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Azlocillin compound and preparation method and preparation thereof

A technology of azlocillin sodium and composition, applied in the field of preparation of azlocillin sodium injection preparation, can solve the problems of difficult dispensing, difficult dispensing, poor stability of preparations and the like, and achieve good sample quality, good quality and stability good effect

Inactive Publication Date: 2014-06-04
NORTH CHINA PHARMA COMPANY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The object of the present invention is to overcome existing azlocillin sodium powder injection in the preparation process that the medicine is not easy to pack, and the stability of the preparation is relatively poor, to provide a new preparation method of azlocillin sodium powder injection, The method of the present invention preferably azlocillin sodium granules overcomes the problem that azlocillin sodium is not easy to pack in the prior art, and effectively improves the stability of the preparation

Method used

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  • Azlocillin compound and preparation method and preparation thereof
  • Azlocillin compound and preparation method and preparation thereof
  • Azlocillin compound and preparation method and preparation thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0012] Example 1 Preparation of Azlocillin Sodium for Injection (1.0g)

[0013] The vials are washed and sterilized by dry heat at 350°C in a tunnel sterilizer before being sent to the packing room. 50.0kg of azlocillin is sieved with a particle size distribution of 60 mesh and 70% to 100% is intercepted. After cleaning and unpacking, the clarity is sent to the In the B-level packaging room, the original drug is packaged into 50,000 sterilized vials with an airflow packaging machine under A-level laminar flow, and the temperature and humidity of the controlled environment are 18-26°C, 45%RH.

Embodiment 2

[0014] Preparation of Example 2 Azlocillin Sodium for Injection 2.0g

[0015] The vials are washed and sterilized by dry heat at 350°C in a tunnel sterilizer, and then sent to the packaging room. Take 50.0kg of azlocillin, sieve with a particle size distribution of 60 mesh, cut off 90% to 100% of the cleanliness, and send it to the In the B-level packaging room, the original drug is packaged into 25,000 sterilized vials under the A-level laminar flow using an airflow packaging machine, and the temperature and humidity of the controlled environment are 18-26°C, 45%RH.

Embodiment 3

[0016] Preparation of Example 3 Azlocillin Sodium for Injection 2.0g

[0017] The vials are washed and sterilized by dry heat at 350°C in a tunnel sterilizer, and then sent to the packing room. Take 50.0kg of azlocillin, sieve with a particle size distribution of 60 mesh, cut off 70% to 90% of the cleanliness and send it to the In the B-level packaging room, the original drug is packaged in 25,000 sterilized vials with an airflow packaging machine under the A-level laminar flow, and the temperature and humidity of the controlled environment are 25°C and 45%RH.

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Abstract

The invention discloses an azlocillin medicine composition. A preparation method of the medicine composition comprises the following steps: disinfecting and sterilizing azlocillin sodium powder after sieving to obtain sterile azlocillin sodium powder and feeding the sterile azlocillin sodium powder to a clean region for later use; cleaning and sterilizing small bottles for subpackaging the azlocillin sodium powder and then feeding to the clean region for later use; subpackaging the sterile azlocillin sodium powder into the sterilized bottles; and covering by butyl rubber stoppers and then pressing by aluminum caps to seal, so as to obtain an azlocillin sodium powder injection. By adopting the method disclosed by the invention, the azlocillin sodium particles are optimized, the defect that the azlocillin sodium is difficult to subpackage in the prior art is effectively overcome, and the stability of the preparation is remarkably improved; the product performance test shows that the azlocillin medicine composition prepared by the preparation method is good in quality, and the test indexes are free of significant changes after long-term tests for more than 12 months, and accord with the quality standard, which shows that the preparation is good in stability.

Description

technical field [0001] The invention relates to a preparation method of powder injections and products thereof, in particular to a preparation method of azlocillin sodium powder injections and products thereof, and belongs to the field of preparation of azlocillin sodium injection preparations. Background technique [0002] Azlocillin is a broad-spectrum penicillin antibiotic with similar antibacterial effect to piperacillin and strong anti-Pseudomonas aeruginosa activity. Clinically, it is mainly used for various infections caused by sensitive Gram-positive bacteria and negative bacteria and Pseudomonas aeruginosa infection, including sepsis, meningitis, endocarditis, suppurative pleurisy, peritonitis and lower respiratory tract, gastrointestinal tract Tract, biliary tract, urinary tract, bone and soft tissue and reproductive organs infection, gynecological and obstetric infection, malignant otitis externa, burn, skin and surgical infection, etc. Azlocillin sodium for inje...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/14A61K31/431A61P31/04
Inventor 吴烨
Owner NORTH CHINA PHARMA COMPANY
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