CN107625772A - A kind of pharmaceutical composition of piperacillin sodium and tazobactam sodium compound - Google Patents
A kind of pharmaceutical composition of piperacillin sodium and tazobactam sodium compound Download PDFInfo
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- CN107625772A CN107625772A CN201710912669.1A CN201710912669A CN107625772A CN 107625772 A CN107625772 A CN 107625772A CN 201710912669 A CN201710912669 A CN 201710912669A CN 107625772 A CN107625772 A CN 107625772A
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- CN
- China
- Prior art keywords
- sodium
- tazobactam
- piperacillin
- pharmaceutical composition
- avocin
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Abstract
The present invention relates to a kind of pharmaceutical composition of piperacillin sodium and tazobactam sodium compound.The present invention is used as stabilizer using Sodium Caprylate, and polysorbate is used as emulsifying agent, and trehalose is effectively improved the stability of avocin and sodium-tazobactam in preparation and storing process as frozen-dried supporting agent, the effect of ensure that Clinical practice and security.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition of piperacillin sodium and tazobactam sodium compound.
Background technology
Piperacillin category penicillins broad-spectrum antibiotic, mainly made by disturbing the synthesis of bacteria cell wall to play sterilization
With, the infection being mainly used in caused by pseudomonas aeruginosa and various gram negative bacillis, but easily by bacteriogenic beta-lactam
Enzyme hydrolysis and produce drug resistance.
Tazobactam Sodium is a kind of beta-lactamase inhibitor of irreversible competitive type, and its own has without antibacterial activity
Potent Inhibitory activity, its drug effect can be strengthened and extend its action time by being shared with Piperacillin, there is obvious synergy.
Piperacillin sodium and tazobactam sodium
Piperacillin sodium and tazobactam sodium compound preparation quantity is big, curative for effect, and market prospects are good, but with most of cephalos
Bacteriums antibiotic is the same, and preparation stabilization is poor, it is impossible to meets quality requirement.
The content of the invention
It is stable the invention provides one kind in order to solve the problems, such as existing piperacillin sodium and tazobactam sodium stability difference
Piperacillin sodium and tazobactam sodium compound preparation, and provide its preparation method.
The present invention provides a kind of piperacillin sodium and tazobactam sodium composition, and it includes following component by weight：
4 parts of avocin；
1 part of sodium-tazobactam；
Polysorbate 1-5 parts；
Sodium Caprylate 2-5 parts；
Trehalose 5-20 parts.
The present invention is had as stabilizer, polysorbate using Sodium Caprylate as emulsifying agent, trehalose as frozen-dried supporting agent
The stability of avocin and sodium-tazobactam in preparation and storing process is improved to effect, and formulation dissolution is quick, protects
The effect of having demonstrate,proved Clinical practice and security.
The preparation method of the present invention is as follows：
Step (1), by polysorbate, Sodium Caprylate water for injection solvent, then adds Piperacillin under inert gas shielding
Sodium and sodium-tazobactam, it is well mixed, 90 DEG C of heating water baths are stirred to molten condition；
Aforesaid liquid is incubated under the conditions of 70-90 DEG C and uses tissue mincer shear agitation 10min, rotating speed 1 by step (2)
5000r/min, obtains colostric fluid, then through high pressure dispersing emulsification machine circulating emulsion 4 times, obtains emulsion；
Step (3) adds trehalose into emulsion, and packing is filtered after dissolving, freeze-drying, obtains piperacillin sodium and tazobactam
Sodium suspension injection powder.
Embodiment
Embodiment 1Piperacillin sodium and tazobactam sodium（4:1）The preparation of suspension injection powder
Prescription (100 bottles)：
Avocin 50g
Sodium-tazobactam 12.5g
Polysorbate 50g
Sodium Caprylate 50g
Trehalose 100g
Preparation method
Under inert gas shielding, by polysorbate, Sodium Caprylate water for injection solvent, avocin and his azoles are then added
Batan sodium, it is well mixed, 90 DEG C of heating water baths are stirred to molten condition.Aforesaid liquid is incubated under the conditions of 70-90 DEG C and uses group
Stamping machine shear agitation 10min, the 5000r/min of rotating speed 1 are knitted, obtains colostric fluid, then through high pressure dispersing emulsification machine circulating emulsion 4 times, is obtained
Emulsion.Trehalose is added into emulsion, packing is filtered after dissolving, freeze-drying, piperacillin sodium and tazobactam sodium is obtained and mixes
Outstanding powder-injection.
