益肾清列口服液的质量标准研究

Study on the quality standard for Yishenqinlie oral Liquid

目的:建立益肾清列口服液的质量标准。方法:采用TLC法对益肾清列口服液中白术、白芍、菟丝子定性鉴别;采用HPLC法对其中菟丝子中主要有效成分金丝桃苷进行含量测定。结果:方中各药TLC鉴别法分离好、专属性强、重现性好、阴性无干扰;HPLC法中,以金丝桃苷浓度为横坐标、相应峰面积为纵坐标得回归方程为Y=1.782×10~7X-3 736.7 (r=0.999 9),金丝桃苷浓度在0.005 15～0.103 00 mg/mL范围内线性关系良好,平均加样回收率为97.9%,RSD为2.1%(n=6)。结论:该研究建立的定性定量方法分离好、专属性强、结果准确、重现性好,可有效控制益肾清列口服液质量。

Objective:To establish the quality standard of Yishenqinlie oral liquid. Methods: Rhizoma Atractylodis Macrocephalae,Radix paeoniae alba,Semen Cuscutae in Yishenqinlie oral liquid were identified by TLC,and the content of hyperoside was determined by HPLC. Results:The method for TLC identification had a good specificity and repeatability,and there was no interference in the blank sample. The regression equation of hyperoside was Y=1.782×10^7 X-3 736.7(r=0.999 9),showing a good linearity in the range of 0.005 15 to 0.103 mg/mL. The average recovery of hyperoside was 97.9%,RSD was2.1%(n=6). Conclusion:The qualitative and quantitative method were simple,specific,accurate and reliable,which could be used to effectively control the quality of Yishenqinlie oral liquid.