CN102058675A - Traditional Chinese medicinal preparation for treating ischemic cardiovascular and cerebrovascular diseases and preparation method thereof - Google Patents
Traditional Chinese medicinal preparation for treating ischemic cardiovascular and cerebrovascular diseases and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a traditional Chinese medicinal preparation for treating ischemic cardiovascular and cerebrovascular diseases and a preparation method thereof. The preparation method comprises the following steps of: performing extraction and refining on ginseng, rhizoma corydalis and divaricate saposhnikovia root to obtain extract with high active ingredient content, adding the extract into pharmaceutic adjuvant in a ratio of 1:1-5 and 1:1-8, and mixing uniformly to prepare soft capsules and pills respectively. The pulse-invigorating soft capsules and pulse-invigorating pills, which are prepared from the extract obtained by the technology of separation and extraction of modern traditional Chinese medicines, fully retain the active ingredients and improve the bioavailability of medicaments; meanwhile, a preparation process of the extract adopts a simple and economic method, is convenient for operation and can well meet the requirements for industrialization production.
Description
Technical field
The invention belongs to the Chinese medicine preparation technical field, relate to a kind of Chinese medicine preparation that is used for the treatment of ischemic cardio cerebrovascular diseases, in particular, is a kind of soft capsule and drop pill and their preparation method that contains Radix Ginseng, Radix Saposhnikoviae extract.
Background technology
Change along with growth in the living standard and rhythm of life, " three-hypers disease " (being hypertension, hyperglycemia and hyperlipidemia) that is called as " affluenza ", as " the old times king thanks to a preceding swallow; fly into common people house ", the cardiovascular and cerebrovascular disease M ﹠ M that causes because of " three-hypers disease " rises year by year.Hypertensive old people uses depressor to be worthy of careful study, and principle is arranged, and what do you know for the selection of old depressor? different healths, the different state of an illness, old people's body constitution situation all affects and selects medicine in addition.With advancing age, the hypertension prevalence increases gradually.40%～45% suffer from hypertensive also suffer from simultaneously hyperglycemia or hyperlipidemia among the old people more than 60 years old, show according to Ministry of Public Health statistics in 2007, show that according to external data about 50% diabetes patient is associated with multiple infirmitiess of age such as hypertension, hyperlipidemia.Cardiovascular and cerebrovascular disease is a kind of serious threat mankind, and particularly the commonly encountered diseases of middle-aged and elderly people health more than 50 years old even use most advanced, perfect at present treatment means, still can have the cerebrovascular accident survivor life more than 50% not take care of oneself fully! Every year is died from the number of cardiovascular and cerebrovascular disease up to 1,500 ten thousand people in the whole world, occupies various causes of the death first place.Cardiovascular and cerebrovascular disease has become the highest No.1 killer of the human dead cause of disease, also is " the noiseless demon " of health of people.
Cardiovascular and cerebrovascular disease has the characteristics of " sickness rate height, disability rate height, mortality rate height, relapse rate height, complication is how "-" four is high by more than one ", and at present, China cardiovascular and cerebrovascular disease patient has surpassed 2.7 hundred million people! China dies from nearly 3,000,000 people of cardiovascular and cerebrovascular disease every year, accounts for 51% of total dead cause of disease in our state's every year.And the patient 75% who survives disability in various degree, 40% is heavy residual! The relapse rate in 1 year is that the relapse rate in 30%, the five year is up to 59% behind China's apoplexy patient discharge.And secondary prevention do preferably the U.S. only be 10%.Apoplexy patient's relapse rate is compared with the international average level will exceed 1 times because China's medical care insurance covers a people group of mean people!
Summary of the invention
The object of the present invention is to provide a kind of Chinese medicine preparation that is used for the treatment of ischemic cardio cerebrovascular diseases and preparation method thereof.It is to change traditional TONGMAI CHONGJI, oral liquid into soft capsule preparation and drop pill, applicating modern times technology enrichment effective site, improved bioavailability, reduced taking dose, reduced toxic and side effects, increased the types of drugs of treatment ischemic cardio cerebrovascular diseases,, satisfied the demand in market for doctor and patient provides different dosage forms.
