Traditional Chinese medicine composition for regulating abnormal lipid metabolism as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention discloses a traditional Chinese medicine composition for regulating abnormal lipid metabolism as well as a preparation method and application of the traditional Chinese medicine composition. The traditional Chinese medicine composition for regulating abnormal lipid metabolism is prepared from the following raw materials in parts by weight: 10-30 parts of polygonum cuspidatum; 5-15 parts of coptis chinensis; 10-25 parts of radix paeoniae rubra; 8-20 parts of pollen typhae; 8-25 parts of allium macrostemon; and 5-20 parts of dried orange peel. The preparation method of the traditional Chinese medicine composition for regulating the abnormal lipid metabolism comprises the following steps: adding water into the components in the traditional Chinese medicine composition, decocting and extracting, and concentrating, drying and crushing after extracting to obtain the traditional Chinese medicine composition for regulating the abnormal lipid metabolism. The traditional Chinese medicine composition disclosed by the invention is used for preparing medicines for regulating abnormal lipid metabolism. The traditional Chinese medicine composition disclosed by the invention has the characteristics of multiple targets, multiple pathways, toxicity reduction, efficacy enhancement and the like in treatment of the metabolic syndrome; the metabolic syndrome is improved through multiple effects of promoting blood circulation to remove blood stasis, dissolving turbidity and detoxifying; the medicine is used for treating metabolic syndrome patients mainly suffering from central obesity and covers a wide range of people.

Description

Technical Field

[0001] The present invention belongs to the technical field of pharmaceutical preparations, and relates to a traditional Chinese medicine composition for regulating abnormal lipid metabolism, and a preparation method and application thereof. Background Art

[0002] Abnormal lipid metabolism refers to abnormalities in the synthesis, breakdown, digestion, absorption, and transport of lipids in the body, leading to excess or deficiency of lipids in various tissues, thus impairing bodily function. It is a clinical disease cluster characterized by the accumulation of various risk factors, and can easily lead to metabolic diseases such as diabetes, hyperlipidemia, and hyperuria. It is directly associated with cardiovascular and cerebrovascular diseases, posing a serious threat to health. The liver plays a crucial role in maintaining and regulating blood lipid balance and is a key component of lipid production and breakdown. Problems with liver function can lead to imbalances in lipid metabolism. When lipid metabolism is disrupted, lipids can accumulate in the body, leading to conditions such as hyperlipidemia and obesity. Studies have shown that compared with people without abnormal lipid metabolism, those with abnormal lipid metabolism have a threefold increased incidence of cardiovascular disease (coronary heart disease and stroke), a twofold increased risk of cardiovascular death, a 1.5-fold increased risk of total mortality, and a fivefold increased risk of diabetes (in those who do not yet have diabetes). The International Diabetes Federation (IDF) defines metabolic syndrome as follows: central obesity (waist circumference ≥ 94 cm for European men and ≥ 80 cm for European women; other ethnic groups have their own specific values) plus any two of the following four factors: (1) elevated triglyceride (TG) level: >1.7 mmol / L (150 mg / dL), or treatment for this dyslipidemia has been initiated. (2) decreased high-density lipoprotein cholesterol (HDL-C): <1.0 mmol / L (40 mg / dL) for men and <1.3 mmol / L (50 mg / dL) for women, or treatment for this dyslipidemia has been initiated. (3) elevated blood pressure: systolic blood pressure ≥130 mm Hg (1 mm Hg = 0.133 kPa) or diastolic blood pressure ≥85 mm Hg, or hypertension has been diagnosed and treated. (4) Elevated fasting blood glucose (FPG): ≥ 5.6 mmol / L (100 mg / dl), or diagnosed with type 2 diabetes. Factors that cause abnormal lipid metabolism include genetic, environmental, and social and psychological factors. The pathogenesis of ORMS is very complex, involving obesity, IR, inflammation, neuro-humoral and central regulatory mechanisms, and abdominal obesity and IR are its main pathogenesis. Obesity is a multifactorial disease caused by excessive accumulation of adipose tissue, which is caused by changes in the balance of energy intake / expenditure. Obesity induces endocrine changes in the body, and the metabolic level of fat hormones changes accordingly. Adipose tissue is an energy storage tissue according to the needs of the body. It is now believed that adipose tissue is an endocrine organ that can secrete a variety of fat hormones. Current research hotspots include adiponectin, resistin and leptin, which are involved in metabolic disorders such as obesity.

