苯磺酸氨氯地平口腔崩解片处方优化的研究

Study on Formula Optimization of Amlodipine Besylate Oral Rapidly Disintegrating Tablets

目的研究苯磺酸氨氯地平口腔崩解片处方的优化。方法结合矫味剂和β-环糊精包合技术改善口感,通过正交实验筛选最优处方。结果最优处方为:苯磺酸氨氯地平0.3g,β-环糊精1.0g,阿司帕坦0.05g,枸橼酸0.25g,微晶纤维素2.5g,α-乳糖1.35g,甘露醇0.5g,硬脂酸镁0.1g。产品崩解时限为(12.10±0.06)s。结论所得产品能较好地达到口腔崩解片的各项要求。

Objective To study the formula optimization of Amlodipine Besylate oral rapidly disintegrating tablets. Methods Correctant and β-cyclodextrin inclusion technique were used to improve the taste. The optimal formula was determined by orthogonal experiments. Results The optimal formula was as follows： amlodipine besylate 0.3 g, β-cyclodextrin 1.0 g, aspartame 0.05g, citrate 0.25 g, microcrystalline cellulose 2.5 g, α-lactose 1.35 g, mannitol 0.5 g, magnesium stearate 0.1 g. The disintegration time of the finished product was 12.10 s ± 0.06 s. Conclusion The finished product can meet the needs for oral rapidly disintegrating tablets quite well.