Blood lipid regulating drug composition and preparation thereof

Abstract

The present application discloses a Chinese medicine composition, which is made of raw materials containing the following medicinal materials in weight: 1-25 weight parts of Pueraria root, 1-40 weight parts of Poria cocos or Ganoderma lucidum, 1-30 weight parts of Crataegus pinnatifida, 1-20 weight parts of Atractylodes macrocephala, 1-8 weight parts of Red yeast rice, as well as a preparation containing the composition and a preparation method thereof. The Chinese medicine composition or preparation of the present application has a good preventive and therapeutic effect and auxiliary regulation effect on cardiovascular diseases, especially spleen deficiency and dampness syndrome.

Description

Technical Field

[0001] The invention belongs to the field of traditional Chinese medicine, and relates to a composition comprising atractylodes macrocephala, red yeast rice and the like, and a preparation method and use thereof. Background Art

[0002] The incidence of hyperlipidemia in my country has reached 20%, and the number of adults with dyslipidemia is close to 160 million. The process of dyslipidemia is slow and hidden. Most people have no obvious symptoms and signs in the early stages of development, and it is not easy to detect. Long-term fluctuations in dyslipidemia are an important risk factor for cardiovascular and cerebrovascular diseases, which seriously threatens human health. Early detection and timely prevention can greatly reduce the risk.

[0003] Existing lipid-lowering Western medicines such as statins, fibrates, and niacin can only lower lipids through a single target, such as inhibiting HMG-CoA reductase or activating α (PPARα) receptors, so they are often accompanied by multiple adverse reactions. During treatment, alanine aminotransferase (ALT), aspartate aminotransferase (AST), and creatine kinase (CK) need to be monitored and rechecked regularly.

[0004] However, the above prescription is not applicable to people with spleen deficiency and dampness. Combining the theories of "preventive treatment" and "differentiation and treatment" in traditional Chinese medicine, we have developed lipid-regulating Chinese medicine compositions that can remove dampness and strengthen the spleen, which can both assist in lowering blood lipids and maintain healthy blood lipid levels. Starting from the cause of the disease, we can achieve both symptomatic and root cause treatment, comprehensively regulate the body, and have a higher safety level. This product is of great significance for the prevention, treatment, and auxiliary regulation of people with dyslipidemia or spleen deficiency and dampness. Summary of the invention

[0005] The inventors creatively combined Atractylodes macrocephala, Poria cocos, Crataegus pinnatifida, Pueraria root and Monascus koji according to TCM theory and modern pharmacological research to obtain a Chinese medicine composition and preparation for preventing and treating hyperlipidemia and atherosclerosis. The inventors surprisingly found that the pharmaceutical composition and preparation of the present invention can give full play to the advantages of Chinese medicine in treating cardiovascular diseases, especially spleen deficiency and dampness syndrome, treat both the symptoms and the root cause, and the composition has a good synergistic effect.

[0006] This provides the following invention:

[0007] One or more embodiments of the present application provide a pharmaceutical composition, which is made from raw materials containing the following medicinal materials in parts by weight:

[0008] 1-25 parts by weight of Pueraria root, 1-40 parts by weight of Poria cocos or Ganoderma lucidum, 1-30 parts by weight of Hawthorn, 1-20 parts by weight of Atractylodes macrocephala, and 1-8 parts by weight of Red yeast rice.

[0009] In one or more embodiments, the pharmaceutical composition is prepared from raw materials comprising the following medicinal materials in parts by weight:

[0010] 2-19 parts by weight of Pueraria root, 2-22 parts by weight of Poria cocos or Ganoderma lucidum, 2-20 parts by weight of Hawthorn, 2-17 parts by weight of Atractylodes macrocephala, 1-6 parts by weight of Red yeast rice;

[0011] Alternatively, 2-10 parts by weight of Pueraria root, 2-13 parts by weight of Poria cocos or Ganoderma lucidum, 2-11 parts by weight of Hawthorn, 2-8 parts by weight of Atractylodes macrocephala, and 1-4 parts by weight of Red yeast rice;

[0012] Alternatively, 3-6 parts by weight of Pueraria root, 2-9 parts by weight of Poria cocos or 1-4 parts by weight of Ganoderma lucidum, 2-7 parts by weight of Hawthorn, 2-5 parts by weight of Atractylodes macrocephala, and 1-2 parts by weight of Red yeast rice;

[0013] Alternatively, 4-5 parts by weight of Pueraria root, 3-8 parts by weight of Poria cocos or 1-3 parts by weight of Ganoderma lucidum, 3-6 parts by weight of Crataegus, 3-4 parts by weight of Atractylodes macrocephala, and 1-2 parts by weight of Monascus.

[0014] In one or more embodiments, the pharmaceutical composition is prepared from raw materials comprising the following medicinal materials in parts by weight:

[0015] 5 parts by weight of Pueraria root, 5 parts by weight of Poria cocos or 1.25 or 2.5 parts by weight of Ganoderma lucidum, 5 parts by weight of Crataegus pinnatifida, 3 parts by weight of Atractylodes macrocephala, 1 part by weight of Monascus koji; or

[0016] Or, 4 parts by weight of Pueraria root, 3 parts by weight of Poria cocos or 0.75 or 1.5 parts by weight of Ganoderma lucidum, 3 parts by weight of Crataegus, 3 parts by weight of Atractylodes macrocephala, 1 part by weight of Monascus; or,

[0017] Or, 4 parts by weight of Pueraria root, 6 parts by weight of Poria cocos or 1.5 or 3 parts by weight of Ganoderma lucidum, 6 parts by weight of Crataegus pinnatifida, 3 parts by weight of Atractylodes macrocephala, 1 part by weight of Monascus koji; or,

[0018] Or, 4 parts by weight of Pueraria root, 4 parts by weight of Poria cocos or 1 or 2 parts by weight of Ganoderma lucidum, 3 parts by weight of Crataegus, 3 parts by weight of Atractylodes macrocephala, 0.75 parts by weight of Monascus; or,

[0019] Or, 5 parts by weight of Pueraria root, 5.33 parts by weight of Poria cocos or 1.33 or 2.67 parts by weight of Ganoderma lucidum, 4 parts by weight of Crataegus pinnatifida, 4 parts by weight of Atractylodes macrocephala, 1 part by weight of Monascus; or,

[0020] Or, 4 parts by weight of Pueraria root, 4 parts by weight of Poria cocos or 1 or 2 parts of Ganoderma lucidum, 3 parts by weight of Crataegus, 3 parts by weight of Atractylodes macrocephala, 0.5 parts by weight of Monascus; or,

[0021] Or, 4 parts by weight of Pueraria root, 4 parts by weight of Poria cocos or 1 or 2 parts of Ganoderma lucidum, 3 parts by weight of Crataegus, 3 parts by weight of Atractylodes macrocephala, 1 part by weight of Monascus; or,

[0022] Alternatively, 5 parts by weight of Pueraria root, 8 parts by weight of Poria cocos or 2 or 4 parts by weight of Ganoderma lucidum, 4 parts by weight of Crataegus, 4 parts by weight of Atractylodes macrocephala, and 1 part by weight of Monascus.

[0023] In one or more embodiments, the raw materials for making the pharmaceutical composition further include one or more of the following medicinal materials in parts by weight: 1-3 parts by weight of lotus leaf, 1-3 parts by weight of rhodiola rosea, 2-4 parts by weight of tangerine peel, and 3-5 parts by weight of coix seed.

[0024] In one or more embodiments, the pharmaceutical composition is made from a raw material comprising or containing the following parts by weight of a medicinal material:

[0025] 4 parts by weight of Pueraria root, 3 parts by weight of Ganoderma lucidum, 3 parts by weight of Crataegus pinnatifida, 3 parts by weight of Atractylodes macrocephala, 1 part by weight of Monascus sylvestris, and 2 parts by weight of Rhodiola rosea; or,

[0026] 5 parts by weight of Pueraria root, 5 parts by weight of Poria cocos, 5 parts by weight of Hawthorn, 3 parts by weight of Atractylodes macrocephala, 1 part by weight of Monascus, and 2 parts by weight of Lotus leaf; or

[0027] 5 parts by weight of Pueraria root, 5 parts by weight of Poria cocos, 5 parts by weight of Crataegus pinnatifida, 3 parts by weight of Atractylodes macrocephala, 1 part by weight of Monascus koji, and 3 parts by weight of dried tangerine peel; or

[0028] 5 parts by weight of Pueraria root, 5 parts by weight of Poria cocos, 5 parts by weight of Hawthorn, 3 parts by weight of Atractylodes macrocephala, 1 part by weight of Monascus, 3 parts by weight of Tangerine peel, and 5 parts by weight of Coix seed.

[0029] In one or more embodiments, the raw material is a mixture of powders and / or extracts of the medicinal materials.

[0030] In one or more embodiments, the raw material is a mixture of extracts of the medicinal materials other than red yeast rice and powder or granules of red yeast rice.

[0031] In one or more embodiments, the raw material is a mixture of extracts of the medicinal materials other than red yeast rice, and red yeast rice extract and red yeast rice powder or granules.

[0032] In one or more embodiments, the extract is an extract of water, an alcohol solvent or an ester solvent.

[0033] In one or more embodiments, the alcohol solvent is ethanol, methanol, or an aqueous solution thereof.

[0034] In one or more embodiments, the ester solvent is ethyl acetate.

[0035] In one or more embodiments, the raw material is a mixture of Pueraria extract, Poria extract or Ganoderma lucidum extract, Crataegus extract, Atractylodes macrocephala extract, and Red yeast rice or Red yeast rice extract.

[0036] In one or more embodiments, the extract is an extract of water, an alcohol solvent or an ester solvent.

[0037] In one or more embodiments, the alcohol solvent is ethanol or methanol.

[0038] In one or more embodiments, the ester solvent is ethyl acetate.

[0039] In one or more embodiments, the raw material is a mixture of Pueraria extract, Poria extract or Ganoderma lucidum extract, Hawthorn extract, Atractylodes macrocephala extract, and Red yeast rice or Red yeast rice extract, as well as one or more extracts of lotus leaf, Rhodiola rosea, tangerine peel and Coix seed.

[0040] In one or more embodiments, the extract is an extract of water, an alcohol solvent or an ester solvent.

[0041] In one or more embodiments, the alcohol solvent is ethanol or methanol.

[0042] In one or more embodiments, the ester solvent is ethyl acetate.

[0043] In one or more embodiments, the red yeast rice extract is prepared by one of the following methods:

[0044] Take red yeast rice, add 2-10 W / V times of 50%-90% ethanol, methanol or ethyl acetate each time, heat and reflux to extract for 1-3 hours, filter, extract the residue 1-3 times; combine the filtrate, concentrate under reduced pressure, and dry to obtain red yeast rice extract; or

[0045] Take 1 part by weight of red yeast rice, add 3 parts by volume of 75% ethanol, heat and reflux for extraction for 3 hours, and filter the extract; add 2 parts by volume of 75% ethanol to the residue, heat and reflux for extraction for 2 hours, filter the extract, combine the two filtrates, recover ethanol under reduced pressure, concentrate to a concentrated solution with a relative density of 0.95-1.06 at 55-60° C., and dry to obtain a red yeast rice extract;

[0046] Take red yeast rice, add 2-10 W / V times of 50%-90% ethanol, methanol or ethyl acetate each time, heat and reflux to extract for 1-3 hours, filter, and extract the residue 1-3 times; combine the filtrate, concentrate under reduced pressure, add 0.5-4 V / V times of water to the concentrate, mix well, let stand for 2-24 hours, remove the supernatant, and dry to obtain red yeast rice extract; or

[0047] Take 1 weight part of red yeast rice, add 2-4 W / V times of 75% ethanol, heat and reflux to extract for 2-3 hours, filter, and extract the residue 1-3 times; combine the filtrate, concentrate under reduced pressure to a relative density of 0.95-1.06 at 55-60°C, add 1-2 times of water to the concentrated solution and mix well, let it stand for 6-10 hours, remove the supernatant, and dry below 80°C to obtain the red yeast rice extract.

