CN112656919A - A Chinese medicinal composition for treating hyperlipidemia and fatty liver, and its preparation method - Google Patents

Abstract

The invention provides a traditional Chinese medicine composition for treating hyperlipidemia and fatty liver and a preparation method thereof, wherein the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 10-25 parts of cassia seed, 10-25 parts of sweet wormwood herb, 10-40 parts of agilawood, 10-20 parts of radix curcumae, 5-20 parts of gentian, 1-15 parts of green tangerine peel, 5-15 parts of red paeony root, 5-25 parts of geranium wilfordii and 5-20 parts of fructus psoraleae. The traditional Chinese medicine composition can effectively relieve and/or eliminate dizziness, head clouding, and other hyperlipidemia and fatty liver patient clinical symptoms such as acne rosacea, flushing, hypochondriac pain and the like, has an effective rate of 89.5%, and provides a new choice for clinical medication.

Description

A Chinese medicinal composition for treating hyperlipidemia and fatty liver, and its preparation method

Technical Field

The invention relates to the field of traditional Chinese medicines, and in particular relates to a traditional Chinese medicine composition for treating hyperlipidemia and fatty liver and a preparation method thereof.

Background

In recent years, with the improvement of the living standard of people, diseases such as fatty liver and high blood fat (such as hyperlipidemia) are in a trend of rising obviously due to the change of dietary structure, excessive drinking or excessive intake of lipid-containing food and the like.

Hyperlipidemia can be classified into primary and secondary. The primary is related to congenital and heredity, and the secondary is frequently related to metabolic disorder diseases such as diabetes and hypertension, or related to other factors such as age, sex, season, drinking, smoking, diet, physical activity, mental stress, emotional activity, etc. Typically, most patients do not have obvious symptoms and signs of abnormality. Elevated plasma lipoprotein levels are found in many cases when biochemical blood tests are performed for other reasons. Plasma total cholesterol concentrations > 5.17mmol/L (200mg/dl) can be designated as hypercholesterolaemia, and plasma triacylglycerol concentrations > 2.3mmol/L (200mg/dl) as hypertriglyceridemia.

The treatment of hyperlipidemia is classified into non-drug therapy and drug therapy, and the non-drug therapy generally treats hyperlipidemia by methods of weight control, exercise, smoking cessation, diet therapy and the like. The medicine treatment mainly comprises statins and resins for reducing serum total cholesterol and LDL cholesterol, the medicine mainly for reducing serum triacylglycerol comprises fibrates and nicotinic acid, partial patients can have flushing skin itch of the face or burning sensation in the stomach and abdominal discomfort and slight headache after the medicine is taken, the long-term application of the fibrates can induce similar type I autoimmune chronic hepatitis, and the fenofibrate has the side effect of causing liver function abnormality.

The control of hyperlipidemia is a long-term process, and patients who use the medicine to control the hyperlipidemia have the problems of normal blood lipid and rebound after medicine withdrawal. The blood fat is gradually increased and decreased repeatedly, and patients can bear the side effect of the lipid-lowering drug and worry about the rise of the blood fat after the drug is stopped, so that the compliance of the patients taking the lipid-lowering drug is generally poor, the patients suffering from hyperlipidemia are afraid of the damage of dyslipidemia to the bodies, and simultaneously, nothing can be paid to controlling the blood fat.

Fatty liver refers to a pathological condition in which fat is accumulated in liver cells too much due to various causes, thereby affecting the normal function of the liver. The liver is a common pathological change of the liver, which can be manifested as hypodynamia, nausea, vomiting or right epigastric discomfort, etc., seriously threatens the health of human beings, becomes the second largest liver disease next to viral hepatitis, and is known as a common cause of hidden liver cirrhosis. The method for treating fatty liver comprises non-drug and drug treatment modes, wherein the non-drug treatment modes comprise diet structure adjustment, proper exercise, selenium supplement and the like; the medicine treatment generally selects western medicines, and usually selects liver cell protecting, lipid removing medicines, antioxidants and the like, such as vitamin B, C, E, lecithin, ursodeoxycholic acid, silymarin, inosine, coenzyme A, reduced glutathione, taurine, carnitine orotate, glucurolactone, certain lipid lowering medicines and the like, and the medicines are only conditioning and tonifying preparations and have uncertain curative effect. Therefore, although fatty liver is a disease which is extremely harmful to the body and has high morbidity, no effective treatment method exists in the current medical situation.

