CN1954829A - Medical composite for treating cardio-cerebral vascular disease and its preparation method and application - Google Patents
Medical composite for treating cardio-cerebral vascular disease and its preparation method and application Download PDFInfo
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- CN1954829A CN1954829A CN 200510114731 CN200510114731A CN1954829A CN 1954829 A CN1954829 A CN 1954829A CN 200510114731 CN200510114731 CN 200510114731 CN 200510114731 A CN200510114731 A CN 200510114731A CN 1954829 A CN1954829 A CN 1954829A
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Abstract
A composite medicine in the form of injection or orally taken solid or liquid for treating ischemic cerebral apoplexy, coronary heart disease, angina pectoris, cardiac insufficiency, apoplexy sequelae, hepato-renal syndrome, cardiopulmonary disease, diabetes, etc is prepared from general flavone of shortscape fleabane herb and general lactone of 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 such as angina pectoris are commonly encountered diseases, the frequently-occurring diseases of middle-aged and elderly people.Mean that coronary atherosclerosis causes coronary insufficiency, the retrosternal pain that the rapid temporary transient hypoxic-ischemic of cardiac muscle causes.The category such as " thoracic obstruction ", " cardiopalmus ", " angina pectoris " that belongs to the traditional Chinese medical science.Primary disease Chang Fanfu outbreak, touching difficulty heals, and the healthy of people in serious harm.Prevent and treat purpose in order to reach, a large amount of research has been done by many inventors and medicine enterprise, and the product of some treatments also is provided; As: the number of patent application of the applicant's application is: 200410022510.5, name is called the patent application of " a kind of Chinese medicine preparation for the treatment of 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 to improve curative effect greatly, be easy to preparations shaping, improved the safety of preparation and the controllability of quality.
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 Herba Erigerontis total flavones 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 is to be made by Herba Erigerontis total flavones 1～99% and Folium Ginkgo total lactones 99～1% and suitable adjuvant.Be preferably: calculate according to percentage by weight, it is to be made by Herba Erigerontis total flavones 20～80% and Folium Ginkgo total lactones 80～20% and suitable adjuvant.More preferably: calculate according to percentage by weight, it is to be made by Folium Ginkgo total lactones 40～60% and Herba Erigerontis total flavones 60～40% and suitable adjuvant.
Herba Erigerontis total flavones in the described prescription can be the highly finished product of Herba Erigerontis alcohol extract, Herba Erigerontis water extract, Herba Erigerontis water extract-alcohol precipitation extract, Herba Erigerontis semi-bionic extraction thing, Herba Erigerontis 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 flavones ingredient in the compositions, calculate by weight percentage, the lactone component content sum that derives from the flavones ingredient of Herba Erigerontis in the preparation and derive from Folium Ginkgo be not less than deduction adjuvant amount and water quantities in the preparation total solid 50%.General flavone content is not less than 50% in the Herba Erigerontis total flavones, and total lactone is not less than 50% in the Folium Ginkgo extract.
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; Herba Erigerontis total flavones effective site is preparation like this: get the Herba Erigerontis medical material, adding entry or alcoholic solution after the pulverizing extracts, merge extractive liquid,, filter, concentrate the Herba Erigerontis 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, Herba Erigerontis total flavones effective site, with Herba Erigerontis total flavones and Folium Ginkgo total lactones mix homogeneously, add adjuvant and make different preparations.
