CN1278726C - Medicine composition capable of benefiting vital energy, activating pulse, nourishing yin and promoting the secretion of the body fluid and preparation method thereof - Google Patents
Medicine composition capable of benefiting vital energy, activating pulse, nourishing yin and promoting the secretion of the body fluid and preparation method thereof Download PDFInfo
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Abstract
The present invention discloses a medicinal composition for benefiting vital energy, activating pulse, nourishing yin and promoting body fluid secretion and a preparing method thereof. The present invention is characterized in that the medicinal composition is prepared from the effective parts of ginseng and ophiopogon root, and auxiliary materials. The ginseng and the ophiopogon root are used to prepare the effective parts thereof by using different extracting methods to prepare injection. Additionally, the present invention limits the content of panoxadiol saponin which has good pharmacological action and haemolytic adverse reaction. The preparations of the present invention are more safe in clinical application. The results of pharmacological experiments show that the preparations of the medical composition have better pharmacological action and safety that of the similar medicines sold on markets.
Description
Technical field
The invention belongs to technical field of traditional Chinese medicine pharmacy, be specifically related to a kind of QI invigorating and give birth to arteries and veins, pharmaceutical composition of YIN nourishing and the production of body fluid promoting and preparation method thereof.
Background technology
Radix Ginseng is an Araliaceae, have that strongly invigorating primordial QI, multiple arteries and veins take off admittedly, the effect of invigorating the spleen to benefit the lung, promoting the production of body fluid and inducing sedation of the mind, mainly contain the ginsenoside in the Radix Ginseng, content is about 4%, be divided into olive acids, panoxadiol's class, panaxatriol's class by the aglycon difference, what have fine pharmacologically active is Panaxadiol saponin, protopanaxatriol ginsenoside, and monomer saponin has-R
o, RA
o, Ra
1,-Ra
2,-Ra
3,-Rb
1,-Rb
2,-Rb
3,-Rc ,-Rd ,-Re ,-Rg
1,-Rg
2,-Rg
3,-Rh
1,-Rh
2Deng; other is a polysaccharide; aminoacid; volatile oil; fatty acid; trace element; vitamin etc.; consult document and patent; we learn; Panaxadiol saponin has great pharmacological effects; relevant bibliographical information is more; as: panoxadiol's saponins is to rat myocardial cell calcium channel blocking action (preclinical medicine and clinical; 1994; 02); panoxadiol's monomer is to the single calcium channel analysis and the ESR spectrum research (preclinical medicine and clinical of rat heart muscle effect; 1994; 04); panoxadiol's saponins is to myocardial ischemia-reperfusion dog CO; influence (Norman Bethune Medical University's journal 1995 of TPVR and serum N E content; 05); Panaxadiol saponin is to protective effect (the Chinese Pharmacological circular of pallasiomy acute cerebral ischemia-reperfusion injury; 1996; 06); panoxadiol's saponins is to influence (Chinese Chinese medicine science and technology 200403) of cleft lip blood reperfusion injury cardiac hemodynamic etc.; therefore Radix Ginseng has great pharmacological effects; but the ginsenoside's has a haemolysis (Chinese Pharmaceutical Journal; the 31st the 12nd phase of volume of December in 1996; the Radix Panacis Quinquefolii saponin haemolysis is observed); experimentation shows; the ginsenoside mainly is that Panaxadiol saponin has haemolysis is arranged; therefore; when research and development Radix Ginseng ejection preparation; should control the amount of Panaxadiol saponin; the standard of standard just can better be provided for clinical practice; to reduce untoward reaction, for the patient provides safety; effective preparation.
Radix Ginseng, Radix Ophiopogonis, prescription was prepared into SHENMAI ZHUSHEYE, and is very extensive in clinical practice, obtained extraordinary curative effect, obtains doctor and patient's approval; Pass through lot of experiments, the utilization Chinese medical theory, with the Radix Ginseng is monarch drug, compatibility Radix Ophiopogonis, fixture has supplementing QI to prevent collapse, YIN nourishing and the production of body fluid promoting, give birth to the effect of arteries and veins, the shock, coronary heart disease, viral myocarditis, chronic cardiopulmonary disease, the granulocytopenia that are used for the treatment of type of deficiency of both QI and YIN, patent " application of SHENMAI ZHUSHEYE in making cancer therapy drug " (application number 94107143) have only simply been introduced Radix Ginseng, Radix Ophiopogonis and have been adopted ethanol extraction, leaching process are not described in detail; Patent " a kind of frozen powder for injection containing ginseng extract " (application number 94113809) has been introduced simple ethanol extraction of Radix Ginseng, Radix Ophiopogonis, and extracting solution carries out preparation to be handled postlyophilization and prepare lyophilized powder, and this method is existing report in the document in early days; Only simply introduced ethanol extracts the method for Radix Ginseng, Radix Ophiopogonis respectively to patent " a kind of Rhizoma Zingiberis Recens infusion solutions preparation method " (application number 98112180), and this method also is to have report in the document in early days; Patent " a kind of aseptic ' Shenmai ' powder for injection and preparation method thereof " (application number 99115060) has adopted the resin chromatographic column to carry out purification, but the resin column that adopts what type is not described, can't in reality, implement, and will carry out twice resin column, operate loaded down with trivial details complexity.
Summary of the invention
For these reasons, the present invention carries out distinct methods extraction purification to ginseng, dwarf lilyturf tuber and obtains effective site, mixes with pharmaceutic adjuvant, is prepared into ejection preparation, and in preparation process, not only controlled the content of effective site: the ginsenoside is (with ginsenoside Rg, Rb
1, Re meter) for 50%-85%, effective site Radix Ophiopogonis (in ophiopogonin) be 50%-85%; Also good to pharmacological action but panoxadiol that have a haemolysis has carried out content control, Panaxadiol saponin in the Radix Ginseng effective site is (with ginsenoside Rb
1Meter) be 10%-30%; Therefore, can make preparation of the present invention in process of clinical application, safer, effective; Pharmacological evaluation shows that the present invention respectively organizes preparation and has better pharmacological action.
The purpose of this invention is to provide a kind of QI invigorating and give birth to arteries and veins, the pharmaceutical composition of YIN nourishing and the production of body fluid promoting and preparation thereof.
Another object of the present invention provides a kind of QI invigorating and gives birth to arteries and veins, the pharmaceutical composition of YIN nourishing and the production of body fluid promoting and the preparation method of preparation thereof.
The present invention is achieved by the following technical solutions.
One. process recipes
(1) raw medicinal material weight portion ratio of the present invention is:
Radix Ginseng 6-9, Radix Ophiopogonis 5-15;
(2) Radix Ginseng effective site preparation
Controlling index is: the ginsenoside is (with ginsenoside Rg, Rb
1, Re meter) be 50%-85%; Wherein control Panaxadiol saponin (with ginsenoside Rb
1Meter) be 10%-30%.
Method one: get Radix Ginseng and put into the Chinese medicine multi-function extractor, with 6-8 doubly, concentration is 60%-70% ethanol extraction 1-3 hour, extracts 2-4 time, filters, it is extremely most that merge extractive liquid, reclaims ethanol; Macroporous adsorptive resins on the extracting solution, use earlier the distilled water eluting, the eluting distilled water is 10-15 a times of column volume, eluent discards, reuse 60%-70% ethanol carries out gradient elution, and eluting ethanol is 6-10 times of column volume, and eluent reclaims ethanol to most, concentrated, dry, obtain Radix Ginseng effective site;
Method two: get Radix Ginseng and put into the Chinese medicine multi-function extractor, with 6-8 doubly, concentration is 60%-70% ethanol extraction 1-3 hour, extracts 2-4 time, filters, it is extremely most that merge extractive liquid, reclaims ethanol; Extracting solution merges n-butanol layer with 2-5 times of water-saturated n-butanol extraction 2-4 time, reclaims n-butyl alcohol to the greatest extent, concentrates, and drying obtains Radix Ginseng effective site;
Method three: get Radix Ginseng and put into the Chinese medicine multi-function extractor, with 6-8 doubly, concentration is 60%-70% ethanol extraction 1-3 hour, extracts 2-4 time, filters, it is extremely most that merge extractive liquid, reclaims ethanol; Extracting solution is 1.01-1.05 when being dissolved in water to 20 ℃ of relative densities, filters with the 0.1um filter element earlier, and filtrate is the hollow fiber column of 3000-8000 with the intercepting molecular weight, carry out ultrafiltration, ultrafiltration 3-5 time keeps permeate, and concentrate drying obtains Radix Ginseng effective site;
Method four: get Radix Ginseng and put into the Chinese medicine multi-function extractor, add water 10-20 doubly, extract 2-4 time, each 2-4 hour, filter, merge extractive liquid,, relative density is 1.05-1.10 when being concentrated to 50 ℃, adds ethanol, and the concentration of alcohol that makes solution is 60%-80%, left standstill 12-24 hour, keep supernatant, reclaim ethanol to the greatest extent, adding water, to make solution relative density in the time of 20 ℃ be 1.01-1.05, filter with the 0.1um filter element earlier, filtrate is the hollow fiber column of 3000-8000 with the intercepting molecular weight, carries out ultrafiltration, ultrafiltration 3-5 time, keep permeate, concentrate drying obtains Radix Ginseng effective site;
(3) effective site preparation Radix Ophiopogonis
Controlling index is: effective site Radix Ophiopogonis (in ophiopogonin) is 50%-85%.
