CN111110735A

CN111110735A - Lipid-lowering pharmaceutical composition, preparation method and application

Info

Publication number: CN111110735A
Application number: CN202010129214.4A
Authority: CN
Inventors: 张远哲; 黎豫川; 罗熙林; 蔡琨; 马鹏
Original assignee: Guizhou University of Traditional Chinese Medicine
Current assignee: Guizhou University of Traditional Chinese Medicine
Priority date: 2020-02-28
Filing date: 2020-02-28
Publication date: 2020-05-08

Abstract

The invention relates to a lipid-lowering pharmaceutical composition, a preparation method and application, wherein the composition comprises the following drugs: the medicine composition is prepared by water extraction, has the drug effects of soothing the liver, regulating qi, clearing heat, promoting diuresis, promoting blood circulation, removing blood stasis, reducing fat and reducing weight, has an obvious curative effect in clinical use, has important significance for reducing blood fat, reducing the risk of cardiovascular diseases of patients with later-stage hyperlipidemia and improving the life quality of the patients, and has the advantages of high safety, economy, practicability, convenience in taking and the like.

Description

Lipid-lowering pharmaceutical composition, preparation method and application

Technical Field

The invention relates to the field of medicine invention, in particular to a lipid-lowering medicine composition, a preparation method and application.

Background

Hyperlipidemia is a disease in which one or more of triglyceride, total cholesterol, and low density lipoprotein in blood is abnormally increased or high density lipoprotein is abnormally decreased due to abnormal lipid metabolism in the body. The traditional Chinese medicine considers that the formation of the hyperlipemia is closely related to phlegm and stasis. The traditional Chinese medicine considers that qi of liver and gallbladder is not dispersed, qi of heart and spleen is deficient, and kidneys are involved as main internal factors; overeating fat and sweet food, overage, exhaustion, excessive drinking and internal injury due to seven emotions are the main causes of hyperlipidemia, as described in Danxi Heart Law: the theory that qi and blood are mixed, all diseases are not born, all diseases are born, and the liver accumulation is recorded as fat qi is also known. Once liver qi fails to reach and qi movement is not regulated, qi, blood and body fluids are disregulated, body fluids are transported and transformed into dampness, and the dampness is collected to form phlegm, which indicates that the change of qi movement of liver and gallbladder and seven emotions can affect the metabolism of qi, blood and body fluids, the fluid is refined into dampness and phlegm, the phlegm dampness is stagnated in various parts of the body for a long time to form blood stasis which obstructs qi movement, the qi stagnation can not promote the blood and body fluids to move, the phlegm is turbid and the blood stasis is endogenous, and the two influence and cause each other, so that the occurrence of hyperlipidemia is caused, and the relevance of the phlegm stasis of the traditional medicine and the hyperlipidemia of the modern medicine is reflected.

There are various treatments for hyperlipidemia, such as: the compatibility and application of the prescription for treating the hyperlipidaemia are discussed, wherein PATTANAMONGKOL PERERAN (Linyuxin), Nanjing university of traditional Chinese medicine, 2017-03-22, and the former 5 hyperlipidemia syndromes are the syndrome of phlegm-blood stasis (93/28.70%), the syndrome of phlegm-turbidity obstruction (45/13.89%), the syndrome of liver-kidney yin deficiency (33/10.19%), the syndrome of qi stagnation and blood stasis (27/8.33%) and the syndrome of spleen-kidney yang deficiency (19/5.86%). The first 5 hyperlipemia therapeutic rules are phlegm eliminating and stasis removing (93/28.70%), dampness eliminating and phlegm resolving (45/13.89%), liver and kidney nourishing (33/10.19%), qi promoting and blood circulation promoting (27/8.33%), spleen and kidney warming and invigorating (19/5.86%).

At present, more medicines are used for treating hyperlipemia, and more western medicines such as simvastatin and the like and more traditional Chinese medicine compositions are used, such as:

comparison document 1: application No. CN200710004517.8, title of the invention: a Chinese medicinal composition with effects of reducing blood lipid and reducing weight comprises the following components: 0.5-1 part of rhubarb, 1-2 parts of tuckahoe, 1-2 parts of cassia occidentalis, 1-3 parts of raw hawthorn, 1-2 parts of immature bitter orange and 1-3 parts of gynostemma pentaphylla. Decocting radix et rhizoma Rhei, Poria, semen Cassiae, fructus crataegi, fructus Aurantii Immaturus and herba Gynostemmatis in water for 2-3 times,filtering, merging filtrate, standing, filtering, concentrating into thick extract as active component extract, and the said extract has certain blood fat reducing effect, but the present invention has the demerits of ① formula containing rhubarb with the functions of eliminating stagnation and clearing away heatDamp-heatPurging fire, cooling blood, removing blood stasis, removing toxic substance, etcEfficacy ofBut for weak people, the traditional Chinese medicine composition is easy to cause adverse symptoms such as diarrhea and hypodynamia, ② the whole prescription is not provided with medicines for nourishing blood and promoting blood circulation and is not suitable for hyperlipemia caused by phlegm stasis, the preparation method of ③ is not clear in water adding amount and decoction time, and the extraction rate of effective components is not easy to master.

The invention relates to a comparison document 2, application number is CN03109063.X, the invention name is a traditional Chinese medicine formula for treating hyperlipidemia, the invention is scientifically prepared by six traditional Chinese medicines of 30-50% of rhubarb, 30-40% of cassia seed, 10-20% of salvia miltiorrhiza, 5-10% of dried orange peel, 2-5% of ginseng and 2-5% of poria cocos according to the proportion, the formula is suitable for patients with cardiovascular and cerebrovascular diseases of hypercholesterolemia and hypertriglyceridemia, and has the functions of coronary artery dilation and myocardial ischemia protection, and the curative effect is better especially for patients with coronary heart disease and angina pectoris of hyperlipidemia, but the invention has the defects that the ① formula contains rhubarb which has the effects of removing stagnation and clearing away stasisDamp-heatPurging fire, cooling blood, removing blood stasis, removing toxic substance, etcEfficacy of② Ginseng radix is a tonic for people with weak constitution and has the disadvantage of nourishing and greasiness and obstructing qi movement, ③ the formula is suitable for patients with cardiovascular and cerebrovascular diseases with hypercholesterolemia and hypertriglyceridemia, and the whole formula is not suitable for treating simple hyperlipidemia (other diseases are not formed yet).

Comparison document 3: application No.:CN200610068698.6the invention name is as follows:medicine for treating fatty liver and preparation Method of producing a composite materialThe invention is composed of (by weight ratio) oriental wormwood 2-3, cape jasmine 0.6-1, prepared rhubarb 0.6-1, raw fleece-flower root 2-3, giant knotweed rhizome 1.5-2, oriental water plantain rhizome 2-3, cassia occidentalis 2-3, root of red rooted salvia 1.5-2, raw haw 2-3, curcuma longa 1-1.5, ginseng 0.6-1, gynostemma pentaphylla 2-3, aloe 0.15-0.2, the preparation method is: respectively taking materials according to the weight ratio; pulverizing radix et rhizoma Rhei preparata, radix Polygoni Multiflori, radix Ginseng, rhizoma Curcumae Longae, and rhizoma Alismatis into powder; herba Artemisiae Scopariae, fructus Gardeniae, rhizoma Polygoni Cuspidati, semen Cassiae, Saviae Miltiorrhizae radix, fructus crataegi, and herba GynostemmatisThe invention has the advantages of reducing blood fat, resisting peroxidation damage, obviously improving liver fat metabolism, resisting fatty liver, protecting liver and reducing blood fat, having small toxicity and high safety, being capable of delaying or preventing the generation of hepatic fibrosis and liver cirrhosis, and particularly having better curative effect on coronary heart disease and angina pectoris patients with hyperlipidemia, but the invention has the defects that the ① prescription contains rhubarb which has the functions of removing accumulation stagnation, clearing away heat and toxic materials, and has the advantages of reducing blood fat, resisting peroxidation damage, obviously improving liver fat metabolism, resisting fatty liver, protecting liver and reducing blood fatDamp-heatPurging fire, cooling blood, removing blood stasis, removing toxic substance, etcEfficacy ofThe Chinese medicinal composition has the advantages of good curative effect, no record on the treatment effect of hyperlipidemia caused by phlegm stasis, long decoction time of ⑤ and high cost, can be used for treating the adverse symptoms of diarrhea, weakness and the like easily caused by weak people, ② ginseng is a powerful tonic medicine and has the defect of nourishing and obstructing qi movement after long-term administration, ③ has more medicinal ingredients and high cost, the ④ formula is used for reducing blood fat, resisting peroxidation injury, obviously improving liver fat metabolism, resisting fatty liver, protecting liver and reducing blood fat, and the treatment effect of hyperlipidemia caused by phlegm stasis is not recorded.

