环孢菌素A血药浓度快速检测试纸的初步研制  

Primary Preparation of Test Papers for Rapid Detection of Blood Concentration of Cyclosporin A

作　　者：吕宗杰[1] 郑永[2] 程渝[1] 

机构地区：[1]重庆市妇幼保健院,重庆400013 [2]重庆医科大学附属第二医院,重庆400010

出　　处：《中国药房》2013年第33期3087-3089,共3页China Pharmacy

摘　　要：目的:制备环孢菌素A(CsA)血药浓度快速检测试纸。方法:将胶体金标记的CsA单克隆抗体吸附在玻璃纤维素膜上组装成试纸,将人工抗原固化于适合的硝酸纤维素膜上,组装成检测试纸。考察检测试纸对血浆中CsA的检测范围、定量限、回收率、精密度、稳定性,以及不同浓度阿奇霉素、兰索拉唑、头孢拉定、氨溴索、格列本脲对检测试纸的测定是否有影响,并与荧光偏振免疫分析法比较10份CsA血浆样品的检测结果。结果:该试纸对血浆中CsA的检测质量浓度线性范围为5～600ng/m(lr=0.9981),定量限为5ng/ml,回收率为86.51%～112.43%,日内、日间RSD均小于20%(n=5);常温下放置15d不稳定,4℃下放置3个月稳定;阿奇霉素、兰索拉唑、头孢拉定、氨溴索、格列本脲对检测试纸的影响均小于4ng/ml;2种方法10份血浆样品的检测结果间差异无统计学意义(P>0.05)。结论:成功制备了CsA血药浓度快速检测试纸,且其特异性较好。OBJECTIVE： To prepare test papers for rapid detection of blood concentration of cyclosporin A （CsA）. METH- ODS： CsA monoclonal antibody was marked by colloidal gold and attached to fiberglas cellulose membranes, and then assembled into test papers; artificial antigen was solidified onto cellulose nitrate membranes, and then assembled into test papers. The detec- tion range, limit of quantification, recovery, precision and stability of CsA were detected in plasma. The effects of different concen- trations of azithromycin, lansoprazole, cefradine, ambroxol and glibenclamide on test papers were also determined. Results of 10 plasma samples of CsA were compared between test paper and fluorescence polarization immunoassay. RESULTS： The detection range of CsA is 5-600 ng/ml by test papers （r=0.998 1 ）. The limit of quantification was 5 ng/ml, and recovery rates were 86.51%-112.43%. RSDs of intra-day and inter-day were lower than 20% （n=5）. CsA was not stable within 15 d at room tempera- ture, but it was stable within 3 months at 4 ℃. The blood concentrations of azithromycin, lansoprazole, cefradine, ambroxol and glibenclamide were all lower than 4 ng/ml and had no significant effect on test paper. There was no statistical significance in the de- termination results of 10 plasma samples by 2 methods （P〉0.05）. CONCLUSIONS： Test papers for rapid detection of blood con- centration of CsA have been developed successfully and show sound specificity.

关 键 词：环孢菌素A 快速检测试纸 血药浓度 制备 

分 类 号：R96[医药卫生—药理学] R979.5[医药卫生—药学]