As a traditional treasure in China, the traditional Chinese medicine plays an important role in clinically treating hyperlipidemia and fatty liver. If a new compound preparation for effectively treating hyperlipemia and fatty liver can be developed in the traditional Chinese medicine, a new choice is provided for the clinical medication of hyperlipemia and fatty liver in China.

Disclosure of Invention

The invention aims to provide a traditional Chinese medicine composition for treating hyperlipidemia and fatty liver and a preparation method thereof, which can effectively relieve and/or eliminate dizziness, face blush, hypochondriac pain and other hyperlipidemia and fatty liver patient clinical symptoms, and provide a new choice for clinical medication.

In order to achieve the purpose, the technical scheme adopted by the invention is as follows:

the invention aims to provide a traditional Chinese medicine composition which comprises the following raw materials in parts by weight: 10-25 parts of cassia seed, 10-25 parts of sweet wormwood herb, 10-40 parts of agilawood, 10-20 parts of radix curcumae, 5-20 parts of gentian, 1-15 parts of green tangerine peel, 5-15 parts of red paeony root, 5-25 parts of geranium wilfordii and 5-20 parts of fructus psoraleae.

In a specific embodiment of the invention, the raw materials comprise the following components in parts by weight: 15-20 parts of semen cassiae, 15-20 parts of sweet wormwood, 20-30 parts of agilawood, 10-15 parts of radix curcumae, 10-20 parts of gentian, 5-10 parts of green tangerine peel, 10-15 parts of red paeony root, 10-15 parts of geranium and 10-15 parts of fructus psoraleae.

In a specific embodiment of the invention, the raw materials comprise the following components in parts by weight: 20 parts of cassia seed, 20 parts of sweet wormwood, 30 parts of agilawood, 15 parts of radix curcumae, 15 parts of gentian, 5 parts of green tangerine peel, 10 parts of red paeony root, 15 parts of geranium wilfordii and 15 parts of fructus psoraleae;

or comprises 15 parts of cassia seed, 15 parts of sweet wormwood, 20 parts of agilawood, 15 parts of turmeric root-tuber, 15 parts of gentian, 10 parts of green tangerine orange peel, 10 parts of red paeony root, 10 parts of geranium wilfordii and 10 parts of malaytea scurfpea fruit.

Wherein:

the semen Cassiae is dry mature seed of Cassia obtusifolia L. or Cassia tora L;

the herba Artemisiae Annuae is dried aerial part of Artemisia annua L;

the lignum Aquilariae Resinatum is Aquilaria sinensis (Lour.) Gilg wood containing resin;

the radix curcumae is a dried root tuber of Curcuma wenyujin Y.H.Chenet C.Ling, Curcuma longa L.Cucuma kwangsiensis S.G.Lee et C.F.Liang or Curcuma phaeocaulis Val.;

the radix Gentianae is dried root and rhizome of Gentiana manshurica Kitag, Gentiana scabra Bge, Gentiana triflora pall or Gentiana rigescens Franch;

the pericarpium Citri Reticulatae viride is pericarp of dried young fruit or immature fruit of Citrus reticulata Blanco and its cultivar;

the radix Paeoniae Rubra is dried root of Paeonia lactiflora pall or Paeonia veitchii Lynch;

geranium wild, Geranium wilfordii Maxim, or Geranium carolinium L;

the fructus psoraleae is dry mature fruit of Psoralea corilifolia L.

