艾迪注射液薄膜过滤无菌检查法的建立及验证

目的：建立艾迪注射液薄膜过滤无菌检查法,并验证其准确性和可靠性。方法：按照《中国药典：二部》2010版《附录无菌检查》项下薄膜过滤法做无菌检查;取相应量艾迪注射液经全封闭无菌滤器滤过后,每个滤桶用300 mL（pH 7.0）无菌氯化钠-蛋白胨缓冲液冲洗;然后,在各滤桶中接种阳性菌,在适宜培养条件下培养,并逐日观察其结果。结果：在24 h内大肠埃希菌、金黄色葡萄球菌、生孢梭菌和白假丝酵母菌均生长良好,而枯草芽孢杆菌和黑曲霉在48 h内生长良好。结论：本文检验条件下艾迪注射无抑菌活性或抑菌活性可以忽略,即可用薄膜过滤法做无菌检查。

Validation of Membrane Filtration Sterile Test forAidi-injection

Objective： To establish the membrane-filter procedure for Aidi-injection and to validate the accuracy and reliability of the method. Methods： The method was constructed according to the instructions in the appendix of ＂the Chinese phamacopoeia＂（2010 edition）. The rinse volume of pH 7.0 NaCl-peptone medium is 300 mL. Results： The result showed that Escherichia coli, Staphylococcus aureus, Clostridium sporogenes and Candida albicans grew well in 24 h while Bacillus subtilis and Aspergillus niger grew well in 48 h. Conclusion： The above mentioned method can be used for the sterility test of Aidi-injection.