CN101049332A - Method for preparing injection preparation of freeze drying powder of Xuesaitong - Google Patents
Method for preparing injection preparation of freeze drying powder of Xuesaitong Download PDFInfo
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Abstract
A freeze-dried powder injection 'Xuesaitong' for treating thrombus is prepared from notoginseng through reflux extracting in alcohol, adsorbing by macroreticular resin, filtering to obtain liquid extract, adding precipient, and freeze-drying.
Description
Technical field
The present invention relates to a kind of preparation method of injection preparation of freeze drying powder of Xuesaitong, belong to field of traditional Chinese.
Background technology
Radix Notoginseng claims Radix Notoginseng, Panax pseudoginseng, Radix Stephaniae Sinicae (Radix Stephaniae Dielsianae), mountain lacquer again, is araliaceae ginseng plant Panax notoginseng (Burk) F.H.Chen.; Be the distinctive medical material kind of China, since Compendium of Material Medica is included, the history in existing 500 years, Li Shizhen (1518-1593 A.D.) is said: " give birth in kind cave remote mountains, all states, Nandan, Guangxi, it is dried cruelly to adopt root, yellow black.Unity thing, shape are slightly like Pseudobulbus Bletillae (Rhizoma Bletillae); Elder such as old Radix Rehmanniae have joint.It is little sweet and bitter to distinguish the flavor of, quite seemingly the flavor of Radix Ginseng ".Supplementary Amplifications of the Compendium of Materia Medica is said: " ginseng qi-tonifying the first, Radix Notoginseng enrich blood the first, are the most precious person of Chinese medicine ".
Radix Notoginseng have invigorate blood circulation, effect such as pain relieving, hemostasis, blood stasis dispelling, detumescence.Be usually used in treating traumatic injury, postpartum stagnation, metrorrhagia, amenorrhea and various hemorrhage.
Radix Notoginseng is described as " king of Radix Ginseng " by people, its total saponin content is about 12%, is the main pharmacological component of Radix Notoginseng; Now from Radix Notoginseng, separate and obtain 20 kinds of dammarane (Dammarane) type saponin, difference according to prosapogenins structure after the hydrolysis, be divided into ginsenoside (Ginsenoside) Rg, Rb, Ro, three types, comprise: ginsenoside Rg1, Rg2, Rb1, Rb2, Rb3, Rc, Rd, Re, Rh, F2, arasaponin R1, R2, R3, R6, Fa, Fc, Fe, R4 etc.; And contain Radix Notoginseng flavone A, Radix Notoginseng flavone B, volatile oil, alkaloid, polysaccharide, aminoacid-β-oxalyl group-L-a, β-diaminopropionic acid effective ingredient such as (deneichine).
Therefore, the extracting method for compound components of panax notoginseng has a lot of researchs and report.Such as, patent documentation 200310104043.6, denomination of invention is a kind of preparation method of Radix Notoginseng total arasaponins injection, the filtration step of this method all adopts membrane separating method or microfiltration method.They can be according to the different sizes of the effective ingredient of medicinal liquid, microorganism, microgranule, selecting the molecular cut off scope for use is 1500 to 10,0000 film material to the impurity in the injection, microorganism (invalid components and pyrogen material) is undertaken once by its molecular weight size or gradation is held back, and realize to remove impurity and microorganism.
Patent documentation 02131193.5, the extracting method of denomination of invention arasaponin, utilize strong polar macroporous adsorption resin that the effective ingredient of Radix Notoginseng is carried out separation and purification, in the product in the arasaponin content of each monomer saponin be ginsenoside Rg1 〉=30%, Re 〉=5.0%, Rb1 〉=5.0% and arasaponin R1 〉=20.0%.
Patent documentation 200510049903.X, denomination of invention is to extract the method for saponin active ingredient from Radix Notoginseng, be to be 20～80 orders with the pseudo-ginseng grinding particle size, respectively take by weighing 10g and put into A, B, C, a D extraction pot, in the D jar, add 5～10 times of volumes, 35～90% alcoholic solution, temperature rise to 35～80 ℃, and the stage is extracted 20～60min.Carry out the extraction of D, C, B, A jar successively, the active constituent content of extracting solution in A, B, four jars of C, D is successively decreased successively.Subsequently, when a certain extraction time in stage finished, the jar that has extracted four times medical material place carried out deslagging and dosing, and the extracting solution effective ingredient is the highest carries out discharge opeing, and other extracting solution is according to oppositely moving every a unit.After carrying out four circulations, merge extractive liquid.