[0003] Reduced adiponectin levels in obese patients are one of the molecular mechanisms leading to insulin resistance. Resistin is a hormone associated with obesity and diabetes. Studies have shown that excessive resistin secretion can increase blood glucose levels and reduce insulin sensitivity, making resistin a link between obesity and insulin resistance. Leptin can reduce pancreatic fat deposition, leading to obesity and impairing β-cell function. Reduced β-cell function weakens the insulin-stimulating effect of glucagon-like peptide-1 (GLP-1) and, in turn, leads to abnormal function of the GLP-1 receptor agonist. Insulin resistance (IR) is a pathological condition in which insulin-stimulated glucose uptake and utilization are reduced, resulting in decreased responsiveness and sensitivity to the physiological effects of insulin. The resulting disturbances in glucose and lipid metabolism can lead to a variety of metabolic disorders, including diabetes, coronary heart disease, obesity, and metabolic syndrome. IR is a major factor in metabolic inflammation and a central link in the pathogenesis of numerous metabolic diseases. Therefore, obesity causes abnormal secretion of adipokines, which contribute to insulin resistance and lead to metabolic disorders such as glucose and lipids. Identifying therapeutic targets for IR is crucial for the prevention and treatment of diseases associated with abnormal lipid metabolism.

[0004] Dyslipidemia is a metabolic disorder characterized by obesity, hyperglycemia, hypertension, and dyslipidemia. It is a significant risk factor for type 2 diabetes, cardiovascular diseases, and other conditions. Currently, there is a lack of therapeutic drugs on the market. Summary of the Invention

[0005] The purpose of the present invention is to provide a traditional Chinese medicine composition for regulating abnormal lipid metabolism and its preparation method and application.

[0006] This study utilizes modern pharmaceutical technology and advanced analytical methods, combined with clinical application and production practices, to conduct experimental research on the preparation process, pilot validation, and quality standards of Tiaozhi Huomai Granules. Currently, no similar formulations are available on the market. To address this shortage of clinical medications, this Chinese medicine formulation is being promoted and applied, potentially benefiting a wider range of patients with abnormal lipid metabolism.

[0007] The present invention provides a traditional Chinese medicine composition for regulating abnormal lipid metabolism, wherein the raw materials thereof are composed of the following components in parts by weight: 10-30 parts of Polygonum cuspidatum; 5-15 parts of Coptis chinensis; 10-25 parts of Red Peony Root; 8-20 parts of Pollen Typhae; 8-25 parts of Allium macrostemon; 5-20 parts of Tangerine Peel.

[0008] In the above-mentioned traditional Chinese medicine composition, the traditional Chinese medicine composition is composed of the following components in parts by mass: 12 parts of Polygonum cuspidatum; 8 parts of Coptis chinensis; 12 parts of Red Peony Root; 8 parts of Pollen Typhae; 8 parts of Allium macrostemon; and 8 parts of Tangerine Peel.

[0009] The present invention also provides a method for preparing the above-mentioned traditional Chinese medicine composition for regulating abnormal lipid metabolism, comprising the following steps: adding water to each component of the traditional Chinese medicine composition for decoction extraction, concentrating after extraction, drying, and crushing to obtain the traditional Chinese medicine composition for regulating abnormal lipid metabolism.

[0010] In the above preparation method, the water decoction extraction process is to add water and decoct 1 to 3 times (preferably 2 times), the mass of water added each time is 6 to 10 times (preferably 8 times) the total mass of the components in the traditional Chinese medicine composition, and the time for each water decoction extraction can be 1 to 2 hours (preferably 1.5 hours).

