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目的:对银屑灵优化方进行质量标准研究,建立该制剂的定量检测方法。方法:采用高效液相色谱法对处方中组分中药的5个指标成分绿原酸、芍药苷、异嗪皮啶、落新妇苷、黄杞苷进行含量测定,色谱条件为Inertsil ODS-3色谱柱,流动相为甲醇-0.1%甲酸溶液,梯度洗脱,检测波长为330 nm和230 nm。结果:5个指标成分含量测定中,绿原酸、芍药苷、异嗪皮啶、落新妇苷、黄杞苷浓度分别在1.79~115μg/m L(R~2=0.9992)、5.84~750μg/m L(R~2=0.9997)、0.54~87.5μg/m L(R~2=0.9989)、7.81~1000μg/m L(R~2=0.9994)、3.91~500μg/m L(R~2=0.9992)范围内峰面积与进样量呈良好的线性关系。结论:所建立的HPLC定量方法简便、准确、重复性好、专属性强,可用于银屑灵优化方的质量控制。
OBJECTIVE: To study the quality standard of psoriasis prescription and to establish a quantitative test method for this preparation. Methods: The content of chlorogenic acid, paeoniflorin, isoxapide, astilbin and huangqi glycosides were determined by HPLC. The chromatographic conditions were Inertsil ODS-3 The mobile phase consisted of methanol-0.1% formic acid and eluted with a gradient of 330 nm and 230 nm. Results: The concentrations of chlorogenic acid, paeoniflorin, isopzamid, astilbin, and huangqiidin were 1.79 ~ 115μg / m L (R ~ 2 = 0.9992), 5.84 ~ 750μg / (R 2 = 0.9997), 0.54-87.5 μg / m L (R 2 = 0.9989), 7.81-1000 μg / m L (R 2 = 0.9994), 3.91-500 μg / m L (R 2 = 0.9992) within the peak area and injection volume showed a good linear relationship. Conclusion: The established HPLC method is simple, accurate, reproducible and specific. It can be used for the quality control of PZQ optimization.