克霉唑滴眼液无菌检查方法的建立

Validation of Sterility Test Method of Clotrimazole Eye Drops

目的建立克霉唑滴眼液无菌检查方法。方法参照中国药典2015版无菌检查法要求,采用薄膜过滤法对克霉唑滴眼液进行无菌检查,并进行方法验证。结果采用薄膜过滤法,以白色念珠菌为阳性对照菌,pH7.0无菌氯化钠蛋白胨缓冲液为冲洗液,冲洗量800 mL/筒,以1%卵磷酯聚山梨酯80醇溶液为中和剂,方法可行,检验结果符合规定。结论薄膜过滤法可有效消除克霉唑滴眼液的抑菌活性,可按此方法进行无菌检查。

OBJECTIVE To establish the sterility test method for Clotrimazole eye drops. METHODS According to the sterility test in the general monograph of Chinese Pharmacopoeia （2015） , membrane-filter procedure was used for the sterility test of Clotrimazole eye drops. RESULTS Membrane-filter procedure was conducted and Candida albicans was taken as positive control germs. With pH7.0 sterile Sodium Chloride Peptone buffer as rinse liquid, rinse volume of 800 mL per barrel, with 1% lecithin polysorbate 80 alcohol solution as neutralizing agent. It was applicable and reliable to adopt the conditions of sterility test reassured by validation test. CONCLUSION Membrane-filter procedure can eliminate the bacteriostatic activity of Clotrimazole eye drops. It also can be used for the sterility test of Clotrimazole eye drops.