益精灵口服液质量标准研究

Study on Quality Standards of Yijingling Oral Solution

目的对益精灵口服液的质量标准进行研究。方法采用薄层色谱法对处方中的何首乌、补骨脂进行定性鉴别,采用高效液相色谱法对制剂中何首乌的成分二苯乙烯苷含量进行测定。结果定性鉴别方法专属性强。二苯乙烯苷质量浓度在0.625～160μg/mL范围内与峰面积线性关系良好,r=0.999 9,平均加样回收率为102.28%,RSD为2.06%(n=9)。结论该方法简便、专属、重现性好,可有效控制益精灵口服液的质量。

Objective To study the quality standards of Yijingling Oral Solution. Methods TLC method was used for the identification of Radix Polygoni Multiflori, Psoralea corylifolia L.. The content of 2, 3,5,4＇-stilbene glycoside was determined by HPLC. Results The identification method was specific. Linear range of determination of 2,3,5,4＇ -stilbene glycoside was 0. 625- 160 ug/mL（ r = 0. 999 9）. The average recovery was 102.28%, RSD was 2.06% （n = 9）. Conclusion The method is simple, accurate and reproducible for the quality control of Yijingling Oral Solution.