficial Effects

[0024] The Chinese medicine composition for treating dyslipidemia-related diseases provided by the present invention has the active components of each raw material coordinated and synergistic, has the effects of relieving depression, removing phlegm and clearing turbidity, and is clinically used to treat dyslipidemia caused by qi stagnation and phlegm, with significant effects. Furthermore, the price and cost of each raw material component are low. The preparation method is not very harsh, easy to operate, and the decoction is convenient for patients to make and take it by themselves, and other processing methods can also be combined to prepare other dosage forms.

[0025] Through the preparation method provided by the present invention application, the present invention prepares a Chinese medicine composition for treating dyslipidemia-related diseases. In its animal experiment, after the model animals took 8 weeks of treatment, triglyceride (TG) decreased significantly; low-density lipoprotein cholesterol (LDL-C) decreased significantly; liver tissue pathological sections showed that fatty degeneration of liver cells and inflammatory cell infiltration were improved; ileum tissue structure was clear, arranged more neatly, and the structure was more complete; aspartate aminotransferase (AST) level decreased significantly. In clinical trials, it has significant therapeutic effects on patients with dyslipidemia caused by qi stagnation and phlegm stagnation, improves the clinical symptoms of patients with dyslipidemia caused by qi stagnation and phlegm stagnation, and has no adverse reactions. DETAILED DESCRIPTION

[0026] The present application will be further described in detail below in conjunction with specific implementations. It should be understood that the specific implementations described herein are only used to explain the technical solutions and inventive concepts of the present invention, rather than being a limiting description of the present invention.

[0027] It should also be noted that, for the sake of convenience of description, any part not explicitly described should be understood as conventional means or solutions in the prior art, which can achieve the technical effects of the present invention in combination with the technical features shown in the present invention. In the absence of conflict, the specific additional technical features in the embodiments and examples of the present invention can be combined or replaced with each other.

[0028] In a first aspect, the present application provides a traditional Chinese medicine composition for treating diseases related to dyslipidemia, which is prepared from at least the following raw material components: by weight, 3-10 parts of sea buckthorn, 3-24 parts of cyperus rotundus, 3-15 parts of tangerine peel, 3-30 parts of pinellia, 6-30 parts of poria, 3-24 parts of atractylodes, 3-12 parts of amomum, 3-30 parts of Shenqu, 5-60 parts of charred hawthorn, 3-24 parts of chuanxiong and 3-30 parts of stir-fried gardenia.

[0029] Preferably, the Chinese medicine composition is prepared from the following multiple raw material components: 5-10 parts of seabuckthorn, 5-20 parts of cyperus rotundus, 8-12 parts of tangerine peel, 5-26 parts of pinellia, 8-16 parts of poria, 8-18 parts of atractylodes, 3-10 parts of amomum, 10-20 parts of Shenqu, 10-50 parts of charred hawthorn, 6-18 parts of chuanxiong and 8-20 parts of stir-fried gardenia.

[0030] Optimally, the Chinese medicine composition is prepared from the following raw material components: 10 parts of seabuckthorn, 10 parts of cyperus rotundus, 8 parts of dried orange peel, 9 parts of pinellia tuber, 10 parts of tuckahoe, 10 parts of atractylodes, 5 parts of amomum, 15 parts of Shenqu, 15 parts of charred hawthorn, 9 parts of chuanxiong and 10 parts of stir-fried gardenia.

[0031] Furthermore, the Chinese medicine composition is a water-soluble extract of the multiple raw material components.

[0032] Furthermore, the Chinese medicine composition also includes a pharmaceutically acceptable carrier. The Chinese medicine composition can be processed into a variety of dosage forms, including decoctions, powders, pills, pastes, syrups, medicinal teas, granules or capsules, etc. Compared with direct decoctions, concentrated preparations can also be prepared for easy transportation, storage and administration.

[0033] Among them, the pharmaceutically acceptable carriers in the present application include but are not limited to the following: diluents: starch, powdered sugar, lactose, dextrin, microcrystalline cellulose, inorganic salts, sugar alcohols, etc.; wetting agents and binders: purified water, ethanol, gelatin, polyethylene glycol, cellulose derivatives, etc.; disintegrants: starch, sodium carboxymethyl starch, cellulose derivatives, cross-linked polyvinylpyrrolidone, etc.; lubricants: magnesium stearate, micropowdered silica gel, talc, polyethylene glycol, etc.; cosolvents: water, ethanol, glycerol, propylene glycol, liquid paraffin, vegetable oil, etc.; flavoring agents: sucrose, monosaccharides, aromatics, xylitol, oligofructose, etc.; preservatives: benzoic acid, sorbic acid, methyl ester, ethyl ester, propyl ester, etc.