Embodiment 2Piperacillin sodium and tazobactam sodium（4:1）The preparation of suspension injection powder
Prescription (200 bottles)：
Avocin 100g
Sodium-tazobactam 25g
Polysorbate 100g
Sodium Caprylate 100g
Trehalose 200g
Preparation method
Under inert gas shielding, by polysorbate, Sodium Caprylate water for injection solvent, avocin and his azoles are then added
Batan sodium, it is well mixed, 90 DEG C of heating water baths are stirred to molten condition.Aforesaid liquid is incubated under the conditions of 70-90 DEG C and uses group
Stamping machine shear agitation 10min, the 5000r/min of rotating speed 1 are knitted, obtains colostric fluid, then through high pressure dispersing emulsification machine circulating emulsion 4 times, is obtained
Emulsion.Trehalose is added into emulsion, packing is filtered after dissolving, freeze-drying, piperacillin sodium and tazobactam sodium is obtained and mixes
Outstanding powder-injection.
The long-term stable experiment of embodiment 3
Lot number 1：160601 batches：2000 bottles of specifications：1.125g/ bottle is packed：Cillin bottle
Investigation condition：25±2℃/60±10%RH
By long-term stable experiment it can be found that the avocin and Tazobactam Sodium composition of sodium of the present invention are being prepared and deposited
There is good stability, the effect of ensure that Clinical practice and security during storage.
Claims (2)
1. a kind of piperacillin sodium and tazobactam sodium composition, it includes following component by weight：
4 parts of avocin；
1 part of sodium-tazobactam；
Polysorbate 1-5 parts；
Sodium Caprylate 2-5 parts；
Trehalose 5-20 parts.
2. piperacillin sodium and tazobactam sodium composition according to claim 1, it is characterised in that form and be：
Avocin 50g
Sodium-tazobactam 12.5g
Polysorbate 50g
Sodium Caprylate 50g
Trehalose 100g.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201710912669.1A CN107625772A (en) | 2017-09-30 | 2017-09-30 | A kind of pharmaceutical composition of piperacillin sodium and tazobactam sodium compound |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201710912669.1A CN107625772A (en) | 2017-09-30 | 2017-09-30 | A kind of pharmaceutical composition of piperacillin sodium and tazobactam sodium compound |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN107625772A true CN107625772A (en) | 2018-01-26 |
Family
ID=61103605
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201710912669.1A Pending CN107625772A (en) | 2017-09-30 | 2017-09-30 | A kind of pharmaceutical composition of piperacillin sodium and tazobactam sodium compound |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN107625772A (en) |
Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20040204372A1 (en) * | 2003-04-14 | 2004-10-14 | Wyeth Holdings Corporation | Compositions containing pipercillin and tazobactam sodium useful for injection |
| US20070116770A1 (en) * | 2005-11-22 | 2007-05-24 | Christian Garms | Tazobactam/piperacillin lyophilizate |
| CN101632671A (en) * | 2009-08-18 | 2010-01-27 | 海南永田药物研究院有限公司 | Suspensoid powder injection of piperacillin sodium sulbactam sodium medicine composition and novel application thereof |
| CN101632670A (en) * | 2009-08-26 | 2010-01-27 | 海南永田药物研究院有限公司 | Suspension powder injection of piperacillin sodium and tazobactam sodium pharmaceutical composition and new application thereof |
-
2017
- 2017-09-30 CN CN201710912669.1A patent/CN107625772A/en active Pending
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20040204372A1 (en) * | 2003-04-14 | 2004-10-14 | Wyeth Holdings Corporation | Compositions containing pipercillin and tazobactam sodium useful for injection |
| US20070116770A1 (en) * | 2005-11-22 | 2007-05-24 | Christian Garms | Tazobactam/piperacillin lyophilizate |
| CN101632671A (en) * | 2009-08-18 | 2010-01-27 | 海南永田药物研究院有限公司 | Suspensoid powder injection of piperacillin sodium sulbactam sodium medicine composition and novel application thereof |
| CN101632670A (en) * | 2009-08-26 | 2010-01-27 | 海南永田药物研究院有限公司 | Suspension powder injection of piperacillin sodium and tazobactam sodium pharmaceutical composition and new application thereof |
Non-Patent Citations (1)
| Title |
|---|
| 高建青: "《药剂学与工业药剂学实验指导》", 30 June 2012, 浙江大学出版社 * |
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| PB01 | Publication | ||
| PB01 | Publication | ||
| SE01 | Entry into force of request for substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| RJ01 | Rejection of invention patent application after publication |
Application publication date: 20180126 |
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| RJ01 | Rejection of invention patent application after publication |