CN1954828A - 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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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 ginsenoside and arasaponin. 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
Along with steadily improving of people's lives and health level, China's aged population sharply increases; Equally, and compared in the past, huge variation has also taken place in old common disease, cardiovascular and cerebrovascular disease has occupied main body, make gerontal patient disability, can't take care of oneself, disable, and be old dead main arch-criminal, modern society is constituted serious threat.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: 200410022512.4, name is called the patent application of " Chinese medicine pharmaceutical preparation 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 Ginseng total saponins Radix Notoginseng total arasaponins compatibility to make preparation, optimize best prescription and technology; The product that obtains, particularly ejection preparation product can play activating blood circulation to dissipate blood stasis, TONGMAI SHULUO, improve blood circulation and metabolism.For example coronary heart disease is that coronary atherosclerosis causes myocardial ischemia, anoxia and the heart disease that causes, and two medicines share, and can play to improve the myocardial metabolism effect, increase coronary flow, and the blood that improves cardiac muscle is provided with the effect of allevating angina pectoris.The present invention has curative effect preferably for treating cardiovascular and cerebrovascular disease such as coronary heart disease, angina pectoris, arrhythmia, cerebral thrombosis, alzheimer disease etc.And the present invention is pure Chinese medicinal preparation, but the little patients life-time service of its untoward reaction.
The present invention constitutes like this: calculate according to percentage by weight, it is to be made by Radix Ginseng total saponins 1～99% and Radix Notoginseng total arasaponins 99～1% and suitable adjuvant.Be preferably: calculate according to percentage by weight, it is to be made by Radix Ginseng total saponins 30～70% and Radix Notoginseng total arasaponins 70～30% and suitable adjuvant.Say accurately: calculate according to percentage by weight, it is to be made by Radix Notoginseng total arasaponins 45～55% and Radix Ginseng total saponins 55～45% and suitable adjuvant.Radix Ginseng total saponins in the described prescription can be the highly finished product of panaxynol extract, Radix Ginseng water extract, Radix Ginseng water extract-alcohol precipitation extract, Radix Ginseng semi-bionic extraction thing, Radix Ginseng supercritical extract or above each extract; Radix Notoginseng total arasaponins can be the highly finished product of Radix Notoginseng alcohol extract, pseudo-ginseng water extract, Radix Notoginseng water extract-alcohol precipitation extract, Radix Notoginseng semi-bionic extraction thing, Radix Notoginseng supercritical extract or above each extract.Described preparation be directly used in the injection of drug administration by injection, directly for the venous transfusion of intravenous drip, need be used for the concentrated solution for injection of intravenous drip and injectable sterile powder and aseptic block and tablet, capsule, granule, drop pill, pill, soft capsule, oral liquid, oral cavity disintegration tablet or the dispersible tablet that makes with freeze-drying or spray drying method after the dilution.Contain saponin component in the preparation, calculate by weight percentage, in the compositions saponin component content sum be not less than deduction adjuvant amount and water quantities in the preparation total solid 50%.The pharmaceutical composition of described treatment cardiovascular and cerebrovascular disease: total saponin content is not less than 50% in the Radix Ginseng total saponins, and total saponins is not less than 50% in the Radix Notoginseng total arasaponins.
The preparation of drug combination method of described treatment cardiovascular and cerebrovascular disease is
A, Radix Notoginseng total arasaponins effective site are preparations like this: get pseudo-ginseng, adding entry or alcoholic solution after the pulverizing extracts, merge extractive liquid,, filter, concentrate the Radix Notoginseng 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 Notoginseng total arasaponins effective site;
B, Radix Ginseng total saponins effective site are preparations like this: get the ginseng crude drug, adding entry or alcoholic solution after the pulverizing extracts, merge extractive liquid,, filter, concentrate the Radix Ginseng 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 Ginseng total saponins effective site;
C, Radix Ginseng total saponins and Radix Notoginseng total arasaponins mix homogeneously add adjuvant and make different preparations.
