加替沙星无菌检查方法的建立与标准操作探讨

Establish and standard operation process(SOP)discuss in sterility test for gatifloxacin

目的:建立加替沙星原料及制剂无菌检查法及标准操作方法。方法:按2005年版中国药典无菌检查法验证实验的有关要求,通过接种阳性代表菌株,对薄膜过滤、添加中和剂等去除加替沙星抗菌活性的实验方法和条件进行验证,逐步建立加替沙星原料及制剂无菌检查的标准操作方法。结果:在对加替沙星不同原料及制剂样品适当的处理基础上,采用薄膜过滤法,以0.1%蛋白胨水溶液作为冲洗液,约每滤筒300 mL 的冲洗量,每筒培养基中加入0.1 mol·L^(-1)硫酸锰溶液3 mL 可去除加替沙星对细菌的抑菌作用。结论:加替沙星具有较强的抑菌活性,通过适当的样品处理、薄膜过滤法和添加硫酸锰溶液作为重金属络合剂,去除加替沙星抑菌活性,可对解决喹诺酮类抗生素无菌检查问题起到较好的参考作用。

Objective：To establish the standard operation process （SOP）in sterility test for gatifloxacin raw material and preparation. Methods：According to the Chinese pharmacopoeia （2005 edition）, validate the sterility test method of gatifloxacin sample that treated with membrane -filter procedure and neutralizer by control bacteria, which testify the antimicrobial activity was removed thoroughily or not. Results：when the filter was washed with 0. 1% peptone solution 300 mL and 0. 1 mol · L^-1 manganese sulfate solution 3 mL was added into per culture vessel,the control bacteria that added into the culture vessel treated gatifloxacin sample grewth commonly as the positive control. Conclution： The antimicrobial activity strongly of gatifloxacin is able to remove through membrane - filter procedure and neutralizer of metal chelating agent as manganese sulfate. This method is not only an effective SOP in sterility test for gatifloxacin but a valuable reference for other quinolone.