Comparison document 4: application No.:CN201510395355.X，the invention name is as follows:cassia seed blood fat-reducing health-care oral liquid And method for preparing the sameThe cassia seed blood fat reducing health-care oral liquid comprises the following raw materials in parts by weight: 10-50 parts of semen cassiae, 10-20 parts of oriental wormwood, 10-20 parts of pollen typhae, 10-20 parts of salvia miltiorrhiza, 10-20 parts of radix rehmanniae, 10-20 parts of scutellaria baicalensis, 10-20 parts of trichosanthes kirilowii maxim, 10-20 parts of gynostemma pentaphylla, 10-20 parts of sophora fruit, 10-20 parts of pericarpium citri reticulatae, 10-20 parts of polygonum cuspidatum, 10-20 parts of rhizoma alismatis, 10-20 parts of hawthorn, 10-20 parts of radix polygoni multiflori preparata, 10-20 parts of bighead atractylodes rhizome, 10-20 parts of corn stigma, 10-20 parts of tribulus terrestris and 10-20 parts of. a. Parching semen Cassiae; extracting with water to obtain component 1; b. extracting the other raw materials in water for 2 times to obtain component 2; c. extracting the residues of the 2 components with ethanol once to obtain a component 3; d. mixing the 3 components, concentrating, sterilizing with ultraviolet rays, and bottling.

The invention has the following defects that ① adopts 18 medicines, the medicine taste is more, the cost is higher, the preparation method ② adopts ethanol extraction, the cost is higher than that of water extraction, ③ uses cassia seeds instead of oriental wormwood and salvia miltiorrhiza, so that the effects of soothing liver, promoting diuresis, activating blood and reducing fat are achieved for the second time, and the ④ prescription has the effects of reducing blood fat, resisting bacteria, reducing blood sugar and resisting oxidation, and needs to be further demonstrated on the curative effect of the hyperlipidemia caused by phlegm stasis.

Reference 5 application No.:CN201310686776.9，the invention name is as follows:traditional Chinese medicine for treating obese fatty liver Composition comprising a metal oxide and a metal oxideThe traditional Chinese medicine composition for treating the obese fatty liver is characterized by comprising, by weight, 5-15g of radix bupleuri, 15-50g of gynostemma pentaphylla, 5-20g of semen cassiae, 15-35g of salvia chinensis, 5-15g of fried fructus aurantii, 5-15g of prepared rhubarb, 10-20g of radix curcumae, 10-20g of red peony roots, 10-20g of radix clematidis, 15-35g of Japanese ardisia herbs, 15-40g of raw hawthorns, 15-35g of salvia miltiorrhiza, 15-30g of turtle shells and 5-20g of capillary wormwood herbs, the traditional Chinese medicine composition adopts gynostemma pentaphylla, semen cassiae, clematis chinensis, Japanese ardisia herbs and capillary wormwood herbs as main monarch drugs, removes dampness and removes grease, the fructus crataegi, the radix bupleuri, the herba salviae, the fructus aurantii, the rheum, the radix et rhizoma rhei, the qi circulation of promoting digestion, the stagnation of the heat-clearing heat, the blood circulation and dissipating stagnation of the red sage roots, combines the effects of nourishing yin, suppressing yang, softening hardness and dissipating stagnation, the adjuvant drugs for treating the obese fatty liver, and the obesity, compared with the prior art, the traditional Chinese medicine composition for treating the obese fatty liver has the defects of 3514 gDamp-heatPurging fire, cooling blood, removing blood stasis, removing toxic substance, etcEfficacy of③ is used for treating obesity fatty liver, and has therapeutic effect on hyperlipidemia (fatty liver is not formed) caused by phlegm stasis.

Comparison document 6: the application number;CN201610564169.9, inventive name: medicine for treating fatty liver and its preparation Preparation methodThe traditional Chinese medicine composition is mainly prepared from artemisia capillaris, salvia miltiorrhiza, astragalus, rhizoma alismatis, hawthorn, mangnolia officinalis, turtle shell, herba lycopi, endothelium corneum gigeriae galli, radix curcumae, pericarpium citri reticulatae viride, radix gentianae, polygonum multiflorum, semen cassiae, rheum officinale, radix bupleuri, szechwan chinaberry fruit, lotus leaf, indigo naturalis, rhizoma paridis, polygonum cuspidatum and fructus aurantii according to a certain weight ratio, is placed into a medicine decocting container, 8 times of water is added, after being soaked for 100 minutes, the decoction is boiled with strong fire, then the decoction is decocted with slow fire for 20 minutes, a first decoction; (2) adding 6 times of water into the filtered residueThe medicine has the functions of strengthening spleen, eliminating dampness and resolving depression, purging liver fire, removing damp and heat from lower jiao, soothing liver and breaking qi, and eliminating stagnation and dissolving phlegm, and has the advantages of quick response, good curative effect and relapse prevention for treating fatty liver, however, the invention has the defects that ① adopts 22 medicines, the medicine has more medicine tastes and higher cost, ② has no need of further argumentation on the curative effect of hyperlipidemia (fatty liver is not formed yet) caused by phlegm stasis.

Comparison document 7: application No.:CN201310630408.2, inventive name: health care product with blood fat reducing function Article (A)The invention relates to a health product with a blood fat reducing function, which comprises 15-25 parts of kudzuvine root, 8-15 parts of parasitic loranthus, 10-20 parts of cassia seed, 10-20 parts of hawthorn, 8-15 parts of gynostemma pentaphylla, 8-15 parts of giant knotweed, 6-10 parts of artemisia capillaris and 6-10 parts of glossy privet fruit.

The application number is CN200810111719.7, the invention provides a medicine for preventing and treating fatty liver and a preparation method thereof, the medicine comprises 10-40 parts by weight of gynostemma pentaphylla, 5-20 parts by weight of broadleaf holly leaf, 5-20 parts by weight of pseudo-ginseng, 10-30 parts by weight of kudzu root, 5-20 parts by weight of hawthorn, 10-30 parts by weight of salvia miltiorrhiza, 5-20 parts by weight of rhizoma alismatis, 5-20 parts by weight of lotus leaf, 5-20 parts by weight of coptis chinensis, 5-20 parts by weight of oriental wormwood, 5-20 parts by weight of cassia seed, 10-30 parts by weight of codonopsis pilosula, 5-20 parts by weight of white paeony root and 5-20 parts by weight of gardenia, (1) the pseudo-ginseng is taken and crushed into coarse powder, the coarse powder is extracted by refluxing with 6-10-95% of ethanol for 2-4 times, the ethanol is extracted for 1-4 hours each time, the ethanol extract is filtered, the filtrate is merged, the ethanol is recovered under reduced pressure and concentrated to the filtrate with the density of 1.10-1.30 hours, the decoction is taken as a thick powder, the ointment, the decoction of the lotus leaf, the decoction of the ginseng, the decoction of the traditional Chinese herbal medicine is prepared by adding the ginseng, the decoction of the traditional Chinese herbal medicine, the traditional Chinese herbal medicine is prepared by using the traditional medicine, the traditional Chinese herbal medicine, the traditional medicine is prepared by the traditional medicine, the traditional medicine is prepared by the traditional medicine, the.

The invention relates to a traditional Chinese medicine formula for treating hyperlipidemia, and relates to the technical field of traditional Chinese medicines, wherein the traditional Chinese medicine formula comprises rhizoma alismatis, rhizoma polygonati, polygonum multiflorum, fenugreek, semen cassiae, eucommia ulmoides, hawthorn, turmeric, lotus leaves, salvia miltiorrhiza, black beans and Chinese dates.

The invention aims to solve the problems and develops a traditional Chinese medicine compound preparation for treating hyperlipemia, the preparation consists of six traditional Chinese medicines, and the traditional Chinese medicine compound preparation plays a drug effect substance basis of soothing liver and regulating qi, clearing heat and promoting diuresis, activating blood and dissolving stasis, and reducing blood fat and lowering fat, has obvious curative effect in clinical use, has important significance in reducing blood fat, reducing the risk of cardiovascular diseases of patients with later-stage hyperlipemia and improving the life quality of the patients, and has the advantages of high safety, economy, convenience in taking and the like.

