CN1850185A - Yixinshu Injecta for retaliation of Qi and pulse and promotion of blood circulation and removing of blood stasis, and preparing method therefor - Google Patents
Yixinshu Injecta for retaliation of Qi and pulse and promotion of blood circulation and removing of blood stasis, and preparing method therefor Download PDFInfo
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- CN1850185A CN1850185A CN 200610050956 CN200610050956A CN1850185A CN 1850185 A CN1850185 A CN 1850185A CN 200610050956 CN200610050956 CN 200610050956 CN 200610050956 A CN200610050956 A CN 200610050956A CN 1850185 A CN1850185 A CN 1850185A
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Abstract
The present invention relates to a Chinese medicine Yixinshu injection preparation with the functions of supplementing qi, promoting blood circulation, removing stasis, nourishing yin and promoting the production of body fluid for effectively curing the diseases of deficiency of both qi and yin, palpitation, oppressed feeling in chest, chest pain, coronary heart disease and angina pectoris, etc. and its preparation method. It is made up by using extract of 7 Chinese medicinal materials of ginseng, ophiopogon tuber, schisandra berry, astragalus root, salva root and others and adding medicinal auxiliary material including injection water, mannitol, polyethylene glyeol, lactose, dextran, glucose or their mixture through a certain preparation process.
Description
Technical field the present invention is a kind of Yiqi and vein recovery, blood circulation promoting and blood stasis dispelling YIXINSHU ejection preparation and preparation method thereof, belongs to technical field of medicaments.
Background technology YIXINSHU ejection preparation is made up of medical materials such as Radix Ginseng, Radix Ophiopogonis, Fructus Schisandrae Chinensis, the Radix Astragali, Radix Salviae Miltiorrhizae, Rhizoma Chuanxiong, Fructus Crataegis, has Yiqi and vein recovery, blood circulation promoting and blood stasis dispelling, the effect of YIN nourishing and the production of body fluid promoting, be used for deficiency of both QI and YIN, the cardiopalmus irregularly intermittent and regularly intermittent pulse does not uncomfortable in chestly relax, diseases such as chest pain and angina pectoris.Diseases of cardiovascular and cerebrovascular systems is a human the most common class disease, is the No.1 killer who threatens human health at present, has become the first dead cause of disease of world today's population.In China, along with aged tendency of population is quickened, living standards of the people improve, rhythm of life is accelerated, and dietary structure is to hyperpyrexia, high fat development, and cardiovascular system diseases such as coronary heart disease, angina pectoris has also become one of serious disease of harm humans health and life among the crowd, cardiovascular and cerebrovascular disease the patient sharply increase, die from reaching more than 2,400,000 people of cardiovascular disease every year, account for 34% of disease death rate, and in rising trend.On the other hand, because dietary structure changes, cause cholesterol intake too much, and work, life stress strengthen, quantity of motion reduces, reasons such as environmental pollution, the cardiovascular and cerebrovascular disease sickness rate presents the trend of rejuvenation, and three, the quadragenarian people ratio of suffering from cardiovascular and cerebrovascular disease increases year by year, the high rate of cardiovascular disease and mortality rate are subjected to the extensive concern of society day by day.
Because coronary heart disease, angina pectoris are one of common frequently-occurring diseases, longer duration mostly is chronic disease, needs long-term prescription.Treatment coronary heart disease, anginal Western medicine commonly used at present mainly are nitrate esters medicine, beta-blocker, calcium antagonist and medicament for resisting platelet aggregation, have as untoward reaction such as headache, dizzy, blood pressure drops, tachycardias, life-time service also can produce drug resistance.In prior art, using medical materials such as Radix Ginseng, Radix Ophiopogonis, Fructus Schisandrae Chinensis, the Radix Astragali, Radix Salviae Miltiorrhizae, Rhizoma Chuanxiong, Fructus Crataegi to be prepared into YIXINSHU JIAONANG treats, the preparation method of YIXINSHU JIAONANG is to adopt Radix Ginseng crude drug powder to be used as medicine, and Radix Salviae Miltiorrhizae also just extracts pure soluble components.Because Radix Ginseng crude drug powder is used as medicine, after taking, must be earlier by capsular disintegrate, the crude drug powder could dissolve, absorb at gastric gradually, thereby effect is slow, bioavailability is relatively poor; In addition, Radix Salviae Miltiorrhizae only extracts pure soluble components, and up-to-date research data shows, water soluble ingredient salvianolic acid B in the Radix Salviae Miltiorrhizae and pure soluble components Tanshinone I I
AWhen the heart microvascular endothelium carefully damages born of the same parents, all can improve the heart microvascular endothelial cell vigor, reduce lactic acid dehydrogenase and discharge, the reduction nitric oxide is synthetic, Endothelin discharges, and the effect behind the compatibility is better than single component; When myocardial cell injury, the effect of the effect salvianolic acid B of myocardial cell propagation obviously is better than Tanshinone I I
A: salvianolic acid B, Tanshinone I I
AThe release of minimizing lactic acid dehydrogenase, the synthetic effect of nitric oxide are better than both and use separately behind the compatibility, for alleviating the cells injury degree, show the enhancing of cell viability, and the minimizing that lactic acid dehydrogenase discharges also is that the two compatibility effect is better than independent use.Show that thus the water soluble ingredient salvianolic acid class material and the liposoluble constituent tanshinone material of Radix Salviae Miltiorrhizae all have the effect that resists myocardial ischemia, though emphasize particularly on different fields, the effect that both share is better than both and acts on separately.Liposoluble constituent and water soluble ingredient synergism in the Radix Salviae Miltiorrhizae can make drug effect strengthen, and use liposoluble constituent separately, have weakened the drug effect of this prescription greatly.If its whole effective ingredient are made capsule, because the physical characteristic of liposoluble constituent and water soluble ingredient, liposoluble constituent and water soluble ingredient mix in the capsule, and deadlocked mutually, easy disintegrating can not cause delayed action, the problem that bioavailability is low.If make injection, though can improve bioavailability, and play a role rapidly, but, adopt conventional method, the effective ingredient of the very difficult Chinese crude drug of will writing out a prescription extracts fully, because the liposoluble constituent that extracts from medical material is insoluble in the water solublity solvent, and the water soluble ingredient that extracts from medical material is insoluble in the fat-soluble solvent, use the solvent of a kind of solvent or different proportion to mix, if ratio is improper, fat-soluble solvent addition is too small, fat-soluble effective part extract can not dissolve fully, fat-soluble solvent addition is excessive, though fat-soluble effective part extract can dissolve,, the unit volume drug loading of making medicine reduces, and can not reach minimal effective concentration; In the process of preparation injection and concentrated solution for injection, because medicine can not be dissolved in the solvent, precipitate and produce, influence the absorption of medicine during use, reduce curative effect of medication, even cause adverse effect; In preparation during freeze dried powder, because complicated component, in the lyophilization, if directly carry out lyophilizing with medicinal liquid, because finished product is loose, specific surface area is big, very easily moisture absorption can not molding; When preparation spray drying powder, because complicated component, contained polysaccharide stickum is more, can directly influence spray-dired effect, sticking wall, caking phenomenon easily take place, and gained extractum powder hygroscopicity is bigger, is unfavorable for the collection of extract powder; Simultaneously, because the slightly solubility of liposoluble constituent or water soluble ingredient can cause the performance of effective ingredient in intravital absorption of people and effect after the use.
Summary of the invention the object of the present invention is to provide a kind of Yiqi and vein recovery, blood circulation promoting and blood stasis dispelling YIXINSHU ejection preparation and preparation method thereof, mix and make deadlocked not easy disintegrating mutually to overcome in the existing in prior technology capsule liposoluble constituent and water soluble ingredient, delayed action, the problem that bioavailability is low, solved because the injection poorly soluble problem of solvent proportioning due to improper, also solved the problem of freeze dried powder molding difference in the preparation, sticking wall when also having solved spray drying, caking, the problem that the powder hygroscopicity is bigger; The YIXINSHU ejection preparation of the said a kind of Yiqi and vein recovery of the present invention, blood circulation promoting and blood stasis dispelling, by weight percentage, it is to be prepared from by Radix Ginseng 15%, Radix Ophiopogonis 15%, Fructus Schisandrae Chinensis 10%, the Radix Astragali 15%, Radix Salviae Miltiorrhizae 20%, Rhizoma Chuanxiong 10% and Fructus Crataegi 15%, makes with the effective part extract and the adjuvant of these medicinal material extract; Wherein: the effective part extract of medicinal material extract comprises fat-soluble effective part extract, water solublity effective part extract or their mixture; The accessory package explanatory note in brackets is penetrated water, mannitol, lactose, dextran, glucose, Polyethylene Glycol or their mixture.The injection of preparation comprises injection, injectable sterile powder and concentrated solution for injection.
The present invention is achieved in that by weight percentage, gets Radix Ginseng 15%, Radix Ophiopogonis 15%, Fructus Schisandrae Chinensis 10%, the Radix Astragali 15%, Radix Salviae Miltiorrhizae 20%, Rhizoma Chuanxiong 10%, Fructus Crataegi 15% and is ground into fine powder; Radix Ginseng, Fructus Schisandrae Chinensis, the Radix Salviae Miltiorrhizae fat-soluble effective part extract of ethanol extraction, medicinal residues are standby, and filtrate merges, and measuring relative density when being evaporated to 20 ℃ is 1.15-1.12, gets fat-soluble effective part extract, standby; Medicinal residues and Radix Ophiopogonis, the Radix Astragali, Rhizoma Chuanxiong, Fructus Crataegi decoct with water, merge decoction liquor, filter, filtrate is concentrated into 500ml, adds 85% ethanol of equivalent, after fully stirring, standing over night, the elimination precipitate, filtrate recycling ethanol and to measure relative density when being concentrated into 80 ℃ be 1.30-1.36, the water solublity effective part extract; After above-mentioned two kinds of effective part extracts merging, standby; Get above-mentioned effective part extract, the activated feedstock as injection is used is prepared as follows:
(1) preparation of injection: get above-mentioned effective part extract and add injection and be diluted with water to 80% of prescribed volume, stir, adding the dextran that polyethylene glycol 6000 that above-mentioned effective part extract 0.01-0.1 doubly measures and above-mentioned effective part extract 0.05-0.15 doubly measure fully dissolves, the injection active carbon of adding 0.1%, be heated to 80 ℃ and be incubated 10 minutes, filter carbon removal, add the injection water to nearly full dose, it is 7.5 that sodium hydroxide solution with 10% is regulated pH value, with the microporous filter membrane fine straining of 0.45 μ m, and carry out aseptic filtration, the filtrate embedding with the microporous filter membrane of 0.22 μ m, sterilization, promptly;
(2) preparation of freeze-dried powder: get above-mentioned effective part extract and add injection and be diluted with water to 80% of prescribed volume, stir, the mannitol that polyethylene glycol 6000 that adding effective part extract 0.01-0.1 doubly measures and above-mentioned effective part extract 0.2-0.4 doubly measure fully dissolves, the injection active carbon of adding 0.1%, be heated to 80 ℃ and be incubated 10 minutes, filter carbon removal, add the injection water to nearly full dose, it is 7.5 that sodium hydroxide solution with 10% is regulated pH value, microporous filter membrane fine straining with 0.45 μ m, and carry out aseptic filtration with the microporous filter membrane of 0.22 μ m, the filtrate fill in the cillin bottle of 20ml, every bottled 10ml; Place freeze drying box evacuation after-50 ℃ of pre-freeze 3-5 hours then; Condensation temperature remains unchanged, and after 24 hours, unpacks, and makes dried frozen aquatic products, gland, and labeling, promptly;
(3) preparation of sterilized powder: get above-mentioned effective part extract add the injection be diluted with water to regulation volume 80%, stir, adding the lactose that polyethylene glycol 6000 that above-mentioned effective part extract 0.03-0.09 doubly measures and above-mentioned effective part extract 0.06-0.15 doubly measure fully dissolves, the injection active carbon of adding 0.1%, be heated to 80 ℃ and kept 10 minutes, filter carbon removal, add the injection water to nearly full dose, it is 7.5 that sodium hydroxide solution with 10%% is regulated pH value, microporous filter membrane fine straining with 0.45 μ m, and carry out aseptic filtration with the microporous filter membrane of 0.22 μ m, filtrate is sprayed with the spray drying tower under the aseptic condition, makes sterilized powder, packing, labeling, promptly;
(4) preparation of concentrated solution for injection: get above-mentioned effective part extract and add injection and be diluted with water to 80% of prescribed volume, stir, add dextran that mannitol that above-mentioned effective part extract 0.1-0.3 doubly measures and above-mentioned effective part extract 0.12-0.36 doubly measure and the glucose of above-mentioned effective part extract 0.02-0.08, fully dissolving, the injection active carbon of adding 0.1%, be heated to 80 ℃ and be incubated 10 minutes, filter carbon removal, add the injection water to nearly full dose, it is 7.5 that sodium hydroxide solution with 10% is regulated pH value, microporous filter membrane fine straining with 0.45 μ m, and carry out aseptic filtration with the microporous filter membrane of 0.22 μ m, filtrate decompression is concentrated in right amount, embedding, sterilization, promptly.
