【摘要】：目的:制備新型的功能性復(fù)合輔料甘露醇-交聯(lián)聚維酮(Man-Cro),并對其進行質(zhì)量評價。方法:通過處方組成與制備工藝的考察,對該輔料進行了質(zhì)量標(biāo)準(zhǔn)研究與休止角、卡爾指數(shù)等輔助性功能研究,并進行壓片試驗比較。結(jié)果:以共同結(jié)晶法為工藝,確定其處方組成為甘露醇-交聯(lián)聚維酮為80:20,平均粒徑為251μm,休止角小于40°,卡爾指數(shù)在22%~25%之間,該復(fù)合輔料具有良好的膨脹度、流動性、可壓性以及崩解性,同時符合中國藥典對甘露醇及交聯(lián)聚維酮的質(zhì)量要求,適用于口崩片的制備。結(jié)論:功能性復(fù)合輔料Man-Cro制備工藝簡單可行,性能優(yōu)良,可應(yīng)用于直壓性口崩片的制備,質(zhì)量可控。
[Abstract]:Objective: to prepare a new functional compound excipients mannitol crosslinked povidone (Man-Cro) and evaluate its quality. Methods: through the investigation of prescription composition and preparation technology, the quality standard, rest angle, Karl index and other auxiliary functions of the auxiliary material were studied, and the tablet pressing test was compared. Results: the prescription composition of mannitol-crosslinked povidone was 80 鈮，

本文編號：2483098