[0011] In the above preparation method, the drying temperature can be 50-80°C (preferably 60-70°C), the drying time can be 4-7.5h (preferably 6h), and the particle size after pulverization can be 80 mesh.

[0012] The traditional Chinese medicine composition of the present invention is used for preparing medicine for regulating abnormal lipid metabolism.

[0013] In the above application, the lipid metabolism abnormality is a metabolic disorder syndrome characterized by the accumulation of obesity, hyperglycemia, hypertension or dyslipidemia.

[0014] In the present invention, the abnormal lipid metabolism refers to an imbalance in the synthesis, decomposition or transport of lipid substances in the body, which leads to abnormal indicators such as cholesterol and triglycerides in the blood, and is the physiological and pathological process that triggers diseases such as atherosclerosis and coronary heart disease.

[0015] In the above application, the abnormal lipid metabolism is manifested in at least one of improving blood lipid levels, regulating inflammatory responses, regulating liver function indicators and regulating metabolic enzyme levels.

[0016] In the above application, the improvement of blood lipid levels is reflected in reducing the levels of TC, TG, and LDL-C in serum and / or increasing the level of HDL-C; The regulation of inflammatory response and inhibition of inflammatory factors is manifested in inhibiting the level of at least one of the inflammatory factors interleukin 6 (IL-6), interleukin-1β (IL-1β) and tumor necrosis factor α (TNF-α); The regulation of liver function indicators is reflected in reducing the levels of alanine aminotransferase (ALT) and / or aspartate aminotransferase (AST); The regulating metabolic enzyme level is embodied in regulating the level of at least one of hormone-sensitive lipase (HSL), lipoprotein lipase (LPL) and hepatic lipase (HL).

[0017] In the above applications, the dosage form of the drug is at least one of pills, capsules, granules, oral liquids and tablets; suitable drug carriers in the art can be selected for different dosage forms.

[0018] In the present invention, the pharmaceutical carrier used can be solid or liquid; examples of solid carriers include lactose, kaolin, sucrose, talc, gelatin, agar, pectin, gum arabic, magnesium stearate and stearic acid; examples of liquid carriers include syrup, peanut oil, olive oil and water; When preparing compositions for oral dosage forms, any convenient pharmaceutical medium may be used; for example, water, ethanol, oil, alcohol, flavoring agents, preservatives, coloring agents, etc. may be used to form oral liquid preparations, such as suspensions and solutions; and carriers, such as starch, sugars, microcrystalline cellulose, diluents, granulating agents, emulsifiers, lubricants, binders, disintegrants may be used to form oral solid preparations, such as granules, capsules, and tablets; Granules containing the Chinese medicine composition of the present invention can be made through granulation equipment, and one or more auxiliary ingredients or adjuvants such as sucrose, dextrin, steviol glycosides can be optionally used; the unit dosage form usually contains about 1g to 20g of active ingredient, usually 1g, 3g, 5g, 6g, 10g, 15g or 20g; the pharmaceutical preparation may include (if applicable) one or more additional carrier components, such as diluents, buffers, flavorings, binders, preservatives (including antioxidants), etc. In addition, other excipients such as lactose, starch, cellulose derivatives, magnesium stearate, stearic acid, colorants and flavorings can be added, and the components containing the Chinese medicine composition of the present invention can also be prepared in the form of powder or concentrate.

[0019] The principle of the prescription of the Chinese medicine composition of the present invention is: There is no record of abnormal lipid metabolism in traditional Chinese medicine texts. Based on clinical epidemiology and the opinions of modern Chinese medicine scholars, it is classified as "obesity", "diabetes", "phlegm and fluid", "dampness obstruction" and other categories. Based on many years of clinical experience, this research team has innovatively proposed that its key pathogenesis lies in "phlegm and blood stasis blocking the meridians, and long-term depression turning into heat". Phlegm turbidity, blood stasis, depressed heat, and qi stagnation are the main pathological factors of its onset. "The method is established according to the symptoms, and the prescription is based on the method." Therefore, the key to the treatment method is to "activate blood circulation, remove blood stasis, and resolve turbidity and detoxify."

