A traditional Chinese medicine composition with auxiliary hypolipidemic function, and a preparation method and application thereof

Abstract

The application relates to the technical field of traditional Chinese medicines, and particularly discloses a traditional Chinese medicine composition with the function of assisting in reducing blood fat, a preparation method and application thereof. The traditional Chinese medicine composition is composed of traditional Chinese medicinal materials such as radix salviae miltiorrhizae, curcuma longa and gynostemma pentaphyllum. The traditional Chinese medicine composition provided by the application is characterized in that the monarch, the minister, the assistant and the envoy complement each other, and all the medicines are used together to achieve the functions of activating blood, dredging collaterals, resolving phlegm and reducing blood fat. The traditional Chinese medicine composition is simple in medicinal composition, safe and reliable, free of toxic and side effects, helpful to reducing the levels of TC and TG, has the function of assisting in reducing blood fat, and has remarkable effects.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicines, and in particular to a traditional Chinese medicine composition with the function of assisting in lowering blood lipids, and a preparation method and application thereof. Background Art

[0002] Hyperlipidemia is a disorder of lipid metabolism, clinically manifested by elevated plasma total cholesterol (TC), triglycerides (TG), low-density lipoprotein cholesterol (LDL-C), and decreased high-density lipoprotein cholesterol (HDL-C). A 2012-2015 survey of blood lipids in people aged 35 and over in my country revealed an overall prevalence of dyslipidemia of 34.7%. Data from the 2017 Global Burden of Disease (GBD) study in China indicate that elevated low-density lipoprotein cholesterol (LDL-C) levels are the third leading risk factor for cardiovascular disease in China, second only to hypertension and a high-sodium diet.

[0003] Although TCM does not have the disease name "hyperlipidemia", the earliest understanding of hyperlipidemia can be found in the "Inner Canon of Medicine". The "Lingshu•Defend Qi Disorders" records that "people have fat, cream, and meat" and "Fat is blood serum, and Qi is slippery and less." Zhang Jingyue believed that: "Cream is fat cream. Body fluids combine to form cream to fill the voids in the bones, which is the brain, marrow, and essence, blood." Zhang Zhicong, a physician in the Qing Dynasty, also had a detailed discussion on cream: "The Qi of the middle burner steams the body fluids, and its essence... overflows to the outside, the skin and flesh are fat and creamy, and the rest is fat and creamy inside." It can be seen that cream is a component of the human body, produced by water and grain, and has the same origin as body fluids. It is spread with the flow of body fluids, infusing bones, nourishing marrow, moisturizing skin, filling body cavities and exerting normal physiological effects, which is similar to what modern medicine calls blood lipids. Cream and fat are the turbidity of body fluids. Turbidity transforms into cream, and when it solidifies, it turns into fat. Its normal physiology depends on the harmony of the five internal organs, the active production of qi and blood, and the smooth distribution of body fluids. If the internal organs are dysfunctional, coupled with an irregular diet and excessive consumption of fatty and sweet foods, qi and blood circulation will be impeded, and body fluids will not return to their normal state. Turbidity will produce fat and gather phlegm, which will soak into the meridians, causing qi stagnation, blood stasis, and phlegm coagulation, which will block the meridians. Therefore, phlegm is the main symptom in the early stages of this disease. Over time, blood stasis will accumulate, and phlegm and blood stasis will coalesce, blocking the meridians. Blockage of the heart meridians can cause coronary heart disease and myocardial infarction, while blockage of the brain meridians can lead to cerebral thrombosis.

[0004] The 2019 China Cardiovascular Health and Disease Report shows that since 2012, the prevalence of dyslipidemia in the middle-aged and elderly population has been 40.40%, with a total of more than 400 million people. A large amount of research data shows that dyslipidemia is an independent and important risk factor for coronary heart disease, myocardial infarction, sudden cardiac death and ischemic stroke. It causes hidden, gradual, progressive, systemic and organic damage to the body by accelerating systemic atherosclerosis. Studies have shown that for every 1% increase in blood cholesterol levels in the population, the incidence of coronary heart disease increases by 2% to 3%. Therefore, the sharp increase in the number of patients with high blood lipids is closely related to changes in people's lifestyle and eating habits. High blood lipids are common and frequently-occurring diseases in the middle-aged and elderly, known as the'source of 100 diseases', and are closely related to atherosclerosis, diabetes, fatty liver, kidney disease, etc. In particular, there is an important correlation with the incidence of brain and cardiovascular diseases. According to statistics from the China Disease Prevention and Control Center, almost one person dies from cardiovascular and cerebrovascular diseases every minute, accounting for about 40% of all deaths. For a long time, it has been the number one killer of mankind, far exceeding the mortality rate of Alzheimer's disease and traffic accidents. Therefore, dyslipidemia and its underlying dangers cannot be ignored, and how to effectively reduce blood lipids is still a clinical problem that needs to be solved. SUMMARY

[0005] In view of the technical problems of high prevalence of hyperlipidemia and easy induction of other diseases, the present application provides a traditional Chinese medicine composition with auxiliary hypolipidemic function and a preparation method and application thereof.

[0006] In order to achieve the above-mentioned application purposes, the present application adopts the following technical solutions:

[0007] A traditional Chinese medicine composition with auxiliary hypolipidemic function, the traditional Chinese medicine composition comprises the following components in mass parts: Danshen 450-550 parts; turmeric 200-300 parts; Gynostemma pentaphyllum 135-165 parts; Rhizoma polygonati 450-550 parts; hawthorn 450-550 parts; Cassia seed 450-550 parts and lotus leaf 135-165 parts.

[0008] Further, the traditional Chinese medicine composition comprises the following components in mass parts: Danshen 480-520 parts; turmeric 220-280 parts; Gynostemma pentaphyllum 140-160 parts; Rhizoma polygonati 480-520 parts; hawthorn 490-510 parts; Cassia seed 480-510 parts and lotus leaf 140-160 parts.