[0034] In a second aspect, the present application provides a method for preparing a Chinese medicine composition for treating dyslipidemia, wherein the method comprises at least the following steps:

[0035] Step 1: weigh at least the following initial raw material components according to the following weight proportions: 3-10 parts of seabuckthorn, 3-24 parts of cyperus rotundus, 3-15 parts of dried orange peel, 3-30 parts of pinellia tuber, 6-30 parts of tuckahoe, 3-24 parts of atractylodes, 3-12 parts of amomum villosum, 3-30 parts of Shenqu, 5-60 parts of charred hawthorn, 3-24 parts of chuanxiong and 3-30 parts of stir-fried gardenia;

[0036] Step 2: adding water, mixing the mixture in a weight ratio of 6-12:1 between water and the total amount of the above-mentioned raw material components, heating the mixture at at least 80° C. to 100° C. for 0.5-1 hour, filtering the mixture, setting the first filter residue aside, and collecting the first filtrate;

[0037] Step 3: extracting the filter residue with water at least once, mixing the filter residue with a weight ratio of water to the total weight of the initial raw material components of 1-5:1, heating the filter residue at least 80° C. to 100° C. for 0.5-1 hour, filtering the filter residue to obtain a second filter residue, and collecting a second filtrate;

[0038] Step 4: The first filtrate and the second filtrate are combined to obtain an extract containing a Chinese medicine composition for treating dyslipidemia.

[0039] Furthermore, the method can also repeat step 3 to collect a third filtrate, wherein water is added to the second filter residue for extraction, mixed in a weight ratio of 1-5:1 between water and the total weight of the initial raw material components, heated at least 80° C. to 100° C. for 0.5-1 hour, filtered, and the third filtrate is collected.

[0040] Preferably, in the method, the initial raw material components are weighed according to the following weight portions: 5-10 parts of seabuckthorn, 5-20 parts of cyperus rotundus, 8-12 parts of tangerine peel, 5-26 parts of pinellia, 8-16 parts of poria, 8-18 parts of atractylodes, 3-10 parts of amomum, 10-20 parts of Shenqu, 10-50 parts of charred hawthorn, 6-18 parts of chuanxiong and 8-20 parts of stir-fried gardenia.

[0041] Optimally, the method comprises weighing the following initial raw material components in parts by weight: 10 parts of seabuckthorn, 10 parts of cyperus rotundus, 8 parts of dried orange peel, 9 parts of pinellia tuber, 10 parts of tuckahoe, 10 parts of atractylodes, 5 parts of amomum villosum, 15 parts of Shenqu, 15 parts of charred hawthorn, 9 parts of ligusticum chuanxiong and 10 parts of stir-fried gardenia.

[0042] Furthermore, in the method, the extract of the Chinese medicine composition can be taken directly.

[0043] Furthermore, in the method, the first filtrate, the second filtrate and the third filtrate all contain active extracts of various raw materials, which can be used to prepare the dosage form required for the traditional Chinese medicine composition for treating diseases related to dyslipidemia.

[0044] Furthermore, the method also includes combining a pharmaceutically acceptable carrier to process the Chinese medicine composition extract into a variety of dosage forms, including decoctions, powders, pills, pastes, syrups, medicinal teas, granules or capsules.

[0045] In a third aspect, the present application provides a use of a Chinese medicine composition in the preparation of a drug for treating or regulating diseases related to dyslipidemia of qi stagnation and phlegm obstruction type.

[0046] Regarding the therapeutic mechanism of the Chinese medicine composition of this application: Seabuckthorn strengthens the spleen and digests food, relieves cough and eliminates phlegm; Cyperus rotundus enters the liver and gallbladder, regulates the qi mechanism, and relieves the liver and gallbladder qi mechanism obstruction; Tangerine peel, Pinellia ternata, and Poria cocos, these three medicines have the effects of resolving phlegm, regulating qi, and strengthening the spleen and eliminating dampness. Pinellia ternata is bitter and pungent in nature and warm in nature, and is good at removing dampness and phlegm; Tangerine peel is aromatic and pleasing to the spleen, is good at drying dampness and resolving phlegm, and is often used in combination with Pinellia ternata to jointly solve the problem of damp phlegm; Poria cocos is sweet and mild in nature, can move the spleen and eliminate dampness, and the three are matched together to act on the basic pathogenesis of phlegm turbidity. Atractylodes lancea removes spleen dampness and relieves the trouble of phlegm and dampness in the spleen and stomach; Amomum villosum is pungent, dispersing, warming, and has a fragrant smell, which has the effect of promoting qi and removing dampness, awakening the spleen and appetizing; Shenqu and charred hawthorn eliminate accumulation and food, promote the healthy movement of the spleen and stomach, and relieve food depression.

