布南色林分散片的处方研究

Study on the Formula of Blonanserin Dispersible Tablets

目的:采用正交试验筛选布南色林分散片的处方。方法:以内崩解剂微晶纤维素的用量、填充剂乳糖的用量、外崩解剂羧甲基淀粉钠的用量、黏合剂羟丙基甲基纤维素溶液的浓度为考查因素,以分散片的崩解时间、脆碎度和分散均匀性为评价指标进行正交试验,确定最佳处方;并对优化的处方进行工艺验证及质量评价。结果:优选处方为含微晶纤维素30%、乳糖50%、羧甲基淀粉钠0.5%,羟丙基甲基纤维素溶液浓度为2%;所制样品平均崩解时间为10.8s,脆碎度为0.29%,分散均匀性合格,30min药物累积溶出百分率超过75%。结论:布南色林分散片处方设计较为合理。

OBJECTIVE： To optimize the formula of Blonanserin dispersible tablets by orthogonal experiment. METHODS： The formula of tablets was optimized by orthogonal experiment using the amount of microcrystalline cellulose, lactose, sodium carboxymethyl starch and the concentration of hydroxypropyl methyl cellulose as factors and with disintegrating time, friability and the dispersibility homogenization as indices. The optimized preparation technology was verified, the quality of tablets was evaluated. RESULTS： The optimal formula was as follows： the proportions of microcrystalline cellulose, lactose, the sodium carboxymethyl starch and concentration of hydroxypropyl methyl cellulose were 30%, 50%, 0.5% and 2% respectively. The average disintegrating time was 10.8 s and friability was 0.29%, it was good in dispersibility homogenization. The accumulative dissolution rate was over 75% within 30 min. CONCLUSION： The formula of Blonanserin dispersible tablets is reasonable.