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目的:测定自制的制霉菌素口腔双层贴膜在口腔内释药过程。方法:采用剩余量法测定制霉菌素口腔双层贴膜在口腔内释药情况,测定制霉菌素口腔双层贴膜体外释放度,并比较体内外释放的相关性。结果:体外释放方程:ln(100-Q)=-0.089t+4.998,r=0.997 0,口腔内释药方程为ln(100-P)=-0.022t+5.014,r=0.993 5。以体内平均释放百分率(Y,%)对体外平均释放百分率(X,%)回归,得方程Y=0.990X+0.372,r=0.998 0。结论:体内外释放度具有良好的相关性,可以用体外释放度来预测药物的释放。
Objective: To determine the self-made nystatin oral double-layer film in the oral drug release process. Methods: The release of nystatin oral double-layer film in the oral cavity was measured by the residual volume method. The release of nystatin oral double-layer film in vitro was measured, and the correlation between release in vivo and in vitro was compared. Results: In vitro release equation: ln (100-Q) = - 0.089t + 4.998, r = 0.997 0, the oral cavity release equation was ln (100-P) = -0.022t + 5.014, r = 0.993 5. The average in vivo release percentage (Y,%) of the average in vitro release percentage (X,%) regression, the equation Y = 0.990X + 0.372, r = 0.998 0. Conclusion: There is a good correlation between in vitro and in vivo release and the release in vitro can be used to predict drug release.