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目的:探讨生脉分散片的处方与制备工艺参数。方法:以分散片的制粒情况,崩解时限,脆碎度,口感等为考察指标,采用均匀设计法优选生脉分散片的处方与成型工艺。结果:最佳生脉分散片处方为:浸膏粉25%、MCC 58%、CCMCNa8%、CMS-Na 4%、L-HPC 2%、硬脂酸镁2%、甜菊糖1%,其中L-HPC、硬脂酸镁外加,片硬度为25N;优选出的分散片处方崩解时限小于3 min。结论:优选的生脉分散片处方与制备工艺参数稳定可靠,重复性较好,工艺可行。
Objective: To investigate the prescription and preparation process parameters of Shengmai dispersible tablets. Methods: Granules of the dispersible tablets, disintegration time, friability, mouthfeel were taken as indexes to study the prescription and forming process of Shengmai dispersible tablets by the uniform design method. Results: The prescription of Shengmai Dispersible Tablets was as follows: extract powder 25%, MCC 58%, CCMCNa 8%, CMS-Na 4%, L-HPC 2%, magnesium stearate 2% and stevia 1% -HPC, magnesium stearate added, tablet hardness 25N; Dispersed tablet prescription preferred disintegration time is less than 3 min. Conclusion: The prescription and preparation process parameters of Shengmai Dispersible Tablets are stable and reliable, the repeatability is good and the process is feasible.