济众酊的质量标准研究

Quality Standard of Ji Zhong Tincture

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。

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.