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目的:采用高效液相色谱技术建立妇炎康灌肠剂HPLC指纹图谱,同时分析其化学成分的归属。方法:采用Kromasil C18色谱柱(4.6 mm×250 mm,5μm),乙腈-0.04 mol.L-1 KH2 PO4(含0.1%H3 PO4)为流动相进行梯度洗脱,检测波长230 nm,流速1.0 mL.min-1,柱温为30℃。结果:得到分离度较好的妇炎康灌肠剂的指纹图谱,共标定出13个指纹特征峰,方法稳定、重复性好。同时结合复方药物、阴性样品及单味药的物质信息,确定了特征峰的来源。结论:所建立的指纹图谱特征性强、重复性较好,对妇炎康灌肠剂的质量评价有重要参考价值。
OBJECTIVE: To establish the HPLC fingerprinting of Fuyankang enema by HPLC and to analyze the attribution of its chemical composition. Methods: The gradient elution was carried out on a Kromasil C18 column (4.6 mm × 250 mm, 5 μm) with acetonitrile-0.04 mol·L-1 KH2 PO4 (0.1% H3 PO4) as the mobile phase. The detection wavelength was 230 nm and the flow rate was 1.0 mL min-1, the column temperature is 30 ℃. Results: The fingerprints of Fuyankang enema with good resolution were obtained and 13 fingerprint peaks were calibrated. The method was stable and reproducible. Combined with the compound drugs, negative samples and single drug substance information to determine the source of the characteristic peaks. Conclusion: The established fingerprint is strong and reproducible. It has important reference value for the quality evaluation of Fuyankang Enema.