CN112007124A - Application of a traditional Chinese medicine composition in the preparation of a medicine for treating or preventing hyperlipidemia - Google Patents

Abstract

The invention relates to the field of medicines, and in particular relates to application of a traditional Chinese medicine composition in preparation of a medicine for treating or preventing hypertriglyceridemia, wherein the traditional Chinese medicine composition comprises 1.55 parts by weight of cape jasmine, 1.46 parts by weight of poria cocos, 1.31 parts by weight of salvia miltiorrhiza, 1.37 parts by weight of cortex lycii radicis, 1.08 parts by weight of radix pseudostellariae, 0.68 parts by weight of fructus amomi, 3 parts by weight of raw malt and 1 part by weight of Chinese cabbage seed. The traditional Chinese medicine composition has good treatment and/or prevention effects on hypertriglyceridemia.

Description

Application of a traditional Chinese medicine composition in the preparation of a medicine for treating or preventing hyperlipidemia

technical field

The invention relates to the field of medicine, in particular to the application of a traditional Chinese medicine composition in preparing a medicine for treating or preventing hyperlipidemia.

Background technique

Hypertriglyceridemia refers to a disorder of heterologous triglyceride protein synthesis or degradation. It is an important risk factor for the occurrence of metabolic syndrome-related diseases such as coronary heart disease, hypertension, and diabetes. Active control of high triglycerides is an important link in the primary prevention of metabolic syndrome-related diseases.

Triglyceride (Triglyceride, abbreviated TG), also known as fat, is synthesized from dietary fat and liver, and is a fat molecule formed by long-chain fatty acids and glycerol. It is one of the most important lipids in the blood. They are insoluble in water, combine with proteins to form lipoproteins, and circulate in the blood. Diglyceride reacts with a third fatty acyl-CoA molecule to form triglyceride, which plays a catalytic role. Triglycerides are the most abundant lipids in the human body. Most tissues can use triglyceride decomposition products to supply energy. At the same time, liver, adipose and other tissues can also synthesize triglycerides and store them in adipose tissue. Triglyceride is a relatively important indicator in blood lipid examination, and his indicator directly measures a person's health status.

Cholesterol and triglycerides are the main blood lipid components in plasma. Due to the significant changes in dietary structure and lifestyle in recent years, dyslipidemia has become the biggest health hazard for Chinese people.

Blood lipids are the general term for various lipid substances in the blood. The most important of these are cholesterol and triglycerides. Triglycerides are fats that are insoluble in water and combine with proteins to form lipoproteins that circulate in the blood. Mildly elevated triglycerides may be caused by excessive intake of sugary foods, smoking, obesity and other factors. Severe high triglycerides are mostly related to diabetes, liver disease, chronic nephritis, etc., and are generally secondary diseases.

There are not many effective methods for the treatment of hyperlipidemia in modern medicine, and there are few studies on the prognosis of hyperlipidemia patients with the development of western medicine, and the long-term effect is not ideal. In recent years, Chinese medicine has made great progress in the treatment of hyperlipidemia. Chinese medicine adopts dialectical treatment to treat hyperlipidemia in a targeted manner. It has actually been proved that traditional Chinese medicine can prevent the formation of atherosclerosis, which is beneficial to the prevention and treatment of heart, brain and other important organs and vascular diseases, and has obtained good curative effects.

Therefore, it is necessary to develop a new traditional Chinese medicine composition for use in the preparation of medicines for treating or preventing hyperlipidemia.

SUMMARY OF THE INVENTION

In view of the above technical situation, the object of the present invention is to provide a new application of Chinese medicinal composition in the preparation of medicine for treating or preventing hyperlipidemia. It is composed of ginseng, Amomum, raw malt and cabbage.

In the present invention, as one of the embodiments, the Chinese medicine composition is used in the preparation of a medicine for treating or preventing the elevation of serum total cholesterol or triglyceride.

In the present invention, as one of the embodiments, the application of the traditional Chinese medicine composition in the preparation of a medicine for treating or preventing elevated triglycerides.

In the present invention, as one of the embodiments, the application of the traditional Chinese medicine composition in the medicine for the treatment or prevention of elevated triglyceride; preferably the application in the medicine for the treatment or prevention of hypertriglyceridemia.

In the application of the present invention, the dosage range of the traditional Chinese medicine composition is: 5-10 g/day (in traditional Chinese medicine pills) to an adult subject. Calculation), as an exemplary illustration, can be administered to adult subjects 5g/day, 6g/day, 7g/day, 8g/day, 9g/day, 10g/day Chinese medicine pills of the present invention.

