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

作　　者：张俊杰 张雅轩 侯丽爽 蔡泽东 张耀文 张邦乐 ZHANG Junjie;ZHANG Yaxuan;HOU Lishuang;CAI Zedong;ZHANG Yaowen;ZHANG Bangle(Department of Pharmaceutics and Pharmacy Administration,School of Pharmacy,Air Force Medical University,Xi'an 710032,China;Department of Pharmacy,No.963 Hospital of the PLA,Jiamusi 154000,China;Xi'an Maternity and Child Healthcare Hospital,Xi'an 710002,China)

机构地区：[1]空军军医大学药学系药剂学与药事管理学教研室,陕西西安710032 [2]解放军第九六三医院药剂科,黑龙江佳木斯154000 [3]西安市妇幼保健计划生育服务中心,陕西西安710002

出　　处：《空军军医大学学报》2023年第12期1185-1189,共5页Journal of Air Force Medical University

基　　金：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);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)。

摘　　要：目的研制MT5022口腔崩解片。方法采用正交试验对MT5022口腔崩解片的处方进行筛选得到最优处方,并对其进行制剂质量评价。结果MT5022口腔崩解片各组分按质量百分比计算的最优处方为MT5022(4.2%)、羧甲基淀粉钠(2.0%)、低取代羟丙基纤维素(2.0%)、微晶纤维素(30.0%)、阿斯巴甜(1.0%)、硬脂酸镁(1.0%)、甘露醇(59.8%)。制剂质量评价结果表明,所制备的MT5022口腔崩解片的外观性状、崩解时限、脆碎度、溶出度和含量均匀度等均符合《中国药典》中口腔崩解片的相关要求。结论成功制备了MT5022口腔崩解片,为将候选药物MT5022研制成适合军事作业环境使用的新型军用催眠药物奠定基础,也为药物的临床研究提供实验支持。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 

分 类 号：R943[医药卫生—药剂学]