【摘要】：目的:優(yōu)選左羥丙哌嗪-β-環(huán)糊精包合物分散片的處方組成與制備工藝。方法:制備左羥丙哌嗪-β-環(huán)糊精包合物,并以此為中間體添加適宜的輔料制備分散片。以崩解時限、片劑外觀等為評價指標(biāo),進行處方及制備工藝的全面考察優(yōu)化。結(jié)果:分散片最優(yōu)處方為:左羥丙哌嗪-β-環(huán)糊精包合物80.0%,L-HPC10.0%,MCC9.6%,硬脂酸鎂0.4%。其崩解時間不超過60 s,5 min溶出可達(dá)85%以上。結(jié)論:該分散片處方設(shè)計簡單合理,工藝穩(wěn)定可行,符合《中國藥典》2015年版的規(guī)定。
[Abstract]:Objective: to optimize the formulation and preparation of levodropromazine-尾-cyclodextrin inclusion dispersible tablets. Methods: levodropromazine-尾-cyclodextrin inclusion compound was prepared and used as intermediate to prepare dispersible tablets. The disintegrating time and the appearance of tablets were used as evaluation indexes to optimize the formulation and preparation process. Results: the optimal prescription of dispersible tablets was as follows: the inclusion compound of levohydroxypromazine-尾-cyclodextrin was 80. 0. 0 and MCC 9. 6, and magnesium stearate was 0. 4. The disintegration time was less than 60 sm 5 min and the dissolution rate was more than 85%. Conclusion: the formulation of the dispersible tablets is simple and reasonable, the process is stable and feasible, and it is in accordance with the Chinese Pharmacopoeia 2015 edition.
【作者單位】： 貴州大學(xué)藥學(xué)院;貴州省藥食兩用資源應(yīng)用開發(fā)工程實驗室;貴州理工學(xué)院制藥工程學(xué)院;
【基金】：貴州省科技創(chuàng)新人才團隊項目[編號:黔科合人才團隊(2015)4010號] 貴州省科技計劃項目[編號:黔科合G字(2015)4001] 貴州省發(fā)展和改革委員會工程實驗室建設(shè)項目[編號:黔發(fā)改投資(2015)542號]
【分類號】：R943

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