Patent documentation 99106223.X, the production technology of the refining XUESAITONG ZHUSHEYE of denomination of invention comprises 1, the Radix Notoginseng crude drug is decocted 2 times; 2. filtrate is merged, concentrate, and add ethanol; 3. cold preservation is placed after solution being crossed resin column; 4. recovery ethanol; 5. filtering with microporous membrane is regulated pH; 6. concentrated, drying obtains the Radix Notoginseng total arasaponins powder; 7. the Radix Notoginseng total arasaponins powder mixes with water for injection, transfers pH; 8. solution boils, and adds active carbon; 9. filter and fine straining.
Patent documentation 200510090732.5, denomination of invention is a kind of injection preparation of freeze drying powder of Xuesaitong (comprising dedicated solvent) and technology and indication, the preparation that is obtained by the document needs to add the dedicated solvent dissolving before use, use inconvenient, easily pollute and dedicated solvent for containing the alcoholic acid injection solution of 35%-45%, be not suitable for ethanol crowd hypersensitive.
Therefore, research worker is carried out the injection preparation of freeze drying powder of Xuesaitong process modification on this basis, uses to be applicable to the ethanol allergy sufferers.
Summary of the invention
The preparation method that the purpose of this invention is to provide a kind of injection preparation of freeze drying powder of Xuesaitong has solved and need add the dedicated solvent dissolving before existing panax notoginseng saponins for injection is used, and uses inconvenience, problems such as easy pollution, and be applicable to the ethanol allergy sufferers.
In order to realize the object of the invention, the preparation method of a kind of injection preparation of freeze drying powder of Xuesaitong of the present invention comprises the steps:
1) Radix Notoginseng is pulverized, add 1～4 times of amount 70～95% soak with ethanol 12～48 hours, heating and refluxing extraction at least 2 times each 1～3 hour, is filtered; Merging filtrate reclaims ethanol, adds purified water and is diluted to 0.20～0.40g (crude drug)/ml, leaves standstill 12～48 hours after-filtration, gets filtrate;
2) filtrate is crossed macroporous adsorptive resins absorption with the flow velocity of 1.2～1.4BV/h (BV is the resin admission space) then, purified water flushing resin column with 1～3 times of amount of resin, 60～80% soak with ethanol resins of using 1～3 times of amount of resin then are after 30～60 minutes, with 60～80% ethanol of 4～6 times of amounts of resin flow velocity eluting, the purified water flushing resin column of 1～3 times of amount of reuse resin with 1.0～1.2BV/h; Collect eluent and flushing liquor, flow velocity with 6.0～6.5BV/h is crossed decolorizing resin, 85～95% the ethanol that adds 1～3 times of amount of resin again is with identical flow velocity flushing resin column, merge just flow liquid and eluent, the active carbon that adds crude drug weight 1～3% was in 30～50 ℃ of insulation decolourings 40～60 minutes, filter, reclaim ethanol to there not being the alcohol flavor; Add water for injection again and be diluted to the solution of 1～2g (crude drug)/ml, fill, sterilization, cold preservation 3～9 days, room temperature was placed 30～60 days;
3) again with medicinal liquid through 0.45～0.65 μ m membrane filtration, in adjust pH to 5.5～6.5 below 50 ℃, the post-heating to 75 that stirs～85 ℃ add 0.1～0.3% active carbon, boiled 10～25 minutes, be cooled to room temperature, adjust pH to 5.5～6.5, fill behind 0.2 μ m membrane filtration, the inflated with nitrogen gland, sterilization is refrigerated to icingly, places 3～5 months in shady and cool place of lucifuge or room temperature after changing ice;
4) medicinal liquid after the negative catalysis is diluted to concentration by Radix Notoginseng total arasaponins 0.15～0.25g/ml with water for injection, heated and boiled is filtered, lyophilization, or be ground into fine powder after the lyophilization promptly.
Wherein, add excipient in the medicinal liquid after the step 4) negative catalysis, after adding the injection water earlier and making excipient dissolving, add activated carbon decolorizing again, filter aqueous solution; Aqueous solution is joined in the medicinal liquid after the negative catalysis, be diluted to every 1ml with water for injection and contain Radix Notoginseng total arasaponins 0.15～0.25g, excipient 1.5～12.5mg, heated and boiled is filtered, lyophilization, or be ground into fine powder after the lyophilization promptly.
Described excipient is mannitol, lactose or glucosan etc.
The backflow number of times is three times in the step 1), preferably, adds 2 times of amount 90% soak with ethanol Radix Notoginseng 12 hours, and heating and refluxing extraction 2 hours is filtered; Add 1.5 times of amount 90% alcohol reflux 1.5 hours again, filter; Extract again 1 time with method.
