College of Pharmacy, Shenyang Pharmaceutical University, Shenyang, PR China.
College of Pharmacy, Shenyang Pharmaceutical University, Shenyang, PR China.
J Pharm Biomed Anal. 2019 Oct 25;175:112715. doi: 10.1016/j.jpba.2019.06.012. Epub 2019 Jun 10.
A systematic quantitative fingerprint method (SQFM) was applied to evaluate the quality of compound liquorice tablets (CPLTs) in this paper. The method contained three main parameters: macroscopic qualitative similarity (S), macro quantitative similarity (P) and a leveling variance coefficient (α), which were used to analyze the similarity of curves and evaluate the fingerprints of CPLTs. Firstly, Differential Scanning Calorimetry (DSC) was applied to analyze CPLTs and the active raw materials (RMs). At the same time, the change of appearance and weight during DSC testing revealed that the two main thermal processes of CPLTs were between 240-320 °C and 400-500 °C. The DSC fingerprint (DSC-FP) of 49 batches of CPLTs was collected and the enthalpy values were calculated. Then, we studied the dissolution of CPLTs, collected ultraviolet fingerprints (UV-FP) and the P was used to plot the dissolution curve. The results showed that the dissolution and enthalpy had a negative correlation, and the formula was y= -32.38x+3207.49 with r= -0.83. Finally, the High Performance Liquid Chromatography fingerprint (HPLC-FP) of 49 batches of CPLTs was collected and assessed by SQFM. The results of quality evaluation of CPLTs by HPLC-FP combined with DSC-FP showed that 49 batches were divided into 4 levels, which could evaluate the quality of the drug more comprehensively and objectively.
本文采用系统的定量指纹方法（SQFM）评估复方甘草片（CPLT）的质量。该方法包含三个主要参数：宏观定性相似度（S）、宏观定量相似度（P）和均衡方差系数（α），用于分析曲线的相似度并评估 CPLT 的指纹图谱。首先，采用差示扫描量热法（DSC）分析 CPLT 和活性原料药（RMs）。同时，DSC 测试过程中外观和重量的变化表明 CPLT 的两个主要热过程分别在 240-320°C 和 400-500°C。收集了 49 批 CPLT 的 DSC 指纹图谱（DSC-FP）并计算了焓值。然后，我们研究了 CPLT 的溶解情况，收集了紫外指纹图谱（UV-FP）并使用 P 绘制了溶解曲线。结果表明，溶解和焓值呈负相关，其公式为 y=-32.38x+3207.49，r=-0.83。最后，收集了 49 批 CPLT 的高效液相色谱指纹图谱（HPLC-FP），并采用 SQFM 进行评估。通过 HPLC-FP 与 DSC-FP 结合对 CPLT 质量的评价结果表明，49 批被分为 4 个等级，能够更全面、更客观地评估药物的质量。