The inventor finds that the surface area of the medicinal powder is larger when the raw powder is used for medicine, so that the effective components in the medicinal materials can be absorbed in vivo, but further finds that the effective components are still required to be dissolved and absorbed in vivo without being extracted from the medicinal materials, the effect is slow relative to the extract, although the toxic and side effects of harmful components in the medicinal materials on human bodies are weakened, the effect is slow, the medicinal powder is suitable for long-term administration, and the raw powder can be prepared into administration forms such as pills, capsules and the like; the medicinal materials are extracted and prepared into other administration forms such as transdermal absorption preparations, external lotion, in-vivo implanted preparations, injection and the like, so that the toxic and side effects are less, the targeting property of the medicine can be enhanced, and the medicine effect can be improved.

The invention also aims to provide a preparation method of the traditional Chinese medicine composition, which is characterized by comprising the following steps: the raw materials are combined according to the weight portion.

Further, the preparation method comprises one or more of the following items (1) to (3);

(1) taking the powder of each raw medicinal material; (2) mixing; (3) and (4) extracting.

Further, the solvent for extraction is water or alcohol;

further, the alcohol is 40% to 95% vv ethanol aqueous solution, preferably 50% to 80% vv ethanol aqueous solution.

Wherein, the component (1) can be combined with any one or two of the components (2) and (3), and the raw material medicines taken in the component (1) can be respectively and independently selected from the group consisting of semen Cassiae, herba Artemisiae Annuae, lignum Aquilariae Resinatum, radix Curcumae, radix Gentianae, pericarpium Citri Reticulatae viride, radix Paeoniae Rubra, herba Erodii seu Geranii or fructus Psoraleae to be combined with any one or two of the components (2) and (3), or selected from the group consisting of semen Cassiae, herba Artemisiae Annuae, lignum Aquilariae Resinatum, radix Curcumae, radix Gentianae, pericarpium Citri Reticulatae viride, radix Paeoniae Rubra, herba Erodii seu Geranii and fructus Psoraleae to be combined with any; can be directly mixed with medicinal powder; or making into extract; or mixing part of the above extracts and part of the above medicinal powders.

That is, the following combinations may be included but not limited to:

A. mixing at least two components of the raw material medicinal powder and extracting;

B. respectively and independently extracting the powder of each raw material medicine and then mixing;

for example, semen Cassiae, herba Artemisiae Annuae, lignum Aquilariae Resinatum, radix Curcumae, radix Gentianae, pericarpium Citri Reticulatae viride, radix Paeoniae Rubra, herba Erodii seu Geranii, and fructus Psoraleae by mixing; or extracting semen Cassiae and herba Artemisiae Annuae, and mixing with other raw materials; or mixing semen Cassiae, herba Artemisiae Annuae and lignum Aquilariae Resinatum, extracting other raw materials separately, mixing, etc.

Another object of the present invention is to provide the use of said composition for the preparation of a product for the prevention and/or treatment of disorders of lipid metabolism.

The invention also aims to provide application of the composition in preparing a product for preventing and/or treating one or more of hyperlipidemia, fatty liver diabetes and obesity.

The invention also aims to provide a product, the active ingredients of which comprise the traditional Chinese medicine composition;

further, the preparation form of the product is selected from one or more of gastrointestinal absorption preparation, transdermal absorption preparation, in-vivo implantation preparation and injection; the preferable preparation form is a preparation absorbed through gastrointestinal tract;

furthermore, the formulation of the gastrointestinal absorption preparation is selected from powder, tablets, granules, paste, powder, capsules, pills and oral liquid, and further is tablets and granules.

The active ingredients can be mixed with pharmaceutically acceptable auxiliary materials to prepare a product; by "pharmaceutically acceptable" is meant any substance that does not interfere with the effectiveness of the biological activity of the active ingredient and is not toxic to the host to which it is administered.