Disclosure of Invention

The invention aims to provide a pharmaceutical composition for treating lipid lowering.

Another object of the present invention is to provide a process for preparing a lipid-lowering pharmaceutical composition.

The invention also aims to provide the application of the pharmaceutical composition in the treatment of the hyperlipidaemia.

The composition of the invention comprises the following medicaments: 10-30 g of oriental wormwood, 10-30 g of salvia miltiorrhiza, 10-30 g of raw hawthorn, 10-30 g of gynostemma pentaphylla, 10-30 g of cassia occidentalis and 10-30 g of lotus leaf.

Preferably, the composition of the present invention consists of the following drugs: 12-28 g of oriental wormwood, 12-28 g of salvia miltiorrhiza, 12-28 g of raw hawthorn, 12-28 g of gynostemma pentaphylla, 12-28 g of cassia occidentalis and 12-28 g of lotus leaf.

Further preferably, the composition of the present invention is composed of the following drugs: 14-26 g of oriental wormwood, 14-26 g of salvia miltiorrhiza, 14-26 g of raw hawthorn, 14-26 g of gynostemma pentaphylla, 14-26 g of cassia occidentalis and 14-26 g of lotus leaf.

Further preferably, the composition of the present invention is composed of the following drugs: 16-24 g of oriental wormwood, 16-24 g of salvia miltiorrhiza, 16-24 g of raw hawthorn, 16-24 g of gynostemma pentaphylla, 16-24 g of cassia occidentalis and 16-24 g of lotus leaf.

Further preferably, the composition of the present invention is composed of the following drugs: 18-22 g of oriental wormwood, 18-22 g of salvia miltiorrhiza, 18-22 g of raw hawthorn, 18-22 g of gynostemma pentaphylla, 18-22 g of cassia occidentalis and 18-22 g of lotus leaf.

Still more preferably, the composition of the present invention is composed of the following drugs: 20g of oriental wormwood, 20g of salvia miltiorrhiza, 20g of raw hawthorn, 20g of gynostemma pentaphylla, 20g of cassia occidentalis and 20g of lotus leaf.

The preparation method of the pharmaceutical composition comprises the following steps: taking the medicine according to the formula amount, adding 8-10 times of water to soak for 20-40 minutes, decocting for 2 times, heating and boiling for 1 time, decocting for 20-30 minutes, filtering, taking filtrate for later use, using the medicine residue for 2 times of decoction, adding 6-8 times of water to the medicine residue, heating and boiling, decocting for 15-25 minutes, filtering, taking filtrate, combining the filtrate obtained after 2 times of decoction, mixing uniformly to obtain decoction, or adding pharmaceutically acceptable auxiliary materials into the filtrate by a pharmaceutically conventional method to prepare a pharmaceutically acceptable preparation.

Preferably, the preparation method of the pharmaceutical composition of the present invention comprises the following steps: taking the medicine according to the formula amount, adding 9 times of water to soak for 30 minutes, decocting for 2 times, heating and boiling for 1 st time, decocting for 25 minutes, filtering, taking filtrate for standby, adding medicine residues to the decoction for 2 times, heating and boiling the medicine residues with 7 times of water, decocting for 20 minutes, filtering, taking filtrate, combining the filtrates obtained by 2 times of decoction, mixing uniformly to obtain decoction, or adding pharmaceutically acceptable auxiliary materials into the filtrate by a pharmaceutically conventional method to prepare a pharmaceutically acceptable dosage form.

The acceptable dosage forms of the invention are capsules, granules, tablets, pills and oral liquid.

The application of the pharmaceutical composition in the aspect of treating hyperlipemia is disclosed.

The term "times" means the weight ratio of the medicinal materials.

The pharmaceutically acceptable auxiliary materials are selected from one or more of fillers, binders, disintegrants, lubricants, surfactants or flavoring agents.

The taking method of the solid preparation of the invention comprises the following steps: orally administered at a dose of 2-4g three times a day, or following the prescription.

The prescription source is as follows:

hyperlipidemia is a disease in which one or more of triglyceride, total cholesterol, and low density lipoprotein in blood is abnormally increased or high density lipoprotein is abnormally decreased due to abnormal lipid metabolism in the body. The traditional Chinese medicine considers that the formation of the hyperlipemia is closely related to phlegm and stasis. The traditional Chinese medicine considers that qi of liver and gallbladder is not dispersed, qi of heart and spleen is deficient, and kidneys are involved as main internal factors; overeating a patient with obesity, exhaustion, excessive drinking and internal injury due to seven emotions are the main causes of hyperlipidemia, for example, Danxi Xin Fa: the theory that qi and blood are mixed, all diseases are not born, all diseases are born, and the liver accumulation is recorded as fat qi is also known. Once liver qi fails to reach and qi movement is not regulated, qi, blood and body fluids are disregulated, body fluids are transported and transformed into dampness, and the dampness is collected to form phlegm, which indicates that the change of qi movement of liver and gallbladder and seven emotions can affect the metabolism of qi, blood and body fluids, the fluid is refined into dampness and phlegm, the phlegm dampness is stagnated in various parts of the body for a long time to form blood stasis which obstructs qi movement, the qi stagnation can not promote the blood and body fluids to move, the phlegm is turbid and the blood stasis is endogenous, and the two influence and cause each other, so that the occurrence of hyperlipidemia is caused, and the relevance of the phlegm stasis of the traditional medicine and the hyperlipidemia of the modern medicine is reflected.

The traditional Chinese medicine composition is not prepared from salvia miltiorrhiza in the clinical application at first, and the effect can be seen at the beginning of treatment from the aspect of removing dampness and reducing phlegm in the process of treating hyperlipidaemia patients, but the effect is not before the late period of treatment. According to the traditional Chinese medicine pathogenesis of hyperlipidemia, the traditional Chinese medicine mainly combines two pathological products of phlegm and stasis, not only needs to treat phlegm, but also needs to promote blood circulation and remove blood stasis, so that the blood circulation and blood stasis promoting medicine is added in the application of the formula, and after clinical exploration, the addition of the salvia miltiorrhiza one medicine can obviously improve the curative effect and reduce the risk of cardiovascular diseases of patients with later-stage hyperlipidemia, so that the formula is finally determined to be composed of oriental wormwood, the salvia miltiorrhiza, gynostemma pentaphylla, raw hawthorn, lotus leaves and cassia occidentalis.

Square solution: the oriental wormwood is bitter, pungent and slightly cold, has the functions of tonifying spleen, stomach, liver and gallbladder channels, clearing heat and promoting diuresis, soothing liver and gallbladder and removing jaundice, and the formula is mainly used for soothing liver and removing dampness; salvia miltiorrhiza, recorded in Bencao gang mu, has the effects of bitter and slightly cold taste, entering heart and liver meridians and activating blood and dissolving stasis, also recorded in Bencao Zhenzhen, has the effect of breaking blood stasis of Salvia miltiorrhiza , but has the effects of promoting new fetus growth, regulating menstruation … and the like, and has the effect of removing blood stasis in general, and the formula is mainly used for activating blood and dissolving stasis; the virgate wormwood herb and the red sage root are used together to play the roles of removing dampness and removing stasis, and are used as monarch drugs; the gynostemma pentaphylla is sweet in taste and cool in nature, enters lung, spleen and kidney channels, benefits qi and strengthens spleen, reduces phlegm and relieves cough, clears away heat and toxic materials, and is mainly used as a ministerial drug for assisting a monarch drug in activating spleen and regulating qi to assist dampness and eliminate phlegm, and promoting blood circulation to remove blood stasis; the raw hawthorn has the functions of strengthening spleen, promoting digestion, promoting qi circulation and removing blood stasis, the lotus leaf and the cassia occidentalis have the functions of relaxing bowel, and the raw hawthorn, the lotus leaf and the cassia occidentalis have the functions of strengthening spleen, promoting digestion, regulating qi, activating blood circulation, eliminating phlegm and removing dampness as assistant and guide medicines. The six medicines are used together to play the functions of dispersing liver qi, regulating qi, clearing heat, promoting diuresis, activating blood circulation to remove blood stasis, reducing lipid and lowering fat, so that the purpose of reducing fat is achieved, the curative effect of clinically treating a patient with hyperlipemia is obvious, and the six medicines are good prescription for reducing lipid, so the six-ingredient lipid-lowering soup is called.

