CN107854656B - Lipid-lowering traditional Chinese medicine composition and preparation method and application thereof - Google Patents
Lipid-lowering traditional Chinese medicine composition and preparation method and application thereof Download PDFInfo
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
- A61K36/539—Scutellaria (skullcap)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/70—Polygonaceae (Buckwheat family), e.g. spineflower or dock
- A61K36/704—Polygonum, e.g. knotweed
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/896—Liliaceae (Lily family), e.g. daylily, plantain lily, Hyacinth or narcissus
- A61K36/8969—Polygonatum (Solomon's seal)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/906—Zingiberaceae (Ginger family)
- A61K36/9066—Curcuma, e.g. common turmeric, East Indian arrowroot or mango ginger
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
Abstract
The invention discloses a lipid-lowering traditional Chinese medicine composition, which comprises the following main active ingredients in parts by weight: 2-9 parts of fried scutellaria baicalensis, 2-12 parts of raw cattail pollen, 2-15 parts of rhizoma polygonati, 2-9 parts of polygonum cuspidatum, 2-12 parts of radix curcumae and 2-15 parts of caper fruit. The invention also discloses application of the composition in preparing lipid-lowering medicines. The invention also provides a pharmaceutical preparation which comprises the composition and preparation auxiliary materials. The composition has remarkable lipid-lowering effect, has more obvious effect than that of each single medicine, and has synergistic effect.
Description
Technical Field
The invention relates to the field of traditional Chinese medicines, in particular to a traditional Chinese medicine composition for reducing blood fat, a preparation method of the composition and application of the composition in the fields of foods, health-care products or traditional Chinese medicines.
Background
Dyslipidemia is usually referred to as elevated plasma Triglycerides (TG) and/or Total Cholesterol (TC), commonly known as hyperlipidemia. Hyperlipidemia in fact also refers broadly to various dyslipidemia including Low Density Lipoprotein (LDL) blood. Although the prevalence rate of blood lipid level and dyslipidemia of Chinese population is lower than that of most western countries, the average serum TC level of the population is gradually increased along with the development of social economy, the improvement of the living standard of people and the change of life style. Meanwhile, diabetes and metabolic syndrome closely related to dyslipidemia are also very common in China. A2010 national survey shows that the prevalence rate of TC & gt 6.22mmol/L is 3.4 percent and 3.2 percent respectively for men and women over 18 years old, and the prevalence rate of TG & gt 2.26mmol/L is 13.8 percent and 8.6 percent respectively for men and women. In 12040 dyslipidemia patients investigated nationwide in 2013, 50% had hypertension, 37.5% had coronary heart disease, and more than 30% had peripheral artery disease. 39% of patients receive lipid-lowering therapy, most of them with statins, with a serum low-density lipoprotein cholesterol (LDL-C) achievement rate of only 25.8%, women and people with increased body mass index (body mass index ≥ 30 kg/m)2) The standard reaching rate is lower and is respectively 22.2 percent and 17.4 percent. The cardiovascular risk is stratified intoThe standard reaching rates of high-risk and extremely-high-risk people are only 19.9 percent and 21.1 percent respectively. Therefore, the medicine focuses on coronary heart disease and stroke for preventing and treating dyslipidemia, and has important public health significance in people in China.
Although there is no name of abnormal blood fat in TCM, there are some records similar to this disease in past medical books. According to the characteristics of dyslipidemia, which is mainly manifested as symptoms such as heavy limbs, dizziness and the like, modern doctors can treat diseases belonging to the categories such as "phlegm syndrome", "damp obstruction", "obstruction of qi in the chest" and "vertigo". The traditional Chinese medicine considers that the cause of the disease is that excessive food intake or abnormal transfusions, utilization and excretion can cause lipid in blood to accumulate, and the excessive lipid is transformed into damp turbidity and turbid phlegm which invades the pulse channel, so that the qi and blood circulation is disturbed, the function of viscera is disordered, and the disease is caused. The pathogenesis of the disease is the syndrome of deficient origin with marked excess, the deficient origin mainly refers to the deficiency and loss of viscera and dysfunction, and the marked excess mainly refers to turbid phlegm, blood stasis and obstructed pulse channels. Brain blood stasis can cause headache, vertigo, and even dementia due to apoplexy; obstruction of heart vessels is manifested as obstruction of qi in the chest and heart pain; liver blood stasis can be manifested as hypochondriac pain and distension and fullness; the stagnant kidney vessel refers to yang deficiency, damp turbidity and blood stasis; stagnant blood in the extremities and pulse causes paralysis, weakness, numbness and numbness.
