龙胆提取物质量标准研究

Study on quality specification of Gentian extract

目的研究龙胆提取物中龙胆苦苷的含量测定和鉴别方法，制定提取物的质量标准。方法采用薄层层析法和高效液相法，对提取物中的龙胆苦苷进行定性鉴别和含量测定。结果通过方法学系统考察和样品的含量测定，建立了龙胆提取物中龙胆苦苷的含量测定方法，测得龙胆苦苷的线性范围为15．84～1014μg·mL^-1，回归方程Y=159014．83＋20306106．76X，r=0．9997，平均回收率为96．57％，RSD为1．78％。结论本实验建立的鉴别和含量测定方法具有专属性强，重现性好，无明显干扰等优点，是控制本品内在标准较理想的方法。

OBJECTIVE To study the identification and content determination method of gentiopicrin in Gentian extract, and to formulate the quality specification. METHODS Gentiopicrin in Gentian extract was identified by thin layer chromatography method and the quantitative determination method was established by HPLC. RESULTS The method of content determination of gentiopicrin was established,the linear range of gentiopicrin was 15.84～1014μg · mL^-1 , and the regression equation was Y =159014.83＋20306106.76 X , r =0. 9997,the average recovery was 96.57%, RSD was 1.78%. CONCLUSION The identification and determination methods were simple, specialized,reproducible and non-interference, and can be used to control the quality of Gentian extract.