CN1981802A - Chinese-medicinal preparation for treating cardiovascular diseases, its production and use - Google Patents
Chinese-medicinal preparation for treating cardiovascular diseases, its production and use Download PDFInfo
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Abstract
A Chinese medicine in the form of injection, dripping pill, or dispersing tablet for treating ischemic cerebral apoplexy, coronary heart disease, angina pectoris, cardiac function insufficiency, apoplexy sequelae, hepatorenal syndrome, cardiopulmonary disease, diabetes, etc is prepared from ginsenoside and astragalus polyose. Its preparing process is also disclosed.
Description
Technical field
The present invention is a kind of Chinese medicine preparation for the treatment of cardiovascular and cerebrovascular disease and its production and application, belongs to technical field of Chinese medicine.
Technical background
According to national health department's investigation statistics, 2004, ten thousand people died from cardiovascular and cerebrovascular disease surplus China had 260, and people's death was just arranged in average per 12 seconds, cardiovascular and cerebrovascular disease patient sum nearly 1.5 hundred million, and annual control expenditure surpasses 100,000,000,000.And the cardiovascular and cerebrovascular disease patient generally has hyperlipemia, hypertension, high blood viscosity, thrombosis, sclerosis of blood vessels, angiostenosis etc.If the Therapeutic Method of " medicine one is controlled, treated the head when the head aches, foot cure foot bitterly " according at present, so the patient must eat every day surplus " lipid lowerers, the depressor, fall the sticking medicine of blood, Pimobendane, thrombolytic medicine " etc. five, six kind even ten in the kind, Western medicine.Better prevent and treat purpose in order to reach, a large amount of research has been done by many inventors and medicine enterprise, and some outstanding treatment products also are provided; As: the number of patent application of the applicant's application is: 200410022503, name is called the patent application of " Chinese medicine preparation of antitumor and enhancing immunity and preparation method thereof ", and the disease that it is used for the treatment for the treatment of cardiac and cerebral vascular diseases has definite curative effect; But in further investigation, find, adopt the effective site compatibility can not only reduce patient's dose, remove the strong composition of some toxic and side effects in the medicinal substances extract, the safety of preparation and the controllability of quality have been improved, greatly improve curative effect, and more help the molding of preparation, reduced some unnecessary technologies in the forming process.
Summary of the invention
The objective of the invention is to: a kind of Chinese medicine preparation for the treatment of cardiovascular and cerebrovascular disease and its production and application is provided; The present invention is directed to prior art, according to cardiovascular and cerebrovascular disease such as coronary heart disease, cerebral thrombosis, alzheimer disease etc. all contract because of blood vessel is narrow, reason such as blood flow minimizing causes the diseases induced principle of blood supply insufficiency, on the basis of experiment screening, adopt Radix Ginseng total saponins, Radix Astragali Mongolici total polysaccharide compatibility to make preparation, optimize best prescription and technology; The product that obtains, particularly ejection preparation product can play activating blood circulation to dissipate blood stasis, TONGMAI SHULUO, improve blood circulation and metabolism.For example coronary heart disease is that coronary atherosclerosis causes myocardial ischemia, anoxia and the heart disease that causes, and two medicines share, and can play to improve the myocardial metabolism effect, increase coronary flow, and the blood that improves cardiac muscle is provided with the effect of allevating angina pectoris.The present invention has curative effect preferably for treating cardiovascular and cerebrovascular disease such as coronary heart disease, angina pectoris, arrhythmia, cerebral thrombosis, alzheimer disease etc.And the present invention is pure Chinese medicinal preparation, but the little patients life-time service of its untoward reaction.
The present invention constitutes like this: calculate according to percentage by weight, it is to be made by Radix Ginseng total saponins 1～99% and Radix Astragali Mongolici total polysaccharide 99～1% and suitable adjuvant.Be preferably: calculate according to percentage by weight, it is to be made by Radix Ginseng total saponins 80～20% and Radix Astragali Mongolici total polysaccharide 20～80% and suitable adjuvant.Say accurately: calculate according to percentage by weight, it is to be made by Radix Ginseng total saponins 40～60%, Radix Astragali Mongolici total polysaccharide 60～40% and suitable adjuvant.Radix Ginseng total saponins in the described prescription can be the highly finished product of panaxynol extract, Radix Ginseng water extract, Radix Ginseng water extract-alcohol precipitation extract, Radix Ginseng semi-bionic extraction thing, Radix Ginseng supercritical extract or above each extract; Radix Astragali Mongolici total polysaccharide can be the (+)-Astragenol extract, Radix Astragali water extract, Radix Astragali water extract-alcohol precipitation extract, Radix Astragali semi-bionic extraction thing, the described preparation of the highly finished product of Radix Astragali supercritical extract or above each extract is the injection that is directly used in drug administration by injection, directly supply the venous transfusion of intravenous drip, need to be used for the concentrated solution for injection of intravenous drip and injectable sterile powder and aseptic block and the tablet that makes with freeze-drying or spray drying method after the dilution, capsule, granule, drop pill, pill, soft capsule, oral liquid, oral cavity disintegration tablet, Sublingual tablet or dispersible tablet.Described preparation can make on the basis that in Radix Ginseng total saponins and the Radix Astragali Mongolici total polysaccharide one or both is prepared into liposome or pro-liposome.Contain saponin component and polysaccharide composition in the preparation, calculate by weight percentage, in the preparation saponin component content, polysaccharide component content sum be not less than deduction adjuvant amount and water quantities in the preparation total solid 50%.Calculate according to percentage by weight, the content of total saponins is not less than 50% in the Radix Ginseng total saponins, and the content of total polysaccharides is not less than 50% in the Radix Astragali Mongolici total polysaccharide.
