氯替泼诺妥布霉素混悬滴眼液微生物限度检查方法的探讨

Disscussion on Microbial Limit Tests Method for Loteprednol Etabonate and Tobramycin Ophthalmic Suspension

目的:建立氯替泼诺妥布霉素混悬滴眼液的微生物限度检查方法。方法:参照中国药典2005年版二部附录微生物限度检查方法进行试验。结果:采用直接接种法对人工污染的六种菌株进行试验,该药品对四株细菌有不同程度的抑菌作用,采用薄膜过滤法用0.1%蛋白胨水加聚山梨酯进行样品处理,300ml0.1%蛋白胨水分三次冲洗,可消除其抑菌成分。结论:建立的氯替泼诺妥布霉素混悬滴眼液微生物限度检查方法简单、准确、可靠。

Objective： To establish microbial limit tests method for loteprednol etabonate and tobramycin ophthalmic suspension. Methods： The experiment was conducted according to the method of the Chinese Pharmacopoeia （2005 edition）. Results： The result was tested by the direct inoculation method to six kinds of artificial contamination strains. The medicine has bacteriostasis action to four kinds of bacteria in different degree. The sample was attenuated in 0.1% peptone solution added polysorbate by the membrane separation process, then washed with 300ml of 0.1% peptone solution three times, so that it can remove bactericidal activity. Conclusion： The established microbial limit tests method for loteprednol etabonate and tobramycin ophthalmic suspension is simple, accurate and reliable.