昆明山海棠片HPLC指纹图谱研究

A Study on the HPLC Fingerprints of the Tripterygium Hypoglaucum Tablet

目的建立昆明山海棠片HPLC指纹图谱。方法采用HPLC法,用中药色谱指纹图谱相似度评价系统2004A(国家药典委员会)对20批昆明山海棠片制剂的数据进行分析、建立其指纹图谱,并对该方法进行方法学验证。结果不同批次样品图谱相似度均在0.9以上,色谱方法可靠。结论建立的指纹图谱能较全面地反映了制剂的质量,其方法可靠且简单易行,具有较好的重复性、适应性,为昆明山海棠片的整体质量评价提供科学依据。

Objective： To establish the HPLC （high performance liquid chromatography ） fingerprints for the Tripterygium Hypoglaucum Tablet. Methods： The data of 20 batches of Tripterygium Hypoglaucum Tablets were analyzed to establish the fingerprints with ＂similarity evaluation system for chromatographic fingerprint of TCM＂ （ version 2004A made by Natinal Pharmacopoeia commission） by HPLC and the established method was methodologically verified. Resuits： The similarity of the different batches was higher than 0.9 and the method was reliable. Conclusion： The established fingerprints can comprehensively reflect the qualities of the tablet and this method is easy, safe and feasible with good repeatability and adaptability to lay a scientific basis for the evaluation of the overall quality of the Tripterygium Hypoglancum Tablet.