药物冻干质控血清的制备及质量评价

The preparation and the quality assessment of the freeze-dried quality control samples used for therapeutic drug monitoring (TDM)

目的 :探讨治疗药物监测 (TDM )质控血清的制备及质量评价。方法 :介绍真空冷冻干燥法制备TDM冻干质控血清及其用法。从均匀性、分装差异、稳定性、浓度设置、定值、测定干扰等方面对冻干质控血清进行质量评价。结果 :被考察冻干质控血清外观均匀 ,复溶后无沉淀 ;分装差异平均 0 .2 4 %。稳定性 :0～ 4℃放置至少 15个月 ,常温至少 6个月 ,4 5℃至少 11d ,浓度几乎无改变。浓度设置合理 ,定值准确 ,一份质控血清控制多种药物 ,且测定无相互干扰。结论 :本冻干质控血清符合治疗药物监测质控血清所需各项质量要求。

OBJECTIVE To study the preparation and the quality assessment of the freeze-dried quality control samples (q.c samples) used for therapeutic drug monitoring (TDM).METHODS The preparation of the q.c samples was described. The quality assessment was investigated by uniformity,quantity difference,stability,concentrations, and interference.RESULTS The q.c samples tested were uniform observably.The mean of quantity difference was 0.24% .The stability: no significant change in concentration was found within 15 months,6 months and 11 days at the temperature 0～4 ℃,18～25 ℃ and 45 ℃,respectively.CONCLUSIONS The quality of the investigated q.c samples complies with the requirement of TDM quality control.