CN1759854A - Chinese materia medica preparation for treating cardiovascular and cerebrovascular diseases, and preparation method - Google Patents
Chinese materia medica preparation for treating cardiovascular and cerebrovascular diseases, and preparation method Download PDFInfo
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- CN1759854A CN1759854A CN 200510070630 CN200510070630A CN1759854A CN 1759854 A CN1759854 A CN 1759854A CN 200510070630 CN200510070630 CN 200510070630 CN 200510070630 A CN200510070630 A CN 200510070630A CN 1759854 A CN1759854 A CN 1759854A
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- flos carthami
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Abstract
A Chinese medicine for treating cardiovascular and cerebrovascular diseases is prepared from safflower and pueraria root through extracting and dispensing. Its preparing process is also disclosed.
Description
Technical field:
The present invention relates to a kind of Chinese medicine preparation for the treatment of cardiovascular and cerebrovascular disease and preparation method thereof, said preparation is formed through extracting processing and preparing by Chinese medicine safflower, Radix Puerariae.
Background technology:
Cardiovascular and cerebrovascular disease as coronary heart disease, cerebral infarction, is human disease and main causes of death, accounts for 1/3rd of general mortality rate, has surpassed cancer at its mortality rate of China.And along with the raising of China along with living standards of the people, the crowd who suffers from cardiovascular disease is huge day by day, leave invalid among the survivor, cause huge life to threaten to the patient, the patient needs to take medicine for a long time or all the life more simultaneously, quality of life is had a strong impact on, and causes white elephant also for patient family and even entire society.
At present, the Chinese medicine and western medicine of treatment coronary heart disease is a lot, but how many Western medicine has some side effect, and almost there be not the effective method Chinese medicine having certain characteristic aspect the treatment cardiovascular and cerebrovascular disease aspect the treatment of cerebrovascular disease, utilize activating blood circulation to dissipate blood stasis method treatment cardiovascular and cerebrovascular disease that certain effect has been arranged, become the focus of cardiovascular and cerebrovascular disease area research in recent years.
Flos Carthami promoting blood circulation to restore menstrual flow, eliminating stasis to stop pain can removing blood stasis to promote tissue regeneration, again can promoting blood circulation and stopping pain, and be the medicine commonly used of the treatment thoracic obstruction, apoplexy.Carthamus yellow is a class water-soluble flavone compounds that extracts from Flos Carthami, be the effective site of Flos Carthami, pharmacodynamic study shows: Flos Carthami has the reduction coronary resistance, increase the effect of coronary flow and myocardial nutrition, Carthamus yellow can dwindle the scope and the degree of the experimental myocardial infarction of rabbit, improves damage and downright bad type electrocardiogram and changes; Also have effects such as anticoagulation, antithrombotic, blood fat reducing, calmness and analgesia preferably; Carthamus yellow can also bring high blood pressure down, blood vessel dilating, improve organ blood supplies such as the heart, brain, its hypotensive effect has that produce effects is fast, effect obviously, characteristics such as longer duration, this is with directly to expand peripheral blood vessel relevant.
Puerarin has the reduction thromboxane A
2(TXA
2) active, raising prostacyclin (PGI
2) level and the effect that improves the HDL level, reducing platelet aggregation and blood viscosity, energy coronary artery dilator and cerebrovascular significantly improve the blood supply of ischemic region cerebral tissue; And have the receptor retardation, mainly act on beta receptor, reduce heart rate and blood pressure lenitively, cardiac load is obviously alleviated, myocardial oxygen consumption significantly descends, thereby limits and dwindle the scope of myocardial infarction effectively.Reduce catecholamine, reduce or block the opening of cell membrane passage, prevent from or alleviate intracellular calcium to overload, thereby play the effect of protection heart and expansion of cerebral vascular.