[0009] Further, the traditional Chinese medicine composition comprises the following components in mass parts: Danshen 500 parts; turmeric 250 parts; Gynostemma pentaphyllum 150 parts; Rhizoma polygonati 500 parts; hawthorn 500 parts; Cassia seed 500 parts and lotus leaf 150 parts.

[0010] The application is formulated according to the theory of TCM collaterals disease, under the treatment principle of 'collaterals should be used for dredging', for the population of hyperlipidemia. Salvia miltiorrhiza is the monarch drug in the prescription, with bitter taste and slightly cold nature. It is returned to heart and liver meridians, and is good at dredging. It is recorded in 'Materia Medica' as 'a medicine for regulating meridians and dredging vessels', and has the effects of activating blood and removing stasis, dredging meridians and collaterals in the prescription. Turmeric, gynostemma pentaphyllum and polygonatum are the ministers. Turmeric has bitter and pungent tastes, warm nature, and is returned to liver and spleen meridians. It has the effects of activating blood and dredging collaterals, and also has the effect of promoting qi. When it is used together with salvia miltiorrhiza, the effect of activating blood and removing stasis and dredging collaterals can be enhanced. Gynostemma pentaphyllum has cold nature and bitter taste, and is returned to lung, spleen and kidney meridians. It has the effects of invigorating spleen and stomach and removing phlegm and dampness. Polygonatum has sweet taste, neutral nature, and is returned to spleen, lung and kidney meridians. It can tonify qi and nourish yin, invigorate spleen and kidney, and has the effect of invigorating spleen and stomach. When the two are used together, the effect of invigorating spleen and stomach can be achieved. When the spleen and stomach are invigorated, the production of qi and blood is sufficient, the distribution of body fluid is smooth, and phlegm and turbid are removed. Hawthorn and cassia seed are the adjuvants. Hawthorn has sour and sweet tastes, and slightly warm nature. It is returned to spleen, stomach and liver meridians. It can'remove food accumulation, resolve meat accumulation, remove phlegm and turbid, and remove stagnated blood and abdominal distension' as recorded in 'Compendium of Materia Medica'. It has the effects of digesting food and invigorating stomach, promoting qi and removing stasis, and removing turbidity and reducing fat. It can remove food accumulation and turbidity, and remove stasis and dredge collaterals. Cassia seed has sweet, bitter and slightly salty tastes, and cold nature. It is returned to liver and large intestine meridians. It can moisten the intestines, promote defecation, reduce weight and reduce fat. When the two are used together, the accumulation of fat and turbidity in the upper part of the body can be removed, and the accumulation of fat and turbidity in the lower part of the body can be removed. The effect of removing turbidity and reducing fat can be achieved. Lotus leaf is the ministerial drug, with bitter taste and neutral nature. It is returned to liver, spleen and stomach meridians. It can'remove stasis' as recorded in 'Compendium of Materia Medica', and can'remove phlegm' as recorded in 'South Yunnan Materia Medica'. It has the effects of removing stasis and phlegm. It can help salvia miltiorrhiza and turmeric to activate blood and remove stasis and dredge collaterals, and help gynostemma pentaphyllum and polygonatum to invigorate spleen and remove phlegm. The effects of activating blood and removing stasis, removing phlegm and dredging collaterals, and removing turbidity and reducing fat can be achieved.

[0011] Compared with the prior art, the Chinese medicine composition with the function of reducing blood fat provided by the application has the following advantages. Salvia miltiorrhiza is used as the monarch drug, and has strong effects of activating blood and dredging collaterals. Turmeric, gynostemma pentaphyllum and polygonatum are used together to activate blood and dredge collaterals, remove heat and phlegm, invigorate spleen and kidney, promote qi and remove stasis, remove turbidity and reduce fat, and help the monarch drug to remove stasis, promote qi and reduce fat. Cassia seed and lotus leaf are used together to remove food and turbidity, promote defecation, reduce fat and remove phlegm. The Chinese medicine composition has the effects of activating blood and dredging collaterals, removing phlegm and reducing fat. The Chinese medicine composition has the advantages of simple drug composition, convenient use, safety and reliability, no toxic and side effects, and the like. It can help to reduce the content of total cholesterol and triglyceride in serum, has the function of reducing blood fat, and has remarkable effects.

[0012] The application further provides a preparation method of the Chinese medicine composition with the function of reducing blood fat.

[0013] The salvia miltiorrhiza, turmeric, gynostemma pentaphyllum, hawthorn, polygonatum, cassia seed and lotus leaf are subjected to water extraction treatment, filtration, and the Chinese medicine extract is obtained.

[0014] The Chinese medicine extract is reduced pressure concentrated to a relative density of 1.15-1.25 at 60 DEG C, and the extract is obtained. The extract is vacuum dried to obtain dry extract, and the dry extract is crushed to obtain Chinese medicine composition dry extract powder.

[0015] The application provides a preparation method of the traditional Chinese medicine composition with the auxiliary blood lipid-lowering function.

[0016] Further, the water extraction treatment comprises first water extraction treatment and second water extraction treatment, the water quantity of the first water extraction treatment is 8-10 times of the total mass of the traditional Chinese medicine, the temperature is 90-100 DEG C, and the time is 1.2-1.8 h; the water quantity of the second water extraction treatment is 8-10 times of the total mass of the traditional Chinese medicine, the temperature is 90-100 DEG C, and the time is 0.8-1.2 h, so that the water and the traditional Chinese medicine are fully contacted, good infiltration and penetration effects are achieved, the subsequent water extraction treatment is facilitated, the active ingredients of the traditional Chinese medicine are not damaged, and the leaching rate is improved.

[0017] Further, the temperature of the reduced-pressure concentration is 50-80 DEG C, and the vacuum degree is 0.04-0.08 MPa; the vacuum degree of the vacuum drying is 0.04-0.10 MPa, the temperature is 60-80 DEG C, and the water content of the dry paste is 5.0%-8.0%.

[0018] Further, the dry paste is crushed and sieved, and the mesh number of the sieve is 80 meshes.

[0019] The application further provides application of the traditional Chinese medicine composition with the auxiliary blood lipid-lowering function in preparation of a medicine with the auxiliary blood lipid-lowering function.

