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이프리플라본 서방정 제조 및 약동학적 평가
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  • 이프리플라본 서방정 제조 및 약동학적 평가
저자명
박경호,Park. Kyoung-Ho
간행물명
藥劑學會誌
권/호정보
1997년|27권 4호|pp.323-329 (7 pages)
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한국약제학회
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이 논문은 한국과학기술정보연구원과 논문 연계를 통해 무료로 제공되는 원문입니다.
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기타언어초록

Ipriflavone is non-hormonal antiosteoporotic drug which inhibits bone resorption by reducing recruitment and/or differentiation of osteoclasts, and stimulates proliferation and differentiation of osteoblast, and also enhances calcitonin secretion in the presence of estrogen. Although some kinds of immediately-released preparation of ipriflavone are available in commercial market, in present study, we tried to formulate sustained-release tablet using coating method with hydrophobic and hydrophilic coating materials. In vitro dissolution test was applied to evaluate sustained-release patterns of several test preparations (Test tablet A, B and C) designed using different preparation method or different compositions. From the results of dissolution test, test tablet A which showed suitable dissolution profile was selected as the candidate of new product. Pharmacokinetic evaluation of test drug, ipriflavone sustained-release tablets, was conducted in 6 beagle dogs weighing $11.5{pm}0.5;Kg$ compared with $Theobon^{circledR}$ tablet, immediately-released tablet (Kukjae Pharm. Co.) as reference drug. Two products were randomly administered to 6 beagle dogs, and after 1 week, cross-over study was conducted. From the present study, AUC and $T_{max}$ of test product were significantly different from those of reference product (p<0.05), respectively$(AUC;:;3646.28{pm}472.56;vs;3646.28{pm}472.56;ng{cdot}hr/ml,;T_{max};:;4.33{pm}1.03;vs;1.42{pm}0.38;hr)$. But $C_{max}$ was not significantly different between two products (p>0.05) $(;512.52{pm}48.18;vs;443.97{pm}140.53;ng/ml)$. From the results of pharmacokinetic evaluations, it was noted that absorption amount of test product was increased, but absorption rate was delayed and $C_{max}$ of two products were not changed. And it was concluded that redesign of the sustained-release preparation which has a lower content of iprifavone rather than test tablet A must be considered.