[关键词]
[摘要]
目的 建立散结镇痛胶囊中酚酸类成分的UPLC指纹图谱,并进行多成分定量分析,为评价散结镇痛胶囊提供依据。方法 采用UPLC法,色谱柱为Phenomenex Kinetex 2.6 μm C18 100 A柱,乙腈-水梯度洗脱,体积流量为1.7 mL/min,柱温40 ℃,检测波长为280、325 nm。结果 得到分离度、重现性均较好的散结镇痛胶囊酚酸类成分UPLC指纹图谱,标示出15个共有峰,各批次样品相似度均在0.96以上;通过对照品比对,确定了5个成分,分别为白藜芦醇、7, 4′-二羟基黄酮、龙血素A、龙血素B和紫檀茋,并对其进行定量分析。结论 同时对散结镇痛胶囊中酚酸类成分进行UPLC指纹图谱和5个指标成分分析,方法快速、简便、准确,可作为全面评价该制剂质量的有效方法之一。
[Key word]
[Abstract]
Objective To establish the UPLC fingerprint for the phenolic constituents in Sanjie Zhentong Capsule (SZC) and to perform the quantitative determination of multi-components. so as to provide a scientific basis for the quality control of SZC. Methods The Phenomenex Kinetex 2.6 μm C18 100 A column was used in the gradient elution with a mobile phase of acetonitrile-water, the flow rate was 1.7 mL/min, the column temperature was 40 ℃, and the detection wavelengths were at 280 and 325 nm. Results The reproducible fingerprint of SZC was established and 15 common peaks were found. The fingerprints showed the good similarity in 10 batches of SZC was above 0.96. Based on the retention time and UV absorption spectra of reference substances, five constituents including loureirin A, loureirin B, 7, 4'-dihydroxy flavone, resveratrol, and pterostilbene were identified and quantitatively analyzed. Conclusion The method is rapid, simple, and accurate, which could be used for the quality control of SZC.
[中图分类号]
[基金项目]
国家科技部“重大新药创制”项目名称:子宫内膜异位症首选用药——散结镇痛胶囊大品种技术改造(2011ZX09201-201-20)