[0047] Regarding the dyslipidemia of qi stagnation and phlegm stagnation type, phlegm turbidity gathers in the stomach, affecting the generation and movement of qi and blood, so when treating, Chuanxiong is added to promote blood circulation. In addition, Yangming is a place with more qi and more blood, and the evil in the Yangming stomach is easy to turn into heat, so a small amount of fried Gardenia is used to clear the heat of phlegm turbidity blocking the Yangming stomach. The Chinese medicine composition provided by the application, the active components of each raw material cooperate, has the effects of relieving depression, removing phlegm, and clearing turbidity, and is clinically used to treat dyslipidemia of qi stagnation and phlegm stagnation type, with significant effect.

[0048] Example

[0049] The technical solution adopted to solve the technical problem is embodied through the preferred implementation method, and each technical feature is described in detail.

[0050] Example 1: Effects of Chinese medicine on blood lipid levels in dyslipidemia model rats

[0051] 1. Materials and Methods

[0052] (1) Experimental animals and groups

[0053] 40 male SPF Wistar rats, weighing 200+20g, were provided by Beijing Weitonglihua Experimental Animal Technology Co., Ltd. All animals were kept in a clean animal room. The sealing, air permeability and ventilation of the rat living environment met the requirements. The room temperature was controlled at 21-24℃, the relative humidity was maintained at 40%-50%, the light was on for 12 hours (12 hours of light during the day and 12 hours of darkness at night), and the rats had free access to food and water. After one week of adaptive feeding, the rats were weighed and abnormal rats were eliminated.

[0054] 40 Wistsr rats were taken and fed adaptively for one week, then weighed and abnormal rats were eliminated. Rats were randomly divided into groups and numbered: normal group (n=10) and high-fat group (30 rats). Specifically, normal group (n=10), model group (n=10), Xuezhikang group (n=10), and Chinese medicine group (n=10). Rats in the normal group were fed with ordinary feed, and rats in the high-fat group were fed with high-fat feed. They were free to eat and drink for 12 weeks to establish an animal model of hyperlipidemia. After another 12 weeks of feeding, the Xuezhikang group and the Chinese medicine group were given Xuezhikang capsules and Chinese medicine gavage, respectively, and the normal group and the model group were given an equal amount of purified water for 8 weeks of intervention.

[0055] (2) Experimental drugs and experimental instruments

[0056] Chinese medicine formula granules, the drug composition is prepared from the following raw materials: 10g of seabuckthorn, 10g of cyperus, 8g of dried orange peel, 9g of pinellia tuber, 10g of tuckahoe, 10g of atractylodes, 5g of amomum, 15g of Shenqu, 15g of charred hawthorn, 9g of chuanxiong, and 10g of stir-fried gardenia. The above ten kinds of Chinese herbal medicine raw materials are made into concentrated granules, for example, 10 times concentrated granules. Specifically, the Chinese medicine concentrated granules are prepared by water decoction extraction, low-temperature concentration, spray drying, dry granulation and packaging.

[0057] Xuezhikang Capsules: Beijing PKU Weixin Biotechnology Co., Ltd. (Batch No.: 20180204).

[0058] Preparation of medicine: The clinical dosage of the Chinese medicine prescription is: based on an adult body weight of 70kg, a total of 101g of crude drugs, and its clinical dosage is 1.44g / kg. Referring to the clinical equivalent dose relationship between rats and humans, the drug dosage conversion coefficient between humans (70kg) and rats (0.2kg) is 6.3. It can be determined that the dosage of the Chinese medicine prescription is 1.44×6.3=9.0g / kg, and the granules corresponding to 101g of crude drugs taken orally by an adult are about 9.2g, 101÷9.2=11.0, so the corresponding Chinese medicine granules are 0.8g / kg.

[0059] The dose of Xuezhikang group was 0.1g / kg.

[0060] (3) Blood biochemical index detection

[0061] After 8 weeks of drug intervention, the rats were fasted for 12-16 hours, but not water. After anesthesia with 6% chloral hydrate according to the rat's weight, 4-6 ml of blood was collected from the rat's abdominal aorta using a disposable blood collection needle. The blood was allowed to stand at room temperature for 1 hour, centrifuged at 4°C, 3500r / min for 15 minutes, and the supernatant was separated as serum. Cobas8000 fully automatic biochemical analyzer (Roche, Germany) was used to detect blood biochemical indicators such as TC, TG, LDL-C, and HDL-C.

[0062] 2. Results

[0063] Compared with the normal group, the four blood lipids of the model group rats, TC, TG, and LDL-C, were significantly increased, and HDL-C was reduced (P < 0.01), which showed that the hyperlipidemia rat model was successfully established. Compared with the model group, after 8 weeks of drug intervention, TC and TG in the Xuezhikang group were significantly decreased (P < 0.01), and HDL-C was significantly increased (P < 0.05); TC, TG, and LDL-C in the Chinese medicine group were significantly reduced (P < 0.01).

