基于超高效液相色谱指纹图谱轮廓的香丹注射液相似度快速评价

目的:建立采用超高效液相色谱指纹图谱轮廓快速评价香丹注射液相似度的方法。方法:采用超高效液相色谱(UPLC)法,以Acquity UPLC BEH C18柱为色谱柱,0.4%甲酸水和乙腈为流动相进行梯度洗脱,紫外检测波长为288 nm,测定了9个不同厂家的样品和其中1个厂家的10批香丹注射液UPLC-UV指纹图谱,再用基线校正、色谱峰匹配等数据预处理方法对指纹图谱进行处理,校正干扰后比较各批次香丹注射液样品的色谱图轮廓考察指纹图谱的相似度。结果:采用色谱指纹图谱轮廓能够在一定程度上反映出注射液的质量变化信息,与采用峰面积的分析方法差异不大,结果相似。结论:本方法可用于测定并比较不同来源的香丹注射液色谱指纹图谱相似度,并为快速中药质量评价和生产工艺监控提供可靠依据。

Fast Assessment on Similarity of Xiangdan Injection Based on Ultra High-performance Liquid Chromatography Fingerprint Profile

Objective: To establish UPLC fingerprint profile for the fast assessment on the similarity of Xiangdan injection. Method: Xiangdan injection was separated on an Acquity UPLC BEH C₁₈ column. The mobile phase consisted of formic acid-water and acetonitrile was used for separation by gradient elution. The detection wavelength was set at 288 nm. The fingerprint profile was then established for analysis of Xiangdan injection from 9 corporations and 10 batches of one corporation on the base of the above chromatogarphy condition. It was pretreated by the methods such as baseline correction and peak matching and then the similarity of fingerprint profile was studied by the comparison of Xiangdan injection from different batches. Result: The fingerprint profile was able to reflect the message of quality change to some extent and it has little differences from the method of peak area. Conclusion: UPLC fingerprint profile can be used for the rapid assessment on the similarity of Xiangdan injection and it provided a good approach to evaluate rapidly the quality of traditional Chinese medicine and control the production process.