国产与进口尼莫地平片的溶出度考察

Study on the Dissolution of Domestic and Imported Nimodipine Tablets

目的:考察国产与进口尼莫地平片的溶出度,为控制国产制剂质量提供依据。方法:参考2005年版《中国药典》相关标准,利用光纤药物溶出度实时测定仪绘制实时溶出曲线,对国产(B、C、D、E)与进口(A)5厂家共5批次尼莫地平片进行考察。结果:5厂家尼莫地平片30min时的溶出度均符合2005年版《中国药典》的规定,其平均累积溶出百分率均在89以上;但溶出速率明显不同,在6min时A、B、C、D、E5厂家产品平均累积溶出百分率分别为29.22、46.83、55.10、71.84、45.72。结论:国产与进口尼莫地平片的溶出过程存在差异,国产厂家应积极改进现有工艺,严格控制药物的溶出速率。

OBJECTIVE： To study the dissolution of domestic and foreign Nimodipine tablets, and to provide reference for the quality improvement of domestic preparations. METHODS： According to the standard stated in Chinese Pharmacopoeia （2005 edition）, the dissolution curve of Nimodipine tablets from domestic pharmaceutical factories （B, C, D, E） and foreign pharmaceutical factory （A） were determined by fiber-optic real-time dissolution test system. RESULTS： The dissolution rates of Nimodipine tablets in 30 min from five pharmaceutical factories met the requirements of Chinese Pharmacopoeia （2005 edition）. The average dissolution percentages of Nimodipine tablets from five pharmaceutical factories were all more than 89 % while the dissolution rates were different. The average dissolution rates of Nimodipine tablets at 6 min from pharmaceutical factory A, B, C, D, E were 29.22%, 46.83%, 55.10%, 71.84% and 45.72%, respectively. CONCLUSION： There is a significant difference in dissolution process between domestic and imported Nimodipine tablets. Domestic pharmaceutical factories should improve preparation technology and control the dissolution rate of drugs.