3D打印克拉霉素胃漂浮缓释片的质量评价  

Quality Evaluation of 3D Printing Clarithromycin Gastric-floating Sustained-release Tablets

作　　者：陈培鸿 刘志挺 黄思玉 陈燕忠[1,2,3,4] 吕竹芬 谢清春[1,2] 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)

机构地区：[1]广东药科大学广东省药物新剂型重点实验室,广州510006 [2]广东药科大学新药研发中心,广州510006 [3]广东省局部精准药物递药制剂工程技术研究中心,广州510006 [4]广州医药研究总院有限公司,广州510006

出　　处：《中国现代应用药学》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)。

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.

关 键 词：3D打印 克拉霉素 胃漂浮 高载药量 缓释 

分 类 号：R941[医药卫生—药剂学]