【摘要】：球結(jié)晶是通過控制重結(jié)晶中藥物分子相互聚合過程,可得到較大粒徑球形藥物顆粒的技術(shù),作為新型的粒子設(shè)計(jì)方法,該技術(shù)可改善粉體性質(zhì)(包括流動(dòng)性、可壓縮性、生物利用度等)、控制過程參數(shù)(溫度、攪拌速率、溶劑種類和用量、輔料種類等)、得到理想粒徑分布的球形顆粒。本文綜述了國內(nèi)外藥劑學(xué)領(lǐng)域球結(jié)晶技術(shù)的相關(guān)研究,著重介紹了經(jīng)典的球結(jié)晶制備方法(球形聚集法、類乳濁液溶劑擴(kuò)散法、氨擴(kuò)散法和結(jié)晶共聚法),從工業(yè)擴(kuò)大生產(chǎn)的角度,在制備方法、過程參數(shù)及粉體性能方面提出了一些想法,為該技術(shù)在藥物的應(yīng)用與推廣方面提供參考。
[Abstract]:Spheroidal crystallization is a technique to obtain large spherical drug particles by controlling the process of drug molecular polymerization in recrystallization. As a new particle design method, the technology can improve the properties of powder (including fluidity, compressibility, etc.) The spherical particles with ideal particle size distribution were obtained by controlling the process parameters (temperature, stirring rate, solvent type and amount, kinds of excipients, etc.). In this paper, the research on spherical crystallization in the field of pharmacy at home and abroad is reviewed, and the classical preparation methods of spherical crystallization (spherical aggregation method, emulsion like solvent diffusion method, ammonia diffusion method and crystallization copolymerization method) are emphatically introduced. From the point of view of expanding industrial production, some ideas on the preparation method, process parameters and powder properties are put forward, which can provide reference for the application and popularization of this technology in the field of medicine application.
【作者單位】： 第二軍醫(yī)大學(xué);總后衛(wèi)生部藥品儀器檢驗(yàn)所;
【基金】：國家“重大新藥創(chuàng)制”科技重大專項(xiàng)(2009ZXJ09004-083) 軍隊(duì)特需藥品專項(xiàng)
【分類號(hào)】：R91
，

本文編號(hào)：2388788