溶血性试验供试品药物浓度的探讨  

Investigation of Entrusted Test Sample's Concentration in Hemolytic Test

作　　者：陈冬芬[1] 匡荣[1] 朱社敏[1] 

机构地区：[1]浙江省食品药品检验所,杭州310004

出　　处：《中国现代应用药学》2010年第4期335-337,共3页Chinese Journal of Modern Applied Pharmacy

基　　金：浙江省中医药管理局基金项目(2007CA104)

摘　　要：目的对溶血性试验供试品药物浓度的设置提出参考性意见。方法根据药物临床使用现状,对溶血试验中供试品的浓度设置进行了分析。结果当药物浓度高于临床使用浓度16.7倍时,可采用药物原液按常规体外试管法进行评价与检查;当药物浓度达不到临床使用浓度的16.7倍时,建议采用在供试品溶液中加入少量血红细胞的方法进行评价与检查,提高临床用药的安全性。结论现行溶血试验中的供试品药物浓度确定值得探讨。OBJECTIVE To provide a referenced suggestion for setting the sample concentration in the hemolytic test. METHODS Analysed the setting of the sample concentration in the hemolytic test according to the current situation used in clinic. RESULTS When the sample concentration is 16.7 times more than the clinical one, the original sample solution can be utilized for evaluation and investigation using the test tube method in vitro. When the sample concentration is 16.7 times less than or equal to the clinical one, the method that a few red cells should be added to the sample solution can be suggested for evaluation and investigation to improve the security in drug use. CONCLUSION The concentration of the sample used in the current hemolytic test deserves farther investigation.

关 键 词：溶血性试验 药物浓度 

分 类 号：R969.11[医药卫生—药理学]