渗透泵药物控释制剂包衣工艺研究进展

陈馨怡, 袁凤, 史楷岐, 杨根生, 杨庆良

中国药学杂志 ›› 2021, Vol. 56 ›› Issue (23) : 1874-1879.

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中国药学杂志
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中国药学杂志 ›› 2021, Vol. 56 ›› Issue (23) : 1874-1879. DOI: 10.11669/cpj.2021.23.002
综述

渗透泵药物控释制剂包衣工艺研究进展

  • 陈馨怡1, 袁凤1, 史楷岐2, 杨根生1, 杨庆良1*
作者信息 +

Recent Advances of Film Coating for Osmotic Drug Delivery Systems

  • CHEN Xin-yi1, YUAN Feng1, SHI Kai-qi2, YANG Gen-sheng1, YANG Qing-liang1*
Author information +
文章历史 +

摘要

渗透泵控释制剂是一种可实现药物匀速释放的膜控型控释制剂,精准的药物控释能力使其成为高端药物制剂领域的研究热点。当前,越来越多的普通口服制剂通过改良型药物申报渠道(505b2)得到了美国食品药品监督管理局(FDA)的批准,成为新型渗透泵控释制剂,大幅减少了服药频次,降低或消除了血药浓度峰谷波动引起的毒副作用。渗透泵控释制剂实现药物匀速释放的关键是其包衣膜(半透膜)质量,目前产业化渗透泵制剂大多利用有机溶剂包衣工艺制备包衣膜,但有机溶剂易燃、易爆及挥发性有机化合物(VOC)排放等问题促使科研人员开发替代型包衣工艺,包括水分散体包衣、热塑包衣、静电干粉包衣及3D打印技术等。笔者总结新型包衣工艺的最新研究进展,探讨每一种包衣工艺的优缺点及其产业化过程需要解决的关键问题,并展望渗透泵控释制剂包衣工艺的应用前景,为其在制药领域的研究和应用提供参考。

Abstract

As one of the oral drug delivery system capable achieving constant drug release rate, osmotic pump is considered as the ultimate ideal drug delivery system. Compared with traditional oral preparation, osmotic pump could precisely control the drug release rate over a prolonged time period, significantly reducing the frequency of drug administrations and eliminating side effects caused by the fluctuation of drug plasma concentration. This review aims to summarize and discuss the newly developed manufacturing methods of the crucial coating film (semipermeable membrane) of the osmotic pump, focusing on the advantages and limitations of each fabricating method. The review also provides future perspectives of the promising applications of each manufacturing procedure for the osmotic pump.

关键词

渗透泵 / 控释制剂 / 包衣工艺 / 半透膜 / 零级释放

Key words

osmotic pump / controlled-release preparation / coating method / semipermeable membrane / zero order release.

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导出引用
陈馨怡, 袁凤, 史楷岐, 杨根生, 杨庆良. 渗透泵药物控释制剂包衣工艺研究进展[J]. 中国药学杂志, 2021, 56(23): 1874-1879 https://doi.org/10.11669/cpj.2021.23.002
CHEN Xin-yi, YUAN Feng, SHI Kai-qi, YANG Gen-sheng, YANG Qing-liang. Recent Advances of Film Coating for Osmotic Drug Delivery Systems[J]. Chinese Pharmaceutical Journal, 2021, 56(23): 1874-1879 https://doi.org/10.11669/cpj.2021.23.002
中图分类号： R944   

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基金

国家自然科学基金项目资助(21808206);宁波市国际合作项目资助(2018D10011);宁波市科技项目资助(2019C10080)
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