文档介绍：中国药物警戒第 8 卷第 2 期 2011 年 2 月 February, 2011, ,
中图分类号：R954 文献标识码：A 文章编号：1672- 8629（2011）02- 0097- 03
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（辽宁省食品药品检验所，辽宁沈阳 110013）
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家企业生产的奥美拉唑肠溶胶囊进
摘要：。 32
行含量波动等个风险因素的评价，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
9 。
关键词：奥美拉唑肠溶胶囊；生产质量；风险评价
The Risk Assessment System for Omeprazole Enteric- coated Capsules Manufacturing
XU Wan -kui YUE Qing -yang PAN yang (Liaoning Provincial institute control of food and drug products,
Liaoning Shenyang 110013, China)
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
虽然合格药品均符合质量标准，但质量标准的局限础在风险识别和风险分析阶段，我们对奥美拉唑肠溶