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目的:建立四妙君逸软膏HPLC指纹图谱分析方法,为制定其质量控制标准提供依据。方法:建立了分析四妙君逸软膏中主要成分的HPLC指纹图谱分离条件,即:色谱柱Ultimate C_(18)-ODS柱(250 mm×4.6 mm,5μm);流动相为乙腈-0.1%磷酸水;流速:1.0 ml·min~(-1);检测波长:280 nm;柱温:35℃,并且对色谱图中的共有峰进行了归属分析。结果:在筛选的最佳分离条件下进行梯度洗脱,四妙君逸软膏中各组分分离效果较好,可得到最优的指纹图谱;经方法学考察表明,所建立的HPLC指纹图谱分析方法精密度、稳定性、重复性均良好,指纹图谱清晰、可辨、易分析;初步确定四妙君逸软膏与四味药材指纹图谱共有峰之间的关系,为四妙君逸软膏的质量控制提供了重要依据。结论:四妙君逸软膏HPLC指纹图谱分析方法可作为质量控制的一项指标,供制订成品质量标准参考。
OBJECTIVE: To establish a HPLC fingerprinting method for the determination of Si Miao Junyi ointment, which provides the basis for establishing its quality control standard. Methods: The separation conditions of HPLC fingerprints of the main components in Si Miao Jun Yi Ointment were established, namely: the column Ultimate C 18 ODS column (250 mm × 4.6 mm, 5 μm); the mobile phase was acetonitrile -0.1% phosphoric acid Water; flow rate: 1.0 ml · min -1; detection wavelength: 280 nm; column temperature: 35 ℃, and the common peaks in the chromatogram were analyzed. Results: The gradient elution was carried out under the optimal conditions of screening. The separation results of each component in S Miao Jun Yi ointment were better, and the optimal fingerprint was obtained. According to the methodological study, the established HPLC fingerprinting The precision, stability and repeatability of the method were all good, and the fingerprint was clear, discernible and easy to analyze. The relationship between the four peaks of the four Miao Junyi ointment and the four peaks of the common fingerprint was initially determined, Provide an important basis. Conclusion: The HPLC fingerprinting method of Si Miao Junyi ointment can be used as an indicator of quality control for the preparation of finished product quality standards reference.