傅贻柯, 徐安行, 鲍进先, 李德林, 张杏芬, 邢昌英. 片剂释放度研究——四种测定方法的比较J. 药学学报, 1980, 15(7): 422-428.
引用本文: 傅贻柯, 徐安行, 鲍进先, 李德林, 张杏芬, 邢昌英. 片剂释放度研究——四种测定方法的比较J. 药学学报, 1980, 15(7): 422-428.
Fu Yike Xu Anxing Bao Jinxian, Li Delin Zhang Xingfen, Xing Changying, . A STUDY OF RELEASE FROM TABLETS A COMPARISON OF FOUR METHODSJ. Acta Pharmaceutica Sinica, 1980, 15(7): 422-428.
Citation: Fu Yike Xu Anxing Bao Jinxian, Li Delin Zhang Xingfen, Xing Changying, . A STUDY OF RELEASE FROM TABLETS A COMPARISON OF FOUR METHODSJ. Acta Pharmaceutica Sinica, 1980, 15(7): 422-428.

片剂释放度研究——四种测定方法的比较

A STUDY OF RELEASE FROM TABLETS A COMPARISON OF FOUR METHODS

  • 摘要: 本实验收集了国内阿司匹林生产样品五种及原料一种,作为典型药品进行了四种方法(杯法,崩解仪法,转篮法及循环法)的体外测定并测定了体内狗血药水平,将体内外测定结果进行了统计分析。以T50%(中位数时间),Td(特征时间63.2%)及m(斜率)三个参数和体内的Tmax(高峰时间),Cmax(高峰浓度)及血药水平时间曲线下面积Auc三个参数作F检验,认为在各方法之间有显著性差异,并且循环法的灵敏性较好,但变异系数以杯法最小,体内外有一定的相关。

     

    Abstract: Samples of aspirin tablets from five manufacturers and one kind of aspirin powder were chosen in this experiment. Using the relationship between the dissolution rate in vitro and the blood drug level in vivo as indexes, we did the experiment for comparison of these four different methods (cup method, disintegration method, rotating basket method and column type method). The parameter T50 (medium time, 50%), Td (characteristic time, 63.2%), m (slope) and Tmax (peak time), Cmax (Peak concentration) and Auc (area under the curve of blood level and time) were acquired.From the F values there appears to be singnificant differences in all parameters(P<0.01) and the sensitivity of column type method is better than the others, but the coefficient of variation of cup method is smaller There is a correlations of results between the parameter in vitro and the peak time in vivo of column type method.

     

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