The present invention also provides a traditional Chinese medicine composition, which, by weight, consists of 1.25-1.55 parts of Gardenia, 1.25-1.46 parts of Poria, 0.925-1.31 parts of Salvia miltiorrhiza, 1.1-1.37 parts of Digupi, and Taizishen It consists of 0.925-1.08 parts, 0.55-0.68 parts of Amomum, 3 parts of raw malt, and 1 part of Caifuzi.

As one of the embodiments, the traditional Chinese medicine composition of the present invention, by weight, consists of 1.55 parts of Gardenia, 1.46 parts of Poria, 1.31 parts of Salvia miltiorrhiza, 1.37 parts of Digupi, 1.08 parts of Taizishen, 0.68 parts of Amomum chinensis, and 3 parts of raw malt. 1 serving, and 1 serving of vegetables.

As one of the embodiments, the traditional Chinese medicine composition of the present invention, by weight, is composed of 1.25 parts of Gardenia, 1.25 parts of Poria, 0.925 parts of Salvia miltiorrhiza, 1.1 parts of Digupi, 0.925 parts of Taizishen, 0.55 parts of Amomum chinensis, and 3.0 parts of raw malt. servings, 1.0 servings of cabbage.

As one of the embodiments, the extract of the traditional Chinese medicine composition of the present invention is ethanol.

The present invention also provides a method for preparing a traditional Chinese medicine composition, the method comprising:

(1) Extracting 2 times of 80% ethanol with 80% ethanol from Zhongdan participating in the prescription, the first time adding 5 times the amount of 80% ethanol to extract for 2 hours, the second time adding 4 times the amount of 80% ethanol to extract for 1.5 hours, and filtering , the medicinal residues are collected in another container for use; the two filtrates before and after are combined, and ethanol is recovered under reduced pressure to a clear paste with a relative density of about 1.20 (70°C), which is set aside for use;

(2) pulverize 1/10 of the recipe amount of Poria cocos through a 100-mesh sieve, sieve out the fine powder, and the remaining coarse particles will be used separately;

(3) add 7 times the amount of water for decocting for 2 hours by adding 7 times the amount of water to the Poria cocos with the prescription proportions of Zhongsheng malt, Digupi, Laifuzi, and Taizi participating in the rest of the prescription, and collect the filtrate; The slag is collected separately for use;

(4) extract volatile oil 2 hours by adding 8 times of water of Amomum chinensis in prescription ratio, collect volatile oil for subsequent use;

(5) merge above-mentioned gained medicinal dregs, add 5 times of water and decoct for 1.5 hours, filter, collect filtrate; then merge with the filtrate in steps (3) and (4), concentrate under reduced pressure to a relative density of about 1.20 clearing paste; combining the obtained clearing paste with salvia miltiorrhiza and gardenia alcohol extracting paste, mixing, concentrating to a thick paste with a relative density of about 1.40, drying under reduced pressure, and pulverizing into fine powder of extract;

(6) Mix and dry extract fine powder, Amomum volatile oil and sterilized Poria fine powder to obtain.

The present invention also provides a preparation containing a traditional Chinese medicine composition, the preparation is composed of a traditional Chinese medicine composition and pharmaceutical excipients, as one of the embodiments, the excipients include but are not limited to beta cyclodextrin, corn starch, talcum powder , or a combination of two or more of them.

In the present invention, as one of the embodiments, the formulations include but are not limited to pills, drop pills, capsules or granules.

Those skilled in the art prepare the traditional Chinese medicine composition of the present invention and the above-mentioned adjuvants including but not limited to the present invention into pills, dripping pills, capsules or granules in combination with common technical knowledge in the art and conventional preparation methods.

As one of the embodiments, the preparation is preferably a pill; as one of the embodiments, the auxiliary materials of the pill are betacyclodextrin, corn starch and talc.

