CN1290510C - Pharmaceutical composition containing gen-seng total saponin and astragalus root total saponin, its preparing process and application - Google Patents
Pharmaceutical composition containing gen-seng total saponin and astragalus root total saponin, its preparing process and application Download PDFInfo
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Abstract
The invention discloses a medicine composition containing total ginseng saponin and total astragalus root saponin, a preparation process thereof and application thereof. The present invention is characterized in that the medicine composition is prepared from the significant parts of total ginseng saponin and total astragalus root saponin respectively obtained from traditional Chinese medicines of ginseng and astragalus root, and medicinal adjuvant materials; besides, the medicine composition is prepared into injections which have the function of curing cardio-cerebrovascular diseases. Pharmacological experiments show that the medicine composition of the present invention has preferable pharmaceutical effects on the treatment of cardio-cerebrovascular diseases due to deficiency of vital energy.
Description
Technical field
The invention belongs to technical field of traditional Chinese medicine pharmacy, be specifically related to a kind of pharmaceutical composition and preparation and application that contains Radix Ginseng total saponins, Radix Astragali total saponins.
Background technology
In the Chinese prescription, the similar compatibility of drugs of performance effect uses, and can heighten the effect of a treatment, and this selects the important content " mutual reinforcement between " in the medicine prescription when being the Chinese traditional treatment disease.
Determining of Chinese medicine compound is on the basis of analyzing pathogenesis, determines method of treatment, method of treatment guidance under form the prescription meet state of an illness needs, prescription is made up of medicine, but it is not the rabble that arbitrarily uses Chinese medicine, but be foundation with the method for treatment, select appropriate drug, appropriate drug dosage, under instruction of Chinese Medicine theory, combine, method of treatment is the theoretical foundation of prescription, and prescription is the imbody of method of treatment, therefore, prescription is a method of treatment, and method of treatment is a prescription, and the two is indivisible.
Radix Ginseng is the dry root of Araliaceae Radix Ginseng Panax ginseng C.A.Mey.; property is sweet; little hardship; flat; return spleen; lung; heart channel; has strongly invigorating primordial QI; multiple arteries and veins takes off admittedly; invigorating the spleen to benefit the lung; promote the production of body fluid; the effect of calming the nerves; Radix Ginseng contains Radix Ginseng total saponins; modern pharmacological research shows; Radix Ginseng total saponins is to rat myocardial cell calcium channel blocking action (preclinical medicine and clinical; 1994; 02); single calcium channel analysis and ESR spectrum research (preclinical medicine and clinical to the rat heart muscle effect; 1994,04); Radix Ginseng total saponins is to myocardial ischemia-reperfusion dog CO; the influence of TPVR and serum N E content (Norman Bethune Medical University's journal 1,995 05); Radix Ginseng total saponins is to protective effect (the Chinese Pharmacological circular of pallasiomy acute cerebral ischemia-reperfusion injury; 1996; 06); Radix Ginseng total saponins is to the influence pharmacological actions such as (Chinese Chinese medicine science and technology 200403) of cleft lip blood reperfusion injury cardiac hemodynamic.The Radix Astragali is the dry root of leguminous plant Radix Astagali or the film folder Radix Astragali, its sweet in the mouth, slightly warm in nature has the effect of QI invigorating tonify deficiency, can give birth to usefulness, also can process usefulness, give birth to can consolidating superficial resistance, and can toxin expelling, anti-skin ulcer granulation promoting; Process with the invigorating middle warmer of energy QI invigorating.Its micromicro diuresis is relieved oedema or abdominal distension through diuresis or purgation wet, and the persistent period is longer.The Radix Astragali also has the enhance immunity system, resists disease, health invigorating, and resisting oxidation and delaying senility is improved cardiac status, antiviral, and function such as anticancer, its drug effect is remarkable, and is with a long history, is widely used, and is one of multiple medium-height grass the effective elements of the medicine.There are some researches show, treat viral myocarditis with the Radix Astragali, its effect obviously is better than general treatment.Modern age, pharmacological research proved; Radix Astragali saponin is one of main component of the Radix Astragali; pharmacological action is extensive; Radix Astragali total saponins has the myocardium shrinkage function of improvement to anxious Terrier; dwindle myocardial infarction area; alleviate the effect of myocardial damage, Radix Astragali total saponins has significant protective effect to the rat heart muscle ischemia that pituitrin causes, can obviously resist BaCl
2Rat ventricular that brings out and CHCL
3Quivering in the mice chamber of bringing out, can improve platelet adhesion rate, decreased heart rate.