[0020] The traditional Chinese medicine composition with the auxiliary blood lipid-lowering function is prepared into different traditional Chinese medicine preparations through conventional means.

[0021] The application further provides a traditional Chinese medicine preparation with the auxiliary blood lipid-lowering function, which contains the traditional Chinese medicine composition with the auxiliary blood lipid-lowering function.

[0022] The traditional Chinese medicine preparation with the auxiliary blood lipid-lowering function contains the traditional Chinese medicine composition, uses salvia miltiorrhiza as a monarch drug, turmeric, gynostemma pentaphyllum and polygonatum sibiricum as ministerial drugs, hawthorn and cassia seed as auxiliary drugs, and lotus leaf as a ministerial drug, and the monarch, ministerial drugs and auxiliary drugs complement each other, and the drugs are used together to achieve the functions of activating blood, dredging collaterals, reducing phlegm and lowering blood lipid.

[0023] Further, the dosage form of the traditional Chinese medicine preparation is a tablet, a capsule, a powder or a granule.

[0024] Further, the dosage form of the traditional Chinese medicine preparation is a tablet.

[0025] Further, the traditional Chinese medicine preparation further comprises pharmaceutically acceptable excipients, and the excipients comprise the following components in mass parts: 75-92 parts of microcrystalline cellulose, 38-42 parts of crosslinked polyvinylpyrrolidone, 14-16 parts of silicon dioxide and 6-8 parts of magnesium stearate.

[0026] Further, the excipients further comprise the following components in mass parts: 26-30 parts of film coating premix I and 3-5 parts of film coating premix II.

[0027] Further, the film coating premix I is at least one of titanium dioxide, sunset yellow aluminum lake, lemon yellow aluminum lake, talc, triethyl glyceride, hydroxypropyl methyl cellulose or polyvinyl alcohol; and the film coating premix II is at least one of medium-chain triglyceride, talc, guar gum, hydroxypropyl methyl cellulose, polyvinyl alcohol or malt dextrin.

[0028] The application further provides a preparation method of the traditional Chinese medicine preparation with the auxiliary blood lipid-lowering function.

[0029] S1, the traditional Chinese medicine composition dry paste powder and microcrystalline cellulose are placed in a mixer, the rotating speed is set to 8 r / min, and pre-mixing is performed for 20 min to prepare mixed powder.

[0030] S2, the mixed powder is placed in a wet method mixing granulator, 90% ethanol is used as a binder to prepare soft material, the soft material is passed through a 16-mesh screen to prepare granules, and wet granules are obtained.

[0031] S3, the wet granules are dried at a drying temperature of 50-60℃ until the moisture content of the granules is 5.0%-8.0%, dry granules are obtained, and the dry granules are placed in a conical granulator and passed through a 1.0-mm conical screen for granulation.

[0032] S4, the granules after granulation, crosslinked polyvinylpyrrolidone, silicon dioxide and magnesium stearate are added to the mixer, and the rotating speed is adjusted to 8 r / min, and the total mixing is performed for 20 min.

[0033] S5, the granules after total mixing are placed in the hopper of a tablet press, the tablet weight is adjusted, and tabletting is performed to obtain raw tablets. DETAILED DESCRIPTION

[0034] In order to make the purpose, technical scheme and advantages of the application clearer, the application will be further described in detail below with examples. It should be understood that the specific examples described herein are only used to explain the application and not to limit the application.

[0035] In order to better illustrate the traditional Chinese medicine composition with the auxiliary blood lipid-lowering function provided by the embodiments of the application, further example illustration is made below through examples.

[0036] Example 1

[0037] A traditional Chinese medicine composition with auxiliary hypolipidemic function, the traditional Chinese medicine composition comprises the following components in mass parts: 500g of Danshen; 250g of Curcuma longa; 150g of Gynostemma pentaphyllum; 500g of Polygonatum; 500g of Crataegus pinnatifida; 500g of Cassia obtusifolia and 150g of Lotus leaf.

[0038] The preparation method of the traditional Chinese medicine composition specifically comprises the following steps:

[0039] The Danshen, Curcuma longa, Gynostemma pentaphyllum, Crataegus pinnatifida, Polygonatum, Cassia obtusifolia and Lotus leaf are subjected to twice water extraction treatment, 9 times the total mass of the traditional Chinese medicine of water is added in the first time, heated to 100℃ and decocted for 1.5h, filtered to obtain the first filtrate, 9 times the total mass of the traditional Chinese medicine of water is added in the second time, heated to 100℃ and decocted for 1.0h, filtered to obtain the second filtrate, and the filtrates are combined to obtain a traditional Chinese medicine extract;

[0040] The traditional Chinese medicine extract is reduced pressure concentrated under the condition of 70℃ and 0.06Mpa vacuum degree to a relative density of 1.20 measured at 60℃ to obtain an extract, and the extract is vacuum dried under the condition of 0.08MPa vacuum degree and 70℃ to obtain a dry extract, and the dry extract is crushed and sieved (sieve mesh size is 80 meshes) to obtain a traditional Chinese medicine dry extract powder.

[0041] The above traditional Chinese medicine composition with auxiliary hypolipidemic function is prepared into a traditional Chinese medicine tablet together with excipients, wherein the excipients comprise the following components in mass parts: 84g of microcrystalline cellulose; 40g of crosslinked polyvinylpyrrolidone; 15g of silicon dioxide and 7g of magnesium stearate, and the preparation method comprises the following steps:

[0042] S1, the traditional Chinese medicine dry extract powder and the microcrystalline cellulose are placed in a mixer, the rotating speed is set to 8r / min, and pre-mixing is performed for 20min to obtain a mixed powder;

[0043] S2, the mixed powder is placed in a wet granulation machine, 90% ethanol is used as a binder to prepare a soft material, the soft material is passed through a 16-mesh sieve, granulation is performed to obtain wet granules;

[0044] S3, the wet granules are dried at a temperature of 55℃ until the moisture content of the granules is 5%, dry granules are obtained, and the dry granules are placed in a conical granulator and passed through a 1.0mm conical sieve for granulation;

[0045] S4, the granules after granulation are taken together with the crosslinked polyvinylpyrrolidone, the silicon dioxide and the magnesium stearate into the mixer, and the rotating speed is adjusted to 8r / min for total mixing for 20min;

[0046] S5, the granules after total mixing are placed in the hopper of a tablet press, the tablet weight is adjusted, and tabletting is performed to obtain tablets.

