盐酸雷尼替丁注射液细菌内毒素检查法研究

The Study of the Bacteria Endotoxin Test for Ranitidine Hydrochloride Injection

目的 :研究盐酸雷尼替丁注射液细菌内毒素检查 (BET)的干扰试验 ,以便建立用 BET代替热原检查 (PT)。方法 :应用 BET来检查盐酸雷尼替丁注射液中的热原 ,考察了盐酸雷尼替丁注射液对 BET检查法的干扰行为。结果 :样品采用灵敏度为 0 .2 5 Eu· ml- 1 的鲎试剂经干扰试验 ,该制剂稀释 4倍 ,对细菌内毒素检查无干扰作用。结论 :本实验具有准确性、可靠性 ,适合盐酸雷尼替丁注射液的 BET检查。

Objective: To establish a method for bacteria endotoxin test (BET) instead of the pyrogen test (PT) through the study of BET for ranitidine hydrochloride injection. Methods: Using BET to detect pyrogen in ranitidine hydrochloride injection, the interference of ranitidine hydrochloride injection to the process of BET was studied. Results: Using sensitivity 0.25 Eu·ml -1 tachypleus amebocyte lysate for endotoxin detection, there is no interference to the BET when it is diluted for 4 time. Conclusions: The meothod is accurate, believable and suitable for the BET of ranitidine hydrochloride injection.