[0020] In the formula, Polygonum cuspidatum is slightly bitter and slightly cold, and has the functions of promoting dampness and jaundice, clearing heat and detoxifying, dispersing blood stasis and relieving pain; Coptis chinensis is bitter and cold, and can clear heat and dampness, purge fire and detoxify. The two herbs together can promote phlegm, disperse blood stasis, and clear heat. Together, they are the main herbs, dispelling phlegm and blood stasis, and clearing heat and toxins; Red Peony Root is good at clearing heat and cooling blood, promoting blood circulation and removing blood stasis, and Pollen Typhae has the functions of stopping bleeding and removing blood stasis. Together, the two herbs are the minister herbs, helping the main herbs to strengthen the blood circulation and blood stasis removal effect; Xiebai regulates qi and relieves chest tightness, promotes yang and disperses stagnation; Tangerine Peel wakes up the spleen and eliminates dampness, and regulates the qi flow in the middle jiao. Together, the two herbs are the adjuvant herbs, which can strengthen the spleen and stomach, regulate qi and eliminate phlegm, and prevent bitter and cold herbs from obstructing qi flow. The whole formula works together to promote blood circulation and remove blood stasis, resolve turbidity and detoxify, so that qi flow is smooth, obstruction is unblocked, turbid evil can be transformed, and phlegm and blood stasis can be removed.

[0021] The prescriptions in traditional Chinese medicine are not simply the sum of single herbs. This prescription is well-formulated and rigorous, combining the functions of resolving phlegm, dispersing blood stasis, clearing away heat and regulating Qi, targeting the basic pathogenesis of abnormal lipid metabolism, thus demonstrating the efficacy of this prescription.

[0022] The present invention has the effects of promoting blood circulation, removing blood stasis, clearing turbidity and detoxifying. It is used for chest tightness, dizziness, obesity, heaviness of limbs, poor appetite, sticky and uncomfortable stools, yellow urine, dark red tongue, enlarged tongue, greasy or yellow tongue coating, and slippery or stringy pulse caused by the combination of blood stasis, dampness and turbidity, which accumulate and transform into heat; and for patients with abnormal lipid metabolism who have the above symptoms.

[0023] The present invention has the following beneficial effects: 1. Dyslipidemia is a metabolic disorder characterized by obesity, hyperglycemia, hypertension, and dyslipidemia. It is a significant risk factor for type 2 diabetes, cardiovascular diseases, and other conditions. Currently, there is a lack of targeted drugs on the market. Metabolic syndrome falls under the Traditional Chinese Medicine (TCM) category of "obesity" and "phlegm-dampness." This invention offers multiple targets, multiple pathways, and toxicity-reducing and efficacy-enhancing properties for the treatment of metabolic syndrome.

[0024] 2. "Phlegm and blood stasis obstructing the meridians, which turns into heat over time" is the basic pathogenesis of metabolic syndrome. Phlegm, blood stasis, heat and qi stagnation are the main pathological factors of its onset. The present invention improves metabolic syndrome through multiple actions such as promoting blood circulation, removing blood stasis, removing turbidity and detoxifying.

[0025] 3. Abdominal obesity is an important factor causing metabolic syndrome. The present invention mainly treats patients with metabolic syndrome caused by central obesity, covering a wide range of people. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] Figure 1 The present invention is a Chinese medicine composition for the observation of LMA rat liver pathological morphology (200 ×), wherein, Figure 1 In the figure, a represents the blank group; b represents the model group; c represents the positive group; d represents the low-dose group; e represents the medium-dose group; and f represents the high-dose group.

[0027] Figure 2 The Chinese medicine combination of the present invention has no effect on the blood lipid level in the serum of LMA rats.

[0028] Figure 3 This is the effect of the Chinese medicine composition of the present invention on the liver function in the serum of LMA rats.

[0029] Figure 4 This is the effect of the Chinese medicine composition of the present invention on the levels of related metabolic enzymes in the serum of LMA rats.

[0030] Figure 5 This is the effect of the Chinese medicine composition of the present invention on the levels of inflammatory factors in LMA rats. DETAILED DESCRIPTION

[0031] Unless otherwise specified, the experimental methods used in the following examples are conventional methods.

