CN111195310A

CN111195310A - Traditional Chinese medicine composition for treating hyperlipidemia

Info

Publication number: CN111195310A
Application number: CN201811367558.8A
Authority: CN
Inventors: 张贵民; 马庆文; 程国良
Original assignee: Lunan Pharmaceutical Group Corp
Current assignee: Lunan Pharmaceutical Group Corp
Priority date: 2018-11-16
Filing date: 2018-11-16
Publication date: 2020-05-26
Also published as: WO2020097963A1

Abstract

The invention belongs to the field of traditional Chinese medicines, and particularly relates to application of a traditional Chinese medicine composition in preparation of a medicine for treating hyperlipidemia. The traditional Chinese medicine composition provided by the invention has the advantages that all the medicines conform to the monarch, minister, assistant and guide compatibility principle, the compatibility is scientific, the disease is hit, the clinical symptoms can be obviously improved, the hyperlipidemia can be effectively treated, and particularly, the effective rate of treatment for the liver-kidney yin deficiency type hyperlipidemia can reach more than 90%.

Description

Traditional Chinese medicine composition for treating hyperlipidemia

Technical Field

The invention relates to a new application of a traditional Chinese medicine composition, in particular to an application of a traditional Chinese medicine composition in preparing a medicine for treating hyperlipidemia, and belongs to the field of traditional Chinese medicines.

Background

Hyperlipidemia, commonly known as hyperlipidemia, refers to a group of diseases caused by various causes, such as increased plasma cholesterol or triglyceride levels or both. Hyperlipemia is the leading cause of cardiovascular and cerebrovascular diseases, the incidence of disease is above 7%, about 9000 ten thousand patients exist in China, and the incidence of hyperlipemia is more than 45 years old and middle-aged. Hyperlipidemia is the most common clinical hyperlipidemia with dyslipidemia, simple hypercholesterolemia, simple hypertriglyceridemia or both.

Modern medicine considers that hyperlipidemia is mainly caused by disorder of fat metabolism of the human body, increase of fat components in blood, increase of blood viscosity, obstruction of blood flow, or arteriosclerosis actuated by deposition of blood fat. The main harm of hyperlipidemia is atherosclerosis, which further causes related diseases, such as coronary heart disease and cerebral arterial thrombosis. In addition, dyslipidemia is also an important risk factor for the development of hypertension, impaired glucose tolerance, and diabetes. Dyslipidemia may also cause fatty liver, liver cirrhosis, cholelithiasis, fundus hemorrhage, blindness, peripheral vascular disease, hyperuricemia.

The traditional Chinese medicine considers that the hyperlipidemia is caused by improper diet, such as overeating fat, sweet and thick taste, or addiction to spicy food, excessive drinking, damage to spleen and stomach, dysfunction of transportation and transformation of the spleen and stomach, stagnation of water and retention of phlegm and dampness, and blockage of pulse channels; in addition, the seven emotions are excessive, the stagnation of liver qi, the failure of catharsis, the long-term qi depression, qi stagnation and blood stasis, and the blockage of pulse channels; the qi stagnation transforming into fire, fire burning fluid into phlegm, phlegm-fire in the interior, phlegm stagnation and blood stasis; deficiency syndrome caused by chronic damage to liver and kidney, excess syndrome caused by stasis, and more common diseases; patients with liver-kidney yin deficiency are rare, and liver-kidney yin deficiency type hyperlipidemia is mostly found in over-middle-aged people with food, and is clinically manifested as vertigo, tinnitus, headache, limb numbness, soreness and weakness of waist and knees, dry mouth and throat, dysphoria with feverish sensation in chest, amnesia, insomnia, red tongue with little coating, and thready and rapid pulse.