The Chinese medicine preparation Chinese medicine effective site of described treatment cardiovascular and cerebrovascular disease is commercially available or prepares as follows:
A, Radix Astragali Mongolici total polysaccharide effective site are preparations like this: get Milkvetch Root, adding entry or alcoholic solution after the pulverizing extracts, merge extractive liquid,, filter, concentrate Radix Astragali crude extract, adopt in ethanol precipitation, column chromatography, extraction, the flocculent precipitation one or more to unite on this basis to use carry out suitably refining, Radix Astragali Mongolici total polysaccharide effective site;
B, Radix Ginseng total saponins effective site are preparations like this: get the ginseng crude drug, adding entry or alcoholic solution after the pulverizing extracts, merge extractive liquid,, filter, concentrate the Radix Ginseng total saponins crude extract, or adopt in ethanol precipitation, column chromatography, extraction, the flocculent precipitation one or more to unite on this basis to use carry out suitably refining, Radix Ginseng total saponins effective site;
Injectable sterile block in the described preparation prepares like this: get Radix Ginseng total saponins, Radix Astragali Mongolici total polysaccharide, press medicine and added mannitol than 1: 3.0 with supplementary product consumption, add 1800ml water for injection, stirring makes dissolving, with saturated sodium hydroxide solution adjust pH to 6.5～7.0, add the injection water to 2000ml, mixing, the needle-use activated carbon of adding 0.5%, boiled 30 minutes, coarse filtration, reuse 0.45 μ m and 0.22 μ m microporous filter membrane filter, the filtrate packing, every bottle of 2.0ml, lyophilization, the equilibration time when the balance solidification point of phase I is 0 ℃ is 2.5 hours, i.e. the time of shelf temperature and product temperature basically identical; The second stage solidification point is from 0 ℃ during to minimum eutectic temperature-18 ℃, and shelf temperature and product temperature equilibration time are 2.5 hours; Phase III continues to be cooled to-45 ℃, needs 2.5 hours approximately, keeps this temperature 2.5 hours, freeze the jail fully until product, promptly begin evacuation, enter drying program, evacuation under-45 ℃ of constant temperature slowly heats up 2～4 ℃/h, to the lowest total of the melting point temperature, the time is about 10 hours, after sublimation drying is finished, continuation is under the low pressure condition, and it is dry to remove residual moisture to heat up, and the time is about 9～10 hours, kept more than 35 ℃ dry 2.5 hours, gland, promptly.
Pro-liposome in the described preparation prepares like this: get Radix Ginseng total saponins, Radix Astragali Mongolici total polysaccharide, add the phosphate buffer dissolving, add in the fused solution of fabaceous lecithin, cholesterol and 18-amine. mixing, stir supersound process, freezing, the dry powder that obtains sieves, promptly.
Described preparation is used to prepare the medicine of diseases such as treatment ischemia apoplexy, angina pectoris, cardiac insufficiency, apoplexy sequela, hepatorenal syndrome, heart and lung diseases, diabetes and complication thereof.
Compared with prior art, the applicant carried out lot of experiments, and filtering out the prescription for the treatment of diseases such as angina pectoris is Radix Ginseng total saponins, Radix Astragali Mongolici total polysaccharide, and best compatibility scope is Radix Ginseng total saponins 40～60%, Radix Astragali Mongolici total polysaccharide 60%～40%.Adopt good, the steady quality of prepared product appearance of the present invention.