[0032] Unless otherwise specified, the materials and reagents used in the following examples can be obtained from commercial sources.

[0033] The formulations of the following Examples 1-2 are shown in Table 1.

[0034] Table 1

[0035] The preparation method of Example 1 is as follows: 1. Extraction process route design Based on the polarity of the effective chemical components contained in each medicinal flavor in this prescription and combined with clinical application, the preparation process of this embodiment was designed, and the preliminary process was determined to be water decoction extraction of all medicinal material slices.

[0036] 2. Experimental study of extraction process 2.1 Orthogonal experimental design and selection of indicator components The results of the single-factor preliminary experiment showed that the main factors affecting the water decoction extraction effect were the number of extractions, extraction time and amount of water added. At the same time, three levels of each factor were determined and an orthogonal test was conducted. The L9(34) orthogonal table was selected for the experiment.

[0037] In this prescription, the main medicinal ingredients are Polygonum cuspidatum and Coptis chinensis. The main active ingredient in Polygonum cuspidatum is emodin, which was found to be low in preliminary experiments. As one of the main medicinal ingredients, Coptis chinensis plays a crucial role in this prescription. Its signature ingredient, berberine hydrochloride, was measured at a high level without interference from other factors. Therefore, the berberine hydrochloride content in Coptis chinensis was used as an indicator to determine the optimal process conditions. The factor levels are shown in Table 2.

[0038] Table 2 Levels of water decoction extraction factors

[0039] 2.2 Test methods and index determination methods Six medicinal materials including Polygonum cuspidatum were weighed according to the prescribed amount, and decocted and extracted according to the orthogonal experimental arrangement (Table 3). The extract was concentrated, dried at low temperature, and crushed. A certain amount of dry powder was accurately weighed, and its berberine hydrochloride content was determined. The amount of berberine hydrochloride extracted per gram of Coptis chinensis was converted as the basis for calculating the extraction efficiency.

[0040] Determination method: High performance liquid chromatography Chromatographic conditions and system suitability test: Octadecylsilane bonded silica gel was used as the filler; the mobile phase was acetonitrile-0.1% phosphoric acid solution (50:50) (with 0.1 g of sodium lauryl sulfate added per 100 mL); the column temperature was 30°C; the detection wavelength was 265 nm; and the injection volume was 10 μL. The theoretical plate number, calculated based on the berberine hydrochloride peak, should be no less than 4000.

[0041] Preparation of reference solution: Take an appropriate amount of berberine hydrochloride reference substance, accurately weigh it, and add mobile phase to make a solution containing 0.02 mg per 1 ml.

[0042] Preparation of test solution: Take about 0.1 g of dry paste powder (passed through No. 3 sieve) and place it in a 50 ml stoppered conical flask. Accurately add 50 ml of mobile phase, stopper tightly, weigh the weight, and ultrasonically treat (power 250 W, frequency 40 kHz) for 40 minutes. Let cool, weigh the weight again, make up the lost weight with mobile phase, shake well, filter, and take the filtrate.

[0043] Determination Method: Accurately pipette 10 μl of each reference solution and test solution into a liquid chromatograph for determination. Determine the berberine hydrochloride content using HPLC. Results are shown in Table 3.

[0044] 2.3 Determination of process parameters Table 3 Orthogonal test schedule and test results

[0045] Table 3 (Continued) Orthogonal test schedule and test results

[0046] Table 4 Analysis of variance of berberine hydrochloride content

[0047] Note: F 0.05 (2, 2) = 19.0 2.4 Determination of process parameters Analysis of variance for berberine hydrochloride (Table 4) showed no significant influence from factors A, B, and C. Visual analysis indicated that the optimal process was A3B2C3. However, due to the small difference between levels 2 and 3, considering both practical production practices and energy-saving costs, the final extraction process was A2B2C2. This involves decoction twice, with the water added 8 times the volume, for 1.5 hours each time.

