不同厂家单硝酸异山梨酯缓释制剂释放度比较

Drug Release Rates of Sustained Release Preparations of 5-ISMN from Different Manufacturers

目的:考察6厂家单硝酸异山梨酯缓释制剂体外释放度的差异。方法:A、B、C、D、E、F厂家样品根据《中国药典》2005年版释放度测定法第一法进行释放度试验,用高效液相色谱法测定释放量,并计算f2因子比较相似性。结果与结论:A厂家与其他5厂家样品释放度的差异主要表现在60min内,其在最初15min内释放速度显著更快。

OBJECTIVE： To compare the drug release rate of 5-ISMN release preparations from 6 manufacturers. METHODS; The release rate test of 5-ISMN sustained release preparations from 6 manufacturers（A, B, C, D, E, and F） were performed in accordance with China Pharmacopeia （2005 edition, the first assaying method of drug release rate） and the release amount was determined by HPLC. f2 factor was calculated to compare their similarity. RESULTS ＆ CONCLUSIONS： The drug release differences between the sample that from manufacturer A and other samples that from other 5 manufacturers mainly presented within 60 minutes, and the drug release rate of the sample from A manufacturer was much faster than the others especially in the first 15 minutes.