摘要
本文研究了法莫替丁的多晶型问题，给出两种晶型的制备方法，并通过红外光谱、粉末Ｘ射线衍射谱和差热分析等测试确定了两种不同晶型的特征。另外，１０名志愿健康受试者分两组口服Ａ，Ｂ晶型的法莫替丁片（４０ｍｇ含量）后，采用ＨＰＬＣ法测定血药浓度，将不同血药浓度对时间的数据进行曲线拟合，计算得绝对生物利用度分别为４６．８％和４９．１％，经统计学处理，两种晶型的片剂在健康人体内的生物利用度无显著性差异（Ｐ＞０．０５）。
The polymorphic modifications of famotidine were described and characterized by their spectroscopic(infrared,X-ray) and some physicochemical data(melting point,DSC data).In addition,to ten healthy volunteers devided into two groups,40 mg of modification A and modification B of famotidine tablets were respectively administered orally,and then automated HPLC was used to analyze famotidine in plasma. The variations in drug concentrations vs.time were fitted to curves.According to a statistical algorithm,the results of calculation showed that the absolute bioavailabilities were 46.8% and 49.1% respectively and P>0. 05.
出处
《中国药物化学杂志》
CAS
CSCD
1994年第2期110-117,共8页
Chinese Journal of Medicinal Chemistry
