CN1232273C - Medicine compositions for treating cardiovascular cranialvascular disease, and its prepn. method - Google Patents
Medicine compositions for treating cardiovascular cranialvascular disease, and its prepn. method Download PDFInfo
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- CN1232273C CN1232273C CN 02153312 CN02153312A CN1232273C CN 1232273 C CN1232273 C CN 1232273C CN 02153312 CN02153312 CN 02153312 CN 02153312 A CN02153312 A CN 02153312A CN 1232273 C CN1232273 C CN 1232273C
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Abstract
The present invention discloses a medicine composition for treating cardiovascular and cerebrovascular diseases, and a preparing method thereof. The medicine composition is prepared from red sage root and safflower as raw medicines.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition and preparation method thereof, particularly relate to a kind of pharmaceutical composition for the treatment of cardiovascular and cerebrovascular disease and preparation method thereof.
Background technology
Coronary heart disease, angina pectoris are clinical common diseases, divide two kinds of fatigue angina pectoris and spontaneous angina pectoriss.The anginal feature of fatigue is that behind rest or the sublingual administration nitroglycerin, pain usually rapidly disappears because the of short duration chest pain that motion or other situations that increases myocardium requirementing keto quantity are brought out is shown effect.The fatigue angina pectoris can be divided three classes: a, preliminary fatigue angina pectoris: the fatigue angina pectoris course of disease is in 1 month.B, stable type fatigue angina pectoris: the fatigue angina pectoris course of disease was stabilized in more than 1 month.C, deterioration type fatigue angina pectoris: number of times, the order of severity and persistent period that the equal extent fatigue is brought out increase the weight of suddenly.The feature of spontaneous angina pectoris is that the chest pain outbreak does not have obvious relation with the increase of myocardium requirementing keto quantity, compares with the fatigue angina pectoris, and this pain general persistence is longer, and degree is heavier, and is difficult for alleviating for nitroglycerin.This type is not seen enzymic change, and electrocardiogram often occurs that some temporary S-T section is forced down or the T ripple changes.Spontaneous angina pectoris can take place separately or merge existence with the fatigue angina pectoris.Cerebral thrombosis is often fallen ill under rest state, great majority do not have obviously headache and vomiting, morbidity can be slower, how to make progress gradually or be stage and carry out, how relevant with cerebral atherosclerosis, also be found in arteritis, hematopathy etc., clear or the slight obstacle of consciousness has internal carotid artery system and or vertebral basilar system sings and symptoms in general morbidity back 1-2 day.Acute onset has inducement more, and premonitory symptom is often arranged before not sending out.The medicine of cardiovascular and cerebrovascular disease must be rapid-action, good effect.
Summary of the invention
The object of the invention is to provide a kind of pharmaceutical composition for the treatment of cardiovascular and cerebrovascular disease and preparation method thereof.
The present invention is achieved through the following technical solutions:
Scheme one:
200～400 parts on 400～800 parts of Flos Carthamis of Radix Salviae Miltiorrhizae
Preferably:
250 parts on 750 parts of Flos Carthamis of Radix Salviae Miltiorrhizae
Can be prepared into small-volume injection: red rooted salvia is made only, is ground into coarse granule, extracts 2～3 times with 30～60% ethanol warm macerating, each 1～2 hour, filter, medicinal residues are standby, filtrate merges, and cold preservation 12～48 hours filters, decompression recycling ethanol, being concentrated into relative density is 1.05～1.15, measuring temperature is 60 ℃, adding 5～10 times of amount waters for injection, is 2～5 with the hydrochloric acid adjust pH, shakes up, cold preservation 12～48 hours filters filtrate for later use; The clean system of flos carthami 250 grams is mixed with Radix Salviae Miltiorrhizae decoction dregs, adds 8～15 times of amount distilled water warm macerating and extracts 2～3 times, each 1～2 hour, filter merging filtrate, be evaporated to closely relatively 1.05～1.15, measuring temperature is 60 ℃, adds ethanol and makes and contain the alcohol amount and reach 50～80%, left standstill 12～48 hours, and filtered decompression recycling ethanol, merge with Radix Salviae Miltiorrhizae extract, regulating pH value is 2～5, high speed centrifugation, and supernatant filters with inoranic membrane, filtrate is used ultrafiltration membrance filter, filtrate reuse NF membrane is filtered, and gets concentrated solution, is settled to 1000ml, adding sodium chloride for injection transfers to etc. and to ooze, regulating pH value is 5.5～7, cold preservation 12～48 hours, and microporous filter membrane filters, add water for injection to 1000ml, embedding, sterilization, promptly.Best: red rooted salvia is made only, is ground into coarse granule, extracts secondary with 50% ethanol warm macerating, each 1h filters, and medicinal residues are standby, filtrate merges, and cold preservation 24h filters, decompression recycling ethanol, being concentrated into relative density is 1.05～1.15, measuring temperature is 60 ℃, adding 15 times of amount waters for injection, is 3～4 with the hydrochloric acid adjust pH, shakes up, cold preservation 48h filters filtrate for later use; Flos carthami is made only, mixes with Radix Salviae Miltiorrhizae decoction dregs, adds 16 times of amount distilled water warm macerating and extracts three times, each 1h filters merging filtrate, be evaporated to relative density 1.10, measuring temperature is 60 ℃, adds ethanol and makes and contain the alcohol amount and reach 60%, leave standstill 48h, filter decompression recycling ethanol, merge with Radix Salviae Miltiorrhizae extract, regulating pH value is 3, high speed centrifugation, supernatant filters with inoranic membrane, and filtrate is used ultrafiltration membrance filter, and filtrate reuse NF membrane is filtered, concentrated solution, be settled to 1000ml, add sodium chloride for injection and transfer to etc. and to ooze, regulating pH value is 7, cold preservation 24h, and microporous filter membrane filters, add water for injection to 1000ml, embedding, sterilization, promptly.