Method one: get Radix Ophiopogonis, put into the Chinese medicine multi-function extractor, with 6-8 doubly, concentration is 55%-75% ethanol extraction 2-4 hour, extract 2-4 time, filter, merge extractive liquid, reclaims ethanol to most, macroporous adsorptive resins on the extracting solution, use earlier distilled water eluting, eluting distilled water is 8-12 times of column volume, and eluent discards, the ethanol elution of reuse 60%-70%, eluting ethanol is 6-10 times of column volume, and eluent reclaims ethanol to the greatest extent, gets effective site Radix Ophiopogonis;
Method two: get and decoct with water three Radix Ophiopogonis, 1 hour for the first time, second, be respectively for three times 45 minutes, 30 minutes, merge extractive liquid,, concentrating under reduced pressure, it is 1.05-1.10 that 50 ℃ of intermittent fever are surveyed relative density, adding ethanol is 75% to containing the alcohol amount, places, and filters, filtrate decompression concentrates, it is 1.05-1.10 that 50 ℃ of intermittent fever are surveyed relative density, and adding ethanol again is 85% to containing the alcohol amount, places, filter, add 40% sodium hydroxide solution adjusting pH value and be respectively about 8, place, filter, Radix Ophiopogonis, filtrate added about dilute hydrochloric acid accent PH to 7, respectively decompression recycling ethanol is to the greatest extent, and add 20 ℃ of intermittent fever of water and survey relative density and be respectively 1.01-1.05, be that the hollow fiber column of 3000-8000 carries out ultrafiltration with the intercepting molecular weight, ultrafiltration 3-5 time, keep permeate, merge permeate, concentrate, drying obtains effective site Radix Ophiopogonis
Method three: get Radix Ophiopogonis, put into the Chinese medicine multi-function extractor, with 6-8 doubly, concentration is 55%-75% ethanol extraction 2-4 hour, extracts 2-4 time, filters, it is extremely most that merge extractive liquid, reclaims ethanol, concentrated solution adds 2-5 times of water-saturated n-butanol, extracts 3-5 time.Keep n-butanol layer, combining extraction liquid reclaims n-butyl alcohol to most, and concentrate drying obtains effective site Radix Ophiopogonis;
(4) get Radix Ginseng effective site 4.5-7.5 weight portion, Radix Ophiopogonis effective site 1-3 weight portion, add the dissolving of injection water fully, fill, sterilization obtain the Rhizoma Zingiberis Recens aqueous injection.
(5) get Radix Ginseng effective site 4.5-7.5 weight portion, Radix Ophiopogonis effective site 1-3 weight portion, sodium chloride 39.5-44.5 weight portion, add the dissolving of injection water fully, fill, sterilization obtains the Rhizoma Zingiberis Recens infusion solution;
(6) get Radix Ginseng effective site 4.5-7.5 weight portion, Radix Ophiopogonis effective site 1-3 weight portion,, freeze-dried excipient 39.5-44.5 weight portion, add the dissolving of injection water fully, fill, drying obtains red ginseng and tuber of dwarf lily turf powder injection;
The invention reside in the content of the extracting method control Radix Ginseng effective site that provides different, Radix Ophiopogonis effective site, method is difference to some extent, but the result of control is that ginsenoside's content is with ginsenoside Rg, Rb
1, Re counts 50%-85%, Radix Ophiopogonis, effective site was counted 50%-85% with ophiopogonin; The present invention also has the Panaxadiol saponin of certain haemolysis to carry out the content qualification again to existing fine pharmacological action, has increased security reliability for the present invention respectively organizes preparation in clinical practice.
Radix Ginseng is ground stem and leaf or subterraneous root.
Macroporous adsorbent resin is nonpolar or the low pole macroporous adsorbent resin.
Two. check and analysis
1. the check and analysis of ginsenoside, Panaxadiol saponin
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.
The preparation of reference substance solution: precision takes by weighing panaxoside Rg, the Rb that is dried to constant weight in phosphorus pentoxide desiccator
1, each 5mg of Re, put in the 25ml measuring bottle, add 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 that each 10mg of Radix Ginseng effective site puts respectively in the 25ml measuring bottle under four kinds of distinct methods of the present invention, add acetonitrile: water (19: 81) is to scale, shake up, precision is measured 5ml, put in the 10ml measuring bottle, add acetonitrile: water (19: 81) is diluted to scale, shakes up, and promptly gets 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, promptly.Calculate the content of Panaxadiol saponin simultaneously, see Table 1:
Ginsenoside, Panaxadiol saponin content are relatively in the table 1 Radix Ginseng effective site
| Group | Content of ginsenoside is (with ginsenoside Rg, Rb 1, Re meter, %) | Panaxadiol saponin content is (with ginsenoside Rb 1Meter, %) |
| Method one method two method three methods four | 76.7 78.2 77.1 77.6 | 25.1 25.6 25.2 24.9 |
2. the extraction ratio of four kinds of different method for extraction and purification of Radix Ginseng relatively
Experimental technique: get Radix Ginseng 150 grams, extract purification according to different technical parameters in four kinds of processes of the present invention, the Radix Ginseng effective site that obtains is weighed, and the value of averaging is calculated, and obtains data, calculates extraction ratio, the results are shown in Table 2:
Table 2 Different Extraction Method extraction ratio relatively
| Group | Crude drug weight (gram) | Effective site average weight (gram) | Extraction ratio (%) |
| Method one method two method three methods four | 150 150 150 150 | 5.7 6.3 5.4 6.1 | 3.8 4.2 3.6 4.1 |
Radix Ophiopogonis the effective site assay
Tlc scanning determination Saponin Radix Ophiopogonis constituents
Experimental drug: ophiopogonin B (ophioponinB), D (ophio-pogoninD) (Shenyang Pharmaceutical University's Chinese patent medicine is analyzed teaching and research room)
Distinct methods effective site Radix Ophiopogonis of the present invention (Tianzhijiao Medication Development Co., Ltd., Guangdong's laboratory provides)
Experimental apparatus: Tianjin, island CS-930 type thin-layer chromatogram scanner; Silica gel plate (German Merck company).
Chromatographic condition: developing solvent is ethyl acetate-methanol-water (15: 5: 1), and developer is 10% sulphuric acid, and scan mode is saw-tooth sweep, SX=6, slit: 1.2mm * 1.2mm.Through in the interscan of 370～700nm scope, determine that 570nm is the mensuration wavelength of ophiopogonin B, D.
The standard curve preparation: precision takes by weighing ophiopogonin B, D, with methanol constant volume, make that its concentration is respectively 0.9,1.0g/L, draw 2.0,4.0,6.0,8.0,10.0 μ L point samples respectively, launch, after the colour developing, measure the area integral value, concentration range is at 2～10 μ g, and the regression equation of ophiopogonin B, D (n=5) is respectively:
Y＝-1.675×104+1.426×104C r＝0.992
Y＝-3.904×104+1.714×104C r＝0.997
Sample determination: get distinct methods effective site Radix Ophiopogonis sample and ophiopogonin B, D contrast liquid point sample 5.0 μ L respectively, measure by the chromatographic condition of Saponin analysis.Assay the results are shown in Table 3.
Table 3 effective site Radix Ophiopogonis assay
| Group | Radix Ophiopogonis, effective site content was (in ophiopogonin, %) |
| Method one method two method three | 80.1 84.3 82.6 |
Radix Ophiopogonis three kinds of different method for extraction and purification extraction ratio relatively
Experimental technique: get gram Radix Ophiopogonis 200, extract purification according to different technical parameters in three kinds of processes of the present invention, effective site Radix Ophiopogonis that obtains is weighed, and the value of averaging is calculated, and obtains data, calculates extraction ratio, the results are shown in Table 4:
Table 4 Different Extraction Method extraction ratio relatively
| Group | Crude drug weight (gram) | Effective site average weight (gram) | Extraction ratio (%) |
| Method one method two method three | 200 200 200 | 1.98 2.12 2.06 | 0.99 1.06 1.03 |
Conclusion: show by above check and analysis experiment, Radix Ginseng effective site of the present invention and Radix Ophiopogonis effective site Different Extraction Method have practical significance.
