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双氯灭痛(DC-Na)控释小丸的制备,成丸百分率受种粒中乳糖/淀粉比例、粘合剂溶液粘度及种粒在包衣锅中滚动时间的影响;小丸的园整度与粘合剂溶液的表面张力显著相关;包衣液组成及浓度,小丸大小分布范围对包衣中粘连影响较大。6名健康自愿者多剂量口服DC-Na控释小丸(CRP)及普通片(CT),比较最低血浆浓度,说明d3已达稳态。稳态时两者之间血浆药物浓度波动指数(FI)存在显著差异(P<0.05),而稳态时一个给药间隔内血浆药物浓度一时间曲线下的面积(AUC)无显著差异(P>0.05),相对生物利用度为86%。
Preparation of diclofenac-controlled (DC-Na) controlled-release pellets, percentage of pellets affected by the lactose / starch ratio in the pellets, the viscosity of the binder solution and the rolling time of the pellets in the coating pan; The surface tension of the solution was significantly correlated. The composition and concentration of the coating solution and the distribution of the size of the pellet greatly influenced the adhesion of the coating. Six healthy volunteers orally administered multiple doses of oral DC-Na controlled release pellets (CRP) and plain tablets (CT), comparing the lowest plasma concentrations, indicating that d3 has reached steady state. There was a significant difference (P <0.05) in the plasma drug concentration fluctuation index (FI) between the two groups at steady state, but there was no significant difference in the area under the time curve of plasma drug concentration (AUC) at one dose interval (P> 0.05), the relative bioavailability was 86%.