CN1634254A - Compound formulation of astragalus root for treating cardiovascular and cerebrovascular diseases and its preparing process - Google Patents
Compound formulation of astragalus root for treating cardiovascular and cerebrovascular diseases and its preparing process Download PDFInfo
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- CN1634254A CN1634254A CN 200410040868 CN200410040868A CN1634254A CN 1634254 A CN1634254 A CN 1634254A CN 200410040868 CN200410040868 CN 200410040868 CN 200410040868 A CN200410040868 A CN 200410040868A CN 1634254 A CN1634254 A CN 1634254A
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Abstract
The invention relates to a compound formulation of astragalus root for treating cardiovascular and cerebrovascular diseases and its preparing process, wherein the formulation is prepared from astragalus root, herb of shortcape fleabane, and notoginseng. The compound is made into the dosage forms of injection and oral preparation.
Description
Technical field: the present invention is a kind of compound formulation of astragalus root for the treatment of cardiovascular and cerebrovascular disease and preparation method thereof, belongs to technical field of Chinese medicine.
Technical background: cardiovascular and cerebrovascular disease such as coronary heart disease, cerebral thrombosis, alzheimer disease etc. all are one of the most common and diseases that harm is maximum in the world today, have become human mortality's one of the main reasons in many countries; According to investigations, sickness rate in recent years has and increases trend year by year, and in, young patient constantly increases, ischemic cardiovascular and cerebral vascular disease has become commonly encountered diseases, the frequently-occurring disease of harm China people ' s health; 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: number of patent application is: 200410040348, name is called " the yellow Chinese medicine preparation of lamp and preparation method and its application ".During the applicant further studies, find that it is not very good only adopting the product curative effect of the Radix Astragali, Herba Erigerontis prescription.For example angina pectoris is a coronary insufficiency, rapid, the temporary transient ischemia of cardiac muscle, the caused syndrome of anoxia.Hemorheological change is parallel with the order of severity of coronary heart disease, and ET can cause that myocardial ischemia, damage, downright bad sample ST change, and the NO that continues the basis discharges, and to keeping the constant state of cardiovascular system significance is arranged.Though the Radix Astragali can be strengthened cardiac contractile force, excited people's nervous function, hemopoietic function etc.; Herba Erigerontis also can blood lipid regulation, suppresses platelet and erythrocyte aggregation, and blood viscosity lowering promotes fibrinolytic, improves hemorheological property; But both compatibilities are failed obviously to improve mice hypoxia-bearing capability, antagonism stress cardiomyopathy myocardial ischemia rat heart muscle ischemia, are improved hemorheology, improve plasma nitric oxide levels, reduce the ET level, and the curative effect of product is still waiting to improve.In view of such circumstances, seek a kind of active drug for the treatment of cardiovascular and cerebrovascular disease, compatibility is simple, therapeutic effect is desirable, does not have toxic and side effects, the thing that preparation technology's rational and effective medicine preparation has become people to be badly in need of solving.
Summary of the invention: the objective of the invention is to: a kind of compound astragalus membranaceus Chinese medicine preparation for the treatment of cardiovascular and cerebrovascular disease and preparation method thereof 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, adopts the Radix Astragali, Herba Erigerontis, Radix Notoginseng compatibility to make preparation; The product that obtains has activating blood circulation to dissipate blood stasis, TONGMAI SHULUO, improves blood circulation and metabolism.Be equipped with Radix Notoginseng and can obviously improve the ability of the Radix Astragali, Herba Erigerontis raising mice anoxia enduring, strengthen antagonism stress cardiomyopathy myocardial ischemia rat heart muscle ischemia, improve hemorheology, improve the function of plasma nitric oxide levels, reduction ET level.Prescription of the present invention plays comprehensive therapeutical effect by too many levels, multipath, is a kind of new drug with development prospect.The present invention not only has curative effect preferably for treating cardiovascular and cerebrovascular disease such as coronary heart disease, angina pectoris, arrhythmia, cerebral thrombosis, alzheimer disease etc., can also be used for diseases such as enhance immunity antitumor, treatment hepatorenal syndrome, heart and lung diseases, diabetes and complication thereof.And the present invention is pure Chinese medicinal preparation, but the little patients life-time service of its untoward reaction, and the present invention also provides a kind of preparation method, guarantees that the product of producing satisfies the treatment needs, can solve the problem that prior art exists.
