Establishment of Dissolution Specifications for Octylonium Bromide Tablets and Pinaverium Bromide Tablets |
Lee, Ryun-Kyung
(Hazardous Substances Analysis Division, Daegu Regional Food & Drug Administration)
Lee, Yoon-Ae (Hazardous Substances Analysis Division, Daegu Regional Food & Drug Administration) Shim, Jee-Youn (Hazardous Substances Analysis Division, Daegu Regional Food & Drug Administration) Kim, Min-A (Hazardous Substances Analysis Division, Daegu Regional Food & Drug Administration) Sohn, Kyung-Hee (National Institute of Food and Drug Safety Evaluation, Osong Health Technology Administration Complex) Park, Hye-Rim (Korea Food & Drug Administration, Osong Health Technology Administration Complex) Kim, Hee-Sung (Korea Food & Drug Administration, Osong Health Technology Administration Complex) Song, Young-Mi (Korea Food & Drug Administration, Osong Health Technology Administration Complex) Lee, Su-Jung (Korea Food & Drug Administration, Osong Health Technology Administration Complex) Sah, Hong-Kee (College of Pharmacy, Ewha Womans University) Choi, Hoo-Kyun (College of Pharmacy, Chson University) Kim, Young-Ok (Korea Food & Drug Administration, Osong Health Technology Administration Complex) Kim, Dong-Sup (National Institute of Food and Drug Safety Evaluation, Osong Health Technology Administration Complex) Cho, Tae-Yong (Hazardous Substances Analysis Division, Daegu Regional Food & Drug Administration) |
1 | Scarpignato, C. and Pelosini, I. : Management of irritable bowel syndrome, novel approaches to the pharmacology of gut motility. Can. J. Gastroenterol. 13, 50A (1999) DOI |
2 | Dai, Y., Liu, J. X., Li, J. X. and Xu, Y. F. : Effect of pinaverium bromide on stress-induced colonic smooth muscle contractility disorder in rats. World J. Gastroenterol. 9, 557 (2003). DOI |
3 | 식품의약품안전청 용역연구개발사업 : 브롬화피나베리움의 생체이 용률시험 및 생물학적동등성시험 표준지침 작성, 한상범 등 (2004). |
4 | 대한약전 9개정 : 경구용의약품의 용출규격 설정 지침 (2007). |
5 | 식품의약품안전청 고시 : 의약품동등성시험관리규정 (2005). |
6 | 대한약전 9개정 : 의약품등 분석법의 밸리데이션에 대한 지침 (2007). |
7 | 식품의약품안전청 연구개발사업 : 고시수재 의약품의 용출규격 설정에 관한 연구, 김영옥 등 (2009). |
8 | 식품의약품안전청 : 대한약전 의약품등 기준 제 3개정 (2007). |
9 | de Weerdt, G. A., Beke, R. P., Verdievel, H. G., Barbier, F., Jonckheere, J. A. and de Leenheer, A. P.: Quantitative gas chromatographic mass spectrometric determination of pinaverium-bromide in human serum. Biomed. Mass Spectrum. 10, 162 (1983). DOI ScienceOn |
10 | 식품의약품안전청 용역연구개발사업 : 의약품 동등성 재평가 대상 성분의 생동성 평가방법에 관한 연구(브롬화옥틸로늄), 강원구 등 (2006). |
11 | Lu, C. L., Chen, C. Y., Chang, F. Y., Chang, S. S., Kang, L. J., Lu, R. H. and Lee, S. D. : Effect of a calcium channel blocker and antispasmodic in diarrhea-predominant irritable bowel syndrome. J. Gastrsenterol. Hepatol. 15, 925 (2000). DOI ScienceOn |
12 | Bouchoucha, M., Faye, A., Devroede, G. and Arsac, M. : Effect of oral pinaverium bromide on colonic response to food in irritable bowel syndrome patients. Biomed. Pharmacother. 54, 381 (2000). DOI ScienceOn |