CN103599189A - Zhenqi Fuzheng (Chinese character) injection preparation and preparation method thereof - Google Patents
Zhenqi Fuzheng (Chinese character) injection preparation and preparation method thereof Download PDFInfo
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Abstract
The invention provides a Zhenqi Fuzheng (Chinese character) injection preparation and a preparation method thereof. The Zhenqi Fuzheng injection preparation is mainly prepared from astragalus membranaceus and glossy privet fruit. The injection preparation disclosed by the invention is good in curative effect, accords with the 'quick-acting, efficient and small-dose' selection principles of the modern formulation, and is the development direction of the modern traditional Chinese medicine. Compared with the traditional oral preparation, the Zhenqi Fuzheng injection preparation has a plurality of advantages.
Description
Technical field
The present invention relates to a kind of body resistance-strengthening Zhenqi ejection preparation and preparation method thereof, belong to the technical field of medicine.
Background technology
At present, the fast development of society has brought many opportunities to all trades and professions, and modern has played irreplaceable initiative effect in current development, and the mankind have done huge contribution for social development; Simultaneously, what follow is that social immense pressure and competitiveness also makes people necessary busy in working and learning, relatively, people have lacked the living habit of many exercises and rule, the various factorss such as awful weather changes in addition, environmental pollution is serious cause modern's body constitution to reduce and very easily ill, such as rheumatism, tumor, bird flu etc.; When modern's body constitution declines relatively, for strengthening body immunity and prevent disease, the medicine of the purposive research and development tool enhancing immunity of many scholar experts in recent years, also obtained no small achievement, but with regard to current achievement, the pharmaceutical preparation of enhancing immunity mainly be take oral granule, capsule etc. as main, because it has reduced bioavailability through first pass effect of hepar; From traditional Chinese medical science angle, enhancing human body immunity power is main is exactly righting, use medicine or the other treatment method of reinforcing body resistance, coordinate the householder methods such as suitable nutrition and functional exercise, with health invigorating, improve the resistance against diseases of body, thus the gas of getting rid of evils to reach Fighting Disease, restorative object.Modern study shows, the ZHENQI FUZHENG JIAONANG being prepared from by the Radix Astragali, Fructus Ligustri Lucidi (granule) has good curative effect to qi-deficiency type tumor patient.Wherein, the Chinese medicine astragalus with effects such as spleen reinforcing yang invigorating, lung benefiting consolidating superficial resistance, promoting pus discharge and tissue regeneration strengthening contains astragalus polysaccharides, multiple flavonoid and saponin component, tool regulates immunologic function, promotes the effects such as hemopoietic function, Fructus Ligustri Lucidi nourishing the liver and kidney in addition, wherein the composition such as contained polysaccharide, saponins has facilitation to humoral immunization, cellular immunization, both share boosting qi and nourishing yin, deficient for prolonged illness, deficiency of both vital energy and Yin; Coordinate operation, radiotherapy, chemotherapy, promote the recovery of normal function.But because existing dosage form is oral formulations, affected the curative effect of medicine.The application will people of forces have applied for that on May 12nd, 2005 name is called: injection preparation of ' Zhenqi and preparation method thereof, application number is: 200510012502.7 patent of invention, but the curative effect of the body resistance-strengthening Zhenqi ejection preparation described in this patent is still not ideal enough, therefore, a kind of working condition is reliable, product curative effect is good, bioavailability is high, the body resistance-strengthening Zhenqi ejection preparation of good stability is that patient is badly in need of, and potential social economic value is also huge simultaneously.
Summary of the invention
Technical problem to be solved by this invention is to provide a kind of body resistance-strengthening Zhenqi ejection preparation and preparation method thereof.
For solving the problems of the technologies described above, the present invention realizes by the following technical solutions:
A body resistance-strengthening Zhenqi ejection preparation, calculates according to composition by weight, and it is prepared from by Radix Astragali 30-80 part, Fructus Ligustri Lucidi 15-40 part and adjuvant.
Above-mentioned body resistance-strengthening Zhenqi ejection preparation calculates according to composition by weight, and it is prepared from by 50 parts of the Radixs Astragali, 25 parts of Fructus Ligustri Lucidi and adjuvant.
The preparation method of above-mentioned body resistance-strengthening Zhenqi ejection preparation is: in writing out a prescription, two taste Chinese medicines are cleaned, and take water as solvent heating extraction, and extracting solution filters, and filtrate is condensed into concentrated solution; Add ethanol to reaching 90% containing alcohol amount, standing, filter, filtrate for later use, crosses hollow fiber column ultrafilter after precipitation is dissolved in water and processes, and molecular cut off is greater than the composition of 6KDa, is evaporated to dryly, pulverizes, and obtains polysaccharide effective site, standby; Precipitate with ethanol gained supernatant is evaporated to without being dissolved in water for injection after alcohol taste, by macroporous resin adsorption, ethanol gradient elution with 30%～95%, eluent is condensed into clear paste, and drying under reduced pressure is ground into fine powder, obtain saponins, flavonoid, terpenoid effective site, mix with above-mentioned polysaccharide effective site, then add pharmaceutically acceptable adjuvant to combine, and make corresponding ejection preparation according to conventional preparation method.