[0064] Table 1. Changes in four blood lipids (TC, TG, HDL-C, LDL-C) ( mmol / L)

[0065]

[0066] Note: Compared with the normal group, * P<0.05, ** P<0.01; compared with the model group, △ P<0.05, △△ P < 0.01;

[0067] Example 2: Verification of the effect of traditional Chinese medicine on the liver tissue structure of dyslipidemia model rats

[0068] 1. Materials and Methods

[0069] The materials and methods in this Example 2 are the same as those in the above Example 1.

[0070] 2. Results

[0071] Normal group: The liver tissue structure is clear and complete, the liver cells have no obvious fatty degeneration, no inflammatory cell infiltration, degeneration, or necrosis. The liver lobule structure is normal, the liver cells are of normal size, the liver cell nucleus is located in the center, the liver plate structure is clear, the liver cell cords are arranged neatly and radially, and the portal area structure is normal.

[0072] Model group: The liver tissue structure is incomplete, the boundaries are unclear, there are many fat droplets of varying sizes in the liver cytoplasm, the liver cells have obvious fatty changes, the volume is significantly enlarged and rounded, and the liver cells are arranged in disorder, the normal radial arrangement structure disappears, the liver cell nuclei are blurred, and a large number of liver cell nuclei are squeezed to one side. The liver plate structure is unclear, inflammatory cell infiltration can be seen in the portal area, accompanied by necrotic foci and liver sinus stenosis. Compared with the normal group, the liver fatty changes and inflammatory infiltration are obvious.

[0073] Xuezhikang group: fatty degeneration occurred in the hepatocyte area, a certain amount of fat vesicles were visible in the hepatocytes, the degree of fatty degeneration was slightly less than that in the model group, the hepatocyte volume increased, the hepatocyte arrangement was disordered, and some hepatocyte nuclei were squeezed to one side. The liver plate structure was unclear.

[0074] Chinese medicine group: The liver tissue structure was blurred, the liver cells underwent fatty degeneration, and the degree of fatty degeneration was improved compared with the model group. The liver cells increased in size, fat vesicles were visible in the liver cell tissue, the volume of lipid droplets decreased, and the liver cell structure was uneven.

[0075] Example 3: Verification of the effect of traditional Chinese medicine on liver function in dyslipidemia model rats

[0076] 1. Materials and Methods

[0077] The materials and methods in this Example 3 are the same as those in the above Example 1.

[0078] 2. Results

[0079] Compared with the model group, AST in the Chinese medicine group decreased significantly (P<0.01), and the difference was statistically significant;

[0080] Table 2. Comparison of liver function (ALT, AST) (Unit U / L)

[0081]

[0082] Note: Compared with the normal group, * P<0.05, ** P<0.01; compared with the model group, △ P<0.05, △△ P<0.01

[0083] Example 4: Analysis of the effectiveness and safety of the Chinese medicine composition for patients with dyslipidemia and blood lipids due to qi stagnation and phlegm obstruction

[0084] 1. Materials and methods

[0085] 1.1 Research Materials

[0086] (1) Research subjects

[0087] A total of 80 patients with dyslipidemia who met the inclusion and exclusion criteria and whose TCM syndromes were consistent with qi stagnation and phlegm obstruction were selected as the observation subjects. A randomized controlled method was used to divide the patients into an experimental group (experimental group) with 40 cases and a Xuezhikang capsule group (control group) with 40 cases.

[0088] (2) Inclusion criteria

[0089] ① Aged between 18 and 80 years old;

[0090] ②Meet the diagnostic criteria for dyslipidemia;

[0091] ③Meet the diagnostic criteria for Qi stagnation and phlegm obstruction syndrome;

[0092] ④ Those who are currently taking other lipid-lowering drugs or therapies (including physical therapy) need to stop taking the drug or stop the therapy, and still meet the above criteria after 2 weeks of washout;

[0093] ⑤ Voluntarily join this study and sign the informed consent.

[0094] (3) Exclusion criteria

[0095] ① Those with secondary hyperlipidemia caused by other diseases such as hypothyroidism, nephrotic syndrome, diabetes, etc.;

[0096] ②Having suffered from acute cardiovascular and cerebrovascular events or severe trauma within 1 year;

[0097] ③ Patients who need to take lipid-lowering drugs for a long time after previous PCI or other major surgery;

[0098] ④ Patients with serious systemic diseases of the heart, brain, liver, kidney, immune system, etc., or mentally ill patients;

[0099] ⑤ Those who are currently taking drugs that affect blood lipid metabolism, such as glucocorticoids, thyroid hormones, medium-potency diuretics, β-receptor antagonists, etc.;

[0100] ⑥ The patient or his / her spouse is in the period of preparing for pregnancy, pregnancy or breastfeeding;

[0101] ⑦ Those who may be allergic to the drugs in this test;

[0102] ⑧Other situations that may affect the evaluation of the efficacy and safety of the investigational drugs.

