CAJ | 학술논문

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。
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.