Preparation of Tetrandrine Solid Dispersion Tablets and Formulation Optimization / 中国药房

ABSTRACT

OBJECTIVE:To optimize preparation formulation of Tetrandrine solid dispersion tablets. METHODS:Tetrandrine solid dispersion tablets were prepared by direct compression method. Excipients were screened with single factor test. Taking disinte-gration time as index,the formulation of Tetrandrine solid dispersion tablets was optimized by orthogonal design using the amount of PVPP,lactose-microcrystalline cellulose proportion and the amount of gum acacia as factors. The optimized formulation was vali-dated. Prepared tablets were compared with Tetrandrine common tablet in dissolution rate,and the contents of the tablets prepared by optimized formulation were also determined. RESULTS:Optimal formulation was as follows as 9.5% PVPP as disintegrating agent,lactose-microcrystalline cellulose(1∶2)as filler,mixing,1% aerosil as lubricant,direct compression. For 3 batches of tab-lets,disintegration time were 79,81 and 78 s;contents were 98.66%,99.24%,99.85%;RSDs were 0.72%,1.16%,1.33%,re-spectively. Combined with Tetrandrine common tablets,the dissolution rate of prepared tablets had been improved significantly. CONCLUSIONS:Tetrandrine solid dispersion tablets are prepared successfully with rational reproducible formulation.