氯霉素滴眼液无菌检查方法的研究

Research of sterility test method for chloramphenicol eye drops

目的建立氯霉素滴眼液的无菌检查方法。方法无菌检查采用薄膜过滤法,冲洗液为0.1%蛋白胨溶液,冲洗量为400 ml/滤筒。结果此法能有效消除抑菌成分的干扰,各试验菌生长良好。结论经方法学验证,所建立的方法适用于氯霉素滴眼液的无菌检查。

Objective To estabhsh a sterility test method for chloramphenicol eye drops. Methods Membrane- filter procedure was applied for sterility test, with 0.1% peptone solution as flushing fluid and 400 ml/filter cartridge as flushing volume. Results This method could effectively eliminate interference by antibacterial components, with good growth of every test organisms. Conclusion Through methodology validation, this established method is suitable for sterility test in chloramphenicol eye drops.