At present, the Chinese medicine and western medicine of treatment coronary heart disease is a lot, but how many Western medicine has some side effect, and almost there be not the effective method Chinese medicine having certain characteristic aspect the treatment cardiovascular and cerebrovascular disease aspect the treatment of cerebrovascular disease, utilize activating blood circulation to dissipate blood stasis method treatment cardiovascular and cerebrovascular disease that certain effect has been arranged, become the focus of cardiovascular and cerebrovascular disease area research in recent years.
Existing medicine belongs to a bit cures the symptoms, not the disease, and some uses expensive composition, and some is cut and interrupt using owing to uncertain therapeutic efficacy in application process.In view of this, the inventor develop a kind of taking convenience, effect steadily, determined curative effect, dosage form is stable, quality controllable and the treatment cardiovascular and cerebrovascular disease pure Chinese medicinal preparation that has no side effect, to satisfy the demand of extensive patients.
Drug injection of the present invention and Flos Carthami injection relatively, we have carried out essence to medicine and have carried, and have improved active constituent content and purity, have strengthened preparation stability, have reduced the preparation specification, better efficacy is used more convenient.
Summary of the invention:
The invention provides a kind of Chinese medicine preparation, said preparation is prepared from Chinese medicine safflower, Radix Puerariae, and said preparation is made by following Chinese medicinal raw materials.
Its set of dispense than (weight portion) in crude drug,
Flos Carthami 2500-10000 part, Radix Puerariae 2000-8000 part.
Preferably Flos Carthami 3000-7000 part, Radix Puerariae 3000-6000 part.
More preferably 5000 parts on Flos Carthami, 4000 parts of Radix Puerariaes.
In more than forming, the weight of medicine is calculated with crude drug, and per 1 part can be 1 gram, also can be kilogram or ton, if be unit with gram, this prescription composition can be made into 1000 doses of pharmaceutical preparatioies.Described 1000 doses of fingers, the final drug preparation of making, as make 1000 of capsule preparations, 1000 in tablet, granule 1000g, oral liquid 1000ml etc., also can make big packing as granule, as the 100-500 bag, specifically can be 100 bags, 125 bags, 200 bags, 250 bags, 500 bags etc., every bag can be used as taking dose 1 time.
More than form, can be made into the preparation of 50-1000 taking dose, as tablet, make 1000, each taking dose can be the 1-20 sheet, can take 50-1000 time altogether.As granule, make 125 bags, take the 1-2 bag at every turn, can take 62-125 time altogether.
More than form to be by weight as proportioning, when producing, can increase or reduce according to corresponding proportion, as large-scale production can be unit with the kilogram, or be unit with the ton, small-scale production can be unit with the milligram also, weight can increase or reduce, but the constant rate of the raw medicinal herbs weight proportion between each composition.
The ratio of above weight proportion obtains through science screening, for especial patient, and as serious symptom or light disease, fat or modest patient, the proportioning of the amount of can corresponding adjustment forming increases or reduces being no more than 100%, and drug effect is constant.
Chinese medicine preparation of the present invention is to process through extraction or other modes by the raw material of Chinese medicine that above-mentioned prescription is formed, and makes pharmaceutically active substance, subsequently, with this material is raw material, adds the medicine acceptable carrier when needing, and makes according to the routine techniques of galenic pharmacy.Described active substance can obtain by extracting raw material of Chinese medicine respectively, also can obtain by the co-extracted raw material of Chinese medicine, also can obtain by other modes, as: by pulverize, squeeze, calcine, grind, sieve, percolation, extraction, water are carried, alcohol extraction, ester are carried, methods such as ketone is carried, chromatography obtain, these active substances can be the material of extractum form, can be that dry extract also can be a fluid extract, make different concentration according to the different needs decision of preparation.
Pharmaceutically active substance in the pharmaceutical preparation of the present invention, its shared percentage by weight in preparation can be 0.1-99.9%, all the other are the medicine acceptable carrier.Pharmaceutical preparation of the present invention exists with unit dosage form, and described unit dosage form is meant the unit of preparation, as every of tablet, capsular every capsules, every of injection etc., in the unit dose, the amount that contains active substance is 5-600mg, preferably 20-400mg.
