压片工艺定量化控制的研究

Studies on quantitative control of tableting technology

目的 对压片工艺进行定量化控制 ,以制备出理想性能的阿司匹林控释片剂。方法 用均匀设计法设计试验 ,制备阿司匹林控释骨架片。测定压制片的抗张强度、脆碎度及释放度等指标 ,多元回归方程得到各考察因素对指标的影响。根据设定的各指标目标值范围 ,利用回归方程选择一个合适的试验条件 ,进行验证试验。结果 压片力、颗粒含水量和颗粒强度是影响片剂抗张强度、脆碎度及释放度的主要因素。验证试验中各指标的测定值与预测值相差不大。结论 在多元回归方程的指导下 ,对压片工艺中主要影响因素———压片力、颗粒含水量及颗粒强度进行定量化控制可制备出理想性能的控释片剂。

OBJECTIVE To prepare the controlled-release matrix tablets with ideal properties by quantitatively controlled method.METHODS Experiments were arranged using uniform design method.Aspirin controlled-release matrix tablets were prepared.The tensile strength,fragility,dissolution were determined.The effects of each factor could be acquired according to multivariate regression equations.An optimum experimental condition was chosen according to the stipulated target ranges of responses and their regression equations,and the verification experiment was made using this experimental condition.RESULTS Tableting strength,humidity in granules and granule strength were the leading factors which affect tensile strength,fragility,dissolution percentage of tablets.Verification experiment showed that the observed results were closed to the predicted.CONCLUSION The controlled release tablets with ideal properties could be prepared when leading influencing factors would be quantitatively controlled with the guidance of multivaiate regression equations.