复方熊胆茵陈颗粒质量标准研究

摘要

目的建立复方熊胆茵陈颗粒的质量标准。方法采用薄层色谱法鉴别制剂中的熊胆粉、茵陈、白术、甘草。采用高效液相色谱法测定制剂中牛磺熊去氧胆酸钠的含量。色谱柱：Kromail 100-5 C18(4.6 mm×250 mm,5µm)；流动相：甲醇-0.03 mol/L磷酸二氢钠溶液(60∶40),pH＝4.4；检测波长：210 nm；流速：1 mL/min；柱温：25℃。结果在薄层色谱中可以检出熊胆粉、茵陈、白术、甘草。牛磺熊去氧胆酸钠在进样量0.1821～1.821 mg 范围内与峰面积积分值线性关系良好(r＝0.99998),平均加样回收率为100.39%,RSD＝1.70%(n＝6)。结论该方法简便、准确、专属性强,可以有效控制复方熊胆茵陈颗粒的质量。%Objective To establish the quality standard for Fufang Xiongdan Yinchen Granule. Methods TLC was employed to identify Pulvis ellis urs, Capillary Wormwood Herbin, Atractylodis Macrocephalae Rhizoma and Glycyrrhizae Radix, and HPLC was used to determine the content of sodium tauroursodeoxycholic acid in Fufang Xiongdan Yinchen Granule. Kromail 100-5 C18 column (4.6 mm× 250 mm, 5 µm) in an oven at 25 ℃ was need, with a mobile phase consisting of methanol-0.03 mol/L sodium dihydrogen phosphate solution (60∶40, pH=4.4) and UV detector at 210 nm, the flow rate was 1.0 mL/min. Results Pulvis ellis urs, Capillary Wormwood Herbin, Atractylodis Macrocephalae Rhizoma and Glycyrrhizae Radix can be detected by TLC. The linearity of sodium tauroursodeoxycholic acid was obtained in the range of 0.182 1-1.821 mg (r=0.999 98). The average recovery was 100.39%, and RSD was 1.70% (n=6). Conclusion The method is simple, accurate, specific, and can control the quality of Fufang Xiongdan Yinchen Granule effectively.