Specifically, the preparation method of above-mentioned body resistance-strengthening Zhenqi ejection preparation is: in writing out a prescription, two taste Chinese medicines are cleaned, and the water of 10 times of recipe quantities of take is solvent, 100 ℃ of heating extraction 3 times, and each 90min, merge extractive liquid,, filters, and filtrate is condensed into concentrated solution; Add 95% ethanol to reaching 90% containing alcohol amount, standing 12h, filters, and filtrate for later use is crossed hollow fiber column ultrafilter after precipitation is dissolved in water and processed, and molecular cut off is greater than the composition of 6KDa, is evaporated to dryly, is ground into 80 order fine powders, obtains polysaccharide effective site, standby; Precipitate with ethanol gained supernatant is evaporated to without being dissolved in water for injection after alcohol taste, with AB-8 type macroporous resin adsorption 12h, with 30%～95% ethanol, press the flow-rate gradient elution of 2.0BV/h, eluent is concentrated into the clear paste that 60 ℃ of relative densities are 1.28,50 ℃ of drying under reduced pressure, be ground into 80 order fine powders, obtain saponins, flavonoid, terpenoid effective site, mix with above-mentioned polysaccharide effective site, add again pharmaceutically acceptable adjuvant to combine, and make corresponding ejection preparation according to conventional preparation method.
Described ejection preparation is injection or injection freeze-dried powder.
Described injection is prepared like this: in writing out a prescription, two taste Chinese medicines are cleaned, and the water of 10 times of recipe quantities of take is solvent, 100 ℃ of heating extraction 3 times, and each 90min, merge extractive liquid,, filters, and filtrate is condensed into concentrated solution; Add 95% ethanol to reaching 90% containing alcohol amount, standing 12h, filters, and filtrate for later use is crossed hollow fiber column ultrafilter after precipitation is dissolved in water and processed, and molecular cut off is greater than the composition of 6KDa, is evaporated to dryly, is ground into 80 order fine powders, obtains polysaccharide effective site, standby; Precipitate with ethanol gained supernatant is evaporated to without being dissolved in water for injection after alcohol taste, with AB-8 type macroporous resin adsorption 12h, with 30%～95% ethanol, press the flow-rate gradient elution of 2.0BV/h, eluent is concentrated into the clear paste that 60 ℃ of relative densities are 1.28,50 ℃ of drying under reduced pressure, be ground into 80 order fine powders, obtain saponins, flavonoid, terpenoid effective site; Mix with above-mentioned polysaccharide effective site, add the Tween 80 of 0.1%～2% recipe quantity, mix, with the water for injection of preparation amount 85%, dissolve, with citric acid, adjust PH to 7.0～7.3, add 0.2% injection active carbon, heating 30min, decompress filter, inject water to again recipe quantity, the filtering with microporous membrane of 0.45 μ m, embedding, adopt 121 ℃ of sterilizing 30min of moist hear heat test, obtain.
Described injection freeze-dried powder is prepared like this: in writing out a prescription, two taste Chinese medicines are cleaned, and the water of 10 times of recipe quantities of take is solvent, 100 ℃ of heating extraction 3 times, and each 90min, merge extractive liquid,, filters, and filtrate is condensed into concentrated solution; Add 95% ethanol to reaching 90% containing alcohol amount, standing 12h, filters, and filtrate for later use is crossed hollow fiber column ultrafilter after precipitation is dissolved in water and processed, and molecular cut off is greater than the composition of 6KDa, is evaporated to dryly, is ground into 80 order fine powders, obtains polysaccharide effective site, standby; Precipitate with ethanol gained supernatant is evaporated to without being dissolved in water for injection after alcohol taste, with AB-8 type macroporous resin adsorption 12h, with 30%～95% ethanol, press the flow-rate gradient elution of 2.0BV/h, eluent is concentrated into the clear paste that 60 ℃ of relative densities are 1.28,50 ℃ of drying under reduced pressure, be ground into 80 order fine powders, obtain saponins, flavonoid, terpenoid effective site; Merge all effective site, add the Tween 80 of 0.1%～2% recipe quantity, mix; Separately get the mannitol of all effective site total amounts 5%～10%, with the water for injection of preparation amount 85%, dissolve; Both mix, and heated and stirred makes to dissolve, and with citric acid, adjusts PH to 7.0～7.3, add again 0.2% injection active carbon, heating 30min, decompress filter, inject water to recipe quantity, the filtering with microporous membrane of 0.22 μ m, is sub-packed in aseptic cillin bottle,-15 ℃ of pre-freeze 2.5h ,-30 ℃ of pre-freeze 2h, are incubated 12h while being warming up to-15 ℃, while being warming up to 0 ℃, be incubated 3h, while being warming up to 10 ℃, be incubated 2h, be finally warming up to 45 ℃ and be dried, keep 12h, obtain.