[0103] (4) Rejection and shedding criteria

[0104] ① Criteria for case exclusion: patients who were mistakenly admitted, misdiagnosed, did not take medication according to the research protocol, violated the regulations on combined medication, had incomplete clinical test data and could not be evaluated for efficacy, etc.

[0105] ② Dropout criteria: included patients are lost to follow-up; or they voluntarily request to withdraw from the trial due to personal reasons and lack of efficacy; or serious adverse reactions occur during the trial; or they are complicated by other diseases; or they are not suitable to continue the trial, etc.

[0106] (5) Provisions on combined medication

[0107] ① During the trial period (including the washout period), other Chinese and Western medicines or other treatments to improve blood lipid levels shall not be used;

[0108] ② If the medicines or treatments cannot be discontinued due to other diseases, detailed records shall be made in the combined medication form;

[0109] ③ For patients with chronic diseases such as diabetes and hypertension, the type and dosage of medications taken should remain unchanged during the trial, and any emergencies must be recorded.

[0110] 1.2 Study plan

[0111] (1) Grouping

[0112] SPSS23 was used for random grouping. The specific operation of generating the random allocation table was to randomly allocate numbers from 1 to 80 to the experimental group and the control group, that is, there were 40 numbers in each group. The patients were numbered 1 to 80 in the order of inclusion, and the corresponding groups were made according to the above random allocation table. The random allocation table was generated and kept by a dedicated person who was not directly involved in the trial.

[0113] (2) Treatment methods

[0114] ① Experimental group:

[0115] The test composition was administered once a day, divided into two doses, for a total of 12 weeks. The dosage form used was Chinese medicine granules.

[0116] It is prepared from the following raw materials: 10g of seabuckthorn, 10g of cyperus rotundus, 8g of tangerine peel, 9g of pinellia, 10g of poria, 10g of atractylodes, 5g of amomum, 15g of Shenqu, 15g of charred hawthorn, 10g of stir-fried gardenia, and 9g of chuanxiong. The medicine is sourced from the Chinese medicine formula granule pharmacy of Guang'anmen Hospital, China Academy of Chinese Medical Sciences.

[0117] ②Control group: Administer Xuezhikang capsules, 0.6g each time, twice a day, for 12 weeks. The manufacturer is Peking University Weixin; the drug source is the Chinese patent medicine pharmacy of Guang'anmen Hospital of China Academy of Chinese Medical Sciences.

[0118] 1.3 Observation items and testing time points

[0119] (1) Efficacy indicators

[0120] ① TCM syndrome score of qi stagnation and phlegm obstruction;

[0121] ② Blood lipid levels (TC, TG, LDL-C, HDL-C).

[0122] (2) Safety indicators

[0123] ① Routine blood test, routine urine test, and electrocardiogram;

[0124] ② Liver function (ALT, AST, ALP), renal function (BUN, Cr), fasting blood glucose GLU;

[0125] ③ Other adverse events, if they occur, should be recorded in detail in a timely manner.

[0126] (3) Testing time: Efficacy and safety indicators were measured before and after treatment. TCM syndrome scores were recorded before enrollment and every four weeks during treatment, for a total of four times.

[0127] 1.4 Statistical analysis

[0128] SPSS23 was used for statistics. If the experimental results satisfied the normal distribution, the chi-square test was used for the count data, the t-test was used for the measurement data within two groups, and the variance analysis was used for multiple groups. If the normal distribution was not satisfied, the rank sum test was used. P<0.05 was considered statistically significant.

[0129] 2. Results

[0130] 2.1 General Information

[0131] 2.1.1 Gender distribution

[0132] The final number of valid cases included in this trial was 70, with 35 cases in each group. As shown in Table 1, there were 18 males (51%) and 17 females (49%) in the experimental group, while there were 20 males (57%) and 14 females (43%) in the Xuezhikang capsule group. The gender of the two groups was analyzed by the χ2 test. 2 The value was 0.740, P = 0.42 (p > 0.05), indicating that there was no significant difference in gender composition between the two groups.

[0133] Table 3. Gender distribution of subjects

[0134]

[0135] 2.1.2 Age, height, BMI

[0136] The average age of the experimental group and the average age of the Xuezhikang capsule group were P>0.05; at the same time, the differences in height, weight, and BMI between the two groups were compared, and the P values ​​were respectively>0.05. This shows that there is no significant difference in age, height, weight, and BMI between the two groups.

