[关键词]
[摘要]
目的 建立养阴清肺糖浆指纹图谱,研究不同厂家和同一厂家不同批次样品的指纹图谱差异,为完善该制剂的质量评价体系奠定基础。方法 采用高效液相色谱法(HPLC)进行测定,Agilent TC-18色谱柱(250 mm×4.6 mm,5 μm),乙腈-0.1%磷酸水溶液梯度洗脱,检测波长为254 nm,柱温为30 ℃,体积流量为0.8 mL/min。结果 建立了养阴清肺糖浆HPLC指纹图谱,标定共有峰23个;不同厂家养阴清肺糖浆相似度差别明显,质量差异较大;同一厂家不同批次间相似度较大,质量稳定。通过聚类分析,将11个厂家的养阴清肺糖浆聚为4类。结论 不同厂家生产的养阴清肺糖浆质量差异显著,有必要对其建立完善的质量评价体系。
[Key word]
[Abstract]
Objective To establish the HPLC fingerprint of Yangyin Qingfei Syrup (YQS), to discuss the differences among the samples from different manufactories and different batches from the same manufactory, and to lay a foundation for optimizing the quality evaluation system. Methods HPLC was used with Agilent TC-18 column (250 mm × 4.6 mm, 5 μm), gradient eluted with acetonitrile-0.1% phosphoric acid. The detection wavelength was 254 nm, column temperature was 30 ℃, and flow rate was 0.8 mL/min. Results The HPLC fingerprint of YQS was established, and 23 common peaks were marked. Obvious differences of similarity and qualities from the different manufactories were observed, and the similarity and qualities from the same manufactory were found to be stable. The 11 samples from the different manufactories were classified into four clusters by cluster analysis. Conclusion The quality of YQS from the different manufactories is obviously different. It is necessary to establish a comprehensive quality evaluation system for YQS.
[中图分类号]
[基金项目]
国家“重大新药创制”科技重大专项(2012ZX09103201-026);国家中医药管理局中医药行业科研专项项目:中成药生产过程再现的关键技术示范研究(200807038);北京中医药大学复方中药制药创新团队(2011-CX70-13)