| 引用本文: | 陈培鸿,刘志挺,黄思玉,陈燕忠,吕竹芬,谢清春.3D打印克拉霉素胃漂浮缓释片的质量评价[J].中国现代应用药学,2022,39(18):2322-2327. |
| CHEN Peihong,LIU Zhiting,HUANG Siyu,CHEN Yanzhong,LYU Zhufen,XIE Qingchun.Quality Evaluation of 3D Printing Clarithromycin Gastric-floating Sustained-release Tablets[J].Chin J Mod Appl Pharm(中国现代应用药学),2022,39(18):2322-2327. |
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| 3D打印克拉霉素胃漂浮缓释片的质量评价 |
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陈培鸿1, 刘志挺1, 黄思玉1,2, 陈燕忠1,2,3,4, 吕竹芬1,2,3,4, 谢清春1,2
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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
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| 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HPMC K15MCR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。 |
| 关键词: 3D打印 克拉霉素 胃漂浮 高载药量 缓释 |
| DOI：10.13748/j.cnki.issn1007-7693.2022.18.004 |
| 分类号:R941 |
| 基金项目: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) |
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| Quality Evaluation of 3D Printing Clarithromycin Gastric-floating Sustained-release Tablets |
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CHEN Peihong1, LIU Zhiting1, HUANG Siyu1,2, CHEN Yanzhong1,2,3,4, LYU Zhufen1,2,3,4, XIE Qingchun1,2
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1.Guangdong Provincial Key Laboratory of Advanced Drug Delivery Systems, Guangdong Pharmaceutical University, Guangzhou 510006, China;2.New Drug R&D Center, Guangdong Pharmaceutical University, Guangzhou 510006, China;3.Guangdong Provincial Engineering Center of Topical Precise Drug Delivery System, Guangzhou 510006, China;4.Guangzhou General Pharmaceutical Research Institute Co., Ltd., Guangzhou 510006, China
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| Abstract: |
| 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. |
| Key words: 3D printing clarithromycin gastric-floating high-drug-loading sustained-release |
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