[关键词]
[摘要]
目的 建立舒肝解郁胶囊的UPLC-MS指纹图谱分析方法,为其质量评价积累数据。方法 以0.1%甲酸-乙腈为流动相,梯度洗脱60 min,使用Agilent Poroshell 120 SB-C18色谱柱(150 mm×4.6 mm,2.7 μm)进行指纹图谱研究,同时通过高效液相色谱-电喷雾离子阱质谱分析方法鉴定部分成分。结果 对其中22个共有峰进行了成分鉴定,对34批舒肝解郁胶囊进行了指纹图谱检测和相似度评价,34批样品的相似度均大于0.960,确立了指纹图谱中的12个特征吸收峰。结论 所建立的舒肝解郁胶囊的指纹图谱特征性和专属性强,该方法可用于舒肝解郁胶囊的质量控制。
[Key word]
[Abstract]
Objective To establish aultra high performance liquid chromatography coupled with mass spectrometry (UPLC-MS) fingerprint for the quality control of Shugan Jieyu Capsules and to accumulate the data used for their quality evaluation. Methods UPLC separation was performed on an Agilent Poroshell 120 SB-C18 column (150 mm × 4.6 mm, 2.7 μm) by gradient elution in 60 min with 0.1% formic acid-acetonitrile as mobile phase. The mass spectrometry detection was performed on a trap equipped with an ESI interface and operated in both positive and negative ionization modes to identify components. Results Twenty-two characteristic common peaks of chemical constituents were identified and 34 batches of Shugan Jieyu Capsules were analyzed. The quanlity of samples was assessed by Similarity Evaluation System for Chromatographic Fingerprint of TCM (2004 A version). The similarities of 34 batches of Shugan Jieyu Capsules were all over 0.960, and 12 characteristic peaks of UPLC fingerprint for Shugan Jieyu Capsules were established. Conclusion The UPLC fingerprint of Shugan Jieyu Capsules is established, the convenient and high specific method could be used to identify and evaluate the quality of Shugan Jieyu Capsules.
[中图分类号]
[基金项目]
四川省重大产业技术创新专项“治疗抑郁症中药新药舒肝解郁胶囊产业化工艺研究”(2012CD00082);四川省科技成果转化项目“治疗抑郁症中药新药舒肝解郁胶囊成果转化”(2012SC0029)