加替沙星滴眼液无菌检查方法的建立

目的：建立加替沙星滴眼液无菌检查方法。方法：参照《中国药典》2005版方法进行试验。结果：采用薄膜过滤法，以0．1％蛋白胨，0．1％吐温-80水溶液作为冲洗液，选择冲洗量为每滤筒800ml，并以0．1mol／L硫酸锰为中和剂，即可消除样品对各菌株的抗菌活性。结论：加替沙星滴眼液可按此方法进行无菌检查。

Sterility test method for gatifloxacin eye drops

Objective： To establish a sterility test method for gatifioxacin eye drops. Methods： A test method was set up and improved on the basis of the official one of Chinese Pharmacopoeia（ edited in 2005 ）. Results： Antibacterial activity of gatifolxacin could be eliminated by membrane filtration method in which a water solution of 0.1% peptone and 0.1% of Tween was used as a rinse solution. The volume of the rinse solution was 800 m1,0.1 mol/L of manganese sulfate solution was used for neutralization. Conclusion： The method established in the paper is valid in sterility test for gatifloxacin eye drops.