目的 考察粉体学性质对替米沙坦氨氯地平双层片制备的影响。方法 选择苯磺酸氨氯地平、替米沙坦以固定剂量组成的复方制剂为研究对象。从粉体学角度考察了粒度分布、休止角、堆密度、固密度等对双层片剂可压性、流动性和成型性的影响。结果 湿法制粒筛网目数对氨氯地平层颗粒粉体学参数影响显著,随着制粒目数增加,休止角明显减小,固密度和压缩度明显增大,含量均一性增加,片质量差异减小;粉末直接压片工艺与湿法40目筛制粒得到氨氯地平层的颗粒的粒度分布基本一致。结论 替米沙坦氨氯地平双层片的制备中各层物料的粉体学性质会影响制剂的成型性和含量均一性。

Objective To investigate the influence of powder properties on preparation of Telmisartan and Amlodipine Bilayer Tablets. Methods Fixed dose containing benzene sulfonic acid and telmisartan in compound preparation were chosen as the research object. Effects of particle size distribution, angle of repose, bulk density, and tap density on the compressibility, flowability, and moldability of bilayer tablets were investigated. Results The effect of sieve mesh of wet granulation on powder properties of amlodipine was significant. As the mesh size of wet granulation increased, the angle of repose decreased, bulk density and compression degree increased obviously, and the uniformity of content increases and the variation of weight decreased. Amlodipine layer distribution of amlodipine particle prepared by the technique of direct powder compression or wet granulation by 40 mesh sieve was basically consistent. Conclusion The powder properties of the materials in the preparation of the bilayer tablets can affect the formability and the content uniformity of Telmisartan and Amlodipine Bilayer Tablets.