[0137] Table 4. Comparison of subjects' age, height, weight and BMI

[0138]

[0139] 2.1.3 Combination of other diseases and smoking and drinking

[0140] As shown in Table 5, the number of patients in the experimental group with diabetes or hypertension was 4 and 10 respectively; the number of patients in the Xuezhikang capsule group with diabetes or hypertension was 6 and 9 respectively. The P value was greater than 0.05, which indicated that there was no difference in the number of patients in the two groups with diabetes or hypertension.

[0141] As shown in Table 5, among the patients in the experimental group, 11 were smokers and 14 were drinkers; among the patients in the Xuezhikang capsule group, 9 were smokers and 12 were drinkers. The P value was greater than 0.05, indicating that there was no statistical difference in the smoking and drinking habits between the two groups.

[0142] Table 5. Comparison of other diseases, smoking and drinking in the two groups (cases)

[0143]

[0144] 2.2 Efficacy indicators

[0145] 2.2.1 Analysis of efficacy on blood lipid levels

[0146] 2.2.1.1 Comparison of blood lipid indexes

[0147] This study evaluated the efficacy of regulating blood lipid levels mainly through four blood lipid indicators. Before treatment, there was no statistically significant difference in the four blood lipid indicators between the two groups (P>0.05); this shows that the blood lipid levels of the two groups of subjects are comparable.

[0148] In terms of TG, after treatment, the TG of the patients in the experimental group was significantly reduced (P < 0.05); while the difference in the TG reduction of the patients in the Xuezhikang group was not statistically significant (P > 0.05), and the improvement of TG levels was poor. In the comparison of the difference before and after treatment, the reduction of TG in the experimental group was greater than that in the Xuezhikang group (P < 0.05). This shows that the experimental combination is significantly better than Xuezhikang in improving TG levels. (See Table 6)

[0149] In terms of TC, after treatment, the TC of the experimental group did not decrease significantly, and the improvement of TC level was poor (P>0.05); while the difference in TC reduction in the Xuezhikang group was statistically significant (P<0.05). In the comparison of the difference before and after treatment, the degree of decrease in TC of Xuezhikang was greater than that of the experimental combination (P<0.05) (see Table 7).

[0150] In terms of HDL-C, after treatment, there was no significant increase in both groups of patients, and there was no statistically significant difference within or between the groups before and after treatment (P>0.05) (see Table 8).

[0151] In terms of LDL-C, after treatment, there was no significant decrease in both groups of patients, and there was no statistically significant difference between the groups before and after treatment (P>0.05). (See Table 9)

[0152] Table 6. Comparison of TG levels between the two groups (mmol / L, )

[0153]

[0154] Table 7. Comparison of TC levels between the two groups (mmol / L, )

[0155]

[0156] Table 8. Comparison of HDL-C levels between the two groups (mmol / L, )

[0157]

[0158] Table 9. Comparison of LDL-C levels between the two groups (mmol / L, )

[0159]

[0160] Note: Difference before and after treatment = post-treatment level - pre-treatment level (Table 6-9).

[0161] 2.2.2 Analysis of efficacy of TCM syndrome score

[0162] As shown in Table 11, before treatment, there was no significant difference in the TCM syndrome scores between the two groups (P>0.05). After 4 weeks of treatment, there was a significant difference in the scores between the two groups (P<0.05), and the score of the test group was lower than that of the Xuezhikang capsule group. The syndrome scores of each group after treatment were significantly lower than those before treatment (P<0.05). This shows that both groups can significantly improve the symptoms of qi stagnation and phlegm obstruction, but the test combination is significantly better than Xuezhikang.

[0163] Table 10. Comparison of different stages of TCM syndrome scores (points, )

[0164]

[0165] Note: Compared with before treatment, * P<0.05, # P<0.05

[0166] According to the data in Table 10, the overall TCM syndrome scores of the two groups showed a continuous downward trend, and the downward trend of the two groups was similar, but the decline in the experimental group was significantly greater. In the first cycle of treatment (0-4 weeks), the syndrome scores of the two groups decreased significantly; in the second cycle (4-8 weeks of treatment), the decline in the experimental group was smaller than before, but the decline was still large, while the decline in the control group was significantly slower than before; in the third cycle (8 weeks of treatment and after treatment), the scores of both groups continued to decline slowly, indicating that the Chinese medicine combination in the experimental group can better and faster improve the symptoms of qi stagnation and phlegm obstruction.

