摘要
盐酸氨基葡萄糖片作为骨关节药物,效果显著,但制剂较不稳定,特别是杂质C(脱氧果糖嗪)较难控制。为了得到质量稳定的制剂,笔者对盐酸氨基葡萄糖片的制备工艺进行了研究。首先通过对原辅料相容性、黏合剂种类与用量、干燥时间、润滑剂用量和包衣增重的研究,筛选出最佳配方和制备条件;然后对以上工艺制得的3批制剂,进行影响因素实验、加速稳定性实验和长期稳定性实验,采用HPLC方法测定杂质质量分数。实验结果表明:利用所选工艺可以制备出质量稳定的片剂,品质优于市售品。
Glucosamine hydrochloride tablet is a kind of significantly effective osteoarthropathy drug.However,preparation of tablet is not stable,especially it is difficult to control content of impurity C(deoxyglycozine).In order to obtain stable tablet,the preparation method for glucosamine hydrochloride tablets was studied.The process parameters including the compatibility of excipients,the type and amount of binders,drying duration,the amount of lubricant and coating weight were studied.The accelerated and long-term stability studies showed that the tablets prepared by the new method were stable,and its quality was better than that of commercial available.
作者
孔剑毅
KONG Jianyi(Zhejiang Chengyi Pharmaceutical Co.,Ltd.,Wenzhou 325700,China)
出处
《发酵科技通讯》
CAS
2019年第1期53-57,共5页
Bulletin of Fermentation Science and Technology
关键词
盐酸氨基葡萄糖片
稳定性研究
制备工艺
glucosamine hydrochloride tablets
stability
preparation method