The objective of the invention is to realize by following technical proposals:
Chinese medicine preparation of the present invention is a qi-circulation promoting soft capsule, and wherein, the ratio of extract and pharmaceutic adjuvant is 1: 1～5.Described each components contents is preferably: the ratio of extract and pharmaceutic adjuvant is 1: 1～4.Described each components contents is preferably: the ratio of extract and pharmaceutic adjuvant is that 1: 3 described pharmaceutic adjuvant is Petiolus Trachycarpi oil, Cera Flava, soybean oil or the like.Chinese medicine preparation of the present invention is a pulse invigorating pill, and wherein the weight ratio of extract and Polyethylene Glycol is 1: 1～8.Described each components contents is preferably: the weight ratio of extract and Polyethylene Glycol is 1: 1～6.
Described each components contents is preferably: the weight ratio of extract and Polyethylene Glycol is 1: 4.Described Polyethylene Glycol is Polyethylene Glycol 100,1000,4000 or 6000 and their mixture.The mixture of preferred especially Macrogol 4000 and polyethylene glycol 6000, its weight ratio is 1: 1～4.
The soft preparation technology of Chinese medicine preparation who is used for the treatment of ischemic cardio cerebrovascular diseases of the present invention comprises:
(1) Radix Ginseng 1250g, Rhizoma Corydalis 1250g are ground into coarse powder, add 2～10 times of 40～80% ethanol of medical material weight, and room temperature dipping 2～5 times each 12～48 hours, merges impregnation liquid;
(2) concentrating under reduced pressure filters, and filtrate is crossed macroporous adsorptive resins, for example macroporous adsorptive resins AB-8 or D101.With the aqueous hydrochloric acid solution washing resin bed of pH2～7 of 3～10 times of amounts of column volume, wash post after, with 30～90% ethanol elutions of 2～5 times of amounts of column volume, collect eluent, concentrating under reduced pressure, vacuum drying, dry extract 50～200g, pulverize standby;
(3) Radix Saposhnikoviae powder is broken into coarse powder, adds 2～10 times of amount 60～90% ethanol, room temperature dipping 2～5 times, each 12～48 hours, merge impregnation liquid, concentrating under reduced pressure, static layering, Radix Saposhnikoviae extract 50～150g, standby;
(4) preparation of soft capsule: according to the above ratio extract and pharmaceutic adjuvant are mixed and made into suspension.Be pressed into soft capsule rolling automatically on the mould machine.Through washing ball, drying, polishing, 1000 soft capsules, packing is promptly;
(5) preparation of drop pill: according to the above ratio extract is mixed with the adjuvant Polyethylene Glycol, stirring makes whole dissolvings and mix homogeneously, keep under 60～90 ℃ of constant temperatures, splash in liquid paraffin or the methyl-silicone oil in 5～10 ℃, be condensed into drop pill, exhaust liquid paraffin or methyl-silicone oil, the choosing grain, 10000 drop pill, promptly.
The present invention has adopted the method for macroporous resin eluting in conjunction with the technological means of modern industry, has improved the purity of Radix Ginseng, Rhizoma Corydalis effective site, for Radix Ginseng, the more effective treatment ischemic cardio cerebrovascular diseases of Rhizoma Corydalis extract provide necessary assurance.Test simultaneously by the different process method is compared, draw and adopt the room temperature dipping, and macroporous resin eluting process combined can improve the conclusion that Radix Ginseng, Rhizoma Corydalis effective ingredient make full use of.This technology can either adapt to suitability for industrialized production, has to have played the effect of giving full play to curative effect of medication.
Qi-circulation promoting soft capsule of the present invention has at utmost kept the active ingredient of three flavor medical materials, and taking convenience.Wherein, the adjuvant of soft capsule is an oil, adds gelatin-sealed, can be suspended in oil of Radix Sapshnikoviae, Radix Ginseng and the Rhizoma Corydalis extract processing technique by the capsule core material of soft capsule in the oil, can fully keep the medicine active ingredient like this.Because all medicines have increased the stability of sour B of red acid and Radix Saposhnikoviae volatile ingredient by the sealing of gelatin flexible glue skin, and do not have drug flavor when taking, the patient is acceptant.
