更昔洛韦分散片的研制及体外溶出特性

目的:研制更昔洛韦分散片,并考察其体外溶出特性。方法:对处方中微晶纤维素与交联聚乙烯吡咯烷酮的用量进行正交试验筛选;采用紫外分光光度法测定更昔洛韦的含量;比较更昔洛韦分散片与普通片、胶囊的溶出度。结果:微晶纤维素与交联聚乙烯吡咯烷酮的最佳处方用量分别为40%、10%;更昔洛韦检测浓度在2～20μg/ml范围内与吸收度的线性关系良好(r=0.9999,n=6);平均回收率为(100.21±0.38)%;日内、日间精密度平均值分别为0.22%、0.32%;分散片可在30s内完全崩解,T50=(0.03±0.001)min,Td=(0.18±0.006)min,均低于普通片和胶囊(P<0.01)。结论:用优化处方制备的更昔洛韦分散片体外溶出特性明显优于普通片和胶囊。

Preparation and Observation of Dissolution Characteristics of Ganciclovir Dispersible Tablets in Vitro

OBJECTIVE:To prepare ganciclovir dispersible tablet and to observe its dissolution property in vitro.METHODS:The dosage of microcrystalline cellulose and crospolyvinylpyrrolidone in the formula were optimized by orthogonal test;The content of ganciclovir was determined by UV spectrophotometry method;Dissolution rates were compared among ganciclovir dispersible tablet,Ganciclovir common tablet and Ganciclovir capsule.RESULTS:The optimized formula dosage of microcrystalline cellulose and crospolyvinylpyrrolidone were40%and10%respectively;The linear concentration range for ganciclovir was2～20μg/ml(r=0.9999,n=6);The average recovery was(100.21±0.38)%;The mean values of intraday and the inter-day precision were0.22%and0.32%respectively;The ganciclovir dispersible tablet could completely disinte-grated within30s,T 50 was(0.03±0.001)min and T d was(0.18±0.006)min,which were all lower than those of the common tablet and capsule(P<0.01).CONCLUSION:The dissolution property in vitro of the optimized ganciclovir dispersible tablet is better than those of the common tablet and capsule.