匹洛卡品滴眼剂中防腐剂的研究

STUDY OF PRESERVATIVE IN P1LOCARPINE EYE DROPS

目的:通过对含不同防腐剂的匹洛卡品滴眼剂的防腐效力的测定,确定理想的眼药防腐剂的选择方法。方法:本试验改进了以往文献记载的防腐剂效力测定的方法,采用USP22版的防腐剂效力测定方法测定防腐效力,并辅以刺激性、配伍变化、稳定性等实验结果,判断防腐剂的防腐效力。结果:在以羟苯乙酯、新洁尔灭、洗必泰、乙酸苯汞为防腐剂的匹洛卡品滴眼剂中,以洗必泰为防腐剂的匹洛卡品滴眼剂防腐效果最好。结论:洗必泰是目前匹洛卡品滴眼剂较为理想的防腐剂。目前我国眼药制剂中常用防腐剂羟苯乙酯,无论在量效关系上,还是在时效关系上均不适合作为眼药防腐剂使用,我国在制剂防腐剂选择问题上还有待于进一步改进和完善。

From study of difference kinds preservative in pilo- carpine eye drops, determine which the best preservative in eye drops. METH-ODS: Preservative effective method in USPXX I RESULTS: Chlorhexidine is the best preservative in pilocarpine. CONCLUSION: Chlorhexidine is better than Ethyl Hydroxybenzoate in eye drops. We must improve the method on se-lect preservative in preparation.