熔融沉积型3D打印技术制备不同释放速率的银杏酮酯片  

Ginkgo biloba Ketone Ester Tablets with different release rates prepared by fused deposition modeling 3D printing technology

作　　者：李永圆 陈晨 王海霞 向蓓蓓[3] 李正[1,2] LI Yong-yuan;CHEN Chen;WANG Hai-xia;XIANG Bei-bei;LI Zheng(College of Pharmaceutical Engineering of Traditional Chinese Medicine,Tianjin University of Traditional Chinese Medicine,Tianjin 301617,China;State Key Laboratory of Component-based Chinese Medicine,Tianjin University of Traditional Chinese Medicine,Tianjin 301617,China;Schol of Chinese Materia Medica,Tianjin University of Traditional Chinese Medicine,Tianjin301617,China)

机构地区：[1]天津中医药大学中药制药工程学院,天津301617 [2]天津中医药大学省部共建组分中药国家重点实验室,天津301617 [3]天津中医药大学中药学院,天津301617

出　　处：《中国中药杂志》2022年第17期4643-4649,共7页China Journal of Chinese Materia Medica

基　　金：国家“重大新药创制”科技重大专项(2018ZX09201011);国家自然科学基金项目(82003944);2022年天津市企业科技特派员项目。

摘　　要：该研究选用具有良好生物相容性和一定黏度的聚乙二醇和交联羧甲基纤维素钠作为制剂辅料,利用熔融沉积型3D打印技术制备了新型银杏酮酯(3D-GBE50)制剂。首先建立了直径为9.00 mm,高度为4.50 mm的圆柱体3D打印模型,进而根据优化的打印辅料配方,设计并打印制备了3种路径(同心圆,之字形和网格状),不同层高和不同填充间隙的3D-GBE50制剂,然后对打印制剂的形态、尺寸、化学性质和溶出活性进行了充分的表征和考察。结果表明,3D-GBE50制剂外观光滑,纹理清晰,脆碎度达标,热稳定性好,化学性质稳定。此外,打印路径,层高和填充间隙这些设计参数对3D-GBE50制剂的释放速率都有直接影响。其中,之字形打印路径的3D-GBE50片剂溶出速率最快,而同心圆和网格状打印路径的3D-GBE50片剂的溶出速率都要慢于市售银杏酮酯片剂。除此之外,层高越高,填充间隙越宽,3D-GBE50片剂的溶出速率越快。该研究表明熔融沉积型3D打印技术可以通过灵活调控打印参数进而调控药物释放活性,为个性化药物制剂制备提供了有效思路和解决方法。The present study prepared a new type of Ginkgo biloba ketone ester(GBE50) preparation from polyethylene glycol and croscarmellose sodium with good biocompatibility and a certain viscosity by fused deposition modeling(FDM)-type 3D printing technique. Firstly, a cylindrical 3D printing model with a diameter of 9.00 mm and a height of 4.50 mm was established. Subsequently, the 3D-GBE50 preparations with three paths(concentric, zigzag, and grid), different layer heights, and different filling gaps were designed and prepared after the optimization of the proportions of excipients. The morphology, size, chemical properties, and dissolution activity of the 3D-GBE50 preparations were fully characterized and investigated. The results showed that 3D-GBE50 preparations had smooth appearance, clear texture, standard friability, good thermal stability, and stable chemical properties. Moreover, the printing path, layer height, and filling gap were directly related to the release rate of 3D-GBE50 preparations. The dissolution of 3D-GBE50 tablets with zigzag printing path was the fastest, while the dissolution rates of 3D-GBE50 tablets with concentric circle and grid-shaped printing paths were slower than that of commercially available G. biloba Ketone Ester Tablets. In addition, the dissolution of 3D-GBE50 tablets was faster with higher layer height and wider filling gap. As revealed by the results, th FDM-type 3D printing technique can flexibly regulate the drug release activity via controlling the printing parameters, providing effective ideas and methods for the pre-paration of personalized pharmaceutical preparations.

关 键 词：3D打印 银杏酮酯 熔融沉积 释放速率 个性化 

分 类 号：TP391.73[自动化与计算机技术—计算机应用技术] TQ461[自动化与计算机技术—计算机科学与技术]