星点设计-效应面法优化盐酸多奈哌齐冻干型口崩片的制备工艺  

Preparation of lyophilized orally disintegrating tablets of donepezil hydrochloride based on central composite design and response surface methodology

作　　者：吴雪纯 邱旖 吴婧楠 孙常胜 蒋巧萍 宇泉霖 宋嘉佳 顾凯琳 郭杏梅 孙腾跃 蔡程科[1] 王洪飞 WU Xue-chun;QIU Yi;WU Jing-nan;SUN Chang-sheng;JIANG Qiao-ping;YU Quan-lin;SONG Jia-jia;GU Kai-lin;GUO Xing-mei;SUN Teng-yue;CAI Cheng-ke;WANG Hong-fei(School of Chinese Meteria Medica,Beijing University of Chinese Medicine,Beijing 102488;Beijing Quantum Hi-tech Pharmaceutical Co.,Ltd.,Beijing 102200)

机构地区：[1]北京中医药大学中药学院,北京102488 [2]北京量子高科制药科技有限公司,北京102200

出　　处：《中南药学》2023年第4期870-875,共6页Central South Pharmacy

基　　金：国家科技重大专项研发项目(No.2011ZX09201-201-15);北京市科技计划专项研发项目(No.Z16010101390)。

摘　　要：目的优化盐酸多奈哌齐冻干型口崩片的制备工艺。方法以口崩片外观性状、崩解时间、含水量为主要考察指标,对盐酸多奈哌齐冻干型口崩片的处方工艺进行单因素和星点设计-效应面法的考察。结果盐酸多奈哌齐冻干型口崩片的最优处方工艺为:普鲁兰多糖9.5mg/片,甘露醇4.9 mg/片,黄原胶0.2 mg/片,制备的口崩片片型饱满、表面光洁、崩解迅速,且室温下放置3个月的稳定性良好。结论优化得到的盐酸多奈哌齐冻干型口崩片制备工艺操作简便、稳定可行,该工艺适用于大规模工业化生产。Objective To optimize the preparation of lyophilised orally disintegrating tablets of donepezil hydrochloride.Methods The prescription process of lyophilised orally disintegrating tablets of donepezil hydrochloride was determined by single-factor and central composite design and response surface methodology,with appearance property,disintegration time and water content as the main indexes.Results The optimal prescription for the lyophilized orally disintegrating tablets of donepezil hydrochloride included:prululan polysaccharide 9.5 mg/tablet,mannitol 4.9 mg/tablet,and xanthan gum 0.2 mg/tablet.The prepared orally disintegrating tablets showed full shaped,smooth surface with rapid disintegration,and good stability at room temperature for 3 months.Conclusion The optimized lyophilized orally disintegrating tablets preparation of donepezil hydrochloride is simple,stable and feasible,and suitable for large-scale industrial production.

关 键 词：盐酸多奈哌齐 冻干型口崩片 星点设计-效应面法 

分 类 号：R943[医药卫生—药剂学]