烟酸凝胶骨架缓释片的处方工艺研究

Formula and Preparation Technology of Gel Matrix Sustained Release Tablet of Nicotinic Acid

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 formula and preparation technology of gel- matrix sustained release tablet of nicotinic acid（GSTNA） . METHODS： The formula of GSTNA was optimized by orthogonal experiment with the amount of hydrophilic gel - matrix material HPMC （K15M, E15- LV） and that of adjuvant calcium hydrogen phosphate（CHP） as factors and with the in vitro release rates as index. Meanwhile, the verification test on the intra and inter batch release rates of the samples was performed. RESULTS： The optimum formula could be seen as follows： the ratios of HPMC （K15M, E15 - LV） and CHP were 4%, 40% and 25% respectively. The GSTNA prepared in this formula achieved a sustained drug release of up to 12 h, and both the intra batch homogenicity and the inter batch reproducibility were satisfactory. CONCLUSION： The GSTNA is reasonable in formula and simple in preparation technology.