Body resistance-strengthening Zhenqi ejection preparation of the present invention is mainly prepared from by the Radix Astragali and Fructus Ligustri Lucidi.Research shows, all contain the compositions such as polysaccharide, saponins, flavonoid and terpenoid, and polysaccharide component is unfavorable for the preparation of injection in prescription in two taste Chinese medicine astragalus and Fructus Ligustri Lucidi; Meanwhile, as Chinese medicine, take effective site and single active ingredient as principal agent the best, preparation more easily carries out quality control as far as possible.But the effective ingredient in Zhenqi Fuzheng prepn, polysaccharide is performed meritorious deeds never to be obliterated, the medicine that other effective sites are principal agent as only take, curative effect of medication can be affected again.Through a large amount of experimentatioies, it is extractant that the present invention selects water, and extracting solution reaches 90% with adding ethanol to containing alcohol amount, precipitate with ethanol 12h, and gained precipitated hollow fiber column ultrafilter to be processed, and can hold back polysaccharide effective site; To after precipitate with ethanol gained supernatant concentrating under reduced pressure, be dissolved in water for injection, with AB-8 type macroporous resin adsorption 12h, with 30%～95% ethanol, press the flow-rate gradient elution of 2.0BV/h, can elute saponins, flavonoid and terpenoid effective site.Although extraction process part of the present invention has effectively extracted the effective site in medicine, but also increased the preparation difficulty of preparation simultaneously, through lot of experiments research, the present invention adopts following method to be prepared, and the medicine of making all can meet the requirement of pharmacopeia aspect stability.
As: while being prepared into injection, effective site is mixed with the Tween 80 of 0.1%～2% recipe quantity, strengthened the dissolubility of the effective ingredient such as terpenoid, injection adopts rare method preparation of joining, do not need to add isotonic agent, directly with water for injection, dissolve, it is 7.0～7.3 that the citric acid of take again regulates PH, with water for injection, add to full dose afterwards, add 0.2% injection active carbon, heating 30min is in order to decolour and to adsorb pyrogen, after decompress filter, crossing aperture is the microporous filter membrane of 0.45 μ m, can remove impurity and pyrogen, to reach the basic demand of injection, adopt 121 ℃ of sterilizing 30min of moist hear heat test to be killed to guarantee all thalline of injection, guarantee the aseptic of injection.
While being prepared into freeze-dried powder, first effective site is mixed with the Tween 80 of 0.1%～2% recipe quantity, to strengthen the dissolubility of the effective ingredient such as terpenoid, then after caffolding agent mannitol being dissolved completely with the amount of making 85% water for injection, both mix, it is good in order to guarantee finished product outward appearance using caffolding agent, avoids agglomerating, does not spray bottle etc.; Heating for dissolving is complete, it is 7.0～7.3 that the citric acid of take again regulates PH, with water for injection, add to full dose afterwards, add 0.2% injection active carbon, heating 30min is in order to decolour and to adsorb pyrogen, after decompress filter, crossing aperture is the microporous filter membrane of 0.22 μ m, can remove impurity and pyrogen, be sub-packed in aseptic cillin bottle ,-15 ℃ of pre-freeze 2.5h,-30 ℃ of pre-freeze 2h, while being warming up to-15 ℃, be incubated 12h, while being warming up to 0 ℃, be incubated 3h, while being warming up to 10 ℃, be incubated 2h, finally be warming up to 45 ℃ and be dried, keep 12h better to guarantee obtained freeze-dried powder.
Applicant has carried out a large amount of experimentatioies, as follows:
Experimental example 1: technological experiment research.
The extraction isolation and purification technical study of 1 Radix Astragali, Fructus Ligustri Lucidi
1.1 Radixs Astragali, Fructus Ligustri Lucidi saponins, flavonoid and the research of ter penoids extraction process conditional filtering
Modern study shows that contained saponin component in the Radix Astragali and Fructus Ligustri Lucidi has the effect of enhancing immunity, and the present invention is directed to injection and freeze-dried powder and design, because saponins, flavonoid and ter penoids are water-soluble, in conjunction with enterprise, produce and consider, reduce cost, for this reason, it is index optimization optimum extraction process that inventor adopts determined by ultraviolet spectrophotometry Radix Astragali total saponins content, and therefore, the water of take extracts prescription as extracting solvent, factor level table, in Table 1, the results are shown in Table 2.