The Injectable sterile block of described compositions prepares like this: get Radix Ginseng total saponins, Radix Notoginseng total arasaponins, 100g mannitol, add 1800ml water for injection, stirring makes dissolving, with saturated sodium hydroxide solution adjust pH to 6.5～7.0, add the injection water to 2000ml, mixing, the needle-use activated carbon of adding 0.5% boiled coarse filtration 30 minutes, reuse 0.45 μ m and 0.22 μ m microporous filter membrane filter, the filtrate packing, every bottle of 2.2.0ml, 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-18 ℃, and shelf temperature and product temperature equilibration time are 2 hours; Phase III continues to be cooled to-45 ℃, needs 2.5 hours approximately, keeps this temperature 2.5 hours, freeze the jail fully until product, promptly begin evacuation, enter drying program, evacuation under-45 ℃ of constant temperature slowly heats up 2～4 ℃/h, to the lowest total of the melting point temperature, the time is about 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 13～16 hours, kept more than 35 ℃ dry 2.5 hours, gland, promptly.
The injection and the concentrated solution for injection of described compositions prepare like this: get Radix Ginseng total saponins, Radix Notoginseng total arasaponins, add an amount of water for injection dissolving, by volume add 0.5% active carbon, boil, keep little 45min that boils, cold slightly filtration, filtrate adds the injection water to ormal weight, with saturated sodium hydroxide solution adjust pH to 6.5～7.0, boils, 4 ℃ of cold preservations are spent the night, coarse filtration, fine straining add the injection water, divide to install to 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 Ginseng total saponins, Radix Notoginseng total arasaponins, and best compatibility scope is Radix Notoginseng total arasaponins 45～55% and Radix Ginseng total saponins 55～45%.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 the hemodynamic influence of rats with myocardial ischemia: select the Wistar rat for use, body constitution amount 250～300g, with 3% pentobarbital sodium (30mg/kg) intraperitoneal injection of anesthesia, rat is faced upward the position is fixed on the self-control Mus plate, the chest cropping is embedded in left lower extremity with the ECG electrode pin and right upper extremity is subcutaneous, cuts off skin along left side the 7th intercostal, peel off chest muscle on a small quantity, cut off pericardium, heart is squeezed out outside the thoracic wall gently, separate ramus descendens anterior arteriae coronariae sinistrae (LAD), behind LAD initial part 2mm place threading, heart is put back to the thoracic cavity rapidly, and postoperative is stablized about 10min, the ligation coronary artery, have an electro-cardiogram immediately, write down and sew up.Electrocardiogram shows that the ST section is significantly raised or during abnormality Q wave, promptly shows acute myocardial ischemia modeling success.Get the rat of modeling success, be divided into model group at random; 1/99 group of Radix Ginseng total saponins/Radix Notoginseng total arasaponins: be called for short 1/99 group; 30/70 group of Radix Ginseng total saponins/Radix Notoginseng total arasaponins: be called for short 30/70; 45/55 group of Radix Ginseng total saponins/Radix Notoginseng total arasaponins: be called for short 45/55; 55/45 group of Radix Ginseng total saponins/Radix Notoginseng total arasaponins: be called for short 55/45; 70/30 group of Radix Ginseng total saponins/Radix Notoginseng total arasaponins: be called for short 70/30; 99/1 group of Radix Ginseng total saponins/Radix Notoginseng total arasaponins: be called for short 99/1; Positive control sorbitrate group: be called for short sorbitrate, 10 every group.In addition the rat of the same age of modeling is not as sham operated rats with 10, and sham operated rats only passes line after opening breast, does not do ligation.Wherein sham operated rats and model group give normal saline 60mg/kg every day, and the different proportioning group of Radix Ginseng total saponins/Radix Notoginseng total arasaponins gives relative medicine 60mg/kg every day, and the sorbitrate group gives sorbitrate 18mg/kg every day, and administration is 7 days altogether.Each group is treated to end time pentobarbital sodium intraperitoneal anesthesia once more respectively.At first intravenous injection heparin whole body anticoagulant, operation separates femoral artery and right common carotid artery.The cardiac hemodynamic parameter is detected in the back.Record left ventricular end diastolic presssure (LVEDP), left chamber maximum collapse (+) and diastole (-) speed (± dp/dt max).