Has the advantages that:

the problems in the prior art and the technical problems solved by the invention and the achieved technical effects are as follows:

1. reference 1, application No. CN200710004517.8, a Chinese medicinal composition with effects of reducing blood fat and reducing weight, has the defects that ① formula contains rhubarb which has the effects of removing food retention and clearing away heatDamp-heatPurging fire, cooling blood, removing blood stasis, removing toxic substance, etcEfficacy ofBut for weak people, the traditional Chinese medicine composition is easy to cause adverse symptoms such as diarrhea and hypodynamia, ② the whole prescription is not provided with medicines for nourishing blood and promoting blood circulation and is not suitable for hyperlipemia caused by phlegm stasis, the preparation method of ③ is not clear in water adding amount and decoction time, and the extraction rate of effective components is not easy to master.

Compared with the comparison document 1, the invention solves the related technical problems and achieves the corresponding technical effects, specifically, the ① formula does not contain rhubarb, is suitable for being taken by people with weak health, the ② formula uses the salvia miltiorrhiza as a blood nourishing and blood circulation promoting medicine, the curative effect is obviously improved, the risk of cardiovascular diseases of patients with later-stage hyperlipemia is reduced, the ③ preparation method has definite water adding amount and decoction time, and the effective components are fully extracted.

2. The comparison document 2, application No. CN03109063.X, "Chinese medicinal formula for treating hyperlipemia", has the following defects that ① formula contains radix et rhizoma Rhei with effects of removing food retention and clearing away heatDamp-heatPurging fire, cooling blood, removing blood stasis, removing toxic substance, etcEfficacy of② Ginseng radix is a powerful tonic for long-term administration and harmful to the balance of qi and blood, ③ the formula is suitable for patients with cardiovascular and cerebrovascular diseases such as hypercholesterolemia and hypertriglyceridemia, and the whole formula is not suitable for treating simple hyperlipidemia.

Compared with the comparison document 2, the invention solves the related technical problems and achieves the corresponding technical effects, and particularly, the ① prescription does not contain rheum officinale and is suitable for people with weak health to take, the ② prescription eliminates ginseng which is a tonic product, the salvia miltiorrhiza has the effects of nourishing blood and invigorating blood circulation, the curative effect of the whole prescription is obviously improved, ③ reduces the risk of cardiovascular diseases of patients with later hyperlipidemia, and ④ aims at the treatment of simple hyperlipidemia.

3. Comparison document 3: disclose aCN200610068698.6，Medicine for treating fatty liver and preparation method thereofThe invention has the following defects that ① formula contains rhubarb which has the effects of removing food retention and clearing away heatDamp-heatPurging fire, cooling blood, removing blood stasis, removing toxic substance, etcWork (Gong) Effect of (1)② Ginseng radix is a powerful tonic for long-term administration and harmful to the balance of qi and blood in human body, ③ has more medicinal ingredients and higher cost, ④ is a medicinal composition for reducing blood fat, resisting peroxidation injury, obviously improving liver fat metabolism, resisting fatty liver, protecting liver and reducing blood fat, has no record on the curative effect of hyperlipidemia caused by phlegm stasis, and ⑤ is a medicinal composition with longer decoction time and higher cost.

Compared with a comparison document 3, the invention solves the related technical problems and achieves the corresponding technical effects, and particularly, the ① prescription does not contain rheum officinale and is suitable for people with weak health to take, the ② prescription eliminates ginseng which is a tonic product, the salvia miltiorrhiza has the effects of nourishing blood and invigorating blood circulation, the curative effect of the whole prescription is obviously improved, ③ reduces the risk of cardiovascular diseases of patients with later-stage hyperlipidemia, the ④ medicine taste is reduced to 6 medicines, the cost is lower, the ⑤ prescription has obvious curative effect on hyperlipidemia caused by phlegm stasis, the ⑥ is decocted for about 1 hour at most, and the cost is lower.

4. Comparison document 4:CN201510395355.X A semen Cassiae oral liquid for reducing blood lipid and protecting health, and its preparation methodHowever, the invention has the defects that ① adopts 18 medicines, the medicine taste is more, the cost is higher, the preparation method ② adopts ethanol extraction, the cost is higher than that of water extraction, ③ uses cassia seeds instead of oriental wormwood and salvia miltiorrhiza, so that the effects of soothing liver, promoting diuresis, activating blood and reducing fat are less, ④ the formula has the effects of reducing blood fat, resisting bacteria, reducing blood sugar and resisting oxidation, and the curative effect of the hyperlipidemia caused by phlegm stasis needs to be further demonstrated.

Compared with the comparison document 4, the Chinese medicinal composition solves the related technical problems, achieves the corresponding technical effect, and has the advantages that ① adopts 6 medicaments, the medicament has less medicinal taste and lower cost, the ② preparation method adopts water extraction, the cost is low, ③ uses artemisia capillaris and salvia miltiorrhiza, so the Chinese medicinal composition has better effects of soothing liver, promoting diuresis, activating blood circulation and reducing fat, and the ④ Chinese medicinal composition has obvious curative effect on hyperlipidemia caused by phlegm stasis.

5. Comparison document 5:CN201310686776.9 traditional Chinese medicine composition for treating obese fatty liverHowever, the invention has the defects that ① adopts 14 medicines, the medicine taste is more, the cost is higher, ② formula contains rhubarb which has the functions of removing food retention and clearing away heatDamp-heatPurging fire, cooling blood, removing blood stasis, removing toxic substance, etcEfficacy of③ is suitable for treating obesity fatty liver and hyperlipidemia (fatty liver is not formed) caused by phlegm stasis.

Compared with the reference 5, the Chinese medicinal composition solves the related technical problems, and achieves the corresponding technical effects that ① adopts 6 medicaments, the medicinal flavor is less, the cost is lower, no rhubarb is contained in the ② formula, the Chinese medicinal composition can be taken by people with weak health for a long time, and ③ has obvious curative effect on hyperlipidemia (fatty liver is not formed yet) caused by phlegm stasis.

6. Comparison document 6:CN201610564169.9 medicine for treating fatty liver and preparation method thereofHowever, the invention has the defects that ① adopts 22 medicines, the medicine taste is more, the cost is higher, ② has to be further demonstrated for treating the fatty liver, and the curative effect of the hyperlipemia (the fatty liver is not formed yet) caused by phlegm stasis is required.

Compared with the comparison document 6, the invention solves the related technical problems and achieves the corresponding technical effects that ① adopts 6 medicines, the medicine taste is less, the cost is lower, and ② has obvious curative effect on hyperlipidemia (fatty liver is not formed yet) caused by phlegm stasis.

7. Comparison document 7:CN201310630408.2 health product with blood fat reducing function① needs to be further demonstrated for the curative effect of hyperlipemia caused by phlegm stasis ② does not define a specific preparation method, and the curative effect needs to be further verified.

Compared with the reference 7, the invention solves the related technical problems and achieves the corresponding technical effects of ① defining the corresponding preparation method, high effective components and obvious curative effect, and ② has obvious curative effect on hyperlipidemia caused by phlegm stasis.

8. The comparison document 8 shows that the drug for preventing and treating the fatty liver and the preparation method thereof are provided with application number CN200810111719.7, but the invention has the defects that ① focuses on the prevention and treatment of the fatty liver, the curative effect of hyperlipidemia caused by phlegm stasis needs to be further demonstrated, ② adopts alcohol extraction, the cost is higher compared with that of water boiling, and ③ has more drugs and higher cost.

Compared with the comparison document 8, the traditional Chinese medicine composition solves the related technical problems and achieves the corresponding technical effects that ① has obvious curative effect on hyperlipidemia caused by phlegm stasis, ② adopts water extraction, the cost is lower, and ③ only has 6 medicines, so the cost is lower.

9. A comparison document 9 shows that CN201310376788.1 is a traditional Chinese medicine formula for treating hyperlipidemia, but the invention has the defects that the ① formula contains black beans and Chinese dates which are used for tonifying, and is not suitable for tonifying hyperlipidemia caused by phlegm stasis, and ② adopts alcohol extraction, so that the cost is higher than that of water decoction.

Compared with the comparison document 9, the invention solves the related technical problems and achieves the corresponding technical effect that ① adopts water extraction and has low cost.