The Injectable sterile block of described compositions prepares like this: get Herba Erigerontis total flavones, Folium Ginkgo total lactones, 100g mannitol, add 1800ml water for injection, stirring makes dissolving, with saturated sodium hydroxide solution adjust pH to 7.0～7.5, 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 1 hour, 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-16 ℃, and shelf temperature and product temperature equilibration time are 1.5 hours; Phase III continues to be cooled to-40 ℃, needs 2 hours approximately, keeps this temperature 2 hours, freeze the jail fully until product, promptly begin evacuation, enter drying program, under-40 ℃ of constant temperature-and evacuation, slowly heat up 2～4 ℃/h, to the lowest total of the melting point temperature, the time is about 12 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 12～15 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 Herba Erigerontis total flavones, 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 7.0～7.5, 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, filtering out the prescription for the treatment of diseases such as angina pectoris is Herba Erigerontis total flavones, Folium Ginkgo total lactones, and best proportion compatibility is Folium Ginkgo total lactones 40～60% and Herba Erigerontis total flavones 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
To Folium Ginkgo total lactones: Herba Erigerontis total flavones divides the test of pesticide effectiveness of having carried out system screening by 1: 99,20: 80,40: 60,60: 40 and 80: 20,99: 1 six combination prescriptions
The prescription screening experimental study conclusion of drug regimen compatibility
Prescription is formed and ratio screening and assessment index
Prescription
Folium Ginkgo total lactones: oil lamp is carefully cultivated the myocardial cell injury test
Numbering platelet aggregation rate (%)
Hot total flavones LDH reduces % CK and reduces %
1 1∶99 60.3％ 40.24％ 31.44％
2 20∶80 57.2％ 42.18％ 36.61％
3 40∶60 51.8％ 49.13％ 43.34％
4 60∶40 52.5％ 48.31％ 41.28％
5 99∶1 56.3％ 41.32％ 39.17％
By experimental result as can be known, Herba Erigerontis total flavones, Folium Ginkgo total lactones are that Folium Ginkgo total lactones 40～60% and Herba Erigerontis total flavones 60～40% o'clock pharmacological action are strong and consumption is lower at proportion compatibility, that is to say that both compatibilities can reach the effect of efficacy enhancing and toxicity reducing.
Experimental example 2: injection Study on Forming
2.1pH value is to the influence of injection
The applicant finds that in development suitable acid-base value is the stable key factor of medicine, and in order to improve the quality of this injection, the applicant placed 3 months for 40 ℃ the injection of 6 kinds of different pH value, investigated its stability respectively.The result shows that 7.0～7.5 pH value scope is the most reasonable.
0 month March
The total lactone of the total lactone of pH value clarity (mg/ml) clarity (mg/ml)
Differ from 1.12 5.0 differ from 1.41
5.5 clear and bright 1.43 differ from 1.28
6.0 clear and bright 1.41 differ from 1.30
6.5 clear and bright 1.47 differ from 1.30
7.0 clear and bright 1.45 clear and bright 1.37
7.5 clear and bright 1.45 clear and bright 1.40
Differ from 1.28 8.0 differ from 1.42
2.2pH value is to the influence of freeze-dried powder
Number 123456789
PH value of solution 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 9.0 before the lyophilizing
The good good job difference of insufficient formability difference difference difference is poor
The yellowish yellowish yellowish-brown deep yellow palm fibre of color and luster
PH value of solution 4.7 5.1 5.6 6.0 6.5 7.3 7.3 8.1 8.8 after the lyophilizing
The result shows that the rational ph value of the present invention scope is 7.0～7.5, and product quality is good.
Experimental example 3: preparation pharmacodynamic experiment
The rat coronary artery ligation causes the influence of myocardial infarction: 40 of extracting male Wistar rats, be divided into 4 groups at random, be Sham-operated control group, model control group, oral liquid 0.3g/kg of the present invention group, injection 0.3g/kg of the present invention group, every group 10, each respectively administration of group, every day 1 time for three days on end.1h after the last administration is with pentobarbital anesthesia, tracheal intubation, artificial respiration.Open breast in the 3rd～4 intercostal,, cause occlusive arteria coronaria district myocardial infarction apart from coronary artery outlet 5mm place's ligation left anterior descending coronary artery.Behind 4h, use the electromagnetic flowmeter determination coronary artery blood flow, and measure the infarcted region area percentage.The results are shown in following table, the coronary flow of medication group significantly increases, and the infarcted region area obviously reduces.
Influence to coronary artery blood flow and infarct size after the rat coronary artery ligation
Coronary flow cerebral infarction dead band area
Group (ml/min.100g) percentage ratio (%)
Sham operated rats 60.12 ± 1.25---
Model group 43.28 ± 3.28 7.99 ± 1.25
Injection group 0.3g/kg 52.17 ± 3.26 5.68 ± 0.39 of the present invention
Injectable powder group 0.3g/kg 48.89 ± 2.03 5.56 ± 0.27 of the present invention
By experimental result as can be known, pharmaceutical preparation of the present invention causes that to coronary occlusion the myocardial ischemia situation can significantly increase coronary flow, and obviously reduces myocardial infarction district area.
