无菌检查试验的先天缺陷及应对策略的思考

目的为了最大程度降低药典无菌检查试验方法缺陷造成的影响，规范我国药品标准中无菌检查试验方法。方法借鉴西方国家对无菌检查法的管理经验，结合我国实际情况，探讨及规范我国药品标准中无菌检查法的具体措施。结果与结论我国药典或相关法规应加强对无菌检查试验的原理、不足和注意事项等的解释说明，对生物制品的无菌检查方法应有专门规定。

Inherent Limitationsof Compendial Sterility Test and Reflection on the Countermeasures

Objective To minimize the impact of sterility test limitations, and to standardize the sterility test method of pharmaceutical standards in China. Methods With reference to the regulation experience of the Western countries, combined with the actual situation in China, the specific measures were explored to standardize the sterility test method of pharmaceutical standards in China. Results and Conclusions Chinese pharmacopoeia or relevant regulations should clarify and explicate the sterility test rationale, limitations and precautions. The method of sterility test for biological products shall have special provisions.