鼻炎灵胶囊中绿原酸和黄芩苷的含量测定及指纹图谱研究

Content determination of chlorogenic acid and baicalin in Biyanling capsules and study on its fingerprint

目的：建立鼻炎灵胶囊的质量控制方法。方法：采用Waters Symmetry C18色谱柱（250mm×4.6mm,5μm）,流动相：1%甲酸水溶液（A）-甲醇（B）、梯度洗脱,0~8min：10%B,8~15min：10%→35%B,15~38min：35%→60%B,38~50min：60%→90%B,50~60min：90%B。检测波长276、327nm,流速1.0ml/min,柱温30℃。对10批鼻炎灵胶囊进行分析,测定了绿原酸和黄芩苷两个有效成分的含量,建立鼻炎灵胶囊的指纹图谱,并计算相似度。结果：两种主要成分的含量测定方法有良好的线性、精密度、重复性、稳定性和准确度,各批次鼻炎灵胶囊的指纹图谱相似度良好（〉0.95）。结论：建立的HPLC法操作简单,重复性好,精密度高,可用于鼻炎灵胶囊的质量控制。

Objective： To establish a quality control method for Biyanling capsule. Methods： The separation was carried out on a Waters Symmetry C18 column（250 mm× 4.6 mm,5 μm）. The mobile phase was composed of 1% formic acid（A） and methanol（B） in gradient elution at a flow rate of 1.0 ml/min, 0-8 min：10% B,8-15 min..10%→35% B,15-38 min：35%→60% B, 38-50 min： 60%→90% B, 50-60 min.. 90 % B. The detection wavelength was set at 276 and 327 nm. The column temperature was 30 ℃. The HPLC method was applied to simultaneously determine the contents of baicalin and chlorogenic acid and develop fingerprints of 10 batches of Biyanling capsules. Results： The linearity, precision, repeatability, stability and accuracy of this method were all good. The similarity degrees of fingerprints were all fine as well （〉0.95）. Conclusion： The HPLC method was simple,reproducible,accurate,and could be used for the quality control of Biyanling capsules.