For proving that medicine provided by the invention has effective effect, the applicant has carried out a series of experiments;
Experimental example 1: to the comparative study of different proportioning pharmacodynamics
We by antiplatelet aggregation test, suppress the mouse tail thrombotest, the prescription of different proportion has been carried out the screening test of system, the result is as follows:
| The prescription research conclusion | |||
| Formula number | Prescription is formed and ratio | The screening and assessment index | |
| Radix Astragali Mongolici total polysaccharide: Radix Ginseng total saponins | Platelet suppression ratio (%) | Thrombosis suppression ratio (%) | |
| 1 2 3 4 5 6 7 8 | 1: 99 20: 80 40: 60 60: 40 80: 20 99: 1 positive controls of model group | 0.24％ 45.6％ 51.1％ 59.9％ 60.6％ 52.3％ 48.2 59.7％ | -0.13％ 23.3％ 34.2％ 41.7％ 40.4％ 35.1％ 25.5％ 40.8％ |
By experimental result as can be known, Radix Ginseng total saponins, the best compatibility scope of Radix Astragali Mongolici total polysaccharide are Radix Ginseng total saponins 60～40% and Radix Astragali Mongolici total polysaccharide 40～60%.
Experimental example 2: injection Study on Forming
2.1 the selection of filler kind and consumption
The applicant finds that in development suitable filler, filler loading are powder injection formulation molding and stable key factor, and in order to improve the quality of this powder injection formulation, at first, the applicant investigates the kind and the consumption of filler.The results are shown in following table.
Different filler kinds and consumption are to the influence of lyophilizing effect
| Filler | Medicine: filler | Color | Mouldability | Water solublity | Clarity |
| Glucose glucose glucosylmannitol sweet mellow wine sweet mellow wine lactose lactose lactose | 1∶2.5 1∶3.0 1∶3.5 1∶2.5 1∶3.0 1∶3.5 1∶2.5 1∶3.0 1∶3.5 | ---yellow yellow faint yellow--- | The carefully not moulding of or not of not moulding of not moulding of or not of not moulding difference | ---be good carefully--- | ---difference good job--- |
As seen, because the eutectic point height of mannitol, good water solubility be beneficial to the lyophilizing and the molding of this product, and other filler all is not suitable for this product, and when medicine: during mannitol=1: 3.0, the formed product effect is best, so definite medicine: mannitol=1: 3.0.
Experimental example 3: preparation pharmacodynamic experiment
Protective effect to Acute Myocardial Ischemia in Rats: get the SD rat; body weight 230～250g; male and female half and half; be divided into model group (giving the equivalent normal saline every day), oral liquid group of the present invention (administration every day 60mg/kg), injection group of the present invention (administration every day 60mg/kg), liposome group of the present invention (administration every day 60mg/kg) and Radix Ginseng/Radix Astragali 60/40 medicinal substances extract proportioning injection group at random and (be called for short medical material compatibility group; administration every day 60mg/kg); every group 10; continuous 7 days, 1h ligation rat coronary artery left anterior descending branch after the last administration.Ventricle is got blood 3ml behind coronary ligation 3h, and centrifugal 5min prepares serum with the speed of 3000 * g, gets serum, measures corresponding index in the serum respectively with superoxide dismutase (SOD), malonaldehyde (MDA) test kit.Win rat heart and discharge hematocele in the chambers of the heart, inhale the branch that anhydrates, reject non-cardiac muscular tissues such as fatty blood vessel, wipe out atrium and right ventricle, stay left ventricle and weigh, calculate infarcted region (weight in wet base) and account for left ventricle (weight in wet base) percentage ratio with normal saline flushing and with filter paper.The results are shown in following table.
Influence to SOD, MDA in myocardial infarct size and the serum behind the rat coronary ligation
| Group | Heart infarction scope (%) | SOD(NU/ml) | MDA(nmol/ml) |
| Model group injection group of the present invention oral liquid group of the present invention liposome group of the present invention medical material compatibility group | 21.5±1.8 14.9±1.6 16.6±1.1 13.8±0.9 16.7±2.0 | 185.3±34.5 341.8±31.2 315.9±45.0 353.4±35.8 296.7±32.6 | 7.96±1.56 4.43±1.27 4.89±1.09 4.07±0.95 5.17±0.78 |
By experimental result as can be known, pharmaceutical preparation of the present invention can obviously improve SOD activity in the coronary ligation rat blood serum, has significantly suppressed the generation of MDA, and obviously reduces myocardial infarction district area, the effect of lipidosome injection group is stronger, and the whole curative effect of preparation of the present invention all is better than medical material compatibility group.