Clinical tests prove that the traditional Chinese medicine composition has the effects of soothing the liver, regulating qi, clearing heat, promoting diuresis, promoting blood circulation, removing blood stasis, reducing fat and fertility, has obvious curative effect in clinical use, has important significance for reducing blood fat, reducing the risk of cardiovascular diseases of patients with later-stage hyperlipemia and improving the life quality of the patients, and has the advantages of high safety, economy, convenience in taking and the like. After the drug is taken, various symptoms of patients are obviously relieved, 6 cases (13%) are clinically controlled, 17 cases (35%) are clinically effective, 21 cases (44%) are effective, 4 cases (8%) are ineffective, and the total effective rate is 92%.

Pharmacodynamic tests prove that the traditional Chinese medicine composition has the effect of reducing the blood lipid level of hyperlipidemic rats, and is mainly reflected in remarkably reducing the serum TC, TG and LDL-C levels of hyperlipidemic rats.

Fourthly, the invention screens the best preparation method through pharmacodynamic tests, and the experimental result shows that: the effect is obviously better than that of water decoction for 1 time after the water decoction is carried out for 2 times and the corresponding decoction time.

Detailed Description

The following examples are intended to illustrate the invention but are not intended to limit the scope of the invention.

Example 1

The formula is as follows: 20g of oriental wormwood, 20g of salvia miltiorrhiza, 20g of hawthorn, 20g of gynostemma pentaphylla, 20g of cassia occidentalis and 20g of lotus leaf.

The preparation method comprises the following steps:

taking the medicine according to the formula amount, adding 9 times of water to soak for 30 minutes, decocting for 2 times, decocting for 25 minutes after heating and boiling for 1 st time, filtering, taking filtrate for standby, adding 7 times of water to the residue, heating and boiling for 20 minutes, filtering, taking filtrate, combining the filtrates obtained after 2 times of decoction, and uniformly mixing to obtain the decoction.

The taking method comprises the following steps: the decoction is taken one dose a day and one dose is taken three times.

Example 2

The preparation method comprises the following steps:

taking the medicine according to the formula amount, adding 9 times of water to soak for 30 minutes, decocting for 2 times, heating and boiling for 1 st time, decocting for 25 minutes, filtering, taking filtrate for standby, adding medicine residues to the decoction for 2 times, heating and boiling the medicine residues for 7 times of water, decocting for 20 minutes, filtering, taking filtrate, combining the filtrates obtained by 2 times of decoction, uniformly mixing, concentrating, drying, crushing into fine powder, adding 1/10 starch, uniformly mixing, and granulating to obtain the granule.

Example 3

The preparation method comprises the following steps:

taking the medicine according to the formula amount, adding 9 times of water to soak for 30 minutes, decocting for 2 times, heating and boiling for 1 st time, decocting for 25 minutes, filtering, taking filtrate for standby, adding medicine residues to the decoction for 2 times, heating and boiling the medicine residues with 7 times of water, decocting for 20 minutes, filtering, taking filtrate, combining the filtrates obtained by 2 times of decoction, uniformly mixing, concentrating, drying, crushing into fine powder, adding 1/10 starch, uniformly mixing, and encapsulating to obtain the capsule of the invention.

Example 4

The preparation method comprises the following steps:

taking the medicine according to the formula amount, adding 9 times of water to soak for 30 minutes, decocting for 2 times, heating and boiling for 1 st time, decocting for 25 minutes, filtering, taking filtrate for standby, adding medicine residues to the decoction for 2 times, heating and boiling the medicine residues with 7 times of water, decocting for 20 minutes, filtering, taking filtrate, combining the filtrates obtained by 2 times of decoction, uniformly mixing, concentrating, drying, crushing into fine powder, adding 1/9 starch, uniformly mixing, and tabletting to obtain the tablet.

Example 5

The preparation method comprises the following steps:

taking the medicine according to the formula amount, adding 9 times of water to soak for 30 minutes, decocting for 2 times, heating and boiling for 1 st time, decocting for 25 minutes, filtering, taking filtrate for standby, adding medicine residues to the decoction for 2 times, heating and boiling the medicine residues for 7 times of water, decocting for 20 minutes, filtering, taking filtrate, combining the filtrates obtained by 2 times of decoction, uniformly mixing, concentrating, drying, crushing into fine powder, adding 1/8 starch, uniformly mixing, and preparing pills to obtain the pills.

Example 6

The preparation method comprises the following steps:

taking the medicine according to the formula amount, adding 8 times of water to soak for 20 minutes, decocting for 2 times, decocting for 20 minutes after heating and boiling for 1 st time, filtering, taking filtrate for standby, adding 6 times of water to the residue for decocting for 2 times, heating and boiling the residue for 15 minutes, filtering, taking filtrate, combining the filtrates obtained by decocting for 2 times, and mixing uniformly to obtain decoction.

Example 7

The preparation method comprises the following steps:

taking the medicine according to the formula amount, adding 10 times of water to soak for 40 minutes, decocting for 2 times, decocting for 30 minutes after boiling for 1 st time, filtering, taking the filtrate for standby, adding 8 times of water to the residue, heating and boiling for 25 minutes, filtering, taking the filtrate, combining the filtrates obtained after 2 times of decoction, and mixing uniformly to obtain the decoction.

Example 8

The formula is as follows: 11g of oriental wormwood, 11g of salvia miltiorrhiza, 10g of hawthorn, 10g of gynostemma pentaphylla, 10g of cassia occidentalis and 10g of lotus leaf.

The preparation method comprises the following steps:

Example 9

The preparation method comprises the following steps:

Example 10

The preparation method comprises the following steps:

Example 11

The preparation method comprises the following steps:

Example 12

The preparation method comprises the following steps:

Example 13

The preparation method comprises the following steps:

Example 14

The preparation method comprises the following steps:

Example 15

The formula is as follows: 30g of oriental wormwood, 30g of salvia miltiorrhiza, 28g of hawthorn, 28g of gynostemma pentaphylla, 28g of cassia occidentalis and 28g of lotus leaf.

The preparation method comprises the following steps:

Example 16

The preparation method comprises the following steps:

Example 17

The preparation method comprises the following steps:

Example 18

The preparation method comprises the following steps:

Example 19

The preparation method comprises the following steps:

Example 20

The preparation method comprises the following steps:

Example 21

The preparation method comprises the following steps:

Example 22

The formula is as follows: 13g of oriental wormwood, 13g of salvia miltiorrhiza, 12g of hawthorn, 13g of gynostemma pentaphylla, 12g of cassia occidentalis and 12g of lotus leaf.

The preparation method comprises the following steps:

Example 23

The preparation method comprises the following steps:

Example 24

The preparation method comprises the following steps:

Example 25

The preparation method comprises the following steps:

Example 26

The preparation method comprises the following steps:

Example 27

The preparation method comprises the following steps:

Example 28

The preparation method comprises the following steps:

Example 29

The formula is as follows: 28g of oriental wormwood, 28g of salvia miltiorrhiza, 25g of hawthorn, 27g of gynostemma pentaphylla, 26g of cassia occidentalis and 26g of lotus leaf.

The preparation method comprises the following steps:

Example 30

The preparation method comprises the following steps:

Example 31

The preparation method comprises the following steps:

Example 32

The preparation method comprises the following steps:

Example 33

The preparation method comprises the following steps:

Example 34

The preparation method comprises the following steps:

Example 35

The preparation method comprises the following steps:

Example 36

The formula is as follows: 17g of oriental wormwood, 17g of salvia miltiorrhiza, 14g of hawthorn, 14g of gynostemma pentaphylla, 14g of cassia occidentalis and 14g of lotus leaf.

The preparation method comprises the following steps:

Example 37

The preparation method comprises the following steps:

Example 38

The preparation method comprises the following steps:

Example 39

The preparation method comprises the following steps:

Example 40

The preparation method comprises the following steps:

EXAMPLE 41

The preparation method comprises the following steps:

Example 42

The preparation method comprises the following steps:

Example 43

The preparation method comprises the following steps:

Example 44

The preparation method comprises the following steps:

Example 45

The preparation method comprises the following steps:

Example 46

The preparation method comprises the following steps:

Example 47

The preparation method comprises the following steps:

Example 48

The preparation method comprises the following steps:

Example 49

The formula is as follows: 26g of oriental wormwood, 26g of salvia miltiorrhiza, 24g of hawthorn, 24g of gynostemma pentaphylla, 25g of cassia occidentalis and 25g of lotus leaf.

The preparation method comprises the following steps:

Example 50

The formula is as follows: 18g of oriental wormwood, 18g of salvia miltiorrhiza, 16g of hawthorn, 17g of gynostemma pentaphylla, 16g of cassia occidentalis and 16g of lotus leaf.

