【摘要】 目的建立益卫康宝胶囊(主要组分为延胡索、当归、三棱等)的质量标准。方法鉴别采用薄层色谱法(TLC),检查项考察装量差异及崩解时限等,含量项采用高效液相色谱法(HPLC)测定制剂中延胡索乙素。色谱条件:SinoChrom ODS-BP(4.6 mm×250 mm,5μm)柱,流动相:0.1%磷酸(用三乙胺调节pH值为6.0)-甲醇(40:60),检测波长282 nm。结果TLC具有专属性,装量差异在±10%范围内,供试样品在7.9~10.7 min的时间范围内全部崩解,含量测定方法准确可靠,线性关系良好,平均回收率97.20%,RSD1.26%。结论该质量标准准确、全面、可靠,适用于益卫康宝胶囊的质量控制。更多还原

【Abstract】 Objective To set up the quality standards of yiwei kangbao capsules. Methods Thin layer chromatography(TLC) was used to identify ferulic acid and tetrahydropalmatine.Content uniformity and time limit of disintegration were examined with weighing and inspection,respectively.HPLC was used to determine the content of tetrahydropalmatine.The chromatographic conditions were : a SinoChrom ODS-BP(4.6 mm×250 mm,5 μm) column served as the solid phase,the mobile phase was methanol-0.1% phosphoric acid solution(pH adjusted to 6.0 with triethylamine)(60:40). the detection wavelength,282 nm. Results The TLC method was shown to be specific.The content difference was in the range of ±10%.The samples used in the examination were totally disintegrated within 7.9-10.7 min.The HPLC method was accurate and reliable,the linear relationships were excellent.The average rate of recovery was 97.20%,with an RSD of 1.26%. Conclusion The quality standards were precise,comprehensive,reliable and suitable for the quality control of yiwei kangbao capsules.更多还原