中成药中非法添加化学药品吲哚美辛检测方法的研究-中国药品标准杂志.PDF

2010 11 6 416 D rug Standards o f C hina 2010, V ol11 N o6 1 2 2 2 徐军辉 , 李存金 , 王仕平 , 杨建春 ( 1, 336028 2, 336000) : 建立中成药中非法添加化学药品吲哚美辛的检测方法: 用化学反应鉴别方法及薄层色谱法, 快速检测 抗风湿类中成药中非法添加的吲哚美辛, 并用 HPLC 法来进一步验证: 化学反应鉴别薄层色谱法专属性强, 高效液相 - 1 2 色谱法吲哚美辛对照品线性范围 795 ~ 7155 m g L ( = 0999 9) , 平均回收率为 9927% , R SD 为 107% ( n = 6) : 本检测方法简便稳定重现性较好, 并具有一定的专属性 : 中成药 吲哚美辛 化学鉴别 TLC HPLC : 9212 : A : 1009 - 3656 ( 20 10) - 6- 4 16- 5 Studies on Determ ination M ethod of Indom etacin Adding Illegally in Antirheum atic Class T raditional ChineseM edicine 1 2 2 2 ( 1J iangxi Province Yichun municipal p eop le s hosp ital 336000; Xu Junhu i, L i Cunjin , W ang Sh ip ing , Y ang Jiangchun 2JiangxiProvinicial Yichun Institutef orDrug Control Yichun 336000) Abstract Objective: T o establish determ ination m ethod of Indom etac in add ing illega lly in antirheum atic class traditiona l Chinese m ed icineM ethods: Identif ication by chem icalm ethods and th inlayer chrom atography, rap id detection o f the antirheum atic c lass tradi tional Ch inese m edic ine illeg ally added ing red ients indom eth acin and to further verify by HPLCR esults: T he chem ical identif ica tion - 1 2 and th inlayer chrom atography is spec if icThe linear range of reference sub stance o f Indom etac in w as 795 ~ 7155 m g L ( = 0999 9) . T he average recovery ra te w as 9927% , and the relation standa rd dev iation ( RSD ) w as 107% ( n= 6) Conclusions: T he m ethod is smi ple, stable, reprodu cible, sp ecif ic w ith good durab ility and h igh sen sitiv ityT he chem ical identif ica tion m e thods and thin layer chrom atography a