综合线性定量指纹法评价退热解毒注射液融合指纹图谱研究

Evaluation of Fusion Fingerprint for Tuire Jiedu Injection by Comprehensive Linear Quantitative Fingerprint Method

该研究引入综合线性定性相似度Sl、综合线性定量相似度Pl%和指纹变异系数α3个参数建立了1种新颖的综合线性指纹图谱评价方法,从定性定量的角度全面评价了中药的整体质量。方法采用高效液相二极管阵列(HPLC/DAD)采集了退热解毒注射液样品在210、254、265、330、360 nm波长下的指纹图谱并进行数据融合,同时定量分析了绿原酸、连翘酯苷A、丹皮酚和柴胡皂苷D 4个指标成分。通过综合线性指纹法鉴定样品质量。结果显示,10批注射液样品被分成5个等级,10批中间体样品被分成4个等级。此外,4个指标成分的定量分析结果与融合指纹图谱的定量相似度Pl%具有高度相关性,表明综合线性定量指纹法具有代替标准物质用于样品定量分析的潜力。该方法为中药整体质量控制提供了一种新思路。

This study introduced the three parameters of comprehensive linear qualitative similarity Sl,comprehensive linear quantitative similarity Pl%and fingerprint variation coefficientαto establish a novel method-comprehensive linear fingerprinting method(CLFM),which comprehensively evaluated the overall quality of traditional Chinese medicine from a qualitative and quantitative perspective.The fingerprints for Tuire Jiedu injection(TJI)samples at 210,254,265,330 and 360 nm wavelengths were collected by high performance liquid chromatography with diode array detection(HPLC/DAD),and followed by the data fusion.Meanwhile,four index components,including chlorogenic acid(CHA),forsythin A(FA),paeonol(PA)and saikosaponin D(SD)were quantitatively analyzed.The quality of the samples was identified by CLFM.Results showed that 10 batches of injection samples were divided into 5 levels,and 10 batches of intermediate samples were divided into 4 levels.The quantitative analysis results of the four index components were highly correlated with the quantitative similarity Pl%of the fingerprint,indicating that the CLFM could be used to replace the standard substance for sample quantitative analysis.This method provides a new idea for the overall quality control of traditional Chinese medicine.