摘要
目的:建立高效液相色谱法检测膏药中硫酸阿托品的含量测定方法,用于市售止痛膏药的药品质量控制。方法:采用萃取技术处理不同膏药样品,得含量测定分析提取物。采用HPLC技术,以ODS C 18色谱柱(250 mm×4.6 mm,5μm),乙腈-磷酸盐缓冲液(取6.8 g磷酸二氢钾溶于1000 mL水中,加入10 mL三乙胺,用磷酸调节pH值至2.8)(7∶93)为流动相,流速为1 mL·min^(-1),检测波长为210 nm,进样体积10μL,测定不同厂家止痛膏药中硫酸阿托品含量。结果:建立了止痛膏药中硫酸阿托品含量测定方法,其在0.0882~0.8820μg具有良好的线性,平均回收率为95.73%,不同厂家止痛膏药中硫酸阿托品含量范围为0.06~0.39 mg/100cm^(2),含量差异很大。结论:该法简便、准确、灵敏度高,重现性好,可以用于止痛膏药中硫酸阿托品含量测定及质量控制。
Objective To establish a method for the determination of atropine sulfate in acesodyne plaster by high performance liquid chromatography(HPLC).Used for quality control of acesodyne plaster.Method Extraction technology was used to extract the atropine sulfate in acesodyne plaster from different production enterprises,HPLC method was developed to determination of atropine sulfate in acesodyne plaster from different production enterprises,and the contents were determined by Phenomenex ODS C 18(4.6 mm×250 mm,5μm),with acetonitrile-phosphate buffered salt solution as the mobile phase for isocratic elution(7∶93),the flow rate was 1 mL·min^(-1),the detection wavelength was 210 nm,injection volume was 10μL.Result The common mode for the determination of atropine sulfate in acesodyne plaster was established.A linear range of 0.0882~0.8820μg,the mean recovery 95.73%.The content of atropine sulfate in analgesic plasters from different production enterprises varies greatly,the range of 0.06~0.39 mg/100cm^(2).Conclusion The method showed to be simple,quick,sensitive,accurate,reproducible and can be used to content determination and control quality of acesodyne plaster from different production enterprises.
作者
吴春燕
张立军
张新玥
张转平
WU Chunyan;ZHANG Lijun;ZHANG Xinyue;ZHANG Zhuanping(Ankang Inspection and Detection Center of Food and Drug Control,Ankang 725000,China;Beijing University of Traditional Chinese Medicine,Beijing 100029,China)
出处
《中国民族民间医药》
2021年第22期29-33,共5页
Chinese Journal of Ethnomedicine and Ethnopharmacy
基金
陕西省社会发展科技攻关项目(2015SF286)。