[0047] Example 2

[0048] A traditional Chinese medicine composition with auxiliary hypolipidemic function, the traditional Chinese medicine composition comprises the following components in mass parts: 550g of Danshen; 300g of Curcuma longa; 165g of Gynostemma pentaphyllum; 550g of Polygonatum; 550g of Crataegus pinnatifida; 550g of Cassia obtusifolia and 165g of Lotus leaf.

[0049] The preparation method of the traditional Chinese medicine composition specifically comprises the following steps:

[0050] The Danshen, Curcuma longa, Gynostemma pentaphyllum, Crataegus pinnatifida, Polygonatum, Cassia obtusifolia and Lotus leaf are subjected to twice water extraction treatment, 9 times the total mass of the traditional Chinese medicine of water is added in the first time, heated to 100℃ and decocted for 1.5h, filtered to obtain a first filtrate, 9 times the total mass of the traditional Chinese medicine of water is added in the second time, heated to 100℃ and decocted for 1.0h, filtered to obtain a second filtrate, and the filtrates are combined to obtain a traditional Chinese medicine extract;

[0051] The traditional Chinese medicine extract is concentrated under reduced pressure at a temperature of 60℃ and a vacuum degree of 0.06Mpa to a relative density of 1.20 measured at 60℃ to obtain an extract, and the extract is vacuum dried at a temperature of 60℃ and a vacuum degree of 0.10MPa to obtain a dry extract, which is crushed and sieved (sieve mesh size is 80 meshes) to obtain a traditional Chinese medicine dry extract powder.

[0052] The above traditional Chinese medicine composition with auxiliary hypolipidemic function is prepared into a traditional Chinese medicine tablet with auxiliary hypolipidemic function together with excipients, wherein the excipients comprise the following components in mass parts: 84g of microcrystalline cellulose; 40g of crosslinked polyvinylpyrrolidone; 15g of silicon dioxide and 7g of magnesium stearate, and the preparation method comprises the following steps:

[0053] S1, the traditional Chinese medicine dry extract powder and the microcrystalline cellulose are placed in a mixer, the rotating speed is set to 8r / min, and pre-mixing is performed for 20min to obtain a mixed powder;

[0054] S2, the mixed powder is placed in a wet granulation machine, 90% ethanol is used as a binder to prepare a soft material, the soft material is passed through a 16-mesh sieve, granulation is performed to obtain wet granules;

[0055] S3, the wet granules are dried at a temperature of 60℃ until the moisture content of the granules is 5%, dry granules are obtained, and the dry granules are placed in a conical granulator and passed through a 1.0mm conical sieve for granulation;

[0056] S4, the granules after granulation are taken together with the crosslinked polyvinylpyrrolidone, the silicon dioxide and the magnesium stearate into the mixer, and the rotating speed is adjusted to 8r / min for total mixing for 20min;

[0057] S5, the granules after total mixing are placed in the hopper of a tablet press, the tablet weight is adjusted, and tabletting is performed to obtain tablets.

[0058] Example 3

[0059] A traditional Chinese medicine composition with auxiliary hypolipidemic function, the traditional Chinese medicine composition comprises the following components in mass parts: Danshen 450g; turmeric 200g; Gynostemma pentaphyllum 135g; Rhizoma polygonati 450g; hawthorn 450g; Cassia obtusifolia 450g and lotus leaf 135g.

[0060] The preparation method of the traditional Chinese medicine composition specifically comprises the following steps:

[0061] The Danshen, turmeric, Gynostemma pentaphyllum, hawthorn, Rhizoma polygonati, Cassia obtusifolia and lotus leaf are subjected to twice water extraction treatment, the first time is to add 8 times the total mass of traditional Chinese medicine water, heated to 90℃ and decocted for 1.8h, filtered to obtain the first filtrate, the second time is to add 8 times the total mass of traditional Chinese medicine water, heated to 90℃ and decocted for 1.2h, filtered to obtain the second filtrate, and the filtrates are combined to obtain a traditional Chinese medicine extract;

[0062] The obtained traditional Chinese medicine extract is reduced pressure concentrated under the condition of temperature 50℃ and vacuum degree 0.08Mpa to relative density 1.15 measured at 60℃ to obtain an extract, and the obtained extract is vacuum dried under the condition of vacuum degree 0.08MPa and temperature 70℃ to obtain a dry extract, and the obtained dry extract is crushed and sieved (sieve mesh number 80 meshes) to obtain a traditional Chinese medicine dry extract powder.

[0063] The above traditional Chinese medicine composition with auxiliary hypolipidemic function is prepared into traditional Chinese medicine granules by a conventional method.

[0064] Example 4

[0065] A traditional Chinese medicine composition with auxiliary hypolipidemic function, the traditional Chinese medicine composition comprises the following components in mass parts: Danshen 480g; turmeric 220g; Gynostemma pentaphyllum 160g; Rhizoma polygonati 520g; hawthorn 490g; Cassia obtusifolia 480g and lotus leaf 160g.

[0066] The preparation method of the traditional Chinese medicine composition specifically comprises the following steps:

[0067] The Danshen, turmeric, Gynostemma pentaphyllum, hawthorn, Rhizoma polygonati, Cassia obtusifolia and lotus leaf are subjected to twice water extraction treatment, the first time is to add 8 times the total mass of traditional Chinese medicine water, heated to 90℃ and decocted for 1.8h, filtered to obtain the first filtrate, the second time is to add 8 times the total mass of traditional Chinese medicine water, heated to 90℃ and decocted for 1.2h, filtered to obtain the second filtrate, and the filtrates are combined to obtain a traditional Chinese medicine extract;

[0068] The obtained traditional Chinese medicine extract is reduced pressure concentrated under the condition of temperature 50℃ and vacuum degree 0.08Mpa to relative density 1.15 measured at 60℃ to obtain an extract, and the obtained extract is vacuum dried under the condition of vacuum degree 0.08MPa and temperature 70℃ to obtain a dry extract, and the obtained dry extract is crushed and sieved (sieve mesh number 80 meshes) to obtain a traditional Chinese medicine dry extract powder.

