酮洛芬滴丸剂的制备及其体外释放特性

摘要

Selected the formability of drop pills as evaluation index to optimize preparation process.Se-lected the in-vitro release as evaluation index to optimize the prescription.The optimal preparation process of ketoprofen pills are as follows:the coolant was dimethyl silicone oil,with the cooling tem-perature 0 ℃,the dripping speed 20 drops/min and the dripping distance 10 cm.The optimal formula-tion was PEG6000 as the matrix and drug:matrix proportion was 1∶3 with CMS-Na as the disintegra-tor and Tween 80 as solubilizer.The in-vitro dissolution rate was 98.64% during 30 min by the disso-lution test.%以滴丸成形性为评价指标，筛选了酮洛芬滴丸的制备工艺；以体外释放度为评价指标，优化了滴丸的处方。结果表明，酮洛芬滴丸剂的最优制备工艺为：冷却液为二甲基硅油，冷却液温度0℃，滴速20滴／min，滴距为10 cm；最优处方为 m（酮洛芬）∶m（PEG6000）＝1∶3，并添加崩解剂羧甲基淀粉钠w（CMS-Na）＝10％和增溶剂 w（吐温-80）＝5％；制备的滴丸在20 min 时体外释放度即达到89．37％，30 min时达到98．64％。