5个企业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 companies in vitro

目的对国内5个企业枸橼酸他莫昔芬片进行体外溶出度考察,为临床合理用药提供依据。方法以紫外分光光度法测定含量,浆法测定溶出度。利用Excel软件的VBA编写宏命令,在计算机上快速算出枸橼酸他莫昔芬片的累积溶出百分率和溶出参数,并对各组之间的溶出参数进行方差分析。结果所测产品的体外溶出均达到中国药典规定的30min溶出应大于标示量75%的要求,但各企业枸橼酸他莫昔芬片的溶出参数(m、t50、td、t80)间存在着高度显著性差异(P<0.01)。结论不同企业枸橼酸他莫昔芬片的溶出参数存在着显著差异,临床用药时应加以注意。

OBJECTIVE To investigate the dissolution of tamoxifen citrate tablets of five companies and to obtain the basis for its rational use.METHODS The concentration of tamoxifen citrate was determined by UV spectrophotometry and the dissolution test was carried out using paddle method.A template was edited with Microsoft Excel to calculate the accumulated dissolution and the dissolution parameters of tamoxifen citrate tablet of different formulations rapidly.The difference between different groups was statistitally evaluated by variance analysis.RESULTS The result showed that the content of the ingredient dissolved within 30min was more than 75% of the labelled amount,which complied with the requirement of ChP,but the dissolution parameter（m,t50,td,t80）of tamoxifen citrate tablets from different companies had very significant difference （P〈0.01）.CONCLUSION There was significant difference in dissolution parameters among the tamoxifen citrate tablets from different companies.It was indicated that attention should be paid to their clinical application.