원문정보
초록
영어
Drugs mostly represent an efficacy or an adverse effect according to their dosage and/or plasma concentrations. Therefore, to investigate the pharmacokinetic behavior of drugs including herbal medicines is necessary both to maximize the drug action and to minimize the adverse effect. To date, pharmacokinetic studies of herbal medicines have been conducted by some experts in this field on the bases of science and knowledge in Korea. On the other hand, in advanced countries, a typical series of pharmacokinetic studies has been conducted by using a harmonized guidance established. Consequently, an administrative support on these studies has to be needed in Korea as well. This study aimed to establish a draft guidance on pharmacokinetic studies of herbal medicines in non-clinical and clinical studies. Literatures previously published as well as guidances in the US, Europe and Japan were summarized for the present guidance. Effect of herbal medicines was listed on the proteins in charge of drug metabolism and transportation, as well as on the pharmacokinetics of chemical drugs. The present suggestion might be helpful to proceed pharmacokinetic studies of herbal medicines efficiently, and further polish should be needed in terms of an administrative point of view.
목차
연구방법
생약제제의 약물동태시험
생약제제 시험의 한계점
유효성분이 밝혀져 있으며 정량이 가능한 경우
유효성분은 밝혀져 있지 않으나 지표물질의 정량은 명확한 경우
유효성분은 밝혀져 있으나 정량은 불가능한 경우
유효성분 및 지표성분이 명확히 밝혀져 있지 않은 경우
생약제제의 약물상호작용
반복투여에 따른 약동학적 변화(Table 1)
생약제제와 타 약제간의 상호작용(Table 2)
결어
참고문헌