[0048] 3. Optimal conditions and methods for key steps in the preparation method (1) Extraction: Add 8 times the amount of water to the six herbs in the prescription and boil them twice, each time for 1.5 hours.

[0049] (2) Concentration: The filtered water extract is heated and concentrated to a thick paste with a relative density of 1.30-1.35 (60°C).

[0050] (3) Crushing: After the thick paste is dried, crush it and pass it through an 80-mesh sieve.

[0051] (4) Therefore, the preparation method of the Chinese medicine composition of the present invention specifically comprises the following steps: adding 8 times the amount of water to the six herbs, namely, Polygonum cuspidatum, Coptis chinensis, Paeonia lactiflora, Pollen truncatum, Allium macrostemon, and Pericarpium Citri Reticulatae, decocting twice for 1.5 hours each time, combining the decoctions, filtering, and concentrating the filtrate to a thick paste with a relative density of 1.30-1.35 (60°C), drying, crushing, and then passing through an 80-mesh sieve to obtain the paste.

[0052] Example 2 1. Experimental Materials 1.1 Animals SD rats (male, SPF grade, 48 rats, weighing (160 ± 20) g, 6-8 months old) were purchased from Sibeifu (Beijing) Biotechnology Co., Ltd., license number: SCXK (Beijing) 2019-0010. The project complies with the requirements of medical ethics (ethics approval number: AWE202305315). The feed required for animal modeling was provided by Xiaoshu Youtai (Beijing) Biotechnology Co., Ltd.: 66.5% rat maintenance feed + 20% sucrose + 15% lard + 2.5% cholesterol + 1% sodium cholate.

[0053] 1.2 Drugs and reagents The Chinese medicine composition Example 2 of the present invention was prepared according to "3. Preferred conditions and methods for key steps in the preparation method" in Example 1 of the present invention. The reagents used in this experiment are shown in Table 5.

[0054] 1.3 Instruments Upright white light photography microscope Eclipse Ci-L Nikon (Japan); pathology slicer RM2016 Shanghai Leica Instrument Co., Ltd.; grinder KZ-III-FP Wuhan Savier Biotechnology Co., Ltd.; microscope Axioscope 5 Carl Zeiss Shanghai Management Co., Ltd.

[0055] Table 5

[0056] Table 5 (Continued)

[0057] 2. Experimental Methods 2.1 Model preparation, animal grouping and drug administration SPF-grade SD male rats were fed a high-fat diet (HFD) for one week after adaptive feeding to establish the LMA rat model. After four weeks of high-fat diet feeding, serum samples were collected from the retinal venous plexus to detect serum TC, TG, LDL-C, and HDL-C indicators to evaluate the success of the model.

[0058] After the model was successfully replicated, the rats were divided into a model group, a positive drug group, and a Chinese medicine Example 2 (low dose, medium dose, and high dose) group, with 8 rats in each group.

[0059] The traditional Chinese medicine composition prepared in Example 2 was divided into three dosage groups: a low-dose 3 g crude drug / (kg·d), a medium-dose 6 g crude drug / (kg·d), and a high-dose 12 g crude drug / (kg·d) group. The positive drug group was orally administered with atorvastatin calcium tablets (Avt) 1.25 mg / (kg·d) with a dosage volume of 10 ml / kg. The blank group and the model group were orally administered with an equal volume of 0.9% normal saline once a day for 4 consecutive weeks.

[0060] 2.2 Sample collection Four weeks after administration, blood was collected from the abdominal aorta of each rat. The blood was then centrifuged at 3500 rpm at 4°C for 15 minutes and the supernatant was collected for later use. Liver tissue was collected, partly fixed with 4% paraformaldehyde, and partly stored frozen at -80°C.

[0061] 2.3 Histopathological examination Liver tissue fixed in 4% paraformaldehyde was obtained, dehydrated, wax-impregnated, embedded, and sectioned. After HE staining, histopathological examination was performed.

