摘要
目的 使用基于半固态挤出的3D打印技术制备一种缓释12 h的克拉霉素(clarithromycin,CAM)胃漂浮片。方法 考察pH敏感型、温敏型、水不溶蚀型高分子凝胶骨架材料与HPMC K15MCR复合使用对CAM释放的影响,评价了CAM胃漂浮缓释片的片重差异、硬度、脆碎度、溶出曲线和溶出机理。结果 通过基于半固态挤出的3D打印技术,仅需使用HPMCK15MCR作为释放阻滞剂,即可制备载药量高达81.7%的CAM胃漂浮缓释片,相关指标符合中国药典2020年版的要求。结论 基于半固态挤出的3D打印技术在制备胃漂浮缓释递药系统领域具有较大的应用潜力。
OBJECTIVE To prepare a 12 h sustained-release clarithromycin(CAM) gastric-floating tablet using semi-solid extrusion based 3D printing technology.METHODS To explore the effect of compound use of pH-sensitive,temperature-sensitive,water-insoluble polymer gel matrix and HPMC K15MCR on the release of CAM,and evaluate the weight variation,hardness,fragility,dissolution curve and dissolution mechanism of CAM gastric-floating sustained-release tablets.RESULTS With the semi-solid extrusion based 3D printing technology,only using HPMC K15MCR as a release blocker could prepare CAM gastric-floating sustained-release tablets with drug loading rate up to 81.7%,and the relevant indicators accessed to the requirement of Chinese Pharmacopoeia 2020 Edition.CONCLUSION The semi-solid extrusion based 3D printing technology has great application potential in preparing gastric-floating sustained-release drug delivery systems.
作者
陈培鸿
刘志挺
黄思玉
陈燕忠
吕竹芬
谢清春
CHEN Peihong;LIU Zhiting;HUANG Siyu;CHEN Yanzhong;LYU Zhufen;XIE Qingchun(Guangdong Pharmaceutical University,Guangdong Provincial Key Laboratory of Advanced Drug Delivery Systems,Guangzhou 510006,China;Guangdong Pharmaceutical University,New Drug R&D Center,Guangzhou 510006,China;Guangdong Provincial Engineering Center of Topical Precise Drug Delivery System,Guangzhou 510006,China;Guangzhou General Pharmaceutical Research Institute Co.,Ltd.,Guangzhou 510006,China)
出处
《中国现代应用药学》
CAS
CSCD
北大核心
2022年第18期2322-2327,共6页
Chinese Journal of Modern Applied Pharmacy
基金
广州市科创委项目—产学研协同创新重大专项资助项目(201704020199)
广东省科技创新战略专项资金(“攀登计划”专项资金)项目(pdjh2020a0298)。
关键词
3D打印
克拉霉素
胃漂浮
高载药量
缓释
3D printing
clarithromycin
gastric-floating
high-drug-loading
sustained-release
