Dou Minhang, Huang Jiayi, Yu Mimi, Li Huahua, Song Yang, Peng Ziwei, Du Shouying, Bai Jie
School of Chinese Materia Medica, Beijing University of Chinese Medicine, Beijing 100029, China.
Beijing Institute for Drug Control, NMPA Key Laboratory for Quality Evaluation of Traditional Chinese Medicine (Traditional Chinese Patent Medicine), Beijing Key Laboratory of Analysis and Evaluation on Chinese Medicine, Beijing 102206, China.
Chin Herb Med. 2023 Jul 26;16(3):449-456. doi: 10.1016/j.chmed.2023.03.005. eCollection 2024 Jul.
Huamaoyan Granules (HMYG) and Huamaoyan Capsules (HMYC) are Chinese patent medicines with different dosage forms of the same prescription. Due to the different preparation process, the chemical composition of these Chinese patent medicines varies greatly among different forms, but there were few studies on the difference comparison and quality control of them. In order to improve the effectiveness and safety in its clinical application, an idea combining high performance liquid chromatography (HPLC) and chemometrics was put forward to study the quality control of Chinese patent medicines in different dosage forms of the same prescription.
The differential markers of HMYG and HMYC were explored based on HPLC fingerprint and chemometrics including orthogonal projections to latent structures-discriminant analysis (OPLS-DA), principal component analysis (PCA), and hierarchical cluster analysis (HCA). Finally, the quantitative analysis method of related components was established by HPLC.
A quality control method for HMYG and HMYC was established. Firstly, the chemical components of HMYG and HMYC were systematically analyzed by HPLC fingerprinting. Further exploration showed that there were 20 characteristic peaks and 57 common peaks. Then, the potential differential markers between HMYG and HMYC were explored by chemometrics, and the differential markers were screened after intersection with the 20 characteristic peaks. Finally, HPLC quantitative analysis methods for nine components were established, including seven differential markers (neochlorogenic acid, protocatechualdehyde, chlorogenic acid, cryptochlorogenic acid, caffeic acid, rosmarinic acid and salvianolic acid A). The results of HPLC quantitative analysis showed that the contents of eight components in HMYG and HMYC samples were significantly different. According to the above results, the differential markers between HMYG and HMYC screened based on HPLC fingerprint and chemometrics can effectively characterize the differences between the two dosage forms.
The present work provides a rapid and effective method for routine quality evaluation and control of HMYG and HMYC. This work also provides feasible methods for the quality evaluation and control of Chinese patent medicines with different dosage forms of the same prescription.
化毛炎颗粒（HMYG）和化毛炎胶囊（HMYC）是同一处方的不同剂型中成药。由于制备工艺不同，这些中成药的化学成分在不同剂型之间差异很大，但对它们的差异比较和质量控制研究较少。为提高其临床应用的有效性和安全性，提出将高效液相色谱法（HPLC）与化学计量学相结合的思路，研究同一处方不同剂型中成药的质量控制。
基于HPLC指纹图谱和化学计量学方法，包括正交投影到潜在结构判别分析（OPLS-DA）、主成分分析（PCA）和层次聚类分析（HCA），探索HMYG和HMYC的差异标志物。最后，采用HPLC建立相关成分的定量分析方法。
建立了HMYG和HMYC的质量控制方法。首先，通过HPLC指纹图谱对HMYG和HMYC的化学成分进行了系统分析。进一步探索发现有20个特征峰和57个共有峰。然后，通过化学计量学方法探索HMYG和HMYC之间的潜在差异标志物，并与20个特征峰进行交集筛选差异标志物。最后，建立了9种成分的HPLC定量分析方法，包括7个差异标志物（新绿原酸、原儿茶醛、绿原酸、隐绿原酸、咖啡酸、迷迭香酸和丹酚酸A）。HPLC定量分析结果表明，HMYG和HMYC样品中8种成分的含量存在显著差异。根据上述结果，基于HPLC指纹图谱和化学计量学筛选出HMYG和HMYC之间的差异标志物，可有效表征两种剂型之间的差异。
本研究为HMYG和HMYC的常规质量评价和控制提供了一种快速有效的方法。本研究也为同一处方不同剂型中成药的质量评价和控制提供了可行的方法。
