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目的优化研制阿昔洛韦胃漂浮片的处方。方法采用粉末直接压片法制备阿昔洛韦胃漂浮片,采用中心复合设计法对阿昔洛韦胃漂浮片的处方进行优化。结果以HPMCK4M和PEOWSRN-205为亲水凝胶骨架、十六醇为助漂剂、碳酸氢钠为产气剂,制备了12h缓释胃漂浮片。该制剂在胃酸中能立即起漂,阿昔洛韦的释放量2h约为30%(w),6h约为60%(w),12h释放量大于90%(w)。结论采用中心复合设计-效应面法优化的处方预测性良好,制得的阿昔洛韦胃漂浮片符合要求。
Objective To optimize the formulation of acyclovir gastric floating tablets. Methods The acyclovir gastric floating tablets were prepared by the powder direct compression method. The prescription of acyclovir gastric floating tablets was optimized by center composite design method. Results HPMCK4M and PEOWSRN-205 as hydrophilic gel skeleton, cetyl alcohol as a bleaching agent, sodium bicarbonate as a gas generating agent, prepared 12h sustained release gastric floating tablets. The preparation can instantly bleach in gastric acid. The release amount of acyclovir is about 30% (w) for 2h, about 60% for 6h and more than 90% for 12h. Conclusion The prescription of center composite design-response surface method has good predictability, and the prepared acyclovir gastric floating tablets meets the requirements.