各位好 最近在看关於口服固体药锭的溶离规范 有些地方不太懂想请教各位 1.关於Two- Tiered Dissolution test 我知道他是要更进一步探讨在胃肠道的吸收 但我不太懂跟SGF(simulated gastric fluid)或是SIF(simulated intestinal fluid)有无添加有什麽关系阿 添加pepsin或是pancreatin有什麽关系吗? 它的原理是什麽啊? 2.关於in vivo- in vitro correlations 我知道这是希望能建立出in vivo-in vitro之间的关联性 这样之後可以用体外的溶离结果判定在体内的溶离可能是怎样 但我不懂的是下面的贴文(取自Guidance for Industry Dissolution Testing of Immediate Release Solid Oral Dosage Forms) If the batches show differences in in vivo performance, then in vitro test conditions can be modified to correspond with the in vivo data to achieve an in vitro-in vivo correlation. If no difference is found in the in vivo performance of the batches and if the in vitro performance is different, it may be possible to modify test conditions to achieve the same dissolution performance of the batches studied in vivo. 我知道如果体外试验一样，体内不一样可以改制程配方 但如果是体内试验一样，体外不一样，有什麽可以修改的地方吗? 一样也是制程相关吗? 3.Validation and Verification of Specifications Two batches with different in vitro profiles should be prepared (mapping approach).These products should then be tested in vivo. If the two products show different in vivo characteristics, then the system is validated. In contrast, if there is no difference in the in vivo performance, the results can be interpreted as verifying the dissolution specification limits as discussed under mapping. Thus, either validation or verification of dissolution specifications should be confirmed.(取自Guidance for Industry Dissolution Testing of Immedia Release Solid Oral Dosage Forms) 这段话是在说，若两批药的制程不一样，以mapping approach方法测试後结果不一样，就 代表这方法是行得通的。反之若这两批药的结果出来是一样的，则代表mapping approach 已经到了侦测极限，是这个意思吗? 不好意思麻烦大家了 --

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