Three. pharmacology embodiment
Embodiment 1
The present invention respectively organizes the preparation hemolytic experiment
Experiment medicine: SHENMAI ZHUSHEYE (Shijiazhuang Shineway Pharmaceutical Co., Ltd);
Ejection preparation of the present invention (Tianzhijiao Medication Development Co., Ltd., Guangdong's laboratory provides)
Normal saline (Tianzhijiao Medication Development Co., Ltd., Guangdong's laboratory provides)
Experimental technique: remove the fibrin rabbit whole blood, add normal saline, shake up, centrifugal, supernatant inclines, wash clearly repeatedly till do not become redness, measure erythrocyte, add normal saline and be diluted to 2% suspension, get SHENMAI ZHUSHEYE, the present invention and respectively organize each 2ml of preparation (the present invention is respectively organized preparation to be handled and the identical solution of commercially available SHENMAI ZHUSHEYE concentration), add 2% red blood cell suspension 2.5ml, add normal saline to 5ml, shake up gently, put in 37 ℃ of waters bath with thermostatic control, observe 3 hours, 4 hours, 6 hours haemolysis situations, experimental result sees Table 5.
Table 5 is respectively organized the haemolysis situation of preparation
| Group | 3 hours | 4 hours | 6 hours |
| Rhizoma Zingiberis Recens arteries and veins injection aqueous injection of the present invention infusion solution of the present invention | +- - - | +- - - | + - - |
| Injectable powder of the present invention | - | - | - |
Annotate :+expression haemolysis ,-represent not haemolysis ,+-expression has haemolysis but not exclusively
Conclusion: show that by above-mentioned experiment the present invention makes the preparation of respectively organizing of the present invention effectively overcome this untoward reaction of haemolysis after the Panaxadiol saponin with haemolysis has been carried out the content qualification, makes said preparation safer in clinical practice.
Embodiment 2
The haemolysis of Radix Ginseng effective site
Get different Radix Ginseng effective sites (with Panaxadiol saponin Rb
1Count 10%, 15%, 25%, 30%, 31%, 35%) carry out above-mentioned hemolytic experiment, the results are shown in Table 6
The haemolysis of the different Radix Ginseng effective sites of table 6
| Group | 3 hours | 4 hours | 6 hours |
| Radix Ginseng effective site is (with Panaxadiol saponin Rb 1Count 10% group) Radix Ginseng effective site is (with Panaxadiol saponin Rb 1Count 15% group) Radix Ginseng effective site is (with Panaxadiol saponin Rb 1Count 25% group) Radix Ginseng effective site is (with Panaxadiol saponin Rb 1Count 30% group) Radix Ginseng effective site is (with Panaxadiol saponin Rb 1Count 31% group) Radix Ginseng effective site is (with Panaxadiol saponin Rb 1Count 35% group) | - - - - - +- | - - - - +- + | - - - - + + |
Annotate :+expression haemolysis ,-represent not haemolysis ,+-expression has haemolysis but not exclusively
Conclusion: by above-mentioned experiment, we determine Radix Ginseng effective site control Panaxadiol saponin Rb of the present invention
1Count 10%-30%.
Embodiment 3
To the Acute Myocardial Ischemia in Rats protective effect
Experiment medicine: SHENMAI ZHUSHEYE (Shijiazhuang Shineway Pharmaceutical Co., Ltd);
Ejection preparation of the present invention (Tianzhijiao Medication Development Co., Ltd., Guangdong's laboratory provides)
(Tianzhijiao Medication Development Co., Ltd., Guangdong's laboratory provides normal saline
Laboratory animal: 50 of animal wister rat, male, body weight (300 ± 20) g,, be divided into 5 groups, 10 every group.
Experimental technique: the ramus descendens anterior arteriae coronariae sinistrae of ligation rat causes the acute myocardial ischemia model.Each group is carried out tail intravenously administrable (1.5g/kg administration), and 20% urethane (1g/kg, ip) anesthesia separates common carotid artery, and parallel trachea is inserted art, connects animal respirator.Left side the 4th intercostal is opened breast, cuts off pericardium, separates ramus descendens anterior arteriae coronariae sinistrae, and the ligation position is done in flat right auricle.The taking-up heart is weighed,-10 ℃ of freezing 30～50min, under the heart ligature, parallel coronary sulcus becomes 5 with the ventricle crosscut, behind the normal saline flushing, the concentration that places the preparation of pH value 8.0 phosphate buffers is 1% triphenyltetrazolium chloride (TTC) solution, 10min dyes in 38 ℃ of waters bath with thermostatic control, normal myocardium is coloured to kermesinus, infarcted myocardium is dyed lark, cuts off the part that myocardium sheet is colored, and the ischemic infarction district cardiac muscle that is not colored is weighed, (the ischemic infarction area accounts for heavy whole-heartedly percentage ratio, the results are shown in Table 7 to calculate the ischemia scope.
Table 7 group preparation is to the Acute Myocardial Ischemia in Rats protective effect
| Group | Heart heavy (g) | Heart infarction heavy (g) | Heart infarction percentage rate (%) |
| Normal saline SHENMAI ZHUSHEYE aqueous injection of the present invention infusion solution of the present invention injectable powder of the present invention | 0.926 0.880 0.901 0.891 0.961 | 0.192 0.103 0.052 0.051 0.053 | 20.73 11.70 ** 0.058 **[ *] 0.057 **[ *] 0.055 **[ *] |
Compare with the normal saline group
*P＜0.0l, compare with positive controls [
*] P＜0.05
Embodiment 4
The short effect of waking up to mice
Laboratory animal: mice: 50 of Kunming kind white mice in vigorous health, body weight 18-22g, male and female half and half.
Experiment medicine: SHENMAI ZHUSHEYE (Shijiazhuang Shineway Pharmaceutical Co., Ltd);
Ejection preparation of the present invention (Tianzhijiao Medication Development Co., Ltd., Guangdong's laboratory provides)
Normal saline (Tianzhijiao Medication Development Co., Ltd., Guangdong's laboratory provides)
Experimental technique: get 50 of mices, be divided into 5 groups at random, every group 10, tail vein injection respectively organizes preparation (dosage is 1.5g crude drug/kg administration) for normal saline solution, SHENMAI ZHUSHEYE and the present invention respectively, once a day, successive administration 2d, 15min after the last administration, the every 20g body weight of mice lumbar injection pentobarbital sodium normal saline solution (3mg/ml) 0.3ml, meter record mice righting reflex loss is calculated each class mean and standard deviation to the time of recovering, and carries out the t check, with blank group comparing difference significance, the results are shown in Table 5.
Table 5 is respectively organized preparation to the short effect of waking up of mice
| Group | Number of animals (only) | Mice recovery time (min) |
| Normal saline SHENMAI ZHUSHEYE aqueous injection of the present invention infusion solution of the present invention injectable powder of the present invention | 10 10 10 10 10 | 29.1±4.0 21.0±3.6 ** 10.9±2.1 **[ *] 10.9±2.0 **[ *] 10.5±1.8 **[ *] |
**P＜0.01。[
*] P＜0.05, processed group and positive controls are relatively.
Conclusion: show that by pharmacological evaluation the present invention respectively organizes preparation and has better pharmacological action.The present invention respectively organizes preparation and also can be used for treatment for cancer.
