고시수재 의약품 중 아세브로필린 캡슐 및 브롬헥신염산염 정의 용출시험법 개발

• 영문명: Development of Dissolution Test Method for Acebrophylline Capsules and Bromhexine Hydrochloride Tablets in Korean Pharmaceutical Codex
• 발행기관: 대한약학회
• 저자명: 이태웅 정래석 정승아 김정현 심영훈 김인규 박창원
• 간행물 정보: 『약학회지』제57권 제3호 (2013년), 226~233쪽, 전체 8쪽
• 주제분류: 의약학 > 기타의약학
• 파일형태: PDF
• 발행일자: 2013.06.30

영문 초록

Although the dissolution test can serve as an effective tool for quality control and predictor of in vivo per- formance, there are a number of drugs with no established dissolution specification in Korean Pharmaceutical Codex (KPC).1) So, with each reference and test drugs, the dissolution test method and an analytical procedure by HPLC were developed and validated to establish dissolution specification for acebrophylline capsules and bromhexine hydrochloride tab- lets. The dissolution condition was determined based on the "Guidelines on Specifications of Dissolution tests for Oral dos- age forms" of Ministry of Food and Drug Safety (MFDS).2) The analytical method of HPLC was validated in specificity, linearity, precision and accuracy. Final dissolution test was performed with commercially available samples of 3 lots to estab- lish specification. In addition, no difference was observed by the inter-laboratory evaluation. Dissolution specifications and conditions will be used for revising the monograph of acebrophylline capsules and bromhexine hydrochloride tablets in next supplement of KPC.1)

목차

실험방법

실험결과 및 고찰

결 론

감사의 말씀

참고문헌

키워드

dissolution test acebrophylline bromhexine hydrochloride