Concrete embodiment:
Embodiments of the invention 1: Radix Ginseng total saponins 60g Radix Astragali Mongolici total polysaccharide 40g
Get Radix Ginseng total saponins, Radix Astragali Mongolici total polysaccharide, press medicine and added mannitol than 1: 3.0 with supplementary product consumption, add 1800ml water for injection, stirring makes dissolving, with saturated sodium hydroxide solution adjust pH to 6.5～7.0, add the injection water to 2000ml, mixing, the needle-use activated carbon of adding 0.5%, boiled 30 minutes, coarse filtration, reuse 0.45 μ m and 0.22 μ m microporous filter membrane filter, the filtrate packing, every bottle of 2.0ml, lyophilization, the equilibration time when the balance solidification point of phase I is 0 ℃ is 2.5 hours, i.e. the time of shelf temperature and product temperature basically identical; The second stage solidification point is from 0 ℃ during to minimum eutectic temperature-18 ℃, and shelf temperature and product temperature equilibration time are 2.5 hours; Phase III continues to be cooled to-45 ℃, needs 2.5 hours approximately, keeps this temperature 2.5 hours, freeze the jail fully until product, promptly begin evacuation, enter drying program, evacuation under-45 ℃ of constant temperature, slowly heat up, 2～4 ℃/h, to the lowest total of the melting point temperature, the time is about 10 hours, after sublimation drying is finished, continuation is under the low pressure condition, and it is dry to remove residual moisture to heat up, and the time is about 9～10 hours, kept more than 35 ℃ dry 2.5 hours, gland promptly gets the Injectable sterile block, one time 2,1 time on the one, with using behind the 250ml0.9% physiological saline solution.Calculate by weight percentage, in the injection saponin component content polysaccharide component content sum be deduction adjuvant amount and water quantities in the preparation total solid 81%.
Wherein, personal total saponins is preparation like this:
Get the ginseng crude drug and add 10 times of amount 60% alcohol reflux three times, each 1 hour, the extracting solution concentrating under reduced pressure reclaimed ethanol, concentrated solution adds 4 times of medical material water gagings changes molten, centrifugal, AB-8 post absorption on the supernatant, be washed to colourless, 70% ethanol of 10 times of column volumes is washed till colourless, D280 post on 70% ethanol elution, 90% ethanol elution, collect the effluent of 5 times of column volumes, the eluent concentrating under reduced pressure, vacuum drying promptly gets Radix Ginseng total saponins.
Radix Astragali Mongolici total polysaccharide is preparation like this:
Milkvetch Root adds 8 times of amount 90% ethanol, water-bath reflux, extract, 3 times, 1h/ time, merge extractive liquid,, decompression recycling ethanol, AB-8 type macroporous adsorbent resin on the concentrated solution, last sample flow velocity 0.2ml/ (cm
2Min), after the completion of the sample, wash with water to effluent colourlessly, it is standby to collect water lotion; After astragalus root dregs after the alcohol extraction is flung to ethanol, add 6 times of water gagings, heating extraction 3 times, 2h/ time.Be evaporated to 1ml/ gram medical material behind the water extract, cold preservation is spent the night, and gets supernatant after centrifugal, adds ethanol content is reached more than 80%, after leaving standstill 24h, inclining supernatant, centrifugal, and precipitation is washed 2 times with proper amount of acetone, put drying in the exsiccator, do the back and grind, promptly get Radix Astragali Mongolici total polysaccharide.
Embodiments of the invention 2: Radix Ginseng total saponins 60g Radix Astragali Mongolici total polysaccharide 40g
Get Radix Ginseng total saponins, Radix Astragali Mongolici total polysaccharide, add an amount of water for injection dissolving, by volume add 0.5% active carbon, boil, keep little 30min that boils, cold slightly filtration, filtrate adds the injection water to ormal weight, with saturated sodium hydroxide solution adjust pH to 6.5～7.0, boils, 4 ℃ of cold preservations are spent the night, coarse filtration, fine straining add the injection water, divide to install to pacify and cut open bottle, seal sterilization, promptly get injection and concentrated solution for injection.
Embodiments of the invention 3: Radix Ginseng total saponins 40g Radix Astragali Mongolici total polysaccharide 60g
Get Radix Ginseng total saponins, Radix Astragali Mongolici total polysaccharide, add an amount of water for injection dissolving, by volume add 0.5% active carbon, boil, keep little 30min that boils, cold slightly filtration, filtrate adds the injection water to ormal weight, with saturated sodium hydroxide solution adjust pH to 6.5～7.0, boils, 4 ℃ of cold preservations are spent the night, coarse filtration, fine straining add the injection water, divide to install to pacify and cut open bottle, seal sterilization, promptly get injection and concentrated solution for injection.
