目录
一、注射剂剂型选择的合理性··········································2
二、注射剂无菌安全存在的问题········································2
（一）注射剂的剂型··················································2
（二）灭菌方法······················································2
（三）无菌检查方法验证的弱项········································2
三、不同灭菌方式的无菌保证水平······································2
（一）灭菌产品的无菌保证要求规定····································2
（二）过度杀灭法····················································3
（三）除菌过滤法····················································3
（四）加大安全生产执法力度··········································3
四、提高注射剂无菌安全水平的对策思考································3
（一）剂型的安全原则················································3
（二）过度杀灭法或残存概率法终端灭菌································3
（三）无菌检查方法的验证和无菌检验的结果····························4
（四）采用无菌制造工艺··············································4
五、总结····························································4
【摘要】 目的 完善注射剂的质量保证体系,确保其质量、疗效和用药安全。方法 本文从剂型选择的合理性、无菌检查的局限性、不同灭菌方式的无菌保证水平、无菌安全的保证要素等方面,对国内注射剂的无菌安全问题进行了分析。结果 根据无菌制剂的无菌保证的要求,提出了在现有条件下提高注射剂的无菌保证水平的可行对策。结论 无菌安全实际上就是避免染菌。在生产过程中避免灭菌不完全和灭菌过程中的二次污染,就能够保证产品的无菌安全。
【关键词】 注射剂;无菌;安全;问题;对策