Scheme two:
20～40 parts on 40～80 parts of Flos Carthamis of Radix Salviae Miltiorrhizae
Preferably:
25 parts on 75 parts of Flos Carthamis of Radix Salviae Miltiorrhizae
Can be prepared into bulk capacity injection: red rooted salvia is made only, is ground into coarse granule, extracts 2～3 times with 30～60% ethanol warm macerating, each 1～2 hour, filter, medicinal residues are standby, filtrate merges, and cold preservation 12～48 hours filters, decompression recycling ethanol, being concentrated into relative density is 1.05～1.15, measuring temperature is 60 ℃, adding 5～10 times of amount waters for injection, is 2～5 with the hydrochloric acid adjust pH, shakes up, cold preservation 12～48 hours filters filtrate for later use.Flos carthami is made only, mixes with Radix Salviae Miltiorrhizae decoction dregs, adds 8～15 times of amount distilled water warm macerating and extracts 2～3 times, each 1～2 hour, filter merging filtrate, be evaporated to closely relatively 1.05～1.15, measuring temperature is 60 ℃, adds ethanol and makes and contain the alcohol amount and reach 50～80%, left standstill 12～48 hours, and filtered decompression recycling ethanol, merge with Radix Salviae Miltiorrhizae extract, regulating pH value is 2～5, high speed centrifugation, and supernatant filters with inoranic membrane, filtrate is used ultrafiltration membrance filter, filtrate reuse NF membrane is filtered, and gets concentrated solution, is settled to 1000ml, adding sodium chloride for injection transfers to etc. and to ooze, regulating pH value is 5.5～7, cold preservation 12～48 hours, and microporous filter membrane filters, add water for injection to 1000ml, embedding, sterilization, promptly.Best: red rooted salvia is made only, is ground into coarse granule, extracts secondary with 50% ethanol warm macerating, each 1h filters, and medicinal residues are standby, filtrate merges, and cold preservation 24h filters, decompression recycling ethanol, being concentrated into relative density is 1.05～1.15, measuring temperature is 60 ℃, adding 15 times of amount waters for injection, is 3～4 with the hydrochloric acid adjust pH, shakes up, cold preservation 48h filters filtrate for later use.Flos carthami is made only, mixes with Radix Salviae Miltiorrhizae decoction dregs, adds 16 times of amount distilled water warm macerating and extracts three times, each 1h filters merging filtrate, be evaporated to relative density 1.10, measuring temperature is 60 ℃, adds ethanol and makes and contain the alcohol amount and reach 60%, leave standstill 48h, filter decompression recycling ethanol, merge with Radix Salviae Miltiorrhizae extract, regulating pH value is 3, high speed centrifugation, supernatant filters with inoranic membrane, and filtrate is used ultrafiltration membrance filter, and filtrate reuse NF membrane is filtered, concentrated solution, be settled to 1000ml, add sodium chloride for injection and transfer to etc. and to ooze, regulating pH value is 7, cold preservation 24h, and microporous filter membrane filters, add water for injection to 1000ml, embedding, sterilization, promptly.
In above high capacity and small-volume injection preparation method, the temperature of warm macerating is 40～70 ℃; Ultracentrifugal speed is more than the 10000r/min; The aperture of inoranic membrane is 0.22～0.65 μ m; Ultrafilter membrane molecular retention amount is below 6000～10000; NF membrane molecular retention amount is 500～2000.Best: the temperature of warm macerating is 50～55 ℃; Ultracentrifugal speed is more than the 14000r/min; The inoranic membrane aperture is 0.45 μ m; Ultrafilter membrane molecular retention amount is below 8000; NF membrane molecular retention amount is 1000.
The application of warm macerating extracting method in this technology: the effective ingredient in Radix Salviae Miltiorrhizae and the Flos Carthami belongs to heat-sensitive ingredients, the method that adopts warm macerating to extract, can prevent preferably that its active ingredient is destroyed in decoction process falls, and guarantees the effective ingredient of said preparation from the source, thereby guarantees the said preparation curative effect.
