7厂家头孢拉定胶囊体外溶出度考察

目的:考察不同厂家生产的头孢拉定胶囊的体外溶出度,为临床选用提供参考。方法:采用转篮法进行体外溶出度试验,以紫外分光光度法测定头孢拉定的含量,计算累积溶出百分率,以双指数模型拟合溶出参数a、b、Td、T80,并用方差分析对组间参数进行统计处理。结果:7厂家头孢拉定胶囊的体外溶出度均符合2005年版《中国药典》中的相关规定,但各厂家产品a、b、Td、T80间均有显著性差异(P<0·01)。结论:不同厂家头孢拉定胶囊的溶出参数存在差异,临床选用时应加以注意。

In Vitro Dissolution of Cefradine Capsules from Seven Different Pharmaceutical Factories

OBJECTIVE： To investigate the dissolution in vitro of cefradine capsules from seven pharmaceutical factories for clinical reference in drug choice. METHODS： The dissolution tests were carried out using basket - rotating method. UV spectrophotometry was used to determine the concentration of cefradine. The cumulative dissolution was calculated and dualindex model was used to fit the dissolution parameters （a, b, Td, and T80） . The differences among groups were statistically evaluated by variance analysis. RESULTS： The dissolution in vitro of cefradine capsules from seven different pharmaceutical factories were all up to the related standards specified in Chinese Pharmacopoeia （2005 edition） . But significant differences were noted in dissolution parameters a, b, Td and T80（P 〈 0.01） among the cefradine capsules from seven different pharmaceutical factories. CONCLUSION： There were significant differences in dissolution parameters among the cefradine capsules from seven different pharmaceutical factories, which should be given full consideration in clinical choice of drugs.