甲氧氯普胺口崩片的制备及体外溶出度考察  

Preparation and in vitro Release of Metoclopramide Orally Disintegrating Tablets

作　　者：谢向阳[1] 周时光[1] 林雯 邢传峰 陈晨[1] 陈鹰[1] 

机构地区：[1]广州军区武汉总医院药剂科,武汉430070 [2]黄石爱康医院检验科 [3]大连美罗药业有限公司

出　　处：《中国药师》2015年第11期1882-1884,1894,共4页China Pharmacist

摘　　要：目的:制备甲氧氯普胺口崩片并优化处方,并对其体外溶出度进行考察。方法:采用全因子试验设计,以填充剂配比(X1)、崩解剂(X2,%)用量为影响因素,以脆碎度(Y1,%)、崩解时限(Y2,s)、甲氧氯普胺在15 min的溶出度(Y3,%)为片剂考察指标优化处方;并考察其在4种溶出介质中的溶出行为。结果:甲氧氯普胺口崩片的最优处方组成为:填充剂甘露醇与微晶纤维素比例为2.5∶1、崩解剂占片重为6.5%。甲氧氯普胺口崩片在4种溶出介质中累积溶出度均大于80%。结论:甲氧氯普胺口崩片处方设计合理,制备工艺可行,质量可控。Objective：To prepare and optimize the formula of metoclopramide orally disintegrating tablets, and investigate the in vitro drug dissolution behavior. Methods：The formula was optimized by full-factorial experiment design, the ratio of mannotil to micro-crystalline cellulose （ X1 ） and the amount of disintegrating agent （ X2 ,%） were selected as the independent variables, and the friabili-ty （ Y1 ,%） , disintegration time （ Y2 , s） and metoclopramide dissolution （ Y3 ,%） were used as the dependent variables. The release rate of metoclopramide orally disintegrating tablets in different dissolution media was studied. Results：The optimum formula of meto-clopramide orally disintegrating tablets was as follows：the ratio of mannotil to microcrystalline cellulose was 2. 5∶ 1, and the amount of disintegrating agent was 6. 5%. The dissolution of metoclopramide orally disintegrating tablets in the different dissolution media was o-ver 80%. Conclusion：The formula design is reasonable, the preparation process is feasible and the quality can be controlled.

关 键 词：甲氧氯普胺 口崩片 全因子试验设计 脆碎度 崩解时限 溶出度 

分 类 号：R975.4[医药卫生—药品]