心安宁片质量标准研究

Studies on Quality Standard of Xin' anning Tablets

目的：建立心安宁片质量标准.方法：采用薄层鉴别方法进行定性鉴别,运用高效液相色谱法测定葛根素的含量.结果：确立了制剂中葛根、制何首乌的鉴别方法.通过方法学系统考察,建立了葛根素的含量测定方法,其葛根素的线性范围为0.212～3.392μg,回归方程：Y=4 528 774X-79 624（r=0.999 9）,平均加样回收率为98.9％,RSD =2.64％ （n =6）.结论：建立的鉴别和含量测定方法简便、准确、重复性好,适用于心安宁片的质量控制.

Objective： To establish the quality standards for Xin＇ anning Tablets. Methods： TLC was adopted for qualitative identification. The content of puerarin was detected by HPLC. Results： The identifying method of kudzu root and Radix Polygonum Multiflorum was established. The determination method for the content of puerarin was established. The calibration curve of puerarin was liner in the range of 0. 212-3. 392 μg. The regression equation was Y = 4 528 774X -79 624 （r = 0. 999 9）. The average recovery was 98. 9% and RSD was 2. 64% （n = 6）. Conclusion： The method is simple, accurate and reproducible. It can be used for the quality control.