The present invention further provides a preparation method of the pill, and the preparation method of the preparation comprises:

(1) Extracting 2 times of 80% ethanol with 80% ethanol from Zhongdan participating in the prescription, the first time adding 5 times the amount of 80% ethanol to extract for 2 hours, the second time adding 4 times the amount of 80% ethanol to extract for 1.5 hours, and filtering , the medicinal residues are collected in another container for use; the two filtrates before and after are combined, and ethanol is recovered under reduced pressure to a clear paste with a relative density of about 1.20 (70°C), which is set aside for use;

(2) 1/10 of the recipe volume of Poria cocos in the recipe is pulverized through a 100-mesh sieve, and the fine powder is sieved, and the remaining coarse particles are set aside for use;

(3) add 7 times the amount of water for decocting for 2 hours by adding 7 times the amount of water to the Poria cocos with the prescription proportions of Zhongsheng malt, Digupi, Laifuzi, and Taizi participating in the rest of the prescription, and collect the filtrate; The slag separator is collected for use;

(4) add 8 times of water in the prescription proportion to extract volatile oil for 2 hours, collect volatile oil, use beta cyclodextrin inclusion, get Amomum vulgaris volatile oil beta cyclodextrin inclusion compound for subsequent use; Amomum glutinosa filtrate Collected separately from the dregs for use;

(5) merge above-mentioned gained medicinal dregs, add 5 times of water for decocting for 1.5 hours, filter, collect filtrate; then merge with step (3) and (4) gained filtrate, concentrate under reduced pressure to a relative density of about 1.20(70 ℃) clearing paste; the obtained clearing paste is combined with Salvia miltiorrhiza and gardenia alcohol clearing paste, mixed, concentrated to a thick paste with a relative density of about 1.40 (70°C), dried under reduced pressure, and pulverized into a fine powder of the extract. Can;

(6) The extract fine powder, Amomum volatile oil beta cyclodextrin inclusion complex and sterilized Poria cocos fine powder are made into pellets with honey water (refined honey: water = 1:3), dried, and mixed with cornstarch and talc. Powder coating, that is.

The new traditional Chinese medicine composition of the invention has a good effect on treating or preventing hyperlipidemia, especially hypertriglyceridemia, and has a good synergistic effect.

Description of drawings

Figure 1 shows the body weight changes of mice fed a high-fat diet treated with the Chinese pills of the present invention.

Figure 2 shows the changes in serum total cholesterol levels of high-fat diet-fed mice treated with the Chinese pills of the present invention.

Figure 3 shows the changes in serum triglyceride levels in high-fat diet-fed mice treated with the Chinese pills of the present invention.

Figure 4 is a representative histological image (H&E, 200X magnification) of mouse liver tissue showing varying degrees of steatosis. A. 0% steatosis; B. 5-10% steatosis; C. 60% steatosis; D. 90% steatosis.

Detailed ways

The present invention is further illustrated by the following examples and experimental examples, which are not intended to limit its scope.

Preparation of traditional Chinese medicine composition

Example 1

1) Chinese medicine composition formula (by weight):

2) Preparation method:

(1) Extracting 2 times of 80% ethanol with 80% ethanol from Zhongdan participating in the prescription, the first time adding 5 times the amount of 80% ethanol to extract for 2 hours, the second time adding 4 times the amount of 80% ethanol to extract for 1.5 hours, and filtering , the medicinal residues are collected in another container for use; the two filtrates before and after are combined, and ethanol is recovered under reduced pressure to a clear paste with a relative density of about 1.20 (70°C), which is set aside for use;

(2) pulverize 1/10 of the recipe amount of Poria cocos through a 100-mesh sieve, sieve out the fine powder, and the remaining coarse particles will be used separately;

(3) add 7 times the amount of water for decocting for 2 hours by adding 7 times the amount of water to the Poria cocos with the prescription proportions of Zhongsheng malt, Digupi, Laifuzi, and Taizi participating in the rest of the prescription, and collect the filtrate; The slag is collected separately for use;

(4) extract volatile oil 2 hours by adding 8 times of water of Amomum chinensis in prescription ratio, collect volatile oil for subsequent use;

(5) merge above-mentioned gained medicinal dregs, add 5 times of water and decoct for 1.5 hours, filter, collect filtrate; then merge with the filtrate in steps (3) and (4), concentrate under reduced pressure to a relative density of about 1.20 clearing paste; combining the obtained clearing paste with salvia miltiorrhiza and gardenia alcohol extracting paste, mixing, concentrating to a thick paste with a relative density of about 1.40, drying under reduced pressure, and pulverizing into fine powder of extract;

(6) Mix and dry extract fine powder, Amomum volatile oil and sterilized Poria fine powder to obtain.

