亚甲蓝注射液细菌内毒素定量法研究.pdfVIP

亚甲蓝注射液细菌内毒素定量法研究 * ( ) 肖贵南 ,许姿敏 ,盛英美 广东省药品检验所 ,广州市 510180 中图分类号 R 927 ;R979 3 文献标识码 A 文章编号 1001- 0408 (2008) 34 - 2698 - 03 摘 要 目的:考察亚甲蓝注射液的细菌内毒素检查法的可行性。方法:采用动态比浊法鲎试验检查样品中的细菌内毒素 ,并与凝 - 1 ( - 1) 胶法结果进行比较。结果 :亚甲蓝注射液在浓度为 0 125 mg ·mL 时对试验无干扰;所测样品 10 mg ·mL 的细菌内毒素含量 均小于 0 25 EU ·mg - 1 ,与凝胶法结果基本一致。结论:可建立该制剂的细菌内毒素检查法。 关键词 亚甲蓝注射液 ;细菌内毒素 ;动态比浊法鲎试验 ;干扰试验 Stud on uantitative Detection of Bacterial Endotoxins in Meth lthioninium Chloride In ection y Q y j XIAO Gui - nan , XU Zi - min , SHEN G Yin g - mei ( Guangdong Instit ute for Drug Cont rol , Guangzhou 510180 , China) ABSTRACT OBJ EC T IV E : To establish a met hod for detectin bacterial endotoxins in met h lt hioninium chloride in ection g y j (MCI) quantitativel y M E THODS : Kinetic t urbidimet ric limulus test was app lied to detect bacterial endotoxins in MCI quantitativel y , and comp ared wit h gel - clot met hod R ESUL TS : MCI was un - interfered wit h t he test for bacterial endo toxins at t he concent ration of 0 125 mg ·mL - 1 ; t he content of bacterial endotoxins in all samp les tested ( 10 mg ·mL - 1) were - 1 not more t han 0 25 EU ·mg , which were in accordance wit h t he result of gel - clot met hod CONCL U