Table 1 factor level table
Table 2 Orthogonal experiment results
According to table 2, analyze known: 4 factors on the impact order size of prescription saponin component lixiviate are: extraction time > extraction time > extracts temperature > liquid ratio; The optimum extraction of prescription is combined as: A
1b
3c
3d
3, the pure water of 10 times of recipe quantities of take is solvent, 100 ℃ are extracted 3 times, each 90min.
1.2 Radixs Astragali, the research of Fructus Ligustri Lucidi polysaccharide separating technology
The Radix Astragali and the Fructus Ligustri Lucidi that take recipe quantity, extract with optimum extraction process, and extracting solution is to be cooled to room temperature, and filtrate is condensed into concentrated solution; Again with some hours (being precipitated as polysaccharide component) of ethanol precipitation, by the design of factor level table 3, carry out separation, every part of precipitation sucking filtration obtaining, with water for injection, dissolve, be settled to 250mL, draw standardize solution sample liquid 1mL in 100mL measuring bottle, inject and be diluted with water to scale, finally adopt ultraviolet spectrophotometry to carry out the mensuration of absorbance.Factor level, in Table 3, the results are shown in Table 4.
Table 3 Radix Astragali, Fructus Ligustri Lucidi polysaccharide separating factor water-glass
Table 4 Radix Astragali, Fructus Ligustri Lucidi polysaccharide separate design result
From table 4 Orthogonal experiment results, analyzed: 3 factors are containing the alcohol amount > concentration of alcohol > sedimentation time on the size order that affects of separating polyose; Its optimal separation is combined as A
3b
1c
3, adding 95% ethanol to being 90% containing alcohol amount, the sedimentation time is 12h, and polysaccharide is carried out to separating effect the best.
The saponins of 1.3 Radixs Astragali and Fructus Ligustri Lucidi, flavonoid and the research of ter penoids purifying process
After lot of documents research and preliminary experiment, adopt AB-8 macroporous resin to carry out purification to saponins, flavonoid and ter penoids.Method is: loading concentration is 0.2g (crude drug)/mL, upper AB-8 macroporous resin (column volume 100mL), upper column flow rate is 1BV/h absorption 12h, use respectively 200mL water for injection and 10%, 20%, 30%, 50%, 80%, 90% and 95% ethanol elution, flavonoid, saponins, ter penoids in above-mentioned ten kinds of concentration eluents are detected, flow velocity is 2BV/h, by eluent evaporate to dryness, to weigh, eluate is dissolved in water difference standardize solution in 250mL measuring bottle, draw respectively above-mentioned solution 0.2mL in 10mL measuring bottle, according to ultraviolet spectrophotometry, carry out the mensuration of absorbance.The results are shown in Table 5.
Each effective ingredient contrast test of table 5 ethanol gradient elution
Above experimental studies results shows, flavones ingredient be take formononetin and detected as index, and low-concentration ethanol elution efficiency is higher, and the best eluant of flavonoid is 30%～70% ethanol; Saponin component be take astragaloside and is detected as index, experimental studies results shows: high concentration ethanol eluting saponins efficiency is higher, best eluting concentration is 50%～95%, terpenoid be take oleanolic acid and is detected as index composition, found that, its 70%～95% concentration of alcohol elution efficiency is the highest.Therefore the condition of optimization purification saponins of the present invention, flavonoid and ter penoids is: adopt AB-8 macroporous resin, 30%～95% ethanol is eluant.
2. two kinds of Study on Forming of the present invention
2.1 injections are investigated by activated carbon dosage
For the color of removing the pyrogen in medicinal liquid and improving medicinal liquid, select respectively the injection active carbon of variable concentrations to carry out experiment screening, experimental result is in Table 6.
Table 6 injection is investigated result with the consumption screening of active carbon
According to table 6, analyze known: the injection of three concentration all can make the clarity of medicinal liquid and aseptic qualified by activated carbon dosage, and along with the increase of activated carbon dosage, active carbon increases gradually to the adsorption rate of effective ingredient, but the stability of its solution also increases gradually.For removing as much as possible thermal source and impurity, by adsorption rate and stability, considered, selecting concentration is that 0.2% injection adsorbs with active carbon.
2.2 freeze-dry process researchs
Lyophilization generally comprises pre-freeze, low-temperature distillation and dry 3 stages, freeze-dry process of the present invention is tested for these 3 stages; Take product shaping, mechanical strength and solubility as evaluation index, obtained freeze-drying product is compared, screen best freeze-dry process.Technological parameter is in Table 7, and handicraft product is relatively in Table 8.