[0069] The traditional Chinese medicine composition with the auxiliary blood lipid-lowering function is prepared into a traditional Chinese medicine powder by a conventional method.

[0070] Example 5

[0071] A traditional Chinese medicine composition with the auxiliary blood lipid-lowering function, which comprises the following components in mass parts: 520 g of Danshen, 280 g of Curcuma, 130 g of Gynostemma, 480 g of Polygonatum, 510 g of Crataegus, 510 g of Cassia and 140 g of Lotus leaf.

[0072] The preparation method of the traditional Chinese medicine composition specifically comprises the following steps:

[0073] The Danshen, Curcuma, Gynostemma, Crataegus, Polygonatum, Cassia and Lotus leaf are subjected to twice water extraction treatment, 8 times the total mass of the traditional Chinese medicines of water is added in the first time, heated to 90 DEG C and decocted for 1.8 h, filtered to obtain a first filtrate, 8 times the total mass of the traditional Chinese medicines of water is added in the second time, heated to 90 DEG C and decocted for 1.2 h, filtered to obtain a second filtrate, and the filtrates are combined to obtain a traditional Chinese medicine extract;

[0074] The traditional Chinese medicine extract is reduced in pressure and concentrated under the conditions of a temperature of 80 DEG C and a vacuum degree of 0.04 MPa to a relative density of 1.20 at 60 DEG C, to obtain an extract, the extract is vacuum dried under the conditions of a temperature of 80 DEG C and a vacuum degree of 0.04 MPa to obtain a dry extract, and the dry extract is crushed and sieved (with a screen mesh of 80 meshes) to obtain a traditional Chinese medicine dry extract powder.

[0075] The traditional Chinese medicine composition with the auxiliary blood lipid-lowering function is prepared into a traditional Chinese medicine capsule by a conventional method.

[0076] Comparative Example 1

[0077] A traditional Chinese medicine composition with the auxiliary blood lipid-lowering function, which is prepared from traditional Chinese medicine raw materials by water decoction extraction, reduces the Danshen component on the basis of Example 1, and other components are the same as those in Example 1, the traditional Chinese medicine raw materials comprise the following components in mass parts: 500 g of Curcuma, 150 g of Gynostemma, 500 g of Polygonatum, 500 g of Crataegus, 500 g of Cassia and 150 g of Lotus leaf. The traditional Chinese medicine composition and the tablet are obtained by using the same preparation method as that in Example 1.

[0078] Comparative Example 2

[0079] A traditional Chinese medicine composition with the auxiliary blood lipid-lowering function, which is prepared from traditional Chinese medicine raw materials by water decoction extraction, reduces the Curcuma component on the basis of Example 1, and other components are the same as those in Example 1, the traditional Chinese medicine raw materials comprise the following components in mass parts: 500 g of Danshen, 150 g of Gynostemma, 500 g of Polygonatum, 500 g of Crataegus, 500 g of Cassia and 150 g of Lotus leaf. The traditional Chinese medicine composition and the tablet are obtained by using the same preparation method as that in Example 1.

[0080] Comparative Example 3

[0081] A traditional Chinese medicine composition with the function of auxiliary lowering blood lipid, the traditional Chinese medicine composition is extracted by water decoction of traditional Chinese medicinal materials, on the basis of Example 1, safflower is replaced by salvia miltiorrhiza, other components are the same as Example 1, the traditional Chinese medicinal materials include the following components in mass fraction: safflower 500g; turmeric 250g; gynostemma pentaphyllum 150g; polygonatum 500g; hawthorn 500g; cassia seed 500g and lotus leaf 150g. The traditional Chinese medicine composition and tablets are obtained by the same preparation method as Example 1.

[0082] Comparative Example 4

[0083] A traditional Chinese medicine composition with the function of auxiliary lowering blood lipid, the traditional Chinese medicine composition is extracted by water decoction of traditional Chinese medicinal materials, on the basis of Example 1, turmeric is replaced by curcuma zedoaria, other components are the same as Example 1, the traditional Chinese medicinal materials include the following components in mass fraction: salvia miltiorrhiza 500g; curcuma zedoaria 250g; gynostemma pentaphyllum 150g; polygonatum 500g; hawthorn 500g; cassia seed 500g and lotus leaf 150g. The traditional Chinese medicine composition and tablets are obtained by the same preparation method as Example 1.

[0084] Comparative Example 5

[0085] A traditional Chinese medicine composition with the function of auxiliary lowering blood lipid, the traditional Chinese medicine composition is extracted by water decoction of traditional Chinese medicinal materials, on the basis of Example 1, gynostemma pentaphyllum is replaced by acanthopanax, other components are the same as Example 1, the traditional Chinese medicinal materials include the following components in mass fraction: salvia miltiorrhiza 500g; turmeric 250g; acanthopanax 150g; polygonatum 500g; hawthorn 500g; cassia seed 500g and lotus leaf 150g. The traditional Chinese medicine composition and tablets are obtained by the same preparation method as Example 1.

[0086] Comparative Example 6

[0087] A traditional Chinese medicine composition with the function of auxiliary lowering blood lipid, the traditional Chinese medicine composition is extracted by water decoction of traditional Chinese medicinal materials, on the basis of Example 1, polygonatum is replaced by dendrobium, other components are the same as Example 1, the traditional Chinese medicinal materials include the following components in mass fraction: salvia miltiorrhiza 500g; turmeric 250g; gynostemma pentaphyllum 150g; dendrobium 500g; hawthorn 500g; cassia seed 500g and lotus leaf 150g. The traditional Chinese medicine composition and tablets are obtained by the same preparation method as Example 1.

