口服固体制剂溶出方法的开发与展望

Discussion on Development and Prospect of Dissolution Method for Oral Solid Dosage Form

适当的溶出方法是药品研究单位在口服固体制剂处方的开发及其工艺优化中应用最频繁,也是最重要的质量控制方法。鉴于国家食品药品监督管理局对仿制药一致性评价的推进",4+7"带量采购的落实及推广,以及对新药研发的鼓励,口服固体制剂处方及其工艺的研究已经受到药品研发机构及药品生产企业更多的关注。为开发出适当的溶出方法,文中重点围绕溶解度的测定、具有区分力溶出方法的开发,基于理论并结合实践做了探究和分析,以期为口服固体制剂的研究者提供参考。

Appropriate dissolution methods are most frequently used.They are most important quality control methods for pharmaceutical research units in the formulation development and process optimization of oral solid dosage form.In view of the National Medical Products Administration(NMPA)’s promotion of generic drug consistency evaluation,the implementation and promotion of"4+7"quantity procurement,and the encouragement of new drug research and development,the researches of oral solid dosage form preparation formulation and processes have been given more attention.In order to develop an appropriate dissolution method,this paper focuses on the determination of solubility and the development of the dissolution method with distinguishing force.Based on the theory and combined with the practice,we conduce exploration and analysis,hoping to provide reference for the researchers of oral solid dosage form.