摘要
目的:对不同厂家硝苯地平缓释片进行体外释放度实验考察,为评定药品的质量提供理论依据。方法:以0.02%的十二烷基硫酸钠为溶出介质,用紫外分光光度法对4个厂家(A、B、C、D)的硝苯地平缓释片进行体外释放度的测定和比较。结果:不同厂家的硝苯地平缓释片溶出速度有显著性差异,溶出速度依次为A>C>B>D。A与C厂家溶出度参数m、T50、Td无显著性差异,但与B、D厂间有显著性差异。结论:C厂家的累积释放度在1 h、4 h、12 h测定时分别为12%～35%、44%～67%和80%以上,可达到缓释、减少用药次数的目的,建议A、B、D厂家改进制备工艺,提高药品质量。
Objective： To provide the basis for evaluating the quality of slow-release tablets of Nifedipine from different manufacturers. Methods： In 0.02% sodium lauryl sulfate, the vitro release rates of Nifedipine from different manufacturers （A, B, C, D ）were tested and compared by Ultraviolet spectrophotometric method. Results： There were significant differences among different manufacturers in dissolution velocity of slow-release tablets of Nifedipine, in order as A〉C〉B〉D. There were no differences between A and C in parameters of T50, To and m, but there were significant differences compare with B and D. Conclusion： Accumulation of release degrees of C in 1 h, 4 h, 12 h are 12% - 35%, 44% - 67% and 80% above. It can reach the purpose of slowing the release of Nifedipine and reduce the dosing frequency. It is advised to A, B and D factory on improving preparation technology to improve the quality of pharmaceuticals.
出处
《天津医科大学学报》
2011年第4期493-495,共3页
Journal of Tianjin Medical University
关键词
硝苯地平
缓释片
释放度
紫外分光光度法
Nifedipine
Slow-release tablet
Release rate
Ultraviolet spectrophotometric method
