加替沙星眼用凝胶中微生物检查法的建立

Establishment of the method for microbial limit test of Gatifloxacin gel for eye

目的完善加替沙星眼用凝胶微生物的限度检查方法。方法采用滤纸过滤(除去辅料)加薄膜过滤(过滤过程中加2%硫酸锰溶液的中和剂)法,去除主药加替沙星的抗菌活性。结果5株验证菌株中枯草芽孢杆菌对主药加替沙星最敏感,可作为加替沙星眼用凝胶微生物检查方法的质控菌株。结论所建方法可检查出眼用凝胶中的细菌、控制菌、霉菌及酵母菌。

OBJECTIVE To establish a method for microbial limit test of Gatifloxacin gel for Eye. METHODS Paper - filter （ removing excipients） and membrane - filter（ adding 2% manganese sulfate solution in filtering course） method was first used to eliminate the antimicrobial activity of Gatifloxacin. RESULTS The method passed the validation test of Chinese Pharmacopoeia 2005 version. Bacillus subtilis was the most sensitive strain being recommended among the five validation strains, which was recommended for positive control in experiments. CONCLUSION The method for microbial limit test of Gatifloxacin gel for eye was ： paper - filter and membrane -filter method, which was first used to bacteria, control bacteria （Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli）, mold and yeasts.