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目的采用Loo-Riegelman法评价溴吡斯的明磷脂复合物纳米乳(PPNE)体内外的相关性。方法制备PPNE后,采用动态膜透析法研究PPNE体外释放行为,高效液相色谱法(HPLC)测定大鼠口服制剂后的血药浓度,以LooRiegelman法计算体内吸收百分数(Fa),并与体外累积释放率作线性回归。结果 PPNE的体外累积释放率(X)与体内Fa(Y)建立的线性方程为Y=1.376 9 X-47.543 2,r=0.941 1,r大于相关系数临界值r(6,0.001)(P<0.001)。结论 PPNE体外释放与体内吸收之间具有良好的相关性。
OBJECTIVE To evaluate the correlation of in vitro and in vivo studies on the lipophilic complex nanoemulsion (PPNE) of dibipims by Loo-Riegelman method. Methods After PPNE was prepared, the release behavior of PPNE in vitro was investigated by dynamic membrane dialysis. The plasma concentrations of PPNE were determined by HPLC after oral administration. The percentage of in vivo absorption was calculated by the method of LooRiegelman, Release rate for linear regression. Results The linear equation of cumulative release rate of PPNE in vitro and Fa (Y) in vivo was Y = 1.376 9 X-47.543 2, r = 0.941 1, r was greater than the correlation coefficient critical value r (6,0.001) (P < 0.001). Conclusion There is a good correlation between in vitro release of PPNE and absorption in vivo.