Each administration group is to the influence of cardiac function
Group LVEDP (mmHg)+dp/dt max (mmHg/s)-dp/dt max (mmHg/s)
Sham operated rats-13.02 ± 1.58 4368.40 ± 468.20 3526.10 ± 326.10
Model group 6.79 ± 2.03 1954.60 ± 237.10 1572.00 ± 178.60
1/99 5.92±1.56. 2148.20±316.80 1928.50±201.30
30/70 5.95±1.62 2249.50±362.70 2015.40±326.70
45/55 5.15±1.83 2805.30±342.50 2281.20±405.80
55/45 5.17±1.34 2818.90±297.80 2307.80±469.20
70/30 5.78±1.91 2295.40±313.30 2015.70±305.00
99/1 6.08±1.15 2194.70±294.60 1932.50±326.70
Sorbitrate 5.33 ± 1.58 2847.20 ± 308.40. 2269.40 ± 294.20
By experimental result as can be known, Radix Ginseng total saponins, the best compatibility scope of Radix Notoginseng total arasaponins are Radix Notoginseng total arasaponins 45～55% and Radix Ginseng total saponins 55～45%.
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 6.5～7.0 pH value scope is the most reasonable.
0 month March
PH value clarity total saponins (mg/ml) clarity total saponins (mg/ml)
Differ from 1.51 5.0 differ from 1.86
5.5 clear and bright 1.88 differ from 1.65
6.0 clear and bright 1.86 differ from 1.62
6.5 clear and bright 1.82 clear and bright 1.79
7.0 clear and bright 1.80 clear and bright 1.77
7.5 clear and bright 1.81 differ from 1.63
Differ from 1.61 8.0 differ from 1.87
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 yellowish-brown deep yellow palm fibre of color and luster
PH value of solution 4.7 5.2 5.4 6.2 6.6 6.9 7.2 8.1 8.7 after the lyophilizing
The result shows that the rational pH value scope of the present invention is 6.5～7.0, and product quality is good.
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 Radix Ginseng/Radix Notoginseng 55/45 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 21.8 ± 2.3 192.74 ± 42.26 7.38 ± 1.81
Injection group 15.6 of the present invention ± 1.5 294.45 ± 34.72 4.37 ± 0.68
Oral liquid group 17.5 of the present invention ± 1.9 259.12 ± 29.04 5.12 ± 1.03
Medical material compatibility group 18.4 ± 1.3 235.87 ± 51.61 5.34 ± 1.11
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 Ginseng total saponins 55g Radix Notoginseng total arasaponins 45g
Get Radix Ginseng total saponins, Radix Notoginseng total arasaponins, 100g mannitol, add 1800ml water for injection, stirring makes dissolving, with saturated sodium hydroxide solution adjust pH to 6.5～7.0, add the injection water to 2000ml, mixing, the needle-use activated carbon of adding 0.5% boiled coarse filtration 30 minutes, reuse 0.45 μ m and 0.22 μ m microporous filter membrane filter, the filtrate packing, every bottle of 2.2.0ml, 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-18 ℃, and shelf temperature and product temperature equilibration time are 2 hours; Phase III continues to be cooled to-45 ℃, need 2.5 hours approximately, kept this temperature 2.5 hours, and froze the jail fully, promptly begin evacuation until product, enter drying program, evacuation under-45 ℃ of constant temperature slowly heats up 2～4 ℃/h, to the lowest total of the melting point temperature, time is about 14 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 13～16 hours, keeps more than 35 ℃ gland dry 2.5 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 saponin component content be deduction adjuvant amount and water quantities in the preparation total solid 84%.
Embodiments of the invention 2: Radix Ginseng total saponins 55g Radix Notoginseng total arasaponins 45g
Get Radix Ginseng total saponins, Radix Notoginseng total arasaponins, add an amount of water for injection dissolving, by volume add 0.5% active carbon, boil, keep little 30min that boils, cold slightly filtration, filtrate adds the injection water to ormal weight, with saturated sodium hydroxide solution adjust pH to 6.5～7.0, boils, 4 ℃ of cold preservations are spent the night, coarse filtration, fine straining add the injection water, divide to install to ampoule bottle, seal sterilization, promptly get injection and concentrated solution for injection.
Embodiments of the invention 3: Radix Ginseng total saponins 55g Radix Notoginseng total arasaponins 45g
Get Radix Ginseng total saponins, Radix Notoginseng total arasaponins, add an amount of water for injection dissolving, add the glucose or the sodium chloride of ormal weight, by volume add 0.5% active carbon behind the mixed dissolution, boil, keep little 30min that boils, cold slightly filtration, filtrate add the injection water to ormal weight, the saturated sodium hydroxide solution of reuse adjust pH to 6.5～7.0, boil, 4 ℃ of cold preservations are spent the night, and coarse filtration, fine straining add the injection water, packing, sterilization promptly gets glucose or sodium chloride intravenous infusion.
