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A kind of pharmaceutical composition of piperacillin sodium sulbactam sodium compound

A technology of piperacillin sodium sulbactam sodium and piperacillin sodium is applied in the directions of active ingredients of heterocyclic compounds, antibacterial drugs, pharmaceutical formulations, etc., and can solve problems such as poor stability of piperacillin sodium and sulbactam sodium.

Active Publication Date: 2020-07-07
山东二叶制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] In order to solve the problem of poor stability of the existing piperacillin sodium sulbactam sodium, the invention provides a stable piperacillin sodium sulbactam sodium compound preparation and its preparation method

Method used

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  • A kind of pharmaceutical composition of piperacillin sodium sulbactam sodium compound
  • A kind of pharmaceutical composition of piperacillin sodium sulbactam sodium compound
  • A kind of pharmaceutical composition of piperacillin sodium sulbactam sodium compound

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] Example 1 Preparation of Piperacillin Sodium Sulbactam Sodium (4:1) Suspension Powder Injection

[0023] Prescription (100 bottles):

[0024] Piperacillin Sodium 50g

[0025] Sulbactam Sodium 12.5g

[0026] Polyvinylpyrrolidone 25g

[0027] Creatinine 50g

[0028] Mannitol 25g

[0029] Trehalose 100g

[0030] Preparation

[0031] Under the protection of inert gas, polyvinylpyrrolidone, creatinine, and mannitol were dissolved in water for injection, then piperacillin sodium and sulbactam sodium were added, mixed uniformly, and heated and stirred in a water bath at 90° C. to a molten state. Under the condition of keeping the above liquid at 70-90°C, shear and stir with a tissue masher for 10min, and the rotation speed is 15000r / min to obtain the primary emulsion, and then circulate emulsification through a high-pressure homogenizer for 4 times to obtain an emulsion. Trehalose is added to the emulsified solution, and after dissolving, it is filtered and packaged, ...

Embodiment

[0032] Example 2 Preparation of Piperacillin Sodium Sulbactam Sodium (4:1) Suspension Powder Injection

[0033] Prescription (200 bottles):

[0034] Piperacillin Sodium 100g

[0035] Sulbactam Sodium 25g

[0036] Polyvinylpyrrolidone 50g

[0037] Creatinine 100g

[0038] Mannitol 50g

[0039] Trehalose 200g

[0040] Preparation

[0041] Under the protection of inert gas, polyvinylpyrrolidone, creatinine, and mannitol were dissolved in water for injection, then piperacillin sodium and sulbactam sodium were added, mixed uniformly, and heated and stirred in a water bath at 90° C. to a molten state. Under the condition of keeping the above liquid at 70-90°C, shear and stir with a tissue masher for 10min, and the rotation speed is 15000r / min to obtain the primary emulsion, and then circulate emulsification through a high-pressure homogenizer for 4 times to obtain an emulsion. Trehalose is added to the emulsified solution, and after dissolving, it is filtered and packaged, ...

Embodiment 3

[0042] Example 3 Long-term stability test

[0043] Batch No. 1: 160515 Batch: 2000 bottles Specification: 0.75g / bottle Packing: Vial

[0044] Inspection conditions: 25±2℃ / 60±10%RH

[0045]

[0046] Through the long-term stability test, it can be found that the composition of piperacillin sodium and sulbactam sodium of the present invention has good stability in the process of preparation and storage, and ensures the efficacy and safety of clinical use.

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Abstract

The invention relates to a medicinal composition of a piperacillin sodium and sulbactam sodium compound. Creatinine and mannitol form a stabilizer, polyvinylpyrrolidone is used as an emulsifier and trehalose is used as a lyophilization supporting agent, so that the stability of piperacillin sodium and sulbactam sodium during preparation and storage is effectively improved, and the therapeutic efficacy and the safety during clinical use are guaranteed.

Description

technical field [0001] The invention relates to a pharmaceutical composition of piperacillin sodium sulbactam sodium compound. Background technique [0002] Piperacillin is a broad-spectrum penicillin antibiotic, mainly by interfering with the synthesis of bacterial cell wall to play a bactericidal effect, mainly for the infection caused by Pseudomonas aeruginosa and various gram-negative bacilli, but easily by the β- resistance by lactamase hydrolysis. [0003] [0004] Piperacillin Sodium [0005] Sulbactam is a β-lactamase inhibitor, its affinity for β-lactamase is far greater than that of other β-lactam antibiotics, and it has no or only weak antibacterial activity, but sulbactam It has irreversible inhibitory effects on most important β-lactamases produced by β-lactam antibiotic-resistant strains. Sulbactam can prevent the destruction of penicillin and cephalosporin antibiotics by drug-resistant bacteria. [0006] [0007] Sulbactam sodium [0008] The compou...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K47/26A61K47/32A61K31/496A61K31/43A61P31/04
Inventor 张健刘洪艳李励蔡露露潘慧琦刘冬
Owner 山东二叶制药有限公司