中国药物警戒 ›› 2011, Vol. 8 ›› Issue (2): 97-99.

• 管理及工作研究 • 上一篇    下一篇

奥美拉唑肠溶胶囊生产质量风险评价系统的建立

徐万魁, 岳青阳, 潘阳   

  1. 辽宁省食品药品检验所,辽宁 沈阳 110013
  • 收稿日期:2015-08-27 修回日期:2015-08-27 出版日期:2011-02-10 发布日期:2015-08-27
  • 作者简介:徐万魁,男,副主任药师,药品检验。

The Risk Assessment System for Omeprazole Enteric-coated Capsules Manufacturing

XU Wan-kui, YUE Qing-yang, PAN yang   

  1. Liaoning Provincial institute control of food and drug products,Liaoning Shenyang 110013, China
  • Received:2015-08-27 Revised:2015-08-27 Online:2011-02-10 Published:2015-08-27

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摘要： 在不同的生产工艺和生产条件下,药品生产质量和风险不同。通过对32家企业生产的奥美拉唑肠溶胶囊进行含量波动等9个风险因素的评价,确立了综合风险评价系统,为药品监管提供更有针对性的监管目标。

关键词: 奥美拉唑肠溶胶囊, 生产质量, 风险评价

Abstract: The manufacturing quality and risk of drug is different, because the manufactring process and environment is different. This paper establishes the integrated risk evaluation system by evaluating 9 risk factors including concentration fluctuations of Omeprazole Enteric-coated Capsules through 32 factories’ products. The purpose of this system is to provide the directed supervision object for government.

Key words: omeprazole enteric-coated capsules, manufacturing quality, risk evaluation

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