At present, most of the drugs for treating hyperlipidemia depend on some western medicine preparations with great side effects, and clinically common drugs for treating hyperlipidemia can be roughly classified into 5 types: (1) a statin; (2) a fibrate; (3) cholesterol absorption inhibitors; (4) resins; (5) nicotinic acid, wherein statins are powerful LDL-c lowering drugs and are the main clinical drugs, but the statins have certain side effects in treating hyperlipidemia, so that part of patients cannot effectively finish the treatment of strengthening lipid lowering.

The traditional Chinese medicine mainly adopts the principle of treatment based on syndrome differentiation, emphasizes the specific analysis of specific conditions from the whole aspect when diagnosing and treating patients with hyperlipemia, and adopts different traditional Chinese medicine prescriptions for patients with hyperlipemia of different types of syndromes. The medicine for patients is mostly decocted by the traditional method, and the Chinese patent medicine products on the market are few. In addition, because fewer patients with liver-kidney yin-deficiency-type hyperlipemia exist, more Chinese patent medicines for treating the disease are few and fewer, but the traditional Chinese medicine considers that the excess syndrome is easy to treat, the deficiency syndrome is difficult to regulate, and the treatment difficulty of liver-kidney yin-deficiency-type hyperlipemia is higher. At present, in the market, the number of Chinese patent medicines capable of effectively treating liver-kidney yin deficiency type hyperlipemia is small, the medication selectivity of patients is poor, the patients cannot be treated in a targeted manner, the curative effect is unsatisfactory, and the development of a Chinese medicinal preparation with small side effect and good curative effect is urgently needed.

The Chinese invention patent (grant publication number: CN1191082A) discloses a Chinese medicinal composition for treating fatty liver and a preparation method thereof, and the product 'Huazhi liver softening granule' prepared by the Chinese invention patent is approved to be on the market and can effectively treat non-alcoholic simple fatty liver clinically.

Disclosure of Invention

The invention relates to a new application of a traditional Chinese medicine composition developed on the basis of the Chinese invention patent CN1191082A in preparing a medicine for treating hyperlipidemia, and particularly has an obvious effect on liver-kidney yin deficiency type hyperlipidemia.

The traditional Chinese medicine composition is mainly prepared from hawthorn, rhizoma alismatis, oriental wormwood, rheum officinale, semen cassiae, herba cephalanoploris, rhizoma atractylodis macrocephalae, grifola, radix bupleuri and liquorice. In addition, fructus Ligustri Lucidi, Ecliptae herba, fructus Lycii, fructus Trichosanthis, and pericarpium Citri Tangerinae can also be added.

The traditional Chinese medicine composition comprises hawthorn, rhizoma alismatis, oriental wormwood, rheum officinale, semen cassiae, herba cephalanoploris, rhizoma atractylodis macrocephalae, grifola, radix bupleuri, liquorice, glossy privet fruit, herba ecliptae, fructus lycii, trichosanthes kirilowii maxim and pericarpium citri reticulatae in parts by weight:

preferably, the traditional Chinese medicine composition comprises the following components in parts by weight:

in a more preferable scheme, the traditional Chinese medicine composition comprises the following components in parts by weight:

in a second preferred embodiment, the traditional Chinese medicine composition comprises the following components in parts by weight:

the above Chinese medicinal composition comprises semen Cassiae preparata, radix et rhizoma Rhei preparata, rhizoma Atractylodis (bran-parched rhizoma Atractylodis), Atractylodis rhizoma (bran-parched rhizoma Atractylodis Macrocephalae), and bupleuri radix (vinegar processed bupleuri radix). Meanwhile, preferably, the glossy privet fruit is wine glossy privet fruit.

The traditional Chinese medicine composition comprises the following components:

purging the kidney and bladder channels, promoting diuresis, eliminating dampness, clearing heat, eliminating turbid pathogen, and reducing blood lipid; hawthorn fruit enters spleen, stomach and liver channels, promotes qi circulation, removes blood stasis, dissolves turbidity and reduces blood fat, and both of them are used as monarch drugs in the formula for treating hyperlipidemia.

