CN104257615A - Dezocine freeze-dried pharmaceutical composition and preparation method thereof - Google Patents
Dezocine freeze-dried pharmaceutical composition and preparation method thereof Download PDFInfo
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- CN104257615A CN104257615A CN201410470463.4A CN201410470463A CN104257615A CN 104257615 A CN104257615 A CN 104257615A CN 201410470463 A CN201410470463 A CN 201410470463A CN 104257615 A CN104257615 A CN 104257615A
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Abstract
The invention discloses a dezocine freeze-dried pharmaceutical composition, which is prepared by the steps of preparing dezocine, a cosolvent, an excipient, a stabilizing agent and a pH regulating agent into a solution and freeze-drying the solution. The prepared freeze-dried preparation disclosed by the invention is low in content of impurities, stable in quality in a storage process, and is free of an organic solvent; and the pharmaceutical composition is safer and more effective in clinical use.
Description
Technical field
The invention belongs to pharmaceutical preparations technology field, in particular to a kind of freeze-drying medicinal composition and preparation method thereof of dezocine.
Background technology
Dezocine is a kind of potent opium kind analgesics.Dezocine can alleviate postoperative pain, and its analgesia intensity, onset time is suitable with morphine with acting duration.Dezocine is white or off-white color crystalline powder, and odorless, dissolves in methanol, ethanol or glacial acetic acid, slightly molten in acetone, ethyl acetate or chloroform, almost insoluble in water, comparatively responsive to the environment such as high temperature, oxidation.
Dezocine injection has gone on the market for many years, containing antioxidant and a large amount of propylene glycol in the prescription that European patent EP 0180303B1 announces.Propylene glycol toxicity and zest less, but there is hemolytic, and dezocine untoward reaction can be increased the weight of; Deposit impurity in process after product sterilizing to increase, darken, be unfavorable for Clinical practice.
Summary of the invention
The invention provides a kind of dezocine freeze-drying medicinal composition and preparation method thereof.Said composition exists with stable solid-state composition, can substantially increase it in storage, stability in transportation, without propylene glycol, thus increase clinical safety.
The object of this invention is to provide a kind of dezocine freeze-drying medicinal composition.
Another object of the present invention is to provide the preparation method of above-mentioned dezocine freeze-drying medicinal composition.
Specifically, the invention provides a kind of freeze-drying medicinal composition of dezocine, it comprises following material, and number is according to listed as parts by weight:
Dezocine 5 ~ 20 parts
Cosolvent 3 ~ 30 parts
Excipient 5 ~ 80 parts
Stabilizing agent 0.05 ~ 1.0 part
And acid-base modifier.
In a kind of preferred embodiment of the present invention, the invention provides a kind of freeze-drying medicinal composition of dezocine, it comprises following material, and number is according to listed as parts by weight:
Dezocine 5 ~ 10 parts
Cosolvent 3 ~ 10 parts
Excipient 5 ~ 50 parts
Stabilizing agent 0.05 ~ 0.25 part
And acid-base modifier.
In embodiments of the invention, dezocine freeze-drying medicinal composition provided by the invention, wherein, described cosolvent be selected from one in lactic acid or citric acid or both, preferred cosolvent is lactic acid.
In embodiments of the invention, dezocine freeze-drying medicinal composition provided by the invention, wherein, described excipient be selected from mannitol, Dextran 40, lactose, trehalose, glucose, cyclodextrin or glycine one or more, preferred excipient is mannitol.
In embodiments of the invention, the freeze-drying medicinal composition of dezocine provided by the invention, wherein, described stabilizing agent be selected from sodium pyrosulfite, sodium sulfite, vitamin C or Cys one or more, preferred stabilizing agent is sodium pyrosulfite.
In embodiments of the invention, the freeze-drying medicinal composition of dezocine provided by the invention, wherein, the consumption of described acid-base modifier is determined by the target zone of the pH of compositions, in preparation process, with acid-base modifier, the pH value of compositions is adjusted to 3.5 ~ 5.0.Acid-base modifier is selected from the suitable acid-base modifier for pharmaceutical preparation, comprises one or more in sodium hydroxide, sodium bicarbonate, sodium hydrogen phosphate or sodium hydrogen phosphate, preferred sodium hydroxide.