Embodiments of the invention 4: Radix Ginseng total saponins 40g Radix Astragali Mongolici total polysaccharide 60g
Get Radix Ginseng total saponins, Radix Astragali Mongolici total polysaccharide, press medicine and added mannitol than 1: 3.0 with supplementary product consumption, add 1800ml water for injection, stirring makes dissolving, with saturated sodium hydroxide solution adjust pH to 6.5～7.0, add the injection water to 2000ml, mixing, the needle-use activated carbon of adding 0.5%, boiled 30 minutes, coarse filtration, reuse 0.45 μ m and 0.22 μ m microporous filter membrane filter, the filtrate packing, every bottle of 2.0ml, lyophilization, the equilibration time when the balance solidification point of phase I is 0 ℃ is 2.5 hours, i.e. the time of shelf temperature and product temperature basically identical; The second stage solidification point is from 0 ℃ during to minimum eutectic temperature-18 ℃, and shelf temperature and product temperature equilibration time are 2.5 hours; Phase III continues to be cooled to-45 ℃, need 2.5 hours approximately, kept this temperature 2.5 hours, freeze the jail fully until product, promptly begin evacuation, enter drying program, evacuation under-45 ℃ of constant temperature, slowly heat up, 2～4 ℃/h, to the lowest total of the melting point temperature, time is about 10 hours, after sublimation drying is finished, continue under the low pressure condition, it is dry to remove residual moisture to heat up, time is about 9～10 hours, kept more than 35 ℃ dry 2.5 hours, and under aseptic condition, divided to install in the cillin bottle, promptly get injectable sterile powder.
Embodiments of the invention 5: Radix Ginseng total saponins 50g Radix Astragali Mongolici total polysaccharide 50g
Get Radix Ginseng total saponins, Radix Astragali Mongolici total polysaccharide, add an amount of water for injection dissolving, by volume add 0.5% active carbon, boil, keep little 30min that boils, cold slightly filtration, filtrate adds the injection water to ormal weight, with saturated sodium hydroxide solution adjust pH to 6.5～7.0, boils, 4 ℃ of cold preservations are spent the night, coarse filtration, fine straining add the injection water, divide to install to pacify and cut open bottle, seal sterilization, promptly get injection and concentrated solution for injection.
Embodiments of the invention 6: Radix Ginseng total saponins 50g Radix Astragali Mongolici total polysaccharide 50g
Get Radix Ginseng total saponins, Radix Astragali Mongolici total polysaccharide, press medicine and added mannitol than 1: 3.0 with supplementary product consumption, add 1800ml water for injection, stirring makes dissolving, with saturated sodium hydroxide solution adjust pH to 6.5～7.0, add the injection water to 2000ml, mixing, the needle-use activated carbon of adding 0.5%, boiled 30 minutes, coarse filtration, reuse 0.45 μ m and 0.22 μ m microporous filter membrane filter, the filtrate packing, every bottle of 2.0ml, lyophilization, the equilibration time when the balance solidification point of phase I is 0 ℃ is 2.5 hours, i.e. the time of shelf temperature and product temperature basically identical; The second stage solidification point is from 0 ℃ during to minimum eutectic temperature-18 ℃, and shelf temperature and product temperature equilibration time are 2.5 hours; Phase III continues to be cooled to-45 ℃, need 2.5 hours approximately, kept this temperature 2.5 hours, freeze the jail fully until product, promptly begin evacuation, enter drying program, evacuation under-45 ℃ of constant temperature, slowly heat up, 2～4 ℃/h, to the lowest total of the melting point temperature, time is about 10 hours, after sublimation drying is finished, continue under the low pressure condition, it is dry to remove residual moisture to heat up, time is about 9～10 hours, kept more than 35 ℃ dry 2.5 hours, and under aseptic condition, divided to install in the cillin bottle, promptly get injectable sterile powder.
Embodiments of the invention 7: Radix Ginseng total saponins 95g Radix Astragali Mongolici total polysaccharide 5g
Get Radix Ginseng total saponins, Radix Astragali Mongolici total polysaccharide, mixing adds an amount of water for injection dissolving, by volume add 0.5% active carbon, boil, keep little 30min that boils, cold slightly filtration, filtrate add the injection water to ormal weight, with saturated sodium hydroxide solution adjust pH to 6.5～7.0, boil, 4 ℃ of cold preservations are spent the night, and coarse filtration, fine straining are 130 ℃ in inlet temperature, leaving air temp is 60 ℃, and air velocity is 20ms
-1Condition under spray drying get powder, packing promptly gets injectable sterile powder.