Pharmaceutical preparation of the present invention can be any pharmaceutically useful dosage form, and these dosage forms comprise: tablet, capsule, oral liquid, syrup, granule, pill, powder, unguentum, sublimed preparation, injection, suppository, cream, spray, drop pill, patch, slow releasing preparation, controlled release preparation.
Pharmaceutical preparation of the present invention, the preparation of its oral administration can contain excipient commonly used, such as binding agent, filler, diluent, tablet agent, lubricant, disintegrating agent, coloring agent, flavoring agent and wetting agent, can carry out coating to tablet in case of necessity.
The filler that is suitable for comprises cellulose, mannitol, lactose and other similar filler.Suitable disintegrating agent comprises starch, polyvinylpyrrolidone and starch derivatives, for example sodium starch glycollate.Suitable lubricant, for example magnesium stearate.The acceptable wetting agent of appropriate drug comprises sodium lauryl sulphate.
Can fill by mixing, the method that tabletting etc. are commonly used prepares solid oral composition.Mix repeatedly active substance is distributed in those compositionss of a large amount of filleies of whole use.
The form of oral liquid for example can be aqueous or oily suspensions, solution, Emulsion, syrup or elixir, perhaps can be a kind of available water before use or other suitable composite dry products of carrier.This liquid preparation can contain conventional additive, such as suspending agent, for example sorbitol, syrup, methylcellulose, gelatin, hydroxyethyl-cellulose, carboxymethyl cellulose, aluminium stearate gel or hydrogenation edible fat, emulsifying agent, for example lecithin, anhydro sorbitol monooleate or arabic gum; Non-aqueous carrier (they can comprise edible oil), for example almond oil, fractionated coconut oil, such as oily ester, propylene glycol or the ethanol of the ester of glycerol; Antiseptic, for example para hydroxybenzene methyl ester or propyl p-hydroxybenzoate or sorbic acid, and if desired, can contain conventional flavouring agent or coloring agent.
For injection, the liquid unit dosage forms of preparation contains active substance of the present invention and sterile carrier.According to carrier and concentration, this chemical compound can be suspended or dissolving.The preparation of solution is normally by being dissolved in active substance in a kind of carrier filter-sterilized before it is packed into a kind of suitable bottle or ampoule, sealing then.For example a kind of local anesthetic of adjuvant, antiseptic and buffer agent also can be dissolved in this carrier.In order to improve its stability, can be after the bottle of packing into that this compositions is freezing, and under vacuum, water is removed.
Pharmaceutical preparation of the present invention, when being prepared into medicament, optionally add suitable medicine acceptable carrier, described medicine acceptable carrier is selected from: mannitol, sorbitol, sodium pyrosulfite, sodium sulfite, sodium thiosulfate, cysteine hydrochloride, TGA, methionine, vitamin C, the EDTA disodium, EDTA calcium sodium, the alkali-metal carbonate of monovalence, acetate, phosphate or its aqueous solution, hydrochloric acid, acetic acid, sulphuric acid, phosphoric acid, aminoacid, sodium chloride, potassium chloride, sodium lactate, xylitol, maltose, glucose, fructose, dextran, glycine, starch, sucrose, lactose, mannitol, silicon derivative, cellulose and derivant thereof, alginate, gelatin, polyvinylpyrrolidone, glycerol, soil temperature 80, agar, calcium carbonate, calcium bicarbonate, surfactant, Polyethylene Glycol, cyclodextrin, beta-schardinger dextrin-, the phospholipid material, Kaolin, Pulvis Talci, calcium stearate, magnesium stearate etc.
Pharmaceutical preparation of the present invention, active component can extract two flavor medicines respectively, and extraction also can mix.When extracting respectively, method is as follows:
The preparation method of Flos Carthami active component Carthamus yellow: take by weighing Flos Carthami, add water temperature and soak, warm macerating liquid is centrifugal, and centrifugal liquid is crossed macroporous resin, carries out eluting, and eluent is crossed detached dowel, gets Carthamus yellow;
The preparation method of Radix Puerariae active component puerarin: get Radix Puerariae and add ethanol extraction, reclaim ethanol, polyamide column is crossed in centrifugal back, and gradient elution, eluent concentrate the back recrystallization and get puerarin;
More than two kinds of active component mix, as active constituents of medicine, add the medicine acceptable carrier after, make pharmaceutical preparation by the galenic pharmacy routine techniques.