The present invention constitutes like this: calculate according to components by weight percent, it is mainly by 1～99 part of the Radix Astragali, or corresponding the weight fraction Radix Astragali extract and the Herba Erigerontis that after extracting, obtain, 99～1 parts of in the Radix Notoginseng one or both, or the Radix Notoginseng that after extracting, obtains of corresponding weight fraction, Radix Astragali extract is made into injection, comprise: injection, the powder pin, freeze-dried powder, tablet, dispersible tablet, capsule, soft capsule, microcapsule, granule, pill, pellet, powder, drop pill, slow releasing preparation, controlled release preparation, oral liquid, gel, soft extract, extractum and membrane.The compound formulation of astragalus root of treatment cardiovascular and cerebrovascular disease of the present invention, calculate according to components by weight percent, it is mainly by 20～80 parts of the Radixs Astragali, or in the Radix Astragali extract that obtains after extracting of corresponding weight fraction and Herba Erigerontis, the Radix Notoginseng one or both 80～20 parts, or Herba Erigerontis, Radix Notoginseng extract that corresponding weight fraction obtains after extraction are made.The compound formulation of astragalus root of treatment cardiovascular and cerebrovascular disease of the present invention, calculate according to components by weight percent, it is by 50 parts of the Radixs Astragali, or 20 parts of the Radix Astragali extract that after extracting, obtains of corresponding weight fraction and Herba Erigerontiss, or 30 parts of the Herba Erigerontis extract that after extracting, obtains of corresponding weight fraction and Radix Notoginseng, or the hot extract of Radix Notoginseng that corresponding weight fraction obtains after extracting is made described extract: the highly finished product that can be alcohol extract, water extract, water extract-alcohol precipitation extract, semi-bionic extraction thing, supercritical extract or above extract.Preparation of the present invention is: injection, comprising: injection, powder pin, freeze-dried powder, tablet, capsule, granule, drop pill, pellet, gel, soft capsule, dispersible tablet.The preparation method of the compound formulation of astragalus root of treatment cardiovascular and cerebrovascular disease of the present invention is: get the Radix Astragali, Herba Erigerontis, water boiling and extraction is filtered, and is refining, and drying gets the Radix Astragali, Herba Erigerontis extract; Get Radix Notoginseng, pulverize, alcohol reflux filters, and is refining, and drying gets Radix Notoginseng extract; Make different preparations respectively after then they being mixed.
The preparation method of the compound formulation of astragalus root of treatment cardiovascular and cerebrovascular disease of the present invention: get the Radix Astragali, Herba Erigerontis, 8 times of water gagings decoct and extract 2 times, each 2 hours, filter D101 type macroporous adsorbent resin on the filtrate, 70% ethanol elution, the eluent water-bath volatilizes, concentrating under reduced pressure, vacuum drying gets the Radix Astragali, Herba Erigerontis extract; Get Radix Notoginseng, be ground into particle diameter is distributed in 0～30 μ m more than 99% micropowder, measure 80% alcohol reflux 2 times for 8 times, each 1 hour, collect extracting solution, centrifugal, get supernatant, reclaim ethanol, get the Radix Notoginseng extracting solution, last D101 type macroporous adsorbent resin, 70% ethanol elution, the eluent concentrating under reduced pressure, vacuum drying gets Radix Notoginseng extract; Make different preparations respectively after then they being mixed.
The preparation method of the compound formulation of astragalus root of treatment cardiovascular and cerebrovascular disease of the present invention: get Radix Astragali extract, Herba Erigerontis extract, Radix Notoginseng extract, add water for injection, and add 0.9% sodium chloride, stir evenly, cold preservation filters, filtrate adds 0.2% active carbon, boils 30 minutes, puts cold, be filtered to clear and brightly, with 10%NaOH adjust pH 7.0～7.5, benefit adds to the full amount of water for injection, filtering with microporous membrane through 0.25～0.45 μ m, fill was sterilized 30 minutes, and was promptly got great transfusion preparation for 115 ℃.
The preparation method of the compound formulation of astragalus root of treatment cardiovascular and cerebrovascular disease of the present invention: get Radix Astragali extract, Herba Erigerontis extract, Radix Notoginseng extract, add water for injection, stir evenly, cold preservation filters, filtrate adds 0.2% active carbon, boiled 30 minutes, and put coldly, be filtered to clear and bright, with 10%NaOH adjust pH 7.0～7.5, in medicinal liquid: it is caffolding agent that the ratio of caffolding agent=1: 2 adds glucosan, and mixing is through the filtering with microporous membrane of 0.25～0.45 μ m, fill, lyophilization, lyophilisation condition :-10 ℃ of pre-freezes 2 hours ,-45 ℃ of pre-freezes began evacuation after 5 hours, and be warming up to-30 ℃, kept 3 hours; Be warming up to-20 ℃, kept 5 hours; Be warming up to-10 ℃, kept 8 hours; Be warming up to 0 ℃, kept 2 hours; Be warming up to 10 ℃, kept 2 hours; Be warming up to 20 ℃, kept 2 hours; Be warming up to 30 ℃, kept 1 hour, promptly get lyophilized injectable powder.
The preparation method of the compound formulation of astragalus root of treatment cardiovascular and cerebrovascular disease of the present invention: get Radix Astragali extract, Herba Erigerontis extract, Radix Notoginseng extract, add water for injection, stir evenly, cold preservation filters, and filtrate adds 0.1% active carbon, boiled 30 minutes, put cold, be filtered to clear and bright, with 10%NaOH adjust pH 7.0～7.5, filtering with microporous membrane through 0.25～0.45 μ m, spray drying, packing promptly gets injectable powder.
The preparation method of the compound formulation of astragalus root of treatment cardiovascular and cerebrovascular disease of the present invention: get Radix Astragali extract, Herba Erigerontis extract, Radix Notoginseng extract, add water for injection, add 0.1% active carbon, boiled 30 minutes, put cold, be filtered to clear and brightly, with 10%NaOH adjust pH 7.0～7.5, benefit adds to the full amount of water for injection, filtering with microporous membrane through 0.25～0.45 μ m, fill was sterilized 30 minutes, and was promptly got injection for 115 ℃.