[0048] In one or more embodiments, the extract of Atractylodes macrocephala, Poria cocos or Ganoderma lucidum, Pueraria root, Crataegus pinnatifida, or Monascus koji is prepared by one of the following methods:

[0049] Take Atractylodes macrocephala, Poria cocos or Ganoderma lucidum, Pueraria root, hawthorn, or take Atractylodes macrocephala, Poria cocos or Ganoderma lucidum, Pueraria root, hawthorn, red yeast rice, add 2-12W / V times of water, soak for 0.5-8h, decoct and extract 1-4 times, each time for 0.5-8h, filter, combine the decoction, concentrate, and dry; or

[0050] Take Atractylodes macrocephala, Poria cocos or Ganoderma lucidum, Pueraria root, hawthorn, or take Atractylodes macrocephala, Poria cocos or Ganoderma lucidum, Pueraria root, hawthorn, red yeast rice, add 8-12W / V times of water, soak for 0.5-4h, decoct and extract 2-3 times, each time for 1-4h, filter, combine the decoction, concentrate, and dry;

[0051] Take Pueraria root, add 8-12 W / V times of 30%-95% ethanol, soak for 0.5-8h, decoct and extract 1-4 times, each time for 0.5-8h, filter the residue, mix the residue with Atractylodes macrocephala, Poria cocos or Ganoderma lucidum, and Crataegus pinnatifida, add 2-12 W / V times of water, soak for 0.5-8h, decoct and extract 1-4 times, each time for 0.5-8h, filter, combine the decoction, concentrate, and dry; or

[0052] Take Pueraria root, add 8-12W / V times of 30%-80% ethanol, soak for 0.5-4h, decoct and extract 2-3 times, each time for 1-4h, filter the residue, mix the residue with Atractylodes macrocephala, Poria cocos or Ganoderma lucidum, and Crataegus pinnatifida, add 8-12W / V times of water, soak for 0.5-2h, decoct and extract 2-3 times, each time for 1-4h, filter, combine the decoction, concentrate, and dry;

[0053] Take hawthorn, add 8-12 W / V times of 30%-95% ethanol, soak for 0.5-8h, decoct and extract 1-4 times, each time for 0.5-8h, filter the residue, mix the residue with Atractylodes macrocephala, Poria cocos or Ganoderma lucidum, and Pueraria root, add 2-12 W / V times of water, soak for 0.5-8h, decoct and extract 1-4 times, each time for 0.5-8h, filter, combine the decoction, concentrate, and dry; or

[0054] Take hawthorn, add 8-12 W / V times of 30%-80% ethanol, soak for 0.5-4h, decoct and extract 2-3 times, each time for 1-4h, filter the residue, mix the residue with Atractylodes macrocephala, Poria cocos or Ganoderma lucidum, and Pueraria root, add 8-12 W / V times of water, soak for 0.5-2h, decoct and extract 2-3 times, each time for 1-4h, filter, combine the decoction, concentrate, and dry;

[0055] Take kudzu root and hawthorn, add 8-12 W / V times of 30%-95% ethanol, soak for 0.5-8h, decoct and extract 1-4 times, each time for 0.5-8h, filter the residue, mix the residue with Poria cocos or Ganoderma lucidum and Atractylodes macrocephala, add 2-12 W / V times of water, soak for 0.5-8h, decoct and extract 1-4 times, each time for 0.5-8h, filter, combine the decoction, concentrate and dry; or

[0056] Take kudzu root and hawthorn, add 8-12 W / V times of 30%-80% ethanol, soak for 0.5-4h, decoct and extract 2-3 times, each time for 1-4h, filter the residue, mix the residue with Poria cocos or Ganoderma lucidum and Atractylodes macrocephala, add 8-12 W / V times of water, soak for 0.5-2h, decoct and extract 2-3 times, each time for 1-4h, filter, combine the decoction, concentrate and dry;

[0057] Take kudzu root, hawthorn, poria or ganoderma, atractylodes, or take atractylodes, poria or ganoderma, kudzu root, hawthorn, red yeast rice, add 8-12 W / V times of 30%-95% ethanol, soak for 0.5-8h, decoct and extract 1-4 times, each time for 0.5-8h, filter, combine the decoction, concentrate, and dry; or

[0058] Take kudzu root, hawthorn, poria or ganoderma, atractylodes, or take atractylodes, poria or ganoderma, kudzu root, hawthorn, red yeast rice, add 8-12 W / V times of 30%-80% ethanol, soak for 0.5-4h, decoct and extract 2-3 times, each time for 1-4h, filter, combine the decoction, concentrate and dry.

[0059] In one or more embodiments, Atractylodes macrocephala, Poria cocos or Ganoderma lucidum, Pueraria root, hawthorn, or one or more of Atractylodes macrocephala, Poria cocos or Ganoderma lucidum, Pueraria root, hawthorn, red yeast rice and optional lotus leaf, Rhodiola rosea, tangerine peel and coix seed are soaked in 2-12 W / V times of water for 0.5-8 h, decocted and extracted 1-4 times, each time for 0.5-8 h, filtered, the decoctions are combined, concentrated and dried; or

[0060] Take Atractylodes macrocephala, Poria cocos or Ganoderma lucidum, Pueraria root, hawthorn, or take Atractylodes macrocephala, Poria cocos or Ganoderma lucidum, Pueraria root, hawthorn, red yeast rice, add 8-12W / V times of water and soak for 0.5-4h, decoct and extract 2-3 times, each time for 1-4h, filter, combine the decoctions, concentrate and dry.

[0061] In one or more embodiments, take Pueraria root and one or more of lotus leaf, rhodiola rosea, tangerine peel and coix seed, add 8-12 W / V times of 30%-95% ethanol to soak for 0.5-8h, decoct and extract 1-4 times, each time for 0.5-8h, filter the residue, mix the residue with Atractylodes macrocephala, Poria cocos or Ganoderma lucidum, and Crataegus pinnatifida, add 2-12 W / V times of water to soak for 0.5-8h, decoct and extract 1-4 times, each time for 0.5-8h, filter, combine the decoction, concentrate, and dry; or

[0062] Take Pueraria root, add 8-12W / V times of 30%-80% ethanol, soak for 0.5-4h, decoct and extract 2-3 times, each time for 1-4h, filter the residue, mix the residue with Atractylodes macrocephala, Poria cocos or Ganoderma lucidum, and Crataegus pinnatifida, add 8-12W / V times of water, soak for 0.5-2h, decoct and extract 2-3 times, each time for 1-4h, filter, combine the decoction, concentrate and dry.

[0063] In one or more embodiments, hawthorn and one or more of lotus leaf, rhodiola rosea, tangerine peel and coix seed are taken, 8-12 W / V times of 30%-95% ethanol is added and soaked for 0.5-8h, decocted and extracted 1-4 times, each time for 0.5-8h, the residue is filtered, the residue is mixed with Atractylodes macrocephala, Poria cocos or Ganoderma lucidum, and Pueraria root, 2-12 W / V times of water is added and soaked for 0.5-8h, decocted and extracted 1-4 times, each time for 0.5-8h, filtered, the decoction is combined, concentrated, and dried; or

[0064] Take hawthorn, add 8-12W / V times of 30%-80% ethanol, soak for 0.5-4h, decoct and extract 2-3 times, each time for 1-4h, filter the residue, mix the residue with Atractylodes macrocephala, Poria cocos or Ganoderma lucidum, and Pueraria root, add 8-12W / V times of water, soak for 0.5-2h, decoct and extract 2-3 times, each time for 1-4h, filter, combine the decoction, concentrate and dry.

[0065] In one or more embodiments, take Pueraria root, hawthorn and one or more of lotus leaf, rhodiola rosea, tangerine peel and coix seed, add 8-12 W / V times of 30%-95% ethanol to soak for 0.5-8h, decoct and extract 1-4 times, each time for 0.5-8h, filter the residue, mix the residue with Poria cocos or Ganoderma lucidum and Atractylodes macrocephala, add 2-12 W / V times of water to soak for 0.5-8h, decoct and extract 1-4 times, each time for 0.5-8h, filter, combine the decoction, concentrate and dry; or

[0066] Take kudzu root and hawthorn, add 8-12W / V times of 30%-80% ethanol, soak for 0.5-4h, decoct and extract 2-3 times, each time for 1-4h, filter the residue, mix the residue with Poria cocos or Ganoderma lucidum and Atractylodes macrocephala, add 8-12W / V times of water, soak for 0.5-2h, decoct and extract 2-3 times, each time for 1-4h, filter, combine the decoction, concentrate and dry.

[0067] In one or more embodiments, take Pueraria root, hawthorn, Poria or Ganoderma lucidum, Atractylodes macrocephala and optionally one or more of lotus leaf, Rhodiola rosea, tangerine peel and Coix seed, add 8-12 W / V times of 30%-95% ethanol, soak for 0.5-8h, decoct and extract 1-4 times, each time for 0.5-8h, filter, combine the decoction, concentrate and dry; or

[0068] Take kudzu root, hawthorn, poria or ganoderma, atractylodes, add 8-12 W / V times of 30%-80% ethanol, soak for 0.5-4h, decoct and extract 2-3 times, each time for 1-4h, filter, combine the decoction, concentrate and dry.

[0069] In the pharmaceutical composition of one or more embodiments, the content of puerarin is greater than 0.7%, the content of polysaccharide components is greater than 3.6%, the content of flavonoid components is greater than 0.8%, and the amount of lovastatin is greater than 0.06%;

[0070] Alternatively, the puerarin content is greater than 0.9%, the polysaccharide content is greater than 3.6%, the flavonoid content is greater than 1.1%, and the lovastatin content is greater than 0.09%;

[0071] Alternatively, the puerarin content is greater than 0.8%, the polysaccharide content is greater than 3.6%, the flavonoid content is greater than 0.9%, and the lovastatin content is greater than 0.07%;

[0072] Alternatively, the puerarin content is greater than 0.9%, the polysaccharide content is greater than 4%, the flavonoid content is greater than 1%, and the lovastatin content is greater than 0.08%;

[0073] Alternatively, the puerarin content is greater than 1.1%, the polysaccharide content is greater than 3.6%, the flavonoid content is greater than 1.1%, and the lovastatin content is greater than 0.06%;

[0074] Alternatively, the puerarin content is greater than 1.16%, the polysaccharide content is greater than 5.14%, the flavonoid content is greater than 1.28%, and the lovastatin content is greater than 0.085%;

[0075] Alternatively, the puerarin content is greater than 1.4%, the polysaccharide content is greater than 7.3%, the flavonoid content is greater than 1.6%, and the lovastatin content is greater than 0.09%;

[0076] Alternatively, the puerarin content is greater than 1.2%, the polysaccharide content is greater than 3.6%, the flavonoid content is greater than 1.1%, and the lovastatin content is greater than 0.09%;

[0077] Alternatively, the puerarin content is greater than 1.8%, the polysaccharide content is greater than 9.38%, the flavonoid content is greater than 2.06%, and the lovastatin content is greater than 0.12%;

[0078] Alternatively, the puerarin content is greater than 2%, the polysaccharide content is greater than 7.4%, the flavonoid content is greater than 1.9%, and the lovastatin content is greater than 0.15%;

[0079] Alternatively, the puerarin content is greater than 2.5%, the polysaccharide content is greater than 12%, the flavonoid content is greater than 2.8%, and the lovastatin content is greater than 0.15%.

[0080] One or more embodiments of the present application provide a pharmaceutical preparation, which comprises the pharmaceutical composition of the present application and a pharmaceutically acceptable excipient.

[0081] In one or more embodiments, the auxiliary material is one or more of a filler, an anti-caking agent, and a lubricant.

[0082] One or more embodiments of the present application may be composed of the following pharmaceutical preparations:

[0083]

[0084] One or more embodiments of the present application may be composed of the following pharmaceutical preparations:

[0085]

[0086] One or more embodiments of the present application may be composed of the following pharmaceutical preparations:

[0087]

[0088] In one or more embodiments, the filler is microcrystalline cellulose or lactose.

[0089] In one or more embodiments, the anti-caking agent is silicon dioxide.

[0090] In one or more embodiments, the lubricant is magnesium stearate.

[0091] In one or more embodiments, the other excipients are coating premixes or antioxidants. One or more embodiments of the present application provide the use of the pharmaceutical composition or pharmaceutical preparation of the present application in the preparation of a drug for treating and / or preventing and / or assisting in the treatment of cardiovascular disease, atherosclerosis, coronary heart disease, hyperlipidemia, assisting in lowering blood lipids or assisting in maintaining blood lipid levels.

[0092] One or more embodiments of the present application provide the use of the pharmaceutical composition or pharmaceutical preparation of the present application in the preparation of a drug for treating and / or preventing and / or assisting in the treatment of spleen deficiency and dampness syndrome, spleen qi deficiency syndrome or spleen yang deficiency syndrome.

[0093] One or more embodiments of the present application provide the use of the pharmaceutical composition or pharmaceutical preparation of the present application in the preparation of a medicine for strengthening the spleen and removing dampness, resolving turbidity and lowering lipids, tonifying the spleen and replenishing qi, warming yang and strengthening the spleen, or soothing the liver.

[0094] In one or more embodiments, the spleen deficiency and dampness excess syndrome has at least two symptoms in ①, or at least one symptom in ① and two symptoms in ②:

[0095] ①Heavy head and fatigue;

[0096] ② Shortness of breath, dizziness, chest tightness, heaviness of limbs, poor appetite, sticky mouth, nausea, loose stools, fat tongue with teeth marks on the edges, white and slippery or greasy tongue coating, and a soft and slow pulse or a weak and feeble pulse.

[0097] In one or more embodiments, the hyperlipidemia is hyperlipidemia of spleen deficiency and dampness excess type.

[0098] In one or more embodiments, the spleen deficiency and dampness excess type hyperlipidemia has two or more symptoms selected from ①-③, or ①-②:

[0099] ① Fatigue, lack of breath, laziness, low voice, dizziness, and cold limbs;

[0100] ②Heaviness of limbs or head and body, chest and abdominal distension, greasy mouth and poor appetite, nausea and vomiting, persistent abdominal pain, poor appetite and abdominal distension, diarrhea and loose stools, edema, turbid urine, excessive vaginal discharge, symptoms of vaginal itching and eczema, fat tongue with teeth marks on the edges, slippery or greasy white tongue coating, and weak or weak pulse;

[0101] ③ Chest tightness or stabbing pain, pale purple tongue, sallow or pale complexion, slippery or wiry pulse.

[0102] One or more embodiments of the present application provide the use of the pharmaceutical composition or pharmaceutical preparation of the present application in the preparation of a regulator for any one or more of VIP, ALB, ALD, AQP3, AQP4, ANP, and TP.