Table 7 parameters of freeze-drying process table
Table 8 freeze-dry process product result table
According to table 8, show: freeze-dry process 2 and 3 all can meet the demands, but the cycle of considering technique 3 is slightly long, in conjunction with actual production and cost-saving consideration, selecting technique 2 is freeze-dry process ,-15 ℃ of pre-freeze 2.5h,-30 ℃ of pre-freeze 2h, while being warming up to-15 ℃, be incubated 12h, while being warming up to 0 ℃, be incubated 3h, while being warming up to 10 ℃, be incubated 2h, finally be warming up to 45 ℃ and be dried, keep 12h and get final product.
The kind of 2.3 caffolding agents and the investigation of consumption
In order to prevent that medicine from disperseing during evacuation in lyophilization together with water vapour, or the loose structure of fuzz after dry, and after guaranteeing to redissolve, in lyophilizing stock solution, the content of each effective ingredient is constant, often need to add suitable caffolding agent.It is caffolding agent that inventor has selected cheap and easy to get, conventional glucose, lactose, mannitol, observes face shaping, color and the redispersibility of lyophilized injectable powder, screens suitable caffolding agent and consumption.The results are shown in Table 9-10.
The kind of table 9 powder pin shaped support agent and the investigation result of consumption
Table 10 freeze-dried powder structural synthesis evaluation criterion
By above-mentioned experiment appraisal result, shown, the difference in appearance of different types of caffolding agent and proportioning obtained freeze-drying product is very large, simultaneously, redispersibility is also affected very large, the jitter time of general glucose is the shortest, but rack forming effect is the poorest, and the rack forming best results of mannitol, jitter time is slightly long compared with other two kinds, but can meet the requirement of injectable powder to jitter time, and the rack forming effect of lactose and jitter time are respectively between glucose and mannitol.Consider, the whole mark of dried frozen aquatic products that mannitol is caffolding agent is high compared with the mark of other caffolding agent, so choose mannitol, is caffolding agent, and consumption is 5% of the former opaque amount of lyophilizing.
Experimental example 2: pharmacodynamic study.
The present invention with the injection freeze-dried powder recorded in " name is called: injection preparation of ' Zhenqi and preparation method thereof, application number is: 200510012502.7 " for contrast medicine.The method preparation that this contrast medicine is recorded according to embodiment in above-mentioned patent application 1; Facing the used time dissolves and dilutes with 5% glucose injection.
Of the present invention group according to method preparation described in the embodiment of the present invention 2; Facing the used time dissolves and dilutes with 5% glucose injection.
1. the immunoregulation effect comparison of pair immunologic hypofunction mice
60 of kunming mices, are divided into 4 groups at random, are respectively normal group (A), cyclophosphamide immunologic hypofunction group (B), cyclophosphamide immunologic hypofunction+matched group (C), cyclophosphamide immunologic hypofunction+of the present invention group (D); Mouse peritoneal injection cyclophosphamide is manufactured to the low drag of immunity function, adopt carbon to clean up the phagocytic function that experiment detects mouse macrophage, measure phagocytic index and activate the phagocytic capacity; The quantitative haemolysis algoscopy of sheep red blood cell (SRBC) is measured serum hemolysin.Phagocytic index K=(log
oD1-log
oD2)/(t
1-t
2), OD in formula
1, OD
2for the optical density of different time institute blood sampling, t
1-t
2for getting the time difference of two blood samples; Activate the phagocytic capacity a=K
1/3* body weight/(liver weight+spleen weight).Experimental result in Table 11, table 12.
Table 11 affects immunologic hypofunction nonspecific immunity of mice
Note: compare with A group,
□p < 0.01
Compare with B group,
*p < 0.05,
*p < 0.01;
Compare with C group,
#p < 0.05
Known according to table 11 result: of the present invention group is starkly lower than normal group with matched group to phagocytic index and the activate the phagocytic capacity of the low mice of cyclophosphamide immunity function, but obviously improve to some extent phagocytic index and the activate the phagocytic capacity (P < 0.01 or P < 0.05) of hypoimmunity mice.With matched group (C group) relatively, the present invention's (D group) improve the phagocytic index of hypoimmunity mice and activate the phagocytic capacity more obviously, outstanding (P < 0.05).
Table 12 forms impact to immunologic hypofunction mice serum hemolysin
Note: compare with A group,
□p < 0.01
Compare with B group,
*p < 0.05,
*p < 0.01;
Compare with C group,
#p < 0.05
From table 12 experimental result: with normal group comparison, cyclophosphamide group mice half hemolysis value obviously reduces (P < 0.01), and of the present invention group is all improved the half haemolysis value (P < 0.01 or P < 0.05) of hypoimmunity mice to some extent with matched group.Compare with matched group (C group), the half haemolysis value that the present invention's (D group) improves hypoimmunity mice is more remarkable.
