制远志饮片质量标准研究

A studies on quality specification of processed radix polygalae

目的建立制远志薄层色谱和高效液相色谱质量标准研究方法。方法以远志对照药材和甘草对照药材为对照品,采用3种薄层色谱系统对制远志进行定性鉴别。应用高效液相色谱法测定制远志中远志皂苷和甘草酸含量。结果氯仿-甲醇-水(25:16:4)展开系统制远志薄层色谱的专属性强;制远志中远志皂苷元含量不低于0.36%,是生品的2倍以上;甘草酸含量不低于0.02%,转移率约为18%。结论方法简便,专属性高,能兼顾制远志中远志和甘草的特点,可作为保证制远志饮片质量和临床疗效的控制方法。

Aim To establish RP-HPLC and TLC methods for quality specification in Processed Radix Polygalae. Methods The qualitative identification of Processed Radix Polygalae was studied by TLC. The content of senegenin and glycyrrhizic acid were determined by RP-HPLC. Results The specificity of chloroform-methanol-water（25：16： 4） development system was the best. The content of senegenin in Processed Radix Polygalae was≥0. 36%, which was more than the content of senegenin in Radix Polygalae;the content of glycyrrhizic acid was ≥0.02%, and the transfer rate was 18%. Conclusion The established method is sensitive,reliable and suitable for the quality control of Processed Radix Polygalae.