熔融沉积3D打印技术制备地高辛分剂量片的研究  被引量:5

Study on the preparation of digoxin divided dose tablets by fused deposition 3D printing technology

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作  者:周永恒 林威 周文志 杨帆[2,3] ZHOU Yongheng;LIN Wei;ZHOU Wenzhi;YANG Fan(Zengcheng District People's Hospital of Guangzhou,Guangzhou 511300,China;Guangdong Provincial Engineering Research Center for Partial Precise Drug Delivery,Guangdong Pharmaceutical University,Guangzhou 510006,China;Guangdong Key Laboratory of New Drug Formulations,Guangdong Pharmaceutical University,Guangzhou 510006,China)

机构地区:[1]广州市增城区人民医院,广东广州511300 [2]广东药科大学新药研发中心/广东省局部精准药物递药制剂工程技术研究中心,广东广州510006 [3]广东药科大学新药研发中心/广东省药物新剂型重点实验室,广东广州510006

出  处:《广东药科大学学报》2020年第3期329-333,共5页Journal of Guangdong Pharmaceutical University

基  金:广州市科技计划项目(2060404);广东省中医药局科研项目(20190411102226)。

摘  要:目的采用熔融沉积3D打印技术(FDM)制备地高辛分剂量片,对制备方法和质量进行可行性评估,为临床个体化给药提供药物制备依据。方法以临床常需分剂量的药物地高辛片(0.25 mg规格)为模型,采用3D打印技术制备小儿常用规格0.041、0.070 mg的分剂量片。将地高辛市售药品磨粉,与泊洛沙姆188、PEG4000按比例混匀制备成打印粉末,通过计算机设计分剂量片的打印参数,采用FDM技术热熔挤出成型,以外观、崩解时限及硬度为指标优化3D打印的处方工艺。结果最佳处方为PEG4000∶泊洛沙姆188∶地高辛∶硬脂酸镁=71.57∶17.89∶5.54∶5.00(质量比),在打印温度56℃、打印速度15 mm/s、层厚0.8 mm时,地高辛分剂量片完整美观。0.041、0.070 mg规格片的含量误差分别为(100.00±2.44)%、(98.59±2.86)%,硬度为(26.17±2.38)、(55.47±4.32)N,60 min溶出限为(99.7±0.8)%、(98.1±1.3)%,含量均匀度分别为2.68、4.27,均符合《中国药典》要求。结论采用FDM技术制备地高辛分剂量片质量保证,制备工艺简单,为个体化给药提出新思路。Objective To prepare digoxin divided dose tablets by using fused deposition 3D printing technology(FDM),and evaluate the feasibility of the quality and preparation method of digoxin divided dose tablets for providing a direction of drug preparation for clinical individualized administration.Methods Based on the clinical investigation of the individualized drug digoxin tablets(0.25 mg size)as a model,the clinical dosages of 0.041 mg and 0.070 mg commonly used in clinical children were prepared.After grinding digoxin drugs on the market into powder,The digoxin drug powder was mixed with poloxamer 188 and PEG4000 in proportion to prepare printing powder,then the printing power was hot melt extruded with FDM technology,and the computer controlled the shape and dosage of the tablet.3D printing prescription process was optimized with appearance,disintegration time limit and hardness as indicators.Results The best prescription was PEG4000∶Poloxamer 188∶Digoxin tablets∶magnesium stearate=71.57∶17.89∶5.54∶5.00.The digoxin divided dose tablets were complete and beautiful when the layer thickness was 0.8 mm at a printing temperature of 56℃with a printing speed of 15 mm/s.The content errors of 0.041 mg and 0.070 mg tablets were(100.00±2.44)%and(98.59±2.86)%,the hardness was(26.17±2.38)N and(55.47±4.32)N,the dissolution limit at 60 min was(99.7±0.8)%and(98.1±1.3)%,and the content uniformity was 2.68 and 4.27,which were in line with the requirements of the Chinese Pharmacopoeia.Conclusion The use of FDM technology to prepare digoxin divided dose tablets has high feasibility and simple preparation process,which is a new idea for individualized drug administration.

关 键 词:3D打印 熔融沉积 地高辛 分剂量片 

分 类 号:R94-03[医药卫生—药剂学]

 

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