Four. preparation embodiment
Embodiment 1
(1) raw medicinal material proportioning weight portion of the present invention is:
Radix Ginseng 120 grams, restrain Radix Ophiopogonis 100;
(2) Radix Ginseng effective site:
Method one: getting Radix Ginseng and put into the Chinese medicine multi-function extractor, is 70% ethanol extraction 3 hours with 8 times, concentration, extracts 4 times, filters, and merge extractive liquid, reclaims ethanol to the greatest extent; NKA type macroporous adsorptive resins on the extracting solution, using distilled water eluting, eluting distilled water earlier is 15 times of column volume, eluent discards, and reuse 70% ethanol carries out gradient elution, and eluting ethanol is 10 times of column volume, eluent reclaims ethanol to the greatest extent, and is concentrated, dry, obtains Radix Ginseng effective site; [ginsenoside is (with ginsenoside Rg, Rb
1, Re) be 85%, wherein control Panaxadiol saponin among the effective site ginsenoside (with ginsenoside Rb
1Meter) be 30%]
Method two: getting Radix Ginseng and put into the Chinese medicine multi-function extractor, is 70% ethanol extraction 3 hours with 8 times, concentration, extracts 4 times, filters, and merge extractive liquid, reclaims ethanol to the greatest extent; Extracting solution merges n-butanol layer with 5 times of water-saturated n-butanol extractions 4 times, reclaims n-butyl alcohol to the greatest extent, concentrates, and drying obtains Radix Ginseng effective site; [ginsenoside is (with ginsenoside Rg, Rb
1, Re) be 85%, wherein control Panaxadiol saponin among the effective site ginsenoside (with ginsenoside Rb
1Meter) be 30%]
Method three: getting Radix Ginseng and put into the Chinese medicine multi-function extractor, is 70% ethanol extraction 3 hours with 8 times, concentration, extracts 4 times, filters, and merge extractive liquid, reclaims ethanol to the greatest extent; Extracting solution is 1.05 when being dissolved in water to 20 ℃ of relative densities, filters with the 0.1um filter element earlier, and filtrate is 8000 hollow fiber column with the intercepting molecular weight, carries out ultrafiltration, ultrafiltration 5 times, and the reservation permeate, concentrate drying obtains Radix Ginseng effective site; [ginsenoside is (with ginsenoside Rg, Rb
1, Re) be 85%, wherein control Panaxadiol saponin among the effective site ginsenoside (with ginsenoside Rb
1Meter) be 30%]
Method four: get Radix Ginseng and put into the Chinese medicine multi-function extractor, add 20 times in water, extract 4 times, each 4 hours, filter, merge extractive liquid,, relative density is 1.10 when being concentrated to 50 ℃, adds ethanol, and the concentration of alcohol that makes solution is 80%, left standstill 24 hours, keep supernatant, reclaim ethanol to the greatest extent, adding water, to make solution relative density in the time of 20 ℃ be 1.05, filter with the 0.1um filter element earlier, filtrate is 8000 hollow fiber column with the intercepting molecular weight, carries out ultrafiltration, ultrafiltration 5 times, keep permeate, concentrate drying obtains Radix Ginseng effective site; [ginsenoside is (with ginsenoside Rg, Rb
1, Re) be 85%, wherein control Panaxadiol saponin among the effective site ginsenoside (with ginsenoside Rb
1Meter) be 30%]
(3) Radix Ophiopogonis effective site:
Method one: getting Radix Ophiopogonis, put into the Chinese medicine multi-function extractor, is 75% ethanol extraction 4 hours with 8 times, concentration, extract 4 times, filter, merge extractive liquid, reclaims ethanol to most, NKA type macroporous adsorptive resins on the extracting solution, using earlier distilled water eluting, eluting distilled water is 12 times of column volume, and eluent discards, the ethanol elution of reuse 70%, eluting ethanol is 10 times of column volume, and eluent reclaims ethanol to the greatest extent, gets effective site Radix Ophiopogonis; [effective site Radix Ophiopogonis (in ophiopogonin) is 85%]
Method two: get and decoct with water three Radix Ophiopogonis, 1 hour for the first time, second, be respectively for three times 45 minutes, 30 minutes, merge extractive liquid,, concentrating under reduced pressure, it is 1.10 that 50 ℃ of intermittent fever are surveyed relative density, adding ethanol is 75% to containing the alcohol amount, places, and filters, filtrate decompression concentrates, it is 1.10 that 50 ℃ of intermittent fever are surveyed relative density, and adding ethanol again is 85% to containing the alcohol amount, places, filter, add 40% sodium hydroxide solution adjusting pH value and be respectively about 8, place, filter, Radix Ophiopogonis, filtrate added about dilute hydrochloric acid accent PH to 7, respectively decompression recycling ethanol is to the greatest extent, and add 20 ℃ of intermittent fever of water and survey relative density and be respectively 1.05, be that 8000 hollow fiber column carries out ultrafiltration with the intercepting molecular weight, ultrafiltration 5 times, keep permeate, merge permeate, concentrate, drying obtains effective site Radix Ophiopogonis [effective site Radix Ophiopogonis (in ophiopogonin) is 85%]
Method three: getting Radix Ophiopogonis, put into the Chinese medicine multi-function extractor, is 75% ethanol extraction 4 hours with 8 times, concentration, extracts 4 times, filters, and merge extractive liquid, reclaims ethanol to the greatest extent, and concentrated solution adds 5 times of water-saturated n-butanols, extracts 5 times.Keep n-butanol layer, combining extraction liquid reclaims n-butyl alcohol to most, and concentrate drying obtains effective site Radix Ophiopogonis; [effective site Radix Ophiopogonis (in ophiopogonin) is 85%]
(4) get Radix Ginseng effective site 4.5 gram, Radix Ophiopogonis effective site 1 gram, add the dissolving of injection water fully, fill, sterilization obtain 1000 bottles of Rhizoma Zingiberis Recens aqueous injection.
(5) get Radix Ginseng effective site 4.5 gram, Radix Ophiopogonis effective site 1 gram, sodium chloride 44.5 grams, add the dissolving of injection water fully, fill, sterilization obtains 1000 bottles of Rhizoma Zingiberis Recens infusion solutions;
(6) get Radix Ginseng effective site 4.5 gram, Radix Ophiopogonis effective site 1 gram,, freeze-dried excipient lactose 44.5 grams, add the dissolving of injection water fully, fill, drying obtains 1000 bottles of red ginseng and tuber of dwarf lily turf powder injection;
Embodiment 2
(1) raw medicinal material proportioning weight portion of the present invention is:
Radix Ginseng 180 grams, restrain Radix Ophiopogonis 300;
(2) Radix Ginseng effective site:
Method one: getting Radix Ginseng and put into the Chinese medicine multi-function extractor, is 60% ethanol extraction 1 hour with 6 times, concentration, extracts 2 times, filters, and merge extractive liquid, reclaims ethanol to the greatest extent; AB-8 type macroporous adsorptive resins on the extracting solution, using distilled water eluting, eluting distilled water earlier is 10 times of column volume, eluent discards, and reuse 60% ethanol carries out gradient elution, and eluting ethanol is 6 times of column volume, eluent reclaims ethanol to the greatest extent, and is concentrated, dry, obtains Radix Ginseng effective site; [ginsenoside is (with ginsenoside Rg, Rb
1, Re) be 50%, wherein control Panaxadiol saponin among the effective site ginsenoside (with ginsenoside Rb
1Meter) be 10%]
Method two: getting Radix Ginseng and put into the Chinese medicine multi-function extractor, is 60% ethanol extraction 1 hour with 6 times, concentration, extracts 2 times, filters, and merge extractive liquid, reclaims ethanol to the greatest extent; Extracting solution merges n-butanol layer with 2 times of water-saturated n-butanol extractions 2 times, reclaims n-butyl alcohol to the greatest extent, concentrate, and drying, [ginsenoside is (with ginsenoside Rg, Rb to obtain Radix Ginseng effective site
1, Re) be 50%, wherein control Panaxadiol saponin among the effective site ginsenoside (with ginsenoside Rb
1Meter) be 10%];
Method three: getting Radix Ginseng and put into the Chinese medicine multi-function extractor, is 60% ethanol extraction 1 hour with 6 times, concentration, extracts 2 times, filters, and merge extractive liquid, reclaims ethanol to the greatest extent; Extracting solution is 1.01 when being dissolved in water to 20 ℃ of relative densities, filters with the 0.1um filter element earlier, and filtrate is 3000 hollow fiber column with the intercepting molecular weight, carries out ultrafiltration, ultrafiltration 3 times, and the reservation permeate, concentrate drying obtains Radix Ginseng effective site; [ginsenoside is (with ginsenoside Rg, Rb
1, Re) be 50%, wherein control Panaxadiol saponin among the effective site ginsenoside (with ginsenoside Rb
1Meter) be 10%]
Method four: get Radix Ginseng and put into the Chinese medicine multi-function extractor, add 10 times in water, extract 2 times, each 2 hours, filter, merge extractive liquid,, relative density is 1.05 when being concentrated to 50 ℃, adds ethanol, and the concentration of alcohol that makes solution is 60%, left standstill 12 hours, keep supernatant, reclaim ethanol to the greatest extent, adding water, to make solution relative density in the time of 20 ℃ be 1.01, filter with the 0.1um filter element earlier, filtrate is 3000 hollow fiber column with the intercepting molecular weight, carries out ultrafiltration, ultrafiltration 3 times, keep permeate, concentrate drying obtains Radix Ginseng effective site; [ginsenoside is (with ginsenoside Rg, Rb
1, Re) be 50%, wherein control Panaxadiol saponin among the effective site ginsenoside (with ginsenoside Rb
1Meter) be 10%]
(3) Radix Ophiopogonis effective site:
Method one: getting Radix Ophiopogonis, put into the Chinese medicine multi-function extractor, is 55% ethanol extraction 2 hours with 6 times, concentration, extract 2 times, filter, merge extractive liquid, reclaims ethanol to most, AB-8 type macroporous adsorptive resins on the extracting solution, using earlier distilled water eluting, eluting distilled water is 8 times of column volume, and eluent discards, the ethanol elution of reuse 60%, eluting ethanol is 6 times of column volume, and eluent reclaims ethanol to the greatest extent, gets effective site Radix Ophiopogonis; [effective site Radix Ophiopogonis (in ophiopogonin) is 50%]
Method two: get and decoct with water three Radix Ophiopogonis, 1 hour for the first time, second, be respectively for three times 45 minutes, 30 minutes, merge extractive liquid,, concentrating under reduced pressure, it is 1.05 that 50 ℃ of intermittent fever are surveyed relative density, adding ethanol is 75% to containing the alcohol amount, places, and filters, filtrate decompression concentrates, it is 1.05 that 50 ℃ of intermittent fever are surveyed relative density, and adding ethanol again is 85% to containing the alcohol amount, places, filter, add 40% sodium hydroxide solution adjusting pH value and be respectively about 8, place, filter, Radix Ophiopogonis, filtrate added about dilute hydrochloric acid accent PH to 7, respectively decompression recycling ethanol is to the greatest extent, and add 20 ℃ of intermittent fever of water and survey relative density and be respectively 1.01-1.05, be that 3000 hollow fiber column carries out ultrafiltration with the intercepting molecular weight, ultrafiltration 3 times, keep permeate, merge permeate, concentrate, drying obtains effective site Radix Ophiopogonis [effective site Radix Ophiopogonis (in ophiopogonin) is 50%]
Method three: getting Radix Ophiopogonis, put into the Chinese medicine multi-function extractor, is 55% ethanol extraction 2 hours with 6 times, concentration, extracts 2 times, filters, and merge extractive liquid, reclaims ethanol to the greatest extent, and concentrated solution adds 2 times of water-saturated n-butanols, extracts 3 times.Keep n-butanol layer, combining extraction liquid reclaims n-butyl alcohol to most, and concentrate drying obtains effective site Radix Ophiopogonis; [effective site Radix Ophiopogonis (in ophiopogonin) is 50%]
(4) get Radix Ginseng effective site 7.5 gram, Radix Ophiopogonis effective site 3 grams, add the dissolving of injection water fully, fill, sterilization obtain 1000 bottles of Rhizoma Zingiberis Recens aqueous injection.