Compared with prior art, the applicant adopts the Radix Astragali, Herba Erigerontis, Radix Notoginseng compatibility to make preparation; The product that obtains has activating blood circulation to dissipate blood stasis, TONGMAI SHULUO, improves blood circulation and metabolism.Be equipped with the energy coronary blood flow increasing, reduce myocardial oxygen consumption, strengthen myocardial hypoxia tolerance, and heart rate there is a Radix Notoginseng of dual regulation, ability, the enhancing that can obviously improve the Radix Astragali, Herba Erigerontis raising mice anoxia enduring resist stress cardiomyopathy myocardial ischemia rat heart muscle ischemia, improve hemorheology, improve the function of plasma nitric oxide levels, reduction ET level.
The applicant found through experiments, the Radix Notoginseng particle diameter of the micro-gasification process different with traditional mechanical breaking method preparation is thin and be evenly distributed, most cells of pseudo-ginseng are breaking cellular wall, the composition that some is present in kytoplasm or the organelle directly comes out, discharge and needn't pass through cell wall (film), thereby the stripping that makes effective ingredient is faster and complete, and the product curative effect is better; The applicant also is determined by experiment the suitable pH value of injection, guaranteed the stable of Radix Notoginseng, Radix Astragali effective ingredient.The product of the application's preparation, the curative effect ideal, safety and stability, solved the problem that prior art exists, the present invention not only has curative effect preferably for treating cardiovascular and cerebrovascular disease such as coronary heart disease, angina pectoris, arrhythmia, cerebral thrombosis, alzheimer disease etc., can also be used for diseases such as enhance immunity antitumor, treatment hepatorenal syndrome, heart and lung diseases, diabetes and complication thereof; The present invention also provides the detailed processing technology of several formulations, can be directly used in and instruct actual production; Reached the purpose of invention.
The applicant has carried out a series of experiments, can prove that medicine provided by the invention has effective effect;
Experimental example 1: compatibility pharmacodynamics comparative study
(1) to the influence of rat heart muscle ischemia: get 30 of Wistar rats, male and female half and half are divided into model group, DENGHUANG ZHUSHEYE group, injection group of the present invention, 10 every group at random.Each medicine group is pressed the 1mL/100g body weight, injects DENGHUANG ZHUSHEYE, injection of the present invention respectively, and model group is given and waited the capacity normal saline to irritate stomach, every day 1 time, successive administration 5 days.The 6th day with 20% urethane 1g/kg intraperitoneal injection of anesthesia rat, it is fixing to lie on the back, with the II record normal ECG that leads, cut off abdominal part, expose stomach, normal saline, DENGHUANG ZHUSHEYE, injection of the present invention are injected with syringe respectively, behind the 0.5h, sublingual vein injection of pituitrin 0.2u/100g body weight has evenly been annotated in the 15s.Injected the back immediate record at once, the different electrocardiograms constantly of 30s, 1,3,5,10,20min.With normal ECG T wave height is benchmark, and the T ripple changes percentage rate for investigating index.
Influence to the rat heart muscle ischemia
Model group DENGHUANG ZHUSHEYE group injection group of the present invention
At once 103.1 ± 21.1 73.3 ± 11.3 58.2 ± 21.6
30s 87.4±22.6 77.6±23.7 67.3±11.4
1min 79.7±22.4 69.9±20.5 55.4±12.3
3min 84.5±11.5 64.0±13.6 52.5±10.3
5min 68.3±12.8 58.1±14.9 47.7±16.9
10min 54.8±16.5 44.4±15.4 42.8±19.4
15min 36.1±2.9 35.3±11.5 34.9±21.5
20min 25.3±5.0 23.6±13.1 21.2±7.3
(2) to the influence of irritability rats with myocardial ischemia blood plasma ET and NO: get 40 of Wistar male rats, be divided into normal control group, model group, DENGHUANG ZHUSHEYE, injection of the present invention at random, 10 every group.Each medicine group is injected DENGHUANG ZHUSHEYE, injection of the present invention respectively by the 1mL/100g body weight, and model group and normal control group such as give respectively at capacity normal saline, every day 1 time, continuous 7 days.In administration the 6th day, modeling.After irritating stomach 1h on the 7th day, lumbar injection 20% urethane 1g/kg, anesthetized rat, abdominal aortic blood 2.5mL, place the test tube that contains 30 μ L10%EDTA and 50mL (50ZU) aprotinin, mixing, 4 ℃, 3000r/min, centrifugal 10min gets blood plasma, and-30 ℃ of refrigerators are preserved, and survey ET.Get 0.9ml blood and place the test tube that contains 01mL3.8% sodium citrate solution, 4 ℃, 3000r/min, centrifugal 10min gets blood plasma, and NO is surveyed in-30 ℃ of preservations.
Influence to the rat heart muscle ischemia
Number of animals (only) ET (ng/L) NO (mmol/L)
Normal control group 10 3.43 ± 0.17 346.2 ± 17.18
Model group 10 3.85 ± 0.21 399.6 ± 11.06
DENGHUANG ZHUSHEYE group 10 3.01 ± 0.18 410.1 ± 20.19
Injection group 10 2.14 of the present invention ± 0.20 450.2 ± 30.28
The result shows, injection group of the present invention has the effect that reduces stress cardiomyopathy myocardial ischemia rat plasma ET content, elevation of NO content, and the influence of rat heart muscle ischemia is better than the DENGHUANG ZHUSHEYE group.