The oriental wormwood enters spleen, liver and gallbladder channels, and clears away damp-heat, promotes bile flow and removes jaundice; the rhubarb enters spleen, liver and large intestine channels, purges and purges accumulation, clears heat and purges fire, cools blood and detoxifies, dispels stasis and dredges the menstrual flow, promotes diuresis and removes jaundice; semen Cassiae enters liver and large intestine channels, clears heat and improves eyesight, and moistens intestines and relieves constipation; the common cephalanoplos herb enters heart and liver channels, cools blood and stops bleeding, removes stasis, detoxifies and eliminates carbuncle; the rhizoma atractylodis and the rhizoma atractylodis macrocephalae enter spleen and liver channels, strengthen spleen and tonify qi, eliminate dampness and promote diuresis; polyporus umbellatus enters kidney and bladder channels to induce diuresis and drain dampness. The Chinese medicinal materials are matched with each other, clear heat and cool blood, remove stasis and dredge vessels, and eliminate turbid pathogen to be damp, and are matched with monarch drugs to enter spleen, kidney and bladder channels, regulate and regulate water channels, and guide damp and turbid pathogen to descend, so that the Chinese medicinal materials are used as ministerial drugs in the formula; also has the efficacy of adjuvant drugs, and can be used for treating dry mouth and throat and dysphoria with feverish sensation in the five hearts.

Fructus Ligustri Lucidi has effects in nourishing liver and kidney, and can be used for treating deficiency of liver-yin and kidney-yin, vertigo, tinnitus, and soreness of waist and knees; herba Ecliptae enters kidney and liver meridians, has effects of nourishing liver and kidney, cooling blood and stopping bleeding, and can be used for treating liver and kidney yin deficiency, vertigo, tinnitus, soreness of waist and knees, yin deficiency and blood heat; fructus Lycii has effects of nourishing liver and kidney, replenishing vital essence and improving eyesight, and can be used for treating consumptive disease and essence deficiency, soreness of waist and knees, giddiness, tinnitus, and blurred vision. The three medicinal materials are used together to nourish liver and kidney, and are used for treating liver and kidney yin deficiency syndrome, and treating soreness and pain of waist and knees, vertigo and tinnitus, and are adjuvant drugs in the formula. Snakegourd fruit enters lung, stomach and large intestine channels, clears heat and washes phlegm, relieves chest stuffiness and stagnation, is used for chest stuffiness and fullness, and also is an adjuvant drug in the formula for treating chest distress and palpitation. In addition, the dried orange peel has the effects of entering lung and spleen channels, regulating qi, strengthening spleen, eliminating dampness and phlegm, and also has the effects of ministerial drugs by combining various medicinal materials with the dried orange peel, entering spleen, kidney and lung, dredging and regulating water channels, promoting diuresis, eliminating dampness and guiding damp and turbid downward.

The bupleurum enters liver, gallbladder and lung channels, disperses and defervesces, soothes liver and relieves depression, lifts yang qi, introduces various medicines into liver channels, soothes liver and relieves depression, removes stasis and eliminates carbuncle, clears away dampness and heat, and has the functions of guiding and reporting meridian; the liquorice enters heart, lung, spleen and stomach channels, tonifies spleen and qi, clears heat and detoxifies, harmonizes the other drugs and regulates the middle warmer and relieves urgency, and the two drugs are guiding drugs in the formula.

In conclusion, the prescription of the invention has scientific, rigorous and orderly monarch, minister, assistant and guide compatibility, more but not more complicated medicinal flavors, complementary medicines, liver and kidney treatment, simultaneous treatment of both symptoms and root causes, heat clearing, dampness removing without impairment of yin, blood circulation promoting without impairment of blood stasis, and the functions of heat clearing, dampness removing, turbidity removing and lipid lowering. Mainly treats hyperlipidemia complicated with liver-kidney yin deficiency type, with symptoms of vertigo, tinnitus, headache, limb numbness, soreness and weakness of waist and knees, dry mouth and throat, dysphoria with feverish sensation in chest, amnesia, insomnia, red tongue with little coating, thready and rapid pulse, and obvious increase of blood fat in clinical tests.

