注射用甲磺酸培氟沙星无菌检查方法学研究

Study on Sterility Test of Pefloxacin Mesylate for Injection

关键词:  注射用甲磺酸培氟沙星  无菌检查  中和剂

Key words:  pefloxacin mesylate for injection  sterility test  neutralizer

摘要:

目的 对注射用甲磺酸培氟沙星无菌检查的方法进行研究。方法 对普通的薄膜过滤冲洗法和培养基中加中和剂处理的方法进行对比研究，同时研究确定中和剂的最佳加入量。结果 在培养基中加入适量中和剂处理的方法优于普通的薄膜过滤冲洗法，其中和剂的最适加入量为3 mL的0.5 mol·L-1 MnSO-4溶液。结论 在培养基中加入适量中和剂处理的方法可有效地降低冲洗剂的用量, 该法适用于注射用甲磺酸培氟沙星的无菌检查。

Abstract:

OBJECTIVE To verify the sterility test of pefloxacin mesylate for injection. METHODS Make sure of the best neutralizer dose added into the culture medium at the same time of comparing the membrane filtration method with the method of adding the neutralizer into the culture medium. RESULTS The method of adding 0.5 mol · L-1 of manganese sulfate solution as neutralizer into the culture medium was better than the membrane filtration method, and the best dose was 3 mL. CONCLUSION The method of adding the neutralizer into the culture medium reduces the flushing dose effectively and can be used in the sterility test of pefloxacin mesylate for injection.