Step 2) adsorption column described in is the D-101 macroporous adsorptive resins, and described decolorizing resin post is a D900 decolorizing resin post.
By the injection preparation of freeze drying powder of Xuesaitong that method of the present invention obtains, pilot process need not drying under reduced pressure and becomes powder, can directly be got through lyophilization by extracting solution, not only simplified technical process, save cost, and can avoid bringing into impurity, improved its dissolubility.The interpolation of excipient not only is beneficial to the lyophilizing molding, also can improve the dissolubility of preparation, thereby need not to add dedicated solvent, directly it is dissolved fully with sodium chloride or glucose injection, be applicable to that to ethanol patient hypersensitive, safety easy to use has reduced the pollution probability.
The specific embodiment
Following examples are used to illustrate the present invention, but are not used for limiting the scope of the invention.
Embodiment 1
1. Radix Notoginseng extraction process
Get the Radix Notoginseng clip, pulverize, add 2 times of amount 90% soak with ethanol 12 hours, heating and refluxing extraction 2 hours is filtered; Add 1.5 times of amount 90% alcohol reflux 1.5 hours again, filter, extract again once with method, merge three times filtrate recycling ethanol, add purified water and be diluted to 0.25g (crude drug)/ml, leave standstill 12 hours after-filtration, filtrate is crossed the absorption of D-101 macroporous adsorptive resins with the flow velocity of 1.3 ± 0.1BV/h, purified water flushing resin column with 1 times of amount of resin, the 70% soak with ethanol resin of using 1 times of amount of resin then is after 30 minutes, with 70% ethanol of 4 times of amounts of resin flow velocity eluting, the purified water flushing resin column of 1 times of amount of reuse resin with 1.0BV/h.Collect eluent and flushing liquor, cross the D900 decolorizing resin with the flow velocity of 6.0BV/h, 85% the ethanol that adds 1 times of amount of resin again is with identical flow velocity flushing resin column, merge just flow liquid and eluent, the active carbon that adds crude drug weight 2% was in 40 ℃ of insulation decolourings 40 minutes, filter, reclaim ethanol to there not being the alcohol flavor.Add water for injection again and be diluted to the solution of 1g (crude drug)/ml, fill, 110 ℃ of sterilizations 30 minutes.Cold preservation 7 days, room temperature was placed 30 days.
With medicinal liquid through 0.45 μ m membrane filtration, in below 50 ℃ with 20%NaOH solution adjust pH to 5.7, the post-heating to 80 ℃ of stirring adds 0.15% active carbon, boiled 15 minutes, be cooled to room temperature, with 20%NaOH adjust pH to 5.7, fill behind 0.2 μ m filter membrane fine straining, the inflated with nitrogen gland, 115 ℃ of sterilizations 30 minutes are refrigerated to icingly, change and staticly behind the ice to be positioned over the shady and cool place of lucifuge three months.
2. the preparation technology of preparation
Medicinal liquid after the negative catalysis is diluted to concentration in Radix Notoginseng total arasaponins 0.20 ± 0.2g/ml with water for injection, heated and boiled, and 0.2 μ m membrane filtration, packing, lyophilization forms.
Embodiment 2
1. Radix Notoginseng extraction process
Get the Radix Notoginseng clip, pulverize, add 1 times of amount 95% soak with ethanol 36 hours, heating and refluxing extraction 3 hours is filtered; Add 3 times of amount 80% alcohol reflux 1 hour again, filter, merge filtrate recycling ethanol twice, add purified water and be diluted to 0.20g (crude drug)/ml, leave standstill 48 hours after-filtration, filtrate is crossed the absorption of D-101 macroporous adsorptive resins with the flow velocity of 1.2BV/h, purified water flushing resin column with 3 times of amounts of resin, the 80% soak with ethanol resin of using 2 times of amounts of resin then is after 40 minutes, with 60% ethanol of 6 times of amounts of the resin flow velocity eluting with 1.2BV/h, the purified water flushing resin column of 2 times of amounts of reuse resin.Collect eluent and flushing liquor, cross the D900 decolorizing resin with the flow velocity of 6.2BV/h, 90% the ethanol that adds 3 times of amounts of resin again is with identical flow velocity flushing resin column, merge just flow liquid and eluent, the active carbon that adds crude drug weight 1% was in 50 ℃ of insulation decolourings 50 minutes, filter, reclaim ethanol to there not being the alcohol flavor.Add water for injection again and be diluted to the solution of 1g (crude drug)/ml, fill, 110 ℃ of sterilizations 30 minutes.Cold preservation 3 days, room temperature was placed 45 days.