Example 2

1) Chinese medicine composition formula (by weight)

2) Preparation method: (1) Extracting the formula and proportion of Zhongdan Participation Gardenia with 80% ethanol for 2 times, adding 5 times the amount of 80% ethanol for 2 hours for the first time, and adding 4 times the amount of 80% ethanol for the second time to extract. 1.5 hours, filter, and collect the dregs in another container for later use; combine the two filtrates before and after, and recover ethanol under reduced pressure to a clear paste with a relative density of about 1.20 (70° C.), set aside for use;

(2) pulverize 1/10 of the recipe amount of Poria cocos through a 100-mesh sieve, sieve out the fine powder, and the remaining coarse particles will be used separately;

(3) add 7 times the amount of water for decocting for 2 hours by adding 7 times the amount of water to the Poria cocos with the prescription proportions of Zhongsheng malt, Digupi, Laifuzi, and Taizi participating in the rest of the prescription, and collect the filtrate; The slag is collected separately for use;

(4) extract volatile oil 2 hours by adding 8 times of water of Amomum chinensis in prescription ratio, collect volatile oil for subsequent use;

(5) merge above-mentioned gained medicinal dregs, add 5 times of water and decoct for 1.5 hours, filter, collect filtrate; then merge with the filtrate in steps (3) and (4), concentrate under reduced pressure to a relative density of about 1.20 clearing paste; combining the obtained clearing paste with salvia miltiorrhiza and gardenia alcohol extracting paste, mixing, concentrating to a thick paste with a relative density of about 1.40, drying under reduced pressure, and pulverizing into fine powder of extract;

(6) Mix and dry extract fine powder, Amomum volatile oil and sterilized Poria fine powder to obtain.

Preparation of traditional Chinese medicine composition pills

Example 3

1) Chinese medicine composition formula (by weight)

2) Accessories

Beta cyclodextrin 0.04

Cornstarch 3% (based on total blend amount)

Talc 0.8% (based on the amount of the blend)

3) Preparation method

(1) Extracting 2 times of 80% ethanol with 80% ethanol from Zhongdan participating in the prescription, the first time adding 5 times the amount of 80% ethanol to extract for 2 hours, the second time adding 4 times the amount of 80% ethanol to extract for 1.5 hours, and filtering , the medicinal residues are collected in another container for use; the two filtrates before and after are combined, and ethanol is recovered under reduced pressure to a clear paste with a relative density of about 1.20 (70°C), which is set aside for use;

(2) 1/10 of the recipe volume of Poria cocos in the recipe is pulverized through a 100-mesh sieve, and the fine powder is sieved, and the remaining coarse particles are set aside for use;

(3) add 7 times the amount of water for decocting for 2 hours by adding 7 times the amount of water to the Poria cocos with the prescription proportions of Zhongsheng malt, Digupi, Laifuzi, and Taizi participating in the rest of the prescription, and collect the filtrate; The slag separator is collected for use;

(4) add 8 times of water in the prescription proportion to extract volatile oil for 2 hours, collect volatile oil, use beta cyclodextrin inclusion, get Amomum vulgaris volatile oil beta cyclodextrin inclusion compound for subsequent use; Amomum glutinosa filtrate Collected separately from the dregs for use;

(5) merge above-mentioned gained medicinal dregs, add 5 times of water for decocting for 1.5 hours, filter, collect filtrate; then merge with step (3) and (4) gained filtrate, concentrate under reduced pressure to a relative density of about 1.20(70 ℃) clearing paste; the obtained clearing paste is combined with Salvia miltiorrhiza and gardenia alcohol clearing paste, mixed, concentrated to a thick paste with a relative density of about 1.40 (70°C), dried under reduced pressure, and pulverized into a fine powder of the extract. Can;

(6) The extract fine powder, Amomum volatile oil beta cyclodextrin inclusion complex and sterilized Poria cocos fine powder are made into pills with honey water (refined honey: water = 1:3), dried, and made into 1000g, with Cornstarch and talc coating, that is.

Example 4

1) Chinese medicine composition

2) Accessories (in parts by weight)

Beta cyclodextrin 0.04

Cornstarch 3% (based on total blend amount)

Talc 0.8% (based on the amount of the blend)

3) Preparation method

(1) Extracting 2 times of 80% ethanol with 80% ethanol from Zhongdan participating in the prescription, the first time adding 5 times the amount of 80% ethanol to extract for 2 hours, the second time adding 4 times the amount of 80% ethanol to extract for 1.5 hours, and filtering , the medicinal residues are collected in another container for use; the two filtrates before and after are combined, and ethanol is recovered under reduced pressure to a clear paste with a relative density of about 1.20 (70°C), which is set aside for use;

(2) 1/10 of the recipe volume of Poria cocos in the recipe is pulverized through a 100-mesh sieve, and the fine powder is sieved, and the remaining coarse particles are set aside for use;

