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Preparation method and product of azlocillin sodium powder injection

The technology of azlocillin sodium powder and azlocillin sodium is applied in the direction of powder delivery, making medicines into special physical or taking forms, antibacterial medicines, etc. Poor preparation stability and other issues, to achieve the effect of good sample quality, good quality and good stability

Inactive Publication Date: 2014-03-12
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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  • Preparation method and product of azlocillin sodium powder injection
  • Preparation method and product of azlocillin sodium powder injection
  • Preparation method and product of azlocillin sodium powder injection

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 a preparation method and a product of azlocillin sodium powder injection. The preparation method comprises the following steps of: screening and disinfecting raw powder of azlocillin sodium to obtain sterile raw powder of azlocillin sodium; transferring the sterile raw powder of azlocillin sodium into a cleaning area to standby; cleaning and sterilizing bottles used for subpackaging the raw powder of azlocillin sodium, and transferring into the clean area to standby; subpackaging the sterile raw powder of azlocillin sodium into the sterile bottles; covering butyl rubber stoppers; pressing aluminum covers to seal to obtain the azlocillin sodium powder injection. According to the method, azlocillin sodium particles are preferred, therefore, the problem of the prior art that azlocillin sodium is difficulty subpackaged is effectively overcome, and the stability of a preparation is improved obviously; the performance detection test shows that the prepared powder injection has high quality, and all detection indexes do not vary obviously after long-term test of more than 12 months and all meet the quality standard, namely, the preparation is high 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): A61J3/02A61K31/431A61K9/14A61P31/04
Inventor 吴烨
Owner NORTH CHINA PHARMA COMPANY
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