精神障礙類化學(xué)藥品為近年來(lái)仿制藥申報(bào)熱點(diǎn)。檢索相關(guān)文獻(xiàn)和國(guó)外審評(píng)報(bào)告，并結(jié)合具體案例，對(duì)常見(jiàn)精神障礙類化學(xué)藥品活性成分的理化性質(zhì)（生物藥劑學(xué)分類、粒徑分布、晶型）進(jìn)行匯總分析，并對(duì)此類藥品口服常釋制劑和調(diào)釋制劑的典型生產(chǎn)工藝（干法直壓工藝、多層壓片工藝、流化床微丸包衣工藝）中的藥學(xué)關(guān)注點(diǎn)進(jìn)行討論，綜合提出結(jié)合藥物特點(diǎn)加強(qiáng)藥學(xué)研究的建議，以期對(duì)精神障礙類化學(xué)仿制藥注冊(cè)申報(bào)提供一定的參考。

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.

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