过程分析比较不同厂家盐酸氨溴索片溶出度  

Process analysis and comparison of dissolution of ambroxol hydrochloride tablets from different manufactories

作　　者：杨淑梅[1] 孔彬 李新霞[3] 陈坚[3] 

机构地区：[1]新疆医科大学第五附属医院,乌鲁木齐830011 [2]新疆富科思生物技术发展有限公司,乌鲁木齐830011 [3]新疆医科大学药学院,乌鲁木齐830054

出　　处：《中国新药杂志》2010年第18期1722-1725,共4页Chinese Journal of New Drugs

基　　金："十一五"国家科技支撑计划重大项目(2006BAK03A16)

摘　　要：目的:利用光纤药物溶出度测定仪,实时监测国内4个不同厂家盐酸氨溴索片的溶出度曲线,以评价其工艺质量。方法:采用测定波长244 nm,参比波长550 nm,温度37℃,转速75 r.min-1,数据采样间隔30 s,监测时间30 min。以盐酸溶液(9→1 000)为溶出介质,浆法,用光程为5 mm的光纤探头监测其溶出曲线,同时用中华人民共和国药典(Chp)2005年版UV法检测,以进行相互对照。结果:4个不同厂家盐酸氨溴索片的溶出度均符合Chp 2005年版规定,但溶出速度和曲线存在差异。结论:光纤药物溶出度实时测定仪监测手段先进,获得的信息更加完整,可以准确、连续、真实地反映药物溶出的过程。Objective： To monitor the drug dissolution of ambroxol hydrochloride tablets from four manufactories and investigate the differences in quality among the tablets by using fiber optic drug dissolution test system.Methods： The paddle method with a rate of 75 r·min-1 was used.The determination and reference wavelengths were set at 244 nm and 550 nm,respectively.Dissolution data was collected every 30 seconds during 30 min run.Ambroxol hydrochloride tablets were dissolved with hydrochloride solution as the solvent（9→1 000） and were determined by 5 mm fiber optic probes.Meanwhile,the UV method in Chinese Pharmalopoeia（Chp） 2005 was used to control each other.Results： The dissolutions of ambroxol hydrochloride tablets produced by all the four manufactories met the standards of Chp 2005.There were apparent differences in dissolution speed and curves.Conclusion： The fiber-optic drug dissolution in situ test system which has an advanced monitoring function can supply more complete data and reflect the real dissolution process accurately and continuously.

关 键 词：盐酸氨溴索 光纤传感 溶出度 

分 类 号：R927.11[医药卫生—药学]