CN107261002B - Traditional Chinese medicine composition for treating hyperlipidemia, preparation method and application thereof - Google Patents

Traditional Chinese medicine composition for treating hyperlipidemia, preparation method and application thereof Download PDF

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CN107261002B
CN107261002B CN201710525218.2A CN201710525218A CN107261002B CN 107261002 B CN107261002 B CN 107261002B CN 201710525218 A CN201710525218 A CN 201710525218A CN 107261002 B CN107261002 B CN 107261002B
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traditional chinese
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CN107261002A (en
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萧伟
周恩丽
韩兆忠
常秀娟
康小东
王永香
王仁杰
王星星
王振中
周习
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Jiangsu Kanion Pharmaceutical Co Ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/53Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
    • A61K36/536Prunella or Brunella (selfheal)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/48Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A61K36/481Astragalus (milkvetch)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/88Liliopsida (monocotyledons)
    • A61K36/899Poaceae or Gramineae (Grass family), e.g. bamboo, corn or sugar cane
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    • A61K2236/00Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30Extraction of the material
    • A61K2236/33Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/331Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation, decoction
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30Extraction of the material
    • A61K2236/33Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/333Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K2236/00Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30Extraction of the material
    • A61K2236/39Complex extraction schemes, e.g. fractionation or repeated extraction steps
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/50Methods involving additional extraction steps
    • A61K2236/51Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/50Methods involving additional extraction steps
    • A61K2236/53Liquid-solid separation, e.g. centrifugation, sedimentation or crystallization

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Abstract

The invention provides a traditional Chinese medicine composition suitable for treating hyperlipidemia, which is prepared from the following raw material medicines: prunellae Spica, radix astragali and rhizoma Phragmitis. In addition, the invention also provides a preparation method and application of the traditional Chinese medicine composition. The invention has the advantages of reducing cholesterol, triglyceride and the like in human blood by combining the components, and is suitable for treating hyperlipidemia and the like. Wherein, the prunella spike is bitter in taste and cold in nature, enters liver and gallbladder meridians, is the key herb for clearing liver heat, cooling liver and calming liver, and is good at treating headache and dizziness caused by hyperactivity of liver yang, and is used as the monarch drug. Reed rhizome, rhizoma Phragmitis, used as an adjuvant drug, clears excess heat in the lung and stomach qi system, nourishes yin and promotes the production of body fluid. Astragalus root, radix astragali, good at entering spleen and stomach, is the source of the vital phlegm that is produced by the spleen and stomach. The traditional Chinese medicine composition provided by the invention has the characteristics of simple formula, obvious curative effect, high safety and the like, and is beneficial to alleviating symptoms of patients with hyperlipidemia and the like.

Description

Traditional Chinese medicine composition for treating hyperlipidemia, preparation method and application thereof
Technical Field
The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition suitable for treating hyperlipidemia, and a preparation method and application thereof.
Background
Hyperlipidemia is a systemic disease caused by abnormal metabolism or operation of fat, usually refers to the elevated normal level of one or more lipids in the plasma. Hyperlipidemia is a common disease and frequently encountered disease of middle-aged and elderly people, and with the improvement of living standard and the change of dietary habits of people, the incidence rate of the disease is obviously increased, and the onset age is advanced. Hyperlipidemia may be secondary to other diseases such as nephrotic syndrome, hypothyroidism, diabetes; or idiopathic, atherosclerosis caused by hyperlipidemia is the leading cause of coronary heart disease, hypertension and cerebrovascular disease, with about 1200 million people dying from cardiovascular disease and cerebral stroke worldwide each year. Therefore, treatment of hyperlipidemia is very important and has attracted high attention from human beings all over the world.
At present, the clinical treatment or prevention of hyperlipidemia usually adopts drugs to regulate blood fat, and the commonly used hypolipidemic drugs mainly comprise the following classes:
(1) statins: the medicine can inhibit the activity of HMG-CoA reductase which is a rate-limiting enzyme for synthesizing cholesterol by liver, thereby blocking the conversion of HMG-CoA to methyldihydroxyvaleric acid, reducing the synthesis of cholesterol by liver, stimulating the generation of LDL receptor and strengthening the clearance of LDL in plasma.
(2) Bile acid sequestrant: the medicine is not absorbed by digestive tract, and forms coordination compound with bile acid in intestinal tract, and is discharged with feces, so as to block enterohepatic circulation of cholic acid, accelerate decomposition of cholesterol in liver into cholic acid, and combine with resin, thereby reducing cholesterol in blood.
(3) A fibrate: increase the esterase activity of lipoprotein aLp (a), increase the clearance of very low density lipoprotein cholesterol (VLDL-C) and Triacylglycerol (TG), thereby reducing VLDL-C and TG, and also reduce low density lipoprotein cholesterol (LDL-C) and serum Total Cholesterol (TC).
(4) Nicotinic acids: inhibiting lipolysis, preventing formation of free fatty acid, and inhibiting synthesis of TG and secretion of VLDL in liver.
