基于HPLC指纹图谱及多成分一测多评法定量的炙甘草饮片质量评价研究

目的建立新生化颗粒原料优质炙甘草饮片质量评价方法。方法采用HPLC法建立优质炙甘草饮片指纹图谱;采用一测多评法同时测定炙甘草饮片中6种有效成分(甘草苷、异甘草苷、甘草酸、甘草素、芹糖甘草苷、芹糖异甘草苷)的含量,通过与外标法进行比较,以确证一测多评法的可行性和科学性。结果以基地收集与市售共计30批炙甘草饮片为研究对象,建立了炙甘草饮片HPLC指纹图谱,确定了14个共有峰,对7个共有峰进行了化学成分确认,并以共有峰的相对保留时间及部分共有峰的相对峰面积比值作为评价指标区分优质饮片与统货饮片;建立了多成分一测多评定量方法,以甘草苷(S1)、甘草酸(S2)为内参物,得到异甘草苷的相对校正因子(fS1/a)平均值为0.502、芹糖甘草苷的相对校正因子(fS2/A)平均值为0.578、芹糖异甘草苷的相对校正因子(fS2/B)平均值为0.252,甘草素的相对校正因子(fS2/C)平均值为0.257,为新生化颗粒原料优质炙甘草饮片制定了更加完善的质量控制指标。结论建立的方法可用于新生化颗粒原料炙甘草饮片的质量评价。

Quality evaluation of Glycyrrhizae Radix et Rhizoma Praeparata Cum Melle based on HPLC fingerprint and multi-component quantitative analysis by QAMS

Objective To establish the quality control method for high-quality Glycyrrhizae Radix et Rhizoma Praeparata Cum Melle (GRRPM) in Xinshenghua Granules (XG). Methods The HPLC fingerprint analysis method for high-quality GRRPM was developed. The method of quantitative analysis of multi-components by single marker (QAMS) for simultaneously determining the six active constituents (liquiritin, isoliquiritin, glycyrrhizic acid, liquiritigenin, liquiritin apioside, and isoliquiritin apioside) was developed and evaluated by comparison of the quantitative results with external standard method. Results The fingerprints of GRRPM were established by HPLC from 30 batches. Fourteen peaks were acquired as common fingerprint peaks and seven peaks among them were identified with chemical reference. The relative retention time of common peaks and the peak area ratio of some common peaks were used to differentiate high-quality products from general products as indicators for fingerprint evaluation. With liquiritin and glycyrrhizic acid as internal standards, QAMS was developed and the mean relative correlation factors (RCFs) of isoliquiritin, liquiritigenin, liquiritin apioside, and isoliquiritin apioside were 0.502, 0.578, 0.252, and 0.257, respectively. The specifications of high-quality GRRPM were established for XG. Conclusion These methods could be used for quality control of high-quality GRRPM of XG.