[0062] 2.4 Testing of blood lipid levels and related indicators Biochemical kits were used to detect serum total cholesterol (TC), triglyceride (TG), low-density lipoprotein cholesterol (LDL), and high-density lipoprotein cholesterol (HDL). ELISA was used to measure serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), lipoprotein lipase (LPL), hepatic lipase (HL), hormone-sensitive triglyceride lipase (HSL), and inflammatory factors interleukin-6 (IL-6), interleukin-1β (IL-1β), and tumor necrosis factor α (TNF-α).

[0063] 2.5 Statistical analysis Data analysis and image processing were performed using Graphpad Priam 9.5 and other software. Quantitative data were expressed as (x ± s). If normal distribution and homogeneous variance were observed, one-way analysis of variance was performed. If normal distribution or heterogeneous variance were observed, nonparametric tests were used. P < 0.05 was considered statistically significant.

[0064] 3. Results 3.1 Effect of the Traditional Chinese Medicine Composition Prepared in Example 2 on Pathological Changes of LMA Rats by HE Staining The pathological staining results of rats in each group are as follows Figure 1 shown.

[0065] The liver cells of the rats in the control group were uniform in size, tightly arranged, plump in morphology, and without lipid deposition; ballooning of liver cells was widely observed in the liver tissues of the rats in the model group, and the cytoplasm showed a loose reticular structure. Fatty degeneration of liver cells was common, and round vacuoles appeared in the cytoplasm; compared with the model group, the fat vacuoles in the liver cells of the rats in each group of Tiaozhi Huomai Granules were reduced to varying degrees, especially in the high-dose group, where the uniformity of liver cell size was significantly restored and fatty degeneration was reduced.

[0066] 3.2 Effect of the Chinese medicine composition prepared in Example 2 on serum lipid levels in LMA rats The results of blood lipid test of rats in each group are shown in Table 6 and Figure 2 shown.

[0067] Table 6

[0068] Note: Compared with the control group ## P<0.01, # P<0.05; **P<0.01, *P<0.05 compared with the model group.

[0069] Compared with the control group, the TG, TC, and LDL levels of the rats in the model group were significantly increased (P<0.01, P<0.05), and the HDL levels were significantly decreased (P<0.05); compared with the model group, the TC, TG, and LDL levels of the positive drug group were significantly decreased (P<0.01, P<0.05), and the HDL levels were significantly increased (P<0.01); compared with the model group, the serum TG, TC, and LDL levels of the rats in each group of the Chinese medicine composition prepared in Example 2 of the present invention decreased to varying degrees, and the differences between the medium and high dose groups were significant (P<0.05, P<0.01), and the medium and high levels of HDL increased significantly (P<0.01); the results showed that the Chinese medicine composition prepared in Example 2 of the present invention can effectively improve the blood lipid levels in the serum of LMA rats and has a significant effect on regulating lipid disorders.

[0070] 3.3 Effect of Chinese Medicine Example 2 on Liver Function in Serum of LMA Rats The liver function test results of rats in each group are shown in Table 7 and Figure 3 shown.

[0071] Compared with the control group, the AST and ALT levels in the model group were significantly increased (P<0.05, P<0.01); compared with the model group, the AST and ALT levels in the positive drug group were significantly decreased (P<0.05, P<0.01); compared with the model group, the serum ALT levels in each dose group of Chinese Medicine Example 2 were significantly decreased (P<0.05, P<0.01), the AST level in the high-dose group was significantly decreased (P<0.01), and the medium-dose group showed a downward trend (P<0.05), indicating that Chinese Medicine Example 2 has a certain liver protective effect and does not cause liver damage.

[0072] Table 7

[0073] Note: Compared with the control group ## P <0.01; compared with the model group** P <0.01,* P <0.05.

[0074] 3.4 Effects of Chinese Medicine Example 2 on the Levels of Related Metabolic Enzymes in the Serum of LMA Rats The liver function test results of rats in each group are shown in Table 7 and Figure 4 shown.