In a kind of preferred embodiment of the present invention, the invention provides a kind of freeze-drying medicinal composition of dezocine, it comprises following material, and number is according to listed as parts by weight:
Dezocine 5 ~ 10 parts
Cosolvent 3 ~ 10 parts
Excipient 5 ~ 50 parts
Stabilizing agent 0.05 ~ 0.25 part
And acid-base modifier;
Wherein, described cosolvent be selected from one in lactic acid or citric acid or both, preferred cosolvent is lactic acid;
Described excipient be selected from mannitol, Dextran 40, lactose, trehalose, glucose, cyclodextrin or glycine one or more, preferred excipient is mannitol;
Described stabilizing agent be selected from sodium pyrosulfite, sodium sulfite, vitamin C or Cys one or more, preferred stabilizing agent is sodium pyrosulfite;
With acid-base modifier, the pH value of compositions is adjusted to 3.5 ~ 5.0; And, acid-base modifier be selected from sodium hydroxide, sodium bicarbonate, sodium hydrogen phosphate or sodium hydrogen phosphate one or more, preferred sodium hydroxide.
In a kind of more preferred of the present invention, the invention provides a kind of freeze-drying medicinal composition of dezocine, it comprises following material, and number is according to listed as parts by weight:
Dezocine 5 ~ 10 parts
Lactic acid 3 ~ 10 parts
5 ~ 50 parts, mannitol
Sodium pyrosulfite 0.05 ~ 0.25 part
And sodium hydroxide;
Wherein, with sodium hydroxide, the pH value of compositions is adjusted to 3.5 ~ 5.0.
On the other hand, the invention provides the preparation method of above-mentioned dezocine freeze-drying medicinal composition, comprise the following steps: be that at least one cosolvent is dissolved in (water oxygen level is less than or equal to 3.5ppm or 3.5mg/L) in the water for injection of inflated with nitrogen, add dezocine, add excipient, stabilizing agent more until completely dissolved, after this solution being filtered after regulating pH to target zone with acid-base modifier, solution is loaded in lyophilization container, lyophilization, obtains dezocine freeze-dried composition.
In a kind of preferred embodiment of the present invention, the invention provides the preparation method of above-mentioned dezocine freeze-drying medicinal composition, use partial syringe water, add cosolvent, then add and add dezocine, excipient and stabilizing agent successively, after dissolving, water for injection is added to full dose, acid-base modifier regulates pH in target zone, and after being filtered by this solution, solution loads in lyophilization container, lyophilization, obtains dezocine freeze-drying medicinal composition of the present invention.
In a kind of preferred embodiment of the present invention, the preparation method of above-mentioned dezocine freeze-drying medicinal composition provided by the invention, wherein, the volume of described partial syringe water is 50 volume % of total dosing volume before lyophilizing.
In a kind of more preferred of the present invention, the invention provides the preparation method of above-mentioned dezocine freeze-drying medicinal composition, get the water for injection (water oxygen level is less than or equal to 3.5ppm or 3.5mg/L) of preparation cumulative volume 50% inflated with nitrogen, water temperature controls below 60 DEG C, turn on agitator, cosolvent is added in material-compound tank, stirring makes to dissolve completely, reenter dezocine, be stirred to dissolve, add excipient again, after stabilizing agent stirring and dissolving, benefit adds to the full amount of water for injection, adding 1mol/L sodium hydroxide solution regulates between pH value to 3.5 ~ 5.0 of medicinal liquid, add decarburization after activated carbon adsorption 15min, pH value and the assay of intermediate medicinal liquid are carried out in sampling, after intermediate detection is qualified, filters, fill, jump a queue, lyophilization, obtain final lyophilized formulations.
In embodiments of the invention, the preparation method of above-mentioned dezocine freeze-drying medicinal composition provided by the invention, wherein, freeze-drying process is: freeze temperature control-50 DEG C ~-35 DEG C 1 ~ 3 hour, then slowly heat up, low-temperature vacuum drying about 12 ~ 15 hours, continue again to be warming up to 10 DEG C, vacuum drying 2 ~ 4 hours, make dried frozen aquatic products temperature reach standard-required, lyophilizing moisture Control is within 5%.
The dezocine freeze-drying medicinal composition that the present invention obtains is contained in the container of the existing lyophilized formulations for pharmaceutical field, can obtain the freeze-dried powder of dezocine.
Compared with prior art, organic solvent-free in dezocine freeze-drying medicinal composition prescription of the present invention, in stability put procedure, impurity is lower, and significant change does not occur color, and Clinical practice safety is higher.
Detailed description of the invention
By following specific embodiment, reader can be helped better to understand the present invention, but following example can not being interpreted as limiting the present invention, under method prerequisite of the present invention, also protection scope of the present invention being belonged to simple transformation of the present invention.
