红净胶囊质量标准研究

Quality standard of Hongjing capsule

目的建立红净胶囊的质量标准。方法采用显微鉴别法鉴别本制剂中的冰片和三七;采用薄层色谱法（TLC）鉴别丹参、冰片和三七;采用高效液相色谱法（HPLC）测定沙利度胺的含量,色谱柱为Inertsustain C18（150 mm×4.6 mm,5μm）;流动相为乙腈-0.1%磷酸水溶液（15∶85,v/v）;检测波长为237 nm。结果在选定的薄层色谱条件下,斑点显色清晰,分离效果良好。沙利度胺浓度在40.32~141.12μg/m L范围内呈良好的线性关系（r=0.999 8）;平均回收率为98.27%,RSD为1.44%（n=9）。结论该方法简便可行,专属性强,重现性好,可用于红净胶囊的质量控制。

Objective To establish the quality standard of Hongjing capsule. Methods Borneol and radix notoginseng from Hongjing capsule were identified by microscopic identification; Salvia miltiorrhiza,borneol and radix notoginseng were identified qualitatively by TLC; HPLC was adopted to determine the content of thalidomide in the preparation,chromatographic column was Inertsustain C18（ 150 mm × 4. 6 mm,5 μm）; acetonitrile-0. 1% phosphoric acid solution（ 15∶ 85,v / v） was as mobile phase,and detection wavelength was at 237 nm. Results Under the condition of selected TLC,the spot color was clear and the separation effect was good. Thalidomide showed a good linear relationship in the range of 40. 32 ~ 141. 12 μg / m L with r = 0. 999 8,and average recovery was 98. 27% with RSD 1.44%（ n = 9）. Conclusion The method is simple and specific with good repeatability and can be used for quality control of Hongjing capsule.