左氧氟沙星注射液无菌检查方法验证

目的：完善左氧氟沙星注射液的无菌检验方法标准。方法：通过确定冲洗量和换冲洗液等，用薄膜过滤法进行。结果：以0．1％蛋白胨水溶液作为冲洗液，每筒冲洗液的量为600mL，每次冲洗100mL，阳性对照菌没有生长，后将每筒冲洗量进一步加大至800mL，阳性对照茵生长良好。然而将冲洗液改为组氨酸-卵磷脂-聚山梨酯80混合溶液后，每筒冲洗量只需300mL，每次冲洗100mL，阳性对照菌生长良好，适用于本品的无菌检查。结论：本法简便，冲洗量相对较少，是一种较为理想的方法，建议将验证方法收载入《中国药典》。

Verification of Sterility Test of Levofloxacin Injection

Objective:A test method for sterility of Levofloxacin Injection was established. Methods:The test method was carried out by thin-membrane filtration method with different irrigation solutions and volume. Results:When 0.1% peptone water was used as washing liquid, all of six strains positive control tubes reveal growth of micro-organism until the total amount of irrigation fluid reach 2400 and the substance control give no evidence of growth. While washing liquid was the histidine-lecithin-Polysorbate 80 mix...