丹参酮Ⅱ_A磺酸钠注射液细菌内毒素检查法的可行性研究

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。

Feasibility of Detecting Bacterial Endotoxin in Sulfotanshinone Sodium Injection by Tachypleus Amebocyte Lysate Test

Objective To establish a method for detecting bacterial endotoxin in sulfotanshinone sodium injection. Methods A preliminary interference test were carried out according to The Guidelines and Procedures Specified in Appendix Ⅺ E,Pharmacopoeia of the People＇s Republic of China（ Vol. Ⅱ,2010）. Three batches of samples were detected by bacterial endotoxin test. Results Using tachypleus amebocyte lysates with a sensitivity of0. 125 EU·ml- 1,the sample did not interfere with the bacterial endotoxin test when sulfotanshinone sodium injection was diluted to 0. 0625 mg·ml- 1with bacterial endotoxin examination water. Conclusion The established method of tachypleus amebocyte lysates test is feasible for detecting bacterial endotoxin in sulfotanshinone sodium injection. This method is also simple,quick and reliable.