With medicinal liquid through 0.65 μ m membrane filtration, in below 50 ℃ with 20%NaOH solution adjust pH to 6.5, the post-heating to 85 ℃ of stirring adds 0.3% active carbon, boiled 25 minutes, be cooled to room temperature, with 20%NaOH adjust pH to 6.5, fill behind 0.2 μ m filter membrane fine straining, the inflated with nitrogen gland, 115 ℃ of sterilizations 30 minutes, be refrigerated to icing, change ice after room temperature placed 4 months.
2. the preparation technology of preparation
Get an amount of mannitol, after adding the injection water and making its dissolving, add active carbon again and stir decolouring in 15 minutes, filter Osmitrol; It is joined in the medicinal liquid after the negative catalysis, be diluted to every 1ml with water for injection and contain Radix Notoginseng total arasaponins 0.18 ± 0.02g, mannitol 6.5mg, heated and boiled, 0.2 μ m membrane filtration, packing, lyophilization forms.
Embodiment 3
1. Radix Notoginseng extraction process
Get the Radix Notoginseng clip, pulverize, add 4 times of amount 70% soak with ethanol 48 hours, heating and refluxing extraction 2.5 hours is filtered; Add 3 times of amount 85% alcohol reflux 2 hours again, filter, extract again once with method, merge three times filtrate recycling ethanol, add purified water and be diluted to 0.40g (crude drug)/ml, leave standstill 24 hours after-filtration, filtrate is crossed the absorption of D-101 macroporous adsorptive resins with the flow velocity of 1.4BV/h, purified water flushing resin column with 2 times of amounts of resin, the 60% soak with ethanol resin of using 3 times of amounts of resin then is after 60 minutes, with 80% ethanol of 5 times of amounts of resin flow velocity eluting, the purified water flushing resin column of 3 times of amounts of reuse resin with 1.0BV/h.Collect eluent and flushing liquor, cross the D900 decolorizing resin with the flow velocity of 6.5BV/h, 95% the ethanol that adds 2 times of amounts of resin again is with identical flow velocity flushing resin column, merge just flow liquid and eluent, the active carbon that adds crude drug weight 3% was in 30 ℃ of insulation decolourings 60 minutes, filter, reclaim ethanol to there not being the alcohol flavor.Add water for injection again and be diluted to the solution of 2g (crude drug)/ml, fill, 110 ℃ of sterilizations 30 minutes.Cold preservation 9 days, room temperature was placed 60 days.
With medicinal liquid through 0.45 μ m membrane filtration, in below 50 ℃ with 20%NaOH solution adjust pH to 5.5, the post-heating to 75 ℃ of stirring adds 0.1% active carbon, boiled 10 minutes, be cooled to room temperature, with 20%NaOH adjust pH to 5.5, fill behind 0.2 μ m filter membrane fine straining, the inflated with nitrogen gland, 115 ℃ of sterilizations 30 minutes are refrigerated to icingly, change and staticly behind the ice to be positioned over the shady and cool place of lucifuge 5 months.
2. the preparation technology of preparation
Get an amount of lactose, after adding the injection water and making its dissolving, add active carbon again and stir decolouring in 15 minutes, filter lactose aqueous solution; It is joined in the medicinal liquid after the negative catalysis, be diluted to every 1ml with water for injection and contain Radix Notoginseng total arasaponins 0.18 ± 0.02g, lactose 1.5mg, heated and boiled, 0.2 μ m membrane filtration, packing, lyophilization forms.
Embodiment 4
Basic process is with embodiment 1, and different is in the process of preparation preparation, to add glucosan 12.5mg in every 1ml solution.
Experimental example
This experimental example is to study the dissolubility and the stability of injection preparation of freeze drying powder of Xuesaitong.
1. particulate matter inspection: get the injection preparation of freeze drying powder of Xuesaitong each 1 (200mg) that adopts embodiment 1-3 method to obtain, add the microgranule inspection and contain the solution that Radix Notoginseng total arasaponins is 0.8mg among every 1ml with purifying waste water to make, do blank with coordinative solvent, check (an appendix IX of Chinese Pharmacopoeia version in 2005 R) in accordance with the law, contain the above microgranule of 10 μ m and must not cross 6000, contain the above microgranule of 25 μ m and must not cross 600.Actual result is for seeing Table 1:
Table 1
| Sample | The microgranule (individual/as to prop up) that 10 μ m are above | The microgranule (individual/as to prop up) that 25 μ m are above |
| 1 | 682 | 56 |
| 2 | 703 | 67 |
| 3 | 655 | 63 |
2. study on the stability: three samples were placed 30 months, respectively get 1 add 6ml sodium chloride or glucose injection after, sample can dissolve fully, places a period of time (18 hours) and does not see and separate out that every inspection is all up to specification.