Experimental example 2: Radix Notoginseng micropowder technical study
(1) particle diameter of Radix Notoginseng micropowder and distribution:
The distribution of lengths diameter Distribution
Interval/μ m number frequency/% accumulation/% number frequency/% accumulates %
0～5 13 4.1 4.1 16 16 16
5～10 145 43.7 48 204 61.5 78.6
10～15 116 34.5 82.1 50 14.7 93.4
15～20 39 11.2 93.5 19 5.3 98.3
20～30 18 5.8 99.2 3 0.8 99.5
30～40 2 0.6 100 1 0.2 100
(2) Panax Notoginseng saponin R g in the Radix Notoginseng
1The stripping percentage rate: get the about 1g of Radix Notoginseng micropowder and coarse powder respectively, the accurate title, decide, drops in the digestion instrument, and according to Chinese Pharmacopoeia (version appendix in 2000) dissolution method, be solvent with 500mL water, the oar method, rotating speed is 50rmin
-1, temperature is (37 ± 0.5) ℃, respectively at 5,10,15,30,45, the 60min 2mL that takes a sample replenishes the water of uniform temp and volume simultaneously in stripping rotor, filter, and gets subsequent filtrate 10 μ L and measures Rg with reversed-phase HPLC
1Content.Calculate different time Rg
1The stripping percentage rate.
Accumulation stripping percentage rate %
Time min coarse powder micropowder
5 50 60
10 58 75
15 65 84
30 78 95
45 88 101
60 94 102
(3) to the influence of stasis syndrome rat blood rheological characteristic: 60 of rats, male and female half and half, body weight 270 ± 20g successive administration 12 days, 1h after the last administration, all the other respectively organize equal sc injection epinephrine 0.8mg/kg, totally twice, two minor tick 4h except that the normal control group.(front and back each 2 hours at interval) immerse 5min in the frozen water, fasting with rat between twice.Femoral artery blood sampling in morning next day, each index of hemorheology is measured in the heparin sodium anticoagulant.
Group plasma viscosity packed cell volume reduced viscosity
Normal control 1.50 ± 0.25 0.43 ± 0.01 7.79 ± 0.47
Model is to 2.18 ± 0.19 0.55 ± 0.07 8.59 ± 2.30
Injection 1.70 of the present invention ± 0.18 0.43 ± 0.05 7.90 ± 3.58
Radix Notoginseng coarse powder preparation 1.89 ± 0.45 0.49 ± 0.21 8.14 ± 1.37
Injection
The result shows, different with traditional mechanical crushing method, it is thin and be evenly distributed that the material of micro-gasification process preparation has a particle diameter, most cells of pseudo-ginseng are breaking cellular wall, the composition that some is present in kytoplasm or the organelle directly comes out, discharge and needn't pass through cell wall (film), thereby make the stripping of effective ingredient faster and complete, the product curative effect is better.
Experimental example 3: Study on Forming
(1) pH value is to the influence of injection: the applicant finds in development, product arasaponin of the present invention, Radix Astragali saponin are one of main onset composition, because of facile hydrolysis causes the medicine instability, its drug effect reduces, suitable acid-base value is the stable key factor of medicine, 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.
0 month March
PH value clarity total saponins (mg/ml) clarity total saponins (mg/ml)
Differ from 1.14 5.0 differ from 1.50
5.5 clear and bright 1.51 differ from 1.27
6.0 clear and bright 1.53 differ from 1.25
6.5 clear and bright 1.49 differ from 1.36
7.0 clear and bright 1.49 clear and bright 1.48
7.5 clear and bright 1.48 clear and bright 1.47
Differ from 1.23 8.0 differ from 1.54
(2) pH 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 4.5 4.8 5.0 5.1 6.5 6.8 7.5 8.1 8.8 after the lyophilizing
The result shows that technology of the present invention is rationally feasible, and product quality is good.
Experimental example 4: preparation pharmacodynamic study
(1) to the influence of blood stasis model rabbit blood rheological characteristic
48 of rabbit are divided into 4 groups at random, and 12 every group, ♀ ♂ half and half is respectively blank group, model control group, positive drug control group and of the present invention group.Each treated animal elder generation auricular vein is injected (iv) administration.Blank and model control group injecting normal saline (NS) 1ml/kg, positive drug group iv puerarin injection 30mg/kg (being made into 30mg/ml) with NS, the medicinal liquid (being made into) of of the present invention group of injection 0.25mg/ml with NF, dosage is 1ml/kg, two weeks of successive administration (14d), in administration the 2nd, 13d, except that the blank group, each rabbit is annotated 10% high molecular dextran 5ml/kg through auricular vein respectively, every day twice, causes blood stasis model.After the last administration, inject 10% high molecular dextran 5ml/kg once more, behind the 15min, heart is taked fasting blood 6ml, carrying out hemorheology index detects, wherein platelet aggregation rate adopts turbidimetry for Determination: the rotary cone-plate viscosity apparatus mensuration of other employing LBY-N6A+ with LBY-NJ2 type platelet aggregation instrument.
