半固体挤出3D打印卡托普利分剂量片的质量评价  

Quality Evaluation of Semi-solid Extrusion 3D-printed Captopril Subdivided Tablets

作　　者：陈杰燕 李思婷 陈君丽 余雅莹 郑子杰 杨帆[2] 罗崇彬[1] CHEN Jie-yan;LI Si-ting;CHEN Jun-li;YU Ya-ying;ZHENG Zi-jie;YANG Fan;LUO Chong-bin(Huadu District People′s Hospital of Guangzhou,Guangzhou 510800,China;The Center for Drug Research and Development,Guangdong Provincial Key Laboratory of Advanced Drug Delivery Systems,Guangdong Provincial Engineering Center of Topical Precise Drug Delivery System,Guangdong Pharmaceutical University,Guangzhou 510006,China)

机构地区：[1]广州市花都区人民医院,广东广州510800 [2]广东药科大学,新药研发中心、广东省药物新剂型重点实验室和广东省局部精准药物递药制剂工程技术研究中心,广东广州510006

出　　处：《海峡药学》2023年第6期5-9,共5页Strait Pharmaceutical Journal

基　　金：广州市卫生健康科技一般引导项目(20221A010080);广东省普通高校“人工智能”重点领域专项(2019KZDZX1019)。

摘　　要：目的对不同剂量的半固体挤出3D打印卡托普利分剂量片进行质量评价,为临床提供精准剂量的分剂量药品。方法对3D打印卡托普利分剂量片剂进行外观、硬度、重量差异、含量、含量均匀度、溶出度和稳定性质量评价,并通过差示扫描量热分析(Differential scanning calorimetry,DSC)对比打印片与市售片中药物的特征峰。结果3D打印卡托普利分剂量片为白色圆柱形网格片,各检测指标均符合2020版《中国药典》要求,DCS图谱中3D打印片和市售片的药物特征峰位置一致。结论半固体挤出3D打印卡托普利分剂量片可用于临床药品分剂量,实现精准医疗服务。OBJECTIVE To evaluate the quality of semi-solid extrusion three-dimensional(3D)printed captopril subdivided tablets with different doses,so as to provide subdivided tablets with precise dosage for clinical application.METHODS The appearance,hardness,mass difference,content,content uniformity,dissolution,and stability of the 3D-printed captopril subdivided tablets were evaluated,and the characteristic peaks of the medicine in the 3D-printed tablets and commercial tablets were compared by differential scanning calorimetry(DSC).RESULTS The 3D-printed captopril subdivided tablets were white cylindrical gridding tablets,and all detection indicators met the requirements of the Chinese Pharmacopoeia.The positions of the medicine characteristic peaks were consistent between the 3D-printed tablets and commercial tablets in the DCS spectrum.CONCLUSION Captopril subdivided tablets prepared using semi-solid extruded 3D printing can be used for clinical drug split doses to achieve precise medical service.

关 键 词：3D打印 半固体挤出 卡托普利 分剂量片 

分 类 号：R94[医药卫生—药剂学]