基于指纹图谱和多组分定量分析的中药制剂洁泽洗液质量评价

Quality Evaluation of Traditional Chinese Medicine Jieze Lotion Based on Combination of Fingerprints and Multi-component Quantitative Analysis

关键词:  洁泽洗液  高效液相色谱法  指纹图谱  多指标成分测定  化学计量学  质量评价

Key words:  Jieze lotion  HPLC  fingerprints  multi-index determination  chemometrics  quality evaluation

摘要:

目的 建立洁泽洗液指纹图谱及多指标成分含量测定的方法，同时采用化学计量学方法对其进行质量评价。方法 采用HPLC-DAD指纹图谱，经对照品比对指认出10个成分，测定并分别计算其含量。采用相似度评价、聚类分析、主成分分析及正交偏最小二乘判别法对数据进行分析。结果 11批样品指纹图谱相似度均>0.95，线性关系良好(r≥0.999 1)，平均加样回收率为89.70%~106.0%，RSD为1.52%~3.41%；该方法的仪器精密度、稳定性、重复性均良好。10个共有峰(没食子酸、原儿茶酸、新绿原酸、单咖啡酰酒石酸、5-O-阿魏酰奎宁酸、绿原酸、盐酸黄柏碱、木兰花碱、4-O-阿魏酰奎宁酸、盐酸小檗碱)含量测定结果分别为40.103~55.841，2.347~6.179，8.336~23.810，7.084~21.956，33.098~53.833，24.597~49.610，21.587~31.188，5.915~13.162，115.381~189.702，31.378~112.686 μg·mL^?1。化学计量学结果显示11批样品可分为4类，用以区分各批次样品的强特征峰为盐酸小檗碱、4-O-阿魏酰奎宁酸、绿原酸、新绿原酸和5-O-阿魏酰奎宁酸。结论 所建方法准确可靠，可用于洁泽洗液的质量控制和综合评价。

Abstract:

OBJECTIVE To establish fingerprints and multi-components determination of Jieze lotion, and use chemometrics methods for quality evaluation. METHODS The HPLC-DAD fingerprints was established and 10 components were recognized by comparison with references. Meanwhile, their contents were determined. The data were evaluated by the methods of chemometrics such as similarity evaluation, cluster analysis, principal component analysis, and orthogonal partial least squares-discriminant analysis. RESULTS The similarity of 11 batches of Jieze lotion were all >0.95. The linearity was good(r≥0. 999 1) and the average recoveries were between 89.70% and 106.0% with the RSD of 1.52%?3.41%. Instrument precision, stability and reproducibility of the method were all great. The contents of the common ten components(gallic acid, protocatechuic acid, neochlorogenic acid, caftaricacid, 5-O-feruloylquinicacid, chlorogenic acid, phellodendrine chloride, magnoflorine, 4-O-feruloylquinic acid, berberinehydrochloride) were 40.103?55.841, 2.347?6.179, 8.336?23.810, 7.084?21.956, 33.098?53.833, 24.597?49.610, 21.587?31.188, 5.915?13.162, 115.381?189.702, 31.378?112.686 μg·mL^?1, respectively. The results of chemometrics showed that the 11 batches of samples could be divided into 4 categories, and the strong characteristic peaks used to distinguish each batch of samples were berberine hydrochloride, 4-O-feruloylquinic acid, chlorogenic acid, neochlorogenic acid and 5-O-feruloylquinic acid. CONCLUSION The method is accurate and reliable, and it can be used for the quality control and comprehensive evaluation of Jieze lotion.