[0103] One or more embodiments of the present application provide the use of the pharmaceutical composition or pharmaceutical preparation of the present application in the preparation of a regulator for any one or more of GAS, MTL, AMY, TPS, and CHE.

[0104] One or more embodiments of the present application provide the use of the pharmaceutical composition or pharmaceutical preparation of the present application in the preparation of any one or more inhibitors of INF-γ, IL-6, and IL-8.

[0105] One or more embodiments of the present application provide a method for establishing an animal model of spleen deficiency and dampness excess, comprising the following steps:

[0106] (1) Grouped administration

[0107] After one week of adaptive feeding, the animals were randomly divided into a blank group, a model group, and a drug-treated group. The blank group and the model group were given corresponding volumes of normal saline, and the drug-treated group was given drugs per kg body weight every day, with an intragastric dose of 1 ml / 100 g body weight, for 4 consecutive weeks. The animals were fed a high-fat diet for 4 consecutive weeks. The high-fat diet consisted of: adding 20.0% sucrose, 15% lard, 1.2% cholesterol, 0.2% sodium cholate, and appropriate amounts of casein, calcium hydrogen phosphate, and stone powder to the maintenance feed.

[0108] (2) Modeling

[0109] Modeling time: 28 days: give high-fat feed, exhaustive swimming every day and diet irregular modeling; after modeling, the animals show decreased swimming endurance, weight loss, reduced food intake, reduced activity, quiet fatigue, and dull fur;

[0110] Index detection: After modeling, the following indicators were detected: (1) TC, TG, LDL, HDL; (2) VIP, ALB, ALD, AQP3, AQP4, ANP, TP; (3) GAS, MTL, AMY, TPS, CHE; (4) body weight, diet, sleep, bowel movements, mental state, coat color, and grip strength;

[0111] The data were statistically analyzed. When the model group was compared with the blank group, P < 0.05 for 3 or more indicators in each group.

[0112] In one or more embodiments, the dietary irregularity is 1 day of fullness and 1 day of fasting, the animals are rats or guinea pigs, and the high-fat feed consists of: adding 20.0% sucrose, 15% lard, 1.2% cholesterol, 0.2% sodium cholate, appropriate amounts of casein, calcium hydrogen phosphate, and stone powder to the feed.

[0113] One aspect of the present invention also relates to a pharmaceutical composition comprising the following components:

[0114] 1-25 parts by weight of Pueraria root, 1-40 parts by weight of Poria cocos, 1-30 parts by weight of Hawthorn, 1-20 parts by weight of Atractylodes macrocephala, and 1-8 parts by weight of Red yeast rice.

[0115] The pharmaceutical composition according to any one of the present invention comprises the following components:

[0116] 2-19 parts by weight of Pueraria root, 2-22 parts by weight of Poria cocos, 2-20 parts by weight of Hawthorn, 2-17 parts by weight of Atractylodes macrocephala, and 1-6 parts by weight of Red Yeast Rice;

[0117] Alternatively, 2-10 parts by weight of Pueraria root, 2-13 parts by weight of Poria cocos, 2-11 parts by weight of Hawthorn, 2-8 parts by weight of Atractylodes macrocephala, and 1-4 parts by weight of Red yeast rice;

[0118] Alternatively, 3-6 parts by weight of Pueraria root, 2-9 parts by weight of Poria cocos, 2-7 parts by weight of Hawthorn, 2-5 parts by weight of Atractylodes macrocephala, and 1-2 parts by weight of Red Yeast Rice;

[0119] Alternatively, 4-5 parts by weight of Pueraria root, 3-8 parts by weight of Poria cocos, 3-6 parts by weight of Crataegus pinnatifida, 3-4 parts by weight of Atractylodes macrocephala, and 1-2 parts by weight of Monascus koji.

[0120] The pharmaceutical composition according to any one of the present invention comprises the following components:

[0121] 5 parts by weight of Pueraria root, 5 parts by weight of Poria cocos, 5 parts by weight of Crataegus pinnatifida, 3 parts by weight of Atractylodes macrocephala, and 1 part by weight of Monascus koji; or

[0122] 4 parts by weight of Pueraria root, 3 parts by weight of Poria cocos, 3 parts by weight of Crataegus pinnatifida, 3 parts by weight of Atractylodes macrocephala, and 1 part by weight of Monascus koji; or

[0123] 4 parts by weight of Pueraria root, 6 parts by weight of Poria cocos, 6 parts by weight of Crataegus pinnatifida, 3 parts by weight of Atractylodes macrocephala, and 1 part by weight of Monascus koji; or

[0124] 5 parts by weight of Pueraria root, 8 parts by weight of Poria cocos, 4 parts by weight of Crataegus, 4 parts by weight of Atractylodes macrocephala, and 1 part by weight of Monascus.

[0125] According to any one of the pharmaceutical compositions of the present invention, the Poria cocos can be replaced by Ganoderma lucidum in an amount of 1-4 or 1-3 parts by weight.

[0126] According to any one of the pharmaceutical compositions of the present invention, it further comprises 1-3 parts by weight of lotus leaf, 1-3 parts by weight of rhodiola rosea, 2-4 parts by weight of tangerine peel, or 3-5 parts by weight of coix seed.

[0127] The pharmaceutical composition according to any one of the present invention comprises the following components:

[0128] 4 parts by weight of Pueraria root, 3 parts by weight of Ganoderma lucidum, 3 parts by weight of Crataegus pinnatifida, 3 parts by weight of Atractylodes macrocephala, 1 part by weight of Monascus sylvestris, and 2 parts by weight of Rhodiola rosea; or,

[0129] 5 parts by weight of Pueraria root, 5 parts by weight of Poria cocos, 5 parts by weight of Hawthorn, 3 parts by weight of Atractylodes macrocephala, 1 part by weight of Monascus, and 2 parts by weight of Lotus leaf; or

[0130] 5 parts by weight of Pueraria root, 5 parts by weight of Poria cocos, 5 parts by weight of Crataegus pinnatifida, 3 parts by weight of Atractylodes macrocephala, 1 part by weight of Monascus koji, and 3 parts by weight of dried tangerine peel; or

[0131] 5 parts by weight of Pueraria root, 5 parts by weight of Poria cocos, 5 parts by weight of Hawthorn, 3 parts by weight of Atractylodes macrocephala, 1 part by weight of Monascus, 3 parts by weight of Tangerine peel, and 5 parts by weight of Coix seed.

[0132] Another aspect of the present invention relates to a pharmaceutical preparation, which comprises the pharmaceutical composition described in any one of the present invention; optionally, the pharmaceutical preparation further comprises a pharmaceutically acceptable excipient.

[0133] According to any one of the pharmaceutical preparations of the present invention, the processing of the components thereof comprises: the following step (1) or (2), and any one of steps (3)-(8); or omitting steps (1) and (2) and using red yeast rice, and any one of steps (3)-(8):

[0134] Specifically,

[0135] The red yeast rice extract can be prepared by the following steps (1) or (2):

[0136] (1) Take 1 part by weight of red yeast rice, add 2-10 times the amount of 50%-90% ethanol, methanol or ethyl acetate each time, heat and reflux to extract for 1-3 hours, filter, and extract the residue 1-3 times; combine the filtrate, concentrate under reduced pressure, and dry to obtain a red yeast rice extract;

[0137] (2) taking 1 part by weight of red yeast rice, adding 2-10 times the amount of 50%-90% ethanol, methanol or ethyl acetate each time, heating and refluxing for extraction for 1-3 hours, filtering, and extracting the residue 1-3 times; combining the filtrate, concentrating under reduced pressure, adding 0.5-4 times water to the concentrate, mixing, leaving for 2-24 hours, removing the supernatant, and drying to obtain a red yeast rice extract;

[0138] Specifically, any one of steps (3) to (8) may be used for preparation;

[0139] (3) Soak Atractylodes macrocephala, Poria cocos, Pueraria root, and Crataegus pinnatifida in 2-12 times the amount of water for 0.5-8 h, decoct and extract 1-4 times, each time for 0.5-8 h, filter, combine the decoction, concentrate, and dry;

[0140] (4) soaking Pueraria root in 8-12 times of 30%-95% ethanol for 0.5-8h, decocting and extracting 1-4 times, each time for 0.5-8h, filtering the residue and soaking Atractylodes macrocephala, Poria cocos, and Crataegus pinnatifida in 2-12 times of water for 0.5-8h, decocting and extracting 1-4 times, each time for 0.5-8h, filtering, combining the decoction, concentrating, and drying;

[0141] (5) Take hawthorn and add 8-12 times the amount of 30%-95% ethanol to soak for 0.5-8h, decoct and extract 1-4 times, each time for 0.5-8h, filter the residue and add 2-12 times the amount of water to soak Atractylodes macrocephala, Poria cocos, and Pueraria root for 0.5-8h, decoct and extract 1-4 times, each time for 0.5-8h, filter, combine the decoction, concentrate, and dry;

[0142] (6) Take kudzu root and hawthorn and add 8-12 times the amount of 30%-95% ethanol to soak for 0.5-8h, decoct and extract 1-4 times, each time for 0.5-8h, filter the residue and add 2-12 times the amount of water to soak for 0.5-8h, decoct and extract 1-4 times, each time for 0.5-8h, filter, combine the decoction, concentrate, and dry;

[0143] (7) Take kudzu root, hawthorn, atractylodes, and poria, add 8-12 times the amount of 30%-95% ethanol, soak for 0.5-8 hours, decoct and extract 1-4 times, each time for 0.5-8 hours, filter, combine the decoction, concentrate, and dry;

[0144] (8) Grind Atractylodes macrocephala, Poria cocos, Pueraria root, and Crataegus pinnatifida into fine powder;

[0145] The preparation method of the ganoderma lucidum, lotus leaf, rhodiola rosea, tangerine peel or coix seed in the composition is the same as the processing method of the Poria cocos in any one of steps (3) to (8).

[0146] According to any one of the pharmaceutical preparations of the present invention, the processing of each component thereof includes the following steps (1) or (2) and any one of steps (3)-(8), or red yeast rice powder and any one of steps (3)-(8):

[0147] According to any one of the pharmaceutical preparations of the present invention, the treatment comprises the following steps 1) or 2), and any one of steps 3)-7); or steps (1) and (2) are omitted and red yeast rice and any one of steps 3)-7) are used:

[0148] 1) The step (1) comprises: taking 1 part by weight of red yeast rice, adding 3 parts by volume of 75% ethanol, heating and refluxing for extraction for 3 hours, and filtering the extract; adding 2 parts by volume of 75% ethanol to the residue, heating and refluxing for extraction for 2 hours, filtering the extract, combining the two filtrates, recovering ethanol under reduced pressure, concentrating to a concentrated solution with a relative density of 0.95-1.06 at 55-60° C., and drying to obtain a red yeast rice extract;

[0149] 2) The step (2) is as follows: taking 1 part by weight of red yeast rice, adding 2-4 times the amount of 75% ethanol, heating and refluxing for extraction for 2-3 hours, filtering, and extracting the residue 1-3 times; combining the filtrate, concentrating under reduced pressure to a relative density of 0.95-1.06 at 55-60° C., adding 1-2 times the amount of water to the concentrate, mixing, leaving for 6-10 hours, removing the supernatant, and drying at below 80° C. to obtain a red yeast rice extract;

[0150] 3) The step (3) is as follows: taking Atractylodes macrocephala, Poria cocos, Pueraria root and Crataegus pinnatifida, adding 8-12 times the amount of water and soaking for 0.5-4h, decocting and extracting 2-3 times, each time for 1-4h, filtering, combining the decoction, concentrating and drying;

[0151] 4) The step (4) is as follows: soak the Pueraria root in 8-12 times of 30%-80% ethanol for 0.5-4h, decoct and extract 2-3 times, each time for 1-4h, filter the residue and soak it with Atractylodes macrocephala, Poria cocos, and Crataegus pinnatifida in 8-12 times of water for 0.5-2h, decoct and extract 2-3 times, each time for 1-4h, filter, combine the decoction, concentrate, and dry;

[0152] 5) The step (5) is as follows: or taking hawthorn, adding 8-12 times the amount of 30%-80% ethanol, soaking for 0.5-4h, decocting and extracting 2-3 times, each time for 1-4h, filtering the residue and adding 8-12 times the amount of water to white atractylodes, poria, and kudzu root, soaking for 0.5-2h, decocting and extracting 2-3 times, each time for 1-4h, filtering, combining the decoction, concentrating, and drying;

[0153] 6) The step (6) is as follows: or taking Pueraria root and Hawthorn, adding 8-12 times the amount of 30%-80% ethanol and soaking for 0.5-4h, decocting and extracting 2-3 times, each time for 1-4h, filtering the residue and adding 8-12 times the amount of water to Atractylodes macrocephala and Poria cocos and soaking for 0.5-2h, decocting and extracting 2-3 times, each time for 1-4h, filtering, combining the decoction, concentrating, and drying;

[0154] 7) The step (7) is as follows: taking Pueraria root, hawthorn, Atractylodes macrocephala, and Poria cocos, adding 8-12 times the amount of 30%-80% ethanol, soaking for 0.5-4h, decocting and extracting 2-3 times, each time for 1-4h, filtering, combining the decoction, concentrating, and drying.

[0155] In one or more embodiments, the extract is concentrated in a conventional way for Chinese medicine, including conventional concentration, reduced pressure concentration, thin film concentration, etc.;

[0156] In one or more embodiments, the relative density of the concentrate or thick paste is 1.01-1.5.

