摘要
目的:制备阿卡波糖分散片并建立其溶出度测定方法。方法:选用微晶纤维素为填充剂,羧甲基淀粉钠、低取代羟丙纤维素、交联聚维酮为崩解剂,硬脂酸镁为润滑剂,微粉硅胶为助流剂;采用高效液相色谱法测定阿卡波糖分散片的溶出度。结果:阿卡波糖分散片的含量测定的线性范围为10～80μg·ml^(-1),平均回收率为100.15%,RSD为0.58%(n=9);溶出度试验表明,30min溶出度检测结果均大于80%(n=6)。结论:该方法简便、准确,可用于本品的质量控制。
Objective： To study the preparation technology and solubility determination of acarbose dispersible tablets. Method： Microcrystalline cellulose was selected for the diluent, sodium carboxymcthyl starch,low-substituted hydroxypropylcellulose and cross- povidone were applied for the disintegrants, and magnesium stearate was used for the lubricants with aerosil as the glidants. The dissolu- tion of acarbose dispersible tablets was determined by HPLC. Result： The linear range of acarbose was within 10-80 μg. ml 1, and the average recovery was 100. 15% with RSD of 0. 58% （ n = 9）. The dissolution of 3 batches of samples was all above 80% （ n = 6 ）. Condusion： The method is simple and accurate. It can be used in the control quality of acarbose tablets.
出处
《中国药师》
CAS
2011年第11期1612-1614,共3页
China Pharmacist
关键词
阿卡波糖
分散片
制备
溶出度
Aearbose
Dispersible tablets
Preparation
Solubility