The existing medicines for reducing blood fat comprise statins, mainly reducing Total Cholesterol (TC) and low-density lipoprotein cholesterol (LDL-C), and also have the effects of reducing glycerol Triacetate (TG) and increasing high-density lipoprotein cholesterol (HDL-C); the fibrates mainly reduce triglyceride, and have the effects of reducing total cholesterol and LDL-C and increasing HDL-C; bile acid sequestrants, which primarily lower total cholesterol and LDL-C. Although reinforced statins can effectively reduce LDL-C levels, some patients still do not reach normal levels even though large doses of statins are used, and some patients are limited because the patients cannot tolerate liver damage and myolysis of statins, so that the research on novel lipid-lowering drugs is particularly important for patients who have poor lipid-lowering effects and intolerance of statins.
The inventor of the present invention has abundant research experience in the field of traditional Chinese medicine, expects to research a traditional Chinese medicine composition which has significant curative effect on hyperlipemia and/or atherosclerosis diseases and small toxic and side effects based on the theory of traditional Chinese medicine, and can be used for treating the diseases.
Disclosure of Invention
One of the technical problems to be solved by the present invention is to provide a traditional Chinese medicine composition with lipid-lowering effect.
The second technical problem to be solved by the invention is to provide the application of the composition in preparing lipid-lowering medicines.
The invention also provides a preparation method of the composition.
The fourth technical problem to be solved by the invention is a pharmaceutical preparation of the composition.
Through years of research, the invention researches a lipid-lowering traditional Chinese medicine composition which is used as an organic whole, has better curative effect than single medicine and has synergistic effect.
In order to solve one of the technical problems, the invention provides a lipid-lowering traditional Chinese medicine composition, which comprises the following raw material medicines in parts by weight as main active ingredients: 2-9 parts of fried scutellaria baicalensis, 2-12 parts of raw cattail pollen, 2-15 parts of rhizoma polygonati, 2-9 parts of polygonum cuspidatum, 2-12 parts of radix curcumae and 2-15 parts of caper fruit.
Specifically, the lipid-lowering traditional Chinese medicine composition mainly comprises the following raw material medicines in parts by weight: 2-9 parts of fried scutellaria baicalensis, 2-12 parts of raw cattail pollen, 2-15 parts of rhizoma polygonati, 2-9 parts of polygonum cuspidatum, 2-12 parts of radix curcumae and 2-15 parts of caper fruit.
The invention is based on the traditional Chinese medicine theory of dyslipidemia, and the traditional Chinese medicine considers that dyslipidemia belongs to the symptoms of deficiency and excess of origin, wherein the deficiency of origin mainly refers to the deficiency and the loss of viscera and dysfunction, and the excess of origin mainly refers to turbid phlegm, blood stasis and incapability of pulse channel. In the lipid-lowering traditional Chinese medicine composition, the fried scutellaria baicalensis has the effects of clearing heat, eliminating dampness and phlegm, and the cattail pollen has the effects of activating blood and dissolving stasis, the two medicines are monarch medicines and have the effects of resisting phlegm and blood stasis, the polygonatum sibiricum has the effects of tonifying spleen and qi, nourishing kidney and replenishing essence so as to tonify deficiency of internal organs, the polygonum cuspidatum has the effects of dispelling wind and removing dampness, the caper fruit has the effects of dispelling wind and removing dampness, the three medicines are ministerial medicines, the deficiency of internal organs and the pathogenic factors of phlegm and dampness are tonified, and the curcuma aromati.
Specifically, as a preferred technical scheme of the invention, the weight ratio of the raw material medicines is as follows:
4.5 to 9 parts of fried scutellaria baicalensis, 6 to 12 grams of raw cattail pollen, 7.5 to 15 parts of rhizoma polygonati, 4.5 to 9 parts of giant knotweed rhizome, 6 to 12 parts of curcuma aromatica and 7.5 to 15 parts of caper fruit.
Specifically, as a preferred technical scheme of the invention, the weight ratio of the raw material medicines is as follows:
9 parts of fried scutellaria baicalensis, 12 parts of raw cattail pollen, 15 parts of rhizoma polygonati, 9 parts of polygonum cuspidatum, 12 parts of radix curcumae and 15 parts of caper fruit.
