光纤传感过程分析9个厂家盐酸环丙沙星片的溶出度  

Monitoring the dissolution of 9 manufacturers′ Ciprofloxacin Hydrochloride tablets by fiber-optic dissolution test

作　　者：沈静[1] 刘炜[1] 李欣[2] 杨淑梅[1] 

机构地区：[1]新疆医科大学第五附属医院药剂科,乌鲁木齐830011 [2]新疆医科大学药学院,乌鲁木齐830011

出　　处：《新疆医科大学学报》2015年第7期866-868,共3页Journal of Xinjiang Medical University

基　　金：新疆医科大学科研创新基金(XJC2012114)

摘　　要：目的利用光纤传感过程分析方法,监测不同厂家盐酸环丙沙星片的溶出度。方法采用《中国药典》2010年版所述方法,测定了9个家盐酸环丙沙星片在0.1mol/L盐酸溶液中的溶出曲线,并采用相似因子法分析结果。结果 9个厂家盐酸环丙沙星片在30min内的累积溶出百分率均>80%,均符合2010年版《中国药典》规定,但不同厂家盐酸环丙沙星片的溶出行为有差异,f2相似因子不同。结论有关厂家应严格按照《中国药典》规定控制产品的内在质量,以保证临床用药安全、有效。Objective To compare the qualities of Ciprofloxacin Hydrochloride tablets from different manu-facturers by fiber-optic real time dissolution test system.Methods By means of the dissolution test ac-cording to ChP（2010）,Ciprofloxacin Hydrochloride Tablets from 9 different manufacturers were studied in the 0.1 mol/L hydrochloric acid solution to determine their stripping curves and analyze the similarity factors.Results 9 Ciprofloxacin Hydrochloride Tablets from different pharmaceutical factories were proved consistent with the provisions in “Chinese Pharmacopoeia （2010 edition）”,with the accumulative release percentage of 80%,but with some different leaching behavior.Conclusion The manufacturers should provide for the quality control of the products in strict accordance with the “China Pharmacopoeia”to ensure the safe and effective use of drugs in clinical practice.

关 键 词：环丙沙星片 过程监测 溶出度 

分 类 号：R914[医药卫生—药物化学]