The preparation method comprises the following steps:

Example 51

The preparation method comprises the following steps:

Example 52

The preparation method comprises the following steps:

Example 53

The preparation method comprises the following steps:

Example 54

The preparation method comprises the following steps:

Example 55

The preparation method comprises the following steps:

Example 56

The preparation method comprises the following steps:

Example 57

The formula is as follows: 24g of oriental wormwood, 24g of salvia miltiorrhiza, 23g of hawthorn, 22g of gynostemma pentaphylla, 23g of cassia occidentalis and 22g of lotus leaf.

The preparation method comprises the following steps:

Example 58

The preparation method comprises the following steps:

Example 59

The preparation method comprises the following steps:

Example 60

The preparation method comprises the following steps:

Example 61

The preparation method comprises the following steps:

Example 62

The preparation method comprises the following steps:

Example 63

The preparation method comprises the following steps:

Example 64

The formula is as follows: 22g of oriental wormwood, 19g of salvia miltiorrhiza, 18g of hawthorn, 18g of gynostemma pentaphylla, 18g of cassia occidentalis and 18g of lotus leaf.

The preparation method comprises the following steps:

Example 65

The preparation method comprises the following steps:

Example 66

The preparation method comprises the following steps:

Example 67

The preparation method comprises the following steps:

Example 68

The preparation method comprises the following steps:

Example 69

The preparation method comprises the following steps:

Example 70

The preparation method comprises the following steps:

In order to further summarize the feasibility of the invention, the inventors performed process screening, pharmacological tests and clinical tests, as follows:

formula, process screening and effect test

1. Formula and process

Experimental example 1

The preparation method comprises the following steps: decocting with purified water once, decocting the liquid medicine with strong fire until boiling, then decocting with slow fire for 20 minutes, then separating the residue from the liquid medicine, filtering the liquid medicine and pouring out, namely the drinking amount of one medicine for one day.

Experimental example 2

The preparation method comprises the following steps:

Experimental example 3

The formula is as follows: 20g of oriental wormwood, 20g of hawthorn, 20g of gynostemma pentaphylla, 20g of cassia occidentalis and 20g of lotus leaf.

The preparation method comprises the following steps:

2. The experimental method comprises the following steps:

(1) method for preparing high-fat feed

Firstly heating 245g of lard oil and 25g of soybean oil to melt, adding 200g of casein, stir-frying, dissolving 16.5g of potassium citrate, 2g of choline tartrate, 125g of maltodextrin and 50g of cellulose by using a proper amount of distilled water, adding the dissolved solution, uniformly mixing, adding 3g of cystine, 10g of compound vitamin, 10g of compound mineral, 5.5g of calcium carbonate, 13g of calcium hydrophosphate, 68.8g of cane sugar and 0.05g of brilliant blue, stir-frying all the substances, uniformly mixing, placing the mixture to normal temperature, preparing the mixture into strips, preparing the feed according to needs, and storing the feed at 4 ℃ for later use.

(2) Animal model

After 72 SD rats are adaptively fed for 1 week, 12 rats are randomly selected as a blank group, common feed is given, high-fat feed is given to the rest rats for molding, all animals freely eat drinking water, 3 rats are randomly selected from the blank group and the molding group every week, tail vein blood is taken, serum Triglyceride (TG), Total Cholesterol (TC), high-density lipoprotein cholesterol (HDL-C) and low-density lipoprotein cholesterol (LDL-C) values are detected, and whether molding is successful is judged. After 6 weeks, the model group and the blank group were compared, and serum TC, TG and LDL-C were increased, and the differences were statistically different from those in the blank group, and the model was judged to be established.

(3) Grouping and administration of drugs

Starting from week 7, all model rats except the blank group were randomly divided into simvastatin group, experimental example 1 group, experimental example 2 group, experimental example 3 group, model group, 12 rats in each group, the blank group rats were gazed with normal saline daily, experimental example 1 group rats were administered six lipid-lowering decoction daily (decocted 1 time, i.e., the drug of experimental example 1), experimental example 2 group rats were administered six lipid-lowering decoction daily (decocted 2 times, i.e., the drug of experimental example 2), experimental example 3 group rats were administered six lipid-lowering decoction daily (decocted 2 times, i.e., the drug of experimental example 3) to remove salvia miltiorrhiza decoction, the administration volumes were 1ml/100g and 1 time/day, simvastatin group was administered simvastatin, and the drug amount was calculated as 10mg/kg, and were continuously gazed for 4 weeks. During the administration period, each group except the blank group was fed with high-fat diet. Body weights were recorded every 3 days during dosing.

(4) Index detection

After 4 weeks of dosing, the rats were fed water-free for 12h, and sacrificed by abdominal aorta bleeding after the last dose.

And (3) detecting the blood lipid level: the full-automatic biochemical analyzer detects Triglyceride (TG), Total Cholesterol (TC), high density lipoprotein cholesterol (HDL-C) and low density lipoprotein cholesterol (LDL-C).

(5) Statistical analysis

The measured data is averaged + -SD

It is shown that SPSS17.0 statistical analysis software is used to analyze and process data, and single-factor analysis of variance (one-way ANOVA) is used to compare between groups, and p < 0.05 is used as difference, which has statistical significance.

3. Results of the experiment

3.1 weight of rats in each group

According to statistical results, the weight of rats in the model group of 7-10 weeks is obviously higher than that of the blank group, and the weight of rats in the simvastatin group and the six-ingredient lipid-lowering soup 2 group is obviously lower than that of rats in the model group (P < 0.01), and the weight of rats in the simvastatin group and the six-ingredient lipid-lowering soup 2 group is not statistically different (P >0.05) compared with that in the model group (P < 0.01).

Table 17-10 weeks change in body weight of each group of animals (g,

)

note: compared with the blank group, # P < 0.05; f < 0.05 compared to model group.

3.2 blood lipid index of each group of rats

3.2.1 blood lipid index of rats before administration

After the model building is successful, the model building rats are randomly grouped, and the blood lipid level of each group of rats after grouping is shown in table 2. The TC, TG and LDL-C levels of rats fed with the high-fat feed are obviously higher than those of rats in a blank group (P is less than 0.01), and the model group, the simvastatin group, the six-flavor lipid-lowering soup 1 group and the six-flavor lipid-lowering soup 2 group have no statistical difference (P is more than 0.05), which indicates that the grouping is reasonable and feasible.

Table 2 blood lipid levels of rats in each group before administration (mmol. L-1,

)

note: compared with the blank group, # P < 0.05; p >0.05 compared to model group.

3.2.2 blood lipid index of rats in each group after administration

The gavage intervention was started 7 weeks after the molding, and after 4 weeks of gavage administration, the blood lipid levels of rats in each group after the administration were shown in tables 3, 4, 5 and 6 every week.

Compared with the blank group, the serum TC, TG and LDL-C levels of the rats in the model group are obviously increased, the difference has statistical significance (P is less than 0.05), and the serum HDL-C level change has no statistical difference (P is more than 0.05).

Compared with the model group, after different intervention measures are given for 4 weeks, the serum TC, TG and LDL-C levels of rats in the six-ingredient lipid-lowering soup 1 group, the six-ingredient lipid-lowering soup 2 group and the simvastatin group are reduced to different degrees, and the difference has statistical significance (P is less than 0.05).

Compared with simvastatin group, the serum TC, TG and LDL-C levels of rats in the six-ingredient lipid-lowering soup 2 group are not obviously different from those of rats; compared with the model group, the change of the serum HDL-C level of each group of animals is not statistically different (P is more than 0.05).

Table 3 blood lipid levels of rats in groups administered week 1 (mmol. L-1,

)

note: compared with the blank group, # P < 0.05; p >0.05 compared to simvastatin group.

Table 4 blood lipid levels (mmol. L-1,

)

note: compared with the blank group, # P < 0.05; compared with the model group, & P & lt, 0.05; p >0.05 compared to simvastatin group.

Table 5 blood lipid levels (mmol. L-1,

)

Table 6 blood lipid levels of rats in each group at week 4 of administration (mmol. L-1,

)

note: compared with the blank group, # P < 0.05; in comparison with the blank set, the results,^Δp is more than 0.05; p < 0.05 compared to model group; p >0.05 compared to simvastatin group.

