盐酸利多卡因眼用凝胶中细菌内毒素检测方法学验证

Validation of the methods for testing bacterial endotoxin in lidocaine hydrochloride ophthalmic gel

目的:建立盐酸利多卡因眼用凝胶中细菌内毒素检查法。方法:按照中国药典2015版四部1143细菌内毒素检查法,确定盐酸利多卡因眼用凝胶的有效稀释浓度和细菌内毒素限值。结果:盐酸利多卡因眼用凝胶经稀释4倍后不干扰鲎试剂与细菌内毒素的凝集反应,其细菌内毒素均小于0.5 EU/ml。结论:本研究的方法简便、准确、可靠,可用于盐酸利多卡因眼用凝胶中细菌内毒素的检查。

Objective： To establish a method for the detection of bacterial endotoxins in lidocaine hydrochloride ophthalmic gel. Methods： The valid dilution concentration and limit value of the gel for the detection of bacterial endotoxin were tested based on the Chinese pharmacopoeia 2015 edition（Volume 4）. Results： The gel sample with 4-fold dilution would not interfere with the agglutination reaction between tachypleus amebocyte lysate and bacterial endotoxins and the values of bacterial endotoxin were all less than 0.5 EU/ml. Conclusion： The established method is simple, rapid, reliable and feasible for the detection of the bacterial endotoxins in lidocaine hydrochloride ophthalmic gel.