The medicine exerts the drug effect and causes the following adverse reactions after long-term administration: gastrointestinal disorders such as dyspepsia, anorexia, nausea, vomiting, satiety, constipation, upset stomach, etc., and frequent use also have a tendency to increase gallstones, and lead to headache, rash, dizziness, blurred vision, and taste disturbance, etc.
Disclosure of Invention
In view of the above, the application provides a traditional Chinese medicine composition for treating hyperlipidemia, a preparation method and an application thereof, and the traditional Chinese medicine composition provided by the invention has a positive and continuous curative effect on hyperlipidemia and has small side effects.
The invention provides a traditional Chinese medicine composition for treating hyperlipidemia, which is prepared from the following raw materials: prunellae Spica, radix astragali and rhizoma Phragmitis.
Preferably, the traditional Chinese medicine composition is prepared from the following raw materials: 5-25 parts of selfheal, 2-15 parts of astragalus and 5-25 parts of reed rhizome. Further preferably, the traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 12-18 parts of selfheal, 8-12 parts of astragalus membranaceus and 12-18 parts of reed rhizome. Still more preferably, the traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 15 parts of selfheal, 10 parts of astragalus and 15 parts of reed rhizome.
The invention provides a traditional Chinese medicine preparation suitable for treating hyperlipidemia, which comprises the traditional Chinese medicine composition and pharmaceutically acceptable auxiliary materials.
Preferably, the dosage form of the traditional Chinese medicine preparation comprises pills, tablets, granules, capsules or mixture.
The invention provides a preparation method of the traditional Chinese medicine composition, which comprises the following steps:
1) mixing radix astragali and rhizoma Phragmitis, extracting with water, and filtering to obtain first filtrate;
extracting Prunellae Spica with ethanol, and filtering to obtain a second filtrate;
2) concentrating the first filtrate to obtain a first concentrated solution;
concentrating the second filtrate to obtain a second concentrated solution;
3) and combining the first concentrated solution and the second concentrated solution to obtain the traditional Chinese medicine composition.
Wherein, the step 1) specifically comprises:
mixing astragalus and reed rhizome, adding water, decocting and extracting for 2-5 times, each time for 1-3 hours, filtering to obtain a first filtrate, and combining the filtrates obtained by multiple water extractions;
extracting the selfheal with ethanol, wherein the concentration of the ethanol is 50-90%, the extraction times are 2-5 times, each time lasts for 1-3 hours, filtering is carried out to obtain a second filtrate, and multiple filtrates are combined.
The step 2) specifically comprises the following steps:
concentrating the combined extract of the first filtrate obtained in the step 1) until the relative density is 1.08-1.10 at 50 ℃, adding ethanol for mixing, keeping stand, taking the supernatant of alcohol precipitation for concentrating again until the relative density is 1.20-1.40 to obtain a concentrated solution, wherein the ethanol content is 50-80% after mixing;
concentrating the combined extracting solution of the second filtrate obtained in the step 1) until the relative density is 1.20-1.40 at 50 ℃ to obtain a second concentrated solution.
The invention also provides application of the traditional Chinese medicine composition in preparation of a medicine for treating hyperlipidemia.
Compared with the prior art, the invention provides a traditional Chinese medicine composition, which comprises the following components: astragalus root, reed rhizome and selfheal. The invention has the advantages of reducing cholesterol, triglyceride and the like in the blood of a human body by combining the components, and is suitable for treating hyperlipidemia. Wherein, the prunella spike is bitter in taste and cold in nature, enters liver and gallbladder meridians, is the key herb for clearing liver heat, cooling liver and calming liver, and is good at treating headache and dizziness caused by hyperactivity of liver yang, and is used as the monarch drug. Reed rhizome, rhizoma Phragmitis, used as an adjuvant drug, clears excess heat in the lung and stomach qi system, nourishes yin and promotes the production of body fluid. Astragalus root, radix astragali, good at entering spleen and stomach, is the source of the vital phlegm that is produced by the spleen and stomach. The traditional Chinese medicine composition provided by the invention has the characteristics of simple formula, obvious curative effect and high safety, and is beneficial to alleviating symptoms of patients with hyperlipidemia and the like.
Detailed Description
The technical solutions in the embodiments of the present invention are clearly and completely described below, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
The invention provides a traditional Chinese medicine composition suitable for treating hyperlipidemia, which is prepared from the following raw materials, preferably from the following raw materials: prunellae Spica, radix astragali and rhizoma Phragmitis.
The traditional Chinese medicine composition provided by the invention can reduce cholesterol, triglyceride and the like in human blood, and is suitable for treating hyperlipidemia. The traditional Chinese medicine for treating hyperlipidemia has the outstanding and unique characteristics, definite and continuous curative effect and small side effect, which cannot be compared with western medicines.
The invention provides a traditional Chinese medicine composition suitable for treating hyperlipidemia, which can be prepared from three components of selfheal, astragalus root and reed rhizome.
