| 摘要 |
This paper analyzes challenges encountered during the scale-up production of small molecule inhibitors, focusing on synthesis efficiency, solubility/bioavailability, quality control, stability/storage, and side effect prediction/control. To address these issues, targeted solutions leveraging modern technologies are proposed and implemented: synthesis efficiency and purity were significantly enhanced through process optimization, green chemistry principles, and efficient catalysts; solubility and bioavailability were improved utilizing solid dispersion and nano-crystal technologies; process scale-up was optimized with online monitoring systems and continuous flow chemistry, ensuring product quality consistency; computer-aided drug design (CADD) was employed to predict and mitigate potential side effects. These integrated approaches effectively addressed key bottlenecks in the industrial-scale manufacturing of small molecule inhibitors. |
