阿昔洛韦滴眼液中苯扎溴铵含量的合理性探讨

摘要

Objective:To find the minimum effective amount of Benzalkonium Bromide in Acyclovir Eye Drops by comparing antimi-crobial 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 estab-lished.%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。