Pulse invigorating pill is a kind of herbal mixture dropping pill formulation that modern high technology is produced of using, and, is splashed in the condensed fluid that mixes and formation through the suitable drip of bore with after the substrate heating and melting becomes solution by medicine.It has the title of solid solution, and dissolution rate is fast, bioavailability is high, and consumption is little, and the effect of having immediate effect.The medicine stability height that adopts drops to make, not facile hydrolysis, be difficult for oxidation, owing under liquid state, operate, no dust pollution, not influenced by crystal formation, be easy to guarantee the quality of medicine, it is quality controllable, dosage form is advanced, quick-acting, efficient, no gastric irritation, dissolving is fast, taking dose is little, stability is high.It is a kind of advanced person's form of Chinese drug.
Qi-circulation promoting soft capsule of the present invention, drop pill have improved bioavailability of medicament, simultaneously simple, the convenient needs that can satisfy the production of industrialization preferably of economic operation of the preparation technology of extract.
Qi-circulation promoting soft capsule of the present invention and pulse invigorating pill prove that in pharmacodynamic study this medical instrument has the drug action of obvious treatment coronary heart disease, and this medicine is expected to become the new good medicine of treatment ischemic cardio cerebrovascular diseases.Below by effect experiment beneficial effect of the present invention is described.
Pharmacological action:
Pharmacological action shows that qi-circulation promoting soft capsule and pulse invigorating pill can the obvious experimental artery thrombosis times of prolong rats.Orally give qi-circulation promoting soft capsule and pulse invigorating pill have tangible curative effect to Acute Myocardial Ischemia in Rats.
The effectiveness of multiple model evaluation qi-circulation promoting soft capsule treatment cardiac-cerebral ischemia is adopted in this research, and compares with the TONGMAI KOUFUYE of having gone on the market.Experimental result shows:
Rats gavaged promotes blood circulation 5,10,20g crude drug/kg, and every day 1 time, continuous 5 days, can suppress in various degree because of the anterior descending coronary ligation causes raising of II lead electrocardiogram ST section, high dose 5min begins onset, keeps more than the 180min; Can dwindle myocardial infarct size, 5.7% (P＞0.05) that descended respectively, infarcted region/hazardous area, 18.2% (P＞0.05), 23.8% (P＜0.05), 12.5% (P＞0.05) that descended respectively, infarcted region/left chamber, 28.1% (P＜0.05), 31.3% (P＜0.05); Suppressing serum myocardium enzyme level raises, AST raises and has suppressed 14.3% (P＞0.05) respectively, 17.9% (P＜0.05), 20.5% (P＜0.05), LDH raises and has suppressed 9.4% (P＞0.05), 14.0% (P＞0.05) respectively, 16.1% (P＜0.05), CK-MB raises and has suppressed-0.5% (P＞0.05) respectively, 8.6% (P＞0.05), 24.6% (P＜0.05).Its function of resisting myocardial ischemia is suitable with isodose TONGMAI KOUFUYE.
Cause on the dog acute myocardial ischemia model in the ligation anterior descending coronary, duodenum promotes blood circulation 2,4,8g crude drug/kg, the degree of ischemia of epicardial electrogram mapping is obviously improved, with matched group relatively, 3 dosage groups, 36.8 ± 17.8% (P＜0.01) that descended respectively, 43.9 ± 20.3% (P＜0.01), 60.9 ± 14.3% (P＜0.001); The ischemia scope also has in various degree dwindles.Myocardial infarct size obviously dwindles, and has dwindled 5.9% (P＞0.05) respectively, 24.8% (P＜0.05), 29.7% (P＜0.05); High dose can obviously suppress the rising of Serum LDH cardiac muscle isozyme level, and middle and high dosage reduces myocardial oxygen consumption; To coronary flow, vascular resistance, system's blood pressure and heart rate do not make significant difference.Its intensity is suitable with TONGMAI KOUFUYE such as dosage such as grade.
The specific embodiment:
The following examples can help those skilled in the art more fully to understand the present invention, but do not limit the present invention in any way.
