五妙水仙膏的质量标准研究

Study on the Quality Standard for Wumiao Shuixian Cream

目的建立五妙水仙膏的质量标准。方法采用薄层色谱法对处方中黄柏、五倍子、紫草3味药材进行定性鉴别;用高效液相法测定制剂中小檗碱的含量,采用AichromBond-AQ-C18色谱柱（4.6 mm×150 mm,5μm）;流动相为乙腈-0.033 mol/L磷酸二氢钾（用磷酸调节pH值为3.0）-0.025 mol/L十二烷基硫酸钠（48∶30∶25）,流速1.0 ml/min,柱温30℃;检测波长345 nm;进样量20μl。用高效液相法对所建立的小檗碱含量测定方法进行方法学验证,证明采用的含量测定方法适合于相应分析要求。验证内容有：线性关系考察,精密度实验,稳定性实验,专属性实验,重复性实验,以及加样回收率实验。结果薄层色谱专属性强;小檗碱的线性范围是0.07-0.28μg,r=0.999 5,平均加样回收率为98.11%,RSD为1.34%（n=6）。结论该方法简便、准确,重现性好,可作为五妙水仙膏质量控制的标准。

Objective To establish the quality standard for Wumiao Shuixian Cream. Methods Cortex Phellodendri chinense, Radix arnebiae and Calla chinesis in this prescription were identified by TLC. The content of the berberine was determined by HPLC ： the column of AichromBond-AQ-C18 （4.6 mm ×150 mm ,5μm）was used . The mobile phase was CH3 CN -0. 033 mol/LKH2PO4 （trithylamine adjusted pH to 3.0） -0.025 mol/L SDS （48： 30：25 ）, at the flow rate of 1.0 ml · min^-1, the column temperature was 30℃, and detection wavelength was 345 nm. Results The study on the quality control showed that the characteristic of identification by TLC was distinct and highly specific, The linear range of berberine was in the range of 0. 07 - 0.28 p.g, r = 0. 9995 ,the average recovery was 98.11% ,RSD = 1.34% （n = 6）. Conclusion The method is simple, accurate and reproducible. It can be used effectively for the quality control of this preparation.