In the above composition, the weight of each raw material drug is calculated by crude drug, as known to those skilled in the art, the above composition is taken as the proportion by weight, and can be increased or decreased according to the corresponding proportion in actual production, but the proportion of the weight proportion of each single raw material drug is not changed.
In order to solve the second technical problem, the invention also provides application of the traditional Chinese medicine composition in preparing lipid-lowering medicines.
The experimental results prove that compared with the single medicines, JZF group of the traditional Chinese medicine composition has obvious effect compared with the single medicines, and the effect of reducing blood fat is increased compared with the effect of using the single medicines, namely the traditional Chinese medicine composition has synergistic effect, and the results are shown in table 1. The traditional Chinese medicine composition has the effect of reducing blood fat in different proportions, and the results are shown in table 2. In addition, the traditional Chinese medicine composition has good dose-effect relationship in lipid lowering effect. Clinical researches show that the traditional Chinese medicine composition has obvious advantages in reducing the LDL-C formula level compared with a simvastatin group. The experiment results prove that the traditional Chinese medicine composition has the effect of reducing blood fat and has definite curative effect.
In order to solve the third technical problem, the invention also provides a medicinal preparation of the traditional Chinese medicine composition, which comprises the important composition and preparation auxiliary materials.
The agent may be in any pharmaceutically acceptable dosage form, including but not limited to: tablets, sugar-coated tablets, film-coated tablets, enteric-coated tablets, capsules, hard capsules, soft capsules, oral liquids, buccal agents, granules, pills, powders, ointments, pellets, suspensions, powders, solutions, injections, suppositories, ointments, plasters, creams, sprays, drops, patches; oral dosage forms are preferably used, including but not limited to: capsule, tablet, oral liquid, granule, pill, powder, pellet, and unguent. The oral preparation may contain conventional formulation adjuvants including excipients such as binders, fillers, diluents, tabletting agents, lubricants, disintegrants, colorants, flavoring agents and wetting agents, and the tablets may be coated if necessary. Among the suitable fillers are cellulose, mannitol, lactose and other similar fillers; suitable disintegrants include starch, polyvinylpyrrolidone and starch derivatives, such as sodium starch glycolate; suitable lubricants include, for example, magnesium stearate. Suitable wetting agents include sodium lauryl sulfate and the like.
In order to solve the fourth technical problem, the invention also provides a preparation method of the traditional Chinese medicine composition. The traditional Chinese medicine composition can be directly prepared into various traditional Chinese medicine oral administration conventional medicaments according to the conventional method in the field or prepared by extraction and processing. The extraction process may be carried out by solvent extraction, steam distillation, sublimation, supercritical extraction, etc. Such as: respectively pulverizing and mixing the raw materials, making into powder mixture, and making into honeyed pill by conventional method in the field; or decocting the raw materials in water for 2 times, boiling for 1 hr, adding 10 times of water for the first time and 8 times of water for the second time, filtering with 10 layers of gauze, mixing the filtrates, concentrating to obtain extract with specific gravity of 1.35, adding appropriate amount of dextrin and sugar powder, drying at 70 deg.C, and making into granule; or decocting the raw materials with appropriate amount of water for 2 times, timing from boiling, each time for 1 hr, and mixing the decoctions; or decocting the raw materials in water for 2 times, boiling for 1 hr, adding 10 times of water for the first time, adding 8 times of water for the second time, filtering with 10 layers of gauze, concentrating the filtrate to obtain dry extract, and making into tablet by conventional method; or reflux-extracting each raw material with 70% ethanol for 2 times, boiling for 1 hr each time, adding 6 times of ethanol for the first time and 4 times of ethanol for the second time, mixing the decoctions, filtering, concentrating under reduced pressure until no ethanol is present, spray-drying to obtain dry extract powder, and making into capsule by conventional method.
The experimental animal and clinical trial prove that the traditional Chinese medicine composition has good safety and good curative effect, and can effectively treat the lipid-lowering effect. The composition is a traditional Chinese medicine composition with good clinical improvement effect, small toxic and side effect and good clinical application prospect.
Detailed Description
The technical solutions of the present invention will be described clearly and completely below, and it should be apparent that the described embodiments are some, but not all, embodiments of the present invention. All other embodiments, which can be obtained by a person skilled in the art without any inventive step based on the embodiments of the present invention, are within the scope of the present invention.
