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磺胺类药物的生物利用度问题,近年来已引起人们重视。作者从全国八大地区选择八个有代表性磺胺嘧啶片产品进行释放度和体内利用度的研究,通过转篮法和循环法二种体外释放测定仪器和兔体内吸收试验,获得如下结果:1.从药峰值、达峰时、吸收曲线下面积全面衡量来看,一个样品质量较好,二个样品较差,一个样品兔体内吸收和体外溶出规律不相来行,原因尚得进一步研究。2.除一个样品外,其它七个样品体内吸收和体外释放间均有平行关系,经数据处理求得一组回归方程式。利用这些方程式可对一些因素进行体内外互推。3.本文研究的转篮法和循环法可作为磺胺嘧啶片体外实验质量控制的试验方法。其中循环法与体内试验结果更接近。循环法的 F 值均大于转篮法,而变异系数小于转篮法,因此循环法的灵敏性和
The bioavailability of sulfonamides has drawn great attention in recent years. The authors selected eight representative sulfadiazine tablets from eight regions of China to study the release and in vivo availability. The results of two in vitro release assays including spin basket and circulation methods and in vivo absorption tests in rabbits showed the following results: 1. From the drug peak, peak, the area under the absorption curve a comprehensive measure of point of view, a sample of good quality, the two samples are poor, a rabbit sample absorption and in vitro dissolution of the law not go, the reasons for further study. In addition to a sample, the other seven samples in vivo absorption and in vitro release have parallel relationship between the data processing obtained a set of regression equations. Using these equations, several factors can be pushed in and out of each other. 3. The spinning basket method and the circulation method studied in this paper can be used as the experimental method for the quality control of sulfadiazine tablets in vitro. Circulation method and in vivo test results are more similar. The F value of the cycle method is greater than the basket method, and the coefficient of variation is less than the basket method, so the sensitivity of the loop method and