The pharmaceutically acceptable auxiliary materials are general names of all the additional materials except the main medicine in the medicine, and the auxiliary materials have the following properties: (1) no toxic effect on human body and few side effects; (2) the chemical property is stable and is not easily influenced by temperature, pH, storage time and the like; (3) has no incompatibility with the main drug, and does not influence the curative effect and quality inspection of the main drug; (4) does not interact with the packaging material. The auxiliary materials in the invention include, but are not limited to, a filler (diluent), a lubricant (glidant or anti-adhesion agent), a dispersing agent, a wetting agent, an adhesive, a regulator, a solubilizer, an antioxidant, a bacteriostatic agent, an emulsifier, a disintegrating agent and the like. The binder comprises syrup, acacia, gelatin, sorbitol, tragacanth, cellulose and its derivatives (such as microcrystalline cellulose, sodium carboxymethylcellulose, ethyl cellulose or hydroxypropyl methylcellulose), gelatin slurry, syrup, starch slurry or polyvinylpyrrolidone; the filler comprises lactose, sugar powder, dextrin, starch and its derivatives, cellulose and its derivatives, inorganic calcium salt (such as calcium sulfate, calcium phosphate, calcium hydrogen phosphate, precipitated calcium carbonate, etc.), sorbitol or glycine, etc.; the lubricant comprises superfine silica gel powder, magnesium stearate, talcum powder, aluminum hydroxide, boric acid, hydrogenated vegetable oil, polyethylene glycol and the like; the disintegrating agent comprises starch and its derivatives (such as sodium carboxymethyl starch, sodium starch glycolate, pregelatinized starch, modified starch, hydroxypropyl starch, corn starch, etc.), polyvinylpyrrolidone or microcrystalline cellulose, etc.; the wetting agent comprises sodium lauryl sulfate, water or alcohol, etc.; the antioxidant comprises sodium sulfite, sodium bisulfite, sodium pyrosulfite, dibutylbenzoic acid, etc.; the bacteriostatic agent comprises 0.5% of phenol, 0.3% of cresol, 0.5% of chlorobutanol and the like; the regulator comprises hydrochloric acid, citric acid, potassium (sodium) hydroxide, sodium citrate, and buffer (including sodium dihydrogen phosphate and disodium hydrogen phosphate); the emulsifier comprises polysorbate-80, sorbitan fatty acid, pluronic F-68, lecithin, soybean lecithin, etc.; the solubilizer comprises Tween-80, bile, glycerol, etc.

Further, the preparation method of the product comprises the following steps: the traditional Chinese medicine composition is prepared into a product.

The invention has the following beneficial effects:

(1) the product prepared from the extract composition of each component of cassia seed, sweet wormwood herb, agilawood, radix curcumae, gentian, green tangerine orange peel, red paeony root, geranium wilfordii and malaytea scurfpea fruit can obviously relieve the clinical symptoms of patients with hyperlipidemia and fatty liver, such as relieving or eliminating dizziness and dizziness, eliminating or relieving acne rosacea, flushing, hypochondrium distending pain and reducing blood cholesterol concentration, has the effective rate of 89.5 percent, and provides a new choice for clinical medication.

(2) The preparation method has the advantages of simple preparation process, mild condition and easy control.

Detailed Description

The present invention is further illustrated by the following examples and specific tests. The following examples are only preferred embodiments of the present invention and are not intended to limit the present invention, and various modifications and changes may be made by those skilled in the art. Any modification, equivalent replacement, or improvement made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

EXAMPLE 1 preparation of granules

Selecting 20g of traditional Chinese medicine cassia seeds, 20g of sweet wormwood, 30g of agilawood, 15g of radix curcumae, 15g of gentian, 5g of green tangerine peel, 10g of red paeony root, 15g of geranium and 15g of fructus psoraleae, mixing and crushing into coarse powder, decocting twice with 10-15 times of water each time for 1h, combining water extract, concentrating into thick paste, drying, grinding, preparing into granules, and bagging to obtain granules, wherein the mass of the content in each bag is 6 g.