Embodiment 1
Preparation technology
Radix Ginseng 1250g, Rhizoma Corydalis 1250g are ground into coarse powder, add 10 times of amount 80% ethanol room temperatures dippings 5 times, each 48 hours, merge impregnation liquid.Decompression recycling ethanol also concentrates, and filters, and filtrate is crossed macroporous adsorbent resin AB-8 post, aqueous hydrochloric acid solution washing resin bed with the pH7 of 10 times of amounts of column volume, after washing post,, collect eluent with 90% ethanol elution of 5 times of amounts of column volume, decompression recycling ethanol, concentrate, vacuum drying gets dry extract, pulverize, standby.
Radix Saposhnikoviae powder 1250g is broken into coarse powder, adds 10 times of amount 90% ethanol room temperatures dippings 5 times, each 48 hours, merges impregnation liquid.Decompression recycling ethanol concentrates, and layering gets Radix Saposhnikoviae extract, and is standby.
(1)
Above-mentioned dry extract and Radix Saposhnikoviae extract are merged, add adjuvant Petiolus Trachycarpi oil 10%, Cera Flava 5%, supply final quantity, make suspension with soybean oil.Be pressed into 1000 of soft capsules on the mould machine rolling automatically.Through washing ball, drying, polishing, packing are promptly.
(2).
Dry extract and Radix Saposhnikoviae extract are merged, add Polyethylene Glycol-4000, stir and make whole dissolvings and mix homogeneously, keep splashing in the liquid paraffin (5～10 ℃) under 60～90 ℃ of constant temperatures, be condensed into drop pill, exhaust liquid paraffin, the choosing grain, promptly.
Embodiment 2
Preparation technology
Radix Ginseng 1250g, Rhizoma Corydalis 1250g are ground into coarse powder, add 2 times of amount 40% ethanol room temperatures dippings 2 times, each 12 hours, merge impregnation liquid.Decompression recycling ethanol also concentrates, and filters, and filtrate is crossed macroporous adsorbent resin D101 post, aqueous hydrochloric acid solution washing resin bed with the pH2 of 3 times of amounts of column volume, after washing post,, collect eluent with 30% ethanol elution of 2 times of amounts of column volume, decompression recycling ethanol, concentrate, vacuum drying gets dry extract, pulverize, standby.
Radix Saposhnikoviae 1250g is ground into coarse powder, adds 2 times of amount 60% ethanol room temperatures dippings 2 times, each 12 hours, merges impregnation liquid.Decompression recycling ethanol concentrates, and layering gets Radix Saposhnikoviae extract, and is standby.
(1).
Dry extract and Radix Saposhnikoviae extract are merged, add Petiolus Trachycarpi oil 12%, Cera Flava 7%g, soybean oil is supplied final quantity, makes suspension.Be pressed into soft capsule rolling automatically on the mould machine.Through washing ball, drying, polishing, packing are promptly.
(2)
Dry extract and Radix Saposhnikoviae extract are merged, add 30% Polyethylene Glycol-4000,50%g Polyethylene Glycol-6000, stir and make whole dissolvings and mix homogeneously, keep splashing in the methyl-silicone oil (5～10 ℃) under 60 ℃ of constant temperatures, be condensed into drop pill.Blot methyl-silicone oil, the choosing grain, promptly.
Embodiment 3
Preparation technology
Radix Ginseng 1250g, Rhizoma Corydalis 1250g are ground into coarse powder, add 5 times of amount 60% ethanol room temperatures dippings 4 times, each 20 hours, merge impregnation liquid.Decompression recycling ethanol also concentrates, and filters, and filtrate is crossed macroporous adsorbent resin AB-8 post, aqueous hydrochloric acid solution washing resin bed with the pH3 of 5 times of amounts of column volume, after washing post,, collect eluent with 50% ethanol elution of 5 times of amounts of column volume, decompression recycling ethanol, concentrate, vacuum drying gets dry extract, pulverize, standby.
Radix Saposhnikoviae 1250g is ground into coarse powder, adds 4 times of amount 70% ethanol room temperatures dippings 2 times, each 20 hours, merges impregnation liquid.Decompression recycling ethanol concentrates, and layering gets Radix Saposhnikoviae extract, and is standby.
(1)
Dry extract and Radix Saposhnikoviae extract are merged, add adjuvant Cera Flava 6%, Petiolus Trachycarpi oil 4%, soybean oil is supplied final quantity, makes suspension.Be pressed into soft capsule rolling automatically on the mould machine.Through washing ball, drying, polishing, packing are promptly.