The experimental procedures, in which specific conditions are not noted in the following examples, are generally carried out according to conventional conditions or according to conditions recommended by the manufacturers. All percentages, ratios, proportions, or parts are by weight unless otherwise specified. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. In addition, any methods and materials similar or equivalent to those described herein can be used in the methods of the present invention. The preferred embodiments and materials described herein are intended to be exemplary only.
Example 1: honeyed pill
The raw material medicaments are taken according to the following weight ratio: 2 g of fried scutellaria baicalensis, 2 g of raw cattail pollen, 2 g of sealwort, 2 g of giant knotweed, 2 g of curcuma aromatica and 2 g of caper fruit.
The seven raw material medicines are respectively crushed and mixed to prepare a powdery mixture, and then the powdery mixture is prepared into honeyed pills according to the conventional method in the field, wherein each honeyed pill is 3g, and the honeyed pill is orally taken 2 times a day and 2 pills each time.
Example 2: granules
The raw material medicaments are taken according to the following weight ratio: 4 g of fried scutellaria baicalensis, 6 g of raw cattail pollen, 7 g of sealwort, 4 g of giant knotweed, 4 g of curcuma aromatica and 7 g of caper fruit.
Decocting the seven raw materials in water for 2 times, wherein the boiling time is 1 hour each time, 10 times of water is added for the first time, 8 times of water is added for the second time, after the decoction is finished, 10 layers of gauze are filtered, the two filtrates are combined, the concentrated extract is obtained until the specific gravity is 1.35, a proper amount of dextrin and sugar powder are added, the extract is dried at 70 ℃, and then granules are prepared, so that the granule is obtained, and the granule is bagged, 10g of the granule is taken orally for 3 times a day, and 1 bag is taken each time.
Example 3: decoction preparation
The raw material medicaments are taken according to the following weight ratio: 9 g of fried scutellaria baicalensis, 12 g of raw cattail pollen, 15 g of sealwort, 9 g of giant knotweed, 12 g of curcuma aromatica and 15 g of caper fruit.
The seven raw material medicines are added with proper amount of water and decocted for 2 times, the boiling time is counted, each time lasts for 1 hour, after the decoction is finished, the two decoction liquids are combined, and the taking method is as follows: is administered twice a day.
Example 4: tablet formulation
The raw material medicaments are taken according to the following weight ratio: 18 g of fried scutellaria baicalensis, 24 g of raw cattail pollen, 30 g of sealwort, 18 g of giant knotweed, 24 g of curcuma aromatica and 30 g of caper fruit.
Decocting the seven raw materials in water for 2 times, wherein 10 times of water is added for the first time and 8 times of water is added for the second time from boiling timing, 1 hour each time, after the decoction is finished, filtering by 10 layers of gauze, concentrating the filtrate to dry extract, and preparing into tablets according to the conventional method in the field, wherein each tablet is 0.5 g, and the oral administration is carried out 3 times a day, and 3 tablets each time.
Example 5: capsule preparation
The raw material medicaments are taken according to the following weight ratio: 36 g of fried scutellaria baicalensis, 48 g of raw cattail pollen, 60 g of sealwort, 36 g of giant knotweed, 48 g of curcuma aromatica and 60 g of caper fruit.
Extracting with 70% ethanol under reflux for 2 times, boiling for 1 hr each time, adding 6 times of ethanol for the first time, adding 4 times of ethanol for the second time, mixing decoctions, filtering, concentrating under reduced pressure until no ethanol is present, spray drying to obtain dry extract powder, and making into capsule by conventional method in the art, wherein each capsule is 0.5 g, and is orally administered 3 times a day, 3 capsules each time.
Example 6: the invention relates to a comparative study on the effects of the traditional Chinese medicine composition and each single medicine for reducing blood fat
The raw material medicaments are taken according to the weight ratio of the embodiment 3, a proper amount of water is added for decocting for 2 times, 1 hour each time when the boiling is timed, after the decoction is finished, the filtration is carried out, the two filtrates are combined, the reduced pressure concentration is carried out, and the freeze-dried powder is freeze-dried to obtain the composition freeze-dried powder (JZF) for standby. The other single medicines are taken according to the corresponding amount in the composition, and the preparation method of the mixture is the same, and the mixture is decocted and concentrated to prepare freeze-dried powder, and the fried scutellaria baicalensis freeze-dried powder (CHQ), the raw cattail pollen freeze-dried powder (SPH), the polygonatum sibiricum freeze-dried powder (HJ), the polygonum cuspidatum freeze-dried powder (HZ), the curcuma aromatica freeze-dried powder (YJ) and the caper fruit freeze-dried powder (CSG) are respectively.