Embodiments of the invention 8: Radix Ginseng total saponins 5g Radix Astragali Mongolici total polysaccharide 95g
Get Radix Ginseng total saponins, Radix Astragali Mongolici total polysaccharide, add an amount of water for injection dissolving, add the glucose or the sodium chloride of ormal weight, by volume add 0.5% active carbon behind the mixed dissolution, boil, keep little 30min that boils, cold slightly filtration, filtrate add the injection water to ormal weight, the saturated sodium hydroxide solution of reuse adjust pH to 6.5～7.0, boil, 4 ℃ of cold preservations are spent the night, and coarse filtration, fine straining add the injection water, packing, sterilization promptly gets glucose or sodium chloride intravenous infusion.
Embodiments of the invention 9: Radix Ginseng total saponins 80g Radix Astragali Mongolici total polysaccharide 20g
With Radix Ginseng total saponins and Radix Astragali Mongolici total polysaccharide mix homogeneously, add 6% carboxymethyl starch sodium and 1.1% sorbitol, compacting promptly gets oral cavity disintegration tablet in flakes.
Embodiments of the invention 10: Radix Ginseng total saponins 20g Radix Astragali Mongolici total polysaccharide 80g
With Radix Ginseng total saponins and Radix Astragali Mongolici total polysaccharide mix homogeneously, will be that 1: 1.5 poloxamer is put in the rustless steel container with the principal agent ratio, add extract, mix homogeneously is heated to 80-85 ℃, treat whole fusions after, 70-75 ℃ of insulation, mechanical high-speed are stirred 15min to evenly, are transferred in the reservoir, the dropping liquid valve is regulated in 70～75 ℃ of insulations, splashes in 30～35 ℃ the vegetable oil, drip apart from 5～6cm, drip 40～45 droplets/minute of speed, to the greatest extent and wipe vegetable oil the drop pill drop that forms, packing promptly gets drop pill.The content sum of saponin component in the preparation and polysaccharide composition is 55-65%.
Wherein, Radix Ginseng total saponins is preparation like this:
Get the ginseng crude drug, add 10 times of amount 60% alcohol reflux three times, each 1 hour, the extracting solution concentrating under reduced pressure reclaimed ethanol, and concentrated solution adds 4 times of medical material water gagings changes molten, centrifugal, D101 type macroporous adsorbent resin on the supernatant, last sample flow velocity 0.2ml/ (cm
2Min), wash remove impurity after the completion of the sample with water, be washed to effluent and do not show the molish reaction, 50% ethanol elution, elution flow rate is 1ml/ (cm
2Min), collect 10 times of resin volume eluents altogether, the eluent concentrating under reduced pressure, vacuum drying promptly gets Radix Ginseng total saponins.
Radix Astragali Mongolici total polysaccharide is preparation like this:
Milkvetch Root adds 8 times of amount 90% ethanol, water-bath reflux, extract, 3 times, 1h/ time, merge extractive liquid,, decompression recycling ethanol, AB-8 type macroporous adsorbent resin on the concentrated solution, last sample flow velocity 0.2ml/ (cm
2Min), after the completion of the sample, wash with water to effluent colourlessly, it is standby to collect water lotion; After astragalus root dregs after the alcohol extraction is flung to ethanol, add 6 times of water gagings, heating extraction 3 times, 2h/ time.Be evaporated to 1ml/ gram medical material behind the water extract, cold preservation is spent the night, and gets supernatant after centrifugal, adds 90% ethanol content is reached more than 60%, after leaving standstill 24h, filter, supernatant and macroporous resin water lotion merge, and are evaporated to small size, put drying in the exsiccator, do the back and grind, promptly get Radix Astragali Mongolici total polysaccharide.
Embodiments of the invention 11: Radix Ginseng total saponins 99g Radix Astragali Mongolici total polysaccharide 1g
With Radix Ginseng total saponins and Radix Astragali Mongolici total polysaccharide mix homogeneously, in principal agent: the ratio of adjuvant=1: 2.1 adds calcium phosphate, by principal agent: the ratio adding pregelatinized starch of adjuvant=1.5: 1, and press principal agent: the crospovidone of adjuvant=3: 1, evenly mixed, make soft material in right amount with 70% ethanol, cross 20 mesh sieve system granules, 50 ℃ of dryings are taken out, and cross 30 mesh sieve granulate, add an amount of Pulvis Talci, micropowder silica gel, evenly mixed, tabletting promptly gets dispersible tablet.
Embodiments of the invention 12: Radix Ginseng total saponins 1g Radix Astragali Mongolici total polysaccharide 99g
With Radix Ginseng total saponins and Radix Astragali Mongolici total polysaccharide mix homogeneously, add 2 times of amount starch, 0.6% lactose, 1.2% microcrystalline Cellulose with an amount of alcoholic solution system soft material, is granulated, and 70 ℃ of forced air dryings are granulated, and granulate promptly gets granule.
