Faculty of Chemistry, Northeast Normal University, 5268 Renmin Street, Changchun, Jilin, 130024, P.R. China.
Jingke-Oude Science and Education Instruments Co., Ltd., Changchun, Jilin, 130024, P.R. China.
Sci Rep. 2019 Nov 19;9(1):17114. doi: 10.1038/s41598-019-53750-w.
Dissolution testing plays many important roles throughout the pharmaceutical industry, from the research and development of drug products to the control and evaluation of drug quality. However, it is a challenging task to perform both high-efficient separation and high-temporal detection to achieve accurate dissolution profile of each active ingredient dissolved from a drug tablet. In our study, we report a novel non-manual-operation method for performing the automatic dissolution testing of drug tablets, by combining a program-controlled sequential analysis and high-speed capillary electrophoresis for efficient separation of active ingredients. The feasibility of the method for dissolution testing of real drug tablets as well as the performance of the proposed system has been demonstrated. The accuracy of drug dissolution testing is ensured by the excellent repeatability of the sequential analysis, as well as the similarity of the evaluation of dissolution testing. Our study show that the proposed method is capable to achieve simultaneous dissolution testing of multiple ingredients, and the matrix interferences can be avoided. Therefore it is of potential valuable applications in various fields of pharmaceutical research and drug regulation.
溶解测试在制药行业中扮演着许多重要的角色，从药物产品的研究和开发到药物质量的控制和评估。然而，要实现对药物片剂中每个活性成分的准确溶解曲线的高效分离和高时间检测，这是一项具有挑战性的任务。在我们的研究中，我们报告了一种新的非手动操作方法，通过结合程控顺序分析和高速毛细管电泳，实现药物片剂的自动溶解测试，从而高效分离活性成分。该方法对实际药物片剂的溶解测试的可行性以及所提出系统的性能已经得到了验证。顺序分析的出色重复性以及对溶解测试评估的相似性，确保了药物溶解测试的准确性。我们的研究表明，该方法能够实现多种成分的同时溶解测试，并且可以避免基质干扰。因此，它在制药研究和药物监管的各个领域都具有潜在的有价值的应用。