120 mice are randomly grouped into 12 mice in each group, simvastatin is used as a positive drug, each test solution is respectively subjected to intragastric administration, the administration is carried out according to the dosage of table 1, the administration lasts for 5 days, after the administration lasts for 2 hours on the 4 th day, except for the normal control group, normal saline (0.5 ml/mouse) is injected into the abdominal cavity, 75% egg yolk emulsion is injected into the abdominal cavity uniformly and repeatedly in each group, the fasting lasts for 12 hours, water is not forbidden, after the last administration lasts for 1 hour, the eyeballs are picked, blood is taken, serum is separated, and each index is measured. The results are shown in Table 1.
TABLE 1 Effect of lyophilized powder of each extract on blood lipid levels in acute hyperlipidemic mice (Mean + -SD)
Note: except the positive medicines, the medicines in other groups are calculated by the weight of crude medicines;ΔΔP<0.01 and normal group; p<0.05，**P<0.01, compared to a model set;#P<0.05, compared to group JZF.
The experimental results show that: compared with a normal control, the model group has very significant difference, and the TC, TG and LDL-C levels are all significantly increased (P < 0.01); compared with the model group, the positive drug treatment group (simvastatin group) has obviously reduced TC, TG and LDL-C levels and shows obvious lipid-lowering effect; after the intervention of the traditional Chinese medicine composition JZF, the levels of Total Cholesterol (TC) and total Triglyceride (TG) in serum are remarkably different from those in a model group (P <0.01), the level of low-density lipoprotein cholesterol (LDL-C) is remarkably different from that in the model group (P <0.05), so that the obvious lipid-lowering effect is shown, the treatment group is not remarkably different from the JZF group of the traditional Chinese medicine composition, and the high-density lipoprotein cholesterol (HDL-C) model group and the treatment group are not remarkably changed, so that the traditional Chinese medicine composition JZF of the invention has an obvious lipid-lowering effect; compared with the model group, only part of the indexes have significant difference (P is less than 0.05), and most of the indexes have no significant difference; compared with the JZF group, the TC, TG and LDL-C levels of the single medicines are obviously different (P is less than 0.05), which indicates that the lipid-lowering effect of the JZF group is obviously enhanced compared with that of the single medicines, namely the traditional Chinese medicine composition has the synergistic effect.
Example 7: the invention discloses a comparative study on the lipid-lowering effect of the traditional Chinese medicine composition with different proportions
Lyophilized powders (compound a, compound B, compound C, compound D and compound E, respectively) of the traditional Chinese medicine composition prepared from the raw material medicines according to the weight ratio of the embodiments 1-5 are taken as experimental objects, a mouse hyperlipidemia model is copied according to the method of the embodiment 6, and different compounds intervene to investigate the lipid-lowering effect of different compound compositions.
The experimental results show that compared with the normal control, the compound has very significant difference, and the TC and TG levels of different compound groups of the invention are obviously lower than those of the model group. The results are shown in table 2, and the lipid-lowering effect of compound C, D and E is very significant, and the results are shown in table 2.
TABLE 2 influence of different lyophilized powders on the relative expression of HCV RNA in cells
(except for the positive drugs, each drug was 50. mu.g/ml)
Note: p <0.05, P <0.01, compared to model groups.
Example 8: lipid-lowering experiment of different doses of drugs on hyperlipidemic rats
Preparation of high fat emulsion
Taking 100g of lard, placing the lard in a 2000ml beaker, heating the lard on an electric furnace to melt the lard, adding 50g of cholesterol, and melting the lard for later use; and adding 10g of sodium cholate, 3g of propylthiouracil, 50ml of tween-80, 50ml of propylene glycol and 700ml of distilled water into another beaker, heating and dissolving, uniformly dispersing with lard at 12000 rpm while the solution is hot, and adding water to dilute the solution to 1500 ml.