Consult patent documentation, do not retrieve the traditional medicine Injectio that carries out the prescription preparation with Radix Ginseng, the Radix Astragali.
Summary of the invention
For these reasons, the present invention is under Chinese medical theory instructs, in conjunction with the clinical practice experience, carry out prescription with Chinese medicine astragalus, Radix Ginseng, carry out the extraction separation purification and obtain saponins effective site effective site, add pharmaceutic adjuvant and be prepared into the ejection preparation for the treatment of cardiovascular and cerebrovascular disease respectively, The pharmacological results shows that the present invention respectively organizes preparation and has better pharmacological action.
The present invention is achieved by the following scheme.
One. process recipes
(1) raw medicinal material of the present invention's use is:
Radix Astragali 2-4 weight portion, Radix Ginseng 1-3 weight portion;
(2) get the Radix Astragali, Radix Ginseng decoction pieces, put into the Chinese medicine multi-function extractor, with water extraction 3-5 time, each 2-4 hour, merge extractive liquid,, extracting solution 30%-50% ethanol precipitation, supernatant is standby, and precipitation is dry removes ethanol extremely to the greatest extent, the drying precipitated water dissolution of using, dissolving is back 60%-70% ethanol precipitation fully, and supernatant and above-mentioned supernatant merge standby;
(3) get standby supernatant, last macroporous adsorptive resins, with 6-10 distilled water eluting doubly, eluent discards, and the 50%-80% ethanol elution of reuse 3-6 times column volume, eluent reclaim ethanol to most, and drying obtains Radix Ginseng total saponins, Radix Astragali total saponins;
(4) preparation of preparation:
The preparation of aqueous injection: get Radix Ginseng total saponins 40-120 weight portion, Radix Astragali total saponins 70-140 weight portion,, transfer pH value 5.5-6.5, use the 0.22um filtering with microporous membrane with meglumine with the water for injection dissolving, sterilization, hydro-acupuncture preparation is made in check;
The preparation of infusion solution: get Radix Ginseng total saponins 40-120 weight portion, Radix Astragali total saponins 70-140 weight portion,, add glucose, transfer pH value 5.5-6.5, use the 0.22um filtering with microporous membrane with meglumine with the water for injection dissolving, sterilization, infusion preparation is made in check;
The preparation of injectable powder: get Radix Ginseng total saponins 40-120 weight portion, Radix Astragali total saponins 70-110 weight portion, excipient 240-390 weight portion adds the dissolving of injection water fully, uses the 0.22um filtering with microporous membrane, drying, and check obtains powder injection formulation;
Two. check and analysis
1. the check and analysis of Radix Ginseng total saponins
According to high effective liquid chromatography for measuring
Chromatographic condition and system suitability test: with octadecylsilane chemically bonded silica is filler; Acetonitrile 0.05% phosphoric acid solution (19: 81) is a mobile phase; The detection wavelength is 203nm.Number of theoretical plate is by ginsenoside Rb
1The note peak calculates, and should be not less than 4000.
The preparation of reference substance solution: precision takes by weighing the ginsenoside Rb that is dried to constant weight in phosphorus pentoxide desiccator
15mg puts in the 25ml measuring bottle, adds acetonitrile: water (19: 81) shakes up to scale, and precision is measured 5ml, puts in the 10ml measuring bottle, adds acetonitrile: water (19: 81) is diluted to scale, shakes up, promptly.
The preparation of need testing solution: get preparation methanol extraction of the present invention, extracting solution recovery methanol is extremely most, drying, and residue 10mg decided in accurate title, uses the mobile phase standardize solution in the 25ml volumetric flask, as need testing solution.
Algoscopy: accurate respectively reference substance solution and each 20 μ l of need testing solution of drawing, inject chromatograph of liquid respectively, measure, through calculating, the results are shown in Table 1.
