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目的采用正交设计多指标综合评价法优化南瓜多糖片剂的处方工艺。方法以累积溶出度、压片合格率以及压片颗粒流动性为指标,运用正交设计法L_9(3~4),结合变异系数法加权综合评价筛选制剂处方,确定南瓜多糖片剂的制备工艺。结果优化所得处方工艺为南瓜多糖330.00 mg,崩解剂聚乙烯吡咯烷酮(PVPP)20.00 mg,填充剂Ca HPO4200.00 mg,5%聚维酮K30(PVPK30)的95%乙醇水溶液作润湿剂和黏合剂,1%硬脂酸镁和2%微粉硅胶混合作润滑剂。以此处方制备的南瓜多糖片累积溶出百分比为97.33%,压片合格率为79.63%,休止角为33.4°。结论优选所得处方工艺简单可行,稳定性好。
Objective To optimize the prescription of pumpkin polysaccharide tablets by orthogonal design and multi-index comprehensive evaluation. Methods The cumulative dissolution rate, the pass rate of tablets and the flowability of tablets were used as indexes. The orthogonal design method L_9 (3-4) was used to determine the prescription of pumpkin polysaccharide tablets by combining with the coefficient of variation . Results The optimized formulation was as follows: the pumpkin polysaccharide 330.00 mg, the disintegrating agent PVPP 20.00 mg, the filler Ca HPO 4200.00 mg, and the povidone K30 (PVPK30) 95% ethanol solution as wetting agent and Binder, 1% magnesium stearate and 2% silica fume as lubricant. The pumpkin polysaccharide prepared by this prescription accumulated dissolution percentage of 97.33%, tablet pass rate of 79.63%, angle of repose of 33.4 °. Conclusion The process of the preferred prescription is simple and feasible, good stability.