Radix Ginseng, Fructus Schisandrae Chinensis, Radix Salviae Miltiorrhizae comprise that with the method for the fat-soluble effective site of ethanol extraction reflux, extract,, percolation extract or dipping extracts.Reflux, extract, be with Radix Ginseng, Fructus Schisandrae Chinensis, Radix Salviae Miltiorrhizae with 85% alcohol reflux 2 times, 3 hours for the first time, 1.5 hours for the second time, filter, merging filtrate is evaporated to relative density 1.15～1.12 (20 ℃), fat-soluble effective part extract; It is that Radix Ginseng, Fructus Schisandrae Chinensis, Radix Salviae Miltiorrhizae are carried out percolation according to the percolation under Chinese Pharmacopoeia 2005 editions appendix IO fluid extract and the extractum item with 85% alcohol dipping after 24 hours that percolation extracts, collect percolate to colourless, merge percolate, filter, medicinal residues are standby, decompression filtrate recycling ethanol, measuring relative density when being evaporated to 20 ℃ is 1.15-1.12, gets fat-soluble effective part extract; Dipping be just Radix Ginseng, Fructus Schisandrae Chinensis, Radix Salviae Miltiorrhizae according to the infusion process under 2005 editions appendix IN of Chinese Pharmacopoeia tincture item with 85% alcohol dipping 3-5 day, take out supernatant, adding 85% ethanol again floods to effective site in accordance with the law and fully leaches, merge impregnation liquid, filter, medicinal residues are standby, decompression filtrate recycling ethanol, measuring relative density when being evaporated to 20 ℃ is 1.15-1.12, gets fat-soluble effective part extract.
The present invention can also realize like this, by weight percentage, get Radix Ginseng 15%, Radix Ophiopogonis 15%, Fructus Schisandrae Chinensis 10%, the Radix Astragali 15%, Radix Salviae Miltiorrhizae 20%, Rhizoma Chuanxiong 10%, Fructus Crataegi 15%, pulverize, Radix Ginseng, Fructus Schisandrae Chinensis, Radix Salviae Miltiorrhizae, Rhizoma Chuanxiong place the extraction kettle cycling extraction of co_2 supercritical fluid extraction machine respectively, collect extract, standby; Medicinal residues and residue Radix Ophiopogonis, the Radix Astragali, Fructus Crataegi decoct with water, and merge decoction liquor, filter, and filtrate is filtered with the ultrafiltration apparatus that can cut 50,000-1000 molecular weight ultrafilter membranes is housed, and liquid on the film is separated with liquid under the film, and liquid discards on the film, and liquid is standby under the film; Liquid filters with the nanofiltration device that the NF membrane that can cut the 100-300 molecular weight is housed under the film, and liquid on the film is separated with liquid under the film, and liquid discards under the film, and liquid on the collection membrane gets water solubility extract; Said extracted thing and water solubility extract are merged, standby; Get above-mentioned effective part extract, be prepared as follows:
(1) preparation of injection: get above-mentioned effective part extract and add injection and be diluted with water to 80% of prescribed volume, stir, adding the dextran that polyethylene glycol 6000 that above-mentioned effective part extract 0.01-0.1 doubly measures and above-mentioned effective part extract 0.05-0.15 doubly measure fully dissolves, the injection active carbon of adding 0.1%, be heated to 80 ℃ and be incubated 10 minutes, filter carbon removal, add the injection water to nearly full dose, it is 7.5 that sodium hydroxide solution with 10% is regulated pH value, with the microporous filter membrane fine straining of 0.45 μ m, and carry out aseptic filtration, the filtrate embedding with the microporous filter membrane of 0.22 μ m, sterilization, promptly;
(2) preparation of freeze-dried powder: get above-mentioned effective part extract and add injection and be diluted with water to 80% of prescribed volume, stir, the mannitol that polyethylene glycol 6000 that adding effective part extract 0.01-0.1 doubly measures and above-mentioned effective part extract 0.3-0.9 doubly measure fully dissolves, the injection active carbon of adding 0.1%, be heated to 80 ℃ and be incubated 10 minutes, filter carbon removal, add the injection water to nearly full dose, it is 7.5 that sodium hydroxide solution with 10% is regulated pH value, microporous filter membrane fine straining with 0.45 μ m, and carry out aseptic filtration with the microporous filter membrane of 0.22 μ m, the filtrate fill in the cillin bottle of 20ml, every bottled 10ml; Place freeze drying box evacuation after-50 ℃ of pre-freeze 3-5 hours then; Condensation temperature remains unchanged, and after 24 hours, unpacks, and makes dried frozen aquatic products, gland, and labeling, promptly;
(3) preparation of sterilized powder: get above-mentioned effective part extract and add injection and be diluted with water to 80% of prescribed volume, stir, adding the lactose that polyethylene glycol 6000 that above-mentioned effective part extract 0.03-0.09 doubly measures and above-mentioned effective part extract 0.06-0.15 doubly measure fully dissolves, the injection active carbon of adding 0.1%, be heated to 80 ℃ and be incubated 10 minutes, filter carbon removal, add the injection water to nearly full dose, it is 7.5 that sodium hydroxide solution with 10%% is regulated pH value, microporous filter membrane fine straining with 0.45 μ m, and carry out aseptic filtration with the microporous filter membrane of 0.22 μ m, filtrate is sprayed with the spray drying tower under the aseptic condition, makes sterilized powder, packing, labeling, promptly;
(1) preparation of concentrated solution for injection: get above-mentioned effective part extract and add injection and be diluted with water to 80% of prescribed volume, stir, add dextran that polyethylene glycol 6000 that above-mentioned effective part extract 0.1-0.3 doubly measures and above-mentioned effective part extract 0.12-0.36 doubly measure and the glucose of above-mentioned effective part extract 0.02-0.08, fully dissolving, the injection active carbon of adding 0.1%, be heated to 80 ℃ and be incubated 10 minutes, filter carbon removal, add the injection water to nearly full dose, it is 7.5 that sodium hydroxide solution with 10% is regulated pH value, microporous filter membrane fine straining with 0.45 μ m, and carry out aseptic filtration with the microporous filter membrane of 0.22 μ m, filtrate decompression is concentrated in right amount, embedding, sterilization, promptly.
It is through extracting respectively that Radix Ginseng, Radix Salviae Miltiorrhizae, Fructus Schisandrae Chinensis and Rhizoma Chuanxiong adopt co_2 supercritical fluid extraction, and the extracting pressure of Radix Ginseng is that 25Mpa, extraction temperature are that 55 ℃, extraction time are 6 hours; Radix Salviae Miltiorrhizae is answered extracting twice, and for the first time the extracting pressure of using is that 20Mpa, extraction temperature are that 40 ℃, extraction time are 4 hours; For the second time the extracting pressure of using is that 35Mpa, extraction temperature are that 65 ℃, extraction time are 8 hours; The extracting pressure of Fructus Schisandrae Chinensis is that 25.3Mpa, extraction temperature are that 60 ℃, extraction time are 6 hours; Rhizoma Chuanxiong is answered extracting twice, and for the first time the extracting pressure of using is that 25.3Mpa, extraction temperature are 60 ℃, 5 hours extraction time, the extracting pressure used for the second time is that 30Mpa, extraction temperature are that 65 ℃, extraction time are 6 hours.
The present invention has Yiqi and vein recovery, blood circulation promoting and blood stasis dispelling, and the effect of YIN nourishing and the production of body fluid promoting is used for deficiency of both QI and YIN, and the cardiopalmus irregularly intermittent and regularly intermittent pulse does not uncomfortable in chestly relax, chest pain and angina pectoris are seen the person that has the above-mentioned symptom.In the effective ingredient of all flavor medicinal material extract of prescription of the present invention, be rich in ginsenoside, salvianolic acid B, Tanshinone I I
A, bioactie agent such as schizandrin, ligustrazine, Fructus Crataegi flavone, astragaloside, for cardiovascular disease reasonable therapeutic effect is arranged; The invention solves preparation during injection in the medicine fat-soluble effective site, water solublity effective site be difficult to mutual miscible problem with solvent, solved that single use effective part extract influences the problem that lyophilizing is shaped in the freeze-drying process, the problem of sticking wall, caking, moisture absorption when also having solved spray drying, fat-soluble effective site or the dissolubility of water solublity effective site in solvent extracted in the medical material have been improved, improved bioavailability of medicament, make curative effect faster, the effect stronger.
In fact core of the present invention is that fat-soluble effective site, the water solublity effective site that will have curative effect extract, and adopts the carbon dioxide supercritical fluid extraction technology in the extraction process, at first extracts the Tanshinone I I of definite ingredients
A, ginsenoside, ligustrazine, schizandrin etc.; The preparation injection adopts composite auxiliary material, makes that effective part extract is dissolved in the solvent fully in the Chinese crude drug, selects the composite auxiliary material ratio of optimization for use, makes injection by dissolving or lyophilization or spray drying.In the preparation of the injection of routine, be to be dissolved into solution mutually with solvent by solid or liquid medicine, filter or fine straining through suitable filter, divide to be filled in the container, or lyophilization, or branch is filled in the container and makes after the spray drying.We find: the present invention adopts prior preparation method, and fat-soluble effective part extract, water solublity effective part extract are dissolved in a kind of solvent simultaneously fully, can not make the solution clarification, influences its absorption thereby generation is muddy.As everyone knows, medicine could absorb after will dissolving in vivo, and therefore, medicine of the present invention has added composite auxiliary material in water for injection, and the polyethylene glycol 6000 in the composite auxiliary material can dissolve fat-soluble effective site rapidly.Two kinds of effective sites of different nature can be dissolved in a kind of solvent, and when preparation effectively molding during lyophilized powder, spray drying, flour extraction height, powder shape be good, be difficult for the moisture absorption becomes key of the present invention.Fat-soluble effective part extract that extracts among the present invention and water solublity effective part extract, solvent with routine is a water for injection, though can be dissolved in the water solublity effective part extract in the water for injection fully, but, fat-soluble effective part extract then can not be dissolved in the water for injection fully, thereby has influenced injection forming quality and curative effect of medication in the preparation; If use conventional water-insoluble solvent as solvent, equally, though fat-soluble effective part extract can be dissolved in this solvent fully,, the water solublity effective part extract can not be dissolved in this solvent fully, has also influenced the quality and the curative effect of injection; Select by experiment, we find that composite auxiliary material that the present invention uses can make water solublity effective part extract and fat-soluble effective part extract be increased in dissolubility in the water for injection, two kinds of effective part extracts that dissolubility is different, have the polarity and the dielectric constant that differ bigger, use composite auxiliary material, can be adjusted to polarity and the dielectric constant close mutually, thereby increase the dissolubility of medicine with medicine, play the effect that improves dissolubility, reach abundant dissolved purpose.The invention solves this problem, in preparation injection process, add composite auxiliary material, the dissolubility of the fat-soluble effective part extract of indissoluble is strengthened, thereby make the medicine accelerate dissolution, absorption increases, and bioavailability improves.Simultaneously, add composite auxiliary material, also can make lyophilized powder forming, spray drying powder not have the phenomenon of sticking wall, caking, moisture absorption.