[0157] In one or more embodiments, the drying method is based on the conventional concentration method of traditional Chinese medicine, such as reduced pressure drying, fluidized drying, freeze drying, infrared drying, etc.

[0158] In one or more embodiments, the drying or concentrating temperature is below 85° C., and the vacuum degree is -0.02 MPa to -0.2 MPa.

[0159] The pharmaceutical preparation of the present invention is an oral pharmaceutical preparation, and its preparation adopts the preparation method of the conventional technology of pharmaceutics, including the step of mixing the main drug and the auxiliary material. The auxiliary material of the oral pharmaceutical preparation is selected from starch, compressible starch, dextrin, lactose, mannitol, calcium sulfate dihydrate, calcium carbonate, magnesium carbonate, water, ethanol, starch slurry, syrup, liquid glucose, maltose, refined honey, sucrose powder, citric acid, essence, acacia glue, gelatin slurry, polyvinyl pyrrolidone (PVP), glue, sodium carboxymethyl cellulose, hydroxypropyl methylcellulose, magnesium stearate, stearic acid, zinc stearate, calcium stearate, talc, microcrystalline cellulose, silicon dioxide, micro powder silica gel, vegetable oil, sodium stearate, glyceryl gelatin, glyceryl monostearate, hydrogenated oil, one or more combinations thereof.

[0160] The oral preparation of the present invention can be any pharmaceutically acceptable dosage form such as tablets, hard capsules, pills, soft capsules, granules, drop pills, syrups, oral liquid preparations, decoctions and extracts.

[0161] The present invention also relates to a method for preparing the above-mentioned pharmaceutical preparation, which comprises the above-mentioned method steps.

[0162] Another aspect of the present invention also relates to the pharmaceutical preparation described in any one of the present invention, wherein the content of puerarin is greater than 1.1%, the content of polysaccharide components is greater than 3.6%, the content of flavonoid components is greater than 1.1%, and the amount of lovastatin is greater than 0.06%; or,

[0163] The puerarin content is greater than 1.2%, the polysaccharide content is greater than 3.6%, the flavonoid content is greater than 1.1%, and the lovastatin content is greater than 0.09%.

[0164] Another aspect of the present invention also relates to the pharmaceutical preparation described in any one of the present invention, wherein the content of puerarin is greater than 2%, the content of polysaccharide components is greater than 7.4%, the content of flavonoid components is greater than 1.9%, and the amount of lovastatin is greater than 0.15%; or,

[0165] The puerarin content is greater than 2.5%, the polysaccharide content is greater than 12%, the flavonoid content is greater than 2.8%, and the lovastatin content is greater than 0.15%.

[0166] Another aspect of the present invention also relates to the use of any one of the pharmaceutical compositions or pharmaceutical preparations of the present invention in the preparation of therapeutic

[0167] The invention also relates to a method for preparing a drug for treating and / or preventing and / or assisting in the treatment of cardiovascular diseases, atherosclerosis, coronary heart disease or hyperlipidemia, or a drug for preparing a drug for treating and / or preventing and / or assisting in the treatment of spleen deficiency and dampness, spleen qi deficiency or spleen yang deficiency, or a drug for strengthening the spleen and removing dampness, resolving turbidity and lowering lipids, tonifying the spleen and replenishing qi, warming yang and strengthening the spleen or soothing the liver.

[0168] Another aspect of the present invention also relates to the preparation of the pharmaceutical composition or pharmaceutical preparation described in any one of the present invention for treating and / or preventing and / or assisting in treating hyperlipidemia of spleen deficiency and dampness excess type.

[0169] Another aspect of the present invention also relates to a pharmaceutical composition or pharmaceutical preparation as described in any one of the present invention for use in the preparation of a treatment and / or prevention and / or adjuvant treatment of spleen deficiency and dampness syndrome, which has at least two symptoms in ①, or at least one symptom in ① and two symptoms in ②:

[0170] ①Heavy head and fatigue;

[0171] ② Shortness of breath, dizziness, chest tightness, heaviness of limbs, poor appetite, sticky mouth, nausea, loose stools, fat tongue with teeth marks on the edges, white and slippery or greasy tongue coating, and a soft and slow pulse or a weak and feeble pulse.

[0172] Another aspect of the present invention also relates to the pharmaceutical composition or pharmaceutical preparation described in any one of the present invention for the preparation of a drug for treating and / or preventing and / or assisting in treating hyperlipidemia of spleen deficiency and dampness excess type having symptoms ①-③, or two or more of ①-②:

[0173] ① Fatigue, lack of breath, laziness, low voice, dizziness, and cold limbs;

[0174] ②Heaviness of limbs or head and body, chest and abdominal distension, greasy mouth and poor appetite, nausea and vomiting, persistent abdominal pain, poor appetite and abdominal distension, diarrhea and loose stools, edema, turbid urine, excessive vaginal discharge, symptoms of vaginal itching and eczema, fat tongue with teeth marks on the edges, slippery or greasy white tongue coating, and weak or weak pulse;

[0175] ③ Symptoms of chest tightness or stabbing pain, pale purple tongue, sallow or pale complexion, and slippery or wiry pulse.

[0176] Another aspect of the present invention also relates to the use of any one of the pharmaceutical compositions or pharmaceutical preparations of the present invention in the preparation of a regulator for any one or more of VIP, ALB, ALD, AQP3, AQP4, ANP, and TP.

[0177] Another aspect of the present invention also relates to the use of any one of the pharmaceutical compositions or pharmaceutical preparations of the present invention in the preparation of a regulator for any one or more of GAS, MTL, AMY, TPS, and CHE.

[0178] Another aspect of the present invention also relates to the use of any one of the pharmaceutical compositions or pharmaceutical preparations of the present invention in the preparation of any one or more inhibitors of INF-γ, IL-6 / IL-8.

[0179] Another aspect of the present invention relates to a method for and / or preventing and / or assisting the treatment of cardiovascular diseases, atherosclerosis, coronary heart disease or hyperlipidemia, or in the preparation of a method for treating and / or preventing and / or assisting the treatment of spleen deficiency and dampness syndrome, spleen qi deficiency syndrome or spleen yang deficiency syndrome, or for invigorating the spleen and removing dampness, resolving turbidity and lowering lipids, invigorating the spleen and replenishing qi, warming yang and invigorating the spleen or soothing the liver, comprising the step of administering or using an effective amount of the pharmaceutical composition or pharmaceutical preparation described in any one of the present invention.

[0180] Another aspect of the present invention relates to a method for establishing an animal model of hyperlipidemia of spleen deficiency and dampness excess type, comprising the following steps:

[0181] (1) Grouped drug administration: After one week of adaptive feeding, the animals were randomly divided into a blank group, a model group, and a drug administration group. The blank group and the model group were given corresponding volumes of normal saline, and the drug administration group was given drugs per kilogram of body weight per day, with an oral gavage dose of 1 ml / 100 g body weight for 4 consecutive weeks.

[0182] The modeling and drug-treated animals were fed a high-fat diet for 4 consecutive weeks. The high-fat diet consisted of: 20.0% sucrose, 15% lard, 1.2% cholesterol, 0.2% sodium cholate, and appropriate amounts of casein, calcium hydrogen phosphate, and stone powder were added to the maintenance diet;

[0183] (2) Modeling:

[0184] Modeling time: 28 days: give high-fat diet, exhaustive swimming and diet every day to build the model;

[0185] After modeling, the animals showed decreased swimming endurance, weight loss, decreased food intake, decreased activity, quietness and fatigue, and dull fur.

[0186] Index detection: After modeling, the following indicators were detected: (1) TC, TG, LDL, HDL; (2) VIP, ALB, ALD, AQP3, AQP4, ANP, TP; (3) GAS, MTL, AMY, TPS, CHE;

[0187] The data were statistically analyzed, and when the model group was compared with the blank group, P < 0.05 for 3 or more indicators in each group;

[0188] In the method of the present invention, the diet is irregular, i.e., one day of fullness and one day of fasting; the animals are rats or guinea pigs; and the high-fat feed is composed of: adding 20.0% sucrose, 15% lard, 1.2% cholesterol, 0.2% sodium cholate, appropriate amounts of casein, calcium hydrogen phosphate, and stone powder to the feed.

[0189] In the present invention:

[0190] Pueraria root is the dried root of Pueraria lobata (Willd.) Ohwi or Puerariathomsonii Benth. of the Leguminosae family.

[0191] Poria cocos is the dried sclerotium of the Polyporaceae fungus Poria cocos (Schw.) Wolf.

[0192] Ganoderma lucidum is the dried fruiting body of the Polyporaceae fungus Ganoderma lucidum (Leyss. ex Fr.) Karst. or Ganoderma sinense Zhao, Xu et Zhang.

[0193] Hawthorn is the dried mature fruit of Crataegus pinnatifida Bge.var.major NEBr. or Crataegus pinnatifida Bge. of the Rosaceae family.

[0194] Atractylodes is the dried rhizome of Atractylodes macrocephala Koidz., a plant of the Asteraceae family.

[0195] Red yeast rice is made by inoculating the strains of Monascus purpureus Went, Monascus anka, and Monascus purpureus of the Ascomycetes class Aspergillus order Aspergillus family on steamed japonica rice or rice kernels and then artificially cultivating them.

[0196] Lotus leaves are the dried leaves of Nelumbo nucifera Gaertn., a plant of the Nymphaeaceae family.

[0197] Rhodiola rosea is Rhodiola saera (Prain) Fu, a plant of the genus Rhodiola in the family Crassulaceae, or Rhodiola saera (Prain) Fu, a plant of the genus Rhodiola in the family Crassulaceae, and the whole plant is used as medicine.

[0198] Tangerine peel is the dried mature peel of the Rutaceae plant Citrus reticulata Blanco and its cultivated varieties.

[0199] Job's tears are the dried mature kernels of the Poaceae plant Coix lacryma-jobi L. var. ma-yuen (Roman.) Stapf.

[0200] The term "red yeast rice" may be in granular or powdered form, and may be ordinary red yeast rice, functional red yeast rice, or other red yeast rices that meet other standards applicable to the present invention.

[0201] Functional red yeast rice: To meet the needs of specific functions, a certain Monascus fermentation process is adopted to obtain red yeast rice with a certain content of lovastatin or other ingredients.

[0202] "Effective amount" refers to a dose that can achieve treatment, prevention, alleviation and / or relief of the diseases or conditions described in the present invention in a subject.

[0203] Hyperlipidemia, also known as dyslipidemia and high blood lipids, refers to abnormal blood lipid-related indicators such as TC, TG, LDL-C, HDL-C, etc.

[0204] In the present invention, unless otherwise specified, the medicinal materials (such as Pueraria root, Atractylodes macrocephala, Crataegus pinnatifida, Poria cocos, Rhodiola rosea, lotus leaf, tangerine peel, Coix seed, Ganoderma lucidum, red yeast rice, etc.) refer to materials that comply with the pharmacopoeia, or can be purchased from commercially available medicinal materials, decoction pieces, or meet other standards that can achieve the purpose of the present invention.

[0205] In the present invention, the concentration of ethanol, unless otherwise specified, refers to the concentration in volume percentage.

[0206] In one or more embodiments, when Atractylodes macrocephala, Pueraria root, Poria cocos, and Crataegus pinnatifida are extracted, the extract yield is 20-40%, 26-34%, or 27-32%.

[0207] In one or more embodiments, the film coating premix can be a commercially available coating agent or a customized coating agent, or a coating premix comprising hydroxypropyl methylcellulose, talc, polyethylene glycol, titanium dioxide, etc., dissolved in ethanol, and prepared into a coating solution.

[0208] Advantageous Effects of the Invention

[0209] One or more embodiments of the present invention have one or more of the following technical effects:

[0210] The composition of the present application has outstanding effects on "excessive dampness" and "spleen deficiency", especially spleen deficiency and excessive dampness, while regulating lipids, achieving both symptomatic and root treatment. The formula of Pueraria lobata, Atractylodes macrocephala, Poria cocos, hawthorn and red yeast rice is reasonable and has a synergistic and synergistic effect.

[0211] At the same time, the advantage of traditional Chinese medicine in "preventive treatment" can be brought into play. It can provide early prevention and treatment for people who have no obvious symptoms or signs in the early stages, or have symptoms of "dampness" or "spleen deficiency", greatly reducing the risk of long-term abnormal blood lipid fluctuations inducing cardiovascular and cerebrovascular diseases, which is of great significance to improving the quality of human life.

[0212] The invention integrates modern technology, the preparation process is scientific and reasonable, and the traditional usage method is restored to the greatest extent, so that the drug preparation is reasonable in use, the efficacy is reliable, and the preparation is easy to carry and take.

[0213] Establish scientific quality control methods and conduct multi-index quality control to ensure stable and controllable product quality, reduce the occurrence of adverse reactions, and solve the problem of instability during long-term storage or transportation. BRIEF DESCRIPTION OF THE DRAWINGS

[0214] Figure 1 : AQP3 immunohistochemistry results of gastric mucosal tissues of rats in each group (hematoxylin staining, 200×).

[0215] Figure 2 : Immunohistochemistry results of AQP3 in intestinal tissues of rats in each group (hematoxylin staining, 200×).

[0216] Figure 3 : Immunohistochemistry results of AQP4 in gastric mucosal tissues of rats in each group (hematoxylin staining, 200×).

