目的 对富马酸喹硫平缓释片处方工艺等进行讨论分析。方法 分析相关国外审评报告、文献及专利,综合提出富马酸喹硫平缓释片处方工艺研究的一般考虑。结果与结论 富马酸喹硫平是第二代非典型抗精神病药物,其仿制药缓控释制剂的研究日渐兴起,其仿制药研究应加强对参比制剂的研究和处方工艺筛选控制,从而促进复杂仿制药的研发。
Abstract
OBJECTIVE To summarize the key points of the preparation process control of quetiapine fumarate extended release tablets. METHODS This article proposed the general consideration on preparation study of quetiapine fumarate extended release tablets based on the analysis the relevant patents and literatures. RESULTS AND CONCLUSION The quetiapine fumarate is a second-generation antipsychotics (SGAs). Extended release quetiapine fumarate generic drugs were developed recently. Further in-depth study is still needed in reference drug study and prescription study in order to promote the future research of complex generic drugs.
关键词
富马酸喹硫平 /
缓控释制剂 /
仿制药 /
处方工艺研究
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Key words
quetiapine fumarate /
extended release /
generic drug /
preparation process parameter study
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中图分类号：
R95
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参考文献
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