CN101028330A - Medicinal composition for treating cardiovascular disease, its production and use - Google Patents
Medicinal composition for treating cardiovascular disease, its production and use Download PDFInfo
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- CN101028330A CN101028330A CN 200610058725 CN200610058725A CN101028330A CN 101028330 A CN101028330 A CN 101028330A CN 200610058725 CN200610058725 CN 200610058725 CN 200610058725 A CN200610058725 A CN 200610058725A CN 101028330 A CN101028330 A CN 101028330A
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Abstract
A composite medicine in the form of injection or orally taken liquid or solid for treating ischemic cerebral apoplexy, coronary heart disease, angina pectoris, cardiac insufficiency, apoplexy sequela, hepatorenal syndrome, pneumocardial disease, and diabetes and its complication is prepared from astragalus root and gingko leaf. Its preparing process is also disclosed.
Description
Technical field
The present invention is a kind of pharmaceutical composition for the treatment of cardiovascular and cerebrovascular disease and its production and application, belongs to technical field of medicaments.
Technical background
Cardiovascular and cerebrovascular disease is meant that blood contamination causes atherosclerosis, thereby causes the corresponding pathological changes that cardiac-cerebral ischemia causes.Comprise: hypertension, atherosclerosis, coronary heart disease (heart infarction and angina pectoris), cerebral ischemia pathological changes (cerebral blood supply insufficiency, cerebral thrombosis, cerebral infarction) and cerebral hemorrhage.Atherosclerosis that causes behind the blood contamination and complication thereof are to cause the first dead killer.Atherosclerosis thrombosis and cause dead ratio to account for 52% of whole death tolls worldwide is considerably beyond the tumor (24%) of second cause of the death.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: number of patent application is: 200410040773.9, name is called the patent application of " compound formulation of astragalus root of treatment cardiovascular and cerebrovascular disease 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 pharmaceutical composition 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 Astragali total saponins and Folium Ginkgo total lactones 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 mainly is to be made by Radix Astragali total saponins 1～99% and Folium Ginkgo total lactones 99～1% and suitable adjuvant.Be preferably: calculate according to percentage by weight, it mainly is to be made by Radix Astragali total saponins 20～80% and Folium Ginkgo total lactones 80～20% and suitable adjuvant.Say accurately: calculate according to percentage by weight, it mainly is to be made by Radix Astragali total saponins 40～60% and Folium Ginkgo total lactones 60～40% and suitable adjuvant.Radix Astragali total saponins in the described prescription 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; Folium Ginkgo total lactones can be the highly finished product of Folium Ginkgo alcohol extract, Folium Ginkgo water extract, Folium Ginkgo water extract-alcohol precipitation extract, Folium Ginkgo semi-bionic extraction thing, Folium Ginkgo supercritical extract or above each extract.Described composite 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 or the dispersible tablet that makes with freeze-drying or spray drying method after the dilution.Contain saponin component and lactone composition in the composite preparation, calculate by weight percentage, saponin component content and lactone component content sum are not less than 50% of the total solid of deducting adjuvant amount and water quantities in the preparation in the composite preparation.Calculate according to percentage by weight, the content of total saponins is not less than 50% in the Radix Astragali total saponins, and the content of total lactone is not less than 50% in the Folium Ginkgo total lactones.
The preparation of drug combination method of described treatment cardiovascular and cerebrovascular disease:
A. Folium Ginkgo total lactones effective site is preparation like this: get the Folium Ginkgo medical material, adding entry or alcoholic solution after the pulverizing extracts, merge extractive liquid,, filter, concentrate ginkgo biloba 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, Folium Ginkgo total lactones effective site;
B. Radix Astragali total saponins effective site is preparation like this: get Milkvetch Root, adding entry or alcoholic solution after the pulverizing extracts, merge extractive liquid,, filter, concentrate Radix Astragali 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 Astragali total saponins effective site.
The Injectable sterile block of described compositions prepares like this: get Radix Astragali total saponins, Folium Ginkgo total lactones, press medicine: supplementary product consumption=1: 3 adding mannitol, add 1800ml water for injection, stirring makes dissolving, with saturated sodium hydroxide solution adjust pH to 6.0～6.5, 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 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-20 ℃, and shelf temperature and product temperature equilibration time are 2 hours; Phase III continues to be cooled to-50 ℃, 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-50 ℃ of constant temperature slowly heats up 2～4 ℃/h, to the lowest total of the melting point temperature, the time is about 14 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 hours, gland, promptly.
The injection and the concentrated solution for injection of described compositions prepare like this: get Radix Astragali total saponins, Folium Ginkgo total lactones, 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 6.0～6.5, boils, 4 ℃ of cold preservations are spent the night, coarse filtration, fine straining add the injection water, divide to install to ampoule bottle, seal sterilization, promptly.