[0217] Figure 4 : Immunohistochemistry results of AQP4 in intestinal tissues of rats in each group (hematoxylin staining, 200×). DETAILED DESCRIPTION

[0218] The embodiments of the present invention will be described in detail below in conjunction with the examples, but those skilled in the art will appreciate that the following examples are only used to illustrate the present invention and should not be considered to limit the scope of the present invention. If no specific conditions are specified in the examples, they are carried out according to normal conditions or the conditions recommended by the manufacturer. If the manufacturer is not specified for the reagents or instruments used, they are all conventional products that can be obtained commercially.

[0219] Preparation Example

[0220] Example 1: Preparation of Composition Tablets

[0221] Tablet A prescription composition: Atractylodes macrocephala 300g, Poria cocos 400g, Pueraria root 400g, Hawthorn 300g, and Monascus yeast 100g.

[0222] Atractylodes macrocephala, Poria cocos, hawthorn and kudzu root are soaked in water for 2 hours, decocted and extracted twice, each time for 2 hours, 10 times the amount of water is added, 10 times the amount of water is added for the second time, decocted and extracted, concentrated and dried to obtain an extract, 420g of the dry extract of the ground component powder is taken, and mixed with 100g of red yeast rice to obtain the raw material. 113.6g of microcrystalline cellulose is sieved through 80 meshes respectively, mixed for 20-40min, mixed evenly, 90% ethanol is added to make a soft material, granulated through a 20 mesh sieve, dried at 55℃-60℃, granulated through a 20 mesh sieve, and the granules are mixed evenly with 6.4g of magnesium stearate that has been sieved through 80 meshes, tableted, and coated to obtain 0.8g / tablet.

[0223] Excipients Tablet A Tablet B Tablet C Tablet D Microcrystalline Cellulose 113.6g 192.8g 74g 133.4g Magnesium Stearate 6.4g 7.2g 6g 6.6g Specification 0.8g / tablet 0.9g / tablet 1.0g / tablet 1.1g / tablet

[0224] Example 2: Preparation of Composition Tablets

[0225] Tablet E prescription composition: Atractylodes macrocephala 300g, Poria cocos 500g, Pueraria root 500g, Hawthorn 500g, Red yeast rice 100g. Atractylodes macrocephala, Poria cocos, Hawthorn 500g, and Red yeast rice 100g are soaked in water for 2 hours, decocted and extracted twice, each time for 2 hours, 10 times the amount of water is added, and 8 times the amount of water is added for the second time, filtered, the filtrate is combined and concentrated, dried, crushed into fine powder and mixed with Red yeast rice powder, microcrystalline cellulose and silicon dioxide are added and sieved separately, mixed evenly according to the prescription ratio, granulated, dried, granulated, the granules are mixed evenly with magnesium stearate, tableted, and coated to obtain the tablet.

[0226] Alternatively, the above may also be accomplished using a dry granulation process.

[0227] Tablet F prescription composition: Atractylodes macrocephala 300g, Poria cocos 400g, Pueraria root 400g, Hawthorn 400g, and Monascus yeast 100g.

[0228] Excipients Tablet E Tablet F Microcrystalline Cellulose 68g 62g Silicon dioxide 6g 12g Magnesium Stearate 6g 6g Specification 1.0g / tablet 1.0g / tablet

[0229] Example 3: Preparation of composition capsules

[0230] Prescription composition: Atractylodes macrocephala 300g, Ganoderma lucidum 300g, Pueraria root 400g, Hawthorn 300g, Red yeast rice 100g, Rhodiola rosea 200g

[0231] Soak Atractylodes macrocephala, Ganoderma lucidum, Hawthorn, Pueraria lobata and Rhodiola rosea in water for 4 hours, decocted and extracted twice, each time for 2 hours, add 10 times the amount of water, filter, combine the decoction and concentrate, dry the concentrate, grind it into fine powder, mix it with red yeast rice powder, and put it into capsules.

[0232] You can also add an appropriate amount of microcrystalline cellulose and 90% ethanol as a wetting agent, make granules, and then put them into capsules.

[0233] Example 4: Preparation of Composition Pills

[0234] Prescription composition: Atractylodes macrocephala 300g, Poria cocos 500g, Pueraria root 500g, Hawthorn 500g, Red yeast rice 100g, Lotus leaf 200g

[0235] Boil Atractylodes macrocephala, Poria cocos, Hawthorn, Pueraria root and lotus leaf in water twice, combine the decoction, filter,

[0236] Concentrate, dry, grind into fine powder, add appropriate amount of starch or microcrystalline cellulose, use appropriate amount of honey or medicinal material extract as adhesive, make pills, polish or coat, and you have it.

[0237] Example 5: Preparation of Composition Powder

[0238] Prescription composition: Atractylodes macrocephala 300g, Ganoderma lucidum 200g, Pueraria root 500g, Hawthorn 500g, Red yeast rice 100g, Tangerine peel 300g, Coix seed 500g

[0239] Atractylodes macrocephala, Poria cocos, hawthorn, Pueraria root, tangerine peel and coix seed are decocted in water twice, the decoctions are combined, filtered, concentrated, dried and crushed into fine powder; red yeast rice is crushed into fine powder, mixed with the above fine powder, sieved and mixed to obtain the product.

[0240] Example 6 Preparation of Composition Tablets

[0241] Tablet formulation quantities are shown in the table below.

[0242] Material Name Daily dosage / g Preparation dosage g / 1000 tablets Red Yeast 1 167 Atractylodes macrocephala 3 500 Pueraria root 4 667 Poria 4 667 hawthorn 3 500 Microcrystalline Cellulose 0.44 73 Silicon dioxide 0.12 20 Magnesium Stearate 0.06 10 Film coating premix 0.18 30

[0243] Daily dosage: 6.0g, 6 tablets, 1.0g / tablet, preparation dosage: 1000g, 1000 tablets.

[0244] Take the formula amount of Atractylodes macrocephala, Pueraria root, Poria cocos and Crataegus pinnatifida, soak them in water for 1 hour, decoct them twice, each time for 2 hours, add 10 times and 8 times of water, filter, combine the filtrates, concentrate under reduced pressure to a thick paste with a relative density of 1.05-1.6, dry under reduced pressure, crush, sieve, mix with red yeast rice powder, microcrystalline cellulose and silicon dioxide, add ethanol water to make a soft material, sieve and granulate, mix the granules after granulation with magnesium stearate, and press to obtain plain tablets. The plain tablets can be coated.

[0245] Example 7 Preparation of Composition Tablets

[0246] Tablet formulation quantities are shown in the table below.

[0247] Material Name Daily dosage / g Preparation dosage / 1000 tablets Red Yeast 0.75 125 Atractylodes macrocephala 3 500 Pueraria root 4 667 Poria 4 667 hawthorn 3 500 Microcrystalline Cellulose 0.97 161 Silicon dioxide 0.12 20 Magnesium Stearate 0.06 10 Film coating premix 0.18 30

[0248] Daily dosage: 6.0g, 6 tablets, 1.0g / tablet, preparation dosage: 1000g, 1000 tablets.

[0249] The preparation method is the same as that of Example 6. After tableting, the plain tablets have a hardness (≥40N) and a disintegration time (≤30min).

[0250] Example 8 Preparation of Composition Tablets

[0251] According to the weight ratio and preparation method of the materials in the formula quantity table of Example 7, large-scale production was carried out (weight unit Kg: red yeast rice 3.75, white atractylodes 15, kudzu root 20, tuckahoe 20, hawthorn 15), and one batch of tablets was prepared. Detection method: Lovastatin, Pueraria root Flavonoids, total flavonoids, crude polysaccharides (identification of Atractylodes macrocephala, Poria cocos, Crataegus pinnatifida by pharmacopoeia methods, identification of red yeast rice by pharmacopoeia methods)

[0252] The result is:

[0253] Puerarin content: 1.504g / 100g; total flavonoids (calculated as rutin) content: 1.880g / 100g;

[0254] The content of lovastatin is 0.116 g / 100 g; the content of crude polysaccharide (calculated as glucose) is 7.962 g / 100 g.

[0255] In pharmaceutical compositions, pharmaceutical preparations and intermediates, the method for detecting the content of puerarin can refer to the pharmacopoeia, and lovastatin, total flavonoids and total polysaccharides can be detected by referring to the methods specified in the existing pharmacopoeia, national standards, industry standards or relevant technical requirements, guidelines, etc. of drugs. For example, lovastatin of the present invention can be detected by the method disclosed in the relevant standards or guidelines of drugs.

[0256] In the raw materials of Example 1, the content of puerarin, the content of polysaccharides, the content of flavonoid components, and the content of lovastatin were 3.26%, 16.45%, 3.73%, and 0.18%, respectively.

[0257] Effect Example

[0258] The following pharmacodynamic tests are used to demonstrate the technical effects of the present invention.

[0259] The inventors conducted research and exploration, established a modeling method for spleen deficiency and dampness, and established different analysis and evaluation dimensions, including spleen deficiency evaluation methods (GAS, MTL, AMY, TPS, CHE, IL-6, IL-8, INF-γ), dampness and turbidity evaluation indicators (TP, ANP, ALB, ALD, VIP, AQP3, AQP4 content of gastric and intestinal tissues and immunohistochemistry results).

[0260] Test Example 1: Effect of the pharmaceutical composition of the present invention on rats with hyperlipidemia of spleen deficiency and dampness excess type

[0261] 1 Materials and methods

[0262] 1.1 Experimental drugs

[0263] Hawthorn, kudzu root, white atractylodes, and tuckahoe were purchased from Beijing Tong Ren Tang Pharmacy, red yeast rice (lovastatin 0.8% content, purchased from Wuhan Jiacheng Biological Products Co., Ltd.), and Xuezhikang (Beijing Peking University Weixin Biotechnology Co., Ltd.). The composition of this application was prepared by the method of the concentrated solution of prescription E in Example 2.

[0264] 1.2 Experimental animals

[0265] SPF grade male healthy SD rats, weighing 180±20 g, were purchased from Sibeifu (Beijing) Experimental Animal Technology Co., Ltd. In the experiment, the relative humidity of the rats was 60%-70%, and the lighting cycle was 12 hours.

[0266] 1.3 Main reagent kits and instruments

[0267] Triglyceride (TG) kit; total cholesterol (TC) kit; high-density lipoprotein (HDL) kit; low-density lipoprotein (LDL) kit; motilin (MTL) kit; gastrin (GAS) kit; albumin (ALB) kit; aldosterone (ALD) kit; trypsin (TPS) kit; vasoactive intestinal peptide (VIP) kit, Amylase kit (Alpha2A-AMY2A), IL-6 and IL-8 (kits) were all purchased from U-Sen Biotechnology Co., Ltd.; cholinesterase (CHE) kit was purchased from Nanjing Jiancheng Biotechnology Co., Ltd.

[0268] 1.4 Grouping and Dosing

[0269] After one week of adaptive feeding, SD rats were randomly divided into a blank group, a spleen deficiency and dampness type hyperlipidemia model group, a Xuezhikang group (0.2 g / kg), a low-dose group of the present application composition (0.79 g / kg, equivalent to 9.5 g / day for humans), a medium-dose group of the present application composition (1.58 g / kg, equivalent to 19 g / day for humans), and a high-dose group of the present application composition (4.75 g / kg, equivalent to 57 g / day for humans), with 10 rats in each group. Except for the blank group and the model group, the remaining groups were given the corresponding drugs every day, with an intragastric dose of 1 ml / 100 g body weight, and the blank group and the model group were given the corresponding volume of normal saline for 4 consecutive weeks.

[0270] 1.5 Modeling method

[0271] A spleen deficiency and dampness-excess model was established by a combination of high-fat diet feeding, unhealthy diet, and swimming fatigue that damaged the spleen. Modeling began after one week of adaptive feeding, and the modeling time was 28 days: high-fat diet (high-fat diet: add 20.0% sucrose, 15% lard, 1.2% cholesterol, 0.2% sodium cholate, appropriate amount of casein, calcium hydrogen phosphate, stone powder, etc. to the maintenance feed) and daily exhaustive swimming combined with unhealthy diet (1 day of fullness, 1 day of fasting, free drinking water) was used to model. When the rats showed decreased swimming endurance, weight loss, reduced food intake, reduced activity, quiet fatigue, and dull fur color, it proved that the spleen deficiency and dampness-excess model was successfully established.

[0272] 1.6 Detection indicators and methods

[0273] (1) General condition: The mental state, hair gloss, bowel movements, food intake, and body weight of each group of rats were observed and recorded daily.

[0274] (2) Blood lipid indexes: Blood was collected from the abdominal aorta and allowed to stand for 2 hours. The blood was then centrifuged at 3000 rpm for 15 minutes to separate the serum. The serum TC, TG, LDL, and HDL blood lipid levels were measured using enzyme-linked immunosorbent assay according to the kit method.

[0275] (3) Indicators related to spleen deficiency: The levels of GAS, MTL, TPS, CHE, IL-6, and IL-8 were detected according to the instructions of the ELISA kit.

[0276] (4) Indicators related to dampness and turbidity: ALB, ALD, and VIP levels were detected according to the instructions of the ELISA kit. Immunohistochemistry was used to determine the protein content of AQP3 and AQP4 in gastric tissue and AQP3 and AQP4 in intestinal tissue. The samples were fixed with 4% paraformaldehyde, embedded in paraffin, and sliced. After dewaxing, hydration, antigen repair, SABC staining, dehydration, transparency, sealing, and microscopic examination, protein expression was observed. Image-proplus 6.0 image processing was used to detect the average integrated optical density (A) value expressed in each tissue section under the same conditions.