Wherein the Prunella vulgaris is named as club grass, Tie-Cao, big head flower and Prunella vulgaris, and is derived from dried fruit cluster of Prunella vulgaris L of Labiatae; harvesting in summer when the fruit cluster is brownish red, removing impurities, and drying in the sun.
The selfheal is bitter in taste and cold in nature, enters liver and gallbladder meridians, is the essential drug for clearing liver heat, cooling liver and calming liver, and is good at treating headache and dizziness caused by hyperactivity of liver yang; the invention uses the compound as a monarch drug. The bulk drug of the invention preferably comprises 5-25 parts by weight of selfheal, more preferably 12-18 parts by weight, and further preferably 15 parts by weight.
The raw materials (medicines) of the invention comprise astragalus; astragalus root, radix astragali, good at entering spleen and stomach, is the source of the vital phlegm that the spleen and stomach are healthy and transported, and is the ministerial drug. Astragalus membranaceus, also called Astragalus membranaceus or Astragalus membranaceus, is commonly used as the root of Astragalus membranaceus or Astragalus membranaceus, which is a plant of Leguminosae. Radix astragali is mainly produced in inner Mongolia, Shanxi, Heilongjiang and other places of China; collected in spring and autumn, removed several roots of fibrous root, dried in the sun, sliced, unprocessed or stir-baked with honey. The astragalus membranaceus can be divided into: radix astragali Mongolici, radix astragali Sinici, radix astragali Japonici, etc.; the invention has no special limitation on the source, and the medicinal materials commonly used in the field can be adopted.
In the invention, the raw material medicine preferably comprises 2-15 parts by weight of astragalus, more preferably 8-12 parts by weight, and further preferably 10 parts by weight.
In the invention, the bulk drug comprises reed rhizome. Reed rhizome, alias: rhizoma Imperatae, rhizoma Phragmitis, Russula aculeatus, rhizoma Phragmitis, rhizoma anemarrhenae, rhizoma Phragmitis, and sweet stem; is fresh or dried rhizome of Phragmitis communis Trin of Gramineae, which can be harvested all year round, removed bud, fibrous root and membranous leaf, and used fresh or dried in the sun.
The reed rhizome clears excess heat in lung and stomach qi system, nourishes yin and promotes the production of body fluid; the invention uses the compound as an adjuvant drug. The bulk drug of the invention preferably comprises 5-25 parts by weight of reed rhizome, more preferably 12-18 parts by weight, and even more preferably 15 parts by weight.
In some embodiments of the present invention, the traditional Chinese medicine composition for treating hyperlipidemia is composed of the following components or prepared from the following bulk drugs in parts by weight: 5-25 parts of selfheal, 2-15 parts of astragalus and 5-25 parts of reed rhizome. In a preferred embodiment of the invention, the traditional Chinese medicine composition is prepared from the following raw material medicines: 12-18 parts of selfheal, 8-12 parts of astragalus and 12-18 parts of reed rhizome. Specifically, the traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 15 parts of selfheal, 10 parts of astragalus and 15 parts of reed rhizome, and the compatibility of the medicines is optimal.
The Chinese medicinal materials in the formula act synergistically, can reduce cholesterol, triglyceride and the like in human blood, and is suitable for treating hyperlipidemia. The traditional Chinese medicine composition provided by the invention has the characteristics of definite curative effect on hyperlipidemia and small side effect. In addition, the invention has simple preparation and easy popularization and application.
The traditional Chinese medicine composition for treating hyperlipidemia can be added with pharmaceutically acceptable auxiliary materials to prepare preparations such as pills, tablets, granules, capsules or mixtures.
Correspondingly, the invention provides a traditional Chinese medicine preparation suitable for treating hyperlipidemia, which comprises the traditional Chinese medicine composition and pharmaceutically acceptable auxiliary materials.
Wherein, the invention has no special limitation to the auxiliary materials and the like allowed by pharmacy; the traditional Chinese medicine preparation suitable for treating hyperlipidemia can be obtained by adopting conventional auxiliary materials in the field according to corresponding preparation methods of different dosage forms. In the embodiment of the invention, the dosage form of the traditional Chinese medicine preparation can be pills, tablets, granules, capsules or mixtures.
The embodiment of the invention provides a preparation method of the traditional Chinese medicine composition, which comprises the following steps:
1) mixing radix astragali and rhizoma Phragmitis, extracting with water, and filtering to obtain first filtrate;
extracting Prunellae Spica with ethanol, and filtering to obtain a second filtrate;
2) concentrating the first filtrate to obtain a first concentrated solution;
concentrating the second filtrate to obtain a second concentrated solution;
3) combining the first concentrated solution and the second concentrated solution to obtain a traditional Chinese medicine composition; or mixing, and drying to obtain the final product.
According to the raw material formula, the reed rhizome and the astragalus are jointly extracted by water, the selfheal is extracted by alcohol, and the filtrate is obtained by filtering respectively. For the convenience of distinction, the rhizoma phragmitis and astragalus membranaceus extracting solution is called a first filtrate, and the selfheal extracting solution is called a second filtrate.