(3) add 7 times the amount of water for decocting for 2 hours by adding 7 times the amount of water to the Poria cocos with the prescription proportions of Zhongsheng malt, Digupi, Laifuzi, and Taizi participating in the rest of the prescription, and collect the filtrate; The slag separator is collected for use;

(4) add 8 times of water in the prescription proportion to extract volatile oil for 2 hours, collect volatile oil, use beta cyclodextrin inclusion, get Amomum vulgaris volatile oil beta cyclodextrin inclusion compound for subsequent use; Amomum glutinosa filtrate Collected separately from the dregs for use;

(5) merge above-mentioned gained medicinal dregs, add 5 times of water for decocting for 1.5 hours, filter, collect filtrate; then merge with step (3) and (4) gained filtrate, concentrate under reduced pressure to a relative density of about 1.20(70 ℃) clearing paste; the obtained clearing paste is combined with Salvia miltiorrhiza and gardenia alcohol clearing paste, mixed, concentrated to a thick paste with a relative density of about 1.40 (70°C), dried under reduced pressure, and pulverized into a fine powder of the extract. Can;

(6) The extract fine powder, Amomum volatile oil beta cyclodextrin inclusion complex and sterilized Poria cocos fine powder are made into pills with honey water (refined honey: water = 1:3), dried, and made into 1000g, with Cornstarch and talc coating, that is.

Test Example 1

Samples and Reagents

Chinese medicine pills of the present invention are prepared according to Example 3;

High-fat diet: (HFD Research Diets, New Brunswick, NJ; Cat. No. D12492), which is 60% fat;

A low-fat control diet (LFD; Research Diets; Cat. No. D12492) was only 10% fat.

Animal models and study design

Five-week-old C57BL/6J male mice were used as an animal model to simulate human metabolic abnormalities.

All mice were housed in a pathogen-free environment with temperature (22±2°C), humidity (40-60%), and a 12:12 hour light-dark cycle. All mice were fed ad libitum. After 7 days of acclimatization to a standard food environment, mice were randomly assigned to: be fed a high-fat diet (HFD; Research Diets, New Brunswick, NJ; Catalog No. D12492) with 60% fat; or its corresponding low-fat diet A fat control diet (LFD; Research Diets; Cat. No. D12492), whose sucrose content matched the HFD, but was only 10% fat.

Mice were divided into different groups according to diet and intervention (Table 1). For all groups, mice were first fed LFD or HFD for 10 weeks, followed by an 8-week intervention period (with Chinese medicine pills or water (as placebo)).

Table 1. Diet and Handling Protocols for Different Groups of Mice

*Dose definition: normal = 46.2 mg/50 g mice; low dose = half the normal dose (23.1 mg/50 g mice); high dose = twice the normal dose (92.4 mg/50 g mice).

Each group consisted of 10 mice. Group 1 consisted of LFD-fed mice (n=10), which served as low-fat normal controls. Group 2 is a model control of HFD-fed mice (n=10). Groups 3, 4 and 5 were HFD-fed mice, administered with different doses (low, normal or high dose) of the Chinese medicine pills of the present invention, respectively.

The normal dose was determined to be 46.2mg Chinese medicine pills/50g mice. Traditional Chinese medicine pills are prepared in the form of suspension in water and administered by oral gavage every day. The high dose was set at twice the normal dose (92.4 mg Chinese medicine pill/50 g mouse), and the low dose was set at half the normal dose (23.1 mg/50 g mouse). As a placebo, no intervention control mice were administered water equivalent to the volume of a Chinese medicine pill.

Mice were weighed weekly and the dose of Chinese medicine pills (or water) for each mouse was based on body weight. Traditional Chinese medicine pills were administered for 8 weeks.

At baseline, (before TCM pill treatment/placebo), 50 μL of blood was collected from the tail vein. Mice were sacrificed at the end of the experiment (8 weeks after intervention), and blood and liver tissue were collected for analysis. All animal experiments were performed in accordance with the Guide for the Use of Laboratory Animals of the Committee on the Use of Live Animals in Teaching and Research of the University of Hong Kong.

Biochemical analysis

Serum ALT and AST were assessed using the ALT/GPT Liqui-UV assay and the AST/GOT Liqui-UV assay (both from Stanbio Laboratory, Boerne, TX), respectively. Serum triglycerides and total cholesterol were analyzed using the LiquiColor triglycerides and cholesterol LiquiColor assays (both from Stanbio Laboratory), respectively.

