摘要
目的 :探讨非肠道用药生产体系中细菌内毒素的控制和验证。方法 :采用细菌内毒素检查法检测并验证生产体系中的细菌内毒素是否得到有效控制。结果 :在控制和验证中应考虑细菌内毒素的累加性 ,建议在各影响环节上制订更严格的限量标准。结论 :细菌内毒素检查法更适应现代制药工业的特点 ,特别是定量检测法是一种快捷、定量的方法 ,能达到事前控制目的 ;另应加强验证后的日常运行管理。
Objective: To explore the control and validation of Bacterial Endotoxin of the parental Drug production system.Method: Bacterial endotoxin test was used to assay and validate if the bacterial endotoxin in the production system were under valid control.Result: The accumulativeness of bacterial endotoxin should be taken into consideration in the control and validation. More limited standard was recommended for all influencing links.Conclusion: Bacterial endotoxin test is more applicable to the modern phamarceutical industry, especially the quantitative assay. It is a rapid, quantitative method which can achieves the purpose of pre-control. Moreover, the routine operation management after validation should be strengthened.
出处
《中国药师》
CAS
2003年第8期487-489,共3页
China Pharmacist
关键词
生产体系
细菌内毒素
控制验证
Production system
Bacterial endotoxins
Control
Validation