目的 考察粉體學(xué)性質(zhì)對(duì)替米沙坦氨氯地平雙層片制備的影響。方法 選擇苯磺酸氨氯地平、替米沙坦以固定劑量組成的復(fù)方制劑為研究對(duì)象。從粉體學(xué)角度考察了粒度分布、休止角、堆密度、固密度等對(duì)雙層片劑可壓性、流動(dòng)性和成型性的影響。結(jié)果 濕法制粒篩網(wǎng)目數(shù)對(duì)氨氯地平層顆粒粉體學(xué)參數(shù)影響顯著,隨著制粒目數(shù)增加,休止角明顯減小,固密度和壓縮度明顯增大,含量均一性增加,片質(zhì)量差異減小;粉末直接壓片工藝與濕法40目篩制粒得到氨氯地平層的顆粒的粒度分布基本一致。結(jié)論 替米沙坦氨氯地平雙層片的制備中各層物料的粉體學(xué)性質(zhì)會(huì)影響制劑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.