光纤法在线考察盐酸曲美他嗪缓释片释放度  

Online monitoring the dissolution of trimetazidine dihydrochloride sustainedrelease tablets with fiber-optic dissolution test system

作　　者：聂微 雷方 李健华 王健松 NIE Wei;LEI Fang;LI Jian-hua;WANG Jian-song(Guangzhou Baiyunshan Pharmaceutical Holdings Co.,Ltd.,Baiyunshan Pharmaceutical General Factory,Guangzhou 510515,China)

机构地区：[1]广州白云山医药集团股份有限公司白云山制药总厂

出　　处：《中国新药杂志》2019年第20期2543-2547,共5页Chinese Journal of New Drugs

基　　金：广州市珠江科技新星专项计划资助项目(201610010130)

摘　　要：目的:运用光纤药物溶出仪对盐酸曲美他嗪缓释片释放度进行实时、原位测定,并与手动取样经紫外分光光度法测定结果进行比较。方法:采用FODT-601FX光纤药物溶出仪,以pH 6.8磷酸盐缓冲液(1000 mL)为溶出介质,浆法,加沉降篮,转速50 r·min^-1,检测波长为232 nm,参比波长为300 nm,测定光程为5 mm。比较光纤法与紫外分光光度法的释放度测定结果。结果:光纤法和紫外分光光度法测得的原研样品和自制样品的释放度基本一致。结论:光纤法和紫外分光光度法的测定结果一致,而光纤法较紫外分光光度法操作简便,获取信息量更大,能更真实地反映样品实时的释放过程。Objective:To monitor instantaneous in-situ dissolution of trimetazidine dihydrochloride sustained-release tablets with fiber-optic dissolution test system,and compare the results with the dissolution of manual sampling solution detected by UV method.Methods:The drug release process was detected by FODT-601 FX fiber-optic dissolution test system.1000 mL aqueous solution of phosphate buffer(pH 6.8)was used as the dissolution medium.Paddle method plus sedimentation basket were adopted to detect dissolution.The paddle rotation rate was 50 r·min^-1.The detection wavelength was set at 232 nm while the reference wavelength was 300 nm.The detection length was 5 mm.The results of dissolution by fiber-optic and UV methods were compared.Results:The results of dissolution of the reference sample and the homemade sample detected by fiber-optic method were consistent with those of UV method.Conclusion:The results of dissolution detected by fiber-optic method and UV method are consistent.Compared with the UV method,the fiber-optic method is easy to operate and it could obtain more data,which could reflect the real-time sample release process more truly.

关 键 词：光纤药物溶出仪 盐酸曲美他嗪缓释片 释放度 

分 类 号：R917[医药卫生—药物分析学] O657.32[医药卫生—药学]