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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。
Objective: To establish a method for rapidly evaluating the similarity of Xiangdan injection by using the outline of ultra-high performance liquid chromatography (HPLC) fingerprint. Methods: The elution was performed on a Waters Acquity UPLC BEH C18 column with a mobile phase of 0.4% formic acid and acetonitrile using UPLC. The UV detection wavelength was 288 nm. Nine different manufacturers Of the samples and one of 10 batches of Xiangdan injection UPLC-UV fingerprint, and then baseline correction, peak matching and other data pretreatment methods for fingerprint mapping, after correcting the interference of batches of Xiangdan injection The chromatograms of samples are examined for similarity of fingerprints. Results: The profile of chromatographic fingerprint can reflect the quality change information of injection to a certain extent, which is similar to the analysis method using the peak area. Conclusion: This method can be used to determine and compare the similarity of chromatographic fingerprints of Xiangdan injection from different sources, and provide a reliable basis for the rapid quality evaluation of traditional Chinese medicine and the monitoring of the production process.