精神障碍类药物特殊制剂的药学研究思考

Pharmaceutical considerations on the development ofgeneric special antipsychotic medicines

化学药物特殊制剂广泛应用于精神障碍类疾病的治疗,成为近期仿制药研发的热点。本文通过对国外审评报告的分析和专利文献的研究等,结合具体的药物案例,综合提出精神障碍类药物特殊制剂的处方工艺、释药机制、原料控制等方面研究的思考。建议考虑临床用药需求进而深入药学研究,以期为精神障碍类特殊仿制药的研发提供更多参考。

The special chemical preparations are widely used in the treatment of mental disorders, they have become hotspots in the application of generic drugs in recent years. Based on the analysis of the relevant review reports and literature abroad, by taking specific cases study, some pharmaceutical considerations on the development of generic special antipsychotic medicines, such as formulation and manufacturing process, drug release mechanism and drug substance control are discussed in this article. It’s recommended to take clinical needs into account and conduct further in-depth pharmaceutical studies, in order to provide some reference for the future generic drug research.