中美现行药典无菌检查法比对

Comparison of Sterility Test Methods Between Current Chinese Pharmacopeia and United States Pharmacopeia

目的比对2020年版《中国药典》与《美国药典·国家处方集》(USP-NF2021)无菌检查法方法与要求的差异。方法以USPNF2021无菌检查法所载内容及要求为参考,并将2020年版《中国药典(四部)》与之进行比对,列出差异项并进行分析。结果中美两国现行药典无菌检查法在培养基配制、阳性对照试验、方法适用性试验、小剂量注射剂无菌检查等多处内容均存在差异。药典修订时可增加对冲洗流速的相关要求等内容。结论中美现行药典中无菌检查法的方法和要求存在一定差异,其产生与无菌质量控制理念相关,有待各自下一版药典修订。

Objective To compare the differences of methods and requirments of the sterility test between Chinese Pharmacopeia(2020 Edition)and United States Pharmacopeia·National Formulary(USP-NF2021).Methods The contents and requirments of sterility test in USP-NF2021 were compared with those in Chinese Pharmacopeia(VolumeⅣ,2020 Edition),the different items were listed and analyzed.Results The sterility test methods in the two pharmacopeias differ in many contents such as the medium preparation,positive reference test,method applicability and sterility test of low dose injection.Relevant requirements for flushing flow rate and other contents could be increased when the two pharmacopeias are revised.Conclusion The methods and requirments of the sterility test between current Chinese Pharmacopeia and United States Pharmacopeia have some differences,the occurrence of which relate to the conception of the sterile quality control and to be revised in their next edition of pharmacopeia.