摘要
目的 :建立氟康唑的溶出度试验方法 ,对 4厂家不同剂型氟康唑的含量与溶出度进行测定。方法 :以盐酸溶液 (9→10 0 0 )作为溶出介质 ,采用桨法测定溶出度 ,转速为 5 0r·min-1,温度为 (37.0± 0 .5 )℃。紫外分光光度法测定含量 ,测定波长为 2 6 1nm ,该方法线性关系良好 (r=0 .9999)。结果 :30min时的溶出度均大于 70 % ,符合中国药典 1995年版规定。片剂与胶囊、国产药与进口药的溶出参数 (t50 ,td,m)无明显差异 (P >0 .0 5 )。结论 :此方法简便、快速、准确 ,可用于控制产品的质量。
OBJECTIVE:To establish a dissolution measurement method for fluconazole,and to determine the content and dissolution of fluconainzole in 4 different dosage forms.METHODS:The dissolution was measured in hydrochloride acid solution (9→1000) as medium.According to the second method described in Chinese Pharmacopoeia (1995) appendix XC,the rotational speed was 50 r·min -1 ,and the temperature (37.0±0.5)℃.The content was measured by UV spectrophotometry at 261 nm.The calibration curve was linear ( r =0.9999).RESULTS:The dissolution in 30 minutes was more than 70%,and there were no significant differences in dissolution parameters ( t 50 , t d,m) among four products ( P >0.05).CONCLUSION:The method was sensitive and reliable.It may be used for the quantitative evaluation of products.
出处
《中国药学杂志》
EI
CAS
CSCD
北大核心
2000年第5期340-341,共2页
Chinese Pharmaceutical Journal
关键词
氟康唑
含量
溶出度
紫外分光度法
剂型
fluconazole,content determination,dissolution,UV spectrophotometry
