指纹图谱、一测多评与模式识别相结合的忍冬藤配方颗粒质量评价

目的 建立指纹图谱、一测多评与化学模式识别分析相结合的忍冬藤配方颗粒质量评价方法。方法 利用制备的15批忍冬藤标准汤剂和10批忍冬藤配方颗粒建立了HPLC指纹图谱，进行相似度评价、层次聚类分析（hierarchical cluster analysis，HCA）、主成分分析（principal component analysis，PCA）及偏最小二乘-判别分析（partial least squares-discriminant analysis，PLS-DA）。建立一测多评法同时测定忍冬藤标准汤剂与配方颗粒中新绿原酸、马钱苷酸、绿原酸、隐绿原酸、当药苷、马钱苷6种成分的含量，同时测定忍冬藤饮片中相应成分的含量，计算从饮片到标准汤剂及配方颗粒的转移率。结果 15批忍冬藤标准汤剂和10批配方颗粒（S16～S25）HPLC指纹图谱有16个共有峰，相似度评价、HCA、PCA、PLS-DA表明，忍冬藤配方颗粒和标准汤剂成分相似。15批忍冬藤标准汤剂（S1～S15）的出膏率为7.80%～14.57%，新绿原酸、马钱苷酸、绿原酸、隐绿原酸、当药苷、马钱苷质量分数分别为2.09～8.60、6.91～21.84、2.71～6.83、1.94～8.72、1.51～6.81、10.26～33.88 mg/g，6种成分从饮片到标准汤剂的转移率分别为24.14%～41.75%、40.64%～70.83%、26.48%～44.22%、29.58%～51.97%、28.96%～46.59%、45.73%～84.73%。10批忍冬藤配方颗粒（S16～S25）的出膏率为14.4%～14.8%，6种成分从饮片到配方颗粒的转移率分别为46.16%～47.20%、41.87%～42.26%、39.64%～40.17%、58.20%～59.42%、31.14%～31.26%、84.06%～86.26%，与饮片到标准汤剂的转移率基本一致。结论 建立基于标准汤剂的忍冬藤配方颗粒的质量控制标准，以出膏率、指纹图谱的一致性、新绿原酸等6种指标成分的含量及转移率等为指标，衡量忍冬藤配方颗粒与标准汤剂的一致性，结果合理可靠，可为忍冬藤配方颗粒的质量控制及工艺研究提供参考。

Quality evaluation of Lonicerae Japonicae Caulis dispensing granules by combination of fingerprint, quantitative analysis of multi-components by single marker and chemical pattern recognition analysis

Objective To establish a method for quality evaluation of Rendongteng (Lonicerae Japonicae Caulis, LJC) dispensing granules by combining fingerprint, quantitative analysis of multi-components by single marker (QAMS) and chemical pattern recognition analysis. Methods The HPLC fingerprint of 15 batches of LJC standard decoctions and 10 batches of dispensing granules were established, and the similarity evaluation, hierarchical cluster analysis (HCA), principal component analysis (PCA) and partial least squares-discriminant analysis (PLS-DA) were also carried out. A QAMS method was established for content determination of six compositions (neochlorogenic acid, loganic acid, chlorogenic acid, cryptochlorogenic acid, sweroside, loganin) from LJC standard decoctions and dispensing granules. The content of the corresponding components in LJC decoction pieces were also detected to calculate the transfer rates from decoction pieces to standard decoctions and dispensing granules. Results Sixteen common peaks were calibrated in characteristic chromatography in 15 batches of LJC standard decoctions (S1—S15) and 10 batches of dispensing granules (S16—S25). The results of similarity evaluation, HCA, PCA and PLS-DA indicated the similarity of ingredients in dispensing granules to those in standard decoctions. In standard decoctions, extraction rates were 7.80%—14.57%, the content of neochlorogenic acid, loganic acid, chlorogenic acid, cryptochlorogenic acid, sweroside, loganin was 2.09—8.60, 6.91—21.84, 2.71—6.83, 1.94—8.72, 1.51—6.81, 10.26—33.88 mg/g and the transfer rates of six ingredients from decoction pieces to standard decoction were 24.14%—41.75%, 40.64%—70.83%, 26.48%—44.22%, 29.58%—51.97%, 28.96%—46.59%, 45.73%—84.73%, respectively. The extraction rates in LJC dispensing granules were 14.4%—14.8%, the transfer rates of these six components from decoction pieces to dispensing granules were 46.16%—47.20%, 41.87%—42.26%, 39.64%—40.17%, 58.20%—59.42%, 31.14%—31.26%, 84.06%—86.26% respectively, with consistence with those from decoction pieces to standard decoction. Conclusion The quality control standards of LJC dispensing granules were established based on standard decoctions. The reasonable and reliable consistency between dispensing granules and standard decoction was further measured by the extraction rates, specific chromatograms, content and transfer rate of six ingredients, which can provide a reference for the quality control and process study of LJC dispensing granules.