Below be that the present invention and conventional method prepare injection and use water for injection and add effect that composite auxiliary material uses relatively:
Table 1 effect relatively
| Common law | The present invention | |||||
| Preparation | Dissolubility | Clarity | Mouldability | Dissolubility | Clarity | Mouldability |
| Injection lyophilized powder spray powder concentrated solution | Poor dissolution poor dissolution poor dissolution poor dissolution | There is muddiness to have muddiness to have muddiness that muddiness is arranged | --the sticking wall caking of not molding-- | Dissolving dissolving is fully dissolved dissolving fully fully fully | Clarification clarification clarification clarification | --the not sticking wall of forming is powdery-- |
As can be seen, use composite auxiliary material of the present invention can improve the dissolubility of its effective site from above table, the injection dissolubility of preparation is good, the lyophilized powder good moldability, and the spray drying powder powder does not evenly have adhesion.
The conventional method of mentioning in the preparation method that provides, prior art, prior art etc. are meant the method that the professional and technical personnel in disclosed technology, this field can consult, implement.
Compared with prior art, pharmaceutical preparation provided by the invention extracts the fat-soluble effective site in the medical material, water solublity effective site, is prepared into injection, makes the dosage form optimization, and effect is rapider.Adopt composite auxiliary material, be dissolved in the extract of fat-soluble effective site, water solublity effective site in the water for injection fully, adopting filtering technique, solution is filtered or fine straining, effective part extract is the molecularity high degree of dispersion in solution in water for injection, can discharge medicine rapidly, and medicine directly absorbs, thereby make the effect of medicine faster, stronger, improved bioavailability; Changed existing capsule because of the full medicinal powder of the ginseng crude drug low shortcoming of bioavailability of being used as medicine, increased the extraction of composition such as ligustrazine in salvianolic acid, the Rhizoma Chuanxiong in the Radix Salviae Miltiorrhizae, made drug effect stronger, solved with conventional method prepare that the lyophilized powder molding is bad, phenomenons such as sticking wall, caking, moisture absorption during spray drying, and the absorption that the liposoluble constituent dissolving not exclusively causes is slow, the problem of weak curative effect, has given full play to the pharmacological action of this prescription.Ejection preparation provided by the invention can arrive coronary artery rapidly after the administration, and blood vessel elasticity is increased, the embolus of alluvial in the mediation cleaning blood vessel, angina pectoris, myocardial infarction that control in time causes because of myocardial ischemia, anoxia.
Be the contrast situation of two kinds of dosage forms below, from comparing result: product provided by the invention more rationally, advantage is obvious.
Table 2 capsule and injection performance of the present invention are relatively
| Dosage form | Character | Use amount | Action time and bioavailability |
| Capsule | The adjuvant amount is few, and the crude drug amount is big, and it is few that unit volume contains the medicine effective ingredient, only contains fat soluble ingredient of red sage root. | The single use amount is big, take often, effect reduces, and is easy to use; | Disintegrate is slow, in the time of 30 minutes in.The difficult absorption, onset is slow. |
| Injection | The adjuvant amount is few, and it is many that unit volume contains the medicine effective ingredient, is rich in ginsenoside, salvianolic acid, ligustrazine. | The single use amount is little, and access times are few, strong drug action. | Easily dissolving easily absorbs, and is rapid-action. |
In order to confirm safety of the present invention and effectiveness, the inventor has carried out the toxicity test and the pharmacological action of this prescription related preparations and has compared, prove this security of products, effectiveness, adopt YIXINSHU injection (lyophilized powder is an example) and YIXINSHU JIAONANG to carry out the main pharmacodynamics experiment contrast, the part pharmacological action of the freeze dried powder for preparing from many aspects research the present invention.
YIXINSHU lyophilized powder toxicity test
1. acute toxicity test
Kunming mouse, 19-22g, ♀ ♂ half and half, each 10 of every group of ♀ ♂ mices, fasting is 6 hours before the experiment, can't help water, and vein is administration (iv), 1 hour feeding after the administration.
The I group: iv10% solution 0.4ml/10g, observed 14 days.
The result: animal non-evident sympton after the administration, i.e. feed in 1 hour after the administration, viewing duration does not have death, weight increase 4-6g.
The II group: iv15% solution 0.4ml/10g, observed 14 days.
The result: animal activity is slightly many after the administration, i.e. feed in 1 hour behind the medicine, and viewing duration does not have 1 death, weight increase 4-6g.
The III group: iv20% solution 0.4ml/10g, observed 14 days.
The result: the movable increase of mice after the administration, the splinting phenomenon appears in mice after 4-5 minute, and is few moving or motionless, reactivated and took food in 24 hours, but activity is still few, is tired shape, recovers the preceding situation of administration in 48 hours, and viewing duration does not have 1 death, weight increase 3-5g.
So: YIXINSHU lyophilized powder ♀ ♂ mice maximum tolerated dose all＞8g/kg
2. long term toxicity test
2.1 method
60 of Wistar rats, body weight 140-160g is divided into 3 groups at random, and 20 every group, ♀ ♂ half and half.The YIXINSHU lyophilized powder is dissolved into the solution of 0.4g/ml with water for injection, and the matched group medicament mixed is taken food in feedstuff.Dosage, medicine I organizes iv4ml/kgd, and medicine II organizes 2ml/kgd, and matched group is fed normal diet, totally 32 days.Each group half animal was got tail blood in the 33rd day and have a blood test and resemble, get carotid artery blood and look into biochemical indicator.Dissect animal, to the heart, liver, spleen, lung, kidney, stomach, intestinal, testis, uterus, ovary, etc. organ make gross examination of skeletal muscle.The pathology microscopy is made in the heart, liver, spleen, lung, kidney, testis, the uterus of the I that gets it filled then group and control animals.Second half animal of two weeks back execution is checked above index.
2.2 result
2.2.1 between general situation administration of animal and withdrawal time, each organizes all no abnormal performance of rat, hair is smooth, and behavior is active, and diet is as usual.
2.2.2 experimental session, each treated animal body weight sustainable growth, there was no significant difference between group.(seeing Table 3)
2.2.3 hemogram the results are shown in table 4, each organizes rat hemogram index all in normal range, there was no significant difference between group.
2.2.4 biochemical indicator the results are shown in table 5, each organizes all indexs of rat all in normal range, there was no significant difference between group.
2.2.5 organ coefficient the results are shown in table 6, each organizes there was no significant difference between the Rats Organs and Tissues coefficient sets.
2.2.6 the pathologic finding gross examination of skeletal muscle, each group all has minority animal lungs that local stasis of blood phenomenon is arranged, and other organs do not have obvious pathological changes.The pathological section microscopy, each is organized the Mus organ and is not all found obvious pathological changes, does not see the pathological change relevant with medicine.
2.3 conclusion: YIXINSHU lyophilized powder administration test in 32 days, organize rat growthing development, hemogram, biochemical indicator for two, organ coefficient, an index such as pathologic finding compares with matched group, equal no significant difference, performance YIXINSHU lyophilized powder does not have the overt toxicity effect to rat.In 2 weeks of drug withdrawal, also do not see the untoward reaction of tardy property.
Table 3 YIXINSHU is frozen in the powder long term toxicity test---and body weight (g) growth pattern (n=10, n=5 after 46 days, X ± s)
| Group | ♂ | |||||
| Before the medicine | Behind the medicine 8 | 16 | 24 | 32 | 46 (my god) | |
| I II contrast | 150.0±8.4 150.6±8.7 150.2±7.5 | 175.9±12.6 181.8±14.9 176.9±18.4 | 219.3±10.5 218.3±25.5 208.1±18.4 | 259.9±19.4 249.0±37.3 231.0±29.3 | 278.5±10.0 272.6±27.9 283.1±15.6 | 302.0±22.8 294.4±31.8 306.8±15.0 |
| Group | ♀ | |||||
| Before the medicine | Behind the medicine 8 | 16 | 24 | 32 | 46 (my god) | |
| I II contrast | 148.4±7.0 150.0±6.9 149.4±6.7 | 173.5±9.3 175.9±12.3 171.8±7.9 | 205.1±22.9 213.6±21.7 194.8±8.5 | 227.3±21.9 238.5±22.8 212.8±12.2 | 255.3±17.2 260.7±24.0 241.8±13.6 | 283.6±18.8 279.2±23.1 284.0±15.5 |
Table 4 YIXINSHU lyophilized powder long term toxicity test---hemogram measurement result (n=10, X ± s)
| Group | Hemoglobin (g/L) | Erythrocyte (* 1012/L) | Platelet (* 109/L) | Leukocyte (* 109/L) | |
| Administration 32 days | I II contrast | 143.87±8.23 144.18±7.54 144.87±8.78 | 5.86±0.32 5.60±0.38 5.53±0.35 | 539.7±14.49 549.4±22.70 541.5±11.75 | 14.80±0.78 13.90±1.16 13.90±0.90 |
| Drug withdrawal 14 days | I II contrast | 146.35±10.23 145.24±10.39 147.27±10.12 | 5.71±0.34 5.91±0.27 5.61±0.38 | 559.1±22.42 559.8±24.43 559.4±26.58 | 13.41±2.04 12.52±1.56 12.97±1.50 |
Table 5 YIXINSHU lyophilized powder long term toxicity test---blood parameters measurement result (n=10, X ± s)
| Group | Blood urea nitrogen (Moml/L) | Creatinine (μ mol/L) | Alanine aminotransferase | Total protein (g/L) | Albumin (g/L) | Globulin (g/L) | |
| Administration 32 days | I II contrast | 7.65±0.68 7.13±0.42 6.93±0.62 | 73.02±25.02 75.57±12.33 71.58±15.80 | 33.11±14.23 37.90±4.59 39.80±11.15 | 75.50±3.84 73.70±4.37 74.10±8.37 | 36.4±2.84 36.1±3.84 37.2±2.49 | 39.1±4.09 37.6±3.24 38.8±3.01 |
| Drug withdrawal 14 days | I II contrast | 6.89±0.50 6.58±0.53 5.99±0.56 | 64.53±10.27 65.42±11.20 63.64±10.09 | 47.80±9.78 49.85±3.52 50.15±8.64 | 76.00±3.53 74.20±3.52 76.10±2.77 | 37.1±2.85 36.4±2.41 37.5±2.72 | 37.0±3.76 37.8±3.36 38.6±2.91 |
Table 6 YIXINSHU lyophilized powder long term toxicity test-Nei organ coefficient (internal organs (g)/body weight 100g, n=10, testis, uterus n=5)
| Group | The heart | Liver | Spleen | Lung | Kidney | Testis | The uterus | |
| Administration 32 days | I II contrast | 0.36±0.04 0.39±0.04 0.38±0.01 | 4.88±0.44 5.15±0.72 5.00±0.52 | 0.54±0.18 0.68±0.21 0.66±0.22 | 0.80±0.16 0.83±0.21 0.81±0.14 | 0.84±0.09 0.86±0.11 0.86±0.11 | 0.97±0.08 1.01±0.11 1.03±0.10 | 0.15±0.05 0.35±0.16 0.26±0.06 |
| Drug withdrawal 14 days | I II contrast | 0.35±0.05 0.37±0.08 0.39±0.05 | 4.77±1.05 4.65±0.84 4.73±0.42 | 0.50±0.17 0.52±0.13 0.68±0.24 | 0.72±0.13 0.71±0.13 0.84±0.25 | 0.76±0.13 0.75±0.12 0.79±0.07 | 1.01±0.11 1.01±0.11 1.05±0.59 | 0.18±0.08 0.18±0.05 0.23±0.07 |
YIXINSHU lyophilized powder Pharmacodynamic test of active extract
1. experiment material
1.1 medicine: the YIXINSHU lyophilized powder, face the solution that the time spent is mixed with 0.4g/ml, provide by Guizhou Xinbang Pharmacy Stock Co., Ltd; FUFANG DANSHEN PIAN, sodium salicylate, the isoproterenol injection, collagen protein-epinephrine mixing derivant: make homogenate with rat depilation skin routinely, centrifugal, spend precipitation centrifugal liquid and epinephrine by 225: 9 mixed, face with now joining.Decoction for removing blood stasis water decoction-alcohol sedimentation liquid is hereinafter to be referred as " decoction for removing blood stasis " (Semen Persicae 12g, Flos Carthami 10g, Fructus Aurantii 6g, Radix Paeoniae Rubra 6g, Radix Bupleuri 3g, Radix Platycodonis 5g, Rhizoma Chuanxiong 5g, Radix Achyranthis Bidentatae 10g, Radix Glycyrrhizae 3g fries in shallow oil into 45ml altogether, every ml is equivalent to primary crude drug 2g for Radix Angelicae Sinensis 10g, Radix Rehmanniae 10g)
1.2 animal: Kunming mouse, wistar rat, Cavia porcellus are provided by the Guiyang Medical College Experimental Animal Center.
