不同厂家苯妥英钠片的体外溶出度比较

目的对国内3个厂家生产的苯妥英钠片剂进行体外溶出度比较，为临床用药提供参考。方法根据2005年版《中国药典（二部）》苯妥荚钠片剂溶出度检查方法，用转篮法进行体外溶出度试验，以紫外分光光度法进行含量测定，计算累积溶出百分率，以威布尔方程拟合溶出参数，并用方差分析对溶出参数进行统计学处理。结果3个厂家苯妥英钠片的体外溶出度均符合药典规定，但其溶出参数（T50,Td）间存在显著性差异（P〈0．01）。结论不同厂家苯妥英钠片的溶出参数存在显著性差异，临床用药时应加以注意。

Comparison of Dissolution of Phenytoin Sodium Tablets from Different Pharmaceutical Companies in Vitro

Objective To compare the dissolution rates in vitro of Phenytoin Sodium Tablets prepared by 3 companies and to provide the reference for rational clinical use. Methods The dissolution of Phenytoin Sodium Tablets was detected by basket method. UV spectra- photometry was used to determine the concentration of phenytoin sodium. The cumulative dissolution was calculated and the Weibull equation was used to fit the dissolution parameters. The difference among different groups was statistically evaluated by variance analysis. Results The in vitro dissolution of Phenytoin Sodium Tables from three different pharmaceutical factories all filled the requirements of Chinese Pharmacopoeia（2005 edition）. But the significant differences among the dissolution parameters T50, Td and m were found（P〈0. 01） in Phenytoin Sodium Tablets produced by three different pharmaceutical factories. Conclusion There is significant difference in the dissolution parameters of Phenytoin Sodium Tablets from three different pharmaceutical factories, indicating that attention should be paid to the difference in clinical use.