2. Radix Astragali total saponins check and analysis
[assay] according to 249 pages of Radixs Astragali of Pharmacopoeia of the People's Republic of China version in 2000 carries out check and analysis, through calculating the content of Radix Astragali total saponins (in astragaloside), sees Table 1:
Active constituent content relatively in table 1 preparation
| Group | Radix Ginseng total saponins is (with ginsenoside Rb 1Meter, the mg/ bottle) | Radix Astragali total saponins (in astragaloside, the mg/ bottle) |
| Aqueous injection of the present invention infusion solution of the present invention | 120.36 118.71 | 101.33 102.57 |
| Injectable powder of the present invention | 117.54 | 99.85 |
Three. pharmacology embodiment
Embodiment 1
The mice with viral myocarditis myocardial damage is influenced
Laboratory animal: 4 the week ages male purebred BALB/c mouse.(causing model of qi-asthenia according to document) by herbal pharmacology teaching and research room of Shenyang Pharmaceutical University
Experiment virus: coxsackie B
3Parent's cardiomyopathy strain (CVB3m) virus stock solution used is tired, and 50% tissue infection rate (TCID) is 10-6.
The experiment medicine: the present invention respectively organizes preparation (Tianzhijiao Medication Development Co., Ltd., Guangdong's laboratory provides)
Commercially available Radix Astragali injection (medicine wholesaling firm in the Temple of the White Dagoba, Beijing buys, and Zhengda Qingchunbao Pharmaceutical Co., Ltd produces)
Normal saline
Experimental technique: the qi-deficiency type mice is divided into 5 groups at random.Model group (infection adds normal saline), 15; Liquid drugs injection injection group of the present invention (infection adds liquid drugs injection injection of the present invention), 15; Injectable powder group of the present invention (infection adds injectable powder of the present invention), 15; Infusion preparation group of the present invention (infection adds great transfusion preparation of the present invention), 15; Matched group, 15 of commercially available Radix Astragali injection groups (infection adds commercially available Radix Astragali injection).Each group is respectively at experiment every Mus lumbar injection 0.1ml on the same day, the CVB3m of 2 * 104TCID 50; Each organizes all continuous 7 days lumbar injections of mice, dosage 16mg effective site/kg, once a day, for the statistics mouse death rate sees Table 2, in experiment the 8th day, the mice that will live was put to death, core dirty in the following part cardiac muscle at 1/3 place, see Table 3 with the change of 10% formalin fixed detection computations histopathology
Table 2 is respectively organized the comparison of the mortality rate of preparation
| Group | Number of animals (only) | Death toll (only) | Mortality rate (%) |
| The commercially available Radix Astragali injection group of model group (infection adds normal saline) (infection adds commercially available Radix Astragali injection) liquid drugs injection injection group of the present invention infusion preparation group of the present invention injectable powder group of the present invention | 15 15 15 15 15 | 10 8 5 4 5 | 66.7 53.3 33.3 26.7 33.3 |
Table 3 is respectively organized the comparison of preparation to myocardium pathological change
| Group | The myocardial necrosis rate | Inflammatory infiltration |
| The commercially available Radix Astragali injection group of model group (infection adds normal saline) (infection adds commercially available Radix Astragali injection) liquid drugs injection injection group of the present invention infusion preparation group of the present invention injectable powder group of the present invention | 3.15％ 2.11％ * 1.75％ ** 1.70％ ** 1.71％ ** | 3.36％ 1.85％ * 1.50％ ** 1.45％ ** 1.44％ ** |
Annotate: compare with the normal saline group,
*P＜0.05,
*P＜0.01
Embodiment 2
To the protective effect of qi-deficiency type Cor Canitis myocardial ischemia
Laboratory animal: Beagle Canis familiaris L., body weight 7.5-10kg.(causing model of qi-asthenia according to document) by herbal pharmacology teaching and research room of Shenyang Pharmaceutical University
The experiment medicine: the present invention respectively organizes preparation (Tianzhijiao Medication Development Co., Ltd., Guangdong's laboratory provides)
Radix astragali saponin injection (the Shanxi academy of traditional Chinese medicine provides)
Normal saline
