药学服务与研究
藥學服務與研究
약학복무여연구
PHARMACEUTICAL CARE AND RESEARCH
2010年
1期
40-43
,共4页
他克莫司%酶增强免疫分析法%质量控制%血药浓度监测
他剋莫司%酶增彊免疫分析法%質量控製%血藥濃度鑑測
타극막사%매증강면역분석법%질량공제%혈약농도감측
tacrolimus%enzyme-multiplied immunoassay technique%therapeutic drug monitoring%quality control
目的:评价酶增强免疫分析法(EMIT)监测患者全血中他克莫司浓度的质量,建立并改进他克莫司血药浓度监测的质量控制方法.方法:以标准质控为样本,进行预防性质量控制和室内质量控制研究.对2008年血药浓度监测中随行质控样本的测定值做回顾性研究并进行统计学分析,建立新的质控规则.结果:他克莫司低、中、高浓度(4.3、8.9、18.0 ng/ml)2009年质控样本的日内、日间RSD为1.8%～11.2%,平均回收率为90.5%～114.0%,符合<中华人民共和国药典>生物样品测定的要求.2008年质控样本的低、中、高浓度(3.8、7.5、15.0 ng/ml)的随行质控RSD分别为21.8%、14.2%和15.5%,适合本单位的质控规则为1_(2S)/1_(3S)/2_(2S)/4_(1S)/7_(tr).结论:EMIT法准确度和精密度良好,是一种较理想的他克莫司血药浓度测定方法,但影响因素较多,特别是温度对其影响较大,因此必须做好质量控制.
目的:評價酶增彊免疫分析法(EMIT)鑑測患者全血中他剋莫司濃度的質量,建立併改進他剋莫司血藥濃度鑑測的質量控製方法.方法:以標準質控為樣本,進行預防性質量控製和室內質量控製研究.對2008年血藥濃度鑑測中隨行質控樣本的測定值做迴顧性研究併進行統計學分析,建立新的質控規則.結果:他剋莫司低、中、高濃度(4.3、8.9、18.0 ng/ml)2009年質控樣本的日內、日間RSD為1.8%～11.2%,平均迴收率為90.5%～114.0%,符閤<中華人民共和國藥典>生物樣品測定的要求.2008年質控樣本的低、中、高濃度(3.8、7.5、15.0 ng/ml)的隨行質控RSD分彆為21.8%、14.2%和15.5%,適閤本單位的質控規則為1_(2S)/1_(3S)/2_(2S)/4_(1S)/7_(tr).結論:EMIT法準確度和精密度良好,是一種較理想的他剋莫司血藥濃度測定方法,但影響因素較多,特彆是溫度對其影響較大,因此必鬚做好質量控製.
목적:평개매증강면역분석법(EMIT)감측환자전혈중타극막사농도적질량,건립병개진타극막사혈약농도감측적질량공제방법.방법:이표준질공위양본,진행예방성질량공제화실내질량공제연구.대2008년혈약농도감측중수행질공양본적측정치주회고성연구병진행통계학분석,건립신적질공규칙.결과:타극막사저、중、고농도(4.3、8.9、18.0 ng/ml)2009년질공양본적일내、일간RSD위1.8%～11.2%,평균회수솔위90.5%～114.0%,부합<중화인민공화국약전>생물양품측정적요구.2008년질공양본적저、중、고농도(3.8、7.5、15.0 ng/ml)적수행질공RSD분별위21.8%、14.2%화15.5%,괄합본단위적질공규칙위1_(2S)/1_(3S)/2_(2S)/4_(1S)/7_(tr).결론:EMIT법준학도화정밀도량호,시일충교이상적타극막사혈약농도측정방법,단영향인소교다,특별시온도대기영향교대,인차필수주호질량공제.
Objective:To evaluate the quality of enzyme-multiplied immunoassay technique(EMIT) for therapeutic drug monitoring(TDM) of tacrolimus,establish and improve the quality control method for TDM of tacrolimus.Methods:Researches on prospective and internal quality control were carried out on standard quality control samples.Results of TDM of control samples in 2008 were retrospectively studied and statistically analyzed.A new quality control rule was established.Results:The inter- and intra-day RSD of low, middle and high concentrations(4.3,8.9,18.0 ng/ml) of tacrolimus,which was quality control sample of batch number 7190,ranged from 1.8%-11.2%,and the average recovery rates were in the range of 90.5%-114.0%.This was up to the requirements of biological sample determination in Chinese Pharmacopoeia.RSD of the low, middle and high concentrations(3.8,7.5,15.0 ng/ml) of control samples in 2008 (the batch number was 2250) were 21.8%,14.2% and 15.5%,respectively.The new quality control rule was 1_(2S)/1_(3S)/2_(2S)/4_(1S)/7_(tr).Conclusion:EMIT method is suitable for TDM of tacrolimus with good accuracy and precision. However, it is susceptible to several factors, especially temperature.Therefore, the quality control must be done carefully.
