Box-Behnken效应面法优化对乙酰氨基酚魔芋胶骨架片的处方

Optimized formulation of konjak glue matrix tablets containing paracetamol by Box-Behnken design

目的:考察对乙酰氨基酚魔芋胶骨架片的制备处方,并考察其体外其释药机制。方法:以体外累积释放度为指标,通过单因素考察找出影响释放的主要因素,再采用Box-Behnken效应面优化法筛选出最佳处方。结果:通过体外释放度考察得到制备对乙酰氨基酚魔芋胶骨架片的最佳处方为药物20%、骨架材料17.95%、乳糖33.05%、淀粉28%、滑石粉1%。体外释放度试验表明其体外释药符合Ritger-Peppas动力学模型。结论:采用湿法制粒压片法制得对乙酰氨基酚魔芋胶骨架片,体外释放度试验表明具有较好的缓释特性。

OBJECTIVE To study the prescription of konjak glue matrix tablets containing paracetamol,and to investigate the in vitro release mechanism.METHODS Box-Behnken response surface methodology was used to predict and test the optimal prescription,then the release mechanism in vitro were studied.RESULTS By using Box-Behnken response surface optimization method,the best prescription for konjak glue matrix tablets containing paracetamol was 20% drug,17.95% skeleton material,33.05% lactose,28% starch and 1% talcum powder and the release in vitro fit into the Ritger-Peppas kinetic model.CONCLUSION Konjak glue matrix tablets containing paracetamol were pressed with the wet granulation method,and drug release in vitro showed that the tablets had sustained-release characteristics.