(5) get Radix Ginseng effective site 7.5 gram, Radix Ophiopogonis effective site 3 grams, sodium chloride 39.5 grams, add the dissolving of injection water fully, fill, sterilization obtains 1000 bottles of Rhizoma Zingiberis Recens infusion solutions.
(6) get Radix Ginseng effective site 7.5 gram, Radix Ophiopogonis effective site 3 grams, freeze-dried excipient sucrose 39.5 grams, add the dissolving of injection water fully, fill, drying obtains 1000 bottles of red ginseng and tuber of dwarf lily turf powder injection.
Embodiment 3
(1) raw medicinal material proportioning weight portion of the present invention is:
Radix Ginseng 150 grams, restrain Radix Ophiopogonis 200;
(2) Radix Ginseng effective site:
Method one: getting Radix Ginseng and put into the Chinese medicine multi-function extractor, is 65% ethanol extraction 2 hours with 7 times, concentration, extracts 3 times, filters, and merge extractive liquid, reclaims ethanol to the greatest extent; D101 type macroporous adsorptive resins on the extracting solution, using distilled water eluting, eluting distilled water earlier is 12 times of column volume, eluent discards, and reuse 65% ethanol carries out gradient elution, and eluting ethanol is 8 times of column volume, eluent reclaims ethanol to the greatest extent, and is concentrated, dry, obtains Radix Ginseng effective site; [ginsenoside is (with ginsenoside Rg, Rb
1, Re) be 79.6%, wherein control Panaxadiol saponin among the effective site ginsenoside (with ginsenoside Rb
1Meter) be 21.2%]
Method two: getting Radix Ginseng and put into the Chinese medicine multi-function extractor, is 65% ethanol extraction 2 hours with 7 times, concentration, extracts 3 times, filters, and merge extractive liquid, reclaims ethanol to the greatest extent; Extracting solution merges n-butanol layer with 4 times of water-saturated n-butanol extractions 3 times, reclaims n-butyl alcohol to the greatest extent, concentrates, and drying obtains Radix Ginseng effective site; [ginsenoside is (with ginsenoside Rg, Rb
1, Re) be 79.9%, wherein control Panaxadiol saponin among the effective site ginsenoside (with ginsenoside Rb
1Meter) be 21.5%]
Method three: getting Radix Ginseng and put into the Chinese medicine multi-function extractor, is 65% ethanol extraction 2 hours with 7 times, concentration, extracts 3 times, filters, and merge extractive liquid, reclaims ethanol to the greatest extent; Extracting solution is 1.04 when being dissolved in water to 20 ℃ of relative densities, filters with the 0.1um filter element earlier, and filtrate is 5000 hollow fiber column with the intercepting molecular weight, carries out ultrafiltration, ultrafiltration 4 times, and the reservation permeate, concentrate drying obtains Radix Ginseng effective site; [ginsenoside is (with ginsenoside Rg, Rb
1, Re) be 79.1%, wherein control Panaxadiol saponin among the effective site ginsenoside (with ginsenoside Rb
1Meter) be 21.6%]
Method four: get Radix Ginseng and put into the Chinese medicine multi-function extractor, add 15 times in water, extract 3 times, each 3 hours, filter, merge extractive liquid,, relative density is 1.08 when being concentrated to 50 ℃, adds ethanol, and the concentration of alcohol that makes solution is 70%, left standstill 20 hours, keep supernatant, reclaim ethanol to the greatest extent, adding water, to make solution relative density in the time of 20 ℃ be 1.04, filter with the 0.1um filter element earlier, filtrate is 5000 hollow fiber column with the intercepting molecular weight, carries out ultrafiltration, ultrafiltration 4 times, keep permeate, concentrate drying obtains Radix Ginseng effective site; (with ginsenoside Rg, Rb
1, Re) be 78.8%, wherein control Panaxadiol saponin among the effective site ginsenoside (with ginsenoside Rb
1Meter) be 20.9%]
(3) Radix Ophiopogonis effective site:
Method one: getting Radix Ophiopogonis, put into the Chinese medicine multi-function extractor, is 60% ethanol extraction 3 hours with 7 times, concentration, extract 3 times, filter, merge extractive liquid, reclaims ethanol to most, D101 type macroporous adsorptive resins on the extracting solution, using earlier distilled water eluting, eluting distilled water is 10 times of column volume, and eluent discards, the ethanol elution of reuse 65%, eluting ethanol is 8 times of column volume, and eluent reclaims ethanol to the greatest extent, gets effective site Radix Ophiopogonis; [effective site Radix Ophiopogonis (in ophiopogonin) is 80.9%]
Method two: get and decoct with water three Radix Ophiopogonis, 1 hour for the first time, second, be respectively for three times 45 minutes, 30 minutes, merge extractive liquid,, concentrating under reduced pressure, it is 1.08 that 50 ℃ of intermittent fever are surveyed relative density, adding ethanol is 75% to containing the alcohol amount, places, and filters, filtrate decompression concentrates, it is 1.06 that 50 ℃ of intermittent fever are surveyed relative density, and adding ethanol again is 85% to containing the alcohol amount, places, filter, add 40% sodium hydroxide solution adjusting pH value and be respectively about 8, place, filter, Radix Ophiopogonis, filtrate added about dilute hydrochloric acid accent PH to 7, respectively decompression recycling ethanol is to the greatest extent, and add 20 ℃ of intermittent fever of water and survey relative density and be respectively 1.08, be that 5000 hollow fiber column carries out ultrafiltration with the intercepting molecular weight, ultrafiltration 3-5 time, keep permeate, merge permeate, concentrate, drying obtains effective site Radix Ophiopogonis [effective site Radix Ophiopogonis (in ophiopogonin) is 81.3%]
Method three: getting Radix Ophiopogonis, put into the Chinese medicine multi-function extractor, is 60% ethanol extraction 3 hours with 7 times, concentration, extracts 3 times, filters, and merge extractive liquid, reclaims ethanol to the greatest extent, and concentrated solution adds 3 times of water-saturated n-butanols, extracts 4 times.Keep n-butanol layer, combining extraction liquid reclaims n-butyl alcohol to most, and concentrate drying obtains effective site Radix Ophiopogonis; [effective site Radix Ophiopogonis (in ophiopogonin) is 81.2%]
(4) get Radix Ginseng effective site 6 gram, Radix Ophiopogonis effective site 2 grams, add the dissolving of injection water fully, fill, sterilization obtain 1000 bottles of Rhizoma Zingiberis Recens aqueous injection.