The preparation method of the traditional Chinese medicine composition comprises the following steps:

(1) pulverizing bupleuri radix, rhizoma Atractylodis, Atractylodis rhizoma and pericarpium Citri Tangerinae, mixing with herba Artemisiae Scopariae, adding water, distilling to extract volatile oil, collecting volatile oil, and distilling to obtain residue and medicinal liquid;

(2) adding β -cyclodextrin into the volatile oil obtained in the step (1) to prepare an inclusion compound for later use;

(3) decocting the medicine residues in the step (1) with water for 0.4-1.0 hour, filtering, and combining the filtrate with the liquid medicine in the step (1) to obtain an extracting solution I;

(4) pulverizing Alismatis rhizoma, fructus Ligustri Lucidi, radix et rhizoma Rhei, and semen Cassiae, extracting with ethanol under reflux for three times (each for 1-2 hr), mixing extractive solutions, filtering, recovering ethanol from the filtrate under reduced pressure, and concentrating to obtain extractive solution II;

(5) decocting decoction pieces of the rest prescription such as fructus Trichosanthis in water twice for 0.5-1.5 hr each time, mixing decoctions, and filtering to obtain extractive solution III;

(6) mixing the extractive solutions I, II and III, concentrating, adding dextrin, stirring, and spray drying to obtain dry extract powder;

(7) and (3) taking the dry powder of the extract in the step (6), adding the volatile oil β -cyclodextrin inclusion compound and the aspartame in the step (1), and uniformly mixing to obtain fine powder of the traditional Chinese medicine composition.

In addition, the traditional Chinese medicine composition can be prepared into clinically acceptable dosage forms such as tablets, pills, chewable agents, oral liquid preparations, capsules, granules and the like directly or by adding pharmaceutically acceptable excipients through conventional processes, and preferably, the dosage forms are granules.

DETAILED DESCRIPTION OF EMBODIMENT (S) OF INVENTION

The following experimental examples are provided to further illustrate the effect of the Chinese medicinal composition for treating hyperlipidemia, and the drugs used in the experimental examples are preferred embodiments of the present invention, but other embodiments of the present invention can achieve similar experimental effects.

Firstly, the traditional Chinese medicine composition has influence on the blood fat level and physiological activity of hyperlipidemic rats

1. Material

1.1 male SD rat of experimental animal, weight 180-: SYXK (lu) 20160006, provided by institute of basic medicine, academy of medical sciences, shandong province.

1.2 Experimental drugs, reagents

1.2.1 Experimental drugs: the traditional Chinese medicine composition obtained in embodiment 3 of the invention;

simvastatin tablet (5 mg/tablet) lunanfibrate pharmaceutical ltd, manufactured under batch No. 20170604.

1.2.2 Experimental reagents: total cholesterol kit, triglyceride kit, low density lipoprotein kit, high density lipoprotein kit, AST kit, ALT kit.

2. Procedure of experiment

2.1 drug dose setting

The invention comprises the following steps: the high, medium and low doses of the rat are respectively 30.8g/kg, 15.4g/kg and 7.7g/kg, which are equivalent to 25.2, 12.6 and 6.3 times of the daily dose of a 70kg human body, and the administration is performed by intragastric administration according to 1ml/100 g.

Simvastatin (5 mg/tablet): the dosage of the rat is 3.6mg/kg, which is equivalent to 6.3 times of the daily dosage of a 70kg human. The preparation is administered by intragastric administration at a dose of 1ml/100 g.

2.2 Molding and administration

2.2.1 Molding

After the rat is purchased, the rat is bred adaptively for 5-7 days.

