诺氟沙星胶囊实时溶出度考察  

Observation of the Real-Time Dissolution of Norfloxacin Capsules from Different Manufacturers

作　　者：杨静[1] 李翔[1] 刘建芳[2] 苗爱东[1] 王文习[2] 

机构地区：[1]北京军区联勤部药品仪器检验所生测室,北京100071 [2]白求恩国际和平医院药剂科,河北石家庄050000

出　　处：《解放军药学学报》2010年第2期128-130,共3页Pharmaceutical Journal of Chinese People's Liberation Army

摘　　要：目的考察用光纤药物溶出度实时测定仪在线监测诺氟沙星胶囊体外溶出度的可行性。方法采用《中国药典》2005年版中诺氟沙星胶囊溶出度测定条件,对8个厂家的诺氟沙星胶囊进行了实时溶出度测定,并与药典方法测定溶出度的结果进行了比较。结果本法自动监测药物溶出的全过程,各溶出曲线存在差异,Td、T50及累积溶出百分率均无显著性差异。结论本法结果准确,实时、在线监测药物溶出的全过程,为改进制剂工艺、全面评价药品内在质量提供了有效参考。Objective To observe the feasibility of monitoring the dissolution of norfloxacin capsules online using the fiber-optic real-time dissolution apparatus and compare the difference of the inherent quality of drugs.Methods The dissolution of norfloxacin capsules by 8 different manufacturers was measured under the conditions specified by the ＂Chinese Pharmacopoeia＂,2005 edition.The results of the measurement were compared with those shown in the ＂Chinese Pharmacopoeia＂.Results The method automatically monitored the whole process of the dissolution of the drugs. Differences were found in the dissolution curves of those drugs. There was no significant difference in the respective results of Td, T50 and the accumulative dissolution percentage.Conclusion The results of the method are accurate,providing valid reference for improving the preparation technology and evaluating the inherent quality of the drugs.

关 键 词：诺氟沙星胶囊 光纤药物溶出度实时测定仪 溶出曲线 

分 类 号：R927.11[医药卫生—药学]