The adjusting of pH value in the technical process: by the adjusting of pH value, remove the invalid elements such as tannin in the red rooted salvia composition, effectively removed and cause the major influence factors that the preparation clarity is bad in the preparation, make preparation finally stable.
The application of Physical Separation Technology---supercentrifugation in this technology: can remove materials such as fine medicinal residues in the Radix Salviae Miltiorrhizae Flos Carthami extract, float, macromole by supercentrifugal process, its technology can effectively prevent loss of active ingredients in Radix Salviae Miltiorrhizae and the Flos Carthami, preserves the active component in the two to greatest extent; Shortened process reduces cost greatly; Can improve the clarity of injection.
The application of membrane separation technique in this injection: the sieving actoion by film, separate on molecular level.The fit applications of membrane separation technique in this technology such as inorganic membrane filtration, ultrafiltration, nanofiltration, filtering with microporous membrane, can effectively remove tannin, protein, pyrogen and residual macromole impurity etc., reach the clarity of improving injection, and the reservation of maximum possible effective ingredient.
Pharmaceutical composition of the present invention has blood circulation promoting and blood stasis dispelling through laboratory observation, TONGMAI SHULUO, the effect of coronary blood flow increasing.Experimental result shows the thoracic obstruction, the apoplexy that can be used for due to the blood stasis impatency, treatment of diseases such as coronary heart disease, myocardial infarction and blood stasis type pulmonary heart disease.
Experimental example 1: pharmaceutical composition of the present invention is to the protective effect of experimental rat cerebral ischemia
Get 50 of healthy male Wistar rats, be divided into 5 groups at random, 10 every group, 2-5 organizes each rat intraperitoneal injection of saline 7.2ml/Kg, this pharmaceutical composition 7.2ml/Kg, 3.6ml/Kg, 1.8ml/Kg respectively, every day 1 time, for three days on end.Behind the last administration 1hr, organize each Mus anesthesia to each, the cervical region median incision, after the 1st group of each Mus separates bilateral carotid 3hr, 2-5 organize that each Mus separates and ligation bilateral carotid 3hr after, put to death broken end, open cranium and get brain, analytical balance claims that wet brain is heavy, and roasting to constant weight in 110 ℃ of baking boxs then, analytical balance is weighed.The result shows that behind healthy rat ligation bilateral common carotid arteries, obvious edema appears in cerebral tissue, shows as that wet brain representation work raises (P＜0.01), cerebral index increases, brain water content significantly increases (P＜0.01); Large, medium and small each dosage of pharmaceutical composition of the present invention also can resist the cerebral tissue edema phenomenon that causes because of cerebral ischemia; wherein heavy dose can make wet brain representation work decline (P＜0.05); dosage big or middle can make brain water content significantly descend (P＜0.05), illustrates that pharmaceutical composition of the present invention has protective effect to rat cerebral ischemia.
Experimental example 2: to get Wistar be 40 of rats in thrombotic influence to rats in vitro, is divided into 4 groups at random, the ear vein drug administration by injection, and blank group is given normal saline 8ml/kg/ days; Matched group is given FUFANG DANSHEN ZHUSHEYE 8ml/kg/ days; Experimental group is given pharmaceutical composition 4.8ml/kg/ of the present invention days respectively, totally 4 days, 30min adopts fasting blood 1.8ml from ventral aorta after the last administration, at once inject in the silicon rubber loop, be installed on the extracorporeal thrombosis forming device,, remove unnecessary blood with 171pm running 15min, the weight in wet base that claims its thrombosis claims its dry weight again.The result: the suppression ratio of wet weight of thrombus and dry weight is respectively: matched group 21.75% (P＜0.01), 39.97% (P＜0.01); The small dose group 16.66% of pharmaceutical composition group of the present invention (P＜0.01), 29.16% (P＜0.01); The heavy dose of group of pharmaceutical composition of the present invention 31.28% (p＜0.01), 46.49% (P＜0.01).
Experimental example 3: pharmaceutical composition of the present invention is to the rheol influence of rabbit blood
Select 8 of healthy rabbits, heart blood sampling before the administration, anticoagulant heparin, have a rest after 4 days, ear vein injected pharmaceutical composition 1.5ml/kg/ of the present invention days, totally 4 days, after the last administration 2 hours, heart blood sampling, anticoagulant heparin, blood before and after the administration is carried out blood rheology parameter respectively to be measured, result: have the obvious suppression whole blood contrast viscosity, whole blood reduced viscosity, packed cell volume and ESR equation K value, all there were significant differences before and after the administration, and plasma viscosity and erythrocyte sedimentation rate are not had influence.