Embodiments of the invention 13: Radix Ginseng total saponins 70g Radix Astragali Mongolici total polysaccharide 30g
With Radix Ginseng total saponins and Radix Astragali Mongolici total polysaccharide mix homogeneously, add the dextrin of equivalent, mix homogeneously is granulated, and is encapsulated, promptly gets capsule.
Embodiments of the invention 14: Radix Ginseng total saponins 30g Radix Astragali Mongolici total polysaccharide 70g
With Radix Ginseng total saponins and Radix Astragali Mongolici total polysaccharide mix homogeneously, add distilled water, filter repeatedly, till the filtrate clarification., filter with absorbent cotton after the stirring and dissolving in filtrate with sucrose, it is an amount of to add distilled water on filter, shakes up, and promptly gets syrup.
Embodiments of the invention 15: Radix Ginseng total saponins 60g Radix Astragali Mongolici total polysaccharide 40g
With Radix Ginseng total saponins, Radix Astragali Mongolici total polysaccharide mix homogeneously, be dissolved in the phosphate buffer (0.1M) standby, a certain proportion of fabaceous lecithin, cholesterol are dissolved in the 18-amine. solution, add in the phosphate-buffered liquor of said medicine, the water-bath type Ultrasound Instrument is handled 10min, gets liposome turbid liquor, the phosphate buffer standardize solution, filtration sterilization, aseptic subpackaged, promptly get lipidosome injection.
Embodiments of the invention 16: Radix Ginseng total saponins 40g Radix Astragali Mongolici total polysaccharide 60g
With Radix Ginseng total saponins, Radix Astragali Mongolici total polysaccharide mix homogeneously, be dissolved in the phosphate buffer (0.1M) standby, a certain proportion of fabaceous lecithin, cholesterol are dissolved in the 18-amine. solution, add in the phosphate-buffered liquor of said medicine, the water-bath type Ultrasound Instrument is handled 8min, gets liposome turbid liquor, behind the frozen drying, cross 180 mesh sieves, aseptic subpackaged, promptly get the pro-liposome injectable powder.
Radix Ginseng total saponins among the above embodiment, Radix Astragali Mongolici total polysaccharide can be with Radix Ginseng total saponins, Radix Astragali Mongolici total polysaccharide commercially available or that make by the inventive method, no matter be alcohol extract, water extract, water extract-alcohol precipitation extract, semi-bionic extraction thing or supercritical extract etc., but, wherein the total saponin content of Radix Ginseng total saponins is greater than 50%, the total polysaccharides content of Radix Astragali Mongolici total polysaccharide can guarantee the therapeutic effect of product like this greater than 50%.
Claims (12)
1, a kind of Chinese medicine preparation for the treatment of cardiovascular and cerebrovascular disease is characterized in that: calculate according to percentage by weight, it is to be made by Radix Ginseng total saponins 1～99% and Radix Astragali Mongolici total polysaccharide 99～1% and suitable adjuvant.
2, according to the Chinese medicine preparation of the described treatment cardiovascular and cerebrovascular disease of claim 1, it is characterized in that: calculate according to percentage by weight, it is to be made by Radix Ginseng total saponins 80～20% and Radix Astragali Mongolici total polysaccharide 20～80% and suitable adjuvant.
3, according to the Chinese medicine preparation of claim 1 or 2 described treatment cardiovascular and cerebrovascular diseases, it is characterized in that: calculate according to percentage by weight, it is to be made by Radix Ginseng total saponins 40～60%, Radix Astragali Mongolici total polysaccharide 60～40% and suitable adjuvant.
4, according to the Chinese medicine preparation of any described treatment cardiovascular and cerebrovascular disease of claim 1～3, it is characterized in that: the Radix Ginseng total saponins in the described prescription can be the highly finished product of panaxynol extract, Radix Ginseng water extract, Radix Ginseng water extract-alcohol precipitation extract, Radix Ginseng semi-bionic extraction thing, Radix Ginseng supercritical extract or above each extract; Radix Astragali Mongolici total polysaccharide can be the highly finished product of (+)-Astragenol extract, Radix Astragali water extract, Radix Astragali water extract-alcohol precipitation extract, Radix Astragali semi-bionic extraction thing, Radix Astragali supercritical extract or above each extract.
5, according to the Chinese medicine preparation of any described treatment cardiovascular and cerebrovascular disease of claim 1～4, it is characterized in that: described preparation be directly used in the injection of drug administration by injection, directly for the venous transfusion of intravenous drip, need be used for the concentrated solution for injection of intravenous drip and injectable sterile powder and aseptic block and tablet, capsule, granule, drop pill, pill, soft capsule, oral liquid, oral cavity disintegration tablet, Sublingual tablet or the dispersible tablet that makes with freeze-drying or spray drying method after the dilution.
