六种释放曲线相似性评价方法在非洛地平缓释片中的应用比较

Comparison and application of six similarity evaluation methods of release profiles in felodipine sustained release tablets

目的比较使用6种不同释放度评价方法在非洛地平缓释片相似性中的应用。方法采用探索性数据分析、单变量方差分析、RESCIGNO指数法、差异因子与相似因子法、威布尔模型拟合和相似等效限法对非洛地平缓释片溶出试验数据进行统计分析。结果探索性数据分析、单变量方差分析的多数时间点的释放度无差异,RESCIGNO指数ξ1=0.0284,ξ2=0.0320,差异因子1=6.45(1【15),相似因子2=64.54(2】50),威布尔模型中原研药与自制药的td和t50的P值分别为0.064和0.062(P】0.05),自制药在测定时间点的释放度均落在原研药的88%～112%内。结论 6种相似性评价方法均适用于非洛地平缓释片释放行为的评价。

Objective To compare six different release rate evaluation methods applied to assess the dissolution similarity of felodipine loaded brand product and self made sustained release tablets.Methods The release rate of the felodipine sustained release tablets was statistical analyzed by the Exploratory data analysis method,Univariate ANOVA method,RESCIGNO index method,difference factor(f 1) and similar factor(f 2) method,the fitting of Weibull model method and Chow and Ki’s method.Results In vitro of release profiles were not significantly different with the most time points in Exploratory Data Analysis and Univariate ANOVA method,RESCIGNO index ξ 1 =0.028 4 and ξ 2 =0.032 0,difference factor 1 =6.45(1 <15)and similar factor 2 =64.54(2 >50),the P value of t d and t 50 was 0.064 and 0.062(P>0.05).In vitro release of the self-made preparation falled in the range of 88% to 112% of the brand product at all time points.Conclusion Six similarity evaluation methods are all suitable to evaluate the release behavior of felodipine sustained release tablets.