[0088] Comparative Example 7

[0089] A traditional Chinese medicine composition with auxiliary hypolipidemic function, which is prepared by water decoction extraction of traditional Chinese medicinal materials, reduces the components of Cassiae Semen and Folii Rosae Laevigatae on the basis of Example 1, and other components are the same as those in Example 1. The traditional Chinese medicinal materials include the following components in mass parts: 500 g of Salvia miltiorrhiza; 250 g of Curcuma longa; 150 g of Gynostemma pentaphyllum; 500 g of Polygonatum sibiricum; and 500 g of Crataegus pinnatifida. The traditional Chinese medicine composition and the tablet are prepared by the same preparation method as that in Example 1.

[0090] In order to better illustrate the characteristics of the traditional Chinese medicine composition with auxiliary hypolipidemic function provided by the embodiments of the present application, the traditional Chinese medicine composition prepared in Example 1 and the traditional Chinese medicine compositions prepared in Comparative Examples 1-7 are respectively used as test objects for prevention and treatment effect test.

[0091] The present application is further described in detail below in combination with animal experiments.

[0092] Test example

[0093] A high-fat diet is used to establish a high-fat blood syndrome model of golden hamsters to verify the influence of the test object on blood lipid level.

[0094] 1 Experimental materials

[0095] 1.1 Test product

[0096] A total of eight samples prepared in Example 1 and Comparative Examples 1-7 are used, and the specific drug composition and clinical dosage are shown in Table 1.

[0097]

[0098] 1.2 Solvent and main reagent

[0099] 1.2.1 Solvent: deionized water, which is self-made by Shijiazhuang Yiling Pharmaceutical Co., Ltd.

[0100] 1.2.1 Positive drug: Fenofibrate, which is provided by ABBOTT LABORATORIES LIMITED, batch number 29164.

[0101] 1.2.3 Main reagent: as shown in Table 2.

[0102]

[0103] 1.3 Experimental system

[0104] 1.3.1 Animal strain: LVG Syrian golden hamsters.

[0105] 1.3.2 Animal level: SPF level.

[0106] 1.3.3 Animal gender and number: 160 male golden hamsters were selected, 152 of which were used in the formal test (before administration), and 120 of which were selected for the administration period after model establishment.

[0107] 1.3.4 Animal age: 6-8 weeks old when received.

[0108] 1.3.5 Animal weight: The weight range of the qualified certificate was 80-100 g when the animals were received.

[0109] 1.3.6 Animal source: Purchased from Beijing Vivotec Laboratories Animal Technology Co., Ltd. Experimental animal production license number: SCXK (Jing) 2016-0011. Certificate number: 110011200105891186, received on August 26, 2020.

[0110] 1.3.7 Raising conditions: The animals were raised in the barrier environment animal room of the New Drug Evaluation Center of Hebei Yiling Pharmaceutical Research Institute Co., Ltd., and the experimental animal use license number was SYXK (Ji) 2020-003. The light was on for 12 hours a day, the temperature was 20-26℃, and the relative humidity was 40-70%. The animals were fed in standard cages, with no more than 5 animals per cage. The cages were kept clean and dry, and the experimental facilities were continuously ventilated and disinfected regularly.

[0111] 1.3.8 Quarantine process: The newly received animals were quarantined for 6 days, and the animals were observed daily for drinking, eating, and health status, as well as signs of disease and death during the quarantine period.

[0112] 1.3.9 Feed: The golden hamster regular feed (SPF hamster growth and reproduction feed, production batch number: 20086113) and high-fat feed (15% lard, 0.2% cholesterol, 84.8% basic feed, batch number 2020081704) were provided by Beijing Keao Huihua Feed Co., Ltd.

[0113] 1.3.10 Drinking water: The animals drank clean water from the ROA50 experimental animal drinking water system every day, and the drinking water bottles were filled for the animals to drink freely. The drinking water bottles were washed and replaced once a day.

[0114] 1.3.11 Bedding: Ordinary grade corn cob bedding, provided by Beijing Keao Huihua Feed Co., Ltd., batch number 20079811; and shaving bedding, provided by Beijing Keao Huihua Feed Co., Ltd., batch number 20049613. The corn cob bedding was used after being autoclaved and replaced every week.

[0115] 1.3.12 Identification: The animals were individually numbered using an animal marker pen (Japan EPS Group, item number: AM15).

[0116] 2 Test method

[0117] 2.1 Dose and grouping

[0118] 152 quarantine qualified male golden hamsters were stratified by body weight and randomly divided into 8 groups, 19 in each group, one of which was a normal control group (19) fed with conventional feed, and the rest (133) were fed with high-fat feed to establish a hyperlipidemia model. After one week, blood was taken from the orbital venous plexus to detect five blood lipids (TC, TG, LDL-C, HDL-C, NEFA), and 105 animals fed with high-fat feed were randomly divided into 10 groups according to TG values, namely model control group, fenofibrate group (0.15g / kg), Example 1 group, Comparative Example 1 group, Comparative Example 2 group, Comparative Example 3 group, Comparative Example 4 group, Comparative Example 5 group, Comparative Example 6 group, and Comparative Example 7 group, with 10 in each group except for 15 in the model control group. 15 animals in the normal control group were selected for subsequent formal tests.

[0119] After grouping the experimental animals, each test drug was administered by gavage at 8 times the recommended human dose. The positive drug fenofibrate was administered at a dose of 0.15g / kg, which was based on reference literature and combined with historical data from the laboratory. The specific dose settings are shown in Table 3.

[0120]

[0121] 2.2 Method of administration

[0122] Gavage administration, with a drug volume of 10ml / kg.

[0123] 2.3 Preparation and storage of test drugs

[0124] The appropriate amount of test sample was weighed into a mortar and ground into fine powder. A small amount of deionized water was added to wet the mortar, and then solvent was added for grinding and suspension. The final volume was adjusted to the target volume. The specific drug concentration is shown in Table 3. All the above solutions were prepared daily before use.

