不同厂家枸橼酸他莫昔芬片的体外溶出度考察

Study on the dissolution of tamoxifen citrate tablets of different manufacturers in vitro

目的:考察国内4个厂家生产的枸橼酸他莫昔芬片的体外溶出度,为临床选用用药提供参考。方法:采用中国药典2010年版中规定的桨法测定溶出度,紫外分光光度计测定溶液吸光度,吸收系数法计算他莫昔芬浓度。利用Excel软件计算累积溶出百分率,并对各厂家之间的溶出度进行比较分析。结果:4个厂家枸橼酸他莫昔芬片的体外溶出度均达到中国药典规定的要求,但各厂家的溶出表现存在一定差异。结论:不同厂家枸橼酸他莫昔芬片的溶出表现存在一定差异,应予关注。

OBJECTIVE To investigate the dissolution of tamoxifen citrate tablets of 4 different manufacturers. METHODS The dissolution test was carried out by paddle method in Chinese Pharmacopoeia 2010 edition, and the absorbance of tamoxifen citrate solution was measured by UV spectrometry, then use the absorption coefficient method to calculate the concentration of tamoxifen citrate. Use Excel software to calculate the cumulative dissolution percentage. RESULTS The dissolution performance of tamoxifen citrate tablets in 4 different manufacturers all reached the Chinese Pharmacopoeia requirements, but there were some differences in dissolution pattern of each brand. CONCLUSION Attentions should be paid in the clinical use of tamoxifen citrate tablets because of the differences dissolution patterns between different manufacturers.