注射用甲磺酸培氟沙星无菌检查方法改进及验证  

The Improvement and Validation on the Steriality Test of the Pefloxacin Mesylate for Injection

作　　者：石蓉 彭诗富 SHI Rong;PENG Shi-fu(Hunan Institute for Drug Control(Hunan Pharmaceutical Excipients Testing and Inspection Center),Hunan Engineering&Technology Research Center for Pharmaceutical Quality Evaluation,Changsha 410001,China;Hunan Institute of Food Quality Supervision Inspection and Research,Changsha 410001,China)

机构地区：[1]湖南省药品检验研究院(湖南药用辅料检验检测中心),湖南省药品质量评价工程技术研究中心,湖南长沙410001 [2]湖南省食品质量监督检验研究院,湖南长沙410001

出　　处：《海峡药学》2020年第3期91-93,共3页Strait Pharmaceutical Journal

摘　　要：目的改进注射用甲磺酸培氟沙星的无菌检查方法。方法通过比较采用薄膜过滤直接冲洗和加入中和剂两种方法,来探索消除样品抑菌性的最佳方式。结果供试品溶液直接过膜后,至少需要500mL 0.1%蛋白胨水冲洗滤膜,才能消除样品抑菌性;而供试品溶液中加入3mL 0.5mol·L^-1 MnSO 4溶液后过膜,用200mL 0.1%蛋白胨水冲洗滤膜,就能达到消除样品抑菌性的效果。结论加入中和剂法,能有效降低冲洗液体积,减少对滤膜的伤害,适用于注射用甲磺酸培氟沙星的无菌检查。OBJECTIVE To improve the steriality test of the pefloxacin mesylate for injection.METHODS compared the direct washing with the neutralizer method of membrane filtration and explored the best way to eliminate the antimicrobial activity of the sample.RESULTS At least 500mL 0.1%peptone water was needed to flush the filter membrane in order to eliminate the antimicrobial activity of sample after transfered the test solution to the membrane directly;while it can eliminate the antimicrobial activity of the sample by washing the membrane with 200mL 0.1%peptone water after transfered the test solution with adding 3mL 0.5mol·L^-1 MnSO4 solution to the membrane.CONCLUSION The membrane filter neutralizer method can effectively reduce the washing liquid volume and reduce the damage to the filter membrane.It is suitable for the sterility test of pefloxacin mesylate for injection.

关 键 词：注射用甲磺酸培氟沙星 无菌检查 冲洗量 中和剂 

分 类 号：R927[医药卫生—药学]