Cefamandole nafate 함유 주사제의 지원자에 대한 생물학적 동등성 실험

• 영문명: Bioequivalence of Cefamandole Nafate I.V. (Mandol and Mancef) of Human Volunteers.
• 발행기관: 대한약학회
• 저자명: 권광일(Kwang Il Kwon) 이혜숙(Hye Suk Lee) 지옥표(Ok Pyo Zee)
• 간행물 정보: 『약학회지』제34권 제5호 (1990년), 334~340쪽, 전체 7쪽
• 주제분류: 의약학 > 기타의약학
• 파일형태: PDF
• 발행일자: 1990.10.28

영문 초록

The bioequivalence of Mandol and Mancef (cefamondole nafate injection preparation) was investigated for 8 healthy human volunteers. Cefamandole nafate hydrolysis to cefamandole base in the blood and shows antibacterial activity. As the rate of the hydrolysis can be varied according to the buffer used in the preparation, the bioequivalence of cefamandole nafate I.V. was studied. A new HPLC method, the column switching technique, was developed and used for the simultaneous determination of cefamandole and cefamandole nafate in the plasma and in the urine. There were no statistically significant difference in between Mandol and Mancef for the parameters of AUC and Cp 0.25 hr even through the power of the test was not enough.

키워드

Cefamandole nafate Cefamandole Bioequivalence Volunteers Bioavailability Human.