2. method and result
2.1 Dichlorodiphenyl Acetate causes the influence of mouse writhing reaction
Get body weight 18-20g, 40 of female, male half and half mices are divided into 4 groups at random, and (other matched group is the ig administration, and is as follows by table 7 intravenously administrable every day.), continuous 5 days.After the last administration 30 minutes, lumbar injection 0.6% acetic acid 0.2ml/ only observed every mice and turned round the body number of times in 15 minutes.The results are shown in Table 7, visible YIXINSHU lyophilized powder high and low dose group and normal saline group relatively have significant difference (P＜0.05), show that this medicine Dichlorodiphenyl Acetate induced mice writhing response has obvious inhibitory action.
Table 7 YIXINSHU lyophilized powder Dichlorodiphenyl Acetate causes the influence of mouse writhing reaction
| Group | N | Dosage (g/kg) | Turn round body number of times (X+SD) | The P value |
| YIXINSHU group normal saline group sodium salicylate group | 10 10 10 10 | 4 1 0.5 | 17.18±7.02 18.18±7.03 27.64±9.27 17.45±6.40 | ＜0.05 ＜0.05 ＜0.05 |
2.2 influence to mice pain threshold in the hot plate method
Get body weight 18-20g female mice and before experiment, on 55 ± 0.5 ℃ hot plate, survey every Mus threshold of pain, screen.Get 40 mices that screening is qualified, be divided into 4 groups at random, repeat to survey its normal pain threshold.Get two subnormal threshold of pain meansigma methodss as this Mus administration before pain threshold.Press table 8 intravenously administrable, each group all, places mice on 55 ± 0.5 ℃ of hot plates after 1 hour in administration, and the record mice surpasses 60 seconds persons and calculated by 60 seconds from putting into the time of licking metapedes.The results are shown in Table 8, difference that as seen there are no significant between each preceding threshold of pain of treated animal administration, after the administration, high dose group can significantly improve the mice pain threshold, and relatively there were significant differences (P＜0.05) with the normal saline group.
Table 8 YIXINSHU lyophilized powder is to the influence of mice pain threshold in the hot plate method
| Group | N | Dosage (g/kg) | The preceding threshold of pain of administration (S) (X ± SD) | The threshold of pain after the administration (S) (X ± SD) | The P value |
| YIXINSHU group normal saline group sodium salicylate group | 10 10 10 10 | 4 1 0.5 | 18.91±6.39 18.82±6.48 17.36±5.79 17.73±5.80 | 27.55±9.61 24.55±8.94 18.27±6.27 27.27±9.37 | ＜0.05 ＞0.05 ＜0.05 |
2.3 collagen protein-epinephrine is brought out the influence that the mice thrombus in vivo forms
Get 40 of 25-30g male mices, be divided into 4 groups at random, press table 9 intravenously administrable every day, a continuous week.After the last administration 30 minutes; the derivant that mixes of tail vein injection collagen protein (225 μ g/ only) and epinephrine (9 μ g/); promptly observe dead mouse number in 5 minutes after the injection and the not recovery number of mice hemiplegia in 15 minutes, calculate the protective rate of this medicine, and carry out X the mouse brain thrombosis
2Assay sees Table 9, and as seen this medicine has significant protective effect to collagen protein-epinephrine inducing mouse thrombus in vivo.
Table 9 YIXINSHU lyophilized powder brings out the influence that the mice thrombus in vivo forms to collagen protein-epinephrine
| Group | N | Dosage (g/kg) | Death toll in 5 minutes (only) | Recover number (only) in 15 minutes | Recovery rate (%) | The P value |
| YIXINSHU group normal saline group sodium salicylate group | 10 10 10 10 | 4 1 0.5 | 3 3 6 2 | 4 3 0 5 | 57.14 42.86 0 62.5 | ＜0.05 ＜0.05 |
2.4 the YIXINSHU lyophilized powder is to the influence of the dirty perfusion of guinea-pig heart
After every guinea pig heart is fixed on the perfusion device, presses table 10 and appointed Rockwell liquid perfusion 10-15 minute with what water recently distilled was prepared, record coronary flow and heart rate the results are shown in Table 10, and as seen this medicine high and low dose group all can make coronary flow increase; Increment rate is respectively 26.3,23.05, all before administration (P＜0.05); Heart rate slows down to some extent, but with administration before relatively, there was no significant difference (P＞0.05).
Table 10 YIXINSHU lyophilized powder is to the influence of the dirty perfusion of guinea-pig heart: (X ± SD; N=10)
| Group | Dosage | Coronary flow (ml/min) | Heart rate (inferior/min) | ||
| Flow | Gradient | Heart rate | Gradient | ||
| The YIXINSHU group | 3ml(3％) | Preceding 8.94 ± 3.21 backs 11.47 ± 3.67 | +28.30 | 104.82±34.00 96.73±31.15 | -8.09 |
| 1ml(3％) | Preceding 9.11 ± 3.36 backs 11.21 ± 3.86 | +23.05 | 104.82±34.14 98.45±32.00 | -6.37 | |
| The FUFANG DANSHEN PIAN group | 2ml(3％) | Preceding 8.44 ± 3.15 backs 11.41 ± 3.67 | +35.19 | 105.36±34.01 97.73±31.51 | -7.63 |
| The isoproterenol group | 1.25μg | Preceding 8.41 ± 3.34 backs 11.62 ± 3.97 | +38.17 | 102.64±33.26 126.27±40.54 | +23.63 |
2.5 the YIXINSHU lyophilized powder is to the influence of normobaric hypoxia mice life span
Get body weight 18-20g male and female half and half mice, be divided into 5 groups at random, press table 11 intravenously administrable every day, continuous 10 days, after the last administration 30 minutes, put into dress 7.5g sodica calx wide mouthed bottle (volume 250ml), the vaseline sealing, the mice time-to-live respectively organized in record, the results are shown in Table 11, as seen this medicine height, middle dosage group energy significant prolongation normobaric hypoxia mice time-to-live, significant difference (P＜0.05) is relatively arranged, show that this medicine can obviously prolong the tolerance time of cardiac muscle and cerebral anoxia with the normal saline group.
Table 11 YIXINSHU lyophilized powder is to the influence of normobaric hypoxia mice life span:
| Group | N | Dosage (g/kg) | Time-to-live (min) (X ± SD) | The P value |
| YIXINSHU group normal saline group propranolol group | 10 10 10 10 10 | 4 1.5 0.5 0.2 | 20.00±6.94 19.64±6.67 17.18±6.06 13.73±4.83 21.73±7.24 | ＜0.05 ＜0.05 ＞0.05 ＜0.05 |
2.6 the YIXINSHU lyophilized powder is to the influence of rat due to the pituitrin at the body acute myocardial ischemia
Get body weight 160-180g, 40 of male and female half and half rats are divided into 4 groups at random, under waking state, use the precordial leads recording ecg.After pressing table 12 intravenously administrable 1h, iv pituitrin injection 0.5u/kg, about 15s injection finishes, trace the Electrocardiographic variation of administration front and back 3min, one of following indication person occurs, be the myocardial ischemia positive: T ripple low flat (reducing former T wave height more than 50%), two-way inversion, the ST level moves down 0.5mv, arrhythmia.Respectively organize the difference of positive rate, the results are shown in Table 12, visible YIXINSHU lyophilized powder has tangible antagonism to Acute Myocardial Ischemia in Rats due to the pituitrin.
Table 12 YIXINSHU lyophilized powder causes the influence (n=10) of rat heart muscle ischemia to pituitrin
| Group | Dosage (g/kg) | The myocardial ischemia situation | The P value | |
| Positive rate (%) | Negative rate (%) | |||
| YIXINSHU group normal saline group FUFANG DANSHEN PIAN group | 3 1 2 | 40 50 90 40 | 60 50 10 60 | ＜0.05 * ＞0.05 ＜0.05 |
2.7 the YIXINSHU lyophilized powder influences microcirculation of mouse auricle
Get 20 of 18-22g mices, the male and female dual-purpose is divided into 4 groups at random, every group 5, im20% urethane 0.07ml/10g anesthesia is drawn the auricle hair gently with medical rubber cream, the mice observation platform is fixed in the position of bowing, and makes Mice Auricle lie in the ear holder, drips 1 drop of liquid paraffin on auricle, with 50-100 times of sem observation Mice Auricle microcirculation, then by table 13iv administration, the microcirculation when observing 15min after the administration is with t check between difference work group before and after the administration, compare with the normal saline group, the results are shown in Table 13.As seen YIXINSHU lyophilized powder high and low dose group has tangible dilating effect to the Mice Auricle blood capillary, the open quantity showed increased of auricle blood capillary, blood flow is a linear flow by the rheology of line grain, and blood flow rate is obviously accelerated, the microcirculatory effect that has clear improvement of visible YIXINSHU lyophilized powder.
3. conclude the speech
Experiment shows; the YIXINSHU lyophilized powder can obviously suppress acetic acid induced mice writhing response; improve mice pain threshold in the hot plate method; collagen protein-epinephrine is brought out the mice thrombus in vivo significant protective effect is arranged; the dirty coronary flow of guinea-pig heart is increased; the rat heart muscle ischemia that obvious antagonism pituitrin causes; obviously prolong the tolerance time of mouse cardiac muscle and cerebral anoxia; and has the obvious microcirculation of mouse auricle effect that improves; these all point out it to have blood circulation promoting and blood stasis dispelling; functions such as pain relieving, this just is used for uncomfortable in chest easypro for this medicine is clinical; diseases such as chest pain provide certain pharmacology's foundation.
Table 13 YIXINSHU lyophilized powder is to microcirculation of mouse auricle influence (X ± SD)
| Group | Dosage (g/kg) | A bore (μ m) | V bore (μ m) | Blood capillary opening amount (μ m) | ||||||
| Before the administration | After the administration | Difference | Before the administration | After the administration | Difference | Before the administration | After the administration | Difference | ||
| YIXINSHU group normal saline group decoction for removing blood stasis | 1 0.25 | 9.6±2.07 8.0±1.58 8.8±1.04 9.4±1.95 | 14.0±2.00 11.2±0.84 9.0±1.22 12.2±1.64 | 4.4±1.14 ※※ 3.2±1.30 ※ 0.6±0.55 2.8±0.84 ※※ | 18.0±3.08 17.0±1.58 18.0±1.58 18.6±3.13 | 25.4±2.07 22.4±1.14 18.2±1.79 23.2±2.77 | 7.4±1.67 ※※ 5.4±1.82 ※※ 0.6±0.89 4.6±1.34 ※※ | 3.8±1.48 3.6±1.14 3.6±0.89 3.8±0.84 | 6.8±1.30 5.8±1.30 3.8±0.84 5.8±0.84 | 3.0±1.00 2.2±0.84 ※ 0.2±0.45 2.0±0.71 ※※ |
※P＜0.05
※※P＜0.01
The specific embodiment
Embodiments of the invention one,
1. get Radix Ginseng 150g, Radix Ophiopogonis 150g, Fructus Schisandrae Chinensis 100g, Radix Astragali 150g, Radix Salviae Miltiorrhizae 200g, Rhizoma Chuanxiong 100g, Fructus Crataegi 150g, pulverize, Radix Ginseng, Fructus Schisandrae Chinensis, twice of alcohol reflux of Radix Salviae Miltiorrhizae, 3 hours for the first time, 1.5 hours for the second time, medicinal residues were standby, filtrate merges, measuring relative density when being evaporated to 20 ℃ is 1.15-1.12, gets pure dissolubility effective part extract, standby;
2. medicinal residues and Radix Ophiopogonis, the Radix Astragali, Rhizoma Chuanxiong, Fructus Crataegi decoct with water 2 times, 2.5 hours for the first time, 1.5 hours for the second time, collecting decoction filters, and filtrate is concentrated into about 500ml, 85% ethanol that adds equivalent, after fully stirring, standing over night, elimination precipitate, filtrate recycling ethanol and to measure relative density when being concentrated into 80 ℃ be 1.30-1.36, the water solublity effective part extract.