Histological analysis

Liver tissue specimens were fixed in 10% buffered formalin, embedded in paraffin, cut to 5 μm thickness, and stained with hematoxylin and eosin. The degree of steatosis was assessed by a pathologist, blinded to the experimental design, and according to the system described by Kleiner et al. (Hepatology 2005;41:1313-21). Fat change was expressed as a percentage of steatotic cells and was classified as previously described: no steatosis (<5% fat change); low-grade steatosis (5-33% fat change); moderate steatosis (>33% fat change) -66% fat change); and severe steatosis (>66% fat change).

Statistical analysis was performed using SPSS 25.0 (SPSS, Chicago, IL). Continuous variables were expressed as mean ± standard error of the mean (SEM) and analyzed using Student's t-test or one-way ANOVA test. Categorical variables were analyzed using the chi-square test or Fisher's exact test. P<0.05 was considered statistically significant.

Experimental results

Baseline Characteristics

Mice assigned to LFD and HFD had comparable body weights (22.5±0.3 g and 22.1±0.1 g, respectively; P=0.331) before being fed the different diets. At week 0 of the intervention (baseline) (ie, after 10 weeks of differential diet and before TCM pill administration), HFD-fed mice (average body weight: 44.1 ± 0.5 g) were more likely than LFD-fed mice (average body weight) : 29.9±0.6 g; P<0.001) was much heavier. After 10 weeks of the diet, the mean weight change of LFD-fed mice was 7.4±0.6 g, while the mean weight change of HFD-fed mice was 22.0±0.5 g (P<0.001).

Serum total cholesterol levels of HFD-fed mice (129.6±3.5 mg/dL) were significantly higher than those of LFD-fed mice (79.1±8.4 mg/dL; P<0.001). Serum glycerol of HFD-fed mice Triester levels (76.0±6.1 mg/dL) were higher than in LFD-fed mice (41.4±3.8 mg/L; P=0.052).

HFD-fed mice were then assigned to receive different doses of Chinese medicine pills (or water as a placebo control). At baseline (start of Chinese medicine pill treatment), body weight, serum total cholesterol and triglycerides were well balanced and comparable between groups of HFD-fed mice that received different treatments (Table 2).

Table 2. Baseline characteristics of different groups of mice

LFD: low-fat diet; HFD: high-fat diet

Influence of the traditional Chinese medicine pill of the present invention on fatty liver mice induced by high-fat diet

average weight

At the end of the experiment, the mean body weight of HFD-fed control mice (Group 2) was 49.2 ± 0.68 g, 14.8% heavier than baseline (pre-treatment) body weight. At the end of treatment, HFD-fed control mice had significantly greater body weight gain than LFD-fed control mice (Group 1), which had an average body weight gain of 3.3% (P=0.041). Body weight was also increased in HFD-fed mice (mean increase: 5.1-12.0%) that received the Chinese medicine pill. Weight gain in each treatment group was slightly lower than in the HFD placebo group, but the difference in weight change was not statistically significant. No dose effect on body weight change was observed in the Chinese medicine pill group (Fig. 1); the experimental results show that the Chinese medicine pill of the present invention effectively reduces the weight gain of mice caused by high-calorie diet, and has corresponding effective prevention or Therapeutic effect.

total cholesterol level

In LFD-fed control mice, total cholesterol levels increased by a further 16.9% at the end of treatment (compared to baseline), while HFD-fed placebo mice had a 57.7% increase in total cholesterol at the end of treatment (P= 0.073). For mice treated with TCM pills (Figure 2), the mean increases in total cholesterol levels at the end of low, normal and high dose TCM pill treatment were 39.4%, 14.6% and 7.9%, respectively. P values (compared to placebo) were 0.388, 0.075 and 0.049, respectively. Overall, a dose effect of serum total cholesterol (P=0.043) was observed by comparing the placebo group and the three dose groups of Chinese medicine pills; Cholesterol-increasing effect, with corresponding effective preventive or therapeutic effect.

Serum triglyceride levels

Compared to baseline, LFD-fed mice had a further 6.5% increase in serum triglyceride levels by the end of the experiment. The mean increase in serum triglycerides in LFD fed mice was significantly less than in HFD fed placebo control mice (35.0% increase from baseline; P=0.022). Serum triglycerides were reduced at the end of treatment in all mice treated with Chinese medicine pills. Mean reductions in triglycerides were 4.2%, 11.2%, and 18.6% in low-dose, normal-dose, and high-dose Chinese pill-treated mice (all P<0.05 compared to placebo; Figure 3). A dose-dependent decrease in serum triglyceride levels was observed in mice treated with Chinese medicine pills (P=0.006); (The experimental results showed that Chinese medicine pills effectively reduced the increase in serum triglycerides in mice caused by high-calorie diet, and had a corresponding effect. effective preventive or therapeutic effect.

