建立龙胆泻肝丸(Longdanxiegan pill,LDXGP)的高效液相色谱(HPLC)指纹图谱,以系统指纹定量法评价其质量。采用RP-HPLC法,以宏定性相似度为参量对12批LDXGP进行聚类分析,确定用其中10批生成对照指纹图谱(RFP),以此RFP为标准用系统指纹定量法评价12批LDXGP质量。以龙胆苦苷为参照物峰,确定60个共有指纹峰,建立了LDXGP的HPLC指纹图谱。用系统指纹定量法鉴别出8批质量合格,1批含量明显偏高,1批含量明显偏低,2批化学成分数量和分布比例不合格。系统指纹定量法将整体定性分析和整体定量分析密切结合,是评价中药质量的有效方法。
Using systematic quantified fingerprint method to assess the HPLC fingerprint of Longdanxiegan pill (LDXGP), in which the chromatographic fingerprints (CFPs) were determined by reversed-phase HPLC. The 12 batches of LDXGP were identified with hierarchical clustering analysis by using micro qualitative similarity as the variable. According to the results of classification, the referential fingerprint (RFP) was synthesized from 10 batches of LDXGP. Taking the RFP for the qualified model, the whole 12 batches of LDXGP were evaluated by the systematic quantified fingerprint method. The CFPs containing 60 co-possessing peaks were obtained when choosing gentiopicroside peak as the referential peak. Among the 12 batches of LDXGP, 8 batches were completely qualified, the content of 1 batch was obviously higher while 1 batch was lower, and the chemieal constituents quantity and distributed proportion in 2 batches were not qualified. Systematic quantified fingerprint method closely combined the macro qualitative analysis with macro quantitative analysis, it can effectively assess the authentic quality of Chinese traditional medicine.