基于熔融沉积3D打印技术制备复方丹参片的工艺分析及可行性评价  

Process Analysis and Feasibility Evaluation of Compound Danshen Tablets Based on Melt Deposition 3D Printing Technology

作　　者：刘威 石亮 王学亮 唐睿 孙传聪 邹田甜 甄珍 LIU Wei;SHI Liang;WANG Xueliang;TANG Rui;SUN Chuancong;ZOU Tiantian;ZHEN Zhen(Shandong Province Higher Education Medical Device New Technology Research and Development Center,Shandong Drug and Food Vocational College,Weihai 264200,China)

机构地区：[1]山东药品食品职业学院山东省高等学校医疗器械新技术研发中心,山东威海264200

出　　处：《中国现代中药》2025年第1期131-136,共6页Modern Chinese Medicine

基　　金：威海市中医药科技项目(2022N-01)。

摘　　要：目的:采用熔融沉积3D打印技术制备复方丹参片,对其制备工艺及可行性进行分析与评价。方法:通过计算机软件设计药片数字模型,设定打印参数,混合配方材料,置于料仓预热,熔融挤出料丝,堆叠成型药片,并检测药片的质量差异度、硬度、崩解时限及成分含量等特征指标。结果:打印过程稳定,打印的复方丹参片外观良好,直径为(8.18±0.10)mm、高度为(3.23±0.09)mm,硬度为(22.56±1.43)N,药片质量差异度为6.1%,崩解时限为(4.4±0.5)min,每片中含丹参酮Ⅱ_(A) 0.39 mg,丹酚酸B 9.1 mg,人参皂苷Rg_(1)、人参皂苷Rb_(1)、三七皂苷R_(1)及人参皂苷Re的总量为14.8 mg。结论:熔融沉积3D打印技术制备复方丹参片的工艺可靠,打印的复方丹参片具有外观良好、载药量精准、崩解速度快、含主药均匀度高等优点。熔融沉积3D打印技术制备复方丹参片具有一定的可行性,可为熔融沉积式3D打印中药片剂的临床应用提供参考。Objective:To prepare compound Danshen Tablets using melt deposition 3D printing technology and to analyze and evaluate the preparation process and feasibility.Methods:A digital model of the tablet was designed using computer software,with printing parameters set.Formula materials were mixed,preheated in the silo,melted and extruded into filament,and stacked to form tablets.Characteristic indicators such as weight variation,hardness,disintegration time,and component content of the tablets were measured.Results:The printing process was stable,and the printed compound Danshen Tablets had a good appearance,with a diameter of(8.18±0.10)mm,a height of(3.23±0.09)mm,a hardness of(22.56±1.43)N,a weight variation of 6.1%,and a disintegration time of(4.4±0.5)min.The tablets contained 0.39 mg of tanshinoneⅡ_(A),9.1 mg of salvianolic acid B,and a total of 14.8 mg of ginsenoside Rg_(1),ginsenoside Rb_(1),notoginsenoside R_(1),and ginsenoside Re.Conclusion:The process of preparing compound Danshen Tablets using melt deposition 3D printing technology is reliable.The printed tablets exhibit advantages such as good appearance,accurate drug loading,fast disintegration,and high uniformity in active ingredient content.The use of melt deposition 3D printing technology for the preparation of compound Danshen Tablets is feasible,and this study provides a reference for the clinical application of 3D-printed Chinese medicine tablets.

关 键 词：3D打印制药 熔融沉积打印技术 复方丹参片 个性化给药 

分 类 号：R286[医药卫生—中药学]