2. conclusion: the curative effect of freeze-dried powder of the present invention is better than contrasting freeze-dried powder.
Compared with prior art, ejection preparation of the present invention is evident in efficacy, good stability, the selection principle that meets modern formulation " quick-acting, efficient, dosage is little " is the developing direction of modern Chinese medicine, compare a lot of advantages with traditional oral formulations, reached goal of the invention.
The specific embodiment
Embodiment 1:
Prescription: Radix Astragali 50g, Fructus Ligustri Lucidi 25g.
Technique: in writing out a prescription, two taste Chinese medicines are cleaned, the water of 10 times of recipe quantities of take is solvent, 100 ℃ of heating extraction 3 times, each 90min, merge extractive liquid,, filters, and filtrate is condensed into concentrated solution; Add 95% ethanol to reaching 90% containing alcohol amount, standing 12h, filters, and filtrate for later use is crossed hollow fiber column ultrafilter after precipitation is dissolved in water and processed, and molecular cut off is greater than the composition of 6KDa, is evaporated to dryly, is ground into 80 order fine powders, obtains polysaccharide effective site, standby; Precipitate with ethanol gained supernatant is evaporated to without being dissolved in water for injection after alcohol taste, with AB-8 type macroporous resin adsorption 12h, with 30%～95% ethanol, press the flow-rate gradient elution of 2.0BV/h, eluent is concentrated into the clear paste that 60 ℃ of relative densities are 1.28,50 ℃ of drying under reduced pressure, be ground into 80 order fine powders, obtain saponins, flavonoid, terpenoid effective site; Mix with above-mentioned polysaccharide effective site, add the Tween 80 of 0.1%～2% recipe quantity, mix, with the water for injection of preparation amount 85%, dissolve, with citric acid, adjust PH to 7.0～7.3, add 0.2% injection active carbon, heating 30min, decompress filter, inject water to again 1000ml, the filtering with microporous membrane of 0.45 μ m, embedding, adopt 121 ℃ of sterilizing 30min of moist hear heat test, obtain injection.
Drug effect: boosting qi and nourishing yin, deficient for prolonged illness, deficiency of both vital energy and Yin.Coordinate operation, radiotherapy, chemotherapy, promote the recovery of normal function.
Specification: every 10ml.
Usage and dosage: intravenous drip, a 50～100ml, to use after 0.9% sodium chloride or 5～10% glucose injection 400～450ml dilution, 1 time on the one.It within 30 days, is a course for the treatment of.
Embodiment 2:
Prescription: Radix Astragali 80g, Fructus Ligustri Lucidi 40g.
Technique: in writing out a prescription, two taste Chinese medicines are cleaned, the water of 10 times of recipe quantities of take is solvent, 100 ℃ of heating extraction 3 times, each 90min, merge extractive liquid,, filters, and filtrate is condensed into concentrated solution; Add 95% ethanol to reaching 90% containing alcohol amount, standing 12h, filters, and filtrate for later use is crossed hollow fiber column ultrafilter after precipitation is dissolved in water and processed, and molecular cut off is greater than the composition of 6KDa, is evaporated to dryly, is ground into 80 order fine powders, obtains polysaccharide effective site, standby; Precipitate with ethanol gained supernatant is evaporated to without being dissolved in water for injection after alcohol taste, with AB-8 type macroporous resin adsorption 12h, with 30%～95% ethanol, press the flow-rate gradient elution of 2.0BV/h, eluent is concentrated into the clear paste that 60 ℃ of relative densities are 1.28,50 ℃ of drying under reduced pressure, be ground into 80 order fine powders, obtain saponins, flavonoid, terpenoid effective site; Merge all effective site, add the Tween 80 of 0.1%～2% recipe quantity, mix; Separately get the mannitol of all effective site total amounts 5%, with the water for injection of preparation amount 85%, dissolve; Both mix, and heated and stirred makes to dissolve, and with citric acid, adjusts PH to 7.0～7.3, add again 0.2% injection active carbon, heating 30min, decompress filter, inject water to 1000ml, the filtering with microporous membrane of 0.22 μ m, is sub-packed in aseptic cillin bottle,-15 ℃ of pre-freeze 2.5h ,-30 ℃ of pre-freeze 2h, are incubated 12h while being warming up to-15 ℃, while being warming up to 0 ℃, be incubated 3h, while being warming up to 10 ℃, be incubated 2h, be finally warming up to 45 ℃ and be dried, keep 12h, obtain injection freeze-dried powder.