Experimental technique: get experimental dogs, be divided into the normal saline group, the radix astragali saponin injection group, aqueous injection group of the present invention, transfusion group of the present invention, injectable powder group of the present invention, the administration group is respectively in the subcutaneous cephalic vein administration of Canis familiaris L. forelimb, the each 4.0mg effective site/kg of dosage, normal saline groups etc. are held inequality, administration every day 1 time, successive administration 3 days, pentobarbital sodium 25mg/kg intravenous anesthesia is used in administration after the 3rd day, tracheal intubation connects artificial respirator positive pressure respiration in addition, and the 5th rib is opened breast from the left side, cut off pericardium, expose heart, the pericardial incision edge is sewn in thoracic wall, divide the second stage of ligation at ramus descendens anterior arteriae coronariae sinistrae, and slow iv lignocaine 8mg/kg is in case the ventricular fibrillation that may cause before the ligation is sewed up pericardium and thoracic wall subsequently.24h behind the heart infarction, Canis familiaris L. is put to death after pentobarbital sodium anesthesia, take out heart rapidly, excision trunk and fatty tissue, check the position of anterior descending branch ligation point, claim heavy whole-heartedly, excise right ventricle and left atrium then, stay interventricular septum and left atrium, claim to such an extent that left ventricle is heavy, from the apex of the heart and beginning and anterior descending branch vertical direction left ventricle is cut into the thick flesh sheet of 2-3mm, be dipped in dyeing 30min in the nitro tetrazolium blue solution (NBT), cut ischemic region cardiac muscular tissue and weigh, the calculating myocardium infarction size, that is: heart infarction scope=ischemic region weight/left ventricle is heavy by * 100%, the results are shown in Table 4.
The influence of table 4 pair qi-deficiency type Cor Canitis chamber infarction size
| Group | Heavy (g) whole-heartedly | Chamber, a left side heavy (g) | Ischemic region heavy (g) | Heart infarction scope (%) |
| Normal saline group radix astragali saponin injection aqueous injection group of the present invention transfusion group of the present invention injectable powder group of the present invention | 68.47±7.62 67.54±8.26 65.17±7.69 68.22±6.25 67.71±7.68 | 44.31±5.28 44.19±4.06 42.06±5.41 44.31±4.58 43.82±4.26 | 11.39±0.77 4.3 8±0.62 2.21±0.23 2.30±0.46 2.20±0.24 | 25.71±1.38 9.91±0.84 * 5.25±0.24 ** 5.19±0.19 ** 5.03±0.19 ** |
Annotate: compare with the normal saline group,
*P＜0.05,
*P＜0.01
Embodiment 3
Protective effect to the qi-deficiency type acute cerebral ischemia in rats
Laboratory animal: the SD rat, body weight (350 ± 47), male and female are regardless of.
The experiment medicine: the present invention respectively organizes preparation (saponins effective site is prepared from, and Tianzhijiao Medication Development Co., Ltd., Guangdong's laboratory provides)
Radix astragali saponin injection (the Shanxi academy of traditional Chinese medicine provides)
Normal saline
Experimental technique: get rat and be divided into normal saline group, radix astragali saponin injection group, aqueous injection group of the present invention, transfusion group of the present invention, injectable powder group of the present invention, the administration group is respectively at intraperitoneal administration, the each 4.0mg effective site/kg of dosage, normal saline groups etc. are held inequality, and administration began experiment in 2 hours.
Acute imperfection cerebral ischemic model: rat pentobarbital sodium (40mg/kg) the ip anesthesia after the administration, the cervical region median incision, tracheal intubation is separated bilateral carotid, and dual ligation is also cut off, and 3h, 6h detect the variation of EEG after cerebral ischemia.Break end fast behind the 6h and get brain, change to detect brain water content and tectology.The results are shown in Table 5:
The change of EEG: the change according to document ischemic stage EEG is divided into 4 grades, the I level by its amplitude decline degree: no change, amplitude are more than 75% of former level; II level: the slight inhibition, be 50%～75% of former level; The III level: moderate suppresses, and is 25%～50% of former level; The IV level: severe inhibition becomes 25% of the former level that is flat to.。
The protective effect of table 5 pair qi-deficiency type acute cerebral ischemia in rats
| Group | The change level of EEG behind the 3h | The change level of EEG behind the 6h | Ischemia side brain hemisphere weight in wet base | Ischemia side brain hemisphere dry weight | Brain water content % |
| Not | Not | g | g | ||
| Physiological saline group XUESAITONG ZHUSHEYE liquid drugs injection group of the present invention transfusion group of the present invention powder-injection group of the present invention | IV II I I I | IV II I I I | 0.81±0.06 0.78±0.03 0.83±0.04 0.71±0.03 0.75±0.04 | 0.12±0.01 0.19±0.02 0.29±0.04 0.24±0.02 0.25±0.03 | 85.19±0.17 74.68±0.26 * 65.26±0.34 ** 66.54±0.19 ** 66.67±0.27 ** |
Annotate: compare with the normal saline group,
*P＜0.05,
*P＜0.01
Conclusion: show that by above pharmacological evaluation the present invention respectively organizes preparation the qi-deficiency type cardiovascular and cerebrovascular disease is had better pharmacological action.
