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目的：建立丹参酮ⅡA 磺酸钠注射液的细菌内毒素检查方法。方法按《中国药典》2010年版（二部）附录ⅪE细菌内毒素检查法进行干扰初筛试验，并对3批样品进行内毒素检查。结果将丹参酮ⅡA 磺酸钠注射液用内毒素检查用水稀释至浓度为0.0625 mg·ml-1，用灵敏度为0.125 EU·ml-1的鲎试剂进行试验，供试品不干扰细菌内毒素检查。结论鲎试剂方法用于丹参酮ⅡA 磺酸钠注射液细菌内毒素检查可行，具有简便、快捷、可靠等优点。“,”Objective To establish a method for detecting bacterial endotoxin in sulfotanshinone sodium in-jection. Methods A preliminary interference test were carried out according to The Guidelines and Procedures Spec-ified in Appendix Ⅺ E,Pharmacopoeia of the People's Republic of China(Vol.Ⅱ,2010). Three batches of sam-ples were detected by bacterial endotoxin test. Results Using tachypleus amebocyte lysates with a sensitivity of 0 . 125 EU·ml-1 ,the sample did not interfere with the bacterial endotoxin test when sulfotanshinone sodium injec-tion was diluted to 0. 0625 mg·ml-1 with bacterial endotoxin examination water. Conclusion The established meth-od of tachypleus amebocyte lysates test is feasible for detecting bacterial endotoxin in sulfotanshinone sodium injec-tion. This method is also simple,quick and reliable.