Objective To compare the release profiles of self-prepared and original levetiracetam sustained-release tablets in 4 kinds of dissolution mediums with different pH in vitro. Methods According to the first dissolution method (basket method) stated in general rule 0931 of Chinese Pharmacopeia (2015 edition Part 4). the rotation speed was 100 r/min with dissolution medium volume of 900 mL. HPLC was adopted to determine the content of levetiracetam in water,pH 1.2 hydrochloric acid,pH 4.5 acetate buffer solution and pH 6.0 phosphate buffer solution,the cumulative dissolution was calculated and the release rate was drawn. The similarity factor(f2)was used to evaluate the similarity of release curves. Results In 4 different dissolution mediums,self-prepared drug release behavior was basically similar to original drug. The release degree was reached at 1,4 and 12 hours,and the f2was more than 50 for both self-prepared and original. Conclusion The self-prepared levetiracetam sustained-release tablets could release completely in 4 kinds of dissolution mediums and the release behavior was similar to original,which could provide a reference for the determination of production process parameters.%目的 比较自研左乙拉西坦缓释片与国外原研药在4种不同pH值溶出介质中的体外释放行为.方法 采用《中国药典》2015年版(四部)通则0931第一法(篮法),转速为100 r/min,分别以水、pH 1.2 HCl溶液、pH 4.5醋酸盐缓冲液和pH 6.0磷酸盐缓冲液为溶出介质,体积为900 mL;以HPLC法测定左乙拉西坦的质量分数,并计算累积释放度,绘制释放曲线;采用相似因子(f2)法评价释放曲线的相似度.结果 在4种不同pH值的溶出介质中,自研左乙拉西坦缓释片和国外原研左乙拉西坦缓释片释放行为基本一致,1、4、12 h时释放度均达到要求,f2均大于50.结论 自研左乙拉西坦缓释片在4种溶介质中均可以达到释放要求,与原研制剂体外释放行为均相似,可为其生产工艺参数的确定提供参考.
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