北京大学学报(医学版) ›› 2021, Vol. 53 ›› Issue (2): 348-354. doi: 10.19723/j.issn.1671-167X.2021.02.020
陈迪1,徐翔宇2,汪明睿1,李芮1,臧根奥2,张悦1,钱浩楠1,闫光荣2,Δ(),范田园1,Δ()
CHEN Di1,XU Xiang-yu2,WANG Ming-rui1,LI Rui1,ZANG Gen-ao2,ZHANG Yue1,QIAN Hao-nan1,YAN Guang-rong2,Δ(),FAN Tian-yuan1,Δ()
摘要:
目的: 探究以熔融沉积成型(fused deposition modeling,FDM)3D打印技术研制胃漂浮制剂的可行性,并对所研制的FDM 3D打印胃漂浮制剂进行相关的体外质量评价。方法: 以盐酸维拉帕米为模型药物,聚乙烯醇(polyvinyl alcohol,PVA)为辅料,利用FDM 3D打印技术制备胶囊型和半球型的两种胃漂浮制剂,其填充率均为15%,层高均为0.2 mm,顶底厚均为0.8 mm,壳数分别为3和4。以扫描电镜观察制剂的形态,以称重法考察制剂的平均质量,采用物性测定仪测定制剂互相垂直的两个方向的硬度,高效液相色谱法测定制剂中的药物含量,并对制剂的体外漂浮和释药行为进行表征。结果: 所制备的FDM 3D打印胶囊型和半球型制剂均形态良好,无打印缺陷;胶囊型和半球型制剂的平均质量分别为(584±13) mg和(550±12) mg;胶囊型和半球型制剂的硬度均大于800.0 N;胶囊型和半球型制剂均实现了体外漂浮且无漂浮滞后时间,体外漂浮时间分别为(3.97±0.41) h和(4.48±0.21) h;胶囊型和半球型制剂在体外释药完全的时间均为3 h。结论: 采用FDM 3D打印技术成功制备了胶囊型和半球型的盐酸维拉帕米胃漂浮制剂。
中图分类号:
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