3. after above-mentioned two kinds of extracts being merged, standby;
4. get above-mentioned effective part extract add the injection be diluted with water to regulation volume 80%, stir, adding the polyethylene glycol 6000 of 0.05 times of amount of above-mentioned effective part extract and the dextran of 0.1 times of amount of above-mentioned effective part extract fully dissolves, the injection active carbon of adding 0.1%, be heated to 80 ℃ and kept 10 minutes, filter carbon removal, add the injection water to nearly full dose, it is 7.5 that sodium hydroxide solution with 10% is regulated pH value, with the microporous filter membrane fine straining of 0.45 μ m, and carry out aseptic filtration, the filtrate embedding with the microporous filter membrane of 0.22 μ m, sterilization, promptly.
Embodiments of the invention two,
1. get Radix Ginseng 150g, Radix Ophiopogonis 150g, Fructus Schisandrae Chinensis 100g, Radix Astragali 150g, Radix Salviae Miltiorrhizae 200g, Rhizoma Chuanxiong 100g, Fructus Crataegi 150g and be ground into fine powder, Radix Ginseng, Fructus Schisandrae Chinensis, Radix Salviae Miltiorrhizae carry out percolation according to the percolation under Chinese Pharmacopoeia 2005 editions appendix IO fluid extract and the extractum item with 85% alcohol dipping after 24 hours, collect percolate to colourless, merge percolate, filter, medicinal residues are standby, decompression filtrate recycling ethanol, measuring relative density when being evaporated to 20 ℃ is 1.15-1.12, get pure dissolubility effective part extract, standby;
2. medicinal residues and Radix Ophiopogonis, the Radix Astragali, Rhizoma Chuanxiong, Fructus Crataegi decoct with water 2 times, 2.5 hours for the first time, 1.5 hours for the second time, collecting decoction filters, and filtrate is concentrated into about 500ml, 85% ethanol that adds equivalent, after fully stirring, standing over night, elimination precipitate, filtrate recycling ethanol and to measure relative density when being concentrated into 80 ℃ be 1.30-1.36, the water solublity effective part extract.
3. after above-mentioned two kinds of extracts being merged, standby;
4. getting above-mentioned effective part extract adds injection and is diluted with water to 80% of prescribed volume, stir, adding the polyethylene glycol 6000 of 0.1 times of amount of above-mentioned effective part extract and the dextran of 0.15 times of amount of above-mentioned effective part extract fully dissolves, the injection active carbon of adding 0.1%, be heated to 80 ℃ and be incubated 10 minutes, filter carbon removal, add the injection water to nearly full dose, it is 7.5 that sodium hydroxide solution with 10% is regulated pH value, with the microporous filter membrane fine straining of 0.45 μ m, and carry out aseptic filtration, the filtrate embedding with the microporous filter membrane of 0.22 μ m, sterilization, promptly.
Embodiments of the invention three,
1. get Radix Ginseng 150g, Radix Ophiopogonis 150g, Fructus Schisandrae Chinensis 100g, Radix Astragali 150g, Radix Salviae Miltiorrhizae 200g, Rhizoma Chuanxiong 100g, Fructus Crataegi 150g and be ground into fine powder, Radix Ginseng, Fructus Schisandrae Chinensis, Radix Salviae Miltiorrhizae according to the infusion process under 2005 editions appendix IN of Chinese Pharmacopoeia tincture item with 85% alcohol dipping 5 days, take out supernatant, adding 85% ethanol again floods to fill to effective site in accordance with the law and send out to leach, merge impregnation liquid, filter, medicinal residues are standby, decompression filtrate recycling ethanol, measuring relative density when being evaporated to 20 ℃ is 1.15-1.12, get pure dissolubility effective part extract, standby;
2. medicinal residues and Radix Ophiopogonis, the Radix Astragali, Rhizoma Chuanxiong, Fructus Crataegi decoct with water 2 times, 2.5 hours for the first time, 1.5 hours for the second time, collecting decoction filters, and filtrate is concentrated into about 500ml, 85% ethanol that adds equivalent, after fully stirring, standing over night, elimination precipitate, filtrate recycling ethanol and to measure relative density when being concentrated into 80 ℃ be 1.30-1.36, the water solublity effective part extract.
3. after above-mentioned two kinds of extracts being merged, standby;
4. getting above-mentioned effective part extract adds injection and is diluted with water to 80% of prescribed volume, stir, adding the polyethylene glycol 6000 of 0.01 times of amount of above-mentioned effective part extract and the dextran of 0.05 times of amount of above-mentioned effective part extract fully dissolves, the injection active carbon of adding 0.1%, be heated to 80 ℃ and kept 10 minutes, filter carbon removal, add the injection water to nearly full dose, it is 7.5 that sodium hydroxide solution with 10% is regulated pH value, with the microporous filter membrane fine straining of 0.45 μ m, and carry out aseptic filtration, the filtrate embedding with the microporous filter membrane of 0.22 μ m, sterilization, promptly.
Embodiments of the invention four,
1. get Radix Ginseng 150g, Radix Ophiopogonis 150g, Fructus Schisandrae Chinensis 100g, Radix Astragali 150g, Radix Salviae Miltiorrhizae 200g, Rhizoma Chuanxiong 100g, Fructus Crataegi 150g and be ground into fine powder, Radix Ginseng, Fructus Schisandrae Chinensis, Radix Salviae Miltiorrhizae carry out percolation according to the percolation under Chinese Pharmacopoeia 2005 editions appendix IO fluid extract and the extractum item with 85% alcohol dipping after 24 hours, collect percolate to colourless, merge percolate, filter, medicinal residues are standby, decompression filtrate recycling ethanol, measuring relative density when being evaporated to 20 ℃ is 1.15-1.12, get pure dissolubility effective part extract, standby;
2. medicinal residues and Radix Ophiopogonis, the Radix Astragali, Rhizoma Chuanxiong, Fructus Crataegi decoct with water 2 times, 2.5 hours for the first time, 1.5 hours for the second time, collecting decoction filters, and filtrate is concentrated into about 500ml, 85% ethanol that adds equivalent, after fully stirring, standing over night, elimination precipitate, filtrate recycling ethanol and to measure relative density when being concentrated into 80 ℃ be 1.30-1.36, the water solublity effective part extract.
3. after above-mentioned two kinds of extracts being merged, standby;
4. getting above-mentioned effective part extract adds injection and is diluted with water to 80% of prescribed volume, stir, adding the polyethylene glycol 6000 of 0.05 times of amount of effective part extract and the mannitol of 0.3 times of amount of above-mentioned effective part extract fully dissolves, the injection active carbon of adding 0.1%, be heated to 80 ℃ and be incubated 10 minutes, filter carbon removal, add the injection water to nearly full dose, it is 7.5 that sodium hydroxide solution with 10% is regulated pH value, microporous filter membrane fine straining with 0.45 μ m, and carry out aseptic filtration with the microporous filter membrane of 0.22 μ m, the filtrate fill in the cillin bottle of 20ml, every bottled 10ml; Place freeze drying box evacuation after-50 ℃ of pre-freeze 3-5 hours then; Condensation temperature remains unchanged, and after 24 hours, unpacks, and makes dried frozen aquatic products, gland, and labeling, promptly;
Embodiments of the invention five,
1. get Radix Ginseng 150g, Radix Ophiopogonis 150g, Fructus Schisandrae Chinensis 100g, Radix Astragali 150g, Radix Salviae Miltiorrhizae 200g, Rhizoma Chuanxiong 100g, Fructus Crataegi 150g and be ground into fine powder, Radix Ginseng, Fructus Schisandrae Chinensis, Radix Salviae Miltiorrhizae carry out percolation according to the percolation under Chinese Pharmacopoeia 2005 editions appendix IO fluid extract and the extractum item with 85% alcohol dipping after 24 hours, collect percolate to colourless, merge percolate, filter, medicinal residues are standby, decompression filtrate recycling ethanol, measuring relative density when being evaporated to 20 ℃ is 1.15-1.12, get pure dissolubility effective part extract, standby;
2. medicinal residues and Radix Ophiopogonis, the Radix Astragali, Rhizoma Chuanxiong, Fructus Crataegi decoct with water 2 times, 2.5 hours for the first time, 1.5 hours for the second time, collecting decoction filters, and filtrate is concentrated into about 500ml, 85% ethanol that adds equivalent, after fully stirring, standing over night, elimination precipitate, filtrate recycling ethanol and to measure relative density when being concentrated into 80 ℃ be 1.30-1.36, the water solublity effective part extract.
3. after above-mentioned two kinds of extracts being merged, standby;
4. getting above-mentioned effective part extract adds injection and is diluted with water to 80% of prescribed volume, stir, adding the polyethylene glycol 6000 of 0.1 times of amount of effective part extract and the mannitol of 0.4 times of amount of above-mentioned effective part extract fully dissolves, the injection active carbon of adding 0.1%, be heated to 80 ℃ and be incubated 10 minutes, filter carbon removal, add the injection water to nearly full dose, it is 7.5 that sodium hydroxide solution with 10% is regulated pH value, microporous filter membrane fine straining with 0.45 μ m, and carry out aseptic filtration with the microporous filter membrane of 0.22 μ m, the filtrate fill in the cillin bottle of 20ml, every bottled 10ml; Place freeze drying box evacuation after-50 ℃ of pre-freeze 3-5 hours then; Condensation temperature remains unchanged, and after 24 hours, unpacks, and makes dried frozen aquatic products, gland, and labeling, promptly;
Embodiments of the invention six,
1. get Radix Ginseng 150g, Radix Ophiopogonis 150g, Fructus Schisandrae Chinensis 100g, Radix Astragali 150g, Radix Salviae Miltiorrhizae 200g, Rhizoma Chuanxiong 100g, Fructus Crataegi 150g and be ground into fine powder, Radix Ginseng, Fructus Schisandrae Chinensis, Radix Salviae Miltiorrhizae according to the infusion process under 2005 editions appendix IN of Chinese Pharmacopoeia tincture item with 85% alcohol dipping 5 days, take out supernatant, adding 85% ethanol again floods to effective site in accordance with the law and fully leaches, merge impregnation liquid, filter, medicinal residues are standby, decompression filtrate recycling ethanol, measuring relative density when being evaporated to 20 ℃ is 1.15-1.12, get pure dissolubility effective part extract, standby;
2. medicinal residues and Radix Ophiopogonis, the Radix Astragali, Rhizoma Chuanxiong, Fructus Crataegi decoct with water 2 times, 2.5 hours for the first time, 1.5 hours for the second time, collecting decoction filters, and filtrate is concentrated into about 500ml, 85% ethanol that adds equivalent, after fully stirring, standing over night, elimination precipitate, filtrate recycling ethanol and to measure relative density when being concentrated into 80 ℃ be 1.30-1.36, the water solublity effective part extract.
3. after above-mentioned two kinds of extracts being merged, standby;
4. getting above-mentioned effective part extract adds injection and is diluted with water to 80% of prescribed volume, stir, adding the polyethylene glycol 6000 of 0.01 times of amount of effective part extract and the mannitol of 0.2 times of amount of above-mentioned effective part extract fully dissolves, the injection active carbon of adding 0.1%, be heated to 80 ℃ and be incubated 10 minutes, filter carbon removal, add the injection water to nearly full dose, it is 7.5 that sodium hydroxide solution with 10% is regulated pH value, microporous filter membrane fine straining with 0.45 μ m, and carry out aseptic filtration with the microporous filter membrane of 0.22 μ m, the filtrate fill in the cillin bottle of 20ml, every bottled 10ml; Place freeze drying box evacuation after-50 ℃ of pre-freeze 3-5 hours then; Condensation temperature remains unchanged, and after 24 hours, unpacks, and makes dried frozen aquatic products, gland, and labeling, promptly;
Embodiments of the invention seven,
1. get Radix Ginseng 150g, Radix Ophiopogonis 150g, Fructus Schisandrae Chinensis 100g, Radix Astragali 150g, Radix Salviae Miltiorrhizae 200g, Rhizoma Chuanxiong 100g, Fructus Crataegi 150g and be ground into fine powder, Radix Ginseng, Fructus Schisandrae Chinensis, Radix Salviae Miltiorrhizae carry out percolation according to the percolation under Chinese Pharmacopoeia 2005 editions appendix IO fluid extract and the extractum item with 85% alcohol dipping after 24 hours, collect percolate to colourless, merge percolate, filter, medicinal residues are standby, decompression filtrate recycling ethanol, measuring relative density when being evaporated to 20 ℃ is 1.15-1.12, get pure dissolubility effective part extract, standby;
2. medicinal residues and Radix Ophiopogonis, the Radix Astragali, Rhizoma Chuanxiong, Fructus Crataegi decoct with water 2 times, 2.5 hours for the first time, 1.5 hours for the second time, collecting decoction filters, and filtrate is concentrated into about 500ml, 85% ethanol that adds equivalent, after fully stirring, standing over night, elimination precipitate, filtrate recycling ethanol and to measure relative density when being concentrated into 80 ℃ be 1.30-1.36, the water solublity effective part extract.
