舒气安神丸定性定量方法研究

目的建立舒气安神丸定性定量方法。方法采用显微鉴别法对制剂中炙甘草、白术、山药、人参和大枣进行定性鉴别,采用薄层色谱法对白术和黄连进行定性鉴别;采用高效液相色谱法测定制剂中丹酚酸B含量,色谱柱为Inertsil C18(150 mm×4.6 mm,5μm),流动相为甲醇-乙腈-0.5%甲酸(30:10:60,v/v/v),流速为1.0 mL·min-1,检测波长286 nm。结果显微鉴别结果清晰。薄层色谱斑点清晰,分离度良好,阴性无干扰,专属性强,重复性良好。丹酚酸B在34.52⁵48.0μg·mL-1与峰面积线性关系良好(r=0.999 4)。平均回收率分别为100.2%、101.7%、100.1%,RSD分别为0.85%、1.0%、1.6%(n=3)。结论本方法简便、可靠、准确,可用于舒气安神丸的质量控制。

Qualitative and quantitative method for Shuqi Anshen pill

Objective To establish the quality standard for Shuqi Anshen pills. Methods Microscopic identification was used for the qualitative identification of Radix Glycyrrhizae Preparata, Rhizoma of Atractylodes Macrocephala, Rhizoma Dioscoreae, Panax Ginseng and Fructus Ziziphi Jujubae in the pill. Thin layer chromatography（TLC） was used for the qualitative identification of rhizoma coptidis and rhizoma of atractylodes macrocephala. The content of salvianolic acid B in the pill was determined by high performance liquid chromatography. Inertsil C18（150 mm×4.6 mm, 5 μm） column was used with methanol-acetontile-5% formic acid（30 ： 10 ： 60,v/v/v） as the mobile phase. The flow rate was 1.0 mL · min- 1 and the detection wavelength was 286 nm. Results The microscopic characteristics were clear. The TLC spots were clear and well separated without negative interference. It was highly specific with satisfactory reproducibility. Good linear relationship（r = 0.999 4） for salvianolic acid B at 34.52-548.0 μg · mL- 1 was obtained. The average recovery of salvianolic acid B was 100.2%, 101.7% and 100.1%, RSD was 0.85%, 1.0%, 1.6%（n = 3）. Conclusion The method is simple, repeatable and can be used for the quality control of Shuqi Anshen pills.