Below beneficial effect by pharmacological evaluation explanation medicine of the present invention:
The pharmacological research of Flos Carthami, Radix Puerariae compound injection (hereinafter to be referred as compound injection)
One, to the protective effect of myocardial ischemia
Get the Wistar rat, be divided into 3 groups at random, be i.e. model control group, treatment group, positive controls.Model control group lumbar injection distilled water, treatment group abdominal cavity give compound injection (100mg/kg body weight), positive controls lumbar injection Flos Carthami injection (100mg/kg body weight), and be administered once every day, continuous 6 days.Behind the last administration 1h, urethane (5%, face upward the position and fix by 20ml/kg) anesthetized rat, cut off animal skin along midsternal line, at left border of sternum 6～7 intercostal openings, extrude heart rapidly after, ligation at once left side heart coronary artery anterior descending branch root, heart is put back to the thoracic cavity, close thoracic cavity and stitching, take out heart behind the 6h ,-20 ℃ of preservations are spent the night.In the experimentation, respectively at (normally), ligation before the operation at once, 2h, 6h recording ecg after the ligation, observe that the ST section changes and myocardial ischemia improvement situation.
The result shows that compound injection treatment group raised significant reduction effect to ECG ST section.Compare with model control group, 2h after the ligation of treatment group, the ST section is raised and is reduced by 43.27%, and 6h after the ligation reduces by 51.64%, P＜0.01, the myocardial ischemia scope reduces by 41.69% (the treatment group is 17.2%, and model group is 29.5%), P＜0.01; Compare with the Flos Carthami injection matched group, 2h after the ligation of treatment group, the ST section is raised and is reduced by 24.37%, and 6h after the ligation reduces by 25.83%, P＜0.05, the myocardial ischemia scope reduces by 16.1% (the treatment group is 17.2%, and positive controls is 20.5%), P＜0.05.The effect of compound injection of the present invention is better than the Flos Carthami injection positive controls.
In sum, compound injection of the present invention has protective effect to the Acute Myocardial Ischemia in Rats that the ligation coronary artery is caused.
Two, to the protective effect of rat cerebral ischemia
(Wu Junfang, Shi Yiju, Liu Tianpei, berberine be to the protective effect of mice and rat cerebral ischemia, Chinese J Pharmacol Toxicol, 1995,9 (2): 100-103 for list of references.) described reversibility middle cerebral artery infraction (MCAO) method duplicates the focal cerebral ischemia in rats model.Divide totally 4 groups of normal control groups, model control group, compound injection treatment group and Flos Carthami injection positive controls of the present invention.Behind the modeling 2h to the nervous symptoms of animal according to document (Bedexson JB.Pitts LH, Tsuji M, et al.Stroke, 1986,17:472.) mark, broken end is got brain after 24 hours, measures the cerebral infarction scope.
Each delayed ischemic neurological deficits grade scoring of organizing rat is: model control group is 8.2 minutes, the treatment group is 5.6 minutes, positive controls is 7.1 minutes, show that compound injection of the present invention can obviously reduce the delayed ischemic neurological deficits grade scoring of rat model, its effect has significance meaning (P＜0.01, P＜0.01).
Each is organized the rat cerebral infarction scope and measures: model control group is 13.7%, and the treatment group is 9.3%, and positive controls is 11.1%, and treatment group and model group relatively reduce by 32.12%, P＜0.01; Treatment group and positive controls relatively reduce by 16.22%, P＜0.05.
The effect of compound injection of the present invention is better than Flos Carthami injection.
Above result shows that compound injection of the present invention has significant protective effect to MCAO cerebral ischemic model rat.