Feeding common feed to rats in a blank group, feeding high-fat and high-cholesterol feed (consisting of 79.7% of common feed, 10% of cholesterol, 10% of lard and 0.3% of sodium cholate) to rats in a model group, and regularly weighing the weight of the rats; and the liver-kidney yin deficiency syndrome is caused by long-term irritability in the first day of model building. After 2 weeks, the tail of the rat is cut to take blood, the total cholesterol level is measured, the physiological activity and daily performance of the rat are observed, and the model building is successful.

The long-term irritability method operates as follows: the two hind limbs of the rat are bound and hung in the cage in pairs upside down to cause obvious irritability which is manifested by screaming, biting and irritability for 5min for the first time, and 10min each day later until the molding is successful.

2.2.2 grouping and administration

After the molding is successful, the blank control group is still fed with common feed, and the molding group rats are still fed with high-fat and high-cholesterol feed and are irritated for a long time.

Grouping: taking 50 rats after successful model building, randomly dividing the rats into a hyperlipemia model group, a positive drug control group (namely a simvastatin group) and three dosage groups of the invention, wherein the total number of the three dosage groups is 5, and each group contains 10 rats; another blank group of 10 rats was used as a blank control group.

Administration: the blank control group and the hyperlipidemia model group are given 10 ml/kg per day^-1·d^-1The physiological saline and the positive drug control group are given with 10 ml/kg suspension^-1·d^-1The preparation of the invention is respectively administered with 10 ml.kg of suspension with corresponding dose^-1·d^-1Gavage, continuous dosing for 30 days, fasting all rats for 12h (without water) on day 30, weighing, and using 3.5% chloral hydrate 10 ml/kg for each group of rats^-1After anesthesia by intraperitoneal injection, the abdominal aorta is bled, and the liver is rapidly taken out, separated and examined.

2.3 detection of indicators

2.3.1 general observations of changes in rat spirit, activity, diet, and body weight. Rat liver weighing and liver index calculation

2.3.2 Biochemical detection of abdominal artery blood sampling, standing the blood for 30min, 3500rmp, 4 ℃, centrifuging for 10min to separate serum, and determining TC, TG, HDL-C, LDL-C, ALT and AST levels.

2.3.3 data processing Using group t test, SAS processing software, mean ± standard deviation of data

Performing one-way anova, comparing groups by using an LSD method, and taking P less than 0.05 as the difference, wherein the difference has statistical significance.

3. Results of the experiment

3.1 Effect on physiological Activity, body weight and liver index changes in rats

3.1.1 during the experiment period, the appearance behaviors of the rats in the blank control group are not abnormal, and compared with the rats in the blank control group, the rats in the model group have reduced activities with the increase of modeling days, and have the phenomena of drowsiness, somnolence, beard drop, fine creaking sound, lusterless hair, dry stool, irritability and the like. After treatment, the conditions of the three dose groups and the positive drug control group of the preparation are improved compared with the model group.

Compared with the body weight of rats in a blank control group, the body weight growth rate of rats in a hyperlipemia model group is obvious, the liver index is obviously increased, and the obvious difference is shown (^△P is less than 0.05); the high, medium and low dose groups and the positive drug control group of the preparation can control the weight gain speed of the rat, and simultaneously reduce the liver index of the rat, and have obvious difference compared with the model group (^*P < 0.05), see Table 1.

TABLE 1 Effect of liver index and body weight of rats in each group

Note: compared with the blank control group, the composition of the composition,^△p is less than 0.05; p < 0.05 compared to the hyperlipidemia model group

3.2 Effect on rat blood lipid levels

Compared with a blank control group, the contents of TC, TG and LDL-C in the serum of rats in the hyperlipemia model group are obviously increased (P is less than 0.05), and the HDL-C level is obviously reduced (^△P is less than 0.01); compared with the hyperlipemia model group, the contents of TC, TG and LDL-C in the serum of rats in the preparation group and the positive medicine simvastatin group are all obviously or extremely obviously reduced (^*P＜0.05，^#P < 0.01), a significant or very significant increase in HDL-C levels (^*P＜0.05，^#P < 0.01), see Table 2.

