脏连丸质量标准研究

Study on the quality specification of Zanglian Pill

目的建立脏连丸的质量控制标准。方法对脏连丸制剂中黄连、槐角、槐花采用薄层色谱法进行了定性鉴别；采用HPLC法测定黄芩中黄芩苷的含量。Intersil C18色谱柱，2％冰醋酸溶液-甲醇（45：55）为流动相；检测波长280nm。结果黄芩苷在0．0434～4.34μg范围内进样量与峰面积呈线性关系，黄芩苷的平均回收率99．2％，相对标偏差（RSD）为1．10％。薄层图谱斑点清晰，空白无干扰。结论方法简便、准确、重现性好，可用于该制剂的质量控制标准。

Objective To establish the quality specification of Zanglian Pill. Methods Rhizoma coptidis, fructus sophorae and flos sophorae were identified by TLC. Radix scutellariae was determined by HPLC. Intersil C18 column was used with the mobile phase of 2 % acetic acid-methanol（45 ： 55） ,at the detection wavelength of 280nm. Results The calibration curve was linear in the range of 0. 0434 - 4.34μg. The average recovery rate of baicalin was 99.2 % with RSD of 1.10 %. The TLC spots developed were fairly clear,and the blank test showed no interference. Conclusion The method developed is simple and accurate with a good reproducibility,and the method can be used for the quality control of Zanglian Pill.