Embodiment 1:
2. preparation process
Use the water for injection of preparation cumulative volume 50%, water temperature controls below 60 DEG C, 3g lactic acid is added in water for injection, after stirring, add 5g dezocine, stirring makes to dissolve completely, water for injection is added to full dose, adding 1mol/L sodium hydroxide solution regulates between pH value to 3.5 ~ 5.0 of medicinal liquid, add decarburization after activated carbon adsorption 15min, filter, fill, partly jump a queue, lyophilization, freeze temperature control-50 DEG C ~-35 DEG C 1 ~ 3 hour, then slowly heat up, low-temperature vacuum drying about 12 ~ 15 hours, continue again to be warming up to 10 DEG C, vacuum drying 2 ~ 4 hours hours, tamponade, outlet, roll lid, obtain final lyophilized formulations.
Embodiment 2:
2. preparation process
Use the water for injection of preparation cumulative volume 50%, water temperature controls below 60 DEG C, 3g lactic acid and 0.15g sodium sulfite are added in water for injection, after stirring, add 5g dezocine, stirring makes to dissolve completely, water for injection is added to full dose, adding 1mol/L sodium carbonate liquor regulates between pH value to 3.5 ~ 5.0 of medicinal liquid, add active carbon room temperature absorption 15min after decarburization, filter, fill, partly jump a queue, lyophilization, freeze temperature control-50 DEG C ~-35 DEG C 1 ~ 3 hour, then slowly heat up, low-temperature vacuum drying about 12 ~ 15 hours, continue again to be warming up to 10 DEG C, vacuum drying 2 ~ 4 hours hours, tamponade, outlet, roll lid, obtain final lyophilized formulations.
Embodiment 3:
2. preparation process
Use the water for injection (water oxygen level is less than or equal to 3.5ppm or 3.5mg/L) of preparation cumulative volume 50% inflated with nitrogen, water temperature controls below 60 DEG C, 5g citric acid is added in water for injection, after stirring, add 5g dezocine, stirring makes to dissolve completely, add 5g Dextran 40, 5g lactose and 0.10g Cys, add to the full amount of water for injection after stirring and dissolving, adding 1mol/L sodium bicarbonate solution regulates between pH value to 3.5 ~ 5.0 of medicinal liquid, add decarburization after activated carbon adsorption 15min, filter, fill, partly jump a queue, lyophilization, freeze temperature control-50 DEG C ~-35 DEG C 1 ~ 3 hour, then slowly heat up, low-temperature vacuum drying about 12 ~ 15 hours, continue again to be warming up to 10 DEG C, vacuum drying 2 ~ 4 hours hours, tamponade, outlet, roll lid, obtain final lyophilized formulations.
Embodiment 4:
2. preparation process
Use the water for injection of preparation cumulative volume 50%, water temperature controls below 60 DEG C, 10g lactic acid is added in water for injection, after stirring, add 5g dezocine, stirring makes to dissolve completely, add 5g lactose again, 5g Dextran 40 and 0.10g sodium sulfite, add to the full amount of water for injection after stirring and dissolving, adding 1mol/L disodium phosphate soln regulates between pH value to 3.5 ~ 5.0 of medicinal liquid, add decarburization after activated carbon adsorption 15min, filter, fill, partly jump a queue, lyophilization, freeze temperature control-50 DEG C ~-35 DEG C 1 ~ 3 hour, then slowly heat up, low-temperature vacuum drying about 12 ~ 15 hours, continue again to be warming up to 10 DEG C, vacuum drying 2 ~ 4 hours hours, tamponade, outlet, roll lid, obtain final lyophilized formulations.
Embodiment 5:
2. preparation process
Use the water for injection (water oxygen level is less than or equal to 3.5ppm or 3.5mg/L) of preparation cumulative volume 50% inflated with nitrogen, water temperature controls below 60 DEG C, by 20g lactic acid, join in water for injection, after stirring, add 10g dezocine, stirring makes to dissolve completely, add 25g glucose 40 again, 25g glycine, 0.5g vitamin C, add to the full amount of water for injection after stirring and dissolving, adding 1mol/L sodium hydroxide solution regulates between pH value to 3.5 ~ 5.0 of medicinal liquid, add decarburization after activated carbon adsorption 15min, filter, fill, partly jump a queue, lyophilization, freeze temperature control-50 DEG C ~-35 DEG C 1 ~ 3 hour, then slowly heat up, low-temperature vacuum drying about 12 ~ 15 hours, continue again to be warming up to 10 DEG C, vacuum drying 2 ~ 4 hours hours, tamponade, outlet, roll lid, obtain final lyophilized formulations.
