光纤传感过程分析温度对盐酸二甲双胍片溶出度测定的影响  

Study on the effect of temperature on the dissolution test of Metformin Hydrochloride Tablets with fiber-optic in-situ dissolution system

作　　者：许萍萍[1] 李新霞[1] 脱鸣富[1] 陈坚[1] 

机构地区：[1]新疆医科大学药学院,新疆乌鲁木齐830054

出　　处：《西北药学杂志》2010年第4期281-283,共3页Northwest Pharmaceutical Journal

基　　金："十一五"国家科技支撑计划重大项目;科学仪器设备研究与研发;光纤药物溶出度过程检测仪产业化示范(No2006BAK03A16)

摘　　要：目的建立以光纤传感过程分析方法测定盐酸二甲双胍片的溶出度,考察温度对溶出度结果的影响。方法采用光纤药物溶出度实时测定仪分别测定标示量为250和500mg的盐酸二甲双胍片的溶出度。测定波长和参比波长分别为250和550nm,探头规格选择1.0和0.5mm,即相对应的光程为2.0和1.0mm。分别在常温和37℃情况下绘制标准曲线以测定溶出度,比较取样分析和原位在线测定溶出度结果。结果当采用常温下绘制的标准曲线测定溶出度时,取样分析与原位在线测定溶出度结果平均相差16.0%(500mg)和11.1%(250mg);采用37℃情况下绘制的标准曲线测定溶出度时,两者误差均≤2.0。结论光纤传感原位在线测定药物的溶出度可以真实反映药物的溶出行为,有利于建立更为科学、有效的药物内在质量评价方法 。Objective To establish an in-situ process dissolution test method of Metformin Hydrochloride Tablets. Method The dissolution of Metformin Hydrochloride Tablets （250 mg and 500 mg） was determined with a fiber-optic dissolution test system （FODT）. The test and reference wavelength were set at 250 nm and 550 nm, respectively,and the path-length of probes were 1.0 and 0.5 mm. The standard curves were made at room temperature and 37 ℃,which were employed to determine the drug dissolution rate and then compared the results of accumulative dissolution rate with the results obtained by sampling method. Results When the standard curve of drug was made at the room temperature, the average errors between, the methods of sampling and FODT were 16.0 % 1500 mg） and 11.1% （ 250 mg ）. But when the standard curves were made at 37 ℃, the average error was smaller than 2.0%. Conclusion Dissolution test of drug determined by the fiber-optic dissolution test system can give the completely dissolution curves of drugs,and is powerful to establish a more scientific and effective evaluation method for the drug quality.

关 键 词：光纤传感 溶出度 盐酸二甲双胍片 温度 

分 类 号：R944[医药卫生—药剂学]