Described compositions is mainly used in 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 Astragali total saponins, Folium Ginkgo total lactones, and best compatibility scope is Folium Ginkgo total lactones 40～60% and Radix Astragali total saponins 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 the ratio Radix Astragali total saponins: Folium Ginkgo total lactones | The screening and assessment index | |
| Platelet suppression ratio (%) | Thrombosis suppression ratio (%) | ||
| 1 | Model group | 0.29％ | -0.31％ |
| 2 | 1∶99 | 47.1％ | 21.5％ |
| 3 | 20∶80 | 51.8％ | 32.8％ |
| 4 | 40∶60 | 59.7％ | 41.6％ |
| 5 | 60∶40 | 60.5％ | 40.7％ |
| 6 | 80∶20 | 50.6％ | 32.5％ |
| 7 | 99∶1 | 45.8％ | 23.4％ |
| 8 | Positive controls | 58.2％ | 39.7％ |
By experimental result as can be known, Radix Astragali total saponins, the best compatibility scope of Folium Ginkgo total lactones are Folium Ginkgo total lactones 40～60% and Radix Astragali total saponins 60～40%.
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 of filler.The results are shown in following table.
Different filler lyophilizing effects relatively
| Filler | Mannitol | Glucose | Lactose | Sodium chloride | HP-β-CD |
| With the effective site ratio | 1∶3 | 1∶3 | 1∶3 | 1∶3 | 1∶3 |
| Mouldability | Good | Not molding | Not molding | Not molding | Not molding |
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, so selection mannitol is filler.
Then, the weight ratio of mannitol and effective ingredient is investigated, be the results are shown in following table.
The proportioning of different pharmaceutical and mannitol is to the influence of lyophilizing effect
| Medicine compares mannitol | Color | Mouldability | Water solublity | Clarity |
| 1∶1 | Yellow | Difference | Good | Difference |
| 1∶2 | Yellow | Good | Good | Difference |
| 1∶3 | Yellow | Good | Good | Good |
| 1∶3.5 | Faint yellow | Good | Good | Difference |
As seen, mannitol: effective ingredient=3: 1 o'clock, formed product is effective, and clarity is good, determines mannitol: effective ingredient=3: 1.
Experimental example 3: preparation pharmacodynamic experiment
Protective effect to Acute Myocardial Ischemia in Rats: get the SD rat; body constitution amount 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) and the Radix Astragali/Folium Ginkgo 50/50 medical material 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 | 21.5±2.9 | 162.4±32.5 | 10.51±1.25 |
| Injection group of the present invention | 12.8±1.7 | 339.6±26.7 | 5.43±1.04 |
| Oral liquid group of the present invention | 14.7±2.1 | 266.1±33.4 | 5.92±0.72 |
| Medical material compatibility group | 15.2±3.2 | 248.3±28.7 | 6.68±0.89 |
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.
Concrete embodiment
Embodiments of the invention 1: Radix Astragali total saponins 60g Folium Ginkgo total lactones 40g
Get Radix Astragali total saponins, Folium Ginkgo total lactones, press medicine: supplementary product consumption=1: 3 adding mannitol, add 1800ml water for injection, stirring makes dissolving, with saturated sodium hydroxide solution adjust pH to 6.0～6.5, 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 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-20 ℃, and shelf temperature and product temperature equilibration time are 2 hours; Phase III continues to be cooled to-50 ℃, 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-50 ℃ of constant temperature, slowly heat up, 2～4 ℃/h, to the lowest total of the melting point temperature, the time is about 14 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 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 total saponins constituents content and lactone component content sum be deduct in the preparation adjuvant amount and water quantities total solid 85%.
Embodiments of the invention 2: Radix Astragali total saponins 40g Folium Ginkgo total lactones 60g
Get Radix Astragali total saponins, Folium Ginkgo total lactones, press medicine: supplementary product consumption=1: 3 adding mannitol, add 1800ml water for injection, stirring makes dissolving, with saturated sodium hydroxide solution adjust pH to 6.0～6.5, 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 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-20 ℃, and shelf temperature and product temperature equilibration time are 2 hours; Phase III continues to be cooled to-50 ℃, 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-50 ℃ of constant temperature slowly heats up 2～4 ℃/h, to the lowest total of the melting point temperature, the time is about 14 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 hours, gland promptly gets the Injectable sterile block.