(5) get Radix Ginseng effective site 6 gram, Radix Ophiopogonis effective site 2 grams, sodium chloride 42 grams, add the dissolving of injection water fully, fill, sterilization obtains 1000 bottles of Rhizoma Zingiberis Recens infusion solutions;
(6) get Radix Ginseng effective site 6 gram, Radix Ophiopogonis effective site 2 grams, freeze-dried excipient mannitol 42 grams add the dissolving of injection water fully, fill, and drying obtains 1000 bottles of red ginseng and tuber of dwarf lily turf powder injection;
Embodiment 4
(1) raw medicinal material proportioning weight portion of the present invention is:
Stem and leaf of Radix Ginseng 120 grams, restrain Radix Ophiopogonis 100;
(2) Radix Ginseng effective site:
Method one: getting Stem and leaf of Radix Ginseng and put into the Chinese medicine multi-function extractor, is 70% ethanol extraction 3 hours with 8 times, concentration, extracts 4 times, filters, and merge extractive liquid, reclaims ethanol to the greatest extent; NKA type macroporous adsorptive resins on the extracting solution, using distilled water eluting, eluting distilled water earlier is 15 times of column volume, eluent discards, and reuse 70% ethanol carries out gradient elution, and eluting ethanol is 10 times of column volume, eluent reclaims ethanol to the greatest extent, and is concentrated, dry, obtains Radix Ginseng effective site; [ginsenoside is (with ginsenoside Rg, Rb
1, Re) be 85%, wherein control Panaxadiol saponin among the effective site ginsenoside (with ginsenoside Rb
1Meter) be 30%]
Method two: getting Stem and leaf of Radix Ginseng and put into the Chinese medicine multi-function extractor, is 70% ethanol extraction 3 hours with 8 times, concentration, extracts 4 times, filters, and merge extractive liquid, reclaims ethanol to the greatest extent; Extracting solution merges n-butanol layer with 5 times of water-saturated n-butanol extractions 4 times, reclaims n-butyl alcohol to the greatest extent, concentrates, and drying obtains Radix Ginseng effective site; [ginsenoside is (with ginsenoside Rg, Rb
1, Re) be 85%, wherein control Panaxadiol saponin among the effective site ginsenoside (with ginsenoside Rb
1Meter) be 30%]
Method three: getting Stem and leaf of Radix Ginseng and put into the Chinese medicine multi-function extractor, is 70% ethanol extraction 3 hours with 8 times, concentration, extracts 4 times, filters, and merge extractive liquid, reclaims ethanol to the greatest extent; Extracting solution is 1.05 when being dissolved in water to 20 ℃ of relative densities, filters with the 0.1um filter element earlier, and filtrate is 8000 hollow fiber column with the intercepting molecular weight, carries out ultrafiltration, ultrafiltration 5 times, and the reservation permeate, concentrate drying obtains Radix Ginseng effective site; [ginsenoside is (with ginsenoside Rg, Rb
1, Re) be 85%, wherein control Panaxadiol saponin among the effective site ginsenoside (with ginsenoside Rb
1Meter) be 30%]
Method four: get Stem and leaf of Radix Ginseng and put into the Chinese medicine multi-function extractor, add 20 times in water, extract 4 times, each 4 hours, filter, merge extractive liquid,, relative density is 1.10 when being concentrated to 50 ℃, adds ethanol, and the concentration of alcohol that makes solution is 80%, left standstill 24 hours, keep supernatant, reclaim ethanol to the greatest extent, adding water, to make solution relative density in the time of 20 ℃ be 1.05, filter with the 0.1um filter element earlier, filtrate is 8000 hollow fiber column with the intercepting molecular weight, carries out ultrafiltration, ultrafiltration 5 times, keep permeate, concentrate drying obtains Radix Ginseng effective site; [ginsenoside is (with ginsenoside Rg, Rb
1, Re) be 85%, wherein control Panaxadiol saponin among the effective site ginsenoside (with ginsenoside Rb
1Meter) be 30%]
(3) Radix Ophiopogonis effective site:
Method one: getting Radix Ophiopogonis, put into the Chinese medicine multi-function extractor, is 75% ethanol extraction 4 hours with 8 times, concentration, extract 4 times, filter, merge extractive liquid, reclaims ethanol to most, NKA type macroporous adsorptive resins on the extracting solution, using earlier distilled water eluting, eluting distilled water is 12 times of column volume, and eluent discards, the ethanol elution of reuse 70%, eluting ethanol is 10 times of column volume, and eluent reclaims ethanol to the greatest extent, gets effective site Radix Ophiopogonis; [effective site Radix Ophiopogonis (in ophiopogonin) is 85%]
Method two: get and decoct with water three Radix Ophiopogonis, 1 hour for the first time, second, be respectively for three times 45 minutes, 30 minutes, merge extractive liquid,, concentrating under reduced pressure, it is 1.10 that 50 intermittent fever are surveyed relative density, adding ethanol is 75% to containing the alcohol amount, places, and filters, filtrate decompression concentrates, it is 1.10 that 50 ℃ of intermittent fever are surveyed relative density, and adding ethanol again is 85% to containing the alcohol amount, places, filter, add 40% sodium hydroxide solution adjusting pH value and be respectively about 8, place, filter, Radix Ophiopogonis, filtrate added about dilute hydrochloric acid accent PH to 7, respectively decompression recycling ethanol is to the greatest extent, and add 20 ℃ of intermittent fever of water and survey relative density and be respectively 1.05, be that 8000 hollow fiber column carries out ultrafiltration with the intercepting molecular weight, ultrafiltration 5 times, keep permeate, merge permeate, concentrate, drying obtains effective site Radix Ophiopogonis [effective site Radix Ophiopogonis (in ophiopogonin) is 85%]
Method three: getting Radix Ophiopogonis, put into the Chinese medicine multi-function extractor, is 75% ethanol extraction 4 hours with 8 times, concentration, extracts 4 times, filters, and merge extractive liquid, reclaims ethanol to the greatest extent, and concentrated solution adds 5 times of water-saturated n-butanols, extracts 5 times.Keep n-butanol layer, combining extraction liquid reclaims n-butyl alcohol to most, and concentrate drying obtains effective site Radix Ophiopogonis; [effective site Radix Ophiopogonis (in ophiopogonin) is 85%]
(4) get Radix Ginseng effective site 4.5 gram, Radix Ophiopogonis effective site 1 gram, add the dissolving of injection water fully, fill, sterilization obtain 1000 bottles of Rhizoma Zingiberis Recens aqueous injection.
(5) get Radix Ginseng effective site 4.5 gram, Radix Ophiopogonis effective site 1 gram, sodium chloride 44.5 grams, add the dissolving of injection water fully, fill, sterilization obtains 1000 bottles of Rhizoma Zingiberis Recens infusion solutions;
(6) get Radix Ginseng effective site 4.5 gram, Radix Ophiopogonis effective site 1 gram,, freeze-dried excipient lactose 44.5 grams, add the dissolving of injection water fully, fill, drying obtains 1000 bottles of red ginseng and tuber of dwarf lily turf powder injection;
Embodiment 5
(1) raw medicinal material proportioning weight portion of the present invention is:
Stem and leaf of Radix Ginseng 180 grams, restrain Radix Ophiopogonis 300;
(2) Radix Ginseng effective site:
Method one: getting Stem and leaf of Radix Ginseng and put into the Chinese medicine multi-function extractor, is 60% ethanol extraction 1 hour with 6 times, concentration, extracts 2 times, filters, and merge extractive liquid, reclaims ethanol to the greatest extent; AB-8 type macroporous adsorptive resins on the extracting solution, using distilled water eluting, eluting distilled water earlier is 10 times of column volume, eluent discards, and reuse 60% ethanol carries out gradient elution, and eluting ethanol is 6 times of column volume, eluent reclaims ethanol to the greatest extent, and is concentrated, dry, obtains Radix Ginseng effective site; [ginsenoside is (with ginsenoside Rg, Rb
1, Re) be 50%, wherein control Panaxadiol saponin among the effective site ginsenoside (with ginsenoside Rb
1Meter) be 10%]
Method two: getting Stem and leaf of Radix Ginseng and put into the Chinese medicine multi-function extractor, is 60% ethanol extraction 1 hour with 6 times, concentration, extracts 2 times, filters, and merge extractive liquid, reclaims ethanol to the greatest extent; Extracting solution merges n-butanol layer with 2 times of water-saturated n-butanol extractions 2 times, reclaims n-butyl alcohol to the greatest extent, concentrate, and drying, [ginsenoside is (with ginsenoside Rg, Rb to obtain Radix Ginseng effective site
1, Re) be 50%, wherein control Panaxadiol saponin among the effective site ginsenoside (with ginsenoside Rb
1Meter) be 10%];
Method three: getting Stem and leaf of Radix Ginseng and put into the Chinese medicine multi-function extractor, is 60% ethanol extraction 1 hour with 6 times, concentration, extracts 2 times, filters, and merge extractive liquid, reclaims ethanol to the greatest extent; Extracting solution is 1.01 when being dissolved in water to 20 ℃ of relative densities, filters with the 0.1um filter element earlier, and filtrate is 3000 hollow fiber column with the intercepting molecular weight, carries out ultrafiltration, ultrafiltration 3 times, and the reservation permeate, concentrate drying obtains Radix Ginseng effective site; [ginsenoside is (with ginsenoside Rg, Rb
1, Re) be 50%, wherein control Panaxadiol saponin among the effective site ginsenoside (with ginsenoside Rb
1Meter) be 10%]
