College of Pharmacy, Shenyang Pharmaceutical University, 110016, China.
College of Pharmacy, Shenyang Pharmaceutical University, 110016, China.
J Pharm Biomed Anal. 2021 Feb 20;195:113867. doi: 10.1016/j.jpba.2020.113867. Epub 2020 Dec 24.
The standard preparation (SP) based on the quantitative fingerprint was proposed to control the quality of compound licorice tablets (CPLTs) in this paper, which is a great way to control the quality consistency nowadays. Here, taking China 145 batches of CPLTs from 9 manufacturers as samples to set up High Performance Liquid Chromatography fingerprints and CPLT-SP, and employing the systematically quantified fingerprint method (SQFM) combined five markers' contents to evaluate their quality. The results showed that all samples were qualified. The quantitative analysis of multi-components by single-marker (QAMS) for the determination of five components in CPLTs was applied, and there was no striking diversity in the results compared to the standard curve method. Furthermore, the correlation between raw materials and preparation of CPLTs was studied for predicting quality intelligently. As well as the ultraviolet full fingerprint dissolution was applied to evaluate the rationality of preparation. The results demonstrated that SQFM based on SP can integrally and perfectly control the quality of HD in best consistency.
本文提出了基于定量指纹的标准制剂（SP）来控制复方甘草片（CPLT）的质量，这是当今控制质量一致性的一种很好的方法。在这里，以 9 家制造商的中国 145 批 CPLT 为样本，建立高效液相色谱指纹图谱和 CPLT-SP，并采用结合了五个标记物含量的系统定量指纹方法（SQFM）来评估其质量。结果表明，所有样品均合格。应用单标记物多成分定量分析（QAMS）测定 CPLT 中的五种成分，与标准曲线法相比，结果没有显著差异。此外，还研究了 CPLT 原料与制剂之间的相关性，以实现智能预测质量。此外，还应用紫外全指纹溶出度来评估制剂的合理性。结果表明，基于 SP 的 SQFM 可以整体、完美地控制 HD 的质量，使其达到最佳一致性。