The experimental results suggest that the experimental example 1 group, the experimental example 2 group and the experimental example 3 group all have the effect of reducing the blood lipid level of the rat with hyperlipidemia, and are mainly reflected in the significant reduction of the serum TC, TG and LDL-C levels of the rat with the hyperlipidemia model, but the experimental results show that the effect of the experimental example 2 group is obviously superior to that of the experimental example 1 group, which may be related to the fact that the effective ingredients of the traditional Chinese medicine in the formula can be fully decocted out by decocting the medicine twice, and the utilization rate of the traditional Chinese medicine can be improved and the waste can be reduced by decocting the medicine twice. Therefore, the preparation of the six-ingredient lipid-lowering decoction is determined by the decoction method 2. The experimental example 3 group has obvious lipid-lowering effect in the first and second weeks of administration, and can obviously lower the levels of TC, TG and LDL-C in the serum of a rat model with hyperlipidemia, but before the lipid-lowering effect is stopped in the third week of administration, the lipid-lowering effect is probably related to the absence of one medicine of Salvia miltiorrhiza in the formula, and the phlegm and blood stasis are combined in the later period of hyperlipidemia, so the effect is not obvious in the later period of treatment if the blood circulation is not activated and the blood stasis is not better than that in the experimental example 2 group.

Third, clinical trial

The invention relates to a traditional Chinese medicine compound preparation for treating hyperlipemia, which consists of six traditional Chinese medicines, plays a drug effect substance basis of soothing liver and regulating qi, clearing heat and promoting diuresis, and reducing fat and fertility, and has obvious clinical use curative effect. Has important significance for reducing blood fat and improving the life quality of patients, and has the advantages of high safety, economy, convenience for taking and the like.

Hyperlipidemia is a disease in which one or more of triglyceride, total cholesterol, and low density lipoprotein in blood is abnormally increased or high density lipoprotein is abnormally decreased due to abnormal lipid metabolism in the body. The traditional Chinese medicine considers that the formation of the hyperlipemia is closely related to phlegm and stasis. The traditional Chinese medicine considers that qi of liver and gallbladder is not dispersed, qi of heart and spleen is deficient, and kidneys are involved as main internal factors; overeating a patient with obesity, exhaustion, excessive drinking and internal injury due to seven emotions are the main causes of hyperlipidemia, as in Danxi Fa: the theory that qi and blood are mixed, all diseases are not born, all diseases are born, and the liver accumulation is recorded as fat qi is also known. Once liver qi fails to reach and qi movement is not regulated, qi, blood and body fluids are disregulated, body fluids are transported and transformed into dampness, and the dampness is collected to form phlegm, which indicates that the change of qi movement of liver and gallbladder and seven emotions can affect the metabolism of qi, blood and body fluids, the fluid is refined into dampness and phlegm, the phlegm dampness is stagnated in various parts of the body for a long time to form blood stasis which obstructs qi movement, the qi stagnation can not promote the blood and body fluids to move, the phlegm is turbid and the blood stasis is endogenous, and the two influence and cause each other, so that the occurrence of hyperlipidemia is caused, and the relevance of the phlegm stasis of the traditional medicine and the hyperlipidemia of the modern medicine is reflected.

The preparation method comprises the following steps:

The taking method comprises the following steps: one dose is taken three times a day.

[ clinical pharmacological research and efficacy ] the recipe initially has no single herb of red sage root in clinical application, and in the course of treatment of hyperlipidemia patients, it is found that the curative effect is seen at the beginning of treatment from the viewpoint of removing dampness and resolving phlegm, but the curative effect is not before the end of treatment. According to the traditional Chinese medicine pathogenesis of hyperlipidemia, the traditional Chinese medicine mainly combines two pathological products of phlegm and stasis, not only needs to treat phlegm, but also needs to promote blood circulation and remove blood stasis, so that the blood circulation and blood stasis promoting medicine is added in the application of the formula, and after clinical exploration, the addition of the salvia miltiorrhiza one medicine can obviously improve the curative effect and reduce the risk of cardiovascular diseases of patients with later-stage hyperlipidemia, so that the formula is finally determined to be composed of oriental wormwood, the salvia miltiorrhiza, gynostemma pentaphylla, raw hawthorn, lotus leaves and cassia occidentalis. The oriental wormwood is bitter, pungent and slightly cold, has the functions of tonifying spleen, stomach, liver and gallbladder channels, clearing heat and promoting diuresis, soothing liver and gallbladder and removing jaundice, and the formula is mainly used for soothing liver and removing dampness; salvia miltiorrhiza, recorded in Bencao gang mu, has the effects of bitter and slightly cold taste, entering heart and liver meridians and activating blood and dissolving stasis, also recorded in Bencao Zhenzhen, has the effect of breaking blood stasis of Salvia miltiorrhiza , but has the effects of promoting new fetus growth, regulating menstruation … and the like, and has the effect of removing blood stasis in general, and the formula is mainly used for activating blood and dissolving stasis; the virgate wormwood herb and the red sage root are used together to play the roles of removing dampness and removing stasis, and are used as monarch drugs; the gynostemma pentaphylla is sweet in taste and cool in nature, enters lung, spleen and kidney channels, benefits qi and strengthens spleen, reduces phlegm and relieves cough, clears away heat and toxic materials, and is mainly used as a ministerial drug for assisting a monarch drug in activating spleen and regulating qi to assist dampness and eliminate phlegm, and promoting blood circulation to remove blood stasis; the raw hawthorn has the functions of strengthening spleen, promoting digestion, promoting qi circulation and removing blood stasis, the lotus leaf and the cassia occidentalis have the functions of relaxing bowel, and the raw hawthorn, the lotus leaf and the cassia occidentalis have the functions of strengthening spleen, promoting digestion, regulating qi, activating blood circulation, eliminating phlegm and removing dampness as assistant and guide medicines. The six medicines are used together to play the functions of dispersing liver qi, regulating qi, clearing heat, promoting diuresis, activating blood circulation to remove blood stasis, reducing lipid and lowering fat, so that the purpose of reducing fat is achieved, the curative effect of clinically treating a patient with hyperlipemia is obvious, and the six medicines are good prescription for reducing lipid, so the six-ingredient lipid-lowering soup is called.

[ MEANS FOR CARRYING OUT THE INVENTION ]

48 outpatients from 3 months in 2018 to 11 months in 2018 to affiliated hospital of traditional Chinese medicine university in Guizhou. 30 men and 18 women; the age is 32-65 years, and the average age is 47 years; the disease course is 6 months to 3 years, and the average is 1.5 years.

The diagnosis standard refers to the hyperlipemia diagnosis standard of 2002 edition of the Ministry of health of traditional Chinese medicine clinical research guidelines, and the blood fat examination is to detect the blood fat level after fasting for 12-14 h under the normal diet condition, and has at least 2 blood sample detection records within 1-2 weeks, wherein the detection meets one of the following conditions, namely ① serum LDL-C3.64mmol/L (140mg/dL) or more, ② serum HDL-C0.91mmol/L (35mg/dL) or less, ③ serum TG1.70mmol/L (150mg/dL) or more, ④ serum TC5.72mmol/L (220mg/dL) or more, and the possibility of secondary dyslipidemia is eliminated.

The syndrome differentiation of traditional Chinese medicine is that damp-heat is accumulated in the interior and turbid-blood stasis is combined. The main symptoms are obesity, heavy head, chest distress, stabbing pain in precordial region and numbness and heaviness of limbs. The secondary symptoms are palpitation, insomnia, sticky and greasy mouth and poor appetite. The tongue is swollen and dark, or dark tongue with petechia or ecchymosis on the tip edge, and yellow and greasy coating. The pulse condition is wiry, slippery or rapid. Has more than 2 main symptoms or 2 secondary symptoms of 1 main symptom, and can be diagnosed according to tongue condition and pulse condition.

The treatment method comprises the following steps: the six-ingredient lipid-lowering decoction is orally taken. 20g of oriental wormwood, 20g of salvia miltiorrhiza, 20g of hawthorn, 20g of gynostemma pentaphylla, 20g of cassia occidentalis and 20g of lotus leaf. The preparation is administered orally in water 1 dose a day, 3 months as a course of treatment. Meanwhile, the patients are instructed to adjust the bad dietary habits, abstain from alcohol, fast food with fatness and greasiness, and cooperate with exercise.

