阿昔洛韦滴眼液中苯扎溴铵含量的合理性探讨  

Exploration of Rational Benzalkonium Bromide Contents in Acyclovir Eye Drops

作　　者：朱荣峰[1] 陈伟盛[1] 简敏骞[1] 朱晓燕[1] 

机构地区：[1]广州市药品检验所,广州510160

出　　处：《中国药品标准》2015年第6期420-424,共5页Drug Standards of China

摘　　要：目的:美国FDA对抑菌剂的最高用量有一定要求,但在最高用量下的最低有效剂量未见明确的筛选方案,通过比较国内外三个药典中抑菌剂效力测定方法,找出阿昔洛韦滴眼液中苯扎溴铵的最低有效浓度。方法:配制不同抑菌剂浓度的阿昔洛韦滴眼液,并加入规定量的5株试验菌株,在0 h,6 h,24 h,7 d,14 d,28 d时间点测定各菌株存活量。结果:通过分析不同抑菌剂浓度下的细菌存活曲线,确定苯扎溴铵最低有效浓度为0.06%。结论:通过苯扎溴铵的合理性探讨,初步提出滴眼剂抑菌剂用量合理化筛选程序。Objective： To find the minimum effective amount of Benzalkonium Bromide in Acyclovir Eye Drops by comparing antimicrobial activity test methods in three nations＇ pharmacopoeia, while FDA has specified the maximum amount of preservative, but there are no guidelines on screening minimum effective amount of preservative. Methods： Acyclovir Eye Drops were prepared with different amount of Benzalkonium Bromide and five testing strains in requisite amount were added, respectively. The numbers of surviving cell forming colonies were determined at 0 h, 6 h, 24 h, 7 d, 14 d and 28 d. Results： The minimum effective amount of Benzalkonium Bromide was 0.06% by analyzing the survival curve on different amount of preservative. Conclusion： According to the exploration of rational Benzalkonium Bromide contents, the guideline on screening minimum effective amount of preservative is preliminarily established.

关 键 词：阿昔洛韦滴眼液 苯扎溴铵 抑菌剂效力测定 

分 类 号：R921.2[医药卫生—药学]