乳病消片定性鉴别及其延胡索乙素的含量测定

Rubingxiao Tablets'Qualitative Identification and Its HPLC Determination of Tetrahydropalmatine

目的建立乳病消片的质量控制标准。方法采用薄层色谱法对片剂中淫羊藿、黄芪、茯苓进行定性鉴别,用高效液相色谱法测定处方中元胡药材延胡索乙素含量。结果淫羊藿、黄芪、茯苓的薄层色谱鉴别色谱特征明显;延胡索乙素进样量在0.144～1.728μg范围内与峰面积呈良好线性关系,r=0.999 9(n=7),平均回收率为98.57%,RSD为1.52%(n=6)。结论所采用方法准确可行,重现性好,可用于乳病消片的质量控制。

Objective To establish the standards of quality control for Rubingxiao Tablets. Methods A qualitative identification method by TLC was established for analysis of Herba Epimedii, Radix Astragali and Poria Cocos. The content of tetrahydropalmatine was deter- mined by HPLC. Results There were the clear spots of Herba Epimedil, Radix Astragali and Poria Cocos in the same place respectively by TLC. The linear range of tetrahydropalmatine was 0. 144- 1. 728μg with r=0. 999 9（ n =7）. The average recovery was 98.57% with RSD of l. 52% （n = 6）. Conclusion The determination result is accurate,reliable and has a good repeatability. It can be used for quality control of Rubingxiao tablets.