精神障碍类化学药品为近年来仿制药申报热点。检索相关文献和国外审评报告，并结合具体案例，对常见精神障碍类化学药品活性成分的理化性质（生物药剂学分类、粒径分布、晶型）进行汇总分析，并对此类药品口服常释制剂和调释制剂的典型生产工艺（干法直压工艺、多层压片工艺、流化床微丸包衣工艺）中的药学关注点进行讨论，综合提出结合药物特点加强药学研究的建议，以期对精神障碍类化学仿制药注册申报提供一定的参考。

Antipsychotic chemical drugs are the hotspots in application of generic drugs in recent years. Based on investigation of relevant literature and foreign review report, combined with specific cases, this article summarized the physical and chemical properties of some active pharmaceutical ingredients (API), such as biopharmaceutical classification system (BCS), particle size distribution and crystal form, and some key points in typical manufacturing process of immediate-release (IR) preparation and modified-release (MR) preparation for such product, proposed some suggestion about establishing further in-depth CMC study, in order to provide some reference for generic chemical antipsychotic drug applications.

R951