Embodiment 6:
2. preparation process
Use the water for injection (water oxygen level is less than or equal to 3.5ppm or 3.5mg/L) of preparation cumulative volume 50% inflated with nitrogen, water temperature controls below 60 DEG C, 10g lactic acid is added in water for injection, after stirring, add 5g dezocine, stirring makes to dissolve completely, add 25g mannitol and 0.10g sodium pyrosulfite again, inject after stirring and dissolving and mend to full dose with water, adding 1mol/L sodium hydroxide solution regulates between pH value to 3.5 ~ 5.0 of medicinal liquid, add decarburization after activated carbon adsorption 15min, filter, fill, partly jump a queue, lyophilization, freeze temperature control-50 DEG C ~-35 DEG C 1 ~ 3 hour, then slowly heat up, low-temperature vacuum drying about 12 ~ 15 hours, continue again to be warming up to 10 DEG C, vacuum drying 2 ~ 4 hours hours, tamponade, outlet, roll lid, obtain final lyophilized formulations.
Embodiment 7:
2. preparation process
Use the water for injection (water oxygen level is less than or equal to 3.5ppm or 3.5mg/L) of preparation cumulative volume 50% inflated with nitrogen, water temperature controls below 60 DEG C, 20g lactic acid is added in water for injection, after stirring, add 10g dezocine, stirring makes to dissolve completely, add 50g mannitol and 0.5g sodium pyrosulfite again, be stirred to dissolve, water for injection is added to full dose, adding 1mol/L sodium hydroxide solution regulates between pH value to 3.5 ~ 5.0 of medicinal liquid, add decarburization after activated carbon adsorption 15min, filter, fill, partly jump a queue, lyophilization, freeze temperature control-50 DEG C ~-35 DEG C 1 ~ 3 hour, then slowly heat up, low-temperature vacuum drying about 12 ~ 15 hours, continue again to be warming up to 10 DEG C, vacuum drying 2 ~ 4 hours hours, tamponade, outlet, roll lid, obtain final lyophilized formulations.
Embodiment 8:
2. preparation process
Use the water for injection (water oxygen level is less than or equal to 3.5ppm or 3.5mg/L) of preparation cumulative volume 50% inflated with nitrogen, water temperature controls below 60 DEG C, 30g lactic acid is added in water for injection, after stirring, add 20g dezocine, stirring makes to dissolve completely, add 80g mannitol and 1.0g sodium pyrosulfite again, be stirred to dissolve, water for injection is added to full dose, adding 1mol/L sodium hydroxide solution regulates between pH value to 3.5 ~ 5.0 of medicinal liquid, add decarburization after activated carbon adsorption 15min, filter, fill, partly jump a queue, lyophilization, freeze temperature control-50 DEG C ~-35 DEG C 1 ~ 3 hour, then slowly heat up, low-temperature vacuum drying about 12 ~ 15 hours, continue again to be warming up to 10 DEG C, vacuum drying 2 ~ 4 hours hours, tamponade, outlet, roll lid, obtain final lyophilized formulations.
Embodiment 9:
According to the more stable formula preparation small injection announced in European patent EP 0180303B1, and contrast with lyophilized formulations.
2. preparation process
Use partial syringe water, add lactic acid, add dezocine, sodium pyrosulfite and propylene glycol successively again, add to full dose by water for injection after dissolving, acid-base modifier regulates between pH to 3.5 ~ 5.0, after being filtered by this solution, solution loads in ampoule bottle, sealing by fusing, steam sterilization, obtains dezocine injection.
Embodiment 10:
Dezocine injection prepared by the dezocine freeze-drying medicinal composition prepared by embodiment 1-8 and embodiment 9, is positioned over acceleration study on the stability under 40 DEG C of lucifuge conditions.
Interpretation of result: according to the dried frozen aquatic products prepared by embodiment 4 ~ 8, accelerated test result is all good, and namely stability is better; Dried frozen aquatic products prepared by embodiment 1, not only insufficient formability, moisture is heterogeneity also, and shelf-stability is poor; Dried frozen aquatic products prepared by embodiment 2, less stable in put procedure; Dried frozen aquatic products prepared by embodiment 3, in put procedure, color sample changes, and related substance changes, less stable, and in this experiment possible, stabilizing agent can not play the effect of the oxidation suppressing principal agent; Sample prepared by embodiment 9, owing to not adding excipient, insufficient formability, moisture heterogeneity, put procedure related substance has certain increase.Product put procedure prepared by visible the present invention is all stable, considerably increases the safety of use, and good can be applicable to clinical practice.Testing result is in table 1.
Table 1 injection dezocine preparation and dezocine injection accelerated stability check result
Claims (10)
1. a dezocine freeze-drying medicinal composition, described dezocine freeze-drying medicinal composition comprises the following material calculated according to parts by weight: dezocine 5 ~ 20 parts, cosolvent 3 ~ 30 parts, excipient 5 ~ 80 parts, stabilizing agent 0.05 ~ 1.0 part and acid-base modifier.
