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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,建立用BET代替热原检查(PT)。方法:按《中国药典》细菌内毒素检查法操作。结果:样品采用灵敏度0．125 EU·ml-1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。
Objective: To investigate the bacterial endotoxin test of ranitidine sodium chloride injection (BET) interference test, the establishment of the BET instead of pyrogen test (PT). Methods: According to “Chinese Pharmacopoeia” bacterial endotoxin test method. Results: There was no inhibitory effect on the sensitivity of the sample to 0.125 EU · ml-1 by the interference test. Conclusion: This experiment has the accuracy and reliability, suitable for ranitidine sodium chloride injection examination.