[0125] 2.4 Administration of test drugs

[0126] A suitable size of disposable sterile syringe and gavage needle was selected, and each group was administered by gavage according to the dose in Table 3, with a drug volume of 10ml / kg. The normal control group and the model control group were given the same volume of deionized water. During the administration process, the drug solution in each group was continuously stirred with a magnetic stirrer to prevent contamination and accidental loss. The drug was administered once a day for 21 consecutive days.

[0127] During the administration process, the normal control group continued to be given maintenance feed, and the model control group and each test drug group continued to be given high-fat feed. Body weight was measured once a week.

[0128] 2.5 Observation index time, content and method

[0129] 2.5.1 Weight

[0130] The body weights of the animals were weighed and recorded once a week during the experiment.

[0131] 2.5.2 Blood lipids and serum biochemical indicators

[0132] Before dosing, approximately 0.5 ml of blood was collected from the orbital venous plexus of all animals and centrifuged at 3000 rpm for 10 minutes. Serum was separated and assayed for lipid profiles (TC, TG, LDL-C, HDL-C, and NEFA) using an automated biochemical analyzer. After 21 days of dosing, all animals were anesthetized with an intraperitoneal injection of 10% chloral hydrate (4.5 ml / kg). Blood was collected via the abdominal aorta, centrifuged, and serum was separated (using the same method as above). Serum was then assayed for lipid profiles and other biochemical parameters. Animals were fasted for 12-16 hours prior to blood collection.

[0133] 2.6 Notification to relevant staff

[0134] Notify the animal room when purchasing animals, and notify the pathology room for treatment when animals show abnormal conditions.

[0135] 2.7 Main instrument systems

[0136] 7080 fully automatic biochemical analyzer, Hitachi, Japan; ZWYR-240 constant temperature incubation shaker, Shanghai Zhicheng Analytical Instrument Manufacturing Co., Ltd.; Mettler ME-104E analytical balance, Mettler-Toledo (Shanghai) Co., Ltd.; DT2000 electronic balance: Changshu Shuangjie Testing Instrument Factory; Gene Speed ​​1580R high-speed refrigerated centrifuge: Gene Co., Ltd.

[0137] 2.8 Statistical methods

[0138] The experimental data are expressed as mean ± standard deviation ( Statistical analysis was performed using SPSS software. Means were compared using one-way analysis of variance. Homogeneity of variance was first tested. If the variances were homogeneous, the least significant difference (LSD) test was used. If the variances were unequal, the Dunnett's T3 test was used. Comparisons between two groups were performed using the independent sample t-test. The test levels were 0.05 and 0.01.

[0139] 3 Results

[0140] 3.1 Weight changes

[0141] The changes in animal body weight during the experiment are shown in Table 4. After feeding with high-fat diet, the body weight of the animals in the model control group increased significantly compared with the normal control group ( P<0.01). Compared with the model control group, the body weight of each administration group was reduced to varying degrees, among which the body weight of the fenofibrate group, the example 1 group, the comparative examples 3, 4 and 5 groups was significantly reduced from the 7th day of administration to the end of administration P <0.01 or P <0.05), the body weight of the comparative example 2 group was significantly reduced from the 14th day of administration to the end of administration P <0.05), the body weight of the comparative examples 1, 6 and 7 groups was significantly reduced only at the end of administration P <0.05).

[0142] Comparison of the body weight between the example 1 group and the comparative example groups: the body weight of the animals in the example 1 group was not significantly different from that of the comparative example groups on the 1st day of administration; on the 7th day of administration, the body weight was significantly lower than that of the comparative examples 1, 6 and 7 groups P <0.05); on the 14th day of administration, the body weight was significantly lower than that of the comparative examples 1, 5, 6 and 7 groups P <0.01 or P <0.05); on the 21st day of administration, the body weight was significantly lower than that of the comparative examples 1, 2, 3, 4, 5, 6 and 7 groups P <0.01 or P <0.05).

[0143]

[0144] 3.2 Changes in blood lipid levels

[0145] 3.2.1 Blood lipid levels before administration (one week after modeling)

[0146] After being fed with high-fat feed for one week, the animals fed with high-fat feed were randomly divided into 10 groups according to the TG value, namely the model control group, the fenofibrate group, the example 1 group, the comparative example 1 group, the comparative example 2 group, the comparative example 3 group, the comparative example 4 group, the comparative example 5 group, the comparative example 6 group and the comparative example 7 group. As shown in Table 5, there was no significant difference in the TC, TG, LDL-C, HDL-C and NEFA levels among the groups after grouping. Compared with the normal control group, the blood lipid level of the model control group was significantly increased P <0.01).

[0147]

[0148] 3.2.2 Blood lipid levels after administration

[0149] The blood lipid levels of each test group after 21 days of continuous gavage administration are shown in Table 6. The blood lipid level of the model control group was still significantly higher than that of the normal control group P<0.01). Comparison between each administration group and the model control group: the TC level of the fenofibrate group, the example 1 group, the comparative examples 3, 4, 5, 6 and 7 groups was significantly reduced (P < 0.01). P <0.01 or P <0.05); the TG level of the fenofibrate group, the example 1 group, the comparative examples 2, 3, 4, 5, 6 and 7 groups was significantly reduced (P < 0.01 or P < 0.05). P <0.01 or P <0.05); the HDL-C level of the fenofibrate group was significantly increased (P < 0.01); the LDL-C level of the fenofibrate group, the example 1 group, the comparative examples 1, 2, 3, 4, 5, 6 and 7 groups was significantly reduced (P < 0.01 or P < 0.05). P <0.01 or P <0.05); the NEFA level of the fenofibrate group, the example 1 group, the comparative examples 1, 2, 3, 4, 5 and 6 groups was significantly reduced (P < 0.01 or P < 0.05). P <0.05). P <0.01 or P <0.05).