2. dezocine freeze-drying medicinal composition according to claim 1, wherein, described dezocine freeze-drying medicinal composition comprises the following material calculated according to parts by weight: dezocine 5 ~ 10 parts, cosolvent 3 ~ 10 parts, excipient 5 ~ 50 parts, stabilizing agent 0.05 ~ 0.25 part and acid-base modifier.
3. dezocine freeze-drying medicinal composition according to claim 1, wherein, described excipient be selected from mannitol, Dextran 40, lactose, sucrose, trehalose, glucose, cyclodextrin or glycine one or more, preferably, be selected from mannitol.
4. dezocine freeze-drying medicinal composition according to claim 1, wherein, described cosolvent be selected from lactic acid or citric acid one or both, preferably, be selected from lactic acid.
5. dezocine freeze-drying medicinal composition according to claim 1, wherein, described stabilizing agent be selected from sodium pyrosulfite, sodium sulfite or vitamin C one or more, preferably, be selected from sodium pyrosulfite.
6. dezocine freeze-drying medicinal composition according to claim 1, wherein, described acid-base modifier be selected from sodium hydroxide, sodium carbonate, sodium bicarbonate or sodium hydrogen phosphate one or more, preferably, be selected from sodium hydroxide.
7. dezocine freeze-drying medicinal composition according to claim 1, wherein, the consumption of described acid-base modifier makes the final ph of this pharmaceutical composition be 3.5 ~ 5.0.
8., for the preparation of a method for the dezocine freeze-drying medicinal composition such as according to any one of claim 1-7, comprise the steps:
Be dissolved in by cosolvent in the water for injection of inflated with nitrogen, add dezocine, add excipient, stabilizing agent more until completely dissolved, after regulating pH with acid-base modifier, filter, lyophilization, obtains described dezocine freeze-drying medicinal composition.
9. method according to claim 8, wherein, described method comprises the steps:
Use partial syringe water, add cosolvent, then add dezocine, excipient and stabilizing agent successively, add to full dose after dissolving by water for injection, acid-base modifier regulates pH to filter, and lyophilization, obtains described dezocine freeze-drying medicinal composition.
10. preparation method according to claim 9, wherein, the volume of described partial syringe water is 50% of total dosing volume before lyophilizing.
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106880586A (en) * | 2015-12-16 | 2017-06-23 | 天津泰普药品科技发展有限公司 | A kind of preparation method of the dezocine injection of stabilization |
| CN108403651A (en) * | 2015-02-13 | 2018-08-17 | 扬子江药业集团有限公司 | dezocine oral preparation |
| CN111939145A (en) * | 2020-07-23 | 2020-11-17 | 深圳大学 | Application of dezocine in preparation of nicotinamide phosphoribosyltransferase inhibitor |
| EP3608306A4 (en) * | 2017-07-03 | 2021-01-20 | Shandong Danhong Pharmaceutical Co., Ltd. | Crystal form and amorphous form of dezocine analogue hydrochloride |
| CN115737571A (en) * | 2021-09-03 | 2023-03-07 | 广州市力鑫药业有限公司 | Pentazocine preparation and preparation method and application thereof |
Family Cites Families (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101147731A (en) * | 2006-11-22 | 2008-03-26 | 陈旭良 | Tramadol hydrochloride and paracetamol combined injection |
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2014
- 2014-09-15 CN CN201410470463.4A patent/CN104257615B/en active Active
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108403651A (en) * | 2015-02-13 | 2018-08-17 | 扬子江药业集团有限公司 | dezocine oral preparation |
| CN106880586A (en) * | 2015-12-16 | 2017-06-23 | 天津泰普药品科技发展有限公司 | A kind of preparation method of the dezocine injection of stabilization |
| EP3608306A4 (en) * | 2017-07-03 | 2021-01-20 | Shandong Danhong Pharmaceutical Co., Ltd. | Crystal form and amorphous form of dezocine analogue hydrochloride |
| CN111939145A (en) * | 2020-07-23 | 2020-11-17 | 深圳大学 | Application of dezocine in preparation of nicotinamide phosphoribosyltransferase inhibitor |
| CN115737571A (en) * | 2021-09-03 | 2023-03-07 | 广州市力鑫药业有限公司 | Pentazocine preparation and preparation method and application thereof |
| CN115737571B (en) * | 2021-09-03 | 2023-09-15 | 广州市力鑫药业有限公司 | Pentazocine Xin Zhiji and preparation method and application thereof |
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