枸橼酸他莫昔芬片在不同溶出介质中的溶出行为比较

A comparison of tamoxifen citrate tablets dissolution behavior in different dissolution media

目的使用光纤药物溶出度实时测定仪在四种不同溶出介质中测定国内2个厂家枸橼酸他莫昔芬片的体外溶出度曲线。方法测定波长275 nm、基准校正波长550 nm、温度37℃、转速100 r.min-1、数据采集间隔时间1 min。分别以0.02 mol.L-1盐酸溶液,pH=4.5磷酸盐缓冲液,pH=6.8磷酸盐缓冲液和水作为溶出介质,浆法,用光程为5 mm的光纤探头监测枸橼酸他莫昔芬片的溶出曲线。并应用相似因子f2法比较溶出曲线的相似性。结果 2个厂家的枸橼酸他莫昔芬片溶出度均符合《中国药典》2010年版规定,但两厂家产品的溶出过程存在差异且同一厂家在不同溶出介质中溶出行为也有很大差异。结论光纤药物溶出实时测定仪能准确连续地反映药物的溶出过程,所得数据完整、真实。

Objective To use the real-time analyzer Fibre drug dissolution to measure in ditro dissolution curves of two domestic manu- facturers citrate tablets tamoxifen in four different dissolution media. Methods We determined at the wavelength of 275 nm, the baseline correction wavelength of 550 nm,temperature 37℃ ,speed 100r · min-1 ,the data acquisition interval 1 min. We used 0.02 mol· L-l hydrochloric acid solution, respectively, pH4.5 phosphate buffered saline, pH6.8 phosphate buffer and water as the dissolution medium, slurry method, optical drive of 5 mm fiber-optic probe tO m0nitori citrate tamoxifen tablets dissolution curve. Results The two manufac- turers＇ citrate tamoxifen tablets dissolutions were in line with provisions of the 2010 edition of ＂Chinese Pharmacopoeia＂ ,but the disso- lution processes of the products of the two manufacturers differed and even for the same manufacturer dissolution behaviors with different dissolution medium were quite different. Conclusion The real-time optical fiber drug dissolution analyzer accurately reflects continuous process of dissolution of the drug, with complete and real resulting data.