缓控释制剂释放度相似性评价方法的应用分析

Analysis of the application of similarity evaluation method for release of controlled release preparations

目的分析缓控释制剂释放度相似性评价方法的应用效果，为临床相关研究提供参考依据。方法选取4个不同厂家的茶碱缓释、控释制剂，分别于不同pH条件下行释放度试验。采用点对点局部比较法对缓控释制剂相似性进行评价，并予以分析。结果兴华制药厂茶碱控释片在pH为8.40介质中的释放度均明显高于其他pH值介质（均P＜0.05）；而pH值为1～7.16介质中的释放度差异均无统计学意义。TheoDug在不同pH值介质中的释放度差异均无统计学意义。Uniphylin在pH为8.40介质中的释放度均明显高于其他pH值介质（均P＜0.05）；而pH值为1～7.16介质中的释放度差异均无统计学意义。TheoventLA在pH为1～5.93时的释放度差异均无统计学意义；而在pH值升至7.16以后，在1～4h时的释放度显著高于其他pH值介质（均P＜0.05）。结论采用点对点局部比较法对缓控释制剂相似性进行评价具有一定的临床应用价值。

Objective To analyze the application effect of similarity evaluation method for release of controlled release preparations,so as to provide reference for clinical related research.Methods Four different preparations of theophylline sustained release and controlled release preparations were selected and released under different pH conditions respectively.The similarity of controlled release preparations was evaluated by point to point local comparison method and analyzed.Results Xinghua pharmaceutical factory of protheo in pH for the release of8.40medium pH value were significantly higher than that in other media(P<0.05).There was no significant difference in the release of pH in1-7.16.The release rate of TheoDug in different pH value media was not statistically significant.Uniphylin in pH for the release of8.40medium pH value were significantly higher than that in other media(P<0.05),while the release rate of pH in1-7.16medium was not statistically significant.There was no significant difference in the release rate of Theovent LA between pH1-5.93,but after the pH value rose to7.16in the1h to release4h when the pH value was significantly higher than that in other media(P<0.05).Conclusion It is of clinical value to evaluate the similarity of controlled release preparations by point to point local comparison.