The specific embodiment
Embodiment 1: Radix Salviae Miltiorrhizae 750g Flos Carthami 250g
More than two flavors, red rooted salvia is made only, is ground into coarse granule, with 50% ethanol warm macerating extraction secondary, each 1h filters, and medicinal residues are standby, filtrate merges, and cold preservation 24h filters, decompression recycling ethanol, being concentrated into relative density is 1.05～1.15, measuring temperature is 60 ℃, adding 15 times of amount waters for injection, is 3～4 with the hydrochloric acid adjust pH, shakes up, cold preservation 48h filters filtrate for later use.Flos carthami is made only, mixes with Radix Salviae Miltiorrhizae decoction dregs, adds 16 times of amount distilled water warm macerating and extracts three times, each 1h filters merging filtrate, be evaporated to relative density 1.10, measuring temperature is 60 ℃, adds ethanol and makes and contain the alcohol amount and reach 60%, leave standstill 48h, filter decompression recycling ethanol, merge with Radix Salviae Miltiorrhizae extract, regulating pH value is 3, the 14000r/min high speed centrifugation, and supernatant filters with 0.45 μ m inoranic membrane, filtrate is 8000 following ultrafiltration membrance filters with the molecular retention amount, filtrate is filtered with the NF membrane of molecular retention amount 1000, gets concentrated solution, is settled to 1000ml, adding sodium chloride for injection transfers to etc. and to ooze, regulating pH value is 7, cold preservation 24h, and microporous filter membrane filters, add water for injection to 1000ml, embedding becomes small-volume injection, sterilization, promptly.
Embodiment 2: Radix Salviae Miltiorrhizae 75g Flos Carthami 25g
More than two flavors, red rooted salvia is made only, is ground into coarse granule, with 50% ethanol warm macerating extraction secondary, each 1h filters, and medicinal residues are standby, filtrate merges, and cold preservation 24h filters, decompression recycling ethanol, being concentrated into relative density is 1.05～1.15, measuring temperature is 60 ℃, adding 15 times of amount waters for injection, is 3～4 with the hydrochloric acid adjust pH, shakes up, cold preservation 48h filters filtrate for later use.Flos carthami is made only, mixes with Radix Salviae Miltiorrhizae decoction dregs, adds 16 times of amount distilled water warm macerating and extracts three times, each 1h filters merging filtrate, be evaporated to relative density 1.10, measuring temperature is 60 ℃, adds ethanol and makes and contain the alcohol amount and reach 60%, leave standstill 48h, filter decompression recycling ethanol, merge with Radix Salviae Miltiorrhizae extract, regulating pH value is 3, the 14000r/min high speed centrifugation, and supernatant filters with 0.45 μ m inoranic membrane, filtrate is 8000 following ultrafiltration membrance filters with the molecular retention amount, filtrate is filtered with the NF membrane of molecular retention amount 1000, gets concentrated solution, is settled to 1000ml, adding sodium chloride for injection transfers to etc. and to ooze, regulating pH value is 7, cold preservation 24h, and microporous filter membrane filters, add water for injection to 1000ml, embedding becomes bulk capacity injection, sterilization, promptly.
Embodiment 3: Radix Salviae Miltiorrhizae 800g Flos Carthami 200g
More than two flavors, red rooted salvia is made only, is ground into coarse granule, with 50% ethanol warm macerating extraction secondary, each 1h filters, and medicinal residues are standby, filtrate merges, and cold preservation 24h filters, decompression recycling ethanol, being concentrated into relative density is 1.05～1.15, measuring temperature is 60 ℃, adding 15 times of amount waters for injection, is 3～4 with the hydrochloric acid adjust pH, shakes up, cold preservation 48h filters filtrate for later use.Flos carthami is made only, mixes with Radix Salviae Miltiorrhizae decoction dregs, adds 16 times of amount distilled water warm macerating and extracts three times, each 1h filters merging filtrate, be evaporated to relative density 1.10, measuring temperature is 60 ℃, adds ethanol and makes and contain the alcohol amount and reach 60%, leave standstill 48h, filter decompression recycling ethanol, merge with Radix Salviae Miltiorrhizae extract, regulating pH value is 3, the 14000r/min high speed centrifugation, and supernatant filters with 0.45 μ m inoranic membrane, filtrate is 8000 following ultrafiltration membrance filters with the molecular retention amount, filtrate is filtered with the NF membrane of molecular retention amount 1000, gets concentrated solution, is settled to 1000ml, adding sodium chloride for injection transfers to etc. and to ooze, regulating pH value is 7, cold preservation 24h, and microporous filter membrane filters, add water for injection to 1000ml, embedding becomes small-volume injection, sterilization, promptly.