6, according to the Chinese medicine preparation of the described treatment cardiovascular and cerebrovascular disease of claim 5, it is characterized in that: described preparation can make on the basis that in Radix Ginseng total saponins and the Radix Astragali Mongolici total polysaccharide one or both is prepared into liposome or pro-liposome.
7, according to the Chinese medicine preparation of any described treatment cardiovascular and cerebrovascular disease in the claim 1～6, it is characterized in that: contain saponin component and polysaccharide composition in the preparation, calculate by weight percentage, in the preparation saponin component content, polysaccharide component content sum be not less than deduction adjuvant amount and water quantities in the preparation total solid 50%.
8, according to the Chinese medicine preparation of the described treatment cardiovascular and cerebrovascular disease of claim 4, it is characterized in that: calculate according to percentage by weight, the content of total saponins is not less than 50% in the Radix Ginseng total saponins, and the content of total polysaccharides is not less than 50% in the Radix Astragali Mongolici total polysaccharide.
9,, it is characterized in that described drug effective region is commercially available or prepares as follows as the Chinese medicine preparation of any described treatment cardiovascular and cerebrovascular disease in the claim 1～6:
A, Radix Astragali Mongolici total polysaccharide effective site are preparations like this: get Milkvetch Root, adding entry or alcoholic solution after the pulverizing extracts, merge extractive liquid,, filter, concentrate Radix Astragali crude extract, adopt in ethanol precipitation, column chromatography, extraction, the flocculent precipitation one or more to unite on this basis to use carry out suitably refining, Radix Astragali Mongolici total polysaccharide effective site;
B, Radix Ginseng total saponins effective site are preparations like this: get the ginseng crude drug, adding entry or alcoholic solution after the pulverizing extracts, merge extractive liquid,, filter, concentrate the Radix Ginseng total saponins crude extract, or adopt in ethanol precipitation, column chromatography, extraction, the flocculent precipitation one or more to unite on this basis to use carry out suitably refining, Radix Ginseng total saponins effective site.
10, preparation method according to the Chinese medicine preparation of any described treatment cardiovascular and cerebrovascular disease in the claim 1～6, it is characterized in that: the Injectable sterile block in the described preparation prepares like this: get Radix Ginseng total saponins, Radix Astragali Mongolici total polysaccharide, press medicine and added mannitol than 1: 3.0 with supplementary product consumption, add 1800ml water for injection, stirring makes dissolving, with saturated sodium hydroxide solution adjust pH to 6.5～7.0, add the injection water to 2000ml, mixing, the needle-use activated carbon of adding 0.5% boiled coarse filtration 30 minutes, reuse 0.45 μ m and 0.22 μ m microporous filter membrane filter, the filtrate packing, every bottle of 2.0ml, lyophilization, equilibration time when the balance solidification point of phase I is 0 ℃ is 2.5 hours, i.e. the time of shelf temperature and product temperature basically identical; The second stage solidification point is from 0 ℃ during to minimum eutectic temperature-18 ℃, and shelf temperature and product temperature equilibration time are 2.5 hours; Phase III continues to be cooled to-45 ℃, needs 2.5 hours approximately, keeps this temperature 2.5 hours, freeze the jail fully until product, promptly begin evacuation, enter drying program, evacuation under-45 ℃ of constant temperature slowly heats up 2～4 ℃/h, to the lowest total of the melting point temperature, the time is about 10 hours, after sublimation drying is finished, continuation is under the low pressure condition, and it is dry to remove residual moisture to heat up, and the time is about 9～10 hours, kept more than 35 ℃ dry 2.5 hours, gland, promptly.
11, according to the preparation method of the Chinese medicine preparation of the described treatment cardiovascular and cerebrovascular disease of claim 6, it is characterized in that: the pro-liposome in the described preparation prepares like this: get Radix Ginseng total saponins, Radix Astragali Mongolici total polysaccharide, add the phosphate buffer dissolving, add in the fused solution of fabaceous lecithin, cholesterol and 18-amine. mixing, stir supersound process, freezing, the dry powder that obtains sieves, promptly.
12, as the application of the Chinese medicine preparation of any described treatment cardiovascular and cerebrovascular disease in the claim 1～6, it is characterized in that: described preparation is used to prepare the medicine that the treatment ischemic is given birth to diseases such as apoplexy, angina pectoris, cardiac insufficiency, apoplexy sequela, hepatorenal syndrome, heart and lung diseases, diabetes and complication thereof.
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| CN 200510134204 CN1981802A (en) | 2005-12-12 | 2005-12-12 | Chinese-medicinal preparation for treating cardiovascular diseases, its production and use |
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