Serum ALT and AST

At the end of the treatment period, LFD-fed control mice had mean serum ALT and AST of 17.6 ± 7.8 U/L and 69.3 ± 5.9 U/L, respectively, lower than HFD-fed placebo mice (ALT: 55.8 ±11.0 U/L; P=0.013 and AST: 128.3±23.1 U/L; P=0.035). Compared with the placebo group, ALT and AST levels were lower in mice treated with Chinese medicine pills, although the difference was not statistically significant and no dose effect was observed (Table 3); ALT and AST are commonly used in clinical practice Liver injury indicators, the research results show that Chinese medicine pills can effectively reduce the effect of high-calorie diet-induced liver injury in mice, and have corresponding effective preventive or therapeutic effects.

Table 3. Liver enzyme levels in different groups of mice at the end of the experiment

*P<0.05 relative to the control group (Group 2)

ALT: alanine aminotransferase; AST: aspartate aminotransferase

Degree of hepatic steatosis

Table 4 Degree of hepatic steatosis in the liver at the end of the experiment

No steatosis (<5% cells with adipose changes); low-grade steatosis (5-33% cells with adipose changes); moderate steatosis (>33-66% cells with adipose changes); severe steatosis (>66 cells with adipose changes) %)

At the end of the experiment, all LFD-fed control mice had less than 5% fat change (no steatosis), while 9 of 10 HFD-fed placebo mice (90%) had severe steatosis (The remaining mice had moderate steatosis). Overall, of the 30 mice treated with the Chinese medicine pill, 15 (50%) had severe steatosis, while 7 (23.3%) had no or low-grade steatosis. The proportion of mice with severe steatosis treated with Chinese medicine pills was significantly lower than that of untreated HFD-fed placebo mice (P=0.025). Representative histological results are shown in Figure 4; the experimental results show that Chinese medicine pills effectively reduce the effect of high-calorie diet-induced liver fat accumulation (ie, fatty liver) in mice, and have corresponding effective preventive or therapeutic effects.

Claims (13)