[0277] 2 Results

[0278] 2.1 Observation of general condition of mice in each group

[0279] After the modeling began, the model group rats gradually developed dry and yellow fur, no luster, loose stools, poor mental state, etc. The drug-treated group rats had neat fur, increased food intake, and good mental state.

[0280] 2.2 Effect of the composition of the present application on food intake and body weight in rats with spleen deficiency and dampness excess type hyperlipidemia complex model

[0281] Compared with the blank group, the food intake of the composite model group decreased (P<0.01), compared with the model group, the food intake of rats in each drug-treated group increased significantly and gradually returned to normal (P<0.01, P<0.01, P<0.01, P<0.01), and compared with the Xuezhikang group, the food intake of the high-dose group of the present application composition increased (P<0.01). The results are shown in Table 1-1.

[0282] Table 1-1 Effect of the composition of the present application on food intake in rats with spleen deficiency and dampness excess type hyperlipidemia complex model ( n=10)

[0283]

[0284] Note: Compared with the blank group, a P<0.05, b P<0.01; compared with the model group, c P<0.05, d P<0.01; compared with the Xuezhikang group, e P<0.05, f P<0.01

[0285] There was no significant difference in body weight between the rats in each group on the first day of the experiment (P>0.05). On the 14th and 28th days of the experiment, the body weight of the rats in the composite model group decreased significantly, and the difference was statistically significant (P<0.01, P<0.01). After the modeling was completed, the body weight of the rats in each drug-administered group increased, and the body weight of the Xuezhikang group and the high-dose group of the present application composition increased significantly, and the difference was statistically significant (P<0.01, P<0.01). The results are shown in Table 1-2.

[0286] Table 1-2 Effect of the composition of the present application on body weight of rats with spleen deficiency and dampness excess type hyperlipidemia complex model ( n=10)

[0287]

[0288] Note: Compared with the blank group, a P<0.05,b P<0.01; compared with the model group, c P<0.05, d P<0.01; compared with the Xuezhikang group, e P<0.05, f P<0.01

[0289] The composition of the present application has a good effect on regulating body weight, and can significantly improve it earlier, with better results.

[0290] 2.3 Effect of the composition of the present application on blood lipids in rats with spleen deficiency and dampness-excess type hyperlipidemia complex model

[0291] Compared with the blank group, the levels of TG, TC, and LDL-C in the model group were significantly increased (P<0.05, P<0.01, P<0.01), while the level of HDL-C did not change significantly.

[0292] Compared with the model group, the TG content of rats in each drug-treated group decreased to a certain extent, and the differences between the Xuezhikang group and the low-, medium- and high-dose groups of the present composition were significant and statistically significant (P<0.01, P<0.05, P<0.01, P<0.01). The TC content of rats in each drug-treated group changed to a certain extent, and the Xuezhikang group and the high-dose group of the present composition significantly decreased, with statistically significant differences (P<0.05, P<0.05). The LDL content of rats in each drug-treated group decreased to a certain extent, and the Xuezhikang group and the high-dose group of the present composition significantly decreased, with statistically significant differences (P<0.05, P<0.01). The HDL content of rats in each drug-treated group increased significantly, with statistically significant differences (P<0.05, P<0.05, P<0.05, P<0.05).

[0293] Compared with the Xuezhikang group, the LDL content in the high-dose group of the present application composition was reduced (P<0.05). The results are shown in Tables 1-3.

[0294] Table 1-3 Effects of the composition of the present application on blood lipids in rats with spleen deficiency and dampness excess type hyperlipidemia complex model ( n=10)

[0295]

[0296] Note: Compared with the blank group, a P<0.05, b P<0.01; compared with the model group, c P<0.05, d P<0.01; compared with the Xuezhikang group, e P<0.05, f P<0.01

[0297] The lipid-lowering effect of the composition of the present application is relatively prominent. It not only has a regulating effect on TG / TC / LDL / HDL, but also has a particularly significant effect on regulating LDL, which is better than Xuezhikang. Low-density lipoprotein LDL plays a very important role in cardiovascular diseases and is a risk factor for atherosclerosis. The higher the low-density lipoprotein, the higher the risk of patients suffering from coronary heart disease and atherosclerotic diseases.

[0298] 2.4 Effect of the composition of the present application on spleen deficiency-related indicators in the serum of rats with a complex model of hyperlipidemia caused by spleen deficiency and dampness excess Compared with the blank group, the levels of GAS, MTL, and TPS in the rats in the complex model group were significantly reduced, and the differences were statistically significant (P<0.01, P<0.01, P<0.01), and CHE was increased (P<0.05).

[0299] Compared with the model group, the GAS levels of rats in each medication group increased, and the difference was statistically significant (P<0.01, P<0.01, P<0.01, P<0.01). Except for the low-dose group of the composition of the present application, the MTL levels of the other groups increased, that is, the Xuezhikang group, the medium-dose group and the high-dose group of the composition of the present application, and the difference was statistically significant (P<0.01, P<0.01, P<0.01). The TPS levels of rats in each medication group increased to a certain extent (P<0.01, P<0.01, P<0.01, P<0.01). The CHE levels of rats in each medication group decreased, which was statistically significant. However, the results of the Xuezhikang group and the low-dose group of the composition of the present application were close (P<0.05, P<0.05), and the difference between the medium-dose group and the high-dose group of the composition of the present application was more significant (P<0.01, P<0.01).

[0300] Compared with the Xuezhikang group, the GAS content in the medium and high dose groups of the composition of the present application increased (P<0.01, P<0.01), and the MTL content in the high dose group increased (P<0.01). The results are shown in Tables 1-4.

[0301] Table 1-4 Effects of the composition of the present application on GAS, MTL, TPS and CHE in rats with hyperlipidemia of spleen deficiency and dampness excess type ( n=10)

[0302]

[0303] Note: Compared with the blank group, a P<0.05, b P<0.01; compared with the model group, c P<0.05, d P<0.01; compared with the Xuezhikang group, e P<0.05, f P<0.0

[0304] Compared with the blank group, the CHE level of rats in the composite model group was significantly increased, and the difference was statistically significant (P<0.05).

[0305] Compared with the composite model group, the CHE levels of rats in each drug administration group were reduced to a certain extent, and the differences were significant and statistically significant. However, the positive drug Xuezhikang group and the low-dose group of the present application composition had significant differences, and the results were close, which was statistically significant (P<0.05, P<0.05). The statistical results of the medium- and high-dose groups of the present application composition were close, and the differences were more significant (P<0.01, P<0.01).

[0306] It can be seen that the effects of the composition of the present application on AMY, GAS and TPS are significantly better than those of Xuezhikang, and the effect of the composition of the present application on spleen and stomach regulation is more prominent.

[0307] 2.5 Effect of the composition of the present application on serum indicators related to dampness and turbidity in rats with a combined model of hyperlipidemia of spleen deficiency and dampness excess

[0308] Compared with the blank group, the ALB level of rats in the model group was decreased (P<0.01), the ALD level was increased (P<0.05), and the VIP level was increased (P<0.05).

[0309] Compared with the model group, the ALB levels of rats in each administration group showed an upward trend, among which the medium and high dose groups of the present application composition increased significantly (P<0.05, P<0.05), the ALD levels of rats in each administration group decreased, and the ALD level in the high dose group of the present application composition decreased significantly (P<0.05), and the VIP levels of rats in each administration group decreased, which was statistically significant (P<0.05, P<0.05, P<0.05, P<0.05). The results are shown in Tables 1-5.

[0310] Table 1-5 Effects of the composition of the present application on ALB, ALD and VIP in rats with hyperlipidemia of spleen deficiency and dampness excess type ( n=10)

[0311]

[0312] Note: Compared with the blank group, a P<0.05, b P<0.01; compared with the model group, c P<0.05, d P<0.01; compared with the Xuezhikang group, e P<0.05, f P<0.01

[0313] The medium and high dose groups of the composition of the present application can increase the ALB content (P<0.05), and the high dose group of the composition of the present application can reduce the ALD content (P<0.05), and the effects are significantly better than those of the Xuezhikang group, and there are statistical differences compared with the model group.

[0314] The composition of the present application can regulate the content of ALB and ALD, control the water metabolism in the body, and prevent water metabolism disorders. It plays an important role in treating excessive dampness in the body and maintaining a constant internal environment of the body. It can be seen that the composition of the present application has an outstanding dehumidifying effect.

[0315] The composition of the present application has obvious effects of strengthening the spleen and removing dampness, and can also be used to treat edema (such as nephrotic syndrome), diarrhea (chronic gastroenteritis), tinnitus, dizziness (Meniere's syndrome), obesity, etc.

[0316] Compared with the blank group, the AQP3 levels in the stomach and intestine tissues of rats in the composite model group were significantly decreased (P<0.01, P<0.01), and the AQP4 levels were significantly increased (P<0.01, P<0.01).

[0317] Compared with the model group, the AQP3 level in the gastric tissue of rats in each drug-treated group increased to a certain extent (P<0.01, P<0.05, P<0.01, P<0.01), and the AQP3 level in the intestinal tissue also increased to varying degrees (P<0.01, P<0.01, P<0.01, P<0.01). The AQP4 level in the gastric tissue of rats in each drug-treated group decreased to a certain extent, and the difference between the Xuezhikang group and the high-dose group of the present composition was statistically significant (P<0.01, P<0.01). The AQP4 level in the intestinal tissue of rats in each drug-treated group also decreased to varying degrees, and the difference between the Xuezhikang group and the medium- and high-dose groups of the present composition was significant (P<0.01, P<0.01, P<0.01).

[0318] Compared with Xuezhikang, the low, medium and high dose groups of the composition of the present application can increase the intestinal AQP3 content (P<0.01, P<0.01, P<0.01), and increase the AQP4 content (P<0.01, P<0.01, P<0.01). The results are shown in Tables 1-6.

[0319] Table 1-6 Effects of the composition of the present application on AQP3 and AQP4 in the stomach and intestine tissues of rats with hyperlipidemia complex model of spleen deficiency and dampness excess ( n=10)

[0320]

[0321] Note: Compared with the blank group, a P<0.05, b P<0.01; compared with the model group, c P<0.05,d P<0.01; compared with the Xuezhikang group, e P<0.05, f P<0.01

[0322] Compared with the blank group, the levels of IL-6 and IL-8 in the composite model group were significantly increased (P<0.001, P<0.01).

[0323] Compared with the composite model group, the IL-6 levels of rats in each administration group decreased to a certain extent, but the difference in the positive drug Xuezhikang group was not significant. The IL-6 levels of the low, medium and high dose groups of the present application composition were significantly reduced, and the difference was statistically significant (P<0.05, P<0.05, P<0.05). The IL-8 levels of rats in each administration group changed, and the high dose group of the present application composition was significantly reduced, and the difference was statistically significant (P<0.01). The results are shown in Tables 1-7.

[0324] Table 1-7 Effects of the composition of the present application on IL-6 and IL-8 in rats with hyperlipidemia complex model of spleen deficiency and dampness excess

[0325]

[0326] Note: Compared with the blank group, a P<0.05, b P<0.01; compared with the model group, c P<0.05, d P<0.01; compared with the Xuezhikang group, e P<0.05, f P<0.01.

[0327] Results (1) Compared with the blank group, the food intake, body weight, gastrin, motilin, trypsin, and albumin levels of the composite model group were significantly decreased (P<0.01); the expression of aquaporin 3 in gastric and intestinal tissues was decreased (P<0.01); the levels of triglycerides, total cholesterol, low-density lipoprotein, cholinesterase, aldosterone, and vasoactive intestinal peptide were increased (P<0.05, P<0.01); and the expression of aquaporin 4 in gastric and intestinal tissues was increased (P<0.01).

[0328] (2) Compared with the composite model group, the composition of the present application and Xuezhikang can increase food intake, body weight, high-density lipoprotein, gastrin, motilin, trypsin levels, and the expression of aquaporin 3 in gastric and intestinal tissues (P<0.05, P<0.01), and the composition of the present application can also increase the level of albumin ALB (P<0.05). The composition of the present application and Xuezhikang can reduce the levels of triglycerides, total cholesterol, low-density lipoprotein, cholinesterase, vasoactive intestinal peptide, and the expression of aquaporin 4 in gastric and intestinal tissues (P<0.05, P<0.01), and the composition of the present application can also reduce the level of aldosterone (P<0.05).

[0329] (3) Compared with the Xuezhikang group, the high-dose group of the composition of the present application can increase food intake, gastrin GAS, motilin MTL levels, and the expression of aquaporin 3 and aquaporin 4 in intestinal tissue (P<0.01), and reduce the level of low-density lipoprotein (P<0.01). The low-dose and medium-dose groups of the composition of the present application can increase the expression of aquaporin 3 and aquaporin 4 in intestinal tissue (P<0.05, P<0.01), the medium-dose group can increase the gastrin GAS level (P<0.01), and the low-dose group can reduce the trypsin level TPS (P<0.05).

[0330] (4) Attachment Figure 1-4 It can be seen that the effects of each dosage group of the present invention on AQP3 and AQP4 in the gastric and intestinal mucosal tissues of rats are relatively obvious, especially the improvement of AQP3 and AQP4 in the intestinal mucosal tissues is significantly better than that of the Xuezhikang group.