Embodiment 4: Radix Salviae Miltiorrhizae 80g Flos Carthami 20g
More than two flavors, red rooted salvia is made only, is ground into coarse granule, with 50% ethanol warm macerating extraction secondary, each 1h filters, and medicinal residues are standby, filtrate merges, and cold preservation 24h filters, decompression recycling ethanol, being concentrated into relative density is 1.05～1.15, measuring temperature is 60 ℃, adding 15 times of amount waters for injection, is 3～4 with the hydrochloric acid adjust pH, shakes up, cold preservation 48h filters filtrate for later use.Flos carthami is made only, mixes with Radix Salviae Miltiorrhizae decoction dregs, adds 16 times of amount distilled water warm macerating and extracts three times, each 1h filters merging filtrate, be evaporated to relative density 1.10, measuring temperature is 60 ℃, adds ethanol and makes and contain the alcohol amount and reach 60%, leave standstill 48h, filter decompression recycling ethanol, merge with Radix Salviae Miltiorrhizae extract, regulating pH value is 3, the 14000r/min high speed centrifugation, and supernatant filters with 0.45 μ m inoranic membrane, filtrate is 8000 following ultrafiltration membrance filters with the molecular retention amount, filtrate is filtered with the NF membrane of molecular retention amount 1000, gets concentrated solution, is settled to 1000ml, adding sodium chloride for injection transfers to etc. and to ooze, regulating pH value is 7, cold preservation 24h, and microporous filter membrane filters, add water for injection to 1000ml, embedding becomes bulk capacity injection, sterilization, promptly.
Embodiment 5: Radix Salviae Miltiorrhizae 600g Flos Carthami 300g
More than two flavors, red rooted salvia is made only, is ground into coarse granule, with 50% ethanol warm macerating extraction secondary, each 1h filters, and medicinal residues are standby, filtrate merges, and cold preservation 24h filters, decompression recycling ethanol, being concentrated into relative density is 1.05～1.15, measuring temperature is 60 ℃, adding 15 times of amount waters for injection, is 3～4 with the hydrochloric acid adjust pH, shakes up, cold preservation 48h filters filtrate for later use.Flos carthami is made only, mixes with Radix Salviae Miltiorrhizae decoction dregs, adds 16 times of amount distilled water warm macerating and extracts three times, each 1h filters merging filtrate, be evaporated to relative density 1.10, measuring temperature is 60 ℃, adds ethanol and makes and contain the alcohol amount and reach 60%, leave standstill 48h, filter decompression recycling ethanol, merge with Radix Salviae Miltiorrhizae extract, regulating pH value is 3, the 14000r/min high speed centrifugation, and supernatant filters with 0.45 μ m inoranic membrane, filtrate is 8000 following ultrafiltration membrance filters with the molecular retention amount, filtrate is filtered with the NF membrane of molecular retention amount 1000, gets concentrated solution, is settled to 1000ml, adding sodium chloride for injection transfers to etc. and to ooze, regulating pH value is 7, cold preservation 24h, and microporous filter membrane filters, add water for injection to 1000ml, embedding becomes small-volume injection, sterilization, promptly.
Embodiment 6: Radix Salviae Miltiorrhizae 60g Flos Carthami 30g
More than two flavors, red rooted salvia is made only, is ground into coarse granule, with 50% ethanol warm macerating extraction secondary, each 1h filters, and medicinal residues are standby, filtrate merges, and cold preservation 24h filters, decompression recycling ethanol, being concentrated into relative density is 1.05～1.15, measuring temperature is 60 ℃, adding 15 times of amount waters for injection, is 3～4 with the hydrochloric acid adjust pH, shakes up, cold preservation 48h filters filtrate for later use.Flos carthami is made only, mixes with Radix Salviae Miltiorrhizae decoction dregs, adds 16 times of amount distilled water warm macerating and extracts three times, each 1h filters merging filtrate, be evaporated to relative density 1.10, measuring temperature is 60 ℃, adds ethanol and makes and contain the alcohol amount and reach 60%, leave standstill 48h, filter decompression recycling ethanol, merge with Radix Salviae Miltiorrhizae extract, regulating pH value is 3, the 14000r/min high speed centrifugation, and supernatant filters with 0.45 μ m inoranic membrane, filtrate is 8000 following ultrafiltration membrance filters with the molecular retention amount, filtrate is filtered with the NF membrane of molecular retention amount 1000, gets concentrated solution, is settled to 1000ml, adding sodium chloride for injection transfers to etc. and to ooze, regulating pH value is 7, cold preservation 24h, and microporous filter membrane filters, add water for injection to 1000ml, embedding becomes bulk capacity injection, sterilization, promptly.
Embodiment 7: Radix Salviae Miltiorrhizae 650g Flos Carthami 400g
More than two flavors, red rooted salvia is made only, is ground into coarse granule, with 50% ethanol warm macerating extraction secondary, each 1h filters, and medicinal residues are standby, filtrate merges, and cold preservation 24h filters, decompression recycling ethanol, being concentrated into relative density is 1.05～1.15, measuring temperature is 60 ℃, adding 15 times of amount waters for injection, is 3～4 with the hydrochloric acid adjust pH, shakes up, cold preservation 48h filters filtrate for later use.Flos carthami is made only, mixes with Radix Salviae Miltiorrhizae decoction dregs, adds 16 times of amount distilled water warm macerating and extracts three times, each 1h filters merging filtrate, be evaporated to relative density 1.10, measuring temperature is 60 ℃, adds ethanol and makes and contain the alcohol amount and reach 60%, leave standstill 48h, filter decompression recycling ethanol, merge with Radix Salviae Miltiorrhizae extract, regulating pH value is 3, the 14000r/min high speed centrifugation, and supernatant filters with 0.45 μ m inoranic membrane, filtrate is 8000 following ultrafiltration membrance filters with the molecular retention amount, filtrate is filtered with the NF membrane of molecular retention amount 1000, gets concentrated solution, is settled to 1000ml, adding sodium chloride for injection transfers to etc. and to ooze, regulating pH value is 7, cold preservation 24h, and microporous filter membrane filters, add water for injection to 1000ml, embedding becomes small-volume injection, sterilization, promptly.
