世界中医药

目的：建立中药银黄片体外溶出度测定的实验方法，为质量控制提供重要指标和参数。方法：参考《中华人民共和国药典》2015版收录的溶出度测定方法第二法-桨法，采用HPLC法，用DAD检测器，Agilent TC-C18（250 mm×4.6 mm，5 μm）色谱柱；流动相：A-0.1%磷酸水，B-0.1%磷酸乙腈，梯度洗脱；流速：1.0 mL/min；进样量：10 μL；检测波长为绿原酸327 nm，黄芩苷276 nm，测定自制银黄片中黄芩苷和绿原酸的溶出度。结果：黄芩苷和绿原酸分别在0.1～20 μM和0.5～30 μM范围内线性关系良好（R2=0.9996）。HPLC法可同时测定中药银黄片中黄芩苷、绿原酸的溶出度。结论：本方法快速、灵敏、准确，重现性好，可用于银黄片中绿原酸和黄芩苷的溶出度测定，为其质量控制提供重要依据。

English Summary:

To establish the determination method of baicalin and chlorogenic acid dissolution in Yinhuang tablets so as to provide criteria and parameters for the quality control of Yinhuang tablets. Methods:The dissolution of chlorogenic acid and baicalin from Yinhuang tablets was determined by HPLC method with DAD detector and Agilent TC-C18 column (250 mm ×4.6 mm, 5 μm) by using mixture of acetonitrile and purified water both containing 0.05% TFA as mobile phase with gradient elution in the current speed of 1.0 mL/min, and the detection wavelength of baicalin and chlorogenic acid were 276 nm and 327 nm, respectively. The dissolution test was operated according to the second dissolution method-oar method recorded on the Chinese medicine pharmacopoeia 2015 edition. Results:It was demonstrated that there was a good linear relationship in the range of 0.1-20 μM in baicalin and 0.5-30 μM in chlorogenic acid (R2=0.9996), respectively. The dissolution of chlorogenic acid and baicalin from Yinhuang tablets could be determined at the same time by the same HPLC method. Conclusion:The HPLC method was rapid, sensitive, accurate, and reproducible. It could be used to determine the baicalin and chlorogenic acid dissolution in Yinhuang tablets and provide important references for the quality control of Yinhuang tablets.

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