Specifically, the extraction steps in the embodiment of the present invention include: mixing reed rhizome and astragalus, adding water, decocting and extracting for 2-5 times, 1-3 hours each time, and filtering to obtain a first filtrate. Such filtration is a means of art well known to those skilled in the art; and combining the filtrates obtained by multiple water extractions to obtain a combined extract. Extracting the selfheal with ethanol, wherein the concentration of the ethanol is 50-90%, the extraction times are 2-5 times, each time lasts for 1-3 hours, filtering is carried out to obtain a second filtrate, and multiple filtrates are combined.
According to the embodiment of the invention, the extracting solution obtained by combining the first filtrate is concentrated to obtain the first concentrated solution. Wherein the concentration temperature is preferably 55-80 ℃. The invention preferably has a relative density of 1.08-1.10 when concentrated to 50 ℃; concentrating, mixing with ethanol, standing, and collecting supernatant after ethanol precipitation.
In some embodiments of the present invention, the preparation method preferably further comprises: and mixing the first concentrated solution and ethanol, standing, taking the supernatant of alcohol precipitation, and then concentrating to obtain a concentrated solution. After the astragalus and reed rhizome extracting solutions are concentrated, the obtained concentrated solution is cooled to the room temperature, then mixed with ethanol, kept stand, and the supernatant liquid after alcohol precipitation is taken. Specifically, ethanol can be added into the concentrated extracting solution to ensure that the alcohol content reaches 50-80%, standing is carried out, and the supernatant fluid after alcohol precipitation is taken. Wherein, ethanol with the volume fraction of 95 percent is preferably added to ensure that the alcohol content reaches 50 to 80 percent. The embodiment of the invention can be kept stand for 24 hours to obtain the supernatant of alcohol precipitation.
In some embodiments of the present invention, the preparation method preferably further comprises: and (3) precipitating the supernatant of the astragalus and the reed rhizome by alcohol, and concentrating to obtain a concentrated solution. Wherein the concentration temperature is preferably 55-80 ℃; can be concentrated to a relative density of 1.20 to 1.40 at 50 ℃.
Meanwhile, in the embodiment of the invention, the combined extract of the second filtrate is concentrated to obtain a second concentrated solution. When the concentration is carried out, the concentration temperature is preferably 55-80 ℃; can be concentrated to a relative density of 1.20 to 1.40 at 50 ℃.
After the first concentrated solution and the second concentrated solution are obtained, the two concentrated solutions are combined to obtain a liquid traditional Chinese medicine composition; or mixing and drying to obtain semisolid or solid Chinese medicinal composition. According to the embodiment of the invention, the combined concentrated solution can be dried by using a belt type vacuum dryer, and the temperature of the belt type vacuum dryer is preferably set to be 100, 95 and 80 ℃; the time is preferably 0.5 to 2 hours.
In some embodiments of the invention, the dried solids are ground into a fine powder and sieved through a 80 mesh sieve to obtain the traditional Chinese medicine composition. The traditional Chinese medicine composition can be uniformly mixed with a proper amount of conventional auxiliary materials and granulated to obtain the granules of the traditional Chinese medicine composition. Or mixing with conventional adjuvants, granulating, and tabletting to obtain tablet of Chinese medicinal composition. Or mixing with conventional adjuvants, granulating, and making into capsule. Wherein the conventional adjuvants include starch, dextrin, etc.
In some preferred embodiments of the present invention, the preparation method of the traditional Chinese medicine composition specifically comprises:
1. mixing radix astragali and rhizoma Phragmitis, decocting in water, and filtering to obtain filtrate;
2. concentrating the filtrate obtained in the step 1 to obtain a concentrated solution;
3. mixing the concentrated solution obtained in the step 2 with ethanol, standing, and taking an alcohol precipitation supernatant;
4. concentrating the alcohol precipitation supernatant to obtain a concentrated solution;
5. extracting Prunellae Spica with ethanol, and filtering to obtain filtrate;
6. concentrating the filtrate obtained in the step 5 to obtain a concentrated solution;
7. and (4) combining the concentrated solutions obtained in the steps (4) and (6), and drying to obtain the traditional Chinese medicine composition.
Preferably, the preparation method specifically comprises the following steps:
1. mixing the astragalus and the reed rhizome, adding water, decocting and extracting for 2-5 times, each time for 1-3 hours, filtering to obtain filtrate, and combining the filtrates obtained by multiple water extractions;
2. concentrating the filtrate obtained in the step 1, wherein the concentration temperature is 55-80 ℃, and the relative density of the filtrate is 1.08-1.10 when the filtrate is concentrated to 50 ℃;
3. mixing the concentrated solution obtained in the step 2 with ethanol, standing for 24 hours to obtain an alcohol precipitation supernatant, wherein the alcohol content of the mixed solution is 50-80%;
4. concentrating the supernatant after alcohol precipitation at the concentration temperature of 55-80 ℃ until the relative density is 1.20-1.40 at 50 ℃;
5. extracting the selfheal with ethanol, wherein the concentration of the ethanol is 50-90%, the extraction times are 2-5 times, each time lasts for 1-3 hours, filtering to obtain filtrate, and combining the multiple filtrates;
6. concentrating the filtrate obtained in the step (5), wherein the concentration temperature is 55-80 ℃, and the relative density is 1.20-1.40 when the filtrate is concentrated to 50 ℃;
7. and (4) combining the concentrated solutions obtained in the steps (4) and (6), and drying to obtain the traditional Chinese medicine composition.