Two. preparation embodiment
Embodiment 1
(1) raw medicinal material of the present invention's use is:
The Radix Astragali 2000 grams, Radix Ginseng 1000 grams;
(2) get the Radix Astragali, Radix Ginseng decoction pieces, put into the Chinese medicine multi-function extractor, with water extraction 3 times, each 2 hours, merge extractive liquid,, extracting solution 30% ethanol precipitation, supernatant is standby, and precipitation is dry removes ethanol extremely to the greatest extent, the drying precipitated water dissolution of using, dissolving is back 60% ethanol precipitation fully, and supernatant and above-mentioned supernatant merge standby;
(3) get standby supernatant, last NKA type macroporous adsorptive resins, with 6 times distilled water eluting, eluent discards, and 50% ethanol elution of 3 times of column volumes of reuse, eluent reclaim ethanol to most, and drying obtains Radix Ginseng total saponins, Radix Astragali total saponins;
(4) preparation of preparation: the preparation of aqueous injection: get Radix Ginseng total saponins 40 grams, Radix Astragali total saponins 70 grams,, transfer pH value 5.5-6.5, use the 0.22um filtering with microporous membrane with meglumine with the water for injection dissolving, sterilization, 1000 bottles of hydro-acupuncture preparations are made in check;
The preparation of infusion solution: get Radix Ginseng total saponins 40 grams, Radix Astragali total saponins 70 grams,, add glucose, transfer pH value 5.5-6.5, use the 0.22um filtering with microporous membrane with meglumine with the water for injection dissolving, sterilization, 1000 bottles of infusion preparations are made in check;
The preparation of injectable powder: get Radix Ginseng total saponins 40 grams, Radix Astragali total saponins 70 grams, excipient sucrose 390 grams add the dissolving of injection water fully, use the 0.22um filtering with microporous membrane, drying, and check obtains 1000 bottles of powder injection formulations;
Embodiment 2
(1) raw medicinal material of the present invention's use is:
The Radix Astragali 4000 can, Radix Ginseng 3000 gram;
(2) get the Radix Astragali, Radix Ginseng decoction pieces, put into the Chinese medicine multi-function extractor, with water extraction 5 times, each 4 hours, merge extractive liquid,, extracting solution 50% ethanol precipitation, supernatant is standby, and precipitation is dry removes ethanol extremely to the greatest extent, the drying precipitated water dissolution of using, dissolving is back 670% ethanol precipitation fully, and supernatant and above-mentioned supernatant merge standby;
(3) get standby supernatant, last AB-8 type macroporous adsorptive resins, with 10 times distilled water eluting, eluent discards, and 80% ethanol elution of 6 times of column volumes of reuse, eluent reclaim ethanol to most, and drying obtains Radix Ginseng total saponins, Radix Astragali total saponins;
(4) preparation of preparation:
The preparation of aqueous injection: get Radix Ginseng total saponins 120 grams, Radix Astragali total saponins 140 grams,, transfer pH value 6.5, use the 0.22um filtering with microporous membrane with meglumine with the water for injection dissolving, sterilization, 1000 bottles of hydro-acupuncture preparations are made in check;
The preparation of infusion solution: get Radix Ginseng total saponins 120 grams, Radix Astragali total saponins 140 grams,, add glucose, transfer pH value 6.5, use the 0.22um filtering with microporous membrane with meglumine with the water for injection dissolving, sterilization, 1000 bottles of infusion preparations are made in check;
The preparation of injectable powder: get Radix Ginseng total saponins 120 grams, Radix Astragali total saponins 140 grams, excipient lactose 240 grams add the dissolving of injection water fully, use the 0.22um filtering with microporous membrane, drying, and check obtains 1000 bottles of powder injection formulations;
Embodiment 3
(1) raw medicinal material of the present invention's use is:
The Radix Astragali 3000 grams, Radix Ginseng 2000 grams;
