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Pharmaceutical composition of piperacillin sodium-tazobactam sodium compound

A technology of tazobactam sodium and piperacillin sodium, which is applied in the direction of active ingredients of heterocyclic compounds, antibacterial drugs, freeze-dried transportation, etc., can solve the problems of poor stability of piperacillin sodium and tazobactam sodium, and achieve Guaranteed efficacy and safety, improved stability, and rapid dissolution

Inactive Publication Date: 2018-01-26
SUZHOU ERYE PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] In order to solve the problem of poor stability of the existing piperacillin sodium-tazobactam sodium, the invention provides a stable piperacillin sodium-tazobactam sodium compound preparation and a preparation method thereof

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] Example 1 Preparation of Piperacillin Sodium-Tazobactam Sodium (4:1) Suspension Powder Injection

[0020] Prescription (100 bottles):

[0021] Piperacillin Sodium 50g

[0022] Tazobactam Sodium 12.5g

[0023] Polysorbate 50g

[0024] Sodium Caprylate 50g

[0025] Trehalose 100g

[0026] Preparation

[0027] Under the protection of an inert gas, polysorbate and sodium octanoate are dissolved in water for injection, then piperacillin sodium and tazobactam sodium are added, mixed evenly, heated and stirred in a water bath at 90°C until molten. The above liquid was kept warm at 70-90°C and sheared and stirred for 10 minutes with a tissue masher at a speed of 15000r / min to obtain a primary emulsion, which was then circulated and emulsified by a high-pressure homogenizer for 4 times to obtain an emulsion. Trehalose is added to the emulsion, dissolved, filtered, subpackaged, and freeze-dried to obtain piperacillin sodium-tazobactam sodium suspension powder for injectio...

Embodiment 2

[0028] Example 2 Preparation of Piperacillin Sodium-Tazobactam Sodium (4:1) Suspension Powder Injection

[0029] Prescription (200 bottles):

[0030] Piperacillin Sodium 100g

[0031] Tazobactam Sodium 25g

[0032] Polysorbate 100g

[0033] Sodium Caprylate 100g

[0034] Trehalose 200g

[0035] Preparation

[0036] Under the protection of an inert gas, polysorbate and sodium octanoate are dissolved in water for injection, then piperacillin sodium and tazobactam sodium are added, mixed evenly, heated and stirred in a water bath at 90°C until molten. The above liquid was kept warm at 70-90°C and sheared and stirred for 10 minutes with a tissue masher at a speed of 15000r / min to obtain a primary emulsion, which was then circulated and emulsified by a high-pressure homogenizer for 4 times to obtain an emulsion. Trehalose is added to the emulsion, dissolved, filtered, subpackaged, and freeze-dried to obtain piperacillin sodium-tazobactam sodium suspension powder for inject...

Embodiment 3

[0037] Embodiment 3 long-term stability test

[0038] Batch number 1: 160601 Batch size: 2000 bottles Specification: 1.125g / bottle Packaging: vials

[0039] Inspection conditions: 25±2℃ / 60±10%RH

[0040]

[0041] Through the long-term stability test, it can be found that the composition of piperacillin sodium and tazobactam sodium of the present invention has good stability during preparation and storage, which ensures the curative effect and safety of clinical use.

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Abstract

The invention relates to a pharmaceutical composition of a piperacillin sodium-tazobactam sodium compound. By adopting sodium caprylate as a stabilizer, polysorbate as an emulsifier and trehalose as afrozen-dried supporting agent, the stability of piperacillin sodium and tazobactam sodium during preparation and storage can be effectively enhanced, and the efficacy and safety of clinical use can be guaranteed.

Description

technical field [0001] The invention relates to a pharmaceutical composition of piperacillin sodium tazobactam sodium compound. Background technique [0002] Piperacillin is a penicillin-like broad-spectrum antibiotic, which mainly plays a bactericidal effect by interfering with the synthesis of bacterial cell walls. It is mainly used for infections caused by Pseudomonas aeruginosa and various Gram-negative bacilli, but it is easily produced by the β- Lactamase hydrolysis and drug resistance. [0003] Tazobactam is an irreversible competitive β-lactamase inhibitor. It has no antibacterial activity itself, but it has a strong enzyme inhibitory effect. It can enhance its efficacy and prolong its action time when combined with piperacillin. There is a clear synergy. [0004] [0005] Piperacillin Sodium Tazobactam Sodium [0006] The piperacillin sodium-tazobactam sodium compound preparation has a large clinical dosage, definite curative effect and good market prospect,...

Claims

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Application Information

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IPC IPC(8): A61K31/496A61K31/431A61K9/19A61K47/12A61K47/26A61P31/04
Inventor 张健姚敏霞沈银兰何星慧潘慧琦刘冬
Owner SUZHOU ERYE PHARMA CO LTD
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