EXAMPLE 2 preparation of tablets

Selecting 20 parts of traditional Chinese medicine cassia seed, 20 parts of sweet wormwood, 30 parts of agilawood, 15 parts of radix curcumae, 15 parts of gentian, 5 parts of green tangerine peel, 10 parts of red paeony root, 15 parts of geranium and 15 parts of fructus psoraleae, performing reflux extraction for 2 times by using 50-80% ethanol in an amount which is 5 times that of the traditional Chinese medicine cassia seed, extracting for 1 hour each time, and combining ethanol extracting solutions; decocting the residue with 5 times of water for 2 times (each time for 30 min), mixing the decoctions, recovering ethanol from the ethanol extractive solution, mixing with the water decoction, concentrating, adding 29 parts of starch, tabletting, and drying to obtain tablet.

The beneficial effects of the granules prepared in example 1 were demonstrated by the following test examples:

test example 1

Statistics of clinical data effects

Patient gender and age range: the age range of male and female elderly patients is 45-75 years, and the history of hyperlipidemia is found to be different from 1 month to nearly 15 years. 207 patients were treated at the clinic.

The current medical history of the patients mainly comprises dizziness, flushing, acne rosacea, hypodynamia, hypochondriac distending pain, listlessness and the like, and the rise of the blood fat and cholesterol level is found by routine inspection of an outpatient clinic.

The therapeutic effect judgment standard is as follows:

(I) the therapeutic effect of the syndrome in traditional Chinese medicine

(1) Clinical control clinical symptoms, signs disappear or essentially disappear.

(2) Has obvious clinical symptoms and physical signs.

(3) Effective clinical symptoms and physical signs are all improved.

(4) No clinical symptoms, no obvious improvement or even aggravation of signs were observed.

(II) laboratory examination therapeutic effect judgment standard

(1) The clinical control laboratory can recover the normal state of each examination.

(2) The effective blood fat detection reaches any one of the following.

TC is decreased by more than or equal to 20 percent, TG is decreased by more than or equal to 40 percent, HDL-C is increased by more than or equal to 0.26mmol/L (10mg/dl), and TC-HDL-C/HDL-C is decreased by more than or equal to 20 percent.

(3) Effective blood lipid detection reaches any one of the following.

TC is decreased by more than or equal to 10 percent and less than 20 percent, TG is decreased by more than or equal to 20 percent and less than 40 percent, HDL-C is increased by more than or equal to 0.104mmol/L (4mg/dl) and less than 0.26mmol/L (10mg/dl), and TC-HDL-C/HDL-C is decreased by more than or equal to 10 percent and less than 20 percent.

(4) And invalid blood fat detection does not meet the above standard.

The treatment method comprises the following steps:

the granules prepared in the embodiment 1 of the invention are orally taken for 2 bags each time, 2 times a day and 1 month as 1 course of treatment.

The treatment effect is as follows:

108 cases of the medicine have obvious effect, the clinical symptoms disappear, and the medicine does not attack in 3 months;

72 cases are effective, accounting for about 34.8%, and the clinical symptoms are relieved;

27 of the cases were ineffective, accounting for about 13.0%.

The results show that the total effective rate of the pharmaceutical composition is 89.5%.

Specific case examples are as follows:

case 1:

for some patients, men in the field, mainly due to chronic red swelling and pain in the nose and cheeks and slight oppression and swelling of the hypochondriac region for 1 year, the patients have physical examination: the nose and cheeks were frequently scattered in red papules with a small amount of purulent exudation. The patient should be rewarded more for a long time and have irregular rest. And (3) diagnosis: rosacea. When the granules prepared in example 1 are used for treatment, the symptoms of slight diarrhea are caused after the granules are taken, the swelling and pain are obviously relieved after one month, the skin is still butterfly red, and the feeling of oppression and expansion of the hypochondrium is eliminated.