Method four: get Stem and leaf of Radix Ginseng and put into the Chinese medicine multi-function extractor, add 10 times in water, extract 2 times, each 2 hours, filter, merge extractive liquid,, relative density is 1.05 when being concentrated to 50 ℃, adds ethanol, and the concentration of alcohol that makes solution is 60%, left standstill 12 hours, keep supernatant, reclaim ethanol to the greatest extent, adding water, to make solution relative density in the time of 20 ℃ be 1.01, filter with the 0.1um filter element earlier, filtrate is 3000 hollow fiber column with the intercepting molecular weight, carries out ultrafiltration, ultrafiltration 3 times, keep permeate, concentrate drying obtains Radix Ginseng effective site; [ginsenoside is (with ginsenoside Rg, Rb
1, Re) be 50%, wherein control Panaxadiol saponin among the effective site ginsenoside (with ginsenoside Rb
1Meter) be 10%]
(3) Radix Ophiopogonis effective site:
Method one: getting Radix Ophiopogonis, put into the Chinese medicine multi-function extractor, is 55% ethanol extraction 2 hours with 6 times, concentration, extract 2 times, filter, merge extractive liquid, reclaims ethanol to most, AB-8 type macroporous adsorptive resins on the extracting solution, using earlier distilled water eluting, eluting distilled water is 8 times of column volume, and eluent discards, the ethanol elution of reuse 60%, eluting ethanol is 6 times of column volume, and eluent reclaims ethanol to the greatest extent, gets effective site Radix Ophiopogonis; [effective site Radix Ophiopogonis (in ophiopogonin) is 50%]
Method two: get and decoct with water three Radix Ophiopogonis, 1 hour for the first time, second, be respectively for three times 45 minutes, 30 minutes, merge extractive liquid,, concentrating under reduced pressure, it is 1.05 that 50 ℃ of intermittent fever are surveyed relative density, adding ethanol is 75% to containing the alcohol amount, places, and filters, filtrate decompression concentrates, it is 1.05 that 50 intermittent fever are surveyed relative density, and adding ethanol again is 85% to containing the alcohol amount, places, filter, add 40% sodium hydroxide solution adjusting pH value and be respectively about 8, place, filter, Radix Ophiopogonis, filtrate added about dilute hydrochloric acid accent PH to 7, respectively decompression recycling ethanol is to the greatest extent, and add 20 ℃ of intermittent fever of water and survey relative density and be respectively 1.01-1.05, be that 3000 hollow fiber column carries out ultrafiltration with the intercepting molecular weight, ultrafiltration 3 times, keep permeate, merge permeate, concentrate, drying obtains effective site Radix Ophiopogonis [effective site Radix Ophiopogonis (in ophiopogonin) is 50%]
Method three: getting Radix Ophiopogonis, put into the Chinese medicine multi-function extractor, is 55% ethanol extraction 2 hours with 6 times, concentration, extracts 2 times, filters, and merge extractive liquid, reclaims ethanol to the greatest extent, and concentrated solution adds 2 times of water-saturated n-butanols, extracts 3 times.Keep n-butanol layer, combining extraction liquid reclaims n-butyl alcohol to most, and concentrate drying obtains effective site Radix Ophiopogonis; [effective site Radix Ophiopogonis (in ophiopogonin) is 50%]
(4) get Radix Ginseng effective site 7.5 gram, Radix Ophiopogonis effective site 3 grams, add the dissolving of injection water fully, fill, sterilization obtain 1000 bottles of Rhizoma Zingiberis Recens aqueous injection.
(5) get Radix Ginseng effective site 7.5 gram, Radix Ophiopogonis effective site 3 grams, sodium chloride 39.5 grams, add the dissolving of injection water fully, fill, sterilization obtains 1000 bottles of Rhizoma Zingiberis Recens infusion solutions.
(6) get Radix Ginseng effective site 7.5 gram, Radix Ophiopogonis effective site 3 grams, freeze-dried excipient sucrose 39.5 grams, add the dissolving of injection water fully, fill, drying obtains 1000 bottles of red ginseng and tuber of dwarf lily turf powder injection.
Embodiment 6
(1) raw medicinal material proportioning weight portion of the present invention is:
Stem and leaf of Radix Ginseng 150 grams, restrain Radix Ophiopogonis 200;
(2) Radix Ginseng effective site:
Method one: getting Stem and leaf of Radix Ginseng and put into the Chinese medicine multi-function extractor, is 65% ethanol extraction 2 hours with 7 times, concentration, extracts 3 times, filters, and merge extractive liquid, reclaims ethanol to the greatest extent; D101 type macroporous adsorptive resins on the extracting solution, using distilled water eluting, eluting distilled water earlier is 12 times of column volume, eluent discards, and reuse 65% ethanol carries out gradient elution, and eluting ethanol is 8 times of column volume, eluent reclaims ethanol to the greatest extent, and is concentrated, dry, obtains Radix Ginseng effective site; [ginsenoside is (with ginsenoside Rg, Rb
1, Re) be 78.3%, wherein control Panaxadiol saponin among the effective site ginsenoside (with ginsenoside Rb
1Meter) be 20.6%]
Method two: getting Stem and leaf of Radix Ginseng and put into the Chinese medicine multi-function extractor, is 65% ethanol extraction 2 hours with 7 times, concentration, extracts 3 times, filters, and merge extractive liquid, reclaims ethanol to the greatest extent; Extracting solution merges n-butanol layer with 4 times of water-saturated n-butanol extractions 3 times, reclaims n-butyl alcohol to the greatest extent, concentrates, and drying obtains Radix Ginseng effective site; [ginsenoside is (with ginsenoside Rg, Rb
1, Re) be 78.9%, wherein control Panaxadiol saponin among the effective site ginsenoside (with ginsenoside Rb
1Meter) be 20.1%]
Method three: getting Stem and leaf of Radix Ginseng and put into the Chinese medicine multi-function extractor, is 65% ethanol extraction 2 hours with 7 times, concentration, extracts 3 times, filters, and merge extractive liquid, reclaims ethanol to the greatest extent; Extracting solution is 1.04 when being dissolved in water to 20 ℃ of relative densities, filters with the 0.1um filter element earlier, and filtrate is 5000 hollow fiber column with the intercepting molecular weight, carries out ultrafiltration, ultrafiltration 4 times, and the reservation permeate, concentrate drying obtains Radix Ginseng effective site; [ginsenoside is (with ginsenoside Rg, Rb
1, Re) be 78.2%, wherein control Panaxadiol saponin among the effective site ginsenoside (with ginsenoside Rb
1Meter) be 20.0%]
Method four: get Stem and leaf of Radix Ginseng and put into the Chinese medicine multi-function extractor, add 15 times in water, extract 3 times, each 3 hours, filter, merge extractive liquid,, relative density is 1.08 when being concentrated to 50 ℃, adds ethanol, and the concentration of alcohol that makes solution is 70%, left standstill 20 hours, keep supernatant, reclaim ethanol to the greatest extent, adding water, to make solution relative density in the time of 20 ℃ be 1.04, filter with the 0.1um filter element earlier, filtrate is 5000 hollow fiber column with the intercepting molecular weight, carries out ultrafiltration, ultrafiltration 4 times, keep permeate, concentrate drying obtains Radix Ginseng effective site; (with ginsenoside Rg, Rb
1, Re) be 79.3%, wherein control Panaxadiol saponin among the effective site ginsenoside (with ginsenoside Rb
1Meter) be 21.0%]
(3) Radix Ophiopogonis effective site:
Method one: getting Radix Ophiopogonis, put into the Chinese medicine multi-function extractor, is 60% ethanol extraction 3 hours with 7 times, concentration, extract 3 times, filter, merge extractive liquid, reclaims ethanol to most, D101 type macroporous adsorptive resins on the extracting solution, using earlier distilled water eluting, eluting distilled water is 10 times of column volume, and eluent discards, the ethanol elution of reuse 65%, eluting ethanol is 8 times of column volume, and eluent reclaims ethanol to the greatest extent, gets effective site Radix Ophiopogonis; [effective site Radix Ophiopogonis (in ophiopogonin) is 81.5%]
Method two: get and decoct with water three Radix Ophiopogonis, 1 hour for the first time, second, be respectively for three times 45 minutes, 30 minutes, merge extractive liquid,, concentrating under reduced pressure, it is 1.08 that 50 ℃ of intermittent fever are surveyed relative density, adding ethanol is 75% to containing the alcohol amount, places, and filters, filtrate decompression concentrates, it is 1.06 that 50 intermittent fever are surveyed relative density, and adding ethanol again is 85% to containing the alcohol amount, places, filter, add 40% sodium hydroxide solution adjusting pH value and be respectively about 8, place, filter, Radix Ophiopogonis, filtrate added about dilute hydrochloric acid accent PH to 7, respectively decompression recycling ethanol is to the greatest extent, and add 20 ℃ of intermittent fever of water and survey relative density and be respectively 1.08, be that 5000 hollow fiber column carries out ultrafiltration with the intercepting molecular weight, ultrafiltration 3-5 time, keep permeate, merge permeate, concentrate, drying obtains effective site Radix Ophiopogonis [effective site Radix Ophiopogonis (in ophiopogonin) is 81.8%]
Method three: getting Radix Ophiopogonis, put into the Chinese medicine multi-function extractor, is 60% ethanol extraction 3 hours with 7 times, concentration, extracts 3 times, filters, and merge extractive liquid, reclaims ethanol to the greatest extent, and concentrated solution adds 3 times of water-saturated n-butanols, extracts 4 times.Keep n-butanol layer, combining extraction liquid reclaims n-butyl alcohol to most, and concentrate drying obtains effective site Radix Ophiopogonis; [effective site Radix Ophiopogonis (in ophiopogonin) is 81.7%]
(4) get Radix Ginseng effective site 7 gram, Radix Ophiopogonis effective site 2.5 grams, add the dissolving of injection water fully, fill, sterilization obtain 1000 bottles of Rhizoma Zingiberis Recens aqueous injection.