Embodiment 8: Radix Salviae Miltiorrhizae 65g Flos Carthami 40g
More than two flavors, red rooted salvia is made only, is ground into coarse granule, with 50% ethanol warm macerating extraction secondary, each 1h filters, and medicinal residues are standby, filtrate merges, and cold preservation 24h filters, decompression recycling ethanol, being concentrated into relative density is 1.05～1.15, measuring temperature is 60 ℃, adding 15 times of amount waters for injection, is 3～4 with the hydrochloric acid adjust pH, shakes up, cold preservation 48h filters filtrate for later use.Flos carthami is made only, mixes with Radix Salviae Miltiorrhizae decoction dregs, adds 16 times of amount distilled water warm macerating and extracts three times, each 1h filters merging filtrate, be evaporated to relative density 1.10, measuring temperature is 60 ℃, adds ethanol and makes and contain the alcohol amount and reach 60%, leave standstill 48h, filter decompression recycling ethanol, merge with Radix Salviae Miltiorrhizae extract, regulating pH value is 3, the 14000r/min high speed centrifugation, and supernatant filters with 0.45 μ m inoranic membrane, filtrate is 8000 following ultrafiltration membrance filters with the molecular retention amount, filtrate is filtered with the NF membrane of molecular retention amount 1000, gets concentrated solution, is settled to 1000ml, adding sodium chloride for injection transfers to etc. and to ooze, regulating pH value is 7, cold preservation 24h, and microporous filter membrane filters, add water for injection to 1000ml, embedding becomes bulk capacity injection, sterilization, promptly.
Claims (9)
1, a kind of pharmaceutical composition for the treatment of cardiovascular and cerebrovascular disease is characterized in that said composition is the intravenous administration formulation of being made by following bulk drugs:
250 parts on 750 parts of Flos Carthamis of Radix Salviae Miltiorrhizae.
2, a kind of pharmaceutical composition for the treatment of cardiovascular and cerebrovascular disease, it is characterized in that said composition is prepared from by the following method: the clean system of red rooted salvia 750 grams, be ground into coarse granule, extract 2～3 times each 1～2 hour with 30～60% ethanol warm macerating, filter, medicinal residues are standby, and filtrate merges, cold preservation 12～48 hours, filter, decompression recycling ethanol, being concentrated into relative density is 1.05～1.15, measuring temperature is 60 ℃, add 15 times of amount waters for injection, with the hydrochloric acid adjust pH is 2～5, shakes up cold preservation 12～48 hours, filter filtrate for later use; The clean system of flos carthami 250 grams is mixed with Radix Salviae Miltiorrhizae decoction dregs, adds 16 times of amount distilled water warm macerating and extracts 2～3 times, each 1～2 hour, filter merging filtrate, be evaporated to relative density 1.05～1.15, measuring temperature is 60 ℃, adds ethanol and makes and contain the alcohol amount and reach 50～80%, left standstill 12～48 hours, and filtered decompression recycling ethanol, merge with Radix Salviae Miltiorrhizae extract, regulating pH value is 2～5, high speed centrifugation, and supernatant filters with inoranic membrane, filtrate is used ultrafiltration membrance filter, filtrate reuse NF membrane is filtered, and gets concentrated solution, is settled to 1000ml, adding sodium chloride for injection transfers to etc. and to ooze, regulating pH value is 5.5～7, cold preservation 12～48 hours, and microporous filter membrane filters, add water for injection to 1000ml, embedding becomes small-volume injection, sterilization, promptly.
3, the preparation of drug combination method of treatment cardiovascular and cerebrovascular disease as claimed in claim 2, it is characterized in that: the clean system of red rooted salvia 750 grams, be ground into coarse granule, extract 2～3 times each 1～2 hour with 30～60% ethanol warm macerating, filter, medicinal residues are standby, and filtrate merges, cold preservation 12～48 hours, filter, decompression recycling ethanol, being concentrated into relative density is 1.05～1.15, measuring temperature is 60 ℃, add 15 times of amount waters for injection, with the hydrochloric acid adjust pH is 2～5, shakes up cold preservation 12～48 hours, filter filtrate for later use; The clean system of flos carthami 250 grams is mixed with Radix Salviae Miltiorrhizae decoction dregs, adds 16 times of amount distilled water warm macerating and extracts 2～3 times, each 1～2 hour, filter merging filtrate, be evaporated to relative density 1.05～1.15, measuring temperature is 60 ℃, adds ethanol and makes and contain the alcohol amount and reach 50～80%, left standstill 12～48 hours, and filtered decompression recycling ethanol, merge with Radix Salviae Miltiorrhizae extract, regulating pH value is 2～5, high speed centrifugation, and supernatant filters with inoranic membrane, filtrate is used ultrafiltration membrance filter, filtrate reuse NF membrane is filtered, and gets concentrated solution, is settled to 1000ml, adding sodium chloride for injection transfers to etc. and to ooze, regulating pH value is 5.5～7, cold preservation 12～48 hours, and microporous filter membrane filters, add water for injection to 1000ml, embedding becomes small-volume injection, sterilization, promptly.