TABLE 2 Effect of serum lipids in groups of rats

Note: compared with the blank control group, the composition of the composition,^△p is less than 0.01; compared with the hyperlipemia model group,^*P＜0.05，^#P＜0.01。

3.3 Effect on rat serum enzymes

Compared with the blank model group, the serum ALT level of the hyperlipemia model group is obviously increased, and the AST level is obviously reduced (^△P is less than 0.05); the serum ALT level of the positive drug control group and the preparation group of the invention is obviously reduced compared with that of the model group^*P < 0.05), AST levels were significantly elevated compared to the model group (^*P < 0.05), see Table 3.

TABLE 3 Effect of serum AST and ALT in various groups of rats

Note: compared with the blank control group, the composition of the composition,^△p is less than 0.05; p < 0.05 compared to the hyperlipidemic model group.

The above experimental examples only show the treatment effect of the traditional Chinese medicine composition on the liver-kidney yin deficiency type hyperlipidemic rat, and pharmacodynamic experiments of other types (including but not limited to simple type, phlegm-dampness blocking type, qi-blood stasis type, phlegm-blood stasis mutual combination type, qi-yin deficiency type and the like) hyperlipidemic rat are also carried out in the practical operation of the invention, and the experimental examples are not listed any more. Experiments prove that the traditional Chinese medicine composition has the effective rate of more than 90 percent when used for treating other types of hyperlipidaemia, and the effect is better than that of a positive medicine control group (namely a simvastatin group), so that the traditional Chinese medicine composition can effectively treat various types of hyperlipidaemia.

The traditional Chinese medicine composition disclosed by the invention has been subjected to animal safety inspection, and various indexes of rats are not abnormally changed after the medicine is taken, so that the traditional Chinese medicine composition disclosed by the invention is proved to be safe and reliable.

Secondly, the traditional Chinese medicine composition preparation product of the invention treats typical cases of hyperlipidemia

1. General data

Through diagnosis, the patients with confirmed hyperlipidemia (liver-kidney yin deficiency type) are 10 patients in total, and the patients with the disease are between 40 and 60 years old, and the disease condition is not significantly different (P is more than 0.05).

1.2 diagnostic criteria for hyperlipidemia:

western diagnostic criteria: the evaluation is carried out according to the standards of ' 2002 edition of clinical research guidelines for new Chinese medicines ' and ' 2016 revision edition of Chinese guidelines for preventing and treating adult dyslipidemia. Under the condition of normal diet, the blood fat can be determined within 2 weeks if 2 times of blood fat determination meet one of the following conditions, and the diagnosis can be confirmed:

(1) cholesterol (TC) ≧ 6.2mmol/L (240mg/dl)

(2) Triglyceride (TG) ≧ 2.3mmol/L (200mg/dl)

(3) Low-density lipoprotein (LDL-C) ≧ 4.1mmol/L (160mg/dl)

The traditional Chinese medicine diagnosis standard is as follows: referring to '2002 edition of clinical research guidelines of new Chinese medicines', the Chinese medicine clinical diagnosis and typing of hyperlipemia is carried out, wherein the clinical manifestations of liver-kidney yin deficiency are as follows:

the main symptoms are: vertigo, tinnitus, soreness of the loins, soft knees, feverish sensation in the palms, soles and chest.

The secondary symptoms are as follows: palpitation, insomnia, constipation, dark urine.

The pulse condition: red or dark tongue with yellow coating, wiry or wiry, thready and rapid pulse.

1.3 Pre-treatment blood lipid conditions there was no significant difference in pre-treatment blood lipid levels, P > 0.05.