(5) get Radix Ginseng effective site 7 gram, Radix Ophiopogonis effective site 2.5 grams, sodium chloride 40.5 grams, add the dissolving of injection water fully, fill, sterilization obtains 1000 bottles of Rhizoma Zingiberis Recens infusion solutions;
(6) get Radix Ginseng effective site 7 gram, Radix Ophiopogonis effective site 2.5 grams, freeze-dried excipient mannitol 40.5 grams add the dissolving of injection water fully, fill, and drying obtains 1000 bottles of red ginseng and tuber of dwarf lily turf powder injection.
Claims (4)
1. a QI invigorating is given birth to arteries and veins, and the pharmaceutical composition of YIN nourishing and the production of body fluid promoting is characterized in that: Radix Ginseng effective site is the 4.5-7.5 weight portion, Radix Ophiopogonis effective site 1-3 weight portion; Wherein the content of Radix Ginseng effective site is with ginsenoside Rg, Rb
1, Re counts 50%-85%, Panaxadiol saponin is with ginsenoside Rb among the control effective site ginsenoside
1Count 10%-30%, Radix Ophiopogonis, effective site was counted 50%-85% with ophiopogonin; Its preparation method is:
(1) raw medicinal material proportioning weight portion is: Radix Ginseng 6-9, Radix Ophiopogonis 5-15;
(2) Radix Ginseng effective site:
Method one: get Radix Ginseng and put into the Chinese medicine multi-function extractor, with 6-8 doubly, concentration is 60%-70% ethanol extraction 1-3 hour, extracts 2-4 time, filters, it is extremely most that merge extractive liquid, reclaims ethanol; Macroporous adsorptive resins on the extracting solution, use earlier the distilled water eluting, the eluting distilled water is 10-15 a times of column volume, eluent discards, reuse 60%-70% ethanol carries out gradient elution, and eluting ethanol is 6-10 times of column volume, and eluent reclaims ethanol to most, concentrated, dry, obtain Radix Ginseng effective site;
Method two: get Radix Ginseng and put into the Chinese medicine multi-function extractor, with 6-8 doubly, concentration is 60%-70% ethanol extraction 1-3 hour, extracts 2-4 time, filters, it is extremely most that merge extractive liquid, reclaims ethanol; Extracting solution merges n-butanol layer with 2-5 times of water-saturated n-butanol extraction 2-4 time, reclaims n-butyl alcohol to the greatest extent, concentrates, and drying obtains Radix Ginseng effective site;
Method three: get Radix Ginseng and put into the Chinese medicine multi-function extractor, with 6-8 doubly, concentration is 60%-70% ethanol extraction 1-3 hour, extracts 2-4 time, filters, it is extremely most that merge extractive liquid, reclaims ethanol; Extracting solution is 1.01-1.05 when being dissolved in water to 20 ℃ of relative densities, filters with the 0.1um filter element earlier, and filtrate is the hollow fiber column of 3000-8000 with the intercepting molecular weight, carry out ultrafiltration, ultrafiltration 3-5 time keeps permeate, and concentrate drying obtains Radix Ginseng effective site;
Method four: get Radix Ginseng and put into the Chinese medicine multi-function extractor, add water 10-20 doubly, extract 2-4 time, each 2-4 hour, filter, merge extractive liquid,, relative density is 1.05-1.10 when being concentrated to 50 ℃, adds ethanol, and the concentration of alcohol that makes solution is 60%-80%, left standstill 12-24 hour, keep supernatant, reclaim ethanol to the greatest extent, adding water, to make solution relative density in the time of 20 ℃ be 1.01-1.05, filter with the 0.1um filter element earlier, filtrate is the hollow fiber column of 3000-8000 with the intercepting molecular weight, carries out ultrafiltration, ultrafiltration 3-5 time, keep permeate, concentrate drying obtains Radix Ginseng effective site;
(3) Radix Ophiopogonis effective site:
Method one: get Radix Ophiopogonis, put into the Chinese medicine multi-function extractor, with 6-8 doubly, concentration is 55%-75% ethanol extraction 2-4 hour, extract 2-4 time, filter, merge extractive liquid, reclaims ethanol to most, macroporous adsorptive resins on the extracting solution, use earlier distilled water eluting, eluting distilled water is 8-12 times of column volume, and eluent discards, the ethanol elution of reuse 60%-70%, eluting ethanol is 6-10 times of column volume, and eluent reclaims ethanol to the greatest extent, gets effective site Radix Ophiopogonis;
Method two: get and decoct with water three Radix Ophiopogonis, 1 hour for the first time, second, be respectively for three times 45 minutes, 30 minutes, merge extractive liquid,, concentrating under reduced pressure, it is 1.05-1.10 that 50 ℃ of intermittent fever are surveyed relative density, adding ethanol is 75% to containing the alcohol amount, places, and filters, filtrate decompression concentrates, it is 1.05-1.10 that 50 ℃ of intermittent fever are surveyed relative density, and adding ethanol again is 85% to containing the alcohol amount, places, filter, add 40% sodium hydroxide solution adjusting pH value and be respectively about 8, place, filter, Radix Ophiopogonis, filtrate added about dilute hydrochloric acid accent PH to 7, respectively decompression recycling ethanol is to the greatest extent, and add 20 ℃ of intermittent fever of water and survey relative density and be respectively 1.01-1.05, be that the hollow fiber column of 3000-8000 carries out ultrafiltration with the intercepting molecular weight, ultrafiltration 3-5 time, keep permeate, merge permeate, concentrate, drying obtains effective site Radix Ophiopogonis;
Method three: get Radix Ophiopogonis, put into the Chinese medicine multi-function extractor, with 6-8 doubly, concentration is 55%-75% ethanol extraction 2-4 hour, extract 2-4 time, filter, merge extractive liquid, reclaims ethanol to most, and concentrated solution adds 2-5 times of water-saturated n-butanol, extract 3-5 time, keep n-butanol layer, combining extraction liquid reclaims n-butyl alcohol to most, concentrate drying obtains effective site Radix Ophiopogonis;
(4) get Radix Ginseng effective site, Radix Ophiopogonis effective site, add the dissolving of injection water fully, fill, sterilization obtain the Rhizoma Zingiberis Recens aqueous injection;
(5) get Radix Ginseng effective site, Radix Ophiopogonis effective site, sodium chloride, add the dissolving of injection water fully, fill, sterilization obtains the Rhizoma Zingiberis Recens infusion solution;
(6) get Radix Ginseng effective site, Radix Ophiopogonis effective site, freeze-dried excipient, add the dissolving of injection water fully, fill, drying obtains red ginseng and tuber of dwarf lily turf powder injection.
2. a kind of QI invigorating according to claim 1 is given birth to arteries and veins, the pharmaceutical composition of YIN nourishing and the production of body fluid promoting, and wherein macroporous adsorbent resin is a nonpolar macroporous adsorption resin.
3. a kind of QI invigorating according to claim 1 is given birth to arteries and veins, the pharmaceutical composition of YIN nourishing and the production of body fluid promoting, and wherein macroporous adsorbent resin is the low pole macroporous adsorbent resin.
4. a kind of QI invigorating according to claim 1 is given birth to arteries and veins, the pharmaceutical composition of YIN nourishing and the production of body fluid promoting, and wherein freeze-dried excipient is a kind of in sucrose, lactose, the mannitol in the injectable powder.
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| CN104623262B (en) * | 2013-11-12 | 2017-12-19 | 华润三九（雅安）药业有限公司 | A kind of Shenmai injection and preparation method thereof |
| CN105267619B (en) * | 2014-06-07 | 2018-05-01 | 兰州大学 | The anti-tumor Chinese medicine compound extract that a kind of suppression ras proto-oncogenes are overexpressed |
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