苯磺酸氨氯地平片的制备工艺研究

Research on the Amlodipine Besylate Tablets Preparation Technology

目的：研究苯磺酸氨氯地平片的制备方法。方法：以制剂的外观、硬度、溶出曲线为指标,筛选片剂处方和制备工艺。结果：最后确定的处方为：苯磺酸氨氯地平6.93 g,微晶纤维素80 g,乳糖80 g,低取代羟丙基纤维素（L-HPC）9 g,5%淀粉浆适量,硬脂酸镁1.5 g。制备工艺为：将处方中的原辅料皆粉碎过80目筛,称取处方量的苯磺酸氨氯地平、微晶纤维素、乳糖、低取代羟丙基纤维素,先将除苯磺酸氨氯地平及硬脂酸镁外的其它辅料混匀,按照等量递增法将苯磺酸氨氯地平与混合好的辅料混匀,加5%淀粉浆制成软材,过20目筛制粒,50~60℃烘干,18目筛整粒,加硬脂酸镁,混合均匀,测颗粒含量,计算片重,7.5 mm浅凹冲压片,即得。结论：本品处方设计合理,工艺稳定可行。

Objective：Amlodipine besylate tablets method.Method：：Approach to the appearance of agents,hardness,dissolution profile as the index,screening and preparation process prescription tablets.Results：Prescription is finalized： amlodipine besylate 6.93 g,microcrystalline cellulose 80 g,lactose 80 g,low substituted hydroxypropyl cellulose（L-HPC）9 g,5% starch amount,magnesium stearate 1.5 g.Preparation process： the prescription of the raw materials are sifted through a 80 mesh sieve,check the prescribed amount of amlodipine besylate,microcrystalline cellulose,lactose,low substituted hydroxypropyl cellulose,the first addition to acid amlodipine,and magnesium stearate other materials outside the mixing,in accordance with the equal incremental method amlodipine besylate mixing materials and mixed well,add 5% starch slurry made of soft material,over 20 mesh sieve system dried grains,50～60 ℃,18 mesh whole,add magnesium stearate,mixing,measuring particle concentration,calculated tablet weight,7.5mm shallow concave stamping film,that is,too.Conclusion： prescribing reasonable design,stable and feasible.