摘要
目的建立复方氨酚烷胺胶囊的最佳溶出度方法。方法采纳《国家药品标准》第16册复方氨酚烷胺片的溶出度测定方法,建立复方氨酚烷胺胶囊的溶出度方法。采用转篮法,以盐酸溶液(9→1000)1000ml为溶出介质,转速75r/min,溶出时间为15min。取样后采用紫外分光光度法,在257nm波长处测定吸光度,按对乙酰氨基酚(C8H9NO2)吸收系数(E1%1cm)715计算各粒的溶出量。结果 3个厂家10批供试品样的测定结果显示其溶出量均不低于标示量的80%。结论本方法符合溶出度方法的建立原则,可作为复方氨酚烷胺胶囊的内在质量控制指标。
Objective To establish a dissolution calibration model for the Compound of Paracetamol and Amantadine Hydrochloride capsule.Methods According to National Drug Standrug Volume 16,the dissolution tests of samples were built up,which based on rotating basket method with speed at 75r/min and the content of paracetamol was measured at 257nm by UV spectrophotometry.Results The dissolution rate was above 80%in ten batch in three different pharmaceutical factories.Conclusion Based on data collected from three factories,the dissolution rates of the Compound Paracetamol and Amantadine Hydrochloride capsules were more than the 80%of labelled amount.The method accord with the principle can be an intrinsic index of the quality control.
出处
《新疆医科大学学报》
CAS
2010年第9期1050-1051,1055,共3页
Journal of Xinjiang Medical University
关键词
复方氨酚烷胺胶囊
溶出度
质量控制
compound paracetamol and amantadine hydrochloride
dissolution
quality control
