泊沙康唑注射液无菌检查方法的建立

目的：建立泊沙康唑注射液的无菌检查方法。方法：按照《中华人民共和国药典》2015年版无菌检测方法适用性实验的有关要求，采用HPLC法测定硝酸纤维膜、尼龙膜、混合纤维素膜和PVDF膜过滤后膜上的样品残留量，确定样品吸附性小的滤膜，选择含聚山梨酯80等组分的优化稀释液以及去除泊沙康唑抗菌活性的冲洗方式等。结果：药典规定的6种试验菌株均可正常生长。结论：泊沙康唑具有较强的抑菌活性，通过适当的样品处理，采用薄膜过滤法能去除泊沙康唑的抑菌性，建立了合理无菌检查方法，并可对其他三唑类产品的无菌检查起到较好的参考作用。

Objective: To establish the sterility test for posaconazole injection. Methods: According to the Chinese Pharmacopoeia (2015 edition)membrane-filter procedure, the residue of posaconazole which filtered through the nitrocellulose membrane, nylon membrane, mixed cellulose ester and PVDF membrane were tested by HPLC. The sterility test method by selecting low absorption filter membrane, adding polysorbate-80 to optimize the component of diluent and rinsing filter method to remove the antimicrobial activity of posaconazole injection was validated. Result: Six test strains required for sterility test according to Chinese pharmacopoeia (2015 edition)exhibited good growth. Conclusion: The strong antimicrobial activity of posaconazole can be removed by treating the sample properly and using the membrane-filter procedure. This is a valuable reference for other triazole sterility tests.

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