Drug effect: boosting qi and nourishing yin, deficient for prolonged illness, deficiency of both vital energy and Yin.Coordinate operation, radiotherapy, chemotherapy, promote the recovery of normal function.
Specification: every 500mg.
Usage and dosage: intravenous drip.Each per kilogram of body weight 60mg, 1 time on the one, or follow the doctor's advice.Before use, first with appropriate sterilized water for injection, fully dissolve, then dilute with sodium chloride injection or 5% glucose injection 500ml.
Embodiment 3:
Prescription: Radix Astragali 30g, Fructus Ligustri Lucidi 15g.
Technique: in writing out a prescription, two taste Chinese medicines are cleaned, the water of 10 times of recipe quantities of take is solvent, 100 ℃ of heating extraction 3 times, each 90min, merge extractive liquid,, filters, and filtrate is condensed into concentrated solution; Add 95% ethanol to reaching 90% containing alcohol amount, standing 12h, filters, and filtrate for later use is crossed hollow fiber column ultrafilter after precipitation is dissolved in water and processed, and molecular cut off is greater than the composition of 6KDa, is evaporated to dryly, is ground into 80 order fine powders, obtains polysaccharide effective site, standby; Precipitate with ethanol gained supernatant is evaporated to without being dissolved in water for injection after alcohol taste, with AB-8 type macroporous resin adsorption 12h, with 30%～95% ethanol, press the flow-rate gradient elution of 2.0BV/h, eluent is concentrated into the clear paste that 60 ℃ of relative densities are 1.28,50 ℃ of drying under reduced pressure, be ground into 80 order fine powders, obtain saponins, flavonoid, terpenoid effective site; Mix with above-mentioned polysaccharide effective site, add the Tween 80 of 0.1%～2% recipe quantity, mix, with the water for injection of preparation amount 85%, dissolve, with citric acid, adjust PH to 7.0～7.3, add 0.2% injection active carbon, heating 30min, decompress filter, inject water to again 1000ml, the filtering with microporous membrane of 0.45 μ m, embedding, adopt 121 ℃ of sterilizing 30min of moist hear heat test, obtain injection.
Drug effect: boosting qi and nourishing yin, deficient for prolonged illness, deficiency of both vital energy and Yin.Coordinate operation, radiotherapy, chemotherapy, promote the recovery of normal function.
Specification: every 10ml.
Usage and dosage: intravenous drip, a 50～100ml, to use after 0.9% sodium chloride or 5～10% glucose injection 400～450ml dilution, 1 time on the one.It within 30 days, is a course for the treatment of.
Claims (7)
1. a body resistance-strengthening Zhenqi ejection preparation, is characterized in that: according to composition by weight, calculate, it is prepared from by Radix Astragali 30-80 part, Fructus Ligustri Lucidi 15-40 part and adjuvant.
2. body resistance-strengthening Zhenqi ejection preparation according to claim 1, is characterized in that: according to composition by weight, calculate, it is prepared from by 50 parts of the Radixs Astragali, 25 parts of Fructus Ligustri Lucidi and adjuvant.
3. the method for preparing body resistance-strengthening Zhenqi ejection preparation described in claim 1 or 2, is characterized in that: in writing out a prescription, two taste Chinese medicines are cleaned, and take water as solvent heating extraction, and extracting solution filters, and filtrate is condensed into concentrated solution; Add ethanol to reaching 90% containing alcohol amount, standing, filter, filtrate for later use, crosses hollow fiber column ultrafilter after precipitation is dissolved in water and processes, and molecular cut off is greater than the composition of 6KDa, is evaporated to dryly, pulverizes, and obtains polysaccharide effective site, standby; Precipitate with ethanol gained supernatant is evaporated to without being dissolved in water for injection after alcohol taste, by macroporous resin adsorption, ethanol gradient elution with 30%～95%, eluent is condensed into clear paste, and drying under reduced pressure is ground into fine powder, obtain saponins, flavonoid, terpenoid effective site, mix with above-mentioned polysaccharide effective site, then add pharmaceutically acceptable adjuvant to combine, and make corresponding ejection preparation according to conventional preparation method.