4, the preparation of drug combination method of treatment cardiovascular and cerebrovascular disease as claimed in claim 3 is characterized in that: the clean system of red rooted salvia 750 grams, be ground into coarse granule, and extract secondary with 50% ethanol warm macerating, each 1h filters, and medicinal residues are standby, filtrate merges, and cold preservation 24h filters, decompression recycling ethanol, being concentrated into relative density is 1.05～1.15, measuring temperature is 60 ℃, adding 15 times of amount waters for injection, is 3～4 with the hydrochloric acid adjust pH, shakes up, cold preservation 48h filters filtrate for later use; The clean system of flos carthami 250 grams is mixed with Radix Salviae Miltiorrhizae decoction dregs, adds 16 times of amount distilled water warm macerating and extracts three times, each 1h filters merging filtrate, be evaporated to relative density 1.10, measuring temperature is 60 ℃, adds ethanol and makes and contain the alcohol amount and reach 60%, leave standstill 48h, filter decompression recycling ethanol, merge with Radix Salviae Miltiorrhizae extract, regulating pH value is 3, high speed centrifugation, supernatant filters with inoranic membrane, and filtrate is used ultrafiltration membrance filter, and filtrate reuse NF membrane is filtered, concentrated solution, be settled to 1000ml, add sodium chloride for injection and transfer to etc. and to ooze, regulating pH value is 7, cold preservation 24h, and microporous filter membrane filters, add water for injection to 1000ml, embedding becomes small-volume injection, sterilization, promptly.
5, a kind of pharmaceutical composition for the treatment of cardiovascular and cerebrovascular disease, it is characterized in that said composition is prepared from by the following method: the clean system of red rooted salvia 75 grams, be ground into coarse granule, extract 2～3 times each 1～2 hour with 30～60% ethanol warm macerating, filter, medicinal residues are standby, and filtrate merges, cold preservation 12～48 hours, filter, decompression recycling ethanol, being concentrated into relative density is 1.05～1.15, measuring temperature is 60 ℃, add 15 times of amount waters for injection, with the hydrochloric acid adjust pH is 2～5, shakes up cold preservation 12～48 hours, filter filtrate for later use; The clean system of flos carthami 25 grams is mixed with Radix Salviae Miltiorrhizae decoction dregs, adds 16 times of amount distilled water warm macerating and extracts 2～3 times, each 1～2 hour, filter merging filtrate, be evaporated to relative density 1.05～1.15, measuring temperature is 60 ℃, adds ethanol and makes and contain the alcohol amount and reach 50～80%, left standstill 12～48 hours, and filtered decompression recycling ethanol, merge with Radix Salviae Miltiorrhizae extract, regulating pH value is 2～5, high speed centrifugation, and supernatant filters with inoranic membrane, filtrate is used ultrafiltration membrance filter, filtrate reuse NF membrane is filtered, and gets concentrated solution, is settled to 1000ml, adding sodium chloride for injection transfers to etc. and to ooze, regulating pH value is 5.5～7, cold preservation 12～48 hours, and microporous filter membrane filters, add water for injection to 1000ml, embedding becomes bulk capacity injection, sterilization, promptly.
6, the preparation of drug combination method of treatment cardiovascular and cerebrovascular disease as claimed in claim 5, it is characterized in that: the clean system of red rooted salvia 75 grams, be ground into coarse granule, extract 2～3 times each 1～2 hour with 30～60% ethanol warm macerating, filter, medicinal residues are standby, and filtrate merges, cold preservation 12～48 hours, filter, decompression recycling ethanol, being concentrated into relative density is 1.05～1.15, measuring temperature is 60 ℃, add 15 times of amount waters for injection, with the hydrochloric acid adjust pH is 2～5, shakes up cold preservation 12～48 hours, filter filtrate for later use; The clean system of flos carthami 25 grams is mixed with Radix Salviae Miltiorrhizae decoction dregs, adds 16 times of amount distilled water warm macerating and extracts 2～3 times, each 1～2 hour, filter merging filtrate, be evaporated to relative density 1.05～1.15, measuring temperature is 60 ℃, adds ethanol and makes and contain the alcohol amount and reach 50～80%, left standstill 12～48 hours, and filtered decompression recycling ethanol, merge with Radix Salviae Miltiorrhizae extract, regulating pH value is 2～5, high speed centrifugation, and supernatant filters with inoranic membrane, filtrate is used ultrafiltration membrance filter, filtrate reuse NF membrane is filtered, and gets concentrated solution, is settled to 1000ml, adding sodium chloride for injection transfers to etc. and to ooze, regulating pH value is 5.5～7, cold preservation 12～48 hours, and microporous filter membrane filters, add water for injection to 1000ml, embedding becomes bulk capacity injection, sterilization, promptly.