(2) get the Radix Astragali, Radix Ginseng decoction pieces, put into the Chinese medicine multi-function extractor, with water extraction 4 times, each 3 hours, merge extractive liquid,, extracting solution 40% ethanol precipitation, supernatant is standby, and precipitation is dry removes ethanol extremely to the greatest extent, the drying precipitated water dissolution of using, dissolving is back 65% ethanol precipitation fully, and supernatant and above-mentioned supernatant merge standby;
(3) get standby supernatant, last D101 type macroporous adsorptive resins, with 8 times distilled water eluting, eluent discards, and 70% ethanol elution of 4 times of column volumes of reuse, eluent reclaim ethanol to most, and drying obtains Radix Ginseng total saponins, Radix Astragali total saponins;
(4) preparation of preparation:
The preparation of aqueous injection: get Radix Ginseng total saponins 86 grams, Radix Astragali total saponins 117.2 grams,, transfer pH value 6.0, use the 0.22um filtering with microporous membrane with meglumine with the water for injection dissolving, sterilization, 1000 bottles of hydro-acupuncture preparations are made in check;
The preparation of infusion solution: get Radix Ginseng total saponins 86 grams, Radix Astragali total saponins 117.2 grams,, add glucose, transfer pH value 6.0, use the 0.22um filtering with microporous membrane with meglumine with the water for injection dissolving, sterilization, 1000 bottles of infusion preparations are made in check;
The preparation of injectable powder: get Radix Ginseng total saponins 86 grams, Radix Astragali total saponins 117.2 grams, excipient mannitol 296.8 grams add the dissolving of injection water fully, use the 0.22um filtering with microporous membrane, drying, and check obtains 1000 bottles of powder injection formulations;
Embodiment 4
(1) raw medicinal material of the present invention's use is:
The Radix Astragali 2500 grams, Radix Ginseng 1500 grams;
(2) get the Radix Astragali, Radix Ginseng decoction pieces, put into the Chinese medicine multi-function extractor, with water extraction 3 times, each 4 hours, merge extractive liquid,, extracting solution 35% ethanol precipitation, supernatant is standby, and precipitation is dry removes ethanol extremely to the greatest extent, the drying precipitated water dissolution of using, dissolving is back 70% ethanol precipitation fully, and supernatant and above-mentioned supernatant merge standby;
(3) get standby supernatant, last NKA type macroporous adsorptive resins, with 7 times distilled water eluting, eluent discards, and 55% ethanol elution of 5 times of column volumes of reuse, eluent reclaim ethanol to most, and drying obtains Radix Ginseng total saponins, Radix Astragali total saponins;
(3) preparation of preparation:
The preparation of aqueous injection: get Radix Ginseng total saponins 62.1 grams, Radix Astragali total saponins 86.1 grams,, transfer pH value 6.5, use the 0.22um filtering with microporous membrane with meglumine with the water for injection dissolving, sterilization, 1000 bottles of hydro-acupuncture preparations are made in check;
The preparation of infusion solution: get Radix Ginseng total saponins 62.1 grams, Radix Astragali total saponins 86.1 grams,, add glucose, transfer pH value 6.5, use the 0.22um filtering with microporous membrane with meglumine with the water for injection dissolving, sterilization, 1000 bottles of infusion preparations are made in check;
The preparation of injectable powder: get Radix Ginseng total saponins 62.1 grams, Radix Astragali total saponins 86.1 grams, excipient mannitol, sucrose 351.8 grams add the dissolving of injection water fully, use the 0.22um filtering with microporous membrane, drying, and check obtains 1000 bottles of powder injection formulations;
Embodiment 5
(1) raw medicinal material of the present invention's use is:
The Radix Astragali 3500 grams, Radix Ginseng 2500 grams;
(2) get the Radix Astragali, Radix Ginseng decoction pieces, put into the Chinese medicine multi-function extractor, with water extraction 5 times, each 2 hours, merge extractive liquid,, extracting solution 45% ethanol precipitation, supernatant is standby, and precipitation is dry removes ethanol extremely to the greatest extent, the drying precipitated water dissolution of using, dissolving is back 70% ethanol precipitation fully, and supernatant and above-mentioned supernatant merge standby;
