中国药房2024，Vol.35Issue(13)：1600-1604,5.DOI:10.6039/j.issn.1001-0408.2024.13.10
SLA型3D打印技术制备盐酸文拉法辛-盐酸氟西汀多层片
Preparation of venlafaxine hydrochloride and fluoxetine hydrochloride multilayer tablets by stereolithography 3D printing technology
摘要
Abstract
OBJECTIVE To prepare venlafaxine hydrochloride and fluoxetine hydrochloride multiplayer tablets by stereolithography(SLA)3D printing technology,and to conduct its quality evaluation and in vitro release investigation.METHODS Using venlafaxine hydrochloride/fluoxetine hydrochloride,photopolymerization monomer PEGDA 400,porogen PEG 300,photoinitiator TPO and light absorber citrine as formulation,SLA 3D printer technology was employed to prepare venlafaxine hydrochloride and fluoxetine hydrochloride multiplayer tablets,with outer diameter of 10 mm,inner diameter of 5 mm,and thickness of 6 mm.Moreover,the tablets'appearance,three-dimensional dimensions,weight uniformity,drug content,internal structural characteristics and in vitro release characteristics were all investigated.RESULTS The multilayer tablets had good printing formability,smooth and round edges,and uniform size and thickness;the outer diameter,inner diameter and thickness were(10.06±0.26),(4.94±0.06),(5.80±0.12)mm(RSD=2.58%,1.21%,2.07%,n=20),and the weight difference all met the requirements.The contents of venlafaxine hydrochloride and fluoxetine hydrochloride were(7.96±0.09)and(11.26±0.46)mg/tablet,respectively.The results of X-ray diffraction and scanning electron microscopy characterization showed that the two drug molecules in the multilayer film existed in an amorphous structure;after the dissolution of the venlafaxine hydrochloride layer,a clear pore structure was formed,while the fluoxetine hydrochloride layer did not show any pore structure.According to the release curve,24 h accumulative release rates of venlafaxine hydrochloride layer and fluoxetine hydrochloride layer were(91.88±0.94)%and(106.25±1.28)%,which were in line with Rigter-Peppas release model.CONCLUSIONS This study successfully prepared venlafaxine hydrochloride and fluoxetine hydrochloride multilayer tablets using SLA 3D printing technology;the multilayer tablets have the advantages of excellent printing formability,which are in line with Rigter-Peppas release model.关键词
立体光刻成型/3D打印技术/多层片/盐酸文拉法辛/盐酸氟西汀/个性化制剂Key words
stereolithography/3D printing technology/multilayer/venlafaxine hydrochloride/fluoxetine hydrochlo-ride/personalized formulations分类
医药卫生引用本文复制引用
徐雷,潘偲莹,陈红梅,杨庆良,杨根生..SLA型3D打印技术制备盐酸文拉法辛-盐酸氟西汀多层片[J].中国药房,2024,35(13):1600-1604,5.基金项目
浙江省自然科学基金项目(No.LY20B060007) （No.LY20B060007）