In addition, the invention also provides application of the traditional Chinese medicine composition in preparing a medicine for treating hyperlipidemia.
The traditional Chinese medicine composition can reduce cholesterol, triglyceride and the like in human blood, can be added with pharmaceutically acceptable auxiliary materials to prepare preparations such as pills, tablets, granules, capsules or mixtures and the like, and is suitable for treating hyperlipidemia and the like. The traditional Chinese medicine is simple to prepare, has obvious curative effects on hyperlipidemia and the like, is superior to the prior art, has no toxic or side effect and high safety, and is beneficial to alleviating symptoms of patients.
For further understanding of the present application, the following embodiments are provided to specifically describe the Chinese medicinal composition for treating hyperlipidemia, its preparation method and application.
Example 1 granules
Adding water 10 times the volume of 1500g of rhizoma Phragmitis and 1000g of radix astragali, extracting for 2 times, each time for 2 hr, mixing extractive solutions, filtering, and concentrating the filtrate to obtain extract with relative density of 1.10(50 deg.C); precipitating the extract with ethanol to obtain 70% ethanol, standing for 24 hr, collecting supernatant, and concentrating under reduced pressure to obtain extract with relative density of 1.30(50 deg.C).
Adding 10 times volume of 70% ethanol into 1500g Prunellae Spica, heating and reflux-extracting for 2 times, each time for 2 hr, mixing extractive solutions, filtering, recovering ethanol, and concentrating to obtain extract with relative density of 1.30(50 deg.C).
Mixing the ethanol extract and water extract to obtain mixed extract, and vacuum drying at 100, 95, and 80 deg.C; the time is 0.5 to 2 hours; and (3) crushing by using a 80-mesh sieve, adding 300-500 g of dextrin into the mixed extract powder, uniformly mixing, and preparing 1000g of granules.
EXAMPLE 2 tablets
Adding 10 times of water into 500g of reed rhizome and 2000g of astragalus, extracting for 2 times, 2 hours each time, combining extracting solutions, filtering, and concentrating the filtrate into an extract with the relative density of 1.10(50 ℃); precipitating the extract with ethanol to obtain 70% ethanol, standing for 24 hr, collecting supernatant, and concentrating under reduced pressure to obtain extract with relative density of 1.30(50 deg.C).
Adding 10 times of 70% ethanol into 600g Prunellae Spica, heating and reflux-extracting for 2 times, each for 2 hr, mixing extractive solutions, filtering, recovering ethanol, and concentrating to obtain extract with relative density of 1.30(50 deg.C).
Mixing the ethanol extract and water extract to obtain mixed extract, and vacuum drying at 100, 95, and 80 deg.C; the time is 0.5 to 2 hours; and (2) crushing by using a 80-mesh sieve, adding 150-250 g of dextrin into the mixed extract powder, uniformly mixing, granulating, tabletting, coating and preparing into 1000 tablets.
EXAMPLE 3 capsules
Adding 10 times of water into 600g of reed rhizome and 1000g of astragalus, extracting for 2 times, 2 hours each time, combining extracting solutions, filtering, and concentrating the filtrate into an extract with the relative density of 1.10(50 ℃); precipitating the extract with ethanol to obtain 70% ethanol, standing for 24 hr, collecting supernatant, and concentrating under reduced pressure to obtain extract with relative density of 1.30(50 deg.C).
Adding 10 times of 70% ethanol into 2500g Prunellae Spica, heating and reflux-extracting for 2 times, each time for 2 hr, mixing extractive solutions, filtering, recovering ethanol, and concentrating to obtain extract with relative density of 1.30(50 deg.C).
Mixing the ethanol extract and water extract to obtain mixed extract, and vacuum drying at 100, 95, and 80 deg.C; the time is 0.5 to 2 hours; and (3) crushing by using a 80-mesh sieve, adding 150-250 g of dextrin into the mixed extract powder, uniformly mixing, granulating, subpackaging and preparing into 1000 capsules.
EXAMPLE 4 pellets
Adding 10 times of water into 600g of reed rhizome and 200g of astragalus, extracting for 2 times, 2 hours each time, combining extracting solutions, filtering, and concentrating the filtrate into an extract with the relative density of 1.10(50 ℃); precipitating the extract with ethanol to obtain 70% ethanol, standing for 24 hr, collecting supernatant, and concentrating under reduced pressure to obtain extract with relative density of 1.30(50 deg.C).