[0167] The specific score values ​​of each symptom are shown in Table 13. Before treatment, there were no significant differences in the symptoms between the groups (P>0.05). Except for "obesity", the other 14 symptoms in the experimental group were significantly improved (*P<0.05), among which the clinical improvement of the 7 symptoms of "heavy head", "dizziness", "sticky mouth", "chest and flank distension", "abdominal distension", "heavy body and drowsiness", and "sticky and uncomfortable stool" was superior to that of the control group (P<0.05), and the improvement of the remaining symptoms was not statistically significant compared with the Xuezhikang Capsule group (P>0.05). Except for "obesity", "dizziness" and "chest tightness", the other 12 items in the control group were significantly improved (#P<0.05). It shows that the experimental combination is more comprehensive and superior in improving the symptoms of qi stagnation and phlegm obstruction in patients.

[0168] The comparison of the difference in the total score of each symptom is shown in Table 11. It can be clearly seen from Table 11 that after treatment, the syndrome score of the experimental group is lower and the decline is greater. Among them, the six symptoms with the largest decline in the experimental group are "dizziness", "sticky and uncomfortable stool", "heaviness and drowsiness", "abdominal distension", "heaviness in the head" and "chest and flank distension"; while the six symptoms with the largest decline in the experimental group are "heaviness and drowsiness", "sticky and uncomfortable stool", "dizziness", "fatigue and fatigue", "heaviness in the head" and "excessive phlegm".

[0169] Table 11. Improvement of symptoms in the two groups (points, )

[0170]

[0171] Note: Compared with the group before treatment * P<0.05, # P<0.05.

[0172] 2.3 Safety indicators

[0173] The safety of the two groups was compared by t-test and rank sum test, including liver and kidney function, fasting blood sugar, blood and urine routine, heart rate, etc. Before treatment, there was no significant difference in the indicators between the two groups, and the P values ​​were all > 0.05. Before and after treatment, there was no significant difference in the indicators between the experimental group and the control group, P > 0.05. After treatment, there was a statistically significant difference in ALP, WBC, HGB and ERY between the two groups ( * P<0.05; the differences in other items were not statistically significant ( *P >0.05).

[0174] The analysis results show that the test composition has no effect on the subjects' liver and kidney function, fasting blood sugar, urine routine, blood routine, and heart rate; Xuezhikang capsule has a greater effect on the subjects' ALP, WBC, HGB, and ERY than the test group drugs, but the difference based on the comparison within the group itself is not statistically significant, so the overall effect is not significant, indicating that the safety of both groups of drugs is relatively high, but the test composition is safer than Xuezhikang capsule. During the trial, no adverse reactions occurred in the test group and Xuezhikang capsule group (see Table 12).

[0175] Table 12. Safety comparison

[0176]

[0177]

[0178] Note: Compared with the control group, * P<0.05.

[0179] Example 5: Typical cases of patients with dyslipidemia treated with Chinese medicine composition

[0180] Han, male, 42 years old, first visit on September 16, 2019. Previously healthy. Main complaint: heavy head, heavy body, sleepy, depressed mood, normal urination, sticky stool. Pale red tongue, slightly thick white fur with teeth marks, deep pulse. Current medical history: I feel heavy head and dizzy in the past two months, occasionally feel dizzy, and nothing is spinning. I get tired easily, usually work hard, depressed mood, good appetite, slightly greasy diet, heavy body, sleepy, normal urination, sticky stool. Auxiliary examination: total cholesterol: 5.75mmol / L, triglycerides: 1.99mmol / L, low-density lipoprotein cholesterol: 3.63mmol / L, high-density lipoprotein cholesterol: 1.17mmol / L. Western medicine diagnosis: dyslipidemia, Chinese medicine syndrome differentiation is qi stagnation and phlegm obstruction syndrome.

[0181] Oral Chinese medicine decoction provided in the embodiment of the present application is given for treatment, and the decoction is decocted from the following herbs: 10g of seabuckthorn, 10g of cyperus, 8g of dried orange peel, 9g of French pinellia, 10g of Poria, 10g of Atractylodes, 5g of Amomum villosum, 15g of Shenqu, 15g of charred hawthorn, 10g of stir-fried gardenia, and 9g of Chuanxiong. After taking the medicine for 4 weeks: the patient's symptoms of heavy head were relieved compared with before, the stool was normal, but he still felt tired and sleepy occasionally, and the sleep quality was average. After taking the medicine for 8 weeks: the patient complained that the symptoms of heavy head and dizziness had been relieved, and the spirit was good. After taking the medicine for 12 weeks: the patient complained that the sleep quality was still average, and the other symptoms had been relieved. The four blood lipids were rechecked and dropped to normal: total cholesterol: 4,28mmol / L, triglycerides: 1.53mmol / L, low-density lipoprotein cholesterol: 2.94mmol / L, high-density lipoprotein cholesterol: 1.07mmol / L.

