银翘解毒片高效液相色谱指纹图谱识别研究

Study of the fingerprint identification for Yinqiao Jiedu Tablet by HPLC

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 the fingerprint identification method by HPLC and provide basis of quality integral control and evaluation for Yinqiao Jiedu Tablet. Methods 10 batches of samples from 4 factories were determined by HPLC. The samples were separated on the column of Hypersil ODS C18( 200 mm × 4. 6 mm,2. 5 μm)with the mobile phase of acetonitrile-0. 1% phosphoric acid solution and gradient elution. The detecting wavelength was set at 230 nm; the column temperature was 30 ℃. The samples' quality was assessed by similarity evaluation system for chromatographic fingerprint of TCM 2004 A. Results Precision,repeatability,stability and fingerprint of all samples were in good state with similarity degree above 0. 90. Conclusion The method is simple,convenient and reliable. It can be used to identify and evaluate the quality of Yinqiao Jiedu Tablet.