目的 以阿司匹林为模型药物,探讨3D打印技术制备个体化需求的、可控释放的阿司匹林片剂的可行性。方法 实验选取羟丙基甲基纤维素10 000 mPa·s(HPMC10000)和聚丙烯酸(PAA)作为缓释层的亲水性基质;羟丙基甲基纤维素100 mPa·s(HPMC100)作为速释层黏合剂,羧甲基淀粉钠(CMS-Na)和羟甲基淀粉钠(SSG)作为速释层的崩解剂,用3D打印机打印了阿司匹林速释缓释双层片。选取100 mg·mL^-1聚乙烯吡咯烷酮(PVPK₃₀)作为速释层黏合剂,交联羧甲基纤维素钠(CC-Na)作为速释层崩解剂,HPMC100作为缓释层的骨架材料,用传统的压片机压制阿司匹林速释缓释双层片,作为对比制剂。考察2种不同生产方式生产的片剂的物理化学性质(片重差异、脆碎度、硬度和厚度)以及释放曲线。结果 2种片剂的物理化学性质均在药典规定范围内。对比2种片剂释放曲线可见,ASA-HPMC(14%,ω)打印片的释放曲线与压片双层片相似,且释放量高于压片双层片。ASA-HPMC(6%,ω)、ASA-HPMC(8%,ω)以及ASA-HPMC(10%,ω) 打印片最终释放量随着亲水性基质HPMC的增加而增高。结论 3D打印机打印的不同形状的片剂具有不同的释放曲线,其中包合打印双层片的释放量高于其他片剂。

OBJECTIVE Taking aspirin as a model drug, the feasibility of the controlled release of aspirin tablets was discussed, which was based on the individual demand of 3D printing technology. METHODS The experiment selected 10 000 mPa·s hydroxypropyl methyl cellulose (HPMC10000) and polyacrylic acid (PAA) as a hydrophilic matrix sustained-release layer; hydroxypropyl methyl cellulose 100 mPa·s (HPMC100) as a quick release layer binder, sodium carboxymethyl starch (CMS-Na) and sodium carboxymethyl starch (SSG) as a quick release layer disintegrating agent, the use of 3D printer to print the slow release of aspirin tablets. Select 100 mg·mL^-1 and polyvinylpyrrolidone (PVPK30) as a quick release layer binder, crosslinking sodium carboxymethyl cellulose (CC-Na) as a quick release layer disintegrating agent, hydroxypropyl methyl cellulose (HPMC100) as the matrix material release layer, with the traditional press pressing speed of aspirin sustained-release tablet, as contrast agents. The physical and chemical properties of tablets produced in two different modes of production (film weight difference, hardness and thickness) and release profile were investigated. RESULTS The physical and chemical properties of the two tablets are all in the Pharmacopoeia. Comparison of two kinds of drug release curve showed that the ASA-HPMC (14%, ω) and the press release curve of double layer tablets printing film is similar, and the release rate is higher than the tablet (6% ω.ASA-HPMC double layer tablets), ASA-HPMC (8%, ω) and ASA-HPMC (10%, ω) printing film final release amount increased with hydrophilic matrix HPMC. CONCLUSION 3D printers print different shapes of tablets with different release profiles, in which the release of the package is higher than the other tablets.