Adding 10 times of 70% ethanol into 1000g Prunellae Spica, heating and reflux-extracting for 2 times, each for 2 hr, mixing extractive solutions, filtering, recovering ethanol, and concentrating to obtain extract with relative density of 1.30(50 deg.C).
Mixing the ethanol extract and water extract to obtain mixed extract, and vacuum drying at 100, 95, and 80 deg.C; the time is 0.5 to 2 hours; and (3) crushing by using a 80-mesh sieve, adding a proper amount of dextrin into the mixed extract powder, uniformly mixing, and making into pills, wherein 1000 pills are prepared.
Example 5 preparation
Adding 10 times of water into 2000g of reed rhizome and 300g of astragalus, extracting for 2 times, 2 hours each time, combining extracting solutions, filtering, and concentrating the filtrate into an extract with the relative density of 1.10(50 ℃); precipitating the extract with ethanol to obtain 70% ethanol, standing for 24 hr, collecting supernatant, and concentrating under reduced pressure to obtain extract with relative density of 1.30(50 deg.C).
Adding 10 times of 70% ethanol into 1000g Prunellae Spica, heating and reflux-extracting for 2 times, each for 2 hr, mixing extractive solutions, filtering, recovering ethanol, and concentrating to obtain extract with relative density of 1.30(50 deg.C).
Mixing the ethanol extract and water extract to obtain mixed extract, adding 100g syrup into the mixed extract, adding water to 10000mL, boiling, cooling, refrigerating, filtering, centrifuging, adding water to 10000mL, mixing, packaging, and making into 1000 oral liquids.
Example 6 Experimental part for drug efficacy
Prevention effect on rat hyperlipidemia
1. Preparation of test drug
(1) The composition of the invention: the alcohol and water extraction mixed extract prepared in the embodiments 1 to 5.
(2) The preparation method of the disassembled extract comprises the steps of weighing 1500g of reed rhizome in ①, adding 10 times of water for 2 times, each time for 2 hours, concentrating the combined extract at 75 ℃ to obtain a concentrated solution (the relative density at 50 ℃ is 1.30), weighing 1000g of astragalus root in ②, adding 10 times of water for 2 times, each time for 2 hours, concentrating the combined extract at 75 ℃ to obtain a concentrated solution (the relative density at 50 ℃ is 1.30), weighing 1500g of selfheal in ③, adding 10 times of 70% ethanol for 2 times, each time for 2 hours, concentrating the combined extract at 70 ℃ to obtain a concentrated solution (the relative density at 50 ℃ is 1.30), weighing 1500 times of reed rhizome in ④, weighing 1000 times of astragalus root in 1000g, adding 10 times of water for 2 times, each time for 2 hours, concentrating the combined extract at 75 ℃ to obtain a concentrated solution (the relative density at 50 ℃ is 1.30), adding 10 times of water for 2 hours, concentrating the combined extract for 2 hours to obtain a concentrated solution (the relative density at 50 ℃ to obtain a combined concentrated solution, adding 10 times of ethanol for 2 hours, concentrating the concentrated solution at 75 ℃ to obtain a combined concentrated solution, concentrating the concentrated solution at 50 ℃ to obtain a combined concentrate at 70 ℃, adding 10 times of ethanol for 2 hours, concentrating the concentrated solution at 1.30, concentrating the concentration at 50 ℃ to obtain a combined concentrate for 1.30, concentrating the concentrated solution at 75 ℃, adding 10 times, concentrating the concentrated solution at 50 ℃ to obtain a combined concentrate for 10 hours, concentrating the concentrated solution at 1.30, and concentrating the concentration of 10 times, and concentrating the concentrated solution at 50 ℃ to obtain a combined concentrate for 2 hours, and concentrating the concentrated solution at 1.30 hours, and concentrating the concentrated solution at 75 ℃, adding 10 times of the concentrated solution after concentrating the concentration of the concentration at 50 ℃ to obtain a combined concentrate at.
(3) Xuezhikang, Biotech company, Beijing, Daweixin, lot number: 20150607.
2. reagent
Total Cholesterol (TC), beijing beihua kangtai clinical reagent limited, batch number: 20140503.
triglyceride (TG), beijing beihua kangtai clinical reagent limited, lot no: 20140201.
high density lipoprotein cholesterol (HDL-C), beijing beihua kangtai clinical reagent limited, lot no: 20140301.
sodium cholate, shanghai aizite biotechnology limited, lot number: CHN 15004003.
Propylthiouracil, Shenzhen Zhongzhi pharmaceutical Co., Ltd, lot number: 20150208.
3. animal(s) production
The clean grade SD rat, male, 200-230 g, SFP grade, provided by Yangzhou university comparison medicine center (production permit: SCXK (Su) 2007-0001).
