归苓散结合剂制备工艺改进及质量标准的研究

Improvement of the Guiling Powder Binder Preparation Process and Quality Criteria Research

目的：改进归苓散结合剂的制备工艺，建立新的质量标准。方法将新工艺生产出的样品，用薄层色谱（ TLC）法对方中柴胡、当归、枳壳进行定性鉴别；用高效液相色谱法测定当归中阿魏酸的含量，与原来产品对照。结果新样品 TLC 斑点清晰、分离度好，阴性对照无干扰。阿魏酸检测浓度在8～40μg· mL －1范围内，与峰面积积分值呈良好线性关系。平均加样回收率为99．58％。 RSD＝0．59％（ n＝6）。结论新工艺生产的样品定性、定量结果均较原产品优。新标准可用于归苓散结合剂的质量控制。

OBJECTIVE To improve the preparation process of Guiling powder binder and establish the new quality standard.METHODS Radix Bupleuri,Angelica sinensis and Hovenia dulcis in sample produced by the new process was qualitative identified by thin layer chromatography （ TLC ） method;high performance liquid chromato-graphic method was used for determination of the content of ferulic acid in Angelica sinensis,with the original product as contrast.RESULTS The TLC spots of new sample were clear,well separated,without the interference of negative control.with concentration of ferulic acid in the range of 8～40μg· mL-1 ,the peak area integral value had good lin-ear relationship.The average recovery was 99.58%, RSD =0.59% （ n =6 ） .CONCLUSION Qualitative and quantitative results of samples made with new process were better than those in the original ones.The new standard can be used for quality control of Guiling powder binder.