Embodiments of the invention 3: Radix Astragali total saponins 50g Folium Ginkgo total lactones 50g
Get Radix Astragali total saponins, Folium Ginkgo total lactones, press medicine: supplementary product consumption=1: 3 adding mannitol, add 1800ml water for injection, stirring makes dissolving, with saturated sodium hydroxide solution adjust pH to 6.0～6.5, 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 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-20 ℃, and shelf temperature and product temperature equilibration time are 2 hours; Phase III continues to be cooled to-50 ℃, 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-50 ℃ of constant temperature slowly heats up 2～4 ℃/h, to the lowest total of the melting point temperature, the time is about 14 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 hours, gland promptly gets the Injectable sterile block.
Embodiments of the invention 4: Radix Astragali total saponins 40g Folium Ginkgo total lactones 60g
Get Radix Astragali total saponins, Folium Ginkgo total lactones, 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 6.0～6.5, boils, 4 ℃ of cold preservations are spent the night, coarse filtration, fine straining add the injection water, divide to install to ampoule bottle, seal sterilization, promptly get injection and concentrated solution for injection.
Embodiments of the invention 5: Radix Astragali total saponins 50g Folium Ginkgo total lactones 50g
Get Radix Astragali total saponins, Folium Ginkgo total lactones, 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 6.0～6.5, 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 6: Radix Astragali total saponins 60g Folium Ginkgo total lactones 40g
Get Radix Astragali total saponins, Folium Ginkgo total lactones, 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 6.0～6.5, boil, 4 ℃ of cold preservations are spent the night, and coarse filtration, fine straining are 110 ℃ in inlet temperature, leaving air temp is 50 ℃, and air velocity is 30ms
-1Condition under spray drying get powder, packing promptly gets injectable sterile powder.
Embodiments of the invention 7: Radix Astragali total saponins 55g Folium Ginkgo total lactones 45g
Get Radix Astragali total saponins, Folium Ginkgo total lactones, 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 6.0～6.5, boils, 4 ℃ of cold preservations are spent the night, coarse filtration, fine straining add the injection water, divide to install to ampoule bottle, seal sterilization, promptly get injection and concentrated solution for injection.
Embodiments of the invention 8: Radix Astragali total saponins 45g Folium Ginkgo total lactones 55g
With Radix Astragali total saponins and Folium Ginkgo total lactones mix homogeneously, add 5% carboxymethyl starch sodium and 1.4% mannitol, compacting promptly gets oral cavity disintegration tablet in flakes.
Embodiments of the invention 9: Radix Astragali total saponins 80g Folium Ginkgo total lactones 20g
With Radix Astragali total saponins and Folium Ginkgo total lactones mix homogeneously, to be that 1: 1.2 poloxamer is put in the rustless steel container with the principal agent ratio, add extract, mix homogeneously, be heated to 80-85 ℃, treat whole fusions after, 70-75 ℃ of insulation, mechanical high-speed stirs 15min to even, be transferred in the reservoir, the dropping liquid valve is regulated in 70～75 ℃ of insulations, splash 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.
Embodiments of the invention 10: Radix Astragali total saponins 20g Folium Ginkgo total lactones 80g
With Radix Astragali total saponins and Folium Ginkgo total lactones mix homogeneously, in principal agent: the ratio of adjuvant=1.5: 1 adds calcium carbonate, by principal agent: the ratio adding pregelatinized starch of adjuvant=1.2: 1, and press principal agent: the crospolyvinylpyrrolidone of adjuvant=4: 1, evenly mixed, make soft material in right amount with 75% ethanol, cross 20 mesh sieve system granules, 55 ℃ 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 11: Radix Astragali total saponins 1g Folium Ginkgo total lactones 99g
With Radix Astragali total saponins and Folium Ginkgo total lactones mix homogeneously, add 2 times of amount starch, 0.6% stevioside, 1.2% microcrystalline Cellulose with an amount of alcoholic solution system soft material, is granulated, and 60 ℃ of forced air dryings are granulated, and granulate promptly gets granule.
Embodiments of the invention 12: Radix Astragali total saponins 99g Folium Ginkgo total lactones 1g
With Radix Astragali total saponins and Folium Ginkgo total lactones mix homogeneously, add the dextrin of equivalent, mix homogeneously is granulated, and promptly gets granule.
Embodiments of the invention 13: Radix Astragali total saponins 30g Folium Ginkgo total lactones 70g
With Radix Astragali total saponins and Folium Ginkgo total lactones mix homogeneously, add the dextrin of equivalent, mix homogeneously is granulated, and is encapsulated, promptly gets capsule.
Embodiments of the invention 14: Radix Astragali total saponins 70g Folium Ginkgo total lactones 30g
With Radix Astragali total saponins and Folium Ginkgo total lactones 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.
Radix Astragali total saponins among the above embodiment, Folium Ginkgo total lactones can be with Radix Astragali total saponins, Folium Ginkgo total lactones 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 Astragali total saponins is greater than 50%, total lactone content of Folium Ginkgo total lactones can guarantee the therapeutic effect of product like this greater than 50%.