[0150] Comparison between the example 1 group and the comparative example groups in terms of blood lipid level: the TC level of the example 1 group had no significant difference with that of the comparative example groups; the TG level of the example 1 group was significantly lower than that of the comparative examples 1, 2, 3, 4, 6 and 7 groups (P < 0.01 or P < 0.05); the HDL-C level of the example 1 group was significantly higher than that of the comparative examples 2, 6 and 7 groups (P < 0.05); the LDL-C level of the example 1 group was significantly lower than that of the comparative example 5 group (P < 0.05); the NEFA level of the example 1 group was significantly lower than that of the comparative examples 6 and 7 groups (P < 0.05). P <0.01 or P <0.05); the HDL-C level of the example 1 group was significantly higher than that of the comparative examples 2, 6 and 7 groups (P < 0.05); the LDL-C level of the example 1 group was significantly lower than that of the comparative example 5 group (P < 0.05); the NEFA level of the example 1 group was significantly lower than that of the comparative examples 6 and 7 groups (P < 0.05). P <0.05). P <0.05). P <0.05).

[0151]

[0152] 4Conclusion

[0153] The experiment adopts high-fat diet to establish a hyperlipidemia model of golden hamsters, and observes the influence of the tested substances on blood lipid level. The test results show that the example 1 and the comparative example groups are continuously given by gavage for 21 days, and the blood lipid of the animals induced by high-fat diet is abnormally increased, and has different degrees of reducing effect, and the effect of the example 1 group is more significant. It is shown that the present application takes salvia miltiorrhiza as the monarch drug, takes curcuma longa, gynostemma pentaphyllum and polygonatum sibiricum as the ministerial drugs, takes hawthorn and cassia seed as the auxiliary drugs, and takes lotus leaf as the ministerial drug, and the drugs are used together to play the functions of activating blood, dredging collaterals, resolving phlegm and reducing lipid.

[0154] From the above data, the traditional Chinese medicine composition provided by the embodiment 1 of the present application is helpful to reduce the content of total cholesterol and triglyceride in serum, is helpful to maintain the healthy level of blood fat, and has the function of assisting in reducing blood fat. The traditional Chinese medicine compositions provided by the embodiments 2 to 5 have the basically equivalent efficacy to the traditional Chinese medicine composition provided by the embodiment 1.

[0155] The above merely describes preferred embodiments of the present application and is not intended to limit the present application, and any modification, equivalent replacement or improvement made within the spirit and principle of the present application shall be included in the protection scope of the present application.

Claims

1. A Chinese medicine composition with the function of assisting in lowering blood lipids, characterized in that: The traditional Chinese medicine composition is composed of the following traditional Chinese medicines in parts by mass: 450-550 parts of salvia miltiorrhiza; 200-300 parts of turmeric; 135-165 parts of gynostemma pentaphyllum; 450-550 parts of polygonatum; 450-550 parts of hawthorn; 450-550 parts of cassia seed and 135-165 parts of lotus leaf.

2. The Chinese medicine composition having the function of assisting in lowering blood lipids according to claim 1, wherein: The traditional Chinese medicine composition is composed of the following traditional Chinese medicines in parts by weight: 480-520 parts of salvia miltiorrhiza, 220-280 parts of turmeric, 140-160 parts of gynostemma pentaphyllum, 480-520 parts of polygonatum, 490-510 parts of hawthorn, 480-510 parts of cassia seeds and 140-160 parts of lotus leaves.

3. The Chinese medicine composition having the function of assisting in lowering blood lipids according to claim 1, characterized in that: The traditional Chinese medicine composition consists of the following traditional Chinese medicines in parts by weight: 500 parts of salvia miltiorrhiza, 250 parts of turmeric, 150 parts of gynostemma pentaphyllum, 500 parts of polygonatum, 500 parts of hawthorn, 500 parts of cassia seed and 150 parts of lotus leaf.

4. The method for preparing the Chinese medicinal composition having the auxiliary blood lipid lowering function according to any one of claims 1 to 3, characterized in that The following steps are involved: Extracting the salvia miltiorrhiza, turmeric, gynostemma pentaphyllum, hawthorn, polygonatum, cassia seed and lotus leaf with water, filtering and obtaining a Chinese medicine extract; The Chinese medicine extract is concentrated under reduced pressure to a relative density of 1.15 to 1.25 measured at 60° C. to obtain an extract, the extract is vacuum dried to obtain a dry paste, and the dry paste is pulverized to obtain a dry paste powder of the Chinese medicine composition.

5. The method for preparing the Chinese medicinal composition having the auxiliary blood lipid lowering function according to claim 4, characterized in that: The water extraction treatment includes a first water extraction treatment and a second water extraction treatment. The water amount of the first water extraction treatment is 8 to 10 times the total mass of the traditional Chinese medicine, the temperature is 90 to 100°C, and the time is 1.2 to 1.8 hours; the water amount of the second water extraction treatment is 8 to 10 times the total mass of the traditional Chinese medicine, the temperature is 90 to 100°C, and the time is 0.8 to 1.2 hours.

6. The method for preparing the Chinese medicinal composition having the auxiliary blood lipid lowering function according to claim 4, characterized in that: The temperature of the reduced pressure concentration is 50-80°C, and the vacuum degree is 0.04-0.08 MPa; the vacuum degree of the vacuum drying is 0.04-0.10 MPa, the temperature is 60-80°C, and the water content of the dry paste is 5.0%-8.0%.

7. Use of the traditional Chinese medicine composition with the auxiliary blood lipid lowering function according to any one of claims 1 to 3 in the preparation of a drug with the auxiliary blood lipid lowering function.

8. A Chinese medicine preparation with the function of assisting in lowering blood lipids, characterized in that: The traditional Chinese medicine preparation contains the traditional Chinese medicine composition with auxiliary blood lipid lowering function according to any one of claims 1 to 3.

9. The Chinese medicinal preparation having the function of assisting in lowering blood lipids according to claim 8, characterized in that: The dosage form of the traditional Chinese medicine preparation is tablets, capsules, powders or granules.

10. The Chinese medicinal preparation having the function of assisting in lowering blood lipids according to claim 8, characterized in that: The invention also includes pharmaceutically acceptable excipients, which include the following components in parts by weight: 75-92 parts of microcrystalline cellulose; 38-42 parts of cross-linked polyvinylpyrrolidone; 14-16 parts of silicon dioxide and 6-8 parts of magnesium stearate.

Images