After the composition consisting of the traditional Chinese medicine extract is compatible for use, the composition can obviously relieve the clinical symptoms of patients with hyperlipidemia and fatty liver, such as dizziness, head misting, acne rosacea, flushing, hypochondriac pain or reduction of blood cholesterol concentration, has the effective rate of 89.5 percent, and provides a new choice for clinical medication.

The above description is only an embodiment of the present invention, and not intended to limit the scope of the present invention, and all modifications of equivalent structures and equivalent processes, which are made by the present specification, or directly or indirectly applied to other related technical fields, are included in the scope of the present invention.

Claims (10)

1. The traditional Chinese medicine composition is characterized by comprising the following raw materials in parts by weight: 10-25 parts of cassia seed, 10-25 parts of sweet wormwood herb, 10-40 parts of agilawood, 10-20 parts of radix curcumae, 5-20 parts of gentian, 1-15 parts of green tangerine peel, 5-15 parts of red paeony root, 5-25 parts of geranium wilfordii and 5-20 parts of fructus psoraleae.

2. The traditional Chinese medicine composition according to claim 1, wherein the raw materials comprise the following components in parts by weight: 15-20 parts of semen cassiae, 15-20 parts of sweet wormwood, 20-30 parts of agilawood, 10-15 parts of radix curcumae, 10-20 parts of gentian, 5-10 parts of green tangerine peel, 10-15 parts of red paeony root, 10-15 parts of geranium and 10-15 parts of fructus psoraleae.

3. The traditional Chinese medicine composition according to claim 1, wherein the raw materials comprise the following components in parts by weight: 20 parts of cassia seed, 20 parts of sweet wormwood, 30 parts of agilawood, 15 parts of radix curcumae, 15 parts of gentian, 5 parts of green tangerine peel, 10 parts of red paeony root, 15 parts of geranium wilfordii and 15 parts of fructus psoraleae;

or comprises 15 parts of cassia seed, 15 parts of sweet wormwood, 20 parts of agilawood, 15 parts of turmeric root-tuber, 15 parts of gentian, 10 parts of green tangerine orange peel, 10 parts of red paeony root, 10 parts of geranium wilfordii and 10 parts of malaytea scurfpea fruit.

4. The preparation method of the traditional Chinese medicine composition according to any one of claims 1 to 3, which comprises the following steps: the raw materials are combined according to the weight portion.

5. The method according to claim 4, wherein the method comprises one or more of the following (1) to (3);

(1) taking the powder of each raw medicinal material; (2) mixing; (3) and (4) extracting.

6. The method according to claim 5, wherein the solvent for extraction is water or alcohol;

further, the alcohol is 40% to 95% vv ethanol aqueous solution, preferably 50% to 80% vv ethanol aqueous solution.

7. Use of a composition according to any one of claims 1 to 3 for the preparation of a product for the prevention and/or treatment of a disorder of lipid metabolism.

8. Use of the composition of any one of claims 1 to 3 in the preparation of a product for preventing and/or treating one or more of hyperlipidemia, fatty liver diabetes and obesity.

9. A product, characterized in that the active ingredient comprises the Chinese medicinal composition of any one of claims 1 to 3;

further, the preparation form of the product is selected from one or more of gastrointestinal absorption preparation, transdermal absorption preparation, in-vivo implantation preparation and injection; the preferable preparation form is a preparation absorbed through gastrointestinal tract;

furthermore, the formulation of the gastrointestinal absorption preparation is selected from powder, tablets, granules, paste, powder, capsules, pills and oral liquid, and further is tablets and granules.

10. A method of making the product of claim 9, comprising: the traditional Chinese medicine composition of any one of claims 1-3 is prepared into a product.