【摘要】 目的分析环孢霉素A(CSA)和普乐可复(FK506)药物浓度监测(TDM)的室内质控结果。方法采用酶放大免疫分析法(EMIT)测定CSA和FK506血药浓度的高、低质控品,绘制质控图,并对2007年的随行质控结果进行统计学分析。结果 EMIT法测定CSA和FK506的日内RSD分别为5.89%～9.41%、8.34%～9.30%,日内方法回收率分别为92.8%～98.3%、89.1%～89.5%;日间RSD分别为8.51%～9.74%、8.46%～8.78%,方法回收率分别为91.0%～102.7%、89.6%～99.1%。2007年随行质控测定值的RSD为10.02%～14.41%,符合《中国药典》对生物样品的测定要求。结论 EMIT法测定CSA和FK506血药浓度准确、稳定性良好,适于临床开展TDM,临床应用时应建立合理的质控体系。更多还原

【Abstract】 OBJECTIVE To analyse the internal quality control( QC) data of Cyclosporine A( CsA) and Tacrolimus( FK506) therapeutic drug monitoring( TDM) in order to improve the accuracy of TDM. METHODS EMIT was used to determine the concentrations of CsA and FK506 in high and low level QC material and QC graph was drawn. All the QC data in 2007 were analysed. RESULTS The in-a-day RSDs of CSA and FK506 were respectively 5. 89%-9. 41% ,and 8. 34%-9. 30% ; the recovery of methodology were 92. 8%-98. 3% and 89. 1%-89. 5% ,respectively. The between days RSDs of them were 8. 51%-9. 74% and 8. 46%-8. 78% , respectively. The recovery of methodology were 91. 0%-102. 7% and 89. 9%-99. 1% ,respectively. The RSDs of all the internal QC data in 2007 were 10. 02%-14. 41% ,which were in accordance with the requirements of Chinese Pharmacopoeia on RSD and the recovery for biological materials ( RSD < 15% and the rate of recovery was in the range from 85% to 115% ) . CONCLUSION EMIT is accurate and stable for the determination of CsA and FK506,and is suitable for clinical TDM. For clinical use,proper QC system should be applied.更多还原