Acute toxicity testing and long term toxicity test prove that medicine of the present invention does not have obvious toxic and side effects, and hepatic and renal function, routine blood test, the blood parameters of animal do not had obvious influence.
A kind of injection for the treatment of cardiovascular and cerebrovascular disease of the present invention can be an injection, capsule, granule, tablet, optimizing injection.Composition Carthamus yellow, puerarin can be mixed in suitable carriers, in diluent or the excipient.
The invention has the advantages that owing to adopt essence to carry, pharmacologically active improves greatly, and is quality controllable, good stability, toxic and side effects reduces, and has good market prospect.
The specific embodiment:
Below further specify the present invention by specific embodiment, but not as limitation of the present invention.
Embodiment 1
Capsule preparation method thereof,
The preparation method of active component is as follows:
The preparation method of Flos Carthami active component Carthamus yellow: take by weighing Flos Carthami 10000g, add water temperature and soak, warm macerating liquid is centrifugal, and centrifugal liquid is crossed macroporous resin, carries out eluting, and eluent is crossed detached dowel, gets Carthamus yellow 96g;
The preparation of Radix Puerariae active component: the preparation method of puerarin: get Radix Puerariae 8000g and add ethanol extraction, reclaim ethanol, polyamide column is crossed in centrifugal back, and gradient elution, eluent concentrate the back recrystallization and get puerarin 39.5g;
Get that two kinds of active component of Flos Carthami and Radix Puerariae are pulverized, behind the mix homogeneously, add a certain amount of adjuvant mix homogeneously and incapsulate, make 1000 capsules, reinstall in the bottle after aluminum-plastic packaged and seal.
Embodiment 2
The preparation of injection
The preparation method of active component is as follows:
The preparation method of Flos Carthami active component Carthamus yellow: take by weighing Flos Carthami 5000g, add water temperature and soak, warm macerating liquid is centrifugal, and centrifugal liquid is crossed macroporous resin, carries out eluting, and eluent is crossed detached dowel, gets Carthamus yellow 60g;
The preparation of Radix Puerariae active component: the preparation method of puerarin: get Radix Puerariae 4000g and add ethanol extraction, reclaim ethanol, polyamide column is crossed in centrifugal back, and gradient elution, eluent concentrate the back recrystallization and get puerarin 26.3g;
Get Flos Carthami active component and Radix Puerariae active component and add water for injection, heated and stirred makes dissolving, and adjust pH filters, add active carbon heating 15 minutes, cooling filters, and adds the volume that the injection water is settled to regulation, with the 0.2 μ m microporous filter membrane fine straining of sterilizing, degerming, bottling, lyophilization gets 1000 bottles (150mg/ bottles).
Embodiment 3
Process for producing granula,
The preparation method of active component is as follows:
The preparation method of Flos Carthami active component Carthamus yellow: take by weighing Flos Carthami 4000g, add water temperature and soak, warm macerating liquid is centrifugal, and centrifugal liquid is crossed macroporous resin, carries out eluting, and eluent is crossed detached dowel, gets Carthamus yellow 48.5g;
The preparation of Radix Puerariae active component: the preparation method of puerarin: get Radix Puerariae 5000g and add ethanol extraction, reclaim ethanol, polyamide column is crossed in centrifugal back, and gradient elution, eluent concentrate the back recrystallization and get puerarin 33.0g;
After getting two kinds of active component pulverizing of Flos Carthami and Radix Puerariae, mix homogeneously, add a certain amount of adjuvant mix homogeneously system granule, get the 1000g granule.
Embodiment 4
Method for preparing tablet thereof,
The preparation method of active component is as follows:
The preparation method of Flos Carthami active component Carthamus yellow: take by weighing Flos Carthami 2500g, add water temperature and soak, warm macerating liquid is centrifugal, and centrifugal liquid is crossed macroporous resin, carries out eluting, and eluent is crossed detached dowel, gets Carthamus yellow 30.4g;
The preparation method of Radix Puerariae active component puerarin: get Radix Puerariae 2000g and add ethanol extraction, reclaim ethanol, polyamide column is crossed in centrifugal back, and gradient elution, eluent concentrate the back recrystallization and get puerarin 19.8g;
After getting two kinds of active component pulverizing of Flos Carthami and Radix Puerariae, mix homogeneously, add a certain amount of adjuvant mix homogeneously tabletting, make 1000.