4. the preparation method of body resistance-strengthening Zhenqi ejection preparation as claimed in claim 3, is characterized in that: in writing out a prescription, two taste Chinese medicines are cleaned, and the water of 10 times of recipe quantities of take is solvent, 100 ℃ of heating extraction 3 times, each 90min, merge extractive liquid,, filter, filtrate is condensed into concentrated solution; Add 95% ethanol to reaching 90% containing alcohol amount, standing 12h, filters, and filtrate for later use is crossed hollow fiber column ultrafilter after precipitation is dissolved in water and processed, and molecular cut off is greater than the composition of 6KDa, is evaporated to dryly, is ground into 80 order fine powders, obtains polysaccharide effective site, standby; Precipitate with ethanol gained supernatant is evaporated to without being dissolved in water for injection after alcohol taste, with AB-8 type macroporous resin adsorption 12h, with 30%～95% ethanol, press the flow-rate gradient elution of 2.0BV/h, eluent is concentrated into the clear paste that 60 ℃ of relative densities are 1.28,50 ℃ of drying under reduced pressure, be ground into 80 order fine powders, obtain saponins, flavonoid, terpenoid effective site, mix with above-mentioned polysaccharide effective site, add again pharmaceutically acceptable adjuvant to combine, and make corresponding ejection preparation according to conventional preparation method.
5. the preparation method of body resistance-strengthening Zhenqi ejection preparation as described in claim 3 or 4, is characterized in that: described ejection preparation is injection or injection freeze-dried powder.
6. the preparation method of body resistance-strengthening Zhenqi ejection preparation as claimed in claim 5, it is characterized in that: described injection is prepared like this: in writing out a prescription, two taste Chinese medicines are cleaned, the water of 10 times of recipe quantities of take is solvent, 100 ℃ of heating extraction 3 times, each 90min, merge extractive liquid,, filters, and filtrate is condensed into concentrated solution; Add 95% ethanol to reaching 90% containing alcohol amount, standing 12h, filters, and filtrate for later use is crossed hollow fiber column ultrafilter after precipitation is dissolved in water and processed, and molecular cut off is greater than the composition of 6KDa, is evaporated to dryly, is ground into 80 order fine powders, obtains polysaccharide effective site, standby; Precipitate with ethanol gained supernatant is evaporated to without being dissolved in water for injection after alcohol taste, with AB-8 type macroporous resin adsorption 12h, with 30%～95% ethanol, press the flow-rate gradient elution of 2.0BV/h, eluent is concentrated into the clear paste that 60 ℃ of relative densities are 1.28,50 ℃ of drying under reduced pressure, be ground into 80 order fine powders, obtain saponins, flavonoid, terpenoid effective site; Mix with above-mentioned polysaccharide effective site, add the Tween 80 of 0.1%～2% recipe quantity, mix, with the water for injection of preparation amount 85%, dissolve, with citric acid, adjust PH to 7.0～7.3, add 0.2% injection active carbon, heating 30min, decompress filter, inject water to again recipe quantity, the filtering with microporous membrane of 0.45 μ m, embedding, adopt 121 ℃ of sterilizing 30min of moist hear heat test, obtain.
7. the preparation method of body resistance-strengthening Zhenqi ejection preparation as claimed in claim 5, it is characterized in that: described injection freeze-dried powder is prepared like this: in writing out a prescription, two taste Chinese medicines are cleaned, the water of 10 times of recipe quantities of take is solvent, 100 ℃ of heating extraction 3 times, each 90min, merge extractive liquid,, filters, and filtrate is condensed into concentrated solution; Add 95% ethanol to reaching 90% containing alcohol amount, standing 12h, filters, and filtrate for later use is crossed hollow fiber column ultrafilter after precipitation is dissolved in water and processed, and molecular cut off is greater than the composition of 6KDa, is evaporated to dryly, is ground into 80 order fine powders, obtains polysaccharide effective site, standby; Precipitate with ethanol gained supernatant is evaporated to without being dissolved in water for injection after alcohol taste, with AB-8 type macroporous resin adsorption 12h, with 30%～95% ethanol, press the flow-rate gradient elution of 2.0BV/h, eluent is concentrated into the clear paste that 60 ℃ of relative densities are 1.28,50 ℃ of drying under reduced pressure, be ground into 80 order fine powders, obtain saponins, flavonoid, terpenoid effective site; Merge all effective site, add the Tween 80 of 0.1%～2% recipe quantity, mix; Separately get the mannitol of all effective site total amounts 5%～10%, with the water for injection of preparation amount 85%, dissolve; Both mix, and heated and stirred makes to dissolve, and with citric acid, adjusts PH to 7.0～7.3, add again 0.2% injection active carbon, heating 30min, decompress filter, inject water to recipe quantity, the filtering with microporous membrane of 0.22 μ m, is sub-packed in aseptic cillin bottle,-15 ℃ of pre-freeze 2.5h ,-30 ℃ of pre-freeze 2h, are incubated 12h while being warming up to-15 ℃, while being warming up to 0 ℃, be incubated 3h, while being warming up to 10 ℃, be incubated 2h, be finally warming up to 45 ℃ and be dried, keep 12h, obtain.
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Application publication date: 20140226 |