糖郁舒颗粒质量标准研究

The quality standards research of Tang Yushu Granules

目的建立糖郁舒颗粒的质量标准。方法采用TLC法对处方中黄连、首乌藤、川芎、石菖蒲进行定性鉴别；采用HPLC法以A：B（93：7）为流动相[A为乙腈-0．05mol／L磷酸二氢钾溶液（50：50）（每100ml中加十二烷基硫酸钠0．4g，再以磷酸调节pH值为4．0）；B为高纯水]，在检测波长345nm处测定表小檗碱、黄连碱、巴马汀、小檗碱总含量。结果TLC鉴别分离度良好，专属性强。盐酸小檗碱含量在0．01912～3．825μg范围内，线性关系良好。相关系数r为1．0000，平均加样回收率为101．03％（RSD为0．94％）。结论该方法简便、准确，重复性好，可有效控制糖郁舒颗粒的质量。

Objective To establish quality standards of Tang Yushu Granules. Methods TLC was used to identify Rhizoma Copit- idis,Ligustici Chuanxiong, Rhizoma Acori Tatarinowii and Caulis Polygoni Multiflori in Tang Yushu Granules. The epiberberine, palmatine, coptisine and berberine hydrochloride were determined by HPLC with a mobile phase of A -B （93：7） [ A is acetonitrile -0.05mol/L potassium dihydrogen phosphate（50：50） （About 0.4g sodium dodecylsulfate added per 100ml）and B was high pure water. ] （ Phosphoric acid to control the pH value of 4.0）. The detection wave length was set at 345nm. Results The identifi- cation by TLC was distinct and highly specific. The linear ranges of berberine hydrochloride was in the ranges of 0. 01912 ~ 3. 825 μg （ r = 1. 000 0）. The sample recoveries was 101.03 % （ RSD = 0.94% ）. Conclusion The methods were simple, accurate, re- producible , and could control the quality of Tang Yushu Granules effectively.