4. Method and results
100 male SD rats with the weight of 200-230 g are taken, and are randomly divided into 10 groups after being adapted to new feeding for 3 days, a blank control group (10 mL/kg of solvent), a model control group (10 mL/kg of solvent), a blood fat recovery group (0.2g/kg), a composition group (3g crude drug/kg), a single-herb extract group (3g crude drug/kg) and a pairwise combined extract group (3g crude drug/kg). Each group was administered by gavage 1 time a day for 2 weeks. Except for the blank control group fed with the ordinary feed, all the other groups were fed with high-fat feed (88.5% of basic mouse feed, 1% of cholesterol, 10% of lard, 0.3% of sodium cholate, 0.2% of propylthiouracil, the mass fractions above). After 2 weeks, rats were subjected to orbital bleeding after fasting for 8 hours before administration, and serum Total Cholesterol (TC), Triglyceride (TG), high density lipoprotein cholesterol (HDL-C), and low density lipoprotein cholesterol (LDL-C) were measured, and the results of the experiment are shown in Table 1.
TABLE 1 preventive effect of the composition of the present invention on hyperlipidemia in rats: (
Figure BDA0001338383060000101
±s,n=5)
Figure BDA0001338383060000102
Figure BDA0001338383060000111
Note: compared with the blank control group, the composition of the composition,ΔP<0.05,ΔΔP<0.01; in comparison to the set of models,*P<0.05,**P<0.01。
as can be seen from Table 1, the serum TC, TG and LDL-C of the model group raised by high fat are obviously increased compared with the blank control group rats (P < 0.01). Under the same feeding condition, the composition can reduce the levels of TC, TG and LDL-C in the serum of rats; the composition of the invention can prevent rat hyperlipidemia.
Second, regulation of rabbit blood lipids
1. Test drug
(1) The composition of the invention: the alcohol and water extraction mixed extract prepared in the embodiments 1 to 5.
(2) The preparation method of the disassembled extract comprises the steps of weighing 1500g of reed rhizome in ①, adding 10 times of water for 2 times, each time for 2 hours, concentrating the combined extract at 75 ℃ to obtain a concentrated solution (the relative density at 50 ℃ is 1.30), weighing 1000g of astragalus root in ②, adding 10 times of water for 2 times, each time for 2 hours, concentrating the combined extract at 75 ℃ to obtain a concentrated solution (the relative density at 50 ℃ is 1.30), weighing 1500g of selfheal in ③, adding 10 times of 70% ethanol for 2 times, each time for 2 hours, concentrating the combined extract at 70 ℃ to obtain a concentrated solution (the relative density at 50 ℃ is 1.30), weighing 1500 times of reed rhizome in ④, weighing 1000 times of astragalus root in 1000g, adding 10 times of water for 2 times, each time for 2 hours, concentrating the combined extract at 75 ℃ to obtain a concentrated solution (the relative density at 50 ℃ is 1.30), adding 10 times of water for 2 hours, concentrating the combined extract for 2 hours to obtain a concentrated solution (the relative density at 50 ℃ to obtain a combined concentrated solution, adding 10 times of ethanol for 2 hours, concentrating the concentrated solution at 75 ℃ to obtain a combined concentrated solution, concentrating the concentrated solution at 50 ℃ to obtain a combined concentrate at 70 ℃, adding 10 times of ethanol for 2 hours, concentrating the concentrated solution at 1.30, concentrating the concentration at 50 ℃ to obtain a combined concentrate for 1.30, concentrating the concentrated solution at 75 ℃, adding 10 times, concentrating the concentrated solution at 50 ℃ to obtain a combined concentrate for 10 hours, concentrating the concentrated solution at 1.30, and concentrating the concentration of 10 times, and concentrating the concentrated solution at 50 ℃ to obtain a combined concentrate for 2 hours, and concentrating the concentrated solution at 1.30 hours, and concentrating the concentrated solution at 75 ℃, adding 10 times of the concentrated solution after concentrating the concentration of the concentration at 50 ℃ to obtain a combined concentrate at.
(3) Xuezhikang, Biotech company, Beijing, Daweixin, lot number: 20150607.
2. reagent
Total Cholesterol (TC), beijing beihua kangtai clinical reagent limited, batch number: 20140503.
triglyceride (TG), beijing beihua kangtai clinical reagent limited, lot no: 20140201.
high density lipoprotein cholesterol (HDL-C), beijing beihua kangtai clinical reagent limited, lot no: 20140301.
sodium cholate, shanghai aizite biotechnology limited, lot number: CHN 15004003.
Propylthiouracil, Shenzhen Zhongzhi pharmaceutical Co., Ltd, lot number: 20150208.
3. animal(s) production
New Zealand rabbits, male rabbits, weight 2.2-2.5 kg, SFP level, are provided by animal breeding farms of Shanqing Longshan in Jiangning county.