[0075] Compared with the control group, HSL in the model group was significantly increased (P<0.01), and LPL and HL were significantly decreased (P<0.01, P<0.05); compared with the model group, HSL in the positive drug group was significantly decreased (P<0.01), and LPL and HL were significantly increased (P<0.01, P<0.05); the serum HSL content of rats in each dose group of Chinese medicine Example 2 was significantly decreased (P<0.01, P<0.05), and the serum LPL and HL contents were significantly increased (P<0.01, P<0.05); the low-dose LPL group had no significant difference but showed an upward trend; the results showed that Chinese medicine Example 2 can promote TG hydrolysis, thereby affecting the lipid metabolism of rats.

[0076] 3.5 Effect of Chinese Medicine Example 2 on Inflammatory Factor Levels in LMA Rats The results of hepatitis factors in rats of each group are shown in Table 8 and Figure 5 shown.

[0077] Compared with the control group, the levels of IL-6, IL-Iβ, and TNF in the model group were significantly increased (P<0.01); compared with the model group, the levels of IL-6, IL-Iβ, and TNF in the positive drug group were significantly decreased (P<0.01); compared with the model group, the levels of IL-6, IL-Iβ, and TNF in the high and medium groups of Tiaozhi Huomai Granules were significantly decreased (P<0.01), showing obvious anti-inflammatory effects.

[0078] Table 8

[0079] Note: Compared with the control group ## P <0.01; compared with the model group** P <0.01,* P <0.05.

Claims

1. A Chinese medicine composition for regulating abnormal lipid metabolism, characterized in that: The raw materials are calculated by weight and consist of the following ingredients: 10-30 parts of Polygonum cuspidatum; 5-15 parts of Coptis chinensis; 10-25 parts of Red Peony Root; 8-20 parts of Pollen Typhae; 8-25 parts of Allium macrostemon; 5-20 parts of Tangerine Peel.

2. The Chinese medicine composition according to claim 1, characterized in that The traditional Chinese medicine composition consists of the following components in parts by mass: 12 parts of Polygonum cuspidatum; 8 parts of Coptis chinensis; 12 parts of Red Peony Root; 8 parts of Pollen Typhae; 8 parts of Allium macrostemon; and 8 parts of Citrus reticulatae.

3. A method for preparing the traditional Chinese medicine composition for regulating abnormal lipid metabolism according to claim 1 or 2, comprising the steps of: adding water to each component of the traditional Chinese medicine composition for decoction extraction, concentrating after extraction, drying, and pulverizing to obtain the traditional Chinese medicine composition for regulating abnormal lipid metabolism.

4. The preparation method according to claim 3, characterized in that The water decoction extraction process is to add water and decoct 1 to 3 times, the mass of water added each time is 6 to 10 times the total mass of each component in the traditional Chinese medicine composition, and the time of each water decoction extraction is 1 to 2 hours; The drying temperature is 50-80° C., and the drying time is 4-7.5 h. The particle size after pulverization is 80 mesh.

5. Use of the traditional Chinese medicine composition according to claim 1 or 2 in the preparation of a medicament for regulating abnormal lipid metabolism.

6. The use according to claim 4 or 5, characterized in that The lipid metabolism abnormality is a metabolic disorder syndrome characterized by the aggregation of obesity, hyperglycemia, hypertension or dyslipidemia.

7. The use according to any one of claims 4 to 6, characterized in that The abnormal lipid metabolism is manifested in at least one of improving blood lipid levels, regulating inflammatory responses, regulating liver function indicators, and regulating metabolic enzyme levels.

8. The use according to any one of claims 4 to 7, characterized in that The improvement of blood lipid levels is reflected in reducing the levels of TC, TG, and LDL-C in serum and / or increasing the level of HDL-C; The regulation of inflammatory response and inhibition of inflammatory factors is manifested in inhibiting the level of at least one of the inflammatory factors interleukin-6, interleukin-1β and tumor necrosis factor α; The regulation of liver function indicators is reflected in reducing the levels of alanine aminotransferase and / or aspartate aminotransferase; The regulating metabolic enzyme level is reflected in regulating the level of at least one of hormone-sensitive lipase, lipoprotein lipase and hepatic lipase.

9. The use according to any one of claims 4 to 8, characterized in that The dosage form of the medicine is at least one of pills, capsules, granules, oral liquid and tablets.

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