Claims (11)
1, a kind of pharmaceutical composition for the treatment of cardiovascular and cerebrovascular disease is characterized in that: calculate according to percentage by weight, it mainly is to be made by Radix Astragali total saponins 1～99% and Folium Ginkgo total lactones 99～1% and suitable adjuvant.
2, according to the pharmaceutical composition of the described treatment cardiovascular and cerebrovascular disease of claim 1, it is characterized in that: calculate according to percentage by weight, it mainly is to be made by Radix Astragali total saponins 20～80% and Folium Ginkgo total lactones 80～20% and suitable adjuvant.
3, according to the pharmaceutical composition of claim 1 or 2 described treatment cardiovascular and cerebrovascular diseases, it is characterized in that: calculate according to percentage by weight, it mainly is to be made by Radix Astragali total saponins 40～60% and Folium Ginkgo total lactones 60～40% and suitable adjuvant.
4, according to the pharmaceutical composition of any described treatment cardiovascular and cerebrovascular disease of claim 1～3, it is characterized in that: the Radix Astragali total saponins in the described prescription 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; Folium Ginkgo total lactones can be the highly finished product of Folium Ginkgo alcohol extract, Folium Ginkgo water extract, Folium Ginkgo water extract-alcohol precipitation extract, Folium Ginkgo semi-bionic extraction thing, Folium Ginkgo supercritical extract or above each extract.
5, according to the pharmaceutical composition of any described treatment cardiovascular and cerebrovascular disease of claim 1～4, it is characterized in that: described composite 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 or the dispersible tablet that makes with freeze-drying or spray drying method after the dilution.
6, according to the pharmaceutical composition of any described treatment cardiovascular and cerebrovascular disease in the claim 1～5, it is characterized in that: contain saponin component and lactone composition in the composite preparation, calculate by weight percentage, saponin component content and lactone component content sum are not less than 50% of the total solid of deducting adjuvant amount and water quantities in the preparation in the preparation.
7, according to the pharmaceutical composition 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 Astragali total saponins, and the content of total lactone is not less than 50% in the Folium Ginkgo total lactones.
8, as the preparation of drug combination method of any described treatment cardiovascular and cerebrovascular disease in the claim 1～5, it is characterized in that:
A. Folium Ginkgo total lactones effective site is preparation like this: get the Folium Ginkgo medical material, adding entry or alcoholic solution after the pulverizing extracts, merge extractive liquid,, filter, concentrate ginkgo biloba 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, Folium Ginkgo total lactones effective site;
B. Radix Astragali total saponins effective site is preparation 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 total saponins effective site.
9, preparation of drug combination method according to the described treatment cardiovascular and cerebrovascular disease of claim 8, it is characterized in that: the Injectable sterile block of described compositions prepares like this: get Radix Astragali total saponins, Folium Ginkgo total lactones, press medicine: supplementary product consumption=1: 3 adding mannitol, add 1800ml water for injection, stirring makes dissolving, with saturated sodium hydroxide solution adjust pH to 6.0～6.5, 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 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-20 ℃, and shelf temperature and product temperature equilibration time are 2 hours; Phase III continues to be cooled to-50 ℃, 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-50 ℃ of constant temperature slowly heats up 2～4 ℃/h, to the lowest total of the melting point temperature, the time is about 14 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 hours, gland, promptly.
10, preparation of drug combination method according to the described treatment cardiovascular and cerebrovascular disease of claim 8, it is characterized in that: the injection and the concentrated solution for injection of described compositions prepare like this: get Radix Astragali total saponins, Folium Ginkgo total lactones, 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 6.0～6.5, boil, coarse filtration is spent the night in 4 ℃ of cold preservations, fine straining, add the injection water, divide to install to ampoule bottle, seal sterilization, promptly.
11, according to the application of the pharmaceutical composition of any described treatment cardiovascular and cerebrovascular disease in the claim 1～5, it is characterized in that: described compositions is mainly used in the application in disease medicaments such as preparation treatment ischemia apoplexy, angina pectoris, cardiac insufficiency, apoplexy sequela, hepatorenal syndrome, heart and lung diseases, diabetes and complication thereof.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200610058725 CN101028330A (en) | 2006-03-03 | 2006-03-03 | Medicinal composition for treating cardiovascular disease, its production and use |
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| Application Number | Priority Date | Filing Date | Title |
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| CN 200610058725 CN101028330A (en) | 2006-03-03 | 2006-03-03 | Medicinal composition for treating cardiovascular disease, its production and use |
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| CN101028330A true CN101028330A (en) | 2007-09-05 |
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| CN 200610058725 Pending CN101028330A (en) | 2006-03-03 | 2006-03-03 | Medicinal composition for treating cardiovascular disease, its production and use |
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