正交试验优化穿心莲内酯口服混悬剂的处方工艺  

Optimization of Formulation Technology for Andrographolide Oral Suspensions by Orthogonal Test

作　　者：王芳[1] 李艳丽[1] 翟文婷[1] 许卉[1] 

机构地区：[1]烟台大学药学院,山东烟台264005

出　　处：《中国实验方剂学杂志》2013年第11期42-44,共3页Chinese Journal of Experimental Traditional Medical Formulae

摘　　要：目的:优选穿心莲内酯混悬剂的处方工艺。方法:采用分散法制备穿心莲内酯混悬剂,以沉降体积比、再分散性和溶出度的综合评分为指标,采用正交试验优选处方。结果:最佳处方工艺为每1 mL混悬剂含穿心莲内酯100 mg,羧甲基纤维素钠5 mg(0.5%),甘油5 mg(0.5%)。制得穿心莲内酯混悬剂的沉降体积比0.99,再分散性良好,1 h溶出度99.59%。结论:优选的处方工艺稳定可行,制剂的物理稳定性良好,符合混悬剂的质量要求。Objective： To optimize formulation technology of andrographolide suspensions. Method： Andrographolide suspensions were prepared by dispersion method.Prescription was optimized by orthogonal test with composite score of sedimentation ratio,re-dispersibility and dissolution as index. Result： Optimum formulation technology was composed of andrographolide 100 mg,glycerol 5 mg （0.5%） and carboxymethyl-cellulose sodium 5 mg （0.5%） per 1 mL suspensions.These prepared andrographolide suspensions showed satisfactory properties including 99% sedimentation ratio and 100% re-dispersibility with dissolution of 99.59% in 1 hour. Conclusion： This optimized formulation technology was stable and feasible, and the obtained andrographolide suspensions had good physical stability which met quality requirements of suspensions.

关 键 词：穿心莲内酯 混悬剂 处方优化 正交设计 

分 类 号：R283.6[医药卫生—中药学]