2 method

2.1 therapeutic Agents

The granules prepared in example 4 of the present invention.

2.2 Observation index

2.2.1 Chinese medicine symptoms and scores are judged by a fractional method to change symptoms and symptom integrals before and after treatment, and Chinese medicine symptoms are observed once before and after treatment to judge the curative effect. The symptoms of the traditional Chinese medicine are counted according to three grades of lightness, middle and weight, 1 grade is counted by lightness, 2 grades is counted by middle degree and 3 grades is counted by weight, and 1 grade is counted by the person with tongue condition and pulse condition according with the dialectical requirement. The tongue and pulse conditions which are asymptomatic and have no symptoms after treatment and do not meet the dialectical requirements are calculated according to 0 point.

2.2.2 serum lipid assays include assays for TC, TG, HDL-c, LDL-c.

2.2.3 safety observations include: general conditions (blood pressure, heart rate, weight) and possible adverse reactions.

3. Therapeutic results

3.1 therapeutic Standard of blood lipid

Refer to the standard of ' 2002 edition of clinical research guidelines for new drugs in traditional Chinese medicine ' and ' 2016 revision edition of Chinese guidelines for preventing and treating adult dyslipidemia.

The effect is shown: the blood fat detection can be any one of the following: TC is reduced by more than or equal to 20 percent, TG is reduced by more than or equal to 40 percent, and HDL-c is increased by more than or equal to 0.26 mmol/L;

the method has the following advantages: the blood fat detection can be any one of the following: TC is reduced by 10-20%, TG is reduced by 20-40%, and HDL-c is increased by 0.104-0.26 mmol/L;

and (4) invalidation: and the blood lipid detection does not meet the above standard.

3.2 integral changes of Chinese medicine syndrome

The Chinese medicine syndrome integration has no obvious difference before the treatment of the patient (P is more than 0.05), and the Chinese medicine syndrome integration is obviously reduced after the treatment (P is less than 0.05), which is shown in a table 4.

TABLE 4 integral changes of Chinese medicine symptoms before and after treatment

n	Before treatment	After treatment
			10	14.33±3.60	4.68±2.81^*

Note: the Chinese medicine has obvious difference after the integral treatment of symptoms compared with before the treatment, and P is less than 0.05.

3.3 blood lipid changes before and after treatment

As can be seen from Table 5, TC, TG, HDL-c and LDL-c before treatment have no significant difference (P is more than 0.05) through detection, and TC, TG and LDL-c are all significantly reduced (P is less than 0.05) after treatment; HDL-c is significantly elevated after treatment. The preparation product of the invention is prompted to effectively reduce the levels of TC, TG and LDL-c in the serum of a patient and improve the level of HDL-c, and the clinical treatment effective rate can reach 90 percent, which is shown in Table 6.

Table 5 comparison of the change in blood lipid levels before and after treatment (mmol/L,

)

item	n	Before treatment	After treatment
				TC	10	6.02±1.03	5.30±0.79^*
TG	10	2.77±1.97	1.80±1.36^*
				HDL-c	10	1.25±0.34	1.32±0.37^*
LDL-c	10	3.53±0.89	2.94±0.71^*

Note: the blood lipid levels after treatment were significantly different from those before treatment, P < 0.05.

TABLE 6 blood lipid efficacy (n,%)

n	Show effect	Is effective	Invalidation	Total effective rate
					10	1	8	1	90％

3.4 changes in body weight, Heart Rate, blood pressure before and after treatment

TABLE 7 changes in body weight, Heart Rate, blood pressure before and after treatment

Note: compared with the treatment before, the weight, the heart rate and the blood pressure after the treatment are obviously different, and P is less than 0.05.

