吡柔比星组胺类物质检查法建立的可行性考察  

Feasibility Study on Test Method Establishment for Histamine-like Substances in Pirarubicin

作　　者：鲁艺[1] 冼静雯[1] 陈润桦 秦美蓉[1] 王晓炜[1] 王平[1] 

机构地区：[1]深圳药品质量标准研究重点实验室深圳市药品检验所,广东深圳518057

出　　处：《中国药师》2016年第2期402-405,共4页China Pharmacist

摘　　要：目的:建立吡柔比星的组胺类物质检查法。方法:按2010年版《中国药典》化学药品注射剂安全性检查法应用指导原则中的组胺类物质检查法进行试验。结果:该品种在0.01 mg·ml^(-1)浓度下对组胺类物质检查无干扰作用;运用建立的方法对10批样品进行组胺类物质检查,结果与降压物质检查法一致。结论:所建立的吡柔比星的组胺类物质检查方法具有可行性,其组胺类物质检查限值可定为1μg·mg^(-1)。Objective： To establish the test method for histamine-like substances in pirarubicin. Methods： According to the method described in the appendix of Chinese Pharmacopoeia （2010 edition）, the test for histamine-like substances was carried out. Resuits： The test for histamine-like substances had no interference under the condition with pirarubicin concentration of 0.01 mg· ml-l. The established test method for histamine-like substances in pirarubicin was applied in 10 samples, and the results were accordant with those of the test method for depressor substances. Conclusion： The test method for histamine-like substances in pirarubicin is feasible -1 with the limit of 1 μg ·mg

关 键 词：吡柔比星 组胺类物质 检查法 

分 类 号：R927.11[医药卫生—药学]