Concrete embodiment
Embodiments of the invention 1: Herba Erigerontis total flavones 40g Folium Ginkgo total lactones 60g
Get Herba Erigerontis total flavones, Folium Ginkgo total lactones and 100g mannitol, add 1800ml water for injection, stirring makes dissolving, with saturated sodium hydroxide solution adjust pH to 7.0～7.5, 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 1 hour, 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-16 ℃, and shelf temperature and product temperature equilibration time are 1.5 hours; Phase III continues to be cooled to-40 ℃, need 2 hours approximately, kept this temperature 2 hours, and froze the jail fully, promptly begin evacuation until product, enter drying program, under-40 ℃ of constant temperature-and evacuation, slowly heat up 2～4 ℃/h, to the lowest total of the melting point temperature, time is about 12 hours, after sublimation drying is finished, continues under the low pressure condition, it is dry to remove residual moisture to heat up, time is about 12～15 hours, keeps more than 35 ℃ gland dry 2 hours, promptly get the Injectable sterile block, one time 2,1 time on the one, with using behind 250ml 0.9% physiological saline solution, calculate by weight percentage, in the injection flavones ingredient and lactone content be deduction adjuvant amount and water quantities in the preparation total solid 81%.
Embodiments of the invention 2: Herba Erigerontis total flavones 40g Folium Ginkgo total lactones 60g
Get Herba Erigerontis total flavones, 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 7.0～7.5, 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 3: Herba Erigerontis total flavones 40g Folium Ginkgo total lactones 60g
Get Herba Erigerontis total flavones, 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 7.0～7.5, 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 4: Herba Erigerontis total flavones 40g Folium Ginkgo total lactones 60g
Get Herba Erigerontis total flavones, Folium Ginkgo total lactones, add 1800ml water for injection, stir and make dissolving, with saturated sodium hydroxide solution adjust pH to 7.0～7.5, 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, divide and install in the enamel tray, lyophilization, the equilibration time when the balance solidification point of phase I is 0 ℃ is 1 hour, 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-16 ℃, and shelf temperature and product temperature equilibration time are 1.5 hours; Phase III continues to be cooled to-40 ℃, need 2 hours approximately, kept this temperature 2 hours, freeze the jail fully until product, promptly begin evacuation, enter drying program, under-40 ℃ of constant temperature-evacuation, slowly heat up, 2～4 ℃/h, to the lowest total of the melting point temperature, time is about 12 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 12～15 hours, kept more than 35 ℃ dry 2 hours, and under aseptic condition, divided to install in the cillin bottle, promptly get injectable sterile powder.
Embodiments of the invention 5: Herba Erigerontis total flavones 40g Folium Ginkgo total lactones 60g
Get Herba Erigerontis total flavones, 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 7.0～7.5, boil, 4 ℃ of cold preservations are spent the night, coarse filtration, fine straining, in inlet temperature is 150 ℃, and leaving air temp is 65 ℃, and air velocity is that spray drying gets powder under the condition of 25ms-1, packing promptly gets injectable sterile powder.
Embodiments of the invention 6: Herba Erigerontis total flavones 20g Folium Ginkgo total lactones 80g
With Herba Erigerontis total flavones and Folium Ginkgo total lactones mix homogeneously, add 6% polyvinylpolypyrrolidone PVPP and 1% mannitol, compacting promptly gets oral cavity disintegration tablet in flakes.
Embodiments of the invention 7: Herba Erigerontis total flavones 80g Folium Ginkgo total lactones 20g
With Herba Erigerontis total flavones and Folium Ginkgo total lactones mix homogeneously, to be that 2: 1 Macrogol 4000 is put in the rustless steel container with the principal agent ratio, add extract, mix homogeneously, be heated to 80-90 ℃, treat whole fusions after, 70-80 ℃ of insulation, mechanical high-speed stirs 15min to even, be transferred in the reservoir, the dropping liquid valve is regulated in 70～80 ℃ of insulations, splash in 30～40 ℃ the dimethicone, drip apart from 7～8cm, drip 45～50 droplets/minute of speed, to the greatest extent and wipe dimethicone the drop pill drop that forms, packing promptly gets drop pill.
