复生康胶囊质量标准的研究

Studies on quality standard of Fushengkang Capsule

目的 建立复生康胶囊质量控制方法。方法 采用薄层色谱法对蒲葵子、喜树果和莪术进行定性鉴别 ,采用 HPLC法测定喜树碱的含量。色谱条件为 :Dikma Diamonsil C1 8柱 (2 5 0 mm× 4.6mm,5μm) ;流动相 :甲醇 -水(5 5∶ 45 ) ;流速 :0 .8m L /min;检测波长 :2 5 4nm。结果 薄层色谱斑点清晰集中 ,喜树碱在 0 .0 5 0 6～ 0 .2 5 3 0μg具有良好线性关系 ,平均回收率为 96.90 % ,RSD=1.74% ,(n=6)。结论 方法灵敏、准确、重现性好、专属性强 。

Object To establish the method for quality control of Fushengkang Capsule. Methods Semen Livistonae Chinensis, Fructus Camptothecae Acuminatae and Rhizoma Curcumae in this capsule were identified by TLC. The content of camptothecine was determined by HPLC. Condition of HPLC was: Dikma Diamonsil C 18 column (250 mm× 4 6 mm, 5 μm) the mobile phase was a mixture of methanol water (55∶45), the flow rate was 0 8 mL/min, and detection wavelength at 254 nm. Results The spots of TLC were clear and concentrative. There was a good linear relationship for camptothecine within the range of 0 050 6 - 0 253 0 μg. The average recovery was 96 90%, RSD=1 74% (n=6). Conclusion This method is sensitive, accurate, reproducible and exclusive. It can be used for quality control of Fushengkang Capsule