摘要
目的:建立丹参注射液中残留过敏性杂质的检测方法。方法:采用间接ELISA法检测过敏性杂质。结果:该方法的线性范围为1～128μg·ml^(-1)(r=0.995 3),检出限为0.25μg·ml^(-1),定量限为1μg·ml^(-1),平均加样回收率为92.7%。对96批市场流通样品进行了测定,8批检出过敏性杂质。结论:该方法前处理简单、精密度较好、特异性强,可用于丹参注射液中过敏性杂质的检测。
Objective：To establish a determination method for the allergic impurities in Danshen injections.Method：The allergic impurities in Danshen injections were determined by an indirect ELISA.Result;The calibration curves of the allergic impurities were linear within the concentration range of 1-128μg·ml-1（r =0.995 3）.The detection limit was 0.25μ·ml-1,the quantitative limit was 1μg·ml-1,and the average recovery was 92.7%.Among a total of 96 batches of Danshen injections,eight batches（8.3%） were positive.Conclusion：The method with simple pretreatment,good precision and promising specificity can be used in the determination of allergic impurities in Danshen injections.
出处
《中国药师》
CAS
2013年第6期820-823,共4页
China Pharmacist
基金
国家科技支撑计划课题(2006BAF07B01)
