李丽，陈雄刚，林红宁,孔令瑞（肇庆市第一人民医院，广东 肇庆 526021）

摘 要 目的：研究雷尼替丁氯化钠注射液细菌内毒素检查（BET）的干扰试验，用BET代替热原检查(PT)。方法：按2000年版药典附录86页细菌内毒素检查法操作。结果：样品采用灵敏度0.125EU/mL的鲎试剂经干扰实验无增强抑制作用。结论：本实验具有准确性、可靠性，适合雷尼替丁氯化钠注射液的检查。

[关键词] 鲎试剂；细菌内毒素；干扰实验；雷尼替丁氯化钠注射液

[中图分类号] R927.12    [文献标识码] A

The Study of the Bacterial Endotoxins Test for Ranitidine in Sodium Chloride Injection

Li Li, CHENG Xionggang (The Zhaoqing First People's Hospital, Zhaoqing, Guangdong, 526021, P. R. China)

ABSTRACT Objective: Through studying the interfere factors test of BET for Ranitidine in Sodium Chloride Injection，to establish a method for Bacterial Endotoxin Test (BET) instead of the Pyrogen Test (PT). Method: According the method of BET approved by Chinese Pharmacopoeia (2000), on page 86 in the appendix. Result: Using limulus amebocyte lysate (LAL) with the sensitivity of 0.125EU·ML^-1 for interfere factors test, there was no inhibition or enhancement action. Conclusion: The method is accurate, believable and suitable for testing Ranitidine in Sodium Chloride Injection.

KEY WORDS Limulus amebocyte lysate(LAL); Bacterial endotoxin; Interfere factors test; Ranitidine in Sodium Chloride Injection