Chen Lingkui, Zhang Zhenwei, Bao Mengfan, Yang Sha, Cai Ming, Lan Lili, Sun Wanyang, Sun Guoxiang
School of Pharmacy, Shenyang Pharmaceutical University, Shenyang, Liaoning 110016, China.
School of Pharmacy, Shenyang Pharmaceutical University, Shenyang, Liaoning 110016, China; Guangdong Engineering Research Center of Chinese Medicine & Disease Susceptibility, Jinan University, Guangzhou 510632, China.
J Pharm Biomed Anal. 2025 Sep 15;263:116925. doi: 10.1016/j.jpba.2025.116925. Epub 2025 Apr 25.
In recent years, the application of traditional Chinese medicine (TCM) has gradually increased in the world, the study of quality control has become more and more important. As a branch of TCM, Mongolian medicine has complex compositions and lacks research on the overall quality. Therefore, in this paper, three fingerprints, high performance liquid chromatography (HPLC), differential scanning calorimetry (DSC) and electrochemical (EC), were established using Huricha Liuwei pills (HLP) as an example, and the quality of the three fingerprints was evaluated by the comprehensive ratio quantitative fingerprint method (CRQFM). To ensure the accuracy of the quantitative analysis, the purity of the fingerprint peaks was verified using the dual-wavelength absorption coefficient ratio (DWACR). And four components were quantified by the multi-markers assay by monolinear method (MAML): gallic acid (GA), chlorogenic acid (CA), hydroxysafflor yellow A (HSYA) and ellagic acid (EA). Based on the EC redox characteristics, the fingerprint efficacy relationship between two fingerprints (HPLC and DSC) and EC activity was established. The results showed that after CRQFM evaluation, 16 batches of samples were categorized into different quality grades. Subsequently, the evaluation results were integrated using the equal weighing method, and the 16 batches of samples had quality grades ranging from 1 to 3. The fingerprint efficacy relationship indicated that more than half of the fingerprint peaks showed good antioxidant activity, including GA, CA and EA. This paper established an effective quality control method for HLP and provided new ideas for the quality evaluation of other TCM.
近年来，中药在世界范围内的应用逐渐增加，质量控制研究变得越来越重要。蒙医药作为中医药的一个分支，成分复杂，缺乏整体质量研究。因此，本文以胡日查六味丸（HLP）为例，建立了高效液相色谱（HPLC）、差示扫描量热法（DSC）和电化学（EC）三种指纹图谱，并采用综合比值定量指纹图谱法（CRQFM）对三种指纹图谱的质量进行评价。为确保定量分析的准确性，采用双波长吸收系数比（DWACR）验证指纹图谱峰的纯度。并采用单线性多指标测定法（MAML）对没食子酸（GA）、绿原酸（CA）、羟基红花黄色素A（HSYA）和鞣花酸（EA）四种成分进行定量。基于EC氧化还原特性，建立了两种指纹图谱（HPLC和DSC）与EC活性之间的指纹图谱-药效关系。结果表明，经CRQFM评价后，16批样品被分为不同的质量等级。随后，采用等权法对评价结果进行整合，16批样品的质量等级为1至3级。指纹图谱-药效关系表明，超过半数的指纹图谱峰具有良好的抗氧化活性，包括GA、CA和EA。本文建立了一种有效的HLP质量控制方法，为其他中药的质量评价提供了新思路。