To rabbit platelet aggregation and fibrinogenic influence (x ± s, n=6)
Group dosage (mg/kg) body weight (kg) platelet aggregation (%) Fibrinogen (g/L)
Blank group-2.31 ± 0.15 15.54 ± 2.46 2.53 ± 1.16
Model group-2.45 ± 0.08 38.27 ± 15.05 2.73 ± 1.41
Positive drug group 30 2.37 ± 0.11 12.74 ± 3.47 3.12 ± 1.83
Of the present invention group 0.25 2.32 ± 0.24 14.80 ± 1.36 2.69 ± 2.32
The result shows: composing prescription preparation of the present invention can obviously improve the hemorheological property of blood stasis model rabbit, and curative effect is good.
(2) experimentation of treatment rat diabetes nephropathy
Select 30 of the healthy male Wistar rats of 150～190g for use, be divided into normal control group, diabetic groups and powder acupuncture treatment group of the present invention at random, every group 10, divide cage to feed, arbitrarily drink water, with diabetes rats, fasting 10h, be dissolved in 0.1mol/L citric acid sodium citrate buffer solution (pH4.5) with streptozotocin, be made into 1% solution, press the 50mg/kg single intraperitoneal injection, get tail vein behind the 5d, measure blood glucose with blood glucose meter, blood glucose 〉=16.7mmol/L is diabetes rat (becoming mould rate 100%).The citric acid citrate buffer solution of normal control group injection respective volume.Injectable powder of the present invention is become 0.5g/L solution with physiological saline solution, and the treatment group is pressed 70mgkg morning every day
-1D
-1Dosage is irritated stomach, and the diabetic groups stomach is raised the normal saline of equivalent, continues to feed to 12 all backs collect specimens, and metabolic cage is collected 24h urine, surveys 24h excretion quantity of urinary protein (UPE).Claim to anaesthetize after the quality, right atrium is got blood and is surveyed Endothelin, puts the method for exempting from and measures insulin, surveys blood urea nitrogen (BUN) with CX 7 automatic biochemistry analyzers, and calculates endogenous creatinine clearance rate (Ccr), and the result proofreaies and correct with the body constitution amount.Get two kidneys, right kidney part is fixed with 4% paraformaldehyde, conventional film-making, and light microscopy checking is measured MGPA and MGV with image analyzer, and left kidney is used to organize the ET assay.
Normal control group diabetic groups injectable powder group of the present invention
MGPA 52.70±0.23 66.17±5.17 54.27±1.06
MGV 410.6±27.8 626.3±19.3 428.3±14.8
BUN 7.12±0.38 12.29±1.56 8.37±2.66
Ccr 5.34±0.89 2.85±0.11 4.20±0.53
UPE 9.65±1.24 41.39±8.21 18.28±1.49
The result shows that preparation of the present invention all has more powerful effect for MGPA, MGV, BUN, Ccr and 24h excretion quantity of urinary protein, can significantly improve the function of diabetic nephropathy rat.
Concrete embodiment:
Embodiments of the invention 1: Radix Astragali 10g, Herba Erigerontis 44g, Radix Notoginseng 55g
Get the Radix Astragali, Herba Erigerontis, 8 times of water gagings decoct and extract 2 times, and each 2 hours, filter, D101 type macroporous adsorbent resin on the filtrate, 70% ethanol elution, the eluent water-bath volatilizes, concentrating under reduced pressure, vacuum drying gets the Radix Astragali, Herba Erigerontis extract; Get Radix Notoginseng, be ground into particle diameter is distributed in 0～30 μ m more than 99% micropowder, measure 80% alcohol reflux 2 times for 8 times, each 1 hour, collect extracting solution, centrifugal, get supernatant, reclaim ethanol, get the Radix Notoginseng extracting solution, last D101 type macroporous adsorbent resin, 70% ethanol elution, eluent concentrating under reduced pressure, vacuum drying gets Radix Notoginseng extract, gets Radix Astragali extract, Herba Erigerontis extract, Radix Notoginseng extract, add water for injection, and add 0.9% sodium chloride, stir evenly, cold preservation, filter, filtrate adds 0.2% active carbon, boils 30 minutes, put cold, be filtered to clear and brightly, with 10%NaOH adjust pH 7.0～7.5, benefit adds to the full amount of water for injection, filtering with microporous membrane through 0.25～0.45 μ m, fill was sterilized 30 minutes, and was promptly got great transfusion preparation for 115 ℃.