Conclusion: injection preparation of freeze drying powder of Xuesaitong of the present invention does not have the need of special dissolvant dissolving, and it is easy to dissolving and good stability.
Claims (5)
1. the preparation method of an injection preparation of freeze drying powder of Xuesaitong is characterized in that, comprises the steps:
1) Radix Notoginseng is pulverized, add 1～4 times of amount 70～95% soak with ethanol 12～48 hours, heating and refluxing extraction at least 2 times each 1～3 hour, is filtered; Merging filtrate reclaims ethanol, adds purified water and is diluted to 0.20～0.40g (crude drug)/ml, leaves standstill 12～48 hours after-filtration, gets filtrate;
2) filtrate is crossed macroporous adsorptive resins absorption with the flow velocity of 1.2～1.4BV/h then, purified water flushing resin column with 1～3 times of amount of resin, 60～80% soak with ethanol resins of using 1～3 times of amount of resin then are after 30～60 minutes, with 60～80% ethanol of 4～6 times of amounts of resin flow velocity eluting, the purified water flushing resin column of 1～3 times of amount of reuse resin with 1.0～1.2BV/h; Collect eluent and flushing liquor, flow velocity with 6.0～6.5BV/h is crossed decolorizing resin, 85～95% the ethanol that adds 1～3 times of amount of resin again is with identical flow velocity flushing resin column, merge just flow liquid and eluent, the active carbon that adds crude drug weight 1～3% was in 30～50 ℃ of insulation decolourings 40～60 minutes, filter, reclaim ethanol to there not being the alcohol flavor; Add water for injection again and be diluted to the solution of 1～2g (crude drug)/ml, fill, sterilization, cold preservation 3～9 days, room temperature was placed 30～60 days;
3) again with medicinal liquid through 0.45～0.65 μ m membrane filtration, in adjust pH to 5.5～6.5 below 50 ℃, the post-heating to 75 that stirs～85 ℃ add 0.1～0.3% active carbon, boiled 10～25 minutes, be cooled to room temperature, adjust pH to 5.5～6.5, fill behind 0.2 μ m membrane filtration, the inflated with nitrogen gland, sterilization is refrigerated to icingly, places 3～5 months in shady and cool place of lucifuge or room temperature after changing ice;
4) medicinal liquid after the negative catalysis is diluted to concentration by Radix Notoginseng total arasaponins 0.15～0.25g/ml with water for injection, heated and boiled is filtered, lyophilization, or be ground into fine powder after the lyophilization promptly.
2. the preparation method of injection preparation of freeze drying powder of Xuesaitong according to claim 1 is characterized in that, adds excipient in the medicinal liquid after the step 4) negative catalysis, after adding the injection water earlier and making excipient dissolving, adds activated carbon decolorizing again, filter aqueous solution; Aqueous solution is joined in the medicinal liquid after the negative catalysis, be diluted to every 1ml with water for injection and contain Radix Notoginseng total arasaponins 0.15～0.25g, excipient 1.5～12.5mg, heated and boiled is filtered, lyophilization, or be ground into fine powder after the lyophilization promptly.
3. the preparation method of injection preparation of freeze drying powder of Xuesaitong according to claim 2 is characterized in that, described excipient is any one in mannitol, lactose or the glucosan.
4. according to the preparation method of any described injection preparation of freeze drying powder of Xuesaitong of claim 1-3, it is characterized in that the backflow number of times is three times in the step 1), preferably, add 2 times of amount 90% soak with ethanol Radix Notoginseng 12 hours, heating and refluxing extraction 2 hours is filtered; Add 1.5 times of amount 90% alcohol reflux 1.5 hours again, filter; Extract again 1 time with method.
5. according to the preparation method of any described injection preparation of freeze drying powder of Xuesaitong of claim 1-4, it is characterized in that step 2) described in adsorption column be the D-101 macroporous adsorptive resins, described decolorizing resin post is a D900 decolorizing resin post.
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| CN102145034A (en) * | 2011-04-14 | 2011-08-10 | 云南文山七丹药业股份有限公司 | Fresh radix notoginseng extract, preparation method and medicinal prescription of fresh radix notoginseng extract |
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| CN103550272A (en) * | 2013-10-25 | 2014-02-05 | 深圳市朗欧生物医药有限公司 | Panax notoginseng composition injection and preparation method thereof |
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| CN105125609B (en) * | 2015-09-30 | 2019-01-15 | 桂林三宝药业有限公司 | A method of extracting notoginseng total saponin from Radix Notoginseng |
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