目的: 建立解郁安神颗粒的多组分含量测定及特征图谱方法与化学计量学结合,对解郁安神颗粒质量进行整体评价。方法: 采用CAPCELL PAK MGⅡC18(250 mm×4.6 mm,5 μm)色谱柱,以乙腈-0.1%磷酸水溶液为流动相,梯度洗脱,流速1.0 mL·min-1,柱温30 ℃,检测波长在237 nm(栀子苷、甘草苷、甘草酸铵)和335 nm(斯皮诺素及3,6'-二芥子酰基蔗糖)5个成分进行含量测定并进行方法学验证。基于多组分含量测定方法,建立样品的特征图谱,并通过化学计量学对样品进行分析评价,找出影响样品质量的主要因素。结果: 建立了解郁安神颗粒的多组分含量测定方法,5个成分在各自范围内线性关系良好,回收率在95.6%~100.0%,对145批次样品进行测定,不合格样品共54批,总不合格率为37.2%;建立了解郁安神颗粒的特征图谱,标定了12个特征峰分别归属于6味药材,通过化学计量学软件分析,10个厂家样品质量存在一定差异,炒栀子与炙甘草质量的优劣是影响样品质量的关键因素。结论: 建立的解郁安神颗粒多组分含量测定方法及特征图谱方法便捷可靠,可用于解郁安神颗粒品质的综合评价。
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