不同厂家利培酮片的体外溶出度比较

Comparison of in vitro Dissolution of Risperidone Pellets from Different Pharmaceutical Factories

目的:比较4个厂家利培酮片的体外溶出度,为临床用药提供参考。方法:采用小杯法进行体外溶出度试验,以高效液相色谱法进行含量测定,计算累积溶出百分率。以威布尔方程拟合溶出参数,并用方差分析对组间溶出参数进行统计学处理。结果:四个厂家所生产的利培酮片体外溶出度均符合《中国药典》2010年版规定,但各厂家利培酮片的溶出参数m、T_(30)、T_(50)、T_d、T_(80)间差异有统计学意义(P<0.01)。结论:不同厂家利培酮片的体外溶出参数存在差异,临床用药时应加以注意。

Objective：To compare the in vitro dissolution of risperidone pellets from different pharmaceutical factories to offer suggestions for clinical use.Method：Dissolution tests were carried out with small glass.method.HPLC method was used to determine the concentration of risperidone.The accumulative dissolution was calculated and the Weibull equation was applied to fit the dissolution parameters. The difference among the groups was statistically evaluated by variance analysis.Result：The in vitro dissolution of these risperidone pellets all met the requirements of Chinese Pharmacopoeia（2010 edition）.However,significant difference in dissolution parameters including m,T_（30）,T_（50）,T_d and T_（80）,was found（P 0.01） among the risperidone pellets.Conclusion：There is significant difference in dissolution parameters of the risperidone pellets from different pharmaceutical factories,suggesting that attention should be paid to their clinical use.