3. after above-mentioned two kinds of extracts being merged, standby;
4. getting above-mentioned effective part extract adds injection and is diluted with water to 80% of prescribed volume, stir, adding the polyethylene glycol 6000 of 0.06 times of amount of above-mentioned effective part extract and the lactose of 0.1 times of amount of above-mentioned effective part extract fully dissolves, the injection active carbon of adding 0.1%, be heated to 80 ℃ and kept 10 minutes, filter carbon removal, add the injection water to nearly full dose, it is 7.5 that the sodium hydroxide solution with 10% is regulated pH value, with the microporous filter membrane fine straining of 0.45 μ m, and carry out aseptic filtration with the microporous filter membrane of 0.22 μ m, filtrate is sprayed with the spray drying tower under the aseptic condition, makes sterilized powder, packing, labeling, promptly;
Embodiments of the invention eight,
1. get Radix Ginseng 150g, Radix Ophiopogonis 150g, Fructus Schisandrae Chinensis 100g, Radix Astragali 150g, Radix Salviae Miltiorrhizae 200g, Rhizoma Chuanxiong 100g, Fructus Crataegi 150g and be ground into fine powder, Radix Ginseng, Fructus Schisandrae Chinensis, Radix Salviae Miltiorrhizae carry out percolation according to the percolation under Chinese Pharmacopoeia 2005 editions appendix IO fluid extract and the extractum item with 85% alcohol dipping after 24 hours, collect percolate to colourless, merge percolate, filter, medicinal residues are standby, decompression filtrate recycling ethanol, measuring relative density when being evaporated to 20 ℃ is 1.15-1.12, get pure dissolubility effective part extract, standby;
2. medicinal residues and Radix Ophiopogonis, the Radix Astragali, Rhizoma Chuanxiong, Fructus Crataegi decoct with water 2 times, 2.5 hours for the first time, 1.5 hours for the second time, collecting decoction filters, and filtrate is concentrated into about 500ml, 85% ethanol that adds equivalent, after fully stirring, standing over night, elimination precipitate, filtrate recycling ethanol and to measure relative density when being concentrated into 80 ℃ be 1.30-1.36, the water solublity effective part extract.
3. after above-mentioned two kinds of extracts being merged, standby;
4. getting above-mentioned effective part extract adds injection and is diluted with water to 80% of prescribed volume, stir, adding the polyethylene glycol 6000 of 0.09 times of amount of above-mentioned effective part extract and the lactose of 0.15 times of amount of above-mentioned effective part extract fully dissolves, the injection active carbon of adding 0.1%, be heated to 80 ℃ and kept 10 minutes, filter carbon removal, add the injection water to nearly full dose, it is 7.5 that the sodium hydroxide solution with 10% is regulated pH value, with the microporous filter membrane fine straining of 0.45 μ m, and carry out aseptic filtration with the microporous filter membrane of 0.22 μ m, filtrate is sprayed with the spray drying tower under the aseptic condition, makes sterilized powder, packing, labeling, promptly;
Embodiments of the invention nine,
1. get Radix Ginseng 150g, Radix Ophiopogonis 150g, Fructus Schisandrae Chinensis 100g, Radix Astragali 150g, Radix Salviae Miltiorrhizae 200g, Rhizoma Chuanxiong 100g, Fructus Crataegi 150g and be ground into fine powder, Radix Ginseng, Fructus Schisandrae Chinensis, Radix Salviae Miltiorrhizae according to the infusion process under 2005 editions appendix IN of Chinese Pharmacopoeia tincture item with 85% alcohol dipping 5 days, take out supernatant, adding 85% ethanol again floods to effective site in accordance with the law and fully leaches, merge impregnation liquid, filter, medicinal residues are standby, decompression filtrate recycling ethanol, measuring relative density when being evaporated to 20 ℃ is 1.15-1.12, get pure dissolubility effective part extract, standby;
2. medicinal residues and Radix Ophiopogonis, the Radix Astragali, Rhizoma Chuanxiong, Fructus Crataegi decoct with water 2 times, 2.5 hours for the first time, 1.5 hours for the second time, collecting decoction filters, and filtrate is concentrated into about 500ml, 85% ethanol that adds equivalent, after fully stirring, standing over night, elimination precipitate, filtrate recycling ethanol and to measure relative density when being concentrated into 80 ℃ be 1.30-1.36, the water solublity effective part extract.
3. after above-mentioned two kinds of extracts being merged, standby;
4. getting above-mentioned effective part extract adds injection and is diluted with water to 80% of prescribed volume, stir, adding the polyethylene glycol 6000 of 0.03 times of amount of above-mentioned effective part extract and the lactose of 0.06 times of amount of above-mentioned effective part extract fully dissolves, the injection active carbon of adding 0.1%, be heated to 80 ℃ and be incubated 10 minutes, filter carbon removal, add the injection water to nearly full dose, it is 7.5 that the sodium hydroxide solution with 10%% is regulated pH value, with the microporous filter membrane fine straining of 0.45 μ m, and carry out aseptic filtration with the microporous filter membrane of 0.22 μ m, filtrate is sprayed with the spray drying tower under the aseptic condition, makes sterilized powder, packing, labeling, promptly;
Embodiments of the invention ten,
1. get Radix Ginseng 150g, Radix Ophiopogonis 150g, Fructus Schisandrae Chinensis 100g, Radix Astragali 150g, Radix Salviae Miltiorrhizae 200g, Rhizoma Chuanxiong 100g, Fructus Crataegi 150g and be ground into fine powder, Radix Ginseng, Fructus Schisandrae Chinensis, Radix Salviae Miltiorrhizae carry out percolation according to the percolation under Chinese Pharmacopoeia 2005 editions appendix IO fluid extract and the extractum item with 85% alcohol dipping after 24 hours, collect percolate to colourless, merge percolate, filter, medicinal residues are standby, decompression filtrate recycling ethanol, measuring relative density when being evaporated to 20 ℃ is 1.15-1.12, get pure dissolubility effective part extract, standby;
2. medicinal residues and Radix Ophiopogonis, the Radix Astragali, Rhizoma Chuanxiong, Fructus Crataegi decoct with water 2 times, 2.5 hours for the first time, 1.5 hours for the second time, collecting decoction filters, and filtrate is concentrated into about 500ml, 85% ethanol that adds equivalent, after fully stirring, standing over night, elimination precipitate, filtrate recycling ethanol and to measure relative density when being concentrated into 80 ℃ be 1.30-1.36, the water solublity effective part extract.
3. after above-mentioned two kinds of extracts being merged, standby;
4. getting above-mentioned effective part extract adds injection and is diluted with water to 80% of prescribed volume, stir, the mannitol and the dextran of 0.24 times of amount of above-mentioned effective part extract and the glucose of above-mentioned effective part extract 0.05 that add 0.2 times of amount of above-mentioned effective part extract, fully dissolving, the injection active carbon of adding 0.1%, be heated to 80 ℃ and be incubated 10 minutes, filter carbon removal, add the injection water to nearly full dose, it is 7.5 that the sodium hydroxide solution with 10% is regulated pH value, microporous filter membrane fine straining with 0.45 μ m, and carry out aseptic filtration with the microporous filter membrane of 0.22 μ m, filtrate decompression is concentrated in right amount, embedding, sterilization, promptly.
Embodiments of the invention 11,
1. get Radix Ginseng 150g, Radix Ophiopogonis 150g, Fructus Schisandrae Chinensis 100g, Radix Astragali 150g, Radix Salviae Miltiorrhizae 200g, Rhizoma Chuanxiong 100g, Fructus Crataegi 150g and be ground into fine powder, Radix Ginseng, Fructus Schisandrae Chinensis, Radix Salviae Miltiorrhizae carry out percolation according to the percolation under Chinese Pharmacopoeia 2005 editions appendix IO fluid extract and the extractum item with 85% alcohol dipping after 24 hours, collect percolate to colourless, merge percolate, filter, medicinal residues are standby, decompression filtrate recycling ethanol, measuring relative density when being evaporated to 20 ℃ is 1.15-1.12, get pure dissolubility effective part extract, standby;
2. medicinal residues and Radix Ophiopogonis, the Radix Astragali, Rhizoma Chuanxiong, Fructus Crataegi decoct with water 2 times, 2.5 hours for the first time, 1.5 hours for the second time, collecting decoction filters, and filtrate is concentrated into about 500ml, 85% ethanol that adds equivalent, after fully stirring, standing over night, elimination precipitate, filtrate recycling ethanol and to measure relative density when being concentrated into 80 ℃ be 1.30-1.36, the water solublity effective part extract.
3. after above-mentioned two kinds of extracts being merged, standby;
4. getting above-mentioned effective part extract adds injection and is diluted with water to 80% of prescribed volume, stir, the mannitol and the dextran of 0.36 times of amount of above-mentioned effective part extract and the glucose of above-mentioned effective part extract 0.08 that add 0.3 times of amount of above-mentioned effective part extract, fully dissolving, the injection active carbon of adding 0.1%, be heated to 80 ℃ and be incubated 10 minutes, filter carbon removal, add the injection water to nearly full dose, it is 7.5 that the sodium hydroxide solution with 10% is regulated pH value, microporous filter membrane fine straining with 0.45 μ m, and carry out aseptic filtration with the microporous filter membrane of 0.22 μ m, filtrate decompression is concentrated in right amount, embedding, sterilization, promptly.
Embodiments of the invention 12,
1. get Radix Ginseng 150g, Radix Ophiopogonis 150g, Fructus Schisandrae Chinensis 100g, Radix Astragali 150g, Radix Salviae Miltiorrhizae 200g, Rhizoma Chuanxiong 100g, Fructus Crataegi 150g and be ground into fine powder, Radix Ginseng, Fructus Schisandrae Chinensis, Radix Salviae Miltiorrhizae according to the infusion process under 2005 editions appendix IN of Chinese Pharmacopoeia tincture item with 85% alcohol dipping 5 days, take out supernatant, adding 85% ethanol again floods to effective site in accordance with the law and fully leaches, merge impregnation liquid, filter, medicinal residues are standby, decompression filtrate recycling ethanol, measuring relative density when being evaporated to 20 ℃ is 1.15-1.12, get pure dissolubility effective part extract, standby;
2. medicinal residues and Radix Ophiopogonis, the Radix Astragali, Rhizoma Chuanxiong, Fructus Crataegi decoct with water 2 times, 2.5 hours for the first time, 1.5 hours for the second time, collecting decoction filters, and filtrate is concentrated into about 500ml, 85% ethanol that adds equivalent, after fully stirring, standing over night, elimination precipitate, filtrate recycling ethanol and to measure relative density when being concentrated into 80 ℃ be 1.30-1.36, the water solublity effective part extract.
3. after above-mentioned two kinds of extracts being merged, standby;
4. getting above-mentioned effective part extract adds injection and is diluted with water to 80% of prescribed volume, stir, the mannitol and the dextran of 0.12 times of amount of above-mentioned effective part extract and the glucose of 0.02 times of amount of above-mentioned effective part extract that add 0.1 times of amount of above-mentioned effective part extract, fully dissolving, the injection active carbon of adding 0.1%, be heated to 80 ℃ and be incubated 10 minutes, filter carbon removal, add the injection water to nearly full dose, it is 7.5 that the sodium hydroxide solution with 10% is regulated pH value, microporous filter membrane fine straining with 0.45 μ m, and carry out aseptic filtration with the microporous filter membrane of 0.22 μ m, filtrate decompression is concentrated in right amount, embedding, sterilization, promptly.
