广东药科大学学报2018,Vol.34Issue(1):11-14,4.DOI:10.16809/j.cnki.2096-3653.2017103001
左乙拉西坦缓释片在4种溶出介质中的体外释放初步研究
Study on the in vitro release profiles of levetiracetam sustained-release tablets in 4 kinds of dissolution mediums
杨永 1刘劲松 1邢海燕2
作者信息
- 1. 安徽中医药大学药学院,安徽 合肥230012
- 2. 合肥市第二人民医院药剂科,安徽 合肥230011
- 折叠
摘要
Abstract
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.关键词
左乙拉西坦缓释片/HPLC法/释放曲线/相似因子f2Key words
levetiracetam sustained-release tablets/HPLC/release profiles/similarity factors f2分类
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杨永,刘劲松,邢海燕..左乙拉西坦缓释片在4种溶出介质中的体外释放初步研究[J].广东药科大学学报,2018,34(1):11-14,4.