益肾乌发口服液质量标准研究

目的:建立益肾乌发口服液的质量标准。方法:采用薄层色谱(TLC)法对制剂中的制何首乌、补骨脂和枸杞子3味药材进行定性鉴别;用高效液相色谱(HPLC)法对方中制何首乌的有效成分二苯乙烯苷进行含量测定。结果:TLC鉴别方法专属性强,在与对照药材及对照品相应的位置上制何首乌、补骨脂和枸杞子显示相同颜色的斑点,阴性对照无干扰。二苯乙烯苷进样量在0.03～0.60μg范围内与峰面积积分值呈良好线性关系(r=0.9999);平均回收率为102.4%,RSD=1.2%(n=6)。结论:所建标准可用于益肾乌发口服液的质量控制。

Quality Standards of Yishen Wufa Oral Solution

OBJECTIVE： To improve the quality standards of Yishen wufa oral solution. METHODS：Polygonum multiflorum, Psoraleae corylifolia and Lycium barbarum in the formulation were identified by TLC qualitatively. The content of stilbene glycoside was determined by HPLC. RESULTS： TLC identification was specific. The TLC spots were clear and well-separated. The linear range of stilbene glycoside was 0.03～0.60 μg（r=0.999 9）with an average recovery of 102.4%（RSD=1.2%,n=6）.CONCLUSION： Established method can be used for the quality control of Yishen wufa oral solution.