硬脂酸镁过度润滑作用对盐酸二甲双胍缓释片的影响  

The effect of excessive lubrication of magnesium stearate on Metformin Hydrochloride Sustained-release Tablets

作　　者：付清爽 李坤娓 王英娟 黄国英 张天 常慧君 FU Qingshuang;LI Kunwei;WANG Yingjuan;HUANG Guoying;ZHANG Tian;CHANG Huijun(Shandong Qidu Pharmaceutical Co.,Ltd.,Zibo 255400,China)

机构地区：[1]山东齐都药业有限公司,山东淄博255400

出　　处：《药学研究》2022年第3期171-174,186,共5页Journal of Pharmaceutical Research

摘　　要：目的考察硬脂酸镁过度润滑作用对盐酸二甲双胍缓释片的影响。方法通过改变硬脂酸镁的用量、改变硬脂酸镁的混合时间、改变加料器转速,制备不同盐酸二甲双胍缓释片。通过对比总混颗粒的粉体性质、片剂的溶出,综合评价硬脂酸镁过度润滑对盐酸二甲双胍缓释片的影响。结果增加硬脂酸镁的用量、延长总混时间、加快加料器的转速均会导致硬脂酸镁过度润滑。表现为颗粒流动性并未明显改善,但可压性显著下降,盐酸二甲双胍缓释片溶出无明显减缓。结论盐酸二甲双胍缓释片的可压性对硬脂酸镁的润滑作用敏感,需控制硬脂酸镁的用量、混合的时间以及加料器的转述,防止过度润滑,造成可压性变差的现象产生。Objective The effect of excessive lubrication of magnesium stearate on Metformin Hydrochloride Sustained-release Tablets was investigated.Methods Different Metformin Hydrochloride Sustained-release Tablets were prepared by changing the dosage of magnesium stearate,changing the mixing time of magnesium stearate,and changing the speed of the feeder.To evaluate the effect of magnesium stearate over lubrication on Metformin Hydrochloride Sustained-release Tablets by comparing the powder properties of the total mixed granules and the dissolution of tablets.Results Increasing the amount of magnesium stearate,prolonging the total mixing time,and speeding up the speed of the feeder will all lead to excessive lubrication of magnesium stearate.The fluidity of the particles has not been significantly improved,but the compressibility is significantly reduced,and the dissolution of Metformin Hydrochloride Sustained-release Tablets does not slow down significantly.Conclusion The compressibility of Metformin Hydrochloride Sustained-release Tablets is sensitive to the lubricating effect of magnesium stearate.It is necessary to control the amount of magnesium stearate,the mixing time,and the feeder transfer to prevent excessive lubrication,resulting in poor compressibility.

关 键 词：硬脂酸镁 盐酸二甲双胍缓释片 可压性 流动性 溶出 过度润滑 

分 类 号：TQ460.6[化学工程—制药化工]