Preparation of test solution
The raw material medicaments are taken according to the weight ratio of the embodiment 3, a proper amount of water is added for decocting for 2 times, 1 hour each time when the boiling is timed, after the decoction is finished, the filtration is carried out, the two filtrates are combined, the reduced pressure concentration is carried out, the freeze-dried powder is frozen and dried to obtain the composition freeze-dried powder (JZF) for standby,
procedure of experiment
The administration mode comprises the following steps: intraperitoneal injection administration, 130 rats are fed with basal feed and observed for 5 days, fasting is carried out for 16 hours, orbital venous plexus is subjected to blood sampling, serum Total Cholesterol (TC), total Triglyceride (TG), high density lipoprotein cholesterol (HDL-C) and low density lipoprotein cholesterol (LDL-C) levels are measured, then high fat emulsion feeding is started, after 4 weeks, fasting is carried out for 16 hours, orbital venous plexus is subjected to blood sampling, serum TC, TG, HDL-C, serum glutamic-pyruvic transaminase (AST) and serum glutamic-pyruvic transaminase (ALT) levels are measured, and after a hyperlipidemia model is determined to be formed by comparing with that before high fat feed feeding, 60 rats are randomly and averagely divided into a high fat model group, a positive control group and 3 experimental groups (three high, medium and low dose groups of JZF respectively) according to TC levels. And (3) continuously feeding high-fat feed to the high-fat model group, continuously feeding the high-fat feed to each dosage group, simultaneously performing intragastric administration of high, medium and low three dosages respectively to JZF, additionally feeding a blank control group to the basic feed, monitoring the weight once a week, adjusting the dosage, detecting the blood fat level once, fasting all rats for 16h after administration for 30 days, collecting blood of orbital venous plexus, and determining the levels of TC, TG, HDL-C, LDL-C, AST and ALT of the serum of each group.
The experimental results show that: JZF-H high dose group, JZF-M medium dose group and JZF-L low dose group can obviously reduce the levels of TC, TG and LDL in the serum of the rat with hyperlipidaemia, and specific experimental results in a certain dose-effect relationship are shown in Table 3. The serum ALT and AST levels are obviously increased after the simvastatin group is administrated for a long time, which indicates that the simvastatin has a certain liver injury effect, but the serum ALT and AST levels of the traditional Chinese medicine lipid-lowering composition have no obvious Shenggai and do not show the liver injury influence. The results show that the traditional Chinese medicine composition for reducing blood fat can obviously reduce the content of total cholesterol in blood serum, thereby playing the role of reducing the blood fat level in blood and reducing atherosclerosis, and can be used for preventing and treating hyperlipidemia and/or atherosclerotic diseases.
TABLE 3 Effect of different administration groups on the TC, TG, HDL, LDL, ALT and AST content in the serum of hyperlipidemic rats
Note: p <0.05, P <0.01, compared before and after treatment for each group.
Example 9: clinical research on treatment of hyperlipidemia by using traditional Chinese medicine composition
In order to show the clinical curative effect of the invention, 80 patients with hyperlipidemia are screened, and referring to the hyperlipidemia diagnosis standard of the national sanitation standards, all patients have TC more than or equal to 5.7mmol/L, TG more than or equal to 1.7mmol/L, HDL-C male less than or equal to 1.04mmol/L, female less than or equal to 1.17mmol/L, and 1 of the 3 indexes exceeds standard. The method eliminates serious liver and kidney dysfunction, pregnant women, lactating women, statin allergic patients, hereditary blood lipid increase, and hyperlipidemia caused by other pathological changes or drugs, and comprises an observation group (the traditional Chinese medicine composition) and a control group (a simvastatin group), wherein each group comprises 40 cases. In addition, a random number table is generated by simulation of an SAS statistical software package, the cases of the standard group are included and excluded according to a research scheme, and the subjects enter a treatment group and a control group in sequence according to the sequence of the included research and the random number.
Treatment groups: the traditional Chinese medicine composition is used for treating diseases (9 g of fried scutellaria baicalensis, 12 g of raw cattail pollen, 15 g of rhizoma polygonati, 9 g of giant knotweed, 12 g of radix curcumae and 15 g of caper fruit are compound prepared traditional Chinese medicine granules), each 1 dose is drunk twice after being brewed, and the traditional Chinese medicine granules are taken once in the morning and at night.
Control group: simvastatin is treated, the dosage is 10 mg/tablet, and the simvastatin is taken one tablet every day and at night. The treatment course of the two groups is 8 weeks.
