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目的建立抗感解毒颗粒的质量控制方法。方法采用TLC法对方中葛根、连翘、栀子、白芷、茵陈进行鉴别;采用HPLC法测定样品中黄芩苷的含量。色谱条件:色谱柱为Diamonsil C18柱(200 mm×4.6 mm,5μm);流动相:甲醇-0.2%磷酸水(40∶60);流速为1.0 ml·min-1;检测波长:280 nm;柱温:室温。结果薄层定性鉴别的斑点清晰,分离效果良好;黄芩苷含量在1~25μg·ml-1范围内线性关系良好(r=0.9997),平均加样回收率为98.28%,RSD为1.43%(n=6)。结论本方法结果准确、操作简单,重复性良好,适合作为该制剂的的质量控制标准。
Objective To establish a quality control method for Kanggan Jiedu granules. Methods The method of TLC was used to identify Pueraria lobata, Forsythia suspense, Gardenia jasminoides, Angelica dahurica and Rhizoma anemarrhena. The contents of baicalin in the samples were determined by HPLC. Chromatographic conditions: a Diamonsil C18 column (200 mm × 4.6 mm, 5 μm); a mobile phase of methanol-0.2% phosphoric acid (40:60); a flow rate of 1.0 ml · min -1; Temperature: room temperature. Results The spots were qualitatively identified by TLC and the separation effect was good. The linearity of baicalin in the range of 1 ~ 25μg · ml-1 was good (r = 0.9997), the average recovery was 98.28% and the RSD was 1.43% (n = 6). Conclusion The method is accurate, simple and reproducible. It is suitable as a quality control standard for this preparation.