济众酊的质量标准研究

目的建立济众酊的质量控制方法。方法采用薄层色谱法鉴别酊剂中主药大黄、广藿香;气相色谱法测定樟脑、薄荷脑的含量。结果济众酊中的大黄、广藿香的薄层色谱具有鉴别特征、斑点清晰、与相应对照品均呈相同的鉴别反应;樟脑在0.040 44～0.505 5 mg.ml-1范围内线性关系良好(r=0.999 9),平均回收率100.8%,RSD为1.1%(n=6);薄荷脑在0.049 84～0.249 2 mg.ml-1范围内线性关系良好(r=0.999 4),平均回收率101.2%,RSD为1.2%(n=6)。结论鉴别方法专属性强、灵敏度高;定量方法简便快速、结果准确且重复性好,可用于制剂的质量控制。

Quality Standard of Ji Zhong Tincture

Objective To establish the quality control standard of Ji Zhong tincture.Methods The main ingredients of rhubard and Herba Pogostemonis were identified by thin-layer chromatography(TLC).The contents of camphor and menthol were determined by GC.Results Chi Chung tincture of Rhubarb and patchouli appeared distinguishing characteristic of TLC,spots were clear,and showed the same reacts with a reference standard.The linear range of camphor was within the range of 0.0404 4~0.505 5 mg·ml-1 with a good linear relationship(r=0.999 9),the average recovery was 100.8%,and RSD was 1.1%(n=6).The linear range of menthol was within the range of 0.0498 4~ 0.249 2 mg·ml-1 with a good linear relationship(r=0.999 4),average recovery was 101.2%,and RSD was 1.2%(n=6).Conclusion The identification method is selective and sensitive.The quantitative method is simple,rapid,accurate and can be used to control the quality of Ji Zhong tincture.