[0182] Although the content of the present invention application has been disclosed as above through specific implementation methods, these embodiments are not used to limit the content of the present invention application. Ordinary technicians in this field can modify or adjust the technical solution of the present invention application according to the explicit or implicit content of the present invention application without departing from the concept and scope of the present invention application. All these changes, substitutions or combinations may fall within the scope of patent protection sought by the present invention application. In other words, the scope of protection of the present invention application shall be based on the scope defined by the claims.

Claims

1. A Chinese medicine composition for treating dyslipidemia-related diseases, characterized in that: The traditional Chinese medicine composition is prepared from at least the following raw material components: by weight, 3-10 parts of seabuckthorn, 3-24 parts of cyperus rotundus, 3-15 parts of dried tangerine peel, 3-30 parts of pinellia, 6-30 parts of tuckahoe, 3-24 parts of atractylodes, 3-12 parts of amomum, 3-30 parts of Shenqu, 5-60 parts of charred hawthorn, 3-24 parts of chuanxiong and 3-30 parts of stir-fried gardenia.

2. The Chinese medicine composition according to claim 1, characterized in that: The Chinese medicine composition is prepared from the following raw material components: by weight, 5-10 parts of seabuckthorn, 5-20 parts of cyperus rotundus, 8-12 parts of dried tangerine peel, 5-26 parts of pinellia tuber, 8-16 parts of tuckahoe, 8-18 parts of atractylodes, 3-10 parts of amomum villosum, 10-20 parts of Shenqu, 10-50 parts of charred hawthorn, 6-18 parts of chuanxiong and 8-20 parts of stir-fried gardenia.

3. The Chinese medicine composition according to claim 1, characterized in that The Chinese medicine composition is prepared from the following raw material components: 10 parts of seabuckthorn, 10 parts of cyperus rotundus, 8 parts of dried orange peel, 9 parts of pinellia tuber, 10 parts of tuckahoe, 10 parts of atractylodes, 5 parts of amomum villosum, 15 parts of Shenqu, 15 parts of charred hawthorn, 9 parts of chuanxiong and 10 parts of stir-fried gardenia.

4. The Chinese medicine composition according to claim 1, characterized in that: The active component in the traditional Chinese medicine composition is the water-soluble extract of the raw material component.

5. The Chinese medicine composition according to claim 1, characterized in that: The traditional Chinese medicine composition also includes a pharmaceutically acceptable carrier.

6. The Chinese medicine composition according to claim 1, characterized in that: The Chinese medicine composition can be processed into decoction, powder, pill, paste, syrup, medicinal tea, granule or capsule.

7. A method for preparing a Chinese medicine composition for treating dyslipidemia, characterized in that: The method comprises at least the following steps: Step 1: weigh the initial raw material components according to the following weight proportions: 3-10 parts of seabuckthorn, 3-24 parts of cyperus rotundus, 3-15 parts of dried orange peel, 3-30 parts of pinellia tuber, 6-30 parts of tuckahoe, 3-24 parts of atractylodes, 3-12 parts of amomum villosum, 3-30 parts of Shenqu, 5-60 parts of charred hawthorn, 3-24 parts of chuanxiong and 3-30 parts of stir-fried gardenia; Step 2: adding water, mixing the mixture in a weight ratio of 6-12:1 between water and the total amount of the above-mentioned raw material components, heating the mixture at at least 80° C. to 100° C. for 0.5-1 hour, filtering the mixture, setting the first filter residue aside, and collecting the first filtrate; Step 3: extracting the filter residue with water at least once, mixing the filter residue with a weight ratio of water to the total weight of the initial raw material components of 1-5:1, heating the filter residue at least 80° C. to 100° C. for 0.5-1 hour, filtering the filter residue to obtain a second filter residue, and collecting a second filtrate; Step 4: The first filtrate and the second filtrate are combined to obtain an extract containing a Chinese medicine composition for treating dyslipidemia.

8. The method according to claim 7, characterized in that The method further comprises repeating step 3 and collecting a third filtrate, wherein water is added to the second filter residue for extraction, mixed in a weight ratio of water to the total weight of the initial raw material components of 1-5:1, heated at least 80°C to 100°C for 0.5-1 hour, filtered, and the third filtrate is collected.

9. The method according to claim 7, characterized in that: The initial raw material components are weighed according to the following weight proportions: 10 parts of seabuckthorn, 10 parts of cyperus rotundus, 8 parts of dried tangerine peel, 9 parts of pinellia, 10 parts of tuckahoe, 10 parts of atractylodes, 5 parts of amomum, 15 parts of Shenqu, 15 parts of charred hawthorn, 9 parts of chuanxiong and 10 parts of stir-fried gardenia.

10. Use of the Chinese medicine composition according to any one of claims 1 to 6 in the preparation of a medicament for treating or regulating diseases related to dyslipidemia of qi stagnation and phlegm obstruction type.

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