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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 investigate the control and validation of bacterial endotoxin in the parenteral drug delivery system. Methods: Bacterial endotoxin test was used to test and verify whether the bacterial endotoxin in the production system was effectively controlled. Results: The accumulation of bacterial endotoxins should be considered in the control and validation, and it is recommended that stricter limits be established on each impact. Conclusion: Bacterial endotoxin test is more suitable for the characteristics of modern pharmaceutical industry, especially quantitative test is a fast and quantitative method to achieve the purpose of pre-control; the other should be to strengthen the day-to-day management of validation.