(2)
Just dry extract and Radix Saposhnikoviae extract merge, and add 70% Polyethylene Glycol-6000, stir and make whole dissolvings and mix homogeneously, keep splashing in the methyl-silicone oil (5～10 ℃) under 60 ℃ of constant temperatures, are condensed into drop pill, exhaust methyl-silicone oil, the choosing grain, promptly.
Embodiment 4
Preparation technology
Radix Ginseng 1250g, Rhizoma Corydalis 1250g are ground into coarse powder, add 5 times of amount 60% ethanol room temperatures dippings 4 times, each 20 hours, merge impregnation liquid.Decompression recycling ethanol also concentrates, and filters, and filtrate is crossed macroporous adsorbent resin D101 post, aqueous hydrochloric acid solution washing resin bed with the pH2 of 3 times of amounts of column volume, after washing post,, collect eluent with 30 ethanol elutions of 2 times of amounts of column volume, decompression recycling ethanol, concentrate, vacuum drying gets dry extract, pulverize, standby.
Radix Saposhnikoviae 1250g is ground into coarse powder, adds 4 times of amount 75% ethanol room temperatures dippings 2 times, each 18 hours, merges impregnation liquid.Decompression recycling ethanol concentrates, and layering gets Radix Saposhnikoviae extract, and is standby.
(1)
Above-mentioned two kinds of extracts merge, and add adjuvant Petiolus Trachycarpi oil 8%, Cera Flava 3%, and soybean oil is supplied final quantity, makes suspension.Be pressed into soft capsule rolling automatically on the mould machine.Through washing ball, drying, polishing, packing are promptly.
(2)
Dry extract and Radix Saposhnikoviae extract are merged, add 20%g Macrogol 4000,50% polyethylene glycol 6000, stir and make whole dissolvings and mix homogeneously, keep splashing in the white oil (5～10 ℃) under 60 ℃ of constant temperatures, be condensed into drop pill, exhaust white oil, the choosing grain, promptly.
Claims (2)
1. Chinese medicine preparation that is used for the treatment of ischemic cardio cerebrovascular diseases is characterized in that:
(1) Radix Ginseng, Rhizoma Corydalis are ground into coarse powder, add 2～10 times of 40～80% ethanol of medical material weight, room temperature dipping 2～5 times each 12～48 hours, merges impregnation liquid;
(2) concentrating under reduced pressure filters, and filtrate is crossed macroporous adsorptive resins, with the aqueous hydrochloric acid solution washing resin bed of pH2～7 of 3～10 times of amounts of column volume, after washing post,, collect eluent, concentrating under reduced pressure with 30～90% ethanol elutions of 2～5 times of amounts of column volume, vacuum drying gets dry extract, pulverizes standby;
(3) Radix Saposhnikoviae powder is broken into coarse powder, adds 2～10 times of amount 60～90% ethanol, room temperature dipping 2～5 times, each 12～48 hours, merge impregnation liquid, concentrating under reduced pressure, static layering, Radix Saposhnikoviae extract, standby;
(4) in proportion above-mentioned 2,3 extracts are merged, add pharmaceutic adjuvant and make suspension, be pressed into soft capsule rolling automatically on the mould machine, through washing ball, drying, polishing, packing are promptly;
(5) in proportion above-mentioned 2,3 extracts are merged, add Polyethylene Glycol, stir and make whole dissolvings and mix homogeneously, keep under 60～90 ℃ of constant temperatures, splash in liquid paraffin or the methyl-silicone oil in 5～10 ℃, be condensed into drop pill, exhaust liquid paraffin or methyl-silicone oil, coating, the choosing grain, promptly.
2. Chinese medicine preparation as claimed in claim 1, wherein, described macroporous adsorptive resins is AB-8, D101.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102228493A (en) * | 2011-06-27 | 2011-11-02 | 北京大学第一医院 | Medicine for treating coronary heart disease |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102228493A (en) * | 2011-06-27 | 2011-11-02 | 北京大学第一医院 | Medicine for treating coronary heart disease |
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Application publication date: 20110518 |