中国现代应用药学
中國現代應用藥學
중국현대응용약학
CONTENTS IN BRIEF
2001年
2期
109-111
,共3页
刘善奎%孙其荣%钟延强%张卫星
劉善奎%孫其榮%鐘延彊%張衛星
류선규%손기영%종연강%장위성
盐酸尼卡地平%缓释微丸%HPLC%体内外相关性
鹽痠尼卡地平%緩釋微汍%HPLC%體內外相關性
염산니잡지평%완석미환%HPLC%체내외상관성
目的:考察盐酸尼卡地平缓释微丸体外释放和人体内吸收的相关 性。方法:体外溶出试验采用转篮法。人体内血药浓度测定采用反相HPLC。 该法以安定为内标,其线性范围为5.0~200.0ng/ml,峰面积比值R对药物浓度C的 回归方程为R=0.05893+0.01237C(r=0.9996,n=6),最低检测浓度为2.5ng/ml,日内 、日间相对标准偏差分别为5.35%和7.27%(n=3),平均回收率为96.94%。 结果:将体外释放百分率F(%)对人体吸收百分率 f(%)进行线性回归,得方程:f=-6.1403+1.2780F(r=0.9681,P<0.01)。结论:盐酸尼卡地平缓释微丸体内吸收百分率与体外释放百分率 间存在良好的相关关系。
目的:攷察鹽痠尼卡地平緩釋微汍體外釋放和人體內吸收的相關 性。方法:體外溶齣試驗採用轉籃法。人體內血藥濃度測定採用反相HPLC。 該法以安定為內標,其線性範圍為5.0~200.0ng/ml,峰麵積比值R對藥物濃度C的 迴歸方程為R=0.05893+0.01237C(r=0.9996,n=6),最低檢測濃度為2.5ng/ml,日內 、日間相對標準偏差分彆為5.35%和7.27%(n=3),平均迴收率為96.94%。 結果:將體外釋放百分率F(%)對人體吸收百分率 f(%)進行線性迴歸,得方程:f=-6.1403+1.2780F(r=0.9681,P<0.01)。結論:鹽痠尼卡地平緩釋微汍體內吸收百分率與體外釋放百分率 間存在良好的相關關繫。
목적:고찰염산니잡지평완석미환체외석방화인체내흡수적상관 성。방법:체외용출시험채용전람법。인체내혈약농도측정채용반상HPLC。 해법이안정위내표,기선성범위위5.0~200.0ng/ml,봉면적비치R대약물농도C적 회귀방정위R=0.05893+0.01237C(r=0.9996,n=6),최저검측농도위2.5ng/ml,일내 、일간상대표준편차분별위5.35%화7.27%(n=3),평균회수솔위96.94%。 결과:장체외석방백분솔F(%)대인체흡수백분솔 f(%)진행선성회귀,득방정:f=-6.1403+1.2780F(r=0.9681,P<0.01)。결론:염산니잡지평완석미환체내흡수백분솔여체외석방백분솔 간존재량호적상관관계。
OBJECTIVE:To study the correlation between the in vitro dissolution of nicardipine sustained release pellets(NCSR) and the in vivo abs orption of healthy volunteers.METHODS:The dissolution test was p roceeded on Chp 95(Ⅱ),method Ⅰ.The drug levels in human plasma were determined by RP-HPLC with diazepam as internal standard.The linear concentration range f or this method was 5.0~200.0ng/ml,with the correlation coefficient of 0.9996,th e average recovery was 96.94%,the RSD of intra -day and intra-da y was 5.35% and 7.47% respectively.The method is simple and accurate.RESU LTS:The in vitro/in vivo regression equation was f=-6.1403+1.2780(r= 0.9681,n=10,P<0.01).CONCLUSION:A good correlativity was showe d between in vivo absorption and in vitro dissolution of NCSR.