Embodiments of the invention 13,
1. get Radix Ginseng 150g, Radix Ophiopogonis 150g, Fructus Schisandrae Chinensis 100g, Radix Astragali 150g, Radix Salviae Miltiorrhizae 200g, Rhizoma Chuanxiong 100g, Fructus Crataegi 150g and be ground into fine powder, Radix Ginseng, Fructus Schisandrae Chinensis, Radix Salviae Miltiorrhizae, Rhizoma Chuanxiong place the extraction kettle of co_2 supercritical fluid extraction machine respectively, the condition that according to the form below is set is regulated extracting pressure, extraction temperature, extraction time, collect extract, standby;
Supercritical fluid extraction extracting pressure, extraction temperature, extraction timetable
| Material | Extracting pressure (MPa) | Extraction temperature (℃) | The extraction time (hour) | |
| Radix Ginseng | 25 | 55 | 6 | |
| Radix Salviae Miltiorrhizae | Use earlier | 35 | 65 | 4 |
| Reuse | 20 | 40 | 8 | |
| Fructus Schisandrae Chinensis | 25.3 | 60 | 6 | |
| Rhizoma Chuanxiong | Use earlier | 30 | 65 | 5 |
| Reuse | 25.3 | 60 | 6 | |
2. medicinal residues and residue Radix Ophiopogonis, the Radix Astragali, Fructus Crataegi decoct with water 2 times, and 2.5 hours for the first time, 1.5 hours for the second time, collecting decoction filters, and filtrate is filtered with the ultrafiltration apparatus that can cut 2.5 ten thousand molecular weight ultrafilter membranes is housed, liquid on the film is separated with liquid under the film, and liquid discards on the film, and liquid is standby under the film; Liquid filters with the nanofiltration device that the NF membrane that can cut 150 molecular weight is housed under the film, and liquid on the film is separated with liquid under the film, and liquid discards under the film, and liquid on the collection membrane gets the water solublity effective part extract;
3. said extracted thing and water solublity effective part extract are merged, standby;
4. getting above-mentioned effective part extract adds injection and is diluted with water to 80% of prescribed volume, stir, adding the polyethylene glycol 6000 of 0.05 times of amount of above-mentioned effective part extract and the dextran of 0.1 times of amount of above-mentioned effective part extract fully dissolves, the injection active carbon of adding 0.1%, be heated to 80 ℃ and be incubated 10 minutes, filter carbon removal, add the injection water to nearly full dose, it is 7.5 that sodium hydroxide solution with 10% is regulated pH value, with the microporous filter membrane fine straining of 0.45 μ m, and carry out aseptic filtration, the filtrate embedding with the microporous filter membrane of 0.22 μ m, sterilization, promptly;
Embodiments of the invention 14,
1. get Radix Ginseng 150g, Radix Ophiopogonis 150g, Fructus Schisandrae Chinensis 100g, Radix Astragali 150g, Radix Salviae Miltiorrhizae 200g, Rhizoma Chuanxiong 100g, Fructus Crataegi 150g and be ground into fine powder, Radix Ginseng, Fructus Schisandrae Chinensis, Radix Salviae Miltiorrhizae, Rhizoma Chuanxiong place the extraction kettle of co_2 supercritical fluid extraction machine respectively, the condition that according to the form below is set is regulated extracting pressure, extraction temperature, extraction time, collect extract, standby;
Supercritical fluid extraction extracting pressure, extraction temperature, extraction timetable
| Material | Extracting pressure (MPa) | Extraction temperature (℃) | The extraction time (hour) | |
| Radix Ginseng | 25 | 55 | 6 | |
| Radix Salviae Miltiorrhizae | Use earlier | 35 | 65 | 4 |
| Reuse | 20 | 40 | 8 | |
| Fructus Schisandrae Chinensis | 25.3 | 60 | 6 | |
| Rhizoma Chuanxiong | Use earlier | 30 | 65 | 5 |
| Reuse | 25.3 | 60 | 6 | |
2. medicinal residues and residue Radix Ophiopogonis, the Radix Astragali, Fructus Crataegi decoct with water 2 times, and 2.5 hours for the first time, 1.5 hours for the second time, collecting decoction filters, and filtrate is filtered with the ultrafiltration apparatus that can cut 50,000 molecular weight ultrafilter membranes is housed, liquid on the film is separated with liquid under the film, and liquid discards on the film, and liquid is standby under the film; Liquid filters with the nanofiltration device that the NF membrane that can cut 300 molecular weight is housed under the film, and liquid on the film is separated with liquid under the film, and liquid discards under the film, and liquid on the collection membrane gets the water solublity effective part extract;
3. said extracted thing and water solublity effective part extract are merged, standby;
4. getting above-mentioned effective part extract adds injection and is diluted with water to 80% of prescribed volume, stir, adding the polyethylene glycol 6000 of 0.1 times of amount of effective part extract and the mannitol of 0.9 times of amount of above-mentioned effective part extract fully dissolves, the injection active carbon of adding 0.1%, be heated to 80 ℃ and be incubated 10 minutes, filter carbon removal, add the injection water to nearly full dose, it is 7.5 that sodium hydroxide solution with 10% is regulated pH value, microporous filter membrane fine straining with 0.45 μ m, and carry out aseptic filtration with the microporous filter membrane of 0.22 μ m, the filtrate fill in the cillin bottle of 20ml, every bottled 10ml; Place freeze drying box evacuation after-50 ℃ of pre-freeze 3-5 hours then; Condensation temperature remains unchanged, and after 24 hours, unpacks, and makes dried frozen aquatic products, gland, and labeling, promptly;
Embodiments of the invention 15,
1. get Radix Ginseng 150g, Radix Ophiopogonis 150g, Fructus Schisandrae Chinensis 100g, Radix Astragali 150g, Radix Salviae Miltiorrhizae 200g, Rhizoma Chuanxiong 100g, Fructus Crataegi 150g and be ground into fine powder, Radix Ginseng, Fructus Schisandrae Chinensis, Radix Salviae Miltiorrhizae, Rhizoma Chuanxiong place the extraction kettle of co_2 supercritical fluid extraction machine respectively, the condition that according to the form below is set is regulated extracting pressure, extraction temperature, extraction time, collect extract, standby;
Supercritical fluid extraction extracting pressure, extraction temperature, extraction timetable
| Material | Extracting pressure (MPa) | Extraction temperature (℃) | The extraction time (hour) | |
| Radix Ginseng | 25 | 55 | 6 | |
| Radix Salviae Miltiorrhizae | Use earlier | 35 | 65 | 4 |
| Reuse | 20 | 40 | 8 | |
| Fructus Schisandrae Chinensis | 25.3 | 60 | 6 | |
| Rhizoma Chuanxiong | Use earlier | 30 | 65 | 5 |
| Reuse | 25.3 | 60 | 6 | |
2. medicinal residues and residue Radix Ophiopogonis, the Radix Astragali, Fructus Crataegi decoct with water 2 times, and 2.5 hours for the first time, 1.5 hours for the second time, collecting decoction filters, and filtrate is filtered with the ultrafiltration apparatus that can cut 1000 molecular weight ultrafilter membranes is housed, liquid on the film is separated with liquid under the film, and liquid discards on the film, and liquid is standby under the film; Liquid filters with the nanofiltration device that the NF membrane that can cut 100 molecular weight is housed under the film, and liquid on the film is separated with liquid under the film, and liquid discards under the film, and liquid on the collection membrane gets the water solublity effective part extract;
3. said extracted thing and water solublity effective part extract are merged, standby;
4. getting above-mentioned effective part extract adds injection and is diluted with water to 80% of prescribed volume, stir, adding the polyethylene glycol 6000 of 0.03 times of amount of above-mentioned effective part extract and the lactose of 0.06 times of amount of above-mentioned effective part extract fully dissolves, the injection active carbon of adding 0.1%, be heated to 80 ℃ and kept 10 minutes, filter carbon removal, add the injection water to nearly full dose, it is 7.5 that the sodium hydroxide solution with 10% is regulated pH value, with the microporous filter membrane fine straining of 0.45 μ m, and carry out aseptic filtration with the microporous filter membrane of 0.22 μ m, filtrate is sprayed with the spray drying tower under the aseptic condition, makes sterilized powder, packing, labeling, promptly;
Embodiments of the invention 16,
1. get Radix Ginseng 150g, Radix Ophiopogonis 150g, Fructus Schisandrae Chinensis 100g, Radix Astragali 150g, Radix Salviae Miltiorrhizae 200g, Rhizoma Chuanxiong 100g, Fructus Crataegi 150g and be ground into fine powder, Radix Ginseng, Fructus Schisandrae Chinensis, Radix Salviae Miltiorrhizae, Rhizoma Chuanxiong place the extraction kettle of co_2 supercritical fluid extraction machine respectively, the condition that according to the form below is set is regulated extracting pressure, extraction temperature, extraction time, collect extract, standby;
Supercritical fluid extraction extracting pressure, extraction temperature, extraction timetable
| Material | Extracting pressure (MPa) | Extraction temperature (℃) | The extraction time (hour) | |
| Radix Ginseng | 25 | 55 | 6 | |
| Radix Salviae Miltiorrhizae | Use earlier | 35 | 65 | 4 |
| Reuse | 20 | 40 | 8 | |
| Fructus Schisandrae Chinensis | 25.3 | 60 | 6 | |
| Rhizoma Chuanxiong | Use earlier | 30 | 65 | 5 |
| Reuse | 25.3 | 60 | 6 | |
2. medicinal residues and residue Radix Ophiopogonis, the Radix Astragali, Fructus Crataegi decoct with water 2 times, and 2.5 hours for the first time, 1.5 hours for the second time, collecting decoction filters, and filtrate is filtered with the ultrafiltration apparatus that can cut 30000 molecular weight ultrafilter membranes is housed, liquid on the film is separated with liquid under the film, and liquid discards on the film, and liquid is standby under the film; Liquid filters with the nanofiltration device that the NF membrane that can cut 200 molecular weight is housed under the film, and liquid on the film is separated with liquid under the film, and liquid discards under the film, and liquid on the collection membrane gets the water solublity effective part extract;
3. said extracted thing and water solublity effective part extract are merged, standby;
4. getting above-mentioned effective part extract adds injection and is diluted with water to 80% of prescribed volume, stir, the polyethylene glycol 6000 and the dextran of 0.24 times of amount of above-mentioned effective part extract and the glucose of 0.05 times of amount of above-mentioned effective part extract that add 0.2 times of amount of above-mentioned effective part extract, fully dissolving, the injection active carbon of adding 0.1%, be heated to 80 ℃ and be incubated 10 minutes, filter carbon removal, add the injection water to nearly full dose, it is 7.5 that the sodium hydroxide solution with 10% is regulated pH value, microporous filter membrane fine straining with 0.45 μ m, and carry out aseptic filtration with the microporous filter membrane of 0.22 μ m, filtrate decompression is concentrated in right amount, embedding, sterilization, promptly.
Claims (6)
1, the YIXINSHU ejection preparation of a kind of Yiqi and vein recovery, blood circulation promoting and blood stasis dispelling, by weight percentage, it is prepared from Radix Ginseng 15%, Radix Ophiopogonis 15%, Fructus Schisandrae Chinensis 10%, the Radix Astragali 15%, Radix Salviae Miltiorrhizae 20%, Rhizoma Chuanxiong 10% and Fructus Crataegi 15%, it is characterized in that: effective part extract and adjuvant with these medicinal material extract are made; Wherein: the effective part extract of medicinal material extract comprises fat-soluble effective part extract, water solublity effective part extract or their mixture; The accessory package explanatory note in brackets is penetrated water, mannitol, lactose, dextran, glucose, Polyethylene Glycol or their mixture.
2, the YIXINSHU ejection preparation of Yiqi and vein recovery according to claim 1, blood circulation promoting and blood stasis dispelling is characterized in that: comprise injection, injectable sterile powder and concentrated solution for injection.