Embodiments of the invention 4: Radix Ginseng total saponins 45g Radix Notoginseng total arasaponins 55g
Get Radix Ginseng total saponins, Radix Notoginseng total arasaponins, add 1700ml water for injection, stir and make dissolving, with saturated sodium hydroxide solution adjust pH to 6.5～7.0, add the injection water to 2000ml, mixing, the needle-use activated carbon of adding 0.5%, boiled 45 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 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-18 ℃, and shelf temperature and product temperature equilibration time are 2 hours; Phase III continues to be cooled to-45 ℃, need 2.5 hours approximately, kept this temperature 2.5 hours, freeze the jail fully until product, promptly begin evacuation, enter drying program, under-45 ℃ of constant temperature-evacuation, slowly heat up, 2～4 ℃/h, to the lowest total of the melting point temperature, time is about 14 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 13～16 hours, kept more than 35 ℃ dry 2.5 hours, and under aseptic condition, divided to install in the cillin bottle, promptly get injectable sterile powder.
Embodiments of the invention 5: Radix Ginseng total saponins 55g Radix Notoginseng total arasaponins 45g
Get Radix Ginseng total saponins, Radix Notoginseng total arasaponins, mixing adds an amount of water for injection dissolving, by volume add 0.5% active carbon, boil, keep little 45min that boils, cold slightly filtration, filtrate add the injection water to ormal weight, with saturated sodium hydroxide solution adjust pH to 6.5～7.0, boil, 4 ℃ of cold preservations are spent the night, and coarse filtration, fine straining are 140 ℃ in inlet temperature, leaving air temp is 60 ℃, and air velocity is 20ms
-1Condition under spray drying get powder, packing promptly gets injectable sterile powder.
Embodiments of the invention 6: Radix Ginseng total saponins 30g Radix Notoginseng total arasaponins 70g
With Radix Ginseng total saponins and Radix Notoginseng total arasaponins mix homogeneously, add 6% polyvinylpolypyrrolidone PVPP and 1.3% mannitol, compacting promptly gets oral cavity disintegration tablet in flakes.
Embodiments of the invention 7: Radix Ginseng total saponins 70g Radix Notoginseng total arasaponins 30g
With Radix Ginseng total saponins and Radix Notoginseng total arasaponins mix homogeneously, to be that 1.6: 1 Macrogol 4000 is put in the rustless steel container with the principal agent ratio, add extract, mix homogeneously, be heated to 85-90 ℃, treat whole fusions after, 75-80 ℃ of insulation, mechanical high-speed stirs 15min to even, be transferred in the reservoir, the dropping liquid valve is regulated in 75～80 ℃ of insulations, splash in 35～40 ℃ the dimethicone, drip apart from 5～6cm, drip 40～45 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: Radix Ginseng total saponins 99g Radix Notoginseng total arasaponins 1g
With Radix Ginseng total saponins and Radix Notoginseng total arasaponins mix homogeneously, in principal agent: the ratio of adjuvant=1.2: 1 adds calcium sulfate, by principal agent: the ratio adding microcrystalline Cellulose of adjuvant=1.2: 1, and press principal agent: the crospovidone of adjuvant=4: 1, evenly mixed, make soft material in right amount with 70% 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 9: Radix Ginseng total saponins 1g Radix Notoginseng total arasaponins 99g
With Radix Ginseng total saponins and Radix Notoginseng total arasaponins mix homogeneously, add 2 times of amount starch, 0.7% stevioside, 1.5% microcrystalline Cellulose with the alcoholic solution system soft material of an amount of polyvinylpyrrolidone k30, is granulated, and 70 ℃ of forced air dryings are granulated, and granulate promptly gets granule.
Embodiments of the invention 10: Radix Ginseng total saponins 60g Radix Notoginseng total arasaponins 40g
With Radix Ginseng total saponins and Radix Notoginseng total arasaponins mix homogeneously, add the starch of equivalent, mix homogeneously is granulated, and is encapsulated, promptly gets capsule.
