应用离心造粒法制备盐酸二甲双胍微丸的研究

Preparation of metformin hydrochloride pellets with centrifugal granulation technique

目的研究离心造粒粉末层积法制备盐酸二甲双胍微丸。方法采用多功能微丸包衣造粒机制备微晶纤维素空白丸芯和盐酸二甲双胍微丸,并且通过产率、粒径和粒径分布、堆密度、表面形态和圆整度、脆碎度和释放度对盐酸二甲双胍微丸进行质量评价。结果以盐酸二甲双胍∶乳糖∶微晶纤维素=100∶5∶3的比例,主机转速150 r/min,喷浆泵转速20 r/min,供粉速度25 r/min,滚圆6 min,进行制备微丸,获得了很好的效果。结论所制备的盐酸二甲双胍微丸圆整度好,粒径均匀,硬度合格,流动性好,释放完全,无骨架结构。

Objective To prepare metformin hydrochloride pellets with centrifugal granulator by powder layering technique. Methods Metformin hydrochloride and MCC pellets were prepared by means of powder layering with the centrifugal granulation equipment and evaluated by yield percentage,angle of repose,bulk density,and friability. Results The preparation process parameters were optimized as follows： the ratio of metformin hydrochloride and lactose and MCC was 100∶5∶3,150 r/min rotating speed of the centrifugal granulation,20 r/min spraying serosity speed,25 r/min purveying powder speed,and the time of spheronization was 6 min.Metformin hydrochlorid pellets were prepared under the condition. Conclution The metformin hydrochloride pellets had good appearance,uniform granulation diameter,standard rigidity,good fluidity and did not have the structure of cage by means of detecting dissolubility.