伤湿止痛膏中非法添加硫酸阿托品的检查  

Inspection of the Illegal Addition of Atropine Sulfate in Shangshi Zhitong Plaster

作　　者：廖立英 肖文涛 LIAO Liying;XIAO Wentao(Jiujiang Inspection,Testing and Certification Center,Jiujiang Jiangxi 332000,China)

机构地区：[1]九江市检验检测认证中心,江西九江332000

出　　处：《药品评价》2023年第8期963-965,共3页Drug Evaluation

摘　　要：目的建立伤湿止痛膏中非法添加硫酸阿托品的检查方法。方法通过薄层色谱(TLC)法建立伤湿止痛膏中颠茄流浸膏的定性检查;通过高效液相色谱(HPLC)手性色谱拆分法对伤湿止痛膏中颠茄流浸膏成分进行确认分析。采用Chiral CD-Ph S5色谱柱(250 mm×4.6 mm,5μm);以磷酸盐缓冲液-乙腈(94∶6)为流动相;流速1.0 mL/min;柱温30℃;检测波长220 nm;进样量为10μL。结果对12家生产企业的12批伤湿止痛膏样品进行检测,有1批样品检出硫酸阿托品。结论HPLC手性色谱拆分法能够很好地检测出样品是否含有非法添加硫酸阿托品成分,专属性强,可为含有托烷类生物碱的中药制剂中非法添加硫酸阿托品检查方法的建立提供参考依据。Objective To establish a method for detecting the illegal addition of atropine sulfate in shangshi zhitong plaster.Methods The qualitative examination of the fluid extract of belladonna in shangshi zhitong plaster was established by TLC.The composition of the fluid extract of belladonna in shangshi zhitong plaster was confirmed and analyzed by HPLC.The chromatographic column was Chiral CD-Ph S5(250 mm×4.6 mm,5μm).Phosphate buffer-acetonitrile(94∶6)was used as mobile phase;flow rate 1.0 mL/min;column temperature 30℃;detection wavelength 220 nm;the sample size was 10μL.Results 12 batches of shangshi zhitong plaster samples from 12 manufacturers were tested,and atropine sulfate was detected in 1 batch of samples.Conclusion HPLC chiral chromatography can well detect whether the sample contains the illegal addition of atropine sulfate,and the specificity is strong.It can provide a reference for the establishment of a method to detect the illegal addition of atropine sulfate in traditional Chinese medicine preparations containing tropane alkaloids.

关 键 词：伤湿止痛膏 硫酸阿托品 薄层色谱 HPLC手性色谱拆分 

分 类 号：R286[医药卫生—中药学]