各位好 最近在看關於口服固體藥錠的溶離規範 有些地方不太懂想請教各位 1.關於Two- Tiered Dissolution test 我知道他是要更進一步探討在胃腸道的吸收 但我不太懂跟SGF(simulated gastric fluid)或是SIF(simulated intestinal fluid)有無添加有什麼關係阿 添加pepsin或是pancreatin有什麼關係嗎? 它的原理是什麼啊? 2.關於in vivo- in vitro correlations 我知道這是希望能建立出in vivo-in vitro之間的關聯性 這樣之後可以用體外的溶離結果判定在體內的溶離可能是怎樣 但我不懂的是下面的貼文(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. 我知道如果體外試驗一樣，體內不一樣可以改製程配方 但如果是體內試驗一樣，體外不一樣，有什麼可以修改的地方嗎? 一樣也是製程相關嗎? 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) 這段話是在說，若兩批藥的製程不一樣，以mapping approach方法測試後結果不一樣，就 代表這方法是行得通的。反之若這兩批藥的結果出來是一樣的，則代表mapping approach 已經到了偵測極限，是這個意思嗎? 不好意思麻煩大家了 --

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