论文部分内容阅读
目的:研究雪莲注射液细菌内毒素检查BET的干扰实验,寻求使用鲎试剂检测雪莲注射液中细菌内毒素的方法。方法:按照《中国药典》2010年版二部收载的细菌内毒素检查方法进行试验。结果:当样品作80倍稀释时,用标示灵敏度为0.5EU.mL-1鲎试剂检测细菌内毒素检查,雪莲注射液对鲎试剂的凝集反应未见干扰作用,测试结果均符合规定。结论:可以用细菌内毒素检查法来控制雪莲注射液的质量。
OBJECTIVE: To study the BET interference test of bacterial endotoxin in Xuelian injection and to find out the method of detecting the bacterial endotoxin in Xuelian injection by using 鲎 reagent. Methods: According to the “Chinese Pharmacopoeia” 2010 edition of the two contained bacterial endotoxin test method for testing. Results: When the samples were diluted 80 times, the bacterial endotoxin was detected by the labeled sensitivity of 0.5EU.mL-1 鲎 reagent, and the results of the test were in accordance with the regulations. Conclusion: Bacterial endotoxin test can be used to control the quality of Xuelian injection.