空军军医大学学报2023，Vol.44Issue(12)：1185-1189,5.DOI:10.13276/j.issn.2097-1656.2023.12.008
新型催眠药物MT5022口腔崩解片的制备与质量评价
Preparation and quality evaluation of the novel hypnotic drug MT5022 orally disintegrating tablets
摘要
Abstract
Objective To prepare MT5022 orally disintegrating tablets.Methods The orthogonal test was used to screen the optimal formula of MT5022 orally disintegrating tablets,and the formulation quality of the prepared tablets was also evaluated.Results The optimal formula of MT5022 orally disintegrating tablets by mass percent was MT5022(4.2％),sodium carboxymethyl starch(2.0％),low-substituted hydroxypropyl cellulose(2.0％),microcrystalline cellulose(30.0％),aspartame(1.0％),magnesium stearate(1.0％)and mannitol(59.8％).The results of quality evaluation showed that the appearance,disintegration time,fragility,dissolution rate,and content uniformity of MT5022 orally disintegrating tablets met the relevant requirements of the Chinese Pharmacopoeia for orally disintegrating tablets.Conclusion MT5022 orally disintegrating tablets are successfully prepared,which lays a foundation for developing the candidate drug MT5022 into a new military hypnotic drug suitable for military operating environments,and provides experimental support for clinical research of the drug.关键词
口腔崩解片/军事作业环境/催眠药物/质量评价Key words
orally disintegrating tablets/military operating environment/hypnotic drug/quality evaluation分类
医药卫生引用本文复制引用
张俊杰,张雅轩,侯丽爽,蔡泽东,张耀文,张邦乐..新型催眠药物MT5022口腔崩解片的制备与质量评价[J].空军军医大学学报,2023,44(12):1185-1189,5.基金项目
国家十三五"重大新药创制"军队特需药品科技重大专项(2018ZX09J18108-004) （2018ZX09J18108-004）
国家十二五"重大新药创制"军队特需药品科技重大专项(2011ZXJ09106-04C) （2011ZXJ09106-04C）