From the content, the preparation product can obviously reduce the Chinese medicine symptom integral of the hyperlipemia patient; after treatment, the content of TC, TG and LDL-c in serum of a patient is obviously reduced, the content of HDL-c is obviously increased, the total effective rate of treatment can reach 90%, and the stagnation-removing and liver-softening granules are prompted to effectively treat hyperlipemia, particularly can be used for pertinently treating liver-kidney yin deficiency type hyperlipemia, regulating the blood lipid level of the patient and improving clinical manifestation symptoms of the patient, and are good in medication compliance and strong in pertinence of the patient.

Third, detailed description of the invention

Example 1:

the prescription is as follows:

wherein semen Cassiae is parched semen Cassiae, radix et rhizoma Rhei is processed radix et rhizoma Rhei, fructus Ligustri Lucidi is wine fructus Ligustri Lucidi, rhizoma Atractylodis is bran parched rhizoma Atractylodis, Atractylodis rhizoma is bran parched Atractylodis rhizoma, and bupleuri radix is vinegar bupleuri radix.

The preparation method comprises the following steps:

Adding pharmaceutically acceptable excipient into the above fine powder, and making into tablet by conventional process.

Example 2:

the prescription is as follows:

The preparation method comprises the following steps:

the preparation method is the same as that of example 1.

Adding pharmaceutically acceptable excipient into the fine powder of the Chinese medicinal composition, and making into capsule by conventional process.

Example 3:

the prescription is as follows:

The preparation method comprises the following steps:

the preparation method is the same as that of example 1.

Example 4:

the prescription is as follows:

The preparation method comprises the following steps:

the preparation method is the same as that of example 1.

Adding pharmaceutically acceptable excipient into the fine powder of the Chinese medicinal composition, and making into granule by conventional process.

Example 5:

the prescription is as follows:

The preparation method comprises the following steps:

the preparation method is the same as that of example 1.

Adding pharmaceutically acceptable excipient into the fine powder of the Chinese medicinal composition, and making into syrup by conventional process.

Example 6:

the prescription is as follows:

The preparation method comprises the following steps:

the preparation method is the same as that of example 1. Adding pharmaceutically acceptable excipient into the fine powder of the Chinese medicinal composition, and making into oral liquid by conventional process.

Claims

1. A Chinese medicinal composition for treating hyperlipidemia is prepared from fructus crataegi, Alismatis rhizoma, herba Artemisiae Scopariae, radix et rhizoma Rhei, semen Cassiae, herba Cephalanoploris, rhizoma Atractylodis, Atractylodis rhizoma, Polyporus, bupleuri radix, and Glycyrrhrizae radix.

2. The use of claim 1, wherein the Chinese medicinal composition further comprises fructus Ligustri Lucidi, Ecliptae herba, fructus Lycii, fructus Trichosanthis, and pericarpium Citri Tangerinae.

3. The use of claim 2, wherein the traditional Chinese medicine composition comprises the following components in parts by weight:

4. the use of claim 3, wherein the traditional Chinese medicine composition comprises the following components in parts by weight:

5. the use of claim 4, wherein the traditional Chinese medicine composition comprises the following components in parts by weight:

6. the use of claim 4, wherein the traditional Chinese medicine composition comprises the following components in parts by weight:

7. the use according to any one of claims 1 to 6, wherein the rhubarb is cooked rhubarb, the cassia seed is parched cassia seed, the atractylodes rhizome is bran-parched atractylodes rhizome, and the bupleurum root is vinegar-processed bupleurum root.

8. The use of any one of claims 2-6, wherein the fructus Ligustri Lucidi is fructus Ligustri Lucidi.

9. The use of any one of claims 1-6, wherein the Chinese medicinal composition is formulated into a clinically acceptable dosage form after addition of excipients; preferably, the clinically acceptable dosage form is tablets, granules, capsules, oral liquid, pills or syrup; further preferably, the clinically acceptable dosage form is granules.

10. The use according to any one of claims 1 to 6, wherein the hyperlipemia is liver-kidney yin deficiency type hyperlipemia.