대한약리학회지 (The Korean Journal of Pharmacology)
- 제26권2호
- /
- Pages.219-226
- /
- 1990
- /
- 0377-9459(pISSN)
Enalapril Maleate 정제의 동등성에 관한 연구 ; 약동학적 성상 및 혈장 ACE 활성도 억제 효과
Comparison of Enalapril Maleate Tablets on Bioavailability and the Time Course of Inhibition of Plasma Angiotensin-Converting Enzyme
- 장인진 (서울대학교 약리학교실 및 서울대 병원 임상약리학 Unit) ;
- 장병수 (대웅제약 중앙연구소 약리연구실) ;
- 신상구 (서울대학교 약리학교실 및 서울대 병원 임상약리학 Unit) ;
- 신재국 (서울대학교 약리학교실 및 서울대 병원 임상약리학 Unit) ;
- 노일근 (대웅제약 중앙연구소 약리연구실) ;
- 이경훈 (서울대학교 의과대학 약리학교실) ;
- 박찬웅 (서울대학교 의과대학 약리학교실)
- Jang, In-Jin (Department of Pharmacology, Seoul National University, College of Medicine and Clinical Pharmacology Unit, Seoul National University Hospital) ;
- Jang, Byung-Soo (Research & Development Center, Daewoong Pharmaceutical Co. Ltd.) ;
- Shin, Sang-Goo (Department of Pharmacology, Seoul National University, College of Medicine and Clinical Pharmacology Unit, Seoul National University Hospital) ;
- Shin, Jae-Gook (Department of Pharmacology, Seoul National University, College of Medicine and Clinical Pharmacology Unit, Seoul National University Hospital) ;
- Rho, Il-Kun (Research & Development Center, Daewoong Pharmaceutical Co. Ltd.) ;
- Lee, Kyeong-Hun (Department of Pharmacology, Seoul National University, College of Medicine) ;
- Park, Chan-Woong (Department of Pharmacology, Seoul National University, College of Medicine)
- 발행 : 1990.12.30
초록
국내 생산 enalapril maleate 10mg 제제
Enalapril maleate tablets of two different producers were tested for bioequivalence. Enalapril is rapidly metabolized to an active metabolite, enalaprilat which inhibits angiotensin-converting enzyme (ACE). The pharmacokinetics of enalapril maleate and the time course of inhibition of plasma ACE activity after administration of the drugs were studied. Two single doses of 10mg each of enalapril maleate were administered orally to twelve male volunteers in a balanced, randomized, two-way crossover investigation. Plasma enalaprilat concentrations were determined over a 23-hour after the dose by enzyme inhibition assay and enalapril by the same method following in vitro hydrolysis. Urinary recoveries of enalapril and enalaprilat were determined for the calculation of renal clearance. Plasma ACE activity was determined by an enzyme assay. Peak plasma levels of enalapril were observed about 1 hour after the doses, and practically all enalapril had disappeared from plasma within 6 hour. Peak enalapril concentrations of both formulations were almost identical (
키워드