Claims (10)
1. pharmaceutical preparation for the treatment of cardiovascular and cerebrovascular disease is characterized in that per 1000 dosage units are made Flos Carthami 2500-10000 part, Radix Puerariae 2000-8000 part by following Chinese medicinal raw materials.
2. the pharmaceutical preparation of claim 1 is characterized in that per 1000 dosage units are made Flos Carthami 3000-7000 part, Radix Puerariae 3000-6000 part by following Chinese medicinal raw materials.
3. the pharmaceutical preparation of claim 1 is characterized in that per 1000 dosage units are made 5000 parts on Flos Carthami, 4000 parts of Radix Puerariaes by following Chinese medicinal raw materials.
4. the pharmaceutical preparation of claim 1, it is characterized in that said preparation is made as the active component of pharmaceutical preparation with being combined by any or several pharmacological components of extracting in the Radix Puerariae by any or several pharmacological components that extract in the Flos Carthami.
5. the pharmaceutical preparation of claim 4 is characterized in that, any or several pharmacological components that extract in the described Flos Carthami are Carthamus yellows, and any or several pharmacological components that extract in the Radix Puerariae are puerarins.
6. the pharmaceutical preparation of claim 1 wherein also comprises the medicine acceptable carrier.
7. the pharmaceutical preparation of claim 4 is injection, tablet, granule, capsule or drop pill.
8. the application of the pharmaceutical preparation of claim 1 in the medicine of preparation treatment cardiovascular and cerebrovascular disease.
9. the preparation method of the pharmaceutical preparation of claim 1 is characterized in that, the process following steps:
The preparation method of Flos Carthami active component Carthamus yellow: take by weighing Flos Carthami, add water temperature and soak, warm macerating liquid is centrifugal, and centrifugal liquid is crossed macroporous resin, carries out eluting, and eluent is crossed detached dowel, gets Carthamus yellow;
The preparation method of Radix Puerariae active component puerarin: get Radix Puerariae and add ethanol extraction, reclaim ethanol, polyamide column is crossed in centrifugal back, and gradient elution, eluent concentrate the back recrystallization and get puerarin; More than two kinds of active component lump together, as active constituents of medicine, this active component with make preparation after the medication medication acceptable carrier mixes.
10, the preparation method of claim 9 is characterized in that, wherein the Flos Carthami inventory is that 2500-10000 part, Radix Puerariae inventory are 2000-8000 part.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510070630 CN1759854A (en) | 2005-05-18 | 2005-05-18 | Chinese materia medica preparation for treating cardiovascular and cerebrovascular diseases, and preparation method |
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| CN 200510070630 CN1759854A (en) | 2005-05-18 | 2005-05-18 | Chinese materia medica preparation for treating cardiovascular and cerebrovascular diseases, and preparation method |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103405533A (en) * | 2013-07-08 | 2013-11-27 | 施健 | Preparation method of healthcare medicament with brain nourishing function |
| CN109771485A (en) * | 2019-02-03 | 2019-05-21 | 中商国能孵化器集团有限公司 | Nontoxic dry toad pharmaceutical composition of one kind and the preparation method and application thereof |
-
2005
- 2005-05-18 CN CN 200510070630 patent/CN1759854A/en active Pending
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103405533A (en) * | 2013-07-08 | 2013-11-27 | 施健 | Preparation method of healthcare medicament with brain nourishing function |
| CN109771485A (en) * | 2019-02-03 | 2019-05-21 | 中商国能孵化器集团有限公司 | Nontoxic dry toad pharmaceutical composition of one kind and the preparation method and application thereof |
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