Embodiments of the invention 2: Radix Astragali 99g, Herba Erigerontis 0.5g, Radix Notoginseng 0.5g
Get the Radix Astragali, Herba Erigerontis, 8 times of water gagings decoct and extract 2 times, and each 2 hours, filter, D101 type macroporous adsorbent resin on the filtrate, 70% ethanol elution, the eluent water-bath volatilizes, concentrating under reduced pressure, vacuum drying gets the Radix Astragali, Herba Erigerontis extract; Get Radix Notoginseng, be ground into particle diameter is distributed in 0～30 μ m more than 99% micropowder, measure 80% alcohol reflux 2 times for 8 times, each 1 hour, collect extracting solution, centrifugal, get supernatant, reclaim ethanol, get the Radix Notoginseng extracting solution, last D101 type macroporous adsorbent resin, 70% ethanol elution, eluent concentrating under reduced pressure, vacuum drying gets Radix Notoginseng extract, gets Radix Astragali extract, Herba Erigerontis extract, Radix Notoginseng extract, add water for injection, stir evenly, cold preservation filters, filtrate adds 0.2% active carbon, boiled 30 minutes, and put coldly, be filtered to clear and bright, with 10%NaOH adjust pH 7.0～7.5, in medicinal liquid: it is caffolding agent that the ratio of caffolding agent=1: 2 adds glucosan, and mixing is through the filtering with microporous membrane of 0.25～0.45 μ m, fill, lyophilization, lyophilisation condition :-10 ℃ of pre-freezes 2 hours ,-45 ℃ of pre-freezes began evacuation after 5 hours, and be warming up to-30 ℃, kept 3 hours; Be warming up to-20 ℃, kept 5 hours; Be warming up to-10 ℃, kept 8 hours; Be warming up to 0 ℃, kept 2 hours; Be warming up to 10 ℃, kept 2 hours; Be warming up to 20 ℃, kept 2 hours; Be warming up to 30 ℃, kept 1 hour, promptly get lyophilized injectable powder
Embodiments of the invention 3: Radix Astragali 20g, Herba Erigerontis 40g, Radix Notoginseng 40g
Get the Radix Astragali, Herba Erigerontis, 8 times of water gagings decoct and extract 2 times, and each 2 hours, filter, D101 type macroporous adsorbent resin on the filtrate, 70% ethanol elution, the eluent water-bath volatilizes, concentrating under reduced pressure, vacuum drying gets the Radix Astragali, Herba Erigerontis extract; Get Radix Notoginseng, be ground into particle diameter is distributed in 0～30 μ m more than 99% micropowder, measure 80% alcohol reflux 2 times for 8 times, each 1 hour, collect extracting solution, centrifugal, get supernatant, reclaim ethanol, get the Radix Notoginseng extracting solution, last D101 type macroporous adsorbent resin, 70% ethanol elution, eluent concentrating under reduced pressure, vacuum drying gets Radix Notoginseng extract, gets Radix Astragali extract, Herba Erigerontis extract, Radix Notoginseng extract, add water for injection, stir evenly cold preservation, filter, filtrate adds 0.1% active carbon, boils 30 minutes, put cold, be filtered to clear and bright, with 10%NaOH adjust pH 7.0～7.5, filtering with microporous membrane through 0.25～0.45 μ m, spray drying, packing promptly gets injectable powder.
Embodiments of the invention 4: Radix Astragali 80g, Herba Erigerontis 10g, Radix Notoginseng 10g
Get the Radix Astragali, Herba Erigerontis, 8 times of water gagings decoct and extract 2 times, and each 2 hours, filter, D101 type macroporous adsorbent resin on the filtrate, 70% ethanol elution, the eluent water-bath volatilizes, concentrating under reduced pressure, vacuum drying gets the Radix Astragali, Herba Erigerontis extract; Get Radix Notoginseng, be ground into particle diameter is distributed in 0～30 μ m more than 99% micropowder, measure 80% alcohol reflux 2 times for 8 times, each 1 hour, collect extracting solution, centrifugal, get supernatant, reclaim ethanol, get the Radix Notoginseng extracting solution, last D101 type macroporous adsorbent resin, 70% ethanol elution, the eluent concentrating under reduced pressure, vacuum drying gets Radix Notoginseng extract, get Radix Astragali extract, Herba Erigerontis extract, Radix Notoginseng extract, add water for injection, add 0.1% active carbon, boiled 30 minutes, put cold, be filtered to clear and brightly, with 10%NaOH adjust pH 7.0～7.5, benefit adds to the full amount of water for injection, filtering with microporous membrane through 0.25～0.45 μ m, fill was sterilized 30 minutes, and was promptly got injection for 115 ℃.
Embodiments of the invention 5: Radix Astragali 50g, Herba Erigerontis 20g, Radix Notoginseng 30g
Get the Radix Astragali, Herba Erigerontis, 8 times of water gagings decoct and extract 2 times, and each 2 hours, filter, D101 type macroporous adsorbent resin on the filtrate, 70% ethanol elution, the eluent water-bath volatilizes, concentrating under reduced pressure, vacuum drying gets the Radix Astragali, Herba Erigerontis extract; Get Radix Notoginseng, be ground into particle diameter is distributed in 0～30 μ m more than 99% micropowder, measure 80% alcohol reflux 2 times for 8 times, each 1 hour, collect extracting solution, centrifugal, get supernatant, reclaim ethanol, get the Radix Notoginseng extracting solution, last D101 type macroporous adsorbent resin, 70% ethanol elution, eluent concentrating under reduced pressure, vacuum drying, get Radix Notoginseng extract, get Radix Astragali extract, Herba Erigerontis extract, Radix Notoginseng extract, add the soybean oil mixing, the pressing pill, promptly get soft capsule, this product oral, three times on the one, each 2.
Embodiments of the invention 6: Radix Astragali 50g, Herba Erigerontis 30g, Radix Notoginseng 20g
Get the Radix Astragali, Herba Erigerontis, 8 times of water gagings decoct and extract 2 times, and each 2 hours, filter, D101 type macroporous adsorbent resin on the filtrate, 70% ethanol elution, the eluent water-bath volatilizes, concentrating under reduced pressure, vacuum drying gets the Radix Astragali, Herba Erigerontis extract; Get Radix Notoginseng, be ground into particle diameter is distributed in 0～30 μ m more than 99% micropowder, measure 80% alcohol reflux 2 times for 8 times, each 1 hour, collect extracting solution, centrifugal, get supernatant, reclaim ethanol, get the Radix Notoginseng extracting solution, last D101 type macroporous adsorbent resin, 70% ethanol elution, eluent concentrating under reduced pressure, vacuum drying gets Radix Notoginseng extract, gets Radix Astragali extract, Herba Erigerontis extract, Radix Notoginseng extract, add the PEG2000 mixing, the dropping preparation method pill promptly gets drop pill.