[0331] (5) The composition of the present application has immunomodulatory and metabolic regulatory effects

[0332] IL-6 is an inflammatory factor mainly secreted by T cells and fibroblasts. It has a predictive effect on the occurrence of metabolic diseases such as blood lipids and blood sugar. The increase in its content can further stimulate the occurrence of inflammatory response and lead to gastrointestinal dysfunction.

[0333] Clinical studies have shown that the serum IL-6 level of patients with weak spleen and stomach and abnormal digestive function can be significantly increased. It is believed that the increase in the level of this indicator may be closely related to the abnormal spleen and stomach function, and the treatment with Xiangsha Liujunzi Decoction has a good effect.

[0334] IL-8 is also a cytokine that mediates inflammation. It can induce chemotaxis of neutrophils and release active substances. Elevated levels of this indicator can lead to mucosal microcirculation disorders and easily cause damage to the gastrointestinal mucosa. This study found that the composition of the present application can effectively reduce the content of pro-inflammatory factors such as IL-6 and IL-8, improve gastrointestinal function, and protect the gastrointestinal mucosa.

[0335] In animal and human experimental studies, it was found that the composition of the present application can treat or improve the following symptoms:

[0336] a) Fatigue, lack of breath, laziness, low voice, dizziness, and cold limbs;

[0337] b) Heaviness of limbs or head and body, chest and abdominal distension, greasy mouth and poor appetite, nausea and vomiting, persistent abdominal pain, poor appetite and abdominal distension, diarrhea and loose stools, edema, turbid urine, excessive vaginal discharge, symptoms of vaginal itching and eczema, fat tongue with teeth marks on the edges, slippery or greasy white tongue coating, and weak or feeble pulse;

[0338] c) Chest tightness or stabbing pain, pale purple tongue, sallow or pale complexion, slippery or astringent pulse;

[0339] Moreover, when the composition of the present application contains Ganoderma lucidum, it can enhance the effect of replenishing qi and calming the mind, can significantly improve the symptoms of shortness of breath, fatigue, weakness, and can enhance the body's immunity. Rhodiola rosea can strengthen the spleen and replenish qi, promote blood circulation and remove blood stasis. The composition containing Rhodiola rosea can significantly improve the symptoms of a) and c).

[0340] Tangerine peel can regulate qi and strengthen the spleen, dry dampness and resolve phlegm, while coix seed can promote diuresis and eliminate dampness, strengthen the spleen and stop diarrhea. After adding these two ingredients to the composition, it can effectively improve symptoms a) and b), while also promoting qi and relieving pain. It has obvious effects on symptoms such as spleen and stomach qi stagnation, vomiting, hiccups, and chest pain.

[0341] Lotus leaves can clear away heat and dampness, promote the development of clear yang, cool blood and stop bleeding, and have strong dampness-removing ability. After adding this medicine to the composition, the symptoms b) can be significantly improved.

[0342] Test Example 2: Comparative Experiment on the Efficacy of Rats with Hyperlipidemia of Spleen Deficiency and Dampness Excess

[0343] 1.1. Experimental Materials

[0344] 1.1.1 Experimental animals

[0345] SPF grade male healthy SD rats, weighing (180±20) g, were purchased from Sibeifu (Beijing) Experimental Animal Technology Co., Ltd. High-fat feed was provided by Sibeifu (Beijing) Experimental Animal Technology Co., Ltd. Rats had free access to water throughout the experiment, the room temperature was 20-22°C, the relative humidity was 60%-70%, and the lighting cycle was 12h, 7:00-19:00 light, 19:00-7:00 dark. The experiment complied with relevant ethical requirements.

[0346] 1.1.2 Experimental drugs

[0347] 1.1.2.1 Test samples

[0348] A. Four-ingredient control formula (red yeast 1g, kudzu root 5g, poria 5g, hawthorn 5g)

[0349] B. Composition 1 (0.75 g red yeast rice, 3 g white atractylodes, 4 g kudzu root, 4 g poria, 3 g hawthorn)

[0350] C. Composition 2 (1g red yeast rice, 5g kudzu root, 5g tuckahoe, 5g hawthorn, 3g atractylodes)

[0351] D. Composition 3 (Monascus 1g, Pueraria lobata 5g, Poria 8g, Hawthorn 4g, Atractylodes macrocephala 4g)

[0352] E. Composition 4 (1g red yeast rice, 5g kudzu root, 5g tuckahoe, 5g hawthorn, 3g atractylodes macrocephala, 3g tangerine peel, 5g coix seed)

[0353] 1.2 Experimental methods

[0354] 1.2.1 Drug preparation

[0355] For each test sample group, the dosage was 10 times the recommended dosage for humans.

[0356] The recommended dosage of test sample A for adults (based on 60kg body weight) is 16g per day, equivalent to 0.27g / kwBW / d. According to the dosing rules, the daily dosage for rats is 2.67g / kgBW.

[0357] The recommended dose of test sample B for adults (based on 60kg body weight) is 14.75g per day, equivalent to 0.25g / kwBW / d. According to the dosing rules, the daily dose for rats is 2.46g / kgBW.

[0358] The recommended dose of the test sample C for adults (based on 60kg body weight) is 19g per day, equivalent to 0.32g / kgBW / d. According to the dosing rules, the daily dose for rats is 3.17g / kgBW.

[0359] The recommended dose of the test sample D for adults (based on 60kg body weight) is 22g per day, equivalent to 0.37g / kgBW / d. According to the dosing rules, the daily dose for rats is 3.67g / kgBW.

[0360] The recommended dose of test sample E for adults (based on 60kg body weight) is 27g per day, equivalent to 0.45g / kgBW / d. According to the dosing rules, the daily dose for rats is 4.5g / kgBW.

[0361] The following is a description of the preparation process of the tested product:

[0362] The raw materials except red yeast rice in the five groups of test sample compositions were soaked in water for 1 hour, decocted and extracted twice, each time for 2 hours, 10 times the amount of water was added for the first time, and 8 times the amount of water was added for the second time. After the filtrate was combined, it was concentrated and dried. The obtained dry paste was crushed and then fully mixed with the corresponding dose of red yeast rice powder to obtain a mixed powder, which was the test sample.

[0363] 1.2.2 Model preparation

[0364] Except for the blank group, the other groups were fed with high-fat diet, fed on odd days and fasted on even days. At the same time, the mice were placed in a cylinder with a water temperature of (20±2)℃ and a depth of 50cm and swam until exhaustion, and stopped when the nose tip was submerged in the water for 10 seconds. The model was established for 10 consecutive weeks.

[0365] 1.2.3 Grouping and Dosing

[0366] 108 SPF healthy male SD rats, weighing (180±20)g, were fed for 7 days. The temperature of the animal room was maintained at about 18℃~25℃, and they were fed with full-price pellet feed freely. Before modeling, they were randomly divided into 5 blank groups and 40 model groups according to their body weight. The body weight was measured once a week.

[0367] On the 8th day of the experiment, except for the blank control group which was fed with ordinary feed, the model group (40 rats) was conditioned with the "excessive fatigue + improper diet + high-fat feed" model of dyslipidemia and spleen deficiency and dampness.

[0368] Four weeks after modeling, blood was collected from the rats in the blank group and the model group without fasting (inner canthus or tail of the eye). Serum was separated as soon as possible after blood collection, and serum TC, TG, LDL-C, and HDL-C levels were measured.

[0369] According to the TC level, the model group was randomly divided into 6 groups: composite model group, four-flavor control group, combination group 1, combination group 2, combination group 3, and combination group 4. After grouping, there were no significant differences in TC, TG, LDL-C, and HDL-C among the model groups. After grouping, there were significant differences in TC, TG, LDL-C, and HDL-C between the model groups and the blank control group.

[0370] After the formal grouping, drug administration began. The intragastric dose was 1 ml / 100 g. Except for the blank group which was given normal saline, the other groups were given corresponding drugs for 6 consecutive weeks.

[0371] 1.2.4 Collection method

[0372] 7 hours after the last oral administration, blood was collected from the rats' orbitals without fasting to measure four blood lipids.

[0373] After that, the subjects were fasted for 12 hours but not water. After weighing their body weight 2 hours before sampling, 0.4 ml / 100 g 10% chloral hydrate was injected intraperitoneally for anesthesia. Blood was collected from the abdominal aorta, left to stand at room temperature for 1-2 hours, centrifuged at 3500 r / min for 15 minutes, serum was separated, and the supernatant was collected and stored at low temperature (4°C) for testing.

[0374] 1.3 Detection indicators

[0375] (1) Four blood lipids: cholesterol (TC), triglycerides (TG), high-density lipoprotein (HDL-C), low-density lipoprotein (LDL-C)

[0376] (2) Indicators of spleen deficiency: interferon-γ (INF-γ), grip strength

[0377] (3) Indicators of dampness: serum total protein (TP), albumin (ALB), atrial natriuretic peptide (ANP), and aldosterone (ALD)

[0378] 1.4 Experimental Results

[0379] 1.4.1 Effects on TC, TG, HDL-C, and LDL-C in rats with hyperlipidemia due to spleen deficiency and dampness excess

[0380] Compared with the blank group, the serum total cholesterol (TC) content of rats in the composite model group was significantly increased (P<0.001). Compared with the composite model group, the difference in composition group 2, composition group 3, and composition group 4 was significantly reduced (P<0.001), and the composition group 1 and the four-flavor control group were reduced (P<0.01).

[0381] Compared with the blank group, the serum triglyceride (TG) content of rats in the composite model group was significantly increased, and the difference was statistically significant (P<0.001). Compared with the composite model group, the serum triglyceride (TG) content of rats in each drug administration group was reduced, and the differences among rats in the composition group 1, composition group 2, composition group 3, and composition group 4 were significant (P<0.001). Compared with the four-flavor control group, the TG levels of the composition group 3 and the composition group 4 were significantly reduced (P<0.05).

[0382] Compared with the blank group, the serum low-density lipoprotein cholesterol (LDL-C) content of rats in the composite model group was significantly increased (P<0.001). Compared with the composite model group, the serum low-density lipoprotein cholesterol (LDL-C) content of rats in each drug-treated group was reduced, and there were significant differences in the four-flavor control group, composite group 1, composite group 2, composite group 3, and composite group 4 (P<0.05, P<0.001, P<0.01, P<0.001, P<0.001).

[0383] Compared with the blank group, the serum high-density lipoprotein cholesterol (HDL-C) content of rats in the composite model group was significantly reduced (P<0.001). Compared with the composite model group, except for the four-flavor control group, the serum high-density lipoprotein cholesterol (HDL-C) content of rats in the other drug-treated groups increased to a certain extent, and there were significant differences among the composition group 1, composition group 2, composition group 3, and composition group 4 (P<0.001, P<0.05, P<0.05, P<0.001). Compared with the four-flavor control group, the composition group 1 and the composition group 4 increased significantly (P<0.001, P<0.05). The results are shown in Table 2-1.

[0384] Table 2-1 Effects on TC, TG, LDL-C, and HDL-C in rats with spleen deficiency and dampness-excess hyperlipidemia complex model ( n=5)

[0385]

[0386] Note: Compared with the blank group, # P<0.05, ## P<0.01, ### P<0.001; compared with the model group, * P<0.05, ** P<0.01, *** P<0.001.

[0387] 1.4.2 Effect on the grip strength of rats with spleen deficiency and dampness excess type hyperlipidemia complex model

[0388] After 4 weeks of administration, compared with the blank group, the gripping force of the rats in the composite model group was significantly reduced (P < 0.001); compared with the model group, the gripping force of the four-flavor control group, the combination group 1, the combination group 2, the combination group 3, and the combination group 4 was significantly increased (P < 0.001). The gripping force enhancement effect of the combination group 1 and the combination group 2 was more significant than that of the four-flavor control group.

[0389] The results are shown in Table 2-2.

[0390] Table 2-2 Effect on the grip strength of rats with spleen deficiency and dampness excess type hyperlipidemia complex model ( n=5)

[0391]

[0392] Note: Compared with the blank group, # P<0.05, ## P<0.01, ### P<0.001; compared with the model group, * P<0.05, ** P<0.01, ***P<0.001.

[0393] 1.4.3 Effects on INF-γ in rats with spleen deficiency and dampness-excess hyperlipidemia complex model

[0394] Compared with the blank group, the INF-γ level of rats in the composite model group was significantly decreased (P<0.01). Compared with the composite model group, the INF-γ levels of the composite group 1, composite group 2, composite group 3, and composite group 4 were significantly increased (P<0.001), and the INF-γ level of the four-flavor control group was increased (P<0.01). The INF-γ level of the four-flavor control group was significantly lower than that of the composite group 1 and composite group 4 (P<0.05).

[0395] The results are shown in Table 2-3.

[0396] Table 2-3 Effect of Composition 1 on INF-γ in Rats with Hyperlipidemia of Spleen Deficiency and Dampness Type ( n=5)

[0397]

[0398] Note: Compared with the blank group, # P<0.05, ## P<0.01, ### P<0.001; compared with the model group, * P<0.05, ** P<0.01, *** P<0.001.

[0399] 1.4.4 Effects on TP and ALB in rats with spleen deficiency and dampness-excess hyperlipidemia complex model

[0400] Compared with the blank group, the TP level of rats in the composite model group was significantly reduced (P<0.01). Compared with the composite model group, except for the four-flavor control group, the TP levels of the other drug-administered groups were increased, and there were significant differences among the composite group 1, composite group 2, composite group 3, and composite group 4. (P<0.05, P<0.001, P<0.05, P<0.01). The TP level of the composite group 2 was significantly higher than that of the four-flavor control group (P<0.05).