And (3) evaluating the curative effect: the method is formulated according to the clinical research guidelines of the Ministry of health for treating hyperlipidemia with new Chinese medicines. The effect is shown: the blood fat detection reaches any one of the following: TC is decreased by more than or equal to 20 percent, or TG is decreased by more than or equal to 40 percent, or HDL-C is increased by more than or equal to 0.26 mmol/L; the method has the following advantages: the blood lipid level can reach any one of the following levels: TC is decreased by more than or equal to 10% < 20%, or TG is decreased by more than or equal to 20% < 40%, or HDL-C is increased by more than or equal to 0.104<0.26 mmol/L; and (4) invalidation: the effective index is not reached after the treatment.

After the drug is taken, various symptoms of patients are obviously relieved, 6 cases (13%) are clinically controlled, 17 cases (35%) are clinically effective, 21 cases (44%) are effective, 4 cases (8%) are ineffective, the total effective rate is 92%, and the blood fat level is obviously reduced after the treatment. See table 7 below for details.

TABLE 7 before and after treatment table of blood lipid level

Specific case 1, money of patient, male, 40 years old, official, first diagnosis in 2018, 6 months and 11 days. The patients with mental fatigue, obesity, heavy limbs, sticky stool, turbid urine for 2-3 times a day. A swollen and dark tongue with yellow and greasy coating and a slippery pulse. Laboratory examination: 4.36mmol/L of serum low-density lipoprotein (LDL-C), 2.31/L of serum Triglyceride (TG) and 5.89mmol/L of serum Total Cholesterol (TC). Traditional Chinese medicine diagnosis: obesity is marked by phlegm-turbid obstruction and endogenous damp-heat. The treatment is mainly to clear heat and remove dampness, reduce phlegm and remove blood stasis, and the prescription is prepared from six ingredients of lipid-lowering soup 3 agents, namely 20g of oriental wormwood, 20g of salvia miltiorrhiza, 20g of hawthorn, 20g of gynostemma pentaphylla, 20g of cassia occidentalis and 20g of lotus leaves. The decoction is taken once a day, 3 times a day, and 3 times a day after being taken for 2018, 6 and 15 months, the patients have better spirit, less defecate times, reduced sticky feeling, fat tongue, dark fur, yellow fur and smooth pulse. Prescription 7 is kept, and the patient is instructed to fast greasy food and exercise properly. 23 days of repeated diagnosis in 6 months in 2018, the indexes of serum LDL-C3.12 mmol/L, serum TG1.89 mmol/L and serum (TC)4.63mmol/L are obviously reduced compared with the indexes of initial diagnosis, and other symptoms are obviously improved. After continuous treatment for 3 months, the symptoms disappear, the spirit is good, the physical quality is reduced by 4.5kg, and no abnormality is found in blood fat inspection.

In case 2, the patient was a liberian woman who was 55 years old and free occupations, and was initially diagnosed in 2018, 9 months and 5 days. Chest distress and pain are diagnosed, accompanied by heaviness of limbs, lassitude, hypodynamia, anorexia, vomiting, nausea, sputum, poor sleep and sticky stool. A fat and dark tongue with yellow and greasy coating and a wiry and smooth pulse, and a plain patient stays up for a long time and has irregular diet. The electrocardiogram of the outpatient examination is shown as follows: sinus rhythm, ST-T changes, blood lipids: 4.27mmol/L of serum low-density lipoprotein (LDL-C), 6.5mmol/L of serum Total Cholesterol (TC) and 2.7mmol/L of serum Triglyceride (TG). Traditional Chinese medicine diagnosis: chest stuffiness and pain, phlegm turbidity and blood stasis. For the treatment, six-ingredient lipid-lowering decoction 3 is used for activating blood circulation to dissipate blood stasis, strengthening spleen and reducing phlegm, and comprises 20g of oriental wormwood, 20g of salvia miltiorrhiza, 20g of hawthorn, 20g of gynostemma pentaphylla, 20g of cassia occidentalis and 20g of lotus leaf. Decocting with water, one dose per day, 3 times per day, and repeating the 9 th 2018, and the patients complain about chest distress and good condition, and have lassitude relieved, but the diet is still poor, and the rest symptoms are the same as before. The original formula is still used, 1 dose is taken after decoction with water, and half a month is taken continuously. Three diagnoses in 9 and 26 months in 2018 show that the general symptoms of the patient are obviously improved without other discomfort. Rechecking the blood fat: serum LDL-C3.21 mmol/L, serum TC4.3mmol/L, serum TG1.6mmol/L, and the patient is ordered to continue taking the medicine for 2 months to consolidate the disease condition, and the Chinese medicinal decoction can be stopped as appropriate after rechecking the blood fat. Regular work and rest, low-salt and low-fat diet and moderate exercise. After 12 months and 1 day in 2018, the symptoms of the patient are obviously relieved, and the blood fat level is recovered to be normal.

While the invention has been described in detail in the foregoing by way of general description, specific embodiments and experiments, it will be apparent to those skilled in the art that certain changes and modifications may be made therein based on the invention. Accordingly, such modifications and improvements are intended to be within the scope of the invention as claimed.

Claims

1. A lipid-lowering pharmaceutical composition, wherein the composition consists of: 10-30 parts of oriental wormwood, 10-30 parts of salvia miltiorrhiza, 10-30 parts of raw hawthorn, 10-30 parts of gynostemma pentaphylla, 10-30 parts of cassia occidentalis and 10-30 parts of lotus leaf.

2. The pharmaceutical composition of claim 1, wherein the composition consists of: 12-28 parts of oriental wormwood, 12-28 parts of salvia miltiorrhiza, 12-28 parts of raw hawthorn, 12-28 parts of gynostemma pentaphylla, 12-28 parts of cassia occidentalis and 12-28 parts of lotus leaf.

3. The pharmaceutical composition of claim 2, wherein the composition consists of: 14-26 parts of oriental wormwood, 14-26 parts of salvia miltiorrhiza, 14-26 parts of raw hawthorn, 14-26 parts of gynostemma pentaphylla, 14-26 parts of cassia occidentalis and 14-26 parts of lotus leaf.

4. The pharmaceutical composition of claim 3, wherein the composition consists of: 16-24 parts of oriental wormwood, 16-24 parts of salvia miltiorrhiza, 16-24 parts of raw hawthorn, 16-24 parts of gynostemma pentaphylla, 16-24 parts of cassia occidentalis and 16-24 parts of lotus leaves.

5. The pharmaceutical composition of claim 4, wherein the composition consists of: 18-22 parts of oriental wormwood, 18-22 parts of salvia miltiorrhiza, 18-22 parts of raw hawthorn, 18-22 parts of gynostemma pentaphylla, 18-22 parts of cassia occidentalis and 18-22 parts of lotus leaf.

6. The pharmaceutical composition of claim 5, wherein the composition consists of: 20 parts of oriental wormwood, 20 parts of salvia miltiorrhiza, 20 parts of raw hawthorn, 20 parts of gynostemma pentaphylla, 20 parts of cassia occidentalis and 20 parts of lotus leaf.

7. A process for preparing a pharmaceutical composition according to any one of claims 1 to 6, comprising the steps of: taking the medicine according to the formula amount, adding 8-10 times of water to soak for 20-40 minutes, decocting for 2 times, heating and boiling for 1 time, decocting for 20-30 minutes, filtering, taking filtrate for later use, using the medicine residue for 2 times of decoction, adding 6-8 times of water to the medicine residue, heating and boiling, decocting for 15-25 minutes, filtering, taking filtrate, combining the filtrate obtained after 2 times of decoction, mixing uniformly to obtain decoction, or adding pharmaceutically acceptable auxiliary materials into the filtrate by a pharmaceutically conventional method to prepare a pharmaceutically acceptable preparation.

8. The process for the preparation of a pharmaceutical composition according to claim 7, characterized in that it comprises the following steps: taking the medicine according to the formula amount, adding 9 times of water to soak for 30 minutes, decocting for 2 times, heating and boiling for 1 st time, decocting for 25 minutes, filtering, taking filtrate for standby, adding medicine residues to the decoction for 2 times, heating and boiling the medicine residues with 7 times of water, decocting for 20 minutes, filtering, taking filtrate, combining the filtrates obtained by 2 times of decoction, mixing uniformly to obtain decoction, or adding pharmaceutically acceptable auxiliary materials into the filtrate by a pharmaceutically conventional method to prepare a pharmaceutically acceptable dosage form.

9. The method for preparing the pharmaceutical composition according to any one of claims 7 to 8, wherein the acceptable dosage form is capsule, granule, tablet, pill or oral liquid.

10. A lipid-lowering pharmaceutical composition, characterized by the use of said pharmaceutical composition for the treatment of hyperlipidemia.