注射用盐酸托泊替康的细菌内毒素检查法研究

Study on Bacterial Endotoxins Test of Topotecan Hydrochloride for Injection

摘要: 目的　建立注射用盐酸托泊替康的细菌内毒素检查法。方法　按中国药典2010年版二部附录ⅪE细菌内毒素检查法。结果　本品稀释为0.04 mg·mL^-1的溶液对细菌内毒素检查无干扰作用。按拟定标准检验，该品种3批样品细菌内毒素检查结果均符合规定。结论　本品可用细菌内毒素检查法代替家兔热原检查法，其细菌内毒素的限值(L)为50 EU·mg^-1。

Abstract: OBJECTIVE　To establish a method for determination of the bacterial endotoxin in topotecan hydrochloride for injection. METHODS　According to Chinese Pharmacopoeia 2010 edition Appendix Ⅺ E bacterial endotoxin test. RESULTS　Dilution sample to 0.04 mg·mL^-1 had no interference to bacterial endotoxin test. The results of bacteria endotoxin test in three batchs all accorded with the standard of the quality control. CONCLUSION　It can be used instead of rabbit pyrogen test method for. The limits of bacterial endotoxin was 50 EU·mg^-1.