[0401] Compared with the blank group, the ALB level of rats in the composite model group was significantly reduced (P<0.01). Compared with the composite model group, the ALB level of rats in each drug-administered group increased to a certain extent, and the ALB level of rats in the four-flavor control group, combination group 1, combination group 2, combination group 3, and combination group 4 increased significantly (P<0.05, P<0.001, P<0.001, P<0.01, P<0.001). The ALB level of the combination group 2 and the combination group 4 was more obvious than that of the four-flavor control group.

[0402] The results are shown in Tables 2-4.

[0403] Table 2-4 Effects on TP and ALB in the composite model of hyperlipidemia with spleen deficiency and dampness excess ( n=5)

[0404]

[0405] Note: Compared with the blank group, # P<0.05, ## P<0.01, ### P<0.001; compared with the model group, * P<0.05, ** P<0.01, *** P<0.001.

[0406] 1.4.5 Effects on ALD and ANP in rats with spleen deficiency and dampness-excess hyperlipidemia complex model

[0407] Compared with the blank group, the ALD level of rats in the composite model group was significantly increased (P<0.01). Compared with the composite model group, the ALD level of rats in the composition 1 group and the composition 2 group was significantly decreased (P<0.001).

[0408] Compared with the blank group, the ANP level of rats in the composite model group was significantly increased (P<0.001). Compared with the composite model group, the ANP levels of the four-flavor control group, the combination group 1, the combination group 2, and the combination group 3 were significantly reduced (P<0.001). The ANP levels of the combination group 1 and the combination group 3 were significantly lower than those of the four-flavor control group.

[0409] The results are shown in Tables 2-5.

[0410] Table 2-5 Effect of Composition 1 on ALD and ANP in Rats with Hyperlipidemia of Spleen Deficiency and Dampness Excessive Type ( n=5)

[0411]

[0412] Note: Compared with the blank group, # P<0.05, ## P<0.01, ### P<0.001; compared with the model group, * P<0.05, ** P<0.01, *** P<0.001.

[0413] 1.5 Discussion

[0414] The spleen is the master of the acquired constitution, the source of Qi and blood biochemistry, and the main muscle. The strength of the limbs' grip and the body's immunity all reflect the state of "spleen deficiency". The experimental results showed that the grip strength and IFN-γ levels of rats in each medication group were significantly improved. It can be seen that the effects of the combination groups 1-4 in strengthening the spleen and removing dampness, clearing turbidity and lowering lipids are significantly better than those of the four-flavor control group.

[0415] In summary, the composition of the present application can effectively improve:

[0416] 1. The composition of this application has outstanding effects in regulating lipids and treating spleen deficiency and dampness syndrome

[0417] Xuezhikang's functions and indications are to clear turbidity and reduce lipids, activate blood circulation and remove blood stasis, and strengthen the spleen and digestion. It is used for hyperlipidemia caused by phlegm and blood stasis, with symptoms of shortness of breath, fatigue, dizziness, headache, chest tightness, abdominal distension, and poor appetite; it can also be used as an auxiliary treatment for other cardiovascular and cerebrovascular diseases caused by hyperlipidemia and atherosclerosis. However, it has no regulating effect on "damp turbidity" such as ALB and ALD.

[0418] The composition of the present application can simultaneously regulate the indicators of spleen deficiency and dampness, and has a better lipid-lowering effect. The effect of strengthening the spleen and removing dampness is outstanding. It can not only strengthen the spleen and stimulate the appetite, effectively regulate the transportation and transformation function of the spleen and stomach, and relieve spleen and stomach weakness; (treatment: anorexia, less food, abdominal distension, fatigue, less breath, low voice, cold limbs, dizziness, sallow complexion, two or more symptoms), but also remove dampness and turbidity (treatment: heavy limbs, diarrhea, loose stools, turbid urine, excessive vaginal discharge, itchy eczema, white and greasy tongue coating, fat tongue, and wet pulse, two or more symptoms).

[0419] 2. The composition of this application treats both the symptoms and the root cause, and is suitable for preventing

[0420] The composition of the present application can regulate the spleen, liver and kidney at the same time, strengthen the spleen, soothe the liver, remove dampness and regulate lipids. The whole formula is reasonably compatible, strengthens the spleen, removes dampness and turbidity to treat the root of the disease, and lowers blood lipids; it promotes blood circulation and removes blood stasis to prevent diseases before they occur, and promotes blood circulation. The invention applies the theory of syndrome differentiation, and scientifically and comprehensively regulates through the present invention, fully demonstrating the advantages of traditional Chinese medicine in preventing health and treating diseases before they occur.

[0421] The composition of the present application is formulated to strengthen the spleen and eliminate dampness, clear turbidity and reduce fat, and hits the pathogenesis. At the same time, it can treat clinical manifestations of abdominal distension and discomfort, poor appetite and greasy mouth, loose stools, heavy head and body, fatigue, or sallow skin and face, edema of limbs, pale and fat tongue, white or greasy tongue coating, and slow and weak pulse.

[0422] In addition, elevated LDL-C or TC in dyslipidemia is an important risk factor for atherosclerotic cardiovascular disease (ASCVD); effectively controlling dyslipidemia and lowering LDL-C levels can significantly reduce the risk of ASCVD and mortality, which is of great significance to improving the quality of human life.

[0423] 3. Significant synergy

[0424] Atractylodes can invigorate the spleen and replenish qi, dry out dampness and promote diuresis, and is used for weak spleen and stomach, poor appetite, loose stools, edema caused by phlegm and fluid retention, and heavy body and fatigue; Red yeast rice has the functions of invigorating the spleen and digesting food, promoting blood circulation and removing blood stasis, and removing turbidity and lipids, and can be used for dyslipidemia caused by spleen deficiency, phlegm turbidity obstruction, and blood stasis blocking the collaterals; the two are used together to invigorate the spleen and stomach, dry out dampness and turbidity, and treat both the symptoms and the root causes. Atractylodes and Red yeast rice are both the main drugs. Poria has the functions of penetrating dampness and invigorating the spleen. Hawthorn can help digestion and invigorate the stomach, and promote qi and dissipate blood stasis. Poria and hawthorn are the minister drugs, and when used together, they can enhance the functions of the main drug in invigorating the spleen and drying dampness, digesting food and removing accumulation, removing turbidity and reducing blood lipids. Pueraria root is used together with Atractylodes and Poria to enhance the functions of invigorating the spleen and promoting digestion, and promoting the clear yang. The whole prescription is reasonably compatible, invigorating the spleen, removing dampness and removing turbidity to treat the root cause of the disease and reduce blood lipids; at the same time, it promotes blood circulation and dissipates blood stasis, and promotes blood circulation to prevent diseases before they occur. The composition of the present application is formulated to invigorate the spleen and eliminate dampness, clear turbidity and reduce fat, hits the pathogenesis, and treats both the symptoms and the root causes.

[0425] 4. Reduce the dosage of medicine and save medicinal resources

[0426] The dosage of each medicinal flavor in the composition of this application is lower than the clinical dosage, and the dosage of some prescriptions is only equivalent to 14.75g of human daily dosage, which greatly reduces the dosage, avoids the possible toxic side effects caused by excessive dosage, and reduces the risk of possible adverse reactions. At the same time, it also solves the shortage of medicinal resources.

[0427] Although the specific embodiments of the present invention have been described in detail, it will be understood by those skilled in the art. According to all the teachings disclosed, various modifications and replacements can be made to those details, and these changes are all within the protection scope of the present invention. The full scope of the present invention is given by the attached claims and any equivalents thereof.

Claims

1. A pharmaceutical composition, which consists of the following components: 1-25 weight parts of Pueraria root, 1-40 weight parts of Poria cocos, 1-30 weight parts of Hawthorn, 1-20 weight parts of Atractylodes macrocephala, and 1-8 weight parts of Red yeast rice.

2. The pharmaceutical composition according to claim 1, which consists of the following components: 2-19 parts by weight of Pueraria root, 2-22 parts by weight of Poria cocos, 2-20 parts by weight of Hawthorn, 2-17 parts by weight of Atractylodes macrocephala, and 1-6 parts by weight of Red yeast rice.

3. The pharmaceutical composition according to claim 2, which consists of the following components: 2-10 parts by weight of Pueraria root, 2-13 parts by weight of Poria cocos, 2-11 parts by weight of Hawthorn, 2-8 parts by weight of Atractylodes macrocephala, and 1-4 parts by weight of Red yeast rice.

4. The pharmaceutical composition according to claim 2, which consists of the following components: 3-6 parts by weight of Pueraria root, 2-9 parts by weight of Poria cocos, 2-7 parts by weight of Hawthorn, 2-5 parts by weight of Atractylodes macrocephala, and 1-2 parts by weight of Red yeast rice.

5. The pharmaceutical composition according to claim 2, which is composed of the following components: 4-5 parts by weight of Pueraria root, 3-8 parts by weight of Poria cocos, 3-6 parts by weight of Crataegus pinnatifida, 3-4 parts by weight of Atractylodes macrocephala, and 1-2 parts by weight of Monascus.

6. The pharmaceutical composition according to claim 1, consisting of the following components: 5 parts by weight of Pueraria root, 5 parts by weight of Poria cocos, 5 parts by weight of Crataegus pinnatifida, 3 parts by weight of Atractylodes macrocephala, and 1 part by weight of Monascus koji.

7. The pharmaceutical composition according to claim 1, which is composed of the following components: 4 parts by weight of Pueraria root, 3 parts by weight of Poria cocos, 3 parts by weight of Crataegus pinnatifida, 3 parts by weight of Atractylodes macrocephala, and 1 part by weight of Monascus.

8. The pharmaceutical composition according to claim 1, which is composed of the following components: 4 parts by weight of Pueraria root, 6 parts by weight of Poria cocos, 6 parts by weight of Crataegus pinnatifida, 3 parts by weight of Atractylodes macrocephala, and 1 part by weight of Monascus koji.

9. The pharmaceutical composition according to claim 1, which is composed of the following components: 5 parts by weight of Pueraria root, 8 parts by weight of Poria cocos, 4 parts by weight of Crataegus pinnatifida, 4 parts by weight of Atractylodes macrocephala, and 1 part by weight of Monascus.

10. A pharmaceutical composition consisting of the following components: 300g of Atractylodes macrocephala, 400g of Poria cocos, 400g of Pueraria root, 300g of Hawthorn, and 100g of Red Yeast Rice.

11. A method for preparing a Chinese medicine composition tablet, comprising: Take 300g of Atractylodes macrocephala, 500g of Poria cocos, 500g of Pueraria root, 500g of Hawthorn, and 100g of Red Yeast Rice; soak the Atractylodes macrocephala, Poria cocos, Hawthorn, and Pueraria root in water for 2 hours, decoct and extract twice, each time for 2 hours, add 10 times the amount of water, and add 8 times the amount of water for the second time, filter, combine the filtrate, concentrate, dry, grind into fine powder and mix with the Red Yeast Rice, add 68g of microcrystalline cellulose and 6g of silicon dioxide, sieve them separately, mix evenly, granulate, dry, granulate, mix the granules evenly with 6g of magnesium stearate, compress into tablets, and coat to obtain.

12. A pharmaceutical preparation, prepared from the pharmaceutical composition according to any one of claims 1 to 10 and pharmaceutically acceptable excipients.

13. The pharmaceutical preparation according to claim 12, wherein the content of puerarin is greater than 1.1%, the content of polysaccharides is greater than 3.6%, the content of flavonoids is greater than 1.1%, and the content of lovastatin is greater than 0.06%.

14. The pharmaceutical preparation according to claim 12, wherein the content of puerarin is greater than 1.2%, the content of polysaccharides is greater than 3.6%, the content of flavonoids is greater than 1.1%, and the content of lovastatin is greater than 0.09%.

15. The pharmaceutical preparation according to claim 14, wherein the content of puerarin is greater than 2%, the content of polysaccharides is greater than 7.4%, the content of flavonoids is greater than 1.9%, and the content of lovastatin is greater than 0.15%.

16. The pharmaceutical preparation according to claim 14, wherein the content of puerarin is greater than 2.5%, the content of polysaccharides is greater than 12%, the content of flavonoid components is greater than 2.8%, and the content of lovastatin is greater than 0.15%.

17. Use of the pharmaceutical composition according to any one of claims 1 to 10 or the pharmaceutical preparation according to any one of claims 12 to 16 in the preparation of a medicament for treating and / or preventing and / or assisting in treating hyperlipidemia of spleen deficiency and dampness excess type.

18. The use according to claim 17, wherein the spleen deficiency and dampness excess type hyperlipidemia has two or more symptoms selected from ①-③, or ①-②: ① Fatigue, lack of breath, laziness, low voice, dizziness, and cold limbs; ②Heaviness of limbs or head and body, chest and abdominal distension, greasy mouth and poor appetite, nausea and vomiting, persistent abdominal pain, poor appetite and abdominal distension, diarrhea and loose stools, edema, turbid urine, excessive vaginal discharge, symptoms of vaginal itching and eczema, fat tongue with teeth marks on the edges, slippery or greasy white tongue coating, and weak or weak pulse; ③ Chest tightness or stabbing pain, pale purple tongue, sallow or pale complexion, slippery or wiry pulse.

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