Embodiments of the invention 7: Radix Astragali 80g, Herba Erigerontis 5g, Radix Notoginseng 15g
Get the Radix Astragali, Herba Erigerontis, 8 times of water gagings decoct and extract 2 times, and each 2 hours, filter, D101 type macroporous adsorbent resin on the filtrate, 70% ethanol elution, the eluent water-bath volatilizes, concentrating under reduced pressure, vacuum drying gets the Radix Astragali, Herba Erigerontis extract; Get Radix Notoginseng, be ground into particle diameter is distributed in 0～30 μ m more than 99% micropowder, measure 80% alcohol reflux 2 times for 8 times, each 1 hour, collect extracting solution, centrifugal, get supernatant, reclaim ethanol, get the Radix Notoginseng extracting solution, last D101 type macroporous adsorbent resin, 70% ethanol elution, eluent concentrating under reduced pressure, vacuum drying gets Radix Notoginseng extract, gets Radix Astragali extract, Herba Erigerontis extract, Radix Notoginseng extract, add 3% sodium carboxymethyl cellulose, extrude a spheronization pill, promptly get pellet.
Embodiments of the invention 8: Radix Astragali 80g, Herba Erigerontis 15g, Radix Notoginseng 5g
Get the Radix Astragali, Herba Erigerontis, 8 times of water gagings decoct and extract 2 times, and each 2 hours, filter, D101 type macroporous adsorbent resin on the filtrate, 70% ethanol elution, the eluent water-bath volatilizes, concentrating under reduced pressure, vacuum drying gets the Radix Astragali, Herba Erigerontis extract; Get Radix Notoginseng, be ground into particle diameter is distributed in 0～30 μ m more than 99% micropowder, measure 80% alcohol reflux 2 times for 8 times, each 1 hour, collect extracting solution, centrifugal, get supernatant, reclaim ethanol, get the Radix Notoginseng extracting solution, last D101 type macroporous adsorbent resin, 70% ethanol elution, eluent concentrating under reduced pressure, vacuum drying, get Radix Notoginseng extract, get Radix Astragali extract, Herba Erigerontis extract, Radix Notoginseng extract, mixing adds 3% sodium carboxymethyl cellulose, it is moistening to add water, make granule, drying adds 1% carboxymethyl starch sodium, tabletting promptly gets dispersible tablet.
Claims (10)
1, a kind of compound formulation of astragalus root for the treatment of cardiovascular and cerebrovascular disease, it is characterized in that: calculate according to components by weight percent, it is mainly by 1～99 part of the Radix Astragali, or corresponding the weight fraction Radix Astragali extract and the Herba Erigerontis that after extracting, obtain, 99～1 parts of in the Radix Notoginseng one or both, or the Radix Notoginseng that after extracting, obtains of corresponding weight fraction, Radix Astragali extract is made into injection, comprise: injection, the powder pin, freeze-dried powder, tablet, dispersible tablet, capsule, soft capsule, microcapsule, granule, pill, pellet, powder, drop pill, slow releasing preparation, controlled release preparation, oral liquid, gel, soft extract, extractum and membrane.
2, according to the compound formulation of astragalus root of the described treatment cardiovascular and cerebrovascular disease of claim 1, it is characterized in that: calculate according to components by weight percent, it is mainly by 20～80 parts of the Radixs Astragali, or in the Radix Astragali extract that obtains after extracting of corresponding weight fraction and Herba Erigerontis, the Radix Notoginseng one or both 80～20 parts, or Herba Erigerontis, Radix Notoginseng extract that corresponding weight fraction obtains after extraction are made.
3, compound formulation of astragalus root according to claim 1 or 2 described treatment cardiovascular and cerebrovascular diseases, it is characterized in that: calculate according to components by weight percent, it is by 50 parts of the Radixs Astragali, or 20 parts of the Radix Astragali extract that after extracting, obtains of corresponding weight fraction and Herba Erigerontiss, or 30 parts of the Herba Erigerontis extract that after extracting, obtains of corresponding weight fraction and Radix Notoginseng, or the hot extract of Radix Notoginseng that corresponding weight fraction obtains after extracting is made described extract: can be alcohol extract, water extract, the water extract-alcohol precipitation extract, the semi-bionic extraction thing, the highly finished product of supercritical extract or above extract.
4, according to the compound formulation of astragalus root of the described this treatment cardiovascular and cerebrovascular disease of claim 1, it is characterized in that: described preparation is: injection, comprising: injection, powder pin, freeze-dried powder, tablet, capsule, granule, drop pill, pellet, gel, soft capsule, dispersible tablet.
