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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 in vitro dissolution rate of 4 manufacturers of risperidone tablets for reference for clinical use. Methods: In vitro dissolution test was carried out by the small cup method, the content was determined by high performance liquid chromatography, and the cumulative dissolution percentage was calculated. Dissolution parameters were fitted to Weibull’s equation, and the dissolution parameters of the groups were statistically analyzed by analysis of variance. Results: The dissolution rates of Risperidone tablets in vitro were in accordance with the requirements of the 2010 edition of Chinese Pharmacopoeia. However, the dissolution parameters of Risperidone tablets were m, T_ (30), T_ (50), T_d and T_ (80) between the two groups was statistically significant (P <0.01). Conclusion: Different manufacturers of risperidone tablets in vitro dissolution parameters differences, clinical medication should be noted.