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 disintegration 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 validated. 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 tablets, disintegration time were 79, 81 and 78 s; contents were 98.66%, 99.24%, 99.85%; RSDs were 0.72%, 1.16%, 1.33%, respectively. 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.
关键词
汉防己甲素固体分散体分散片正交设计制备工艺
Keywords
Tetrandrine solid dispersionDispersion tabletsOrthogonal designPreparation process