Embodiments of the invention 11: Radix Ginseng total saponins 40g Radix Notoginseng total arasaponins 60g
With Radix Ginseng total saponins and Radix Notoginseng total arasaponins mix homogeneously, add the starch of equivalent, mix homogeneously is granulated, and is encapsulated, promptly gets capsule.
Radix Ginseng total saponins among the above embodiment, Radix Notoginseng total arasaponins can be with Radix Ginseng total saponins, Radix Notoginseng total arasaponinss 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 total saponin content of Radix Ginseng total saponins is greater than 50%, and the total saponin content of Radix Notoginseng total arasaponins 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 Radix Ginseng total saponins 1～99% and Radix Notoginseng total arasaponins 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 Radix Ginseng total saponins 30～70% and Radix Notoginseng total arasaponins 70～30% 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 Radix Notoginseng total arasaponins 45～55% and Radix Ginseng total saponins 55～45% 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 Ginseng total saponins in the described prescription can be the highly finished product of panaxynol extract, Radix Ginseng water extract, Radix Ginseng water extract-alcohol precipitation extract, Radix Ginseng semi-bionic extraction thing, Radix Ginseng supercritical extract or above each extract; Radix Notoginseng total arasaponins can be the highly finished product of Radix Notoginseng alcohol extract, pseudo-ginseng water extract, Radix Notoginseng water extract-alcohol precipitation extract, Radix Notoginseng semi-bionic extraction thing, Radix Notoginseng 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 in the compositions, calculate by weight percentage, in the compositions saponin component content be not less than deduction adjuvant amount and water quantities in the composite 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: calculate according to percentage by weight, the content of total saponins is not less than 50% in the Radix Ginseng total saponins, and the content of total saponins is not less than 50% in the Radix Notoginseng total arasaponins.
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, Radix Notoginseng total arasaponins effective site are preparations like this: get pseudo-ginseng, adding entry or alcoholic solution after the pulverizing extracts, merge extractive liquid,, filter, concentrate the Radix Notoginseng 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 Notoginseng total arasaponins effective site;
B, Radix Ginseng total saponins effective site are preparations like this: get the ginseng crude drug, adding entry or alcoholic solution after the pulverizing extracts, merge extractive liquid,, filter, concentrate the Radix Ginseng 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 Ginseng total saponins effective site;
C, Radix Ginseng total saponins and Radix Notoginseng total arasaponins 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 Radix Ginseng total saponins, Radix Notoginseng total arasaponins, 100g mannitol, add 1800ml water for injection, stirring makes dissolving, with saturated sodium hydroxide solution adjust pH to 6.5～7.0, add the injection water to 2000ml, mixing, the needle-use activated carbon of adding 0.5%, boiled 30 minutes, coarse filtration, reuse 0.45 μ m and 0.22 μ m microporous filter membrane filter, the filtrate packing, every bottle of 2.2.0ml, 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-18 ℃, and shelf temperature and product temperature equilibration time are 2 hours; Phase III continues to be cooled to-45 ℃, needs 2.5 hours approximately, keeps this temperature 2.5 hours, promptly begin evacuation, enter drying program, evacuation under-45 ℃ of constant temperature, slowly heat up, 2～4 ℃/h, to the lowest total of the melting point temperature, time is about 14 hours, after sublimation drying is finished, continues under the low pressure condition, heating up, dry the time is about 13～16 hours to remove residual moisture, keeps more than 35 ℃ dry 2.5 hours, gland, promptly.
10, according to the preparation of drug combination method of 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 Ginseng total saponins, Radix Notoginseng total arasaponins, add an amount of water for injection dissolving, by volume add 0.5% active carbon, boil, keep little 45min that boils, cold slightly filtration, filtrate adds the injection water to ormal weight, with saturated sodium hydroxide solution adjust pH to 6.5～7.0, boil, 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.
11, as 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 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.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20110160153A1 (en) * | 2009-12-31 | 2011-06-30 | Guihua Lan | Methods and Compositions for Treating Blood Circulation Disorders |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20110160153A1 (en) * | 2009-12-31 | 2011-06-30 | Guihua Lan | Methods and Compositions for Treating Blood Circulation Disorders |
| US8202553B2 (en) * | 2009-12-31 | 2012-06-19 | Guihua Lan | Methods and compositions for treating blood circulation disorders |
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