(3) get standby supernatant, last D101 type macroporous adsorptive resins, with 9 times distilled water eluting, eluent discards, and 75% ethanol elution of 4 times of column volumes of reuse, eluent reclaim ethanol to most, and drying obtains Radix Ginseng total saponins, Radix Astragali total saponins;
(4) preparation of preparation:
The preparation of aqueous injection: get Radix Ginseng total saponins 99.6 grams, Radix Astragali total saponins 122.9 grams,, transfer pH value 6.0, use the 0.22um filtering with microporous membrane with meglumine with the water for injection dissolving, sterilization, 1000 bottles of hydro-acupuncture preparations are made in check;
The preparation of infusion solution: get Radix Ginseng total saponins 99.6 grams, Radix Astragali total saponins 122.9 grams,, add glucose, transfer pH value 6.0, use the 0.22um filtering with microporous membrane with meglumine with the water for injection dissolving, sterilization, 1000 bottles of infusion preparations are made in check;
The preparation of injectable powder: get Radix Ginseng total saponins 99.6 grams, Radix Astragali total saponins 122.9 grams, excipient sucrose, lactose 277.5 grams add the dissolving of injection water fully, use the 0.22um filtering with microporous membrane, drying, and check obtains 1000 bottles of powder injection formulations;
Embodiment 6
(1) raw medicinal material of the present invention's use is:
The Radix Astragali 2500 grams, Radix Ginseng 2500 grams;
(2) get the Radix Astragali, Radix Ginseng decoction pieces, put into the Chinese medicine multi-function extractor, with water extraction 3 times, each 4 hours, merge extractive liquid,, extracting solution 40% ethanol precipitation, supernatant is standby, and precipitation is dry removes ethanol extremely to the greatest extent, the drying precipitated water dissolution of using, dissolving is back 65% ethanol precipitation fully, and supernatant and above-mentioned supernatant merge standby;
(3) get standby supernatant, last AB-8 type macroporous adsorptive resins, with 7 times distilled water eluting, eluent discards, and 65% ethanol elution of 6 times of column volumes of reuse, eluent reclaim ethanol to most, and drying obtains Radix Ginseng total saponins, Radix Astragali total saponins;
(4) preparation of preparation:
The preparation of aqueous injection: get Radix Ginseng total saponins 101.5 grams, Radix Astragali total saponins 91.3 grams,, transfer pH value 5.5, use the 0.22um filtering with microporous membrane with meglumine with the water for injection dissolving, sterilization, 1000 bottles of hydro-acupuncture preparations are made in check;
The preparation of infusion solution: get Radix Ginseng total saponins 101.5 grams, Radix Astragali total saponins 91.3 grams,, add glucose, transfer pH value 5.5, use the 0.22um filtering with microporous membrane with meglumine with the water for injection dissolving, sterilization, 1000 bottles of infusion preparations are made in check;
The preparation of injectable powder: get Radix Ginseng total saponins 101.5 grams, Radix Astragali total saponins 91.3 grams, excipient mannitol, lactose 307.2 grams add the dissolving of injection water fully, use the 0.22um filtering with microporous membrane, drying, and check obtains 1000 bottles of powder injection formulations;
Embodiment 7
(1) raw medicinal material of the present invention's use is:
The Radix Astragali 3500 grams, Radix Ginseng 1500 grams;
(2) get the Radix Astragali, Radix Ginseng decoction pieces, put into the Chinese medicine multi-function extractor, with water extraction 5 times, each 2 hours, merge extractive liquid,, extracting solution 45% ethanol precipitation, supernatant is standby, and precipitation is dry removes ethanol extremely to the greatest extent, the drying precipitated water dissolution of using, dissolving is back 70% ethanol precipitation fully, and supernatant and above-mentioned supernatant merge standby;
(3) get standby supernatant, last D101 type macroporous adsorptive resins, with 8 times distilled water eluting, eluent discards, and 55% ethanol elution of 5 times of column volumes of reuse, eluent reclaim ethanol to most, and drying obtains Radix Ginseng total saponins, Radix Astragali total saponins;
