Eudragit~NE 30D对药物释放稳定性的影响因素探讨

Discussion on the influencing factors of Eudragit~ NE 30D on the stability of drug release

Eudragit~ NE 30D作为一种常用的缓释包衣、缓释骨架及掩味包衣材料,在药物制剂中应用广泛。而该类水分散体成膜机理较为复杂,对药物释放控制存在不稳定性现象,即物理老化,也是目前该品种应用中存在的最为突出的问题。本文基于丙烯酸树脂成膜机理研究,结合国内外相关文献报道,对Eudragit~ NE 30D物理老化问题的解决及预防措施进行归纳总结,从而促进其在药物制剂,特别是在缓控释制剂中的应用。

Eudragit NE 30D, which is commonly used as a sustained release coating and matrix and taste masking material, has a wide application in the pharmaceutical preparations. The formation of film coatings from the aqueous polymer dispersions is a complex process, highly dependent on additives and process parameters. Release instability of modified release coatings from aqueous polymer dispersions, which is known as physical aging, is a frequently described problem that hinders the general application of such dispersions. Based on the film formation mechanism from aqueous dispersions and the relevant literature reports, the present paper reviewed the technical methods to solve or prevent the physical aging of Eudragit~ NE 30D, which would facilitate the application of the material in pharmaceutical preparations, especially the sustained controlled preparations and taste masking.