Earticle

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 This study aimed to establish a draft guidance on pharmacokinetic studies of herbal medicines in non-clinical and clinical studies.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

Abstract
 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

키워드

저자

• 정원필 [ Wonpill Jung | 대구가톨릭대학교 약학대학 ]
• 노금한 [ Keumhan Noh | 대구가톨릭대학교 약학대학 ]
• 임미선 [ Mi-sun Lim | 경북대학교 의학전문대학원 ]
• 이혜원 [ Hae Won Lee | 경북대학교 의학전문대학원 ]
• 김은정 [ Eun Jung Kim | 식품의약품안전청, 약리연구과 ]
• 윤영란 [ Young-Ran Yoon | 경북대학교 의학전문대학원 ] Correspondence to
• 강원구 [ Wonku Kang | 영남대학교 약학대학 ] Correspondence to

참고문헌

발행기관

간행물

표지보기 관심저널 등록

• 간행물명

  한국임상약학회지 [Korean Journal of Clinical Pharmacy]

• 간기

  계간

• pISSN

  1226-6051

• 수록기간

  1991~2026

• 등재여부

  KCI 등재

• 십진분류

  KDC 518 DDC 615