1. the application of a kind of Chinese medicine composition in the medicine of preparation treatment or prevention of hyperlipidemia, described Chinese medicine composition is made up of Gardenia, Poria, Salvia miltiorrhiza, Digupi, Taizishen, Amomum chinensis, raw malt and Caifuzi composition. 2. The application according to claim 1, characterized in that, the application of the Chinese medicinal composition in the preparation of a medicine for the treatment or prevention of elevated serum total cholesterol or triglyceride. 3. application according to claim 2 is characterized in that, the application of described traditional Chinese medicine composition in the preparation of the medicine of treating or preventing the rise of triglyceride; Preferably in the preparation of the medicine of treating or preventing hypertriglyceridemia applications in . 4. application according to claim 2 is characterized in that, the application of described Chinese medicine composition in the medicine of treating or preventing triglyceride elevation. 5. The application according to claim 1, wherein the dosage of the traditional Chinese medicine composition is: 5-10 g/day. 6. A traditional Chinese medicine composition for use in claim 1, characterized in that, the traditional Chinese medicine composition, by weight, consists of 1.25-1.55 parts of Gardenia, 1.25-1.46 parts of Poria, 0.925-1.31 parts of Salvia miltiorrhiza, It is composed of 1.1-1.37 parts of bone skin, 0.925-1.08 parts of Taizishen, 0.55-0.68 parts of Amomum, 3 parts of raw malt, and 1 part of cabbage. 7. Chinese medicine composition according to claim 6, is characterized in that, described Chinese medicine composition, by weight, is composed of 1.55 parts of Gardenia, 1.46 parts of Poria, 1.31 parts of Salvia miltiorrhiza, 1.37 parts of Digupi, 1.08 parts of Taizishen part, 0.68 part of Amomum, 3 parts of raw malt, and 1 part of cabbage. 8. Chinese medicine composition according to claim 6, is characterized in that, described Chinese medicine composition, by weight, consists of 1.25 parts of Gardenia, 1.25 parts of Poria, 0.925 parts of Salvia miltiorrhiza, 1.1 parts of Digupi, 0.925 parts of Taizishen part, 0.55 part of Amomum, 3.0 part of raw malt, and 1.0 part of Caifuzi. 9. The method for preparing a traditional Chinese medicine composition according to any one of claims 6 to 8, wherein the method comprises: (1) Extracting 2 times of 80% ethanol with 80% ethanol from Zhongdan participating in the prescription, the first time adding 5 times the amount of 80% ethanol to extract for 2 hours, the second time adding 4 times the amount of 80% ethanol to extract for 1.5 hours, and filtering , the medicinal residues are collected in another container for use; the two filtrates before and after are combined, and ethanol is recovered under reduced pressure to a clear paste with a relative density of about 1.20 (70°C), which is set aside for use; (2) 1/10 recipe quantity of Poria is pulverized and passed through a 100-mesh sieve, and the fine powder is sieved, and the remaining coarse particles are set aside for use; (3) add 7 times the amount of water for decocting for 2 hours by adding 7 times the amount of water to the Poria cocos with the prescription proportions of Zhongsheng malt, Digupi, Laifuzi, and Taizi participating in the rest of the prescription, and collect the filtrate; The slag is collected separately for use; (4) extract volatile oil 2 hours by adding 8 times of water of Amomum chinensis in prescription ratio, collect volatile oil for subsequent use; (5) merge above-mentioned gained medicinal dregs, add 5 times of water and decoct for 1.5 hours, filter, collect filtrate; then merge with the filtrate in steps (3) and (4), concentrate under reduced pressure to a relative density of about 1.20 clearing paste; combining the obtained clearing paste with salvia miltiorrhiza and gardenia alcohol extracting paste, mixing, concentrating to a thick paste with a relative density of about 1.40, drying under reduced pressure, and pulverizing into fine powder of extract; (6) Mix and dry extract fine powder, Amomum volatile oil and sterilized Poria fine powder to obtain. 10. The preparation containing the traditional Chinese medicine composition of any one of claims 6 to 8 or the traditional Chinese medicine composition prepared according to the method of claim 9, wherein the preparation is composed of a traditional Chinese medicine composition and pharmaceutical excipients, wherein the The auxiliary materials are beta cyclodextrin, corn starch, talc, or a combination of two or more of them. 11. The preparation according to claim 10, wherein the preparation is a pill, a dripping pill, a capsule, or a granule. 12. The formulation of claim 11, wherein the formulation is a pill. 13. the preparation method of pill according to claim 12, is characterized in that, described preparation method comprises: (1) Extracting 2 times of 80% ethanol with 80% ethanol from Zhongdan participating in the prescription, the first time adding 5 times the amount of 80% ethanol to extract for 2 hours, the second time adding 4 times the amount of 80% ethanol to extract for 1.5 hours, and filtering , the medicinal residues are collected in another container for use; the two filtrates before and after are combined, and ethanol is recovered under reduced pressure to a clear paste with a relative density of about 1.20 (70°C), which is set aside for use; (2) 1/10 recipe quantity of Poria is pulverized to obtain fine powder and coarse grains to be used through a 100-mesh sieve respectively, and the fine powder is sieved out, and the remaining coarse grains are set aside for use separately; (3) add 7 times the amount of water for decocting for 2 hours by adding 7 times the amount of water to the Poria cocos with the prescription proportions of Zhongsheng malt, Digupi, Laifuzi, and Taizi participating in the rest of the prescription, and collect the filtrate; The slag is collected separately for use; (4) add 8 times of water in the prescription proportion to extract volatile oil for 2 hours, collect volatile oil, use beta cyclodextrin inclusion, get Amomum vulgaris volatile oil beta cyclodextrin inclusion compound for subsequent use; Amomum glutinosa filtrate Collect with the dregs separately for use; (5) merge above-mentioned gained medicinal dregs, add 5 times of water and decoct for 1.5 hours, filter, collect filtrate; then merge with the filtrate in steps (3) and (4), concentrate under reduced pressure to a relative density of about 1.20 clearing paste; combining the obtained clearing paste with salvia miltiorrhiza and gardenia alcohol extracting paste, mixing, concentrating to a thick paste with a relative density of about 1.40, drying under reduced pressure, and pulverizing into fine powder of extract; (6) The extract fine powder, Amomum volatile oil beta cyclodextrin inclusion complex and sterilized Poria cocos fine powder are made into pellets with honey water (refined honey: water = 1:3), dried, and mixed with cornstarch and talc. Powder coating, that is.

Images