7, the preparation of drug combination method of treatment cardiovascular and cerebrovascular disease as claimed in claim 6 is characterized in that: the clean system of red rooted salvia 75 grams, be ground into coarse granule, and extract secondary with 50% ethanol warm macerating, each 1h filters, and medicinal residues are standby, filtrate merges, and cold preservation 24h filters, decompression recycling ethanol, being concentrated into relative density is 1.05～1.15, measuring temperature is 60 ℃, adding 15 times of amount waters for injection, is 3～4 with the hydrochloric acid adjust pH, shakes up, cold preservation 48h filters filtrate for later use; The clean system of flos carthami 25 grams is mixed with Radix Salviae Miltiorrhizae decoction dregs, adds 16 times of amount distilled water warm macerating and extracts three times, each 1h filters merging filtrate, be evaporated to relative density 1.10, measuring temperature is 60 ℃, adds ethanol and makes and contain the alcohol amount and reach 60%, leave standstill 48h, filter decompression recycling ethanol, merge with Radix Salviae Miltiorrhizae extract, regulating pH value is 3, high speed centrifugation, supernatant filters with inoranic membrane, and filtrate is used ultrafiltration membrance filter, and filtrate reuse NF membrane is filtered, concentrated solution, be settled to 1000ml, add sodium chloride for injection and transfer to etc. and to ooze, regulating pH value is 7, cold preservation 24h, and microporous filter membrane filters, add water for injection to 1000ml, embedding becomes bulk capacity injection, sterilization, promptly.
8, as the preparation of drug combination method of claim 3,4,6 or 7 described treatment cardiovascular and cerebrovascular diseases, it is characterized in that: the temperature of warm macerating is 40～70 ℃; Ultracentrifugal speed is more than the 10000r/min; The aperture of inoranic membrane is 0.22～0.65 μ m; Ultrafilter membrane molecular retention amount is below 6000～10000; NF membrane molecular retention amount is 500～2000.
9, the preparation of drug combination method of treatment cardiovascular and cerebrovascular disease as claimed in claim 8 is characterized in that: the temperature of warm macerating is 50～55 ℃; Ultracentrifugal speed is more than the 14000r/min; The inoranic membrane aperture is 0.45 μ m; Ultrafilter membrane molecular retention amount is below 8000; NF membrane molecular retention amount is 1000.
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1326520C (en) * | 2003-08-28 | 2007-07-18 | 北京贤达通科技有限公司 | A pharmaceutical composition and application thereof in preparation of medicine for preventing or treating cerebrovascular and cardiovascular disease |
| CN100431562C (en) * | 2004-02-20 | 2008-11-12 | 于文勇 | Chinese traditional medicinal preparation containing red sange root and safflower for treating cardiovascular and cerebrovascular diseases and preparing process thereof |
| CN100455302C (en) * | 2004-11-23 | 2009-01-28 | 郭爱华 | Danshen freeze-drying injection for treating cardiovascular and cerebrovascular diseases and preparation thereof |
| CN100386094C (en) * | 2005-01-25 | 2008-05-07 | 咸阳步长医药科技发展有限公司 | Oral medicine for cardio-cerebral blood vessel diseases and its making method |
| CN100382784C (en) * | 2005-04-11 | 2008-04-23 | 北京正大绿洲医药科技有限公司 | Danhong drip pill prepared from salvia root and carthamus and its preparation method |
| CN100446771C (en) * | 2005-08-18 | 2008-12-31 | 山东轩竹医药科技有限公司 | New medicinal composition |
| CN101002828B (en) * | 2007-01-10 | 2010-11-03 | 厦门国宇知识产权研究有限公司 | Method for preparing Danhong injection, and products thereof |
| CN101129463B (en) * | 2007-08-20 | 2011-09-14 | 正大青春宝药业有限公司 | Method of preparing red sage root injection |
| CN103142725B (en) * | 2013-04-08 | 2014-09-10 | 湖南今珠生物科技有限公司 | Health care agent with pearl powder, rose and radix salviae miltiorrhizae |
| CN104257873B (en) * | 2014-09-04 | 2018-08-14 | 马义磊 | A kind of herbal anesthetic and preparation method thereof |
| CN105920096B (en) * | 2016-06-12 | 2020-05-08 | 南京中医药大学 | Composition of red sage root and safflower, preparation method and application thereof |
| CN107441163A (en) * | 2017-08-04 | 2017-12-08 | 上海华源安徽锦辉制药有限公司 | A kind of preparation method for improving red sage root dropping liquid stability |
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