熔融沉积3D打印技术制备对乙酰氨基酚缓释片及其制剂学评价  

Preparation of Acetaminophen Sustained-release Tablets using melt deposition 3D printing technology and its pharmaceutical evaluation

作　　者：陈铭 王琛 张志强 段美涛 任君刚 林海婷 CHEN Ming;WANG Chen;ZHANG Zhiqiang;DUAN Meitao;REN Jungang;LIN Haiting(Xiamen Medical College,Xiamen 361000,China)

机构地区：[1]厦门医学院,福建厦门361000

出　　处：《药学研究》2024年第2期142-148,共7页Journal of Pharmaceutical Research

基　　金：厦门医学院校级课题[No.KPT2020-03(2)]。

摘　　要：目的 基于熔融沉积成型技术制备对乙酰氨基酚(APAP)片并进行质量评价,为该技术应用于对乙酰氨基酚片剂的3D打印提供试验依据。方法 利用热熔挤出技术熔融沉积成型3D打印技术制备成型片剂。筛选过程中以片剂打印的完整性及体外释放累积百分率确定辅料的用量,最后以正交设计确定最优处方及工艺参数,并对所制备片剂的性能进行评价。结果 最终确定最佳处方为APAP∶塑化乙基纤维素∶羟丙基甲基纤维素∶柠檬酸三乙酯=25∶50∶25∶10,打印温度为160℃。该片剂的6 h累计释放率约为50%,24 h内体外释放度达90%以上。结论 成功制得对乙酰氨基酚片,所得产品外表完整,层间叠加较平整,体外释放较上市对乙酰氨基酚片剂缓慢,药物活性分子在试验温度下含量稳定。Objective In this study,the feasibility of fused deposition molding(FDM)technology for the preparation of Acetaminophen(APAP)Tablets was studied,which provided experimental basis for the application of this technology in 3D printing of Acetaminophen Tablets.Methods Using hot melt extrusion(HME)technology and the fused deposition modeling technology to prepare the molding tablets.During the screening process,the amount and types of excipients,were determined.Then the optimal prescription and process parameters were screened by orthogonal design.Finally the content determination,in vitro release,scanning electron microscope and thermogravimetric analysis were evaluated.Results The final optimized 3D printed APAP tablets prescription was APAP∶plasticized ethyl cellulose∶hypromellose∶triethyl citrate=25∶50∶25∶10,the optimized printing temperature was 160℃.The in vitro release rate of tablets was about 50%at 6 hour and was over 90%within 24 hours.Conclusion APAP tablets were successfully prepared.The resulting product appears a flat surface and the stacking of layers is relatively smooth.The tables has a slower in vitro release rate compared to APAP tables on the market.The active pharmaceutical ingredient is stable in content at the test temperature.

关 键 词：熔融沉积成型技术 3D打印 对乙酰氨基酚 制备工艺 

分 类 号：R944.4[医药卫生—药剂学]