Embodiments of the invention 8: Herba Erigerontis total flavones 99g Folium Ginkgo total lactones 1g
With Herba Erigerontis total flavones and Folium Ginkgo total lactones mix homogeneously, in principal agent: the ratio of adjuvant=1: 2 adds calcium sulfate, by principal agent: the ratio adding microcrystalline Cellulose of adjuvant=1: 1, and press principal agent: the crospovidone of adjuvant=3: 1, evenly mixed, make soft material in right amount with 60% ethanol, cross 20 mesh sieve system granules, 60 ℃ of dryings are taken out granulate, add an amount of Pulvis Talci, micropowder silica gel, evenly mixed, tabletting promptly gets dispersible tablet.
Embodiments of the invention 9: Herba Erigerontis total flavones 1g Folium Ginkgo total lactones 99g
With Herba Erigerontis total flavones and Folium Ginkgo total lactones mix homogeneously, add 2 times of amount starch, 0.7% stevioside, 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 10: Herba Erigerontis total flavones 60g Folium Ginkgo total lactones 40g
With Herba Erigerontis total flavones and Folium Ginkgo total lactones mix homogeneously, add the starch of equivalent, mix homogeneously is granulated, and is encapsulated, promptly gets capsule.
Herba Erigerontis total flavones among the above embodiment, Folium Ginkgo total lactones can be with Herba Erigerontis total flavones, 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 or the like, but: wherein the general flavone content of Herba Erigerontis total flavones is greater than 50%, and total lactone content of Folium Ginkgo total lactones is greater than 50%.Can guarantee the therapeutic effect of product like this.
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 is to be made by Herba Erigerontis total flavones 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 is to be made by Herba Erigerontis total flavones 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 is to be made by Folium Ginkgo total lactones 40～60% and Herba Erigerontis total flavones 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 Herba Erigerontis total flavones in the described prescription can be the highly finished product of Herba Erigerontis alcohol extract, Herba Erigerontis water extract, Herba Erigerontis water extract-alcohol precipitation extract, Herba Erigerontis semi-bionic extraction thing, Herba Erigerontis 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 flavones ingredient in the preparation, calculate by weight percentage, the lactone component content sum that derives from the flavones ingredient of Herba Erigerontis in the preparation and derive from Folium Ginkgo be not less than deduction adjuvant amount and water quantities in the preparation total solid 50%.
7, according to the pharmaceutical composition of the described treatment cardiovascular and cerebrovascular disease of claim 4, it is characterized in that: general flavone content is not less than 50% in the Herba Erigerontis total flavones, and total lactone is not less than 50% in the Folium Ginkgo extract.
8, according to 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 are preparations 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, Herba Erigerontis total flavones effective site are preparations like this: get the Herba Erigerontis medical material, adding entry or alcoholic solution after the pulverizing extracts, merge extractive liquid,, filter, concentrate the Herba Erigerontis 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, Herba Erigerontis total flavones effective site;
C, with Herba Erigerontis total flavones and Folium Ginkgo total lactones mix homogeneously, add adjuvant and make different preparations.
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 Herba Erigerontis total flavones, Folium Ginkgo total lactones, 100g mannitol, add 1800ml water for injection, stirring makes dissolving, with saturated sodium hydroxide solution adjust pH to 7.0～7.5, 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 1 hour, 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-16 ℃, and shelf temperature and product temperature equilibration time are 1.5 hours; Phase III continues to be cooled to-40 ℃, needs 2 hours approximately, keeps this temperature 2 hours, freeze the jail fully until product, promptly begin evacuation, enter drying program, under-40 ℃ of constant temperature-and evacuation, slowly heat up 2～4 ℃/h, to the lowest total of the melting point temperature, the time is about 12 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 12～15 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 Herba Erigerontis total flavones, 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 7.0～7.5, 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 compound formulation of astragalus root of any described treatment cardiovascular and cerebrovascular disease in the claim 1～5, it is characterized in that: described pharmaceutical composition is used for the application at 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 200510114731 CN1954829A (en) | 2005-10-26 | 2005-10-26 | Medical composite for treating cardio-cerebral vascular disease and its preparation method and application |
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| Application Number | Priority Date | Filing Date | Title |
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| CN 200510114731 CN1954829A (en) | 2005-10-26 | 2005-10-26 | Medical composite for treating cardio-cerebral vascular disease and its preparation method and application |
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| CN1954829A true CN1954829A (en) | 2007-05-02 |
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