이토프리드염산염 정과 티로프라미드염산염 정의 용출시험법 개발

• 영문명: Development of Dissolution Test for Itopride Hydrochloride Tablets and Tiropramide Hydrochloride Tablets
• 발행기관: 대한약학회
• 저자명: 김정현 이종화 최란 최연희 이종철 인지혜 이광문 심영훈 강신정 사홍기 최후균 김인규
• 간행물 정보: 『약학회지』제57권 제3호 (2013년), 205~212쪽, 전체 8쪽
• 주제분류: 의약학 > 기타의약학
• 파일형태: PDF
• 발행일자: 2013.06.30

영문 초록

Dissolution test has been performed to control drug quality and to predict in vivo drug release profile of solid dosage forms, so there's a drift towards setting dissolution test instead of disintegration test. However, some solid dosage forms in Korea Pharmaceutical Codex (KPC) are not established the dissolution test yet, so these monographs are necessary to set the specification of dissolution test. In this study, we developed the specification and test method of dissolution test for itopride hydrochloride tablets and tiropramide hydrochloride tablets which are not established the dissolution test yet. According to the 「Manual for Guideline Application for Validation of Analytical Procedures」 and 「Guidelines on Spec- ification of Dissolution test for Oral dosage form」 of Korean harmacopoeia (KP), we validated and established each devel- opment method. Based on the preliminary dissolution profile, we set the dissolution condition(paddle apparatus, pH 1.2 media, 50 rpm). For this condition, we performed the main dissolution test to determine the specification (45 min, 85%). Finally, we validated each analytical method by specificity, linearity, accuracy and precision. These developed methods will be included the next supplement of KPC and also contributed to the quality control of medicines.

목차

실험방법

실험결과 및 고찰

결론

감사의 말씀

참고문헌

키워드

dissolution test itopride hydrochloride tiropramide hydrochloride