4. Method and results
60 male New Zealand rabbits are taken, the weight of the male New Zealand rabbits is 2.2-2.5 kg, 5 male New Zealand rabbits are randomly taken as blank controls, and the male New Zealand rabbits are fed with a common feed. Another 55 rabbits were fed with high fat feed for 3 weeks, fasted (without water) for 12h at the end of 3 weeks, followed by blood sampling at orbit, and serum Total Cholesterol (TC), Triglyceride (TG), high density lipoprotein cholesterol (HDL-C), and low density lipoprotein cholesterol (LDL-C) were measured. The rabbits which are successfully molded are selected and evenly divided into 9 groups, namely a model control group (solvent 5mL/kg), a blood fat recovery group (0.12g/kg), a single-herb extract group (4g crude drug/kg), a pairwise combined extract group (4g crude drug/kg) and a mixed extract group (4g crude drug/kg) of the composition. Each group was administered by gavage 1 time a day for 2 weeks. Orbital bleeds were performed 12h before 2 weeks of administration, and serum Total Cholesterol (TC), Triglyceride (TG), high density lipoprotein cholesterol (HDL-C), and low density lipoprotein cholesterol (LDL-C) were measured, and the results of the experiments are shown in Table 2.
TABLE 2 Regulation of rabbit blood lipids by compositions of the invention: (
Figure BDA0001338383060000121
±s,n=5)
Figure BDA0001338383060000122
Figure BDA0001338383060000131
Note: compared with the blank control group, the composition of the composition,ΔP<0.05,ΔΔP<0.01; in comparison to the set of models,*P<0.05,**P<0.01。
as can be seen from Table 2, the serum TC, TG and LDL-C of the model group are obviously increased (P is less than 0.01) compared with the serum TC, TG, LDL-C and TC/LDL-C of the rabbit of the blank control group, and the values of TC, TG, LDL-C and TC/LDL-C in the serum of the rabbit can be obviously reduced after the composition group is administrated, and the difference is obvious (P is less than 0.05 and 0.01) compared with the model group; the composition of the invention can regulate the blood fat level of high-fat rabbits.
The above description of the embodiments is only intended to facilitate the understanding of the method of the invention and its core idea. It should be noted that, for those skilled in the art, it is possible to make various improvements and modifications to the present invention without departing from the principle of the present invention, and those improvements and modifications also fall within the scope of the claims of the present invention.
The previous description of the disclosed embodiments is provided to enable any person skilled in the art to make or use the present invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other embodiments without departing from the spirit or scope of the invention. Thus, the present invention is not intended to be limited to the embodiments shown herein but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.

Claims (9)

1. The traditional Chinese medicine composition for treating hyperlipidemia is characterized by being prepared from the following raw materials in parts by weight: 5-25 parts of selfheal, 2-20 parts of astragalus and 5-25 parts of reed rhizome.
2. The traditional Chinese medicine composition according to claim 1, which is prepared from the following raw materials in parts by weight: 12-18 parts of selfheal, 8-12 parts of astragalus and 12-18 parts of reed rhizome.
3. The traditional Chinese medicine composition according to claim 2, which is prepared from the following raw materials in parts by weight: 15 parts of selfheal, 10 parts of astragalus and 15 parts of reed rhizome.
4. A traditional Chinese medicine preparation suitable for treating hyperlipidemia, which is characterized by comprising the traditional Chinese medicine composition of any one of claims 1-3 and pharmaceutically acceptable auxiliary materials.
5. The Chinese medicinal preparation as claimed in claim 4, wherein the Chinese medicinal preparation is in the form of pill, tablet, granule, capsule or mixture.
6. A method for preparing the Chinese medicinal composition of any one of claims 1 to 3, comprising the steps of:
1) mixing radix astragali and rhizoma Phragmitis, extracting with water, and filtering to obtain first filtrate;
extracting Prunellae Spica with ethanol, and filtering to obtain a second filtrate;
2) concentrating the first filtrate to obtain a first concentrated solution;
concentrating the second filtrate to obtain a second concentrated solution;
3) and combining the first concentrated solution and the second concentrated solution to obtain the traditional Chinese medicine composition.
7. The preparation method according to claim 6, wherein the step 1) specifically comprises:
mixing astragalus and reed rhizome, adding water, decocting and extracting for 2-5 times, each time for 1-3 hours, filtering to obtain a first filtrate, and combining the filtrates obtained by multiple water extractions;
extracting the selfheal with ethanol, wherein the concentration of the ethanol is 50-90%, the extraction times are 2-5 times, each time lasts for 1-3 hours, filtering is carried out to obtain a second filtrate, and multiple filtrates are combined.
8. The preparation method according to claim 7, wherein the step 2) specifically comprises:
concentrating the combined extract of the first filtrate obtained in the step 1) until the relative density is 1.08-1.10 at 50 ℃, adding ethanol for mixing, keeping stand, taking the supernatant of alcohol precipitation for concentrating again until the relative density is 1.20-1.40 to obtain a concentrated solution, wherein the ethanol content is 50-80% after mixing;
concentrating the combined extracting solution of the second filtrate obtained in the step 1) until the relative density is 1.20-1.40 at 50 ℃ to obtain a second concentrated solution.
9. The use of the Chinese medicinal composition of any one of claims 1-3 in the preparation of a medicament for the treatment of hyperlipidemia.
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