이온교환수지를 이용한 새로운 오메프라졸 복합체 개발

• 영문명: Development of New Omeprazole-Ion Exchange Resin Complex
• 발행기관: 대한약학회
• 저자명: 이계주(Gye Ju Rhee) 이기명(Ki Myung Lee) 김은영(Eun Young Kim) 이창현(Chang Hyun Lee) 황성주(Sung Ju Hwang)
• 간행물 정보: 『약학회지』제38권 제3호 (1994년), 250~264쪽, 전체 15쪽
• 주제분류: 의약학 > 기타의약학
• 파일형태: PDF
• 발행일자: 1994.06.30

영문 초록

Omeprazole(OMZ)-cholestyramine(CHL) and various OMZ-Dowex resin complexes were prepared by reaction between OMZ and activated resins in O.lN NaOH solution. And their physical properties were tested by means of infrared(IR), differential scaning caloimeter(DSC), X-ray diffraction. Chemical stability of OMZ-CHL was increased markedly compared with OMZ and the decomposition of OMZ-CHL followed the pseudo first-order kinetics and the rate constants were 2.743 X 10-4/day at 20oC, 7.83 X 10-3/day under 80% RH and 1.68 X 10-2/day 1 under UV radiation, respectively. On the other hand, the rate constants of OMZ were 2.996 X 10-4/day at 20oC, 1.17 X 10-2/day under 85% RH, and 4.07 X 10-2/day under UV radiation, respectively. The rates of dissolution of OMZ-CHL bulk and OMZ-CHL tablet were 100% and more than 85% in 15 minutes, respectively, which ere increased than OMZ base and OMZ-tablet. In the acute toxicological test, the value of oral LD50(mouse) was 4.608g/kg. OMZ-CHL was pelletized using lactose, polyethyleneglycol(PEG), D-sorbitol, Avicel PH 101, sodium laurylsulfate and polyvinylpyrrolidone(PVP) K-30, and enteric coated with HPMCP, Myvacet, acetone, ethanol and cetanol, of which dissolution rate was found to be more than 85% in 10 minutes. From the above results, it was found that OMZ-CHL is a useful means for development of new oral dosage forms of OMZ.

키워드

Omeparazole Cholestyramine Dowex resin Dissolution Stability Acute toxicity Pelletization.