制粒工艺对盐酸二甲双胍片可压性的影响

Effect of Granulation Process on Compressibility of Metformin Hydrochloride Tablets

分别采用高剪切湿法制粒工艺和流化床制粒工艺制备盐酸二甲双胍颗粒并进行压片,再对颗粒性质(粒度分布、外观、密度和可压性)和片剂性质(硬度和脆碎度)进行比较。采用高剪切湿法制粒工艺制备的颗粒呈圆整、致密状,流动性较好,但可压性较差,片剂硬度最高仅能达到32 N;采用流化床制粒工艺制备的颗粒呈不规则、多孔状。流化床制粒工艺制各的水分含量较高的颗粒可压性较好,片剂硬度可达到120 N,脆碎度较低(0.14%)。结果表明,流化床制粒工艺可用于盐酸二甲双胍片的生产,且在干燥过程须严格控制颗粒的水分含量。

The effects of high shear wet granulation and fluidized bed granulation on the granule properties （panicle size distribution, morphology, density and compressibility） and tablet properties （hardness and friability） of metformin hydrochloride were investigated. The granules from high shear wet granulation process were more spherical and dense compared with the irregular and porosity granules from fluidized bed granulation, but with the poor compressibility （tablet hardness only up to 32 N）. The granules with the higher moisture content prepared by the fluidized bed method had the better compressibility （tablet hardness up to 120 N） and the lower friability （0.14%）. The results showed that the granules prepared by fluidized bed granulation had significantly lower capping tendency of metformin hydrochloride tablets than the tablets from the granules by high shear wet granulation. The fluidized bed granulation process could be used for the production of the metformin hydrochloride tablets, and the moisture content of the granules should be strictly controlled during the drying process.