And (3) judging the curative effect: the judgment is carried out according to the evaluation method of clinical trials of cardiovascular drugs in 1998, and the patient who reaches any index can judge the cardiovascular drugs. The effect is shown: the TC reduction is more than or equal to 20 percent; the TG reduction is more than or equal to 40 percent; the LDL-C is reduced by more than or equal to 20 percent, and the HDL-C is increased by more than or equal to 20 percent. The method has the following advantages: TC is reduced by 10-20%; the TG is reduced by 20 to 40 percent; the LDL-C is reduced by 10 to 20 percent; HDL-C was increased by 0.10 to 0.25 mmol/L. And (4) invalidation: and those not meeting the effective standard.
The results are shown in tables 4 and 5, and are statistically processed using SPSS 13.0 statistical analysis software, the count data is tested by χ 2, and the grade data is analyzed by RIdit. As can be seen from Table 4, the control group had significantly different effects of lowering TG and LDL-C levels (bP <0.05) compared with the treated group. The clinical experiment results of table 5 show that the traditional Chinese medicine composition can obviously reduce the blood lipid level of a patient, and particularly has a remarkably improved curative effect on reducing the LDL-C level compared with that of a control group (simvastatin).
TABLE 4 comparison of blood lipid levels before and after treatment (x. + -. s, mmol/L) between the patients of the observation group and the control group
Note: aP <0.05 compared to control; bP <0.05 compared to pre-treatment.
TABLE 5 comparison of clinical efficacy of patients in the Observation group and the control group (n,%)
In summary, the above embodiments are merely preferred embodiments of the present invention, and are not intended to limit the scope of the present invention, and any modifications, equivalents, improvements, etc. made within the spirit and principle of the present invention should be included in the scope of the present invention.
Claims (7)
1. The lipid-lowering traditional Chinese medicine composition is characterized by comprising the following raw material medicines in parts by weight: 4.5 to 9 parts of fried scutellaria baicalensis, 6 to 12 grams of raw cattail pollen, 7.5 to 15 parts of rhizoma polygonati, 4.5 to 9 parts of giant knotweed rhizome, 6 to 12 parts of curcuma aromatica and 7.5 to 15 parts of caper fruit.
2. The composition of claim 1, wherein the weight ratio of each raw material drug is as follows: 9 parts of fried scutellaria baicalensis, 12 parts of raw cattail pollen, 15 parts of rhizoma polygonati, 9 parts of polygonum cuspidatum, 12 parts of radix curcumae and 15 parts of caper fruit.
3. Use of a composition according to any one of claims 1-2 for the manufacture of a medicament for lowering lipid.
4. A pharmaceutical preparation, characterized by consisting of the composition of any one of claims 1-2 and formulation excipients.
5. The pharmaceutical preparation of claim 4, wherein the preparation is an oral formulation of a traditional Chinese medicine.
6. The pharmaceutical formulation of claim 5, wherein the formulation is a capsule, tablet, oral liquid, granule, pill, powder, pellet, or paste.
7. A method for preparing the composition of claim 1, wherein the method comprises the following steps:
respectively pulverizing and mixing the raw materials, making into powder mixture, and making into honeyed pill by conventional method in the field;
or decocting the raw materials in water for 2 times, boiling for 1 hr, adding 10 times of water for the first time and 8 times of water for the second time, filtering with 10 layers of gauze, mixing the filtrates, concentrating to obtain extract with specific gravity of 1.35, adding appropriate amount of dextrin and sugar powder, drying at 70 deg.C, and making into granule;
or decocting the above materials in water for 2 times, and mixing the decoctions to obtain decoction after boiling for 1 hr;
or decocting the raw materials in water for 2 times, boiling for 1 hr, adding 10 times of water for the first time, adding 8 times of water for the second time, filtering with 10 layers of gauze, concentrating the filtrate to obtain dry extract, and making into tablet by conventional method;
or reflux-extracting each raw material with 70% ethanol for 2 times, boiling for 1 hr each time, adding 6 times of ethanol for the first time and 4 times of ethanol for the second time, mixing the decoctions, filtering, concentrating under reduced pressure until no ethanol is present, spray-drying to obtain dry extract powder, and making into capsule by conventional method.
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| 活血降脂方治疗高脂血症瘀血阻滞证的临床观察;陈二恒等;《河北中医》;20080731;第30卷(第07期);第689-691页 * |
| 益气活血通脉汤治疗冠脉介入术后心绞痛38例;郭琳琳;《中国中医药信息杂志》;20050630;第12卷(第06期);第55-56页 * |
| 降脂汤治疗高脂血症143例临床研究;张明华;《江苏中医》;19981231;第19卷(第11期);第13-14页 * |
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