氯化钾-乙基纤维素骨架缓释片的制备及处方工艺优化  

Preparation of Potassium Chloride-Ethyl Cellulose Sustained-Release Tablets and Optimization of Their Formulation

作　　者：吴剑坤 

机构地区：[1]武汉工程大学化工与制药学院,武汉430205

出　　处：《三峡大学学报（自然科学版）》2017年第6期109-112,共4页Journal of China Three Gorges University：Natural Sciences

摘　　要：研制了氯化钾-乙基纤维素骨架缓释片并优化处方.以乙基纤维素10(以下简称EC)为缓释骨架材料,并以氢化植物油为润滑剂,乙醇为黏合剂,流化床制粒并制备氯化钾-EC骨架缓释片.在处方单因素考察的基础上,选择对缓释片释放行为影响较大的三个处方因素-EC微丸用量、氢化植物油用量、压片压力,以累计释放度为指标,利用正交实验设计L9(34)对缓释片进行优化,将自制的乙基纤维素-氯化钾缓释片与市售产品进行比较.结果表明在3因素中压片的压力对氯化钾-乙基纤维素骨架缓释片的释放度影响最大,最佳处方组成为5%EC占比48.75%,6%EC占比48.75%,氢化植物油2.50%,压片压力设置为30kN.自制的氯化钾-乙基纤维素骨架缓释片具有明显的缓释效果,并优于市售产品.The preparation of potassium chloride-EC sustained-release matrix tablets and optimization of their formulation are conducted. The potassium chloride-EC sustained-release matrix tablets are prepared with EC10 as the matrix, hydrogenated oil as the lubricant and ethanol as the adhesive by fluidized-bed spray gran- ulation. On the basis of single-factor investigation and taking cumulative release percentage degree as index, the formulation of the tablets is optimized by L9（34） orthogonal test design for 3 factors-amount of potassium chloride-EC pellets, amount of hydrogenated oil and pressure of squash. The comparison between the home- made and the commercially available potassium chloride sustained-release tablets in vitro release behavior is made. Among the 3 factors, the pressure of squash shows the biggest impact on the in vitro release percentage degree of the homemade tablets. The most desirable formulation included 48.75 %5 %EC- potassium chloride, 48.75% 6%EC- potassium chloride, 2.5% hydrogenated oil and a pressure of 30 kN for squash. Finally, it is concluded that the homemade EC-potassium chloride sustained-release matrix tablets are superior to the com- mercially available product.

关 键 词：氯化钾缓释片 乙基纤维素 骨架缓释片 处方研究 溶出曲线 

分 类 号：R97[医药卫生—药品]