(5) preparation of preparation:
The preparation of aqueous injection: get Radix Ginseng total saponins 58.9 grams, Radix Astragali total saponins 123.6 grams,, transfer pH value 6.5, use the 0.22um filtering with microporous membrane with meglumine with the water for injection dissolving, sterilization, 1000 bottles of hydro-acupuncture preparations are made in check;
The preparation of infusion solution: get Radix Ginseng total saponins 58.9 grams, Radix Astragali total saponins 123.6 grams,, add glucose, transfer pH value 5.5-6.5, use the 0.22um filtering with microporous membrane with meglumine with the water for injection dissolving, sterilization, 1000 bottles of infusion preparations are made in check;
The preparation of injectable powder: get Radix Ginseng total saponins 58.9 grams, Radix Astragali total saponins 123.6 grams, excipient mannitol, sucrose, lactose 317.5 grams add the dissolving of injection water fully, use the 0.22um filtering with microporous membrane, drying, and check obtains 1000 bottles of powder injection formulations.
Claims (1)
1. preparation of drug combination method that contains Radix Ginseng total saponins, Radix Astragali total saponins is characterized by:
(1) raw medicinal material and weight portion are:
Radix Astragali 2-4 weight portion, Radix Ginseng 1-3 weight portion;
(2) get the Radix Astragali, Radix Ginseng decoction pieces, put into the Chinese medicine multi-function extractor, with water extraction 3-5 time, each 2-4 hour, merge extractive liquid,, extracting solution 30%-50% ethanol precipitation, supernatant is standby, and precipitation is dry removes ethanol extremely to the greatest extent, the drying precipitated water dissolution of using, dissolving is back 60%-70% ethanol precipitation fully, and supernatant and above-mentioned supernatant merge standby;
(3) get standby supernatant, last macroporous adsorptive resins, with 6-10 distilled water eluting doubly, eluent discards, and the 50%-80% ethanol elution of reuse 3-6 times column volume, eluent reclaim ethanol to most, and drying obtains Radix Ginseng total saponins, Radix Astragali total saponins;
(4) formulation preparation:
The preparation of aqueous injection: get Radix Ginseng total saponins 40-120 weight portion, Radix Astragali total saponins 70-140 weight portion, with the water for injection dissolving, with meglumine adjust pH 5.5-6.5, with 0.22 μ m filtering with microporous membrane, sterilization, hydro-acupuncture preparation is made in check;
The preparation of infusion solution: get Radix Ginseng total saponins 40-120 weight portion, Radix Astragali total saponins 70-140 weight portion,, add glucose with the water for injection dissolving, with meglumine adjust pH 5.5-6.5, with 0.22 μ m filtering with microporous membrane, sterilization, infusion preparation is made in check;
The preparation of injectable powder: get Radix Ginseng total saponins 40-120 weight portion, Radix Astragali total saponins 70-140 weight portion, excipient 240-390 weight portion adds the dissolving of injection water fully, and with 0.22 μ m filtering with microporous membrane, drying, check obtains powder injection formulation.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200410098414 CN1290510C (en) | 2004-12-10 | 2004-12-10 | Pharmaceutical composition containing gen-seng total saponin and astragalus root total saponin, its preparing process and application |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200410098414 CN1290510C (en) | 2004-12-10 | 2004-12-10 | Pharmaceutical composition containing gen-seng total saponin and astragalus root total saponin, its preparing process and application |
Publications (2)
| Publication Number | Publication Date |
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| CN1634111A CN1634111A (en) | 2005-07-06 |
| CN1290510C true CN1290510C (en) | 2006-12-20 |
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| CN 200410098414 Expired - Fee Related CN1290510C (en) | 2004-12-10 | 2004-12-10 | Pharmaceutical composition containing gen-seng total saponin and astragalus root total saponin, its preparing process and application |
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