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目的建立银翘解毒片的高效液相色谱(HPLC)指纹图谱方法,为整体控制和评价其质量提供依据。方法采用HPLC法测定4个不同厂家10批银翘解毒片中连翘苷的含量,色谱柱为C18柱(200 mm×4.6 mm,2.5μm),以乙腈-0.1%磷酸水溶液为流动相梯度洗脱,检测波长230 nm,柱温30℃;采用中药色谱指纹图谱相似度评价系统A版(2004)对10批不同样品进行质量评价。结果所测样品的精密度、重复性、稳定性及指纹图谱均较好,相似度均在0.90以上。结论该方法简便、可靠,可用于该制剂的鉴别和质量控制。
OBJECTIVE To establish HPLC fingerprint of Yinqiao Jiedu tablets, and to provide a basis for the overall control and evaluation of its quality. Methods HPLC method was used to determine the content of forsythin in 10 batches of Yinqiao Jiedu tablets from 4 different manufacturers. The column was C18 column (200 mm × 4.6 mm, 2.5 μm) with acetonitrile-0.1% phosphoric acid aqueous solution as mobile phase gradient The detection wavelength was set at 230 nm and the column temperature was set at 30 ℃. The quality evaluation of ten batches of different samples was performed using the similarity evaluation system A (2004). Results The precision, repeatability, stability and fingerprint of the tested samples were good, and the similarities were above 0.90. Conclusion The method is simple and reliable, and can be used for the identification and quality control of the preparation.