3, the preparation method of the YIXINSHU ejection preparation of Yiqi and vein recovery according to claim 1 and 2, blood circulation promoting and blood stasis dispelling, it is characterized in that: by weight percentage, get Radix Ginseng 15%, Radix Ophiopogonis 15%, Fructus Schisandrae Chinensis 10%, the Radix Astragali 15%, Radix Salviae Miltiorrhizae 20%, Rhizoma Chuanxiong 10%, Fructus Crataegi 15%, pulverize; Radix Ginseng, Fructus Schisandrae Chinensis, the Radix Salviae Miltiorrhizae fat-soluble effective part extract of ethanol extraction, medicinal residues are standby, and filtrate merges, and measuring relative density when being evaporated to 20 ℃ is 1.15-1.12, gets fat-soluble effective part extract, standby; Medicinal residues and Radix Ophiopogonis, the Radix Astragali, Rhizoma Chuanxiong, Fructus Crataegi decoct with water, merge decoction liquor, filter, filtrate is concentrated into 500ml, adds 85% ethanol of equivalent, after fully stirring, standing over night, the elimination precipitate, filtrate recycling ethanol and to measure relative density when being concentrated into 80 ℃ be 1.30-1.36, the water solublity effective part extract; After above-mentioned two kinds of effective part extracts merging, standby; Get above-mentioned effective part extract, the activated feedstock as injection is used is prepared as follows:
(1) preparation of injection: get above-mentioned effective part extract and add injection and be diluted with water to 80% of prescribed volume, stir, adding the dextran that polyethylene glycol 6000 that above-mentioned effective part extract 0.01-0.1 doubly measures and above-mentioned effective part extract 0.05-0.15 doubly measure fully dissolves, the injection active carbon of adding 0.1%, be heated to 80 ℃ and kept 10 minutes, filter carbon removal, add the injection water to nearly full dose, it is 7.5 that sodium hydroxide solution with 10% is regulated pH value, with the microporous filter membrane fine straining of 0.45 μ m, and carry out aseptic filtration, the filtrate embedding with the microporous filter membrane of 0.22 μ m, sterilization, promptly;
(2) preparation of freeze-dried powder: get above-mentioned effective part extract add the injection be diluted with water to regulation volume 80%, stir, the mannitol that polyethylene glycol 6000 that adding effective part extract 0.01-0.1 doubly measures and above-mentioned effective part extract 0.2-0.4 doubly measure fully dissolves, the injection active carbon of adding 0.1%, be heated to 80 ℃ and kept 10 minutes, filter carbon removal, add the injection water to nearly full dose, it is 7.5 that sodium hydroxide solution with 10% is regulated pH value, microporous filter membrane fine straining with 0.45 μ m, and carry out aseptic filtration with the microporous filter membrane of 0.22 μ m, the filtrate fill in the cillin bottle of 20ml, every bottled 10ml; Place freeze drying box evacuation after-50 ℃ of pre-freeze 3-5 hours then; Condensation temperature remains unchanged, and after 24 hours, unpacks, and makes dried frozen aquatic products, gland, and labeling, promptly;
(3) preparation of sterilized powder: get above-mentioned effective part extract add the injection be diluted with water to regulation volume 80%, stir, adding the lactose that polyethylene glycol 6000 that above-mentioned effective part extract 0.03-0.09 doubly measures and above-mentioned effective part extract 0.06-0.15 doubly measure fully dissolves, the injection active carbon of adding 0.1%, be heated to 80 ℃ and kept 10 minutes, filter carbon removal, add the injection water to nearly full dose, it is 7.5 that sodium hydroxide solution with 10%% is regulated pH value, microporous filter membrane fine straining with 0.45 μ m, and carry out aseptic filtration with the microporous filter membrane of 0.22 μ m, filtrate is sprayed with the spray drying tower under the aseptic condition, makes sterilized powder, packing, labeling, promptly;
(4) preparation of concentrated solution for injection: get above-mentioned effective part extract add the injection be diluted with water to regulation volume 80%, stir, add dextran that mannitol that above-mentioned effective part extract 0.1-0.3 doubly measures and above-mentioned effective part extract 0.12-0.36 doubly measure and the glucose of above-mentioned effective part extract 0.02-0.08, fully dissolving, the injection active carbon of adding 0.1%, be heated to 80 ℃ and kept 10 minutes, filter carbon removal, add the injection water to nearly full dose, it is 7.5 that sodium hydroxide solution with 10% is regulated pH value, microporous filter membrane fine straining with 0.45 μ m, and carry out aseptic filtration with the microporous filter membrane of 0.22 μ m, filtrate decompression is concentrated in right amount, embedding, sterilization, promptly.
4. the preparation method of the YIXINSHU ejection preparation of Yiqi and vein recovery according to claim 3, blood circulation promoting and blood stasis dispelling is characterized in that: Radix Ginseng, Fructus Schisandrae Chinensis, Radix Salviae Miltiorrhizae comprise that with the method for ethanol extraction reflux, extract,, percolation extract or dipping extracts.
5. the preparation method of the YIXINSHU ejection preparation of Yiqi and vein recovery according to claim 1 and 2, blood circulation promoting and blood stasis dispelling, it is characterized in that: by weight percentage, get Radix Ginseng 15%, Radix Ophiopogonis 15%, Fructus Schisandrae Chinensis 10%, the Radix Astragali 15%, Radix Salviae Miltiorrhizae 20%, Rhizoma Chuanxiong 10%, Fructus Crataegi 15%, pulverize, Radix Ginseng, Fructus Schisandrae Chinensis, Radix Salviae Miltiorrhizae, Rhizoma Chuanxiong place the extraction kettle cycling extraction of co_2 supercritical fluid extraction machine respectively, collect extract, standby; Medicinal residues and residue Radix Ophiopogonis, the Radix Astragali, Fructus Crataegi decoct with water, and merge decoction liquor, filter, and filtrate is filtered with the ultrafiltration apparatus that can cut 50,000-1000 molecular weight ultrafilter membranes is housed, and liquid on the film is separated with liquid under the film, and liquid discards on the film, and liquid is standby under the film; Liquid filters with the nanofiltration device that the NF membrane that can cut the 100-300 molecular weight is housed under the film, and liquid on the film is separated with liquid under the film, and liquid discards under the film, and liquid on the collection membrane gets the water solublity effective part extract; Above-mentioned carbon dioxide supercritical fluid extraction thing and water solublity effective part extract are merged, standby; Get above-mentioned effective part extract, be prepared as follows:
(1) preparation of injection: get above-mentioned effective part extract add the injection be diluted with water to regulation volume 80%, stir, adding the dextran that polyethylene glycol 6000 that above-mentioned effective part extract 0.01-0.1 doubly measures and above-mentioned effective part extract 0.05-0.15 doubly measure fully dissolves, the injection active carbon of adding 0.1%, be heated to 80 ℃ and kept 10 minutes, filter carbon removal, add the injection water to nearly full dose, it is 7.5 that sodium hydroxide solution with 10% is regulated pH value, with the microporous filter membrane fine straining of 0.45 μ m, and carry out aseptic filtration, the filtrate embedding with the microporous filter membrane of 0.22 μ m, sterilization, promptly;
(2) preparation of freeze-dried powder: get above-mentioned effective part extract add the injection be diluted with water to regulation volume 80%, stir, the mannitol that polyethylene glycol 6000 that adding effective part extract 0.01-0.1 doubly measures and above-mentioned effective part extract 0.3-0.9 doubly measure fully dissolves, the injection active carbon of adding 0.1%, be heated to 80 ℃ and kept 10 minutes, filter carbon removal, add the injection water to nearly full dose, it is 7.5 that sodium hydroxide solution with 10% is regulated pH value, microporous filter membrane fine straining with 0.45 μ m, and carry out aseptic filtration with the microporous filter membrane of 0.22 μ m, the filtrate fill in the cillin bottle of 20ml, every bottled 10ml; Place freeze drying box evacuation after-50 ℃ of pre-freeze 3-5 hours then; Condensation temperature remains unchanged, and after 24 hours, unpacks, and makes dried frozen aquatic products, gland, and labeling, promptly;
(3) preparation of sterilized powder: get above-mentioned effective part extract and add injection and be diluted with water to 80% of prescribed volume, stir, adding the lactose that polyethylene glycol 6000 that above-mentioned effective part extract 0.03-0.09 doubly measures and above-mentioned effective part extract 0.06-0.15 doubly measure fully dissolves, the injection active carbon of adding 0.1%, be heated to 80 ℃ and kept 10 minutes, filter carbon removal, add the injection water to nearly full dose, it is 7.5 that sodium hydroxide solution with 10%% is regulated pH value, microporous filter membrane fine straining with 0.45 μ m, and carry out aseptic filtration with the microporous filter membrane of 0.22 μ m, filtrate is sprayed with the spray drying tower under the aseptic condition, makes sterilized powder, packing, labeling, promptly;
(4) preparation of concentrated solution for injection: get above-mentioned effective part extract add the injection be diluted with water to regulation volume 80%, stir, add dextran that polyethylene glycol 6000 that above-mentioned effective part extract 0.1-0.3 doubly measures and above-mentioned effective part extract 0.12-0.36 doubly measure and the glucose of above-mentioned effective part extract 0.02-0.08, fully dissolving, the injection active carbon of adding 0.1%, be heated to 80 ℃ and kept 10 minutes, filter carbon removal, add the injection water to nearly full dose, it is 7.5 that sodium hydroxide solution with 10% is regulated pH value, microporous filter membrane fine straining with 0.45 μ m, and carry out aseptic filtration with the microporous filter membrane of 0.22 μ m, filtrate decompression is concentrated in right amount, embedding, sterilization, promptly.
6. according to the preparation method of the YIXINSHU ejection preparation of the described Yiqi and vein recovery of claim 5, blood circulation promoting and blood stasis dispelling, it is characterized in that: the extracting pressure of Radix Ginseng is that 25Mpa, extraction temperature are that 55 ℃, extraction time are 6 hours; Radix Salviae Miltiorrhizae is answered extracting twice, and for the first time the extracting pressure of using is that 20Mpa, extraction temperature are that 40 ℃, extraction time are 4 hours; For the second time the extracting pressure of using is that 35Mpa, extraction temperature are that 65 ℃, extraction time are 8 hours; The extracting pressure of Fructus Schisandrae Chinensis is that 25.3Mpa, extraction temperature are that 60 ℃, extraction time are 6 hours; Rhizoma Chuanxiong is answered extracting twice, and for the first time the extracting pressure of using is that 25.3Mpa, extraction temperature are 60 ℃, 5 hours extraction time, the extracting pressure used for the second time is that 30Mpa, extraction temperature are that 65 ℃, extraction time are 6 hours.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101804150A (en) * | 2010-03-22 | 2010-08-18 | 贵州信邦制药股份有限公司 | Traditional Chinese medicine composite used for treating left ventricular diastolic dysfunction |
| US20120237625A1 (en) * | 2009-11-30 | 2012-09-20 | Amorepacific Corporation | Metabolism accelerating composition comprising astragali radix extract |
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| CN1325072C (en) * | 2005-04-11 | 2007-07-11 | 安徽科创中药天然药物研究所有限责任公司 | Method for preparing traditional Chinese medicine |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20120237625A1 (en) * | 2009-11-30 | 2012-09-20 | Amorepacific Corporation | Metabolism accelerating composition comprising astragali radix extract |
| US9839660B2 (en) * | 2009-11-30 | 2017-12-12 | Amorepacific Corporation | Metabolism accelerating composition comprising Astragali radix extract |
| CN101804150A (en) * | 2010-03-22 | 2010-08-18 | 贵州信邦制药股份有限公司 | Traditional Chinese medicine composite used for treating left ventricular diastolic dysfunction |
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Effective date of registration: 20181214 Address after: 550018 6th Floor, Kekaiyuan, Koujie Road Estuary, Wudang District, Guiyang City, Guizhou Province Patentee after: Xinbang Pharmacy Co., Ltd., Guizhou Address before: 550003 Xinbang Avenue 227, Baiyun Economic Development Zone, Guiyang City, Guizhou Province Patentee before: Xinbang Yuandong Pharmaceutical Co., Ltd., Guizhou |
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