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目的:优化烟酸凝胶骨架缓释片处方工艺。方法:采用亲水凝胶骨架材料羟丙基甲基纤维素(HPMC)的2种型号K15M、E15-LV及辅料磷酸氢钙的处方用量为因素设计正交试验,以体外释放度为考察指标,优化烟酸凝胶骨架缓释片的处方,并进行批内和批间体外释放度验证试验。结果:优化处方为HPMC(K15M、E15-LV)分别为4%、40%,磷酸氢钙为25%。所制烟酸凝胶骨架缓释片可持续释药12h,批内释放均一性及批间重现性均良好。结论:所选烟酸凝胶骨架缓释片处方合理,工艺简单。
Objective: To optimize the prescription of niacin gel matrix sustained release tablets. Methods: Orthogonal test was designed on the basis of the prescription dosage of two kinds of K15M, E15-LV and excipient dicalcium phosphate (HPMC), the hydrophilic gel matrix material. The release rate in vitro was taken as the index , Optimize the formulation of niacin gel matrix sustained-release tablets, and in-vitro and in-vitro release test verification. Results: The optimal formulation was HPMC (K15M, E15-LV) with 4%, 40% and 25% DCP respectively. The Niacin gel matrix sustained-release tablets sustained release 12h, batch release uniformity and inter-batch reproducibility were good. Conclusion: The selected niacin gel matrix sustained-release tablets prescription is reasonable and the process is simple.