5, as the preparation method of the compound formulation of astragalus root of any described treatment cardiovascular and cerebrovascular disease in the claim 1～4, it is characterized in that: get the Radix Astragali, Herba Erigerontis, water boiling and extraction is filtered, and is refining, and drying gets the Radix Astragali, Herba Erigerontis extract; Get Radix Notoginseng, pulverize, alcohol reflux filters, and is refining, and drying gets Radix Notoginseng extract; Make different preparations respectively after then they being mixed.
6, according to the preparation method of the compound formulation of astragalus root of the described treatment cardiovascular and cerebrovascular disease of claim 5, it is characterized in that: get the Radix Astragali, Herba Erigerontis, 8 times of water gagings decoct and extract 2 times, each 2 hours, filter, D101 type macroporous adsorbent resin on the filtrate, 70% ethanol elution, the eluent water-bath volatilizes, concentrating under reduced pressure, vacuum drying gets the Radix Astragali, Herba Erigerontis extract; Get Radix Notoginseng, be ground into particle diameter is distributed in 0～30 μ m more than 99% micropowder, measure 80% alcohol reflux 2 times for 8 times, each 1 hour, collect extracting solution, centrifugal, get supernatant, reclaim ethanol, get the Radix Notoginseng extracting solution, last D101 type macroporous adsorbent resin, 70% ethanol elution, the eluent concentrating under reduced pressure, vacuum drying gets Radix Notoginseng extract; Make different preparations respectively after then they being mixed.
7, according to the preparation method of the compound formulation of astragalus root of claim 5 or 6 described treatment cardiovascular and cerebrovascular diseases, it is characterized in that: get Radix Astragali extract, Herba Erigerontis extract, Radix Notoginseng extract, add water for injection, and add 0.9% sodium chloride, stir evenly, cold preservation filters, filtrate adds 0.2% active carbon, boiled 30 minutes, and put coldly, be filtered to clear and bright, with 10%NaOH adjust pH 7.0～7.5, benefit adds to the full amount of water for injection, through the filtering with microporous membrane of 0.25～0.45 μ m, fill, sterilized 30 minutes, and promptly got great transfusion preparation for 115 ℃.
8, preparation method according to the compound formulation of astragalus root of claim 5 or 6 described treatment cardiovascular and cerebrovascular diseases, it is characterized in that: get Radix Astragali extract, Herba Erigerontis extract, Radix Notoginseng extract adds water for injection, stirs evenly, cold preservation, filter, filtrate adds 0.2% active carbon, boils 30 minutes, put cold, be filtered to clear and brightly, with 10%NaOH adjust pH 7.0～7.5, by medicinal liquid: the ratio adding glucosan of caffolding agent=1: 2 is a caffolding agent, mixing, through the filtering with microporous membrane of 0.25～0.45 μ m, fill, lyophilization, lyophilisation condition :-10 ℃ of pre-freezes 2 hours,--45 ℃ of pre-freezes began evacuation after 5 hours, and were warming up to-30 ℃, kept 3 hours; Be warming up to-20 ℃, kept 5 hours; Be warming up to-10 ℃, kept 8 hours; Be warming up to 0 ℃, kept 2 hours; Be warming up to 10 ℃, kept 2 hours; Be warming up to 20 ℃, kept 2 hours; Be warming up to 30 ℃, kept 1 hour, promptly get lyophilized injectable powder.
9, according to the preparation method of the compound formulation of astragalus root of claim 5 or 6 described treatment cardiovascular and cerebrovascular diseases, it is characterized in that: get Radix Astragali extract, Herba Erigerontis extract, Radix Notoginseng extract, add water for injection, stir evenly, cold preservation filters, filtrate adds 0.1% active carbon, boils 30 minutes, puts cold, be filtered to clear and bright, with 10%NaOH adjust pH 7.0～7.5, through the filtering with microporous membrane of 0.25～0.45 μ m, spray drying, packing promptly gets injectable powder.
10, according to the preparation method of the compound formulation of astragalus root of claim 5 or 6 described treatment cardiovascular and cerebrovascular diseases, it is characterized in that: get Radix Astragali extract, Herba Erigerontis extract, Radix Notoginseng extract, add water for injection, add 0.1% active carbon, boiled 30 minutes, and put coldly, be filtered to clear and bright, with 10%NaOH adjust pH 7.0～7.5, benefit adds to the full amount of water for injection, through the filtering with microporous membrane of 0.25～0.45 μ m, fill, sterilized 30 minutes, and promptly got injection for 115 ℃.
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| Application Number | Priority Date | Filing Date | Title |
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| CN 200410040868 CN1634254A (en) | 2004-10-15 | 2004-10-15 | Compound formulation of astragalus root for treating cardiovascular and cerebrovascular diseases and its preparing process |
| CN 200510200606 CN1768777A (en) | 2004-10-15 | 2005-10-13 | Compound formulation of astragalus root for treating cardiovascular and cerebrovascular diseases, its preparing process and application |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103070909A (en) * | 2013-01-04 | 2013-05-01 | 云南金七制药有限公司 | Radix notoginseng and astragalus mongholicus soft capsule and preparation method thereof |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103070909A (en) * | 2013-01-04 | 2013-05-01 | 云南金七制药有限公司 | Radix notoginseng and astragalus mongholicus soft capsule and preparation method thereof |
| CN103070909B (en) * | 2013-01-04 | 2015-07-29 | 云南金七制药有限公司 | Three stilbene soft capsules and preparation method thereof |
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