氯化钾-乙基纤维素骨架缓释片的制备及处方工艺优化

摘要

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 granulation.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 homemade 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 commercially available product.%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30 kN.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.