白癜灵颗粒质量标准研究

Study on quality standard for Baidianling granules

目的提高白癜灵颗粒的质量标准。方法采用薄层色谱法鉴别紫草、地榆;高效液相色谱(HPLC)法测定制何首乌中2,3,5,4′-四羟基二苯乙烯-2-O-β-D-葡萄糖苷的含量,色谱条件:使用C18柱(250mm×4.6mm,5μm),乙腈-水(1∶4)为流动相,检测波长为320nm。结果薄层色谱斑点清晰,易于识别;HPLC法测定2,3,5,4′-四羟基二苯乙烯-2-O-β-D-葡萄糖苷的含量在26.84～134.20μg/mL范围内呈现良好的线性关系,r=0.9998,平均回收率为101.2%,RSD=1.3%。结论所建立的标准方法简单,专属性强,结果准确可靠,可以用作白癜灵颗粒的质量控制方法。

Objective To improve the standard of quality of Baidianling Granules. Methods Radix Amebiae and Radix Sanguisorbae were distinguished by thin layer chromatogrphy （TLC）. 2,3,5,4＇ - tetrahydroxystilbene - 2 - O - β - D- glucoside in Prepared Radix Polygoni Multiflori was determined by HPLC. The C18 column （250 × 4.6mm, 5μm） was used. The mobile phase was acetonitrile - water （ 1 ： 4）. The wavelength of detector was set at 320nm. Results The spots were clear in TLC and could be identified easily. The linear detection range of 2,3,5,4＇ - tetrahydroxystilbene- 2 - O - β - D - glucoside was in 26.84 - 134.20 μg/mL, r = 0. 9998. The average recovery was 101.2% and RSD was 1.3 %. Conclusion This method is simple and accurate with a good reproducibility and can be used for the quality control of Baidianling Granules.