摘要
目的:研究硝苯地平缓释片Ⅰ释放度的影响因素。方法:参照国家食品药品监督管理局国家药品标准WS1-(X-056)-2004Z,采用紫外可见分光光度法在237 nm测定吸光度,计算硝苯地平缓释片Ⅰ释放度。结果:对照品性质稳定,多次测量RSD为0.65%;滤膜对2 h释放度结果影响误差为5.1%~9.4%;温度在相差1℃时,吸光度的平均差值为2.3%。结论:对照品在正常检验时不用考虑;温度仅在检验结果为边缘时需要考虑;滤膜是影响释放度结果的主要因素,在检验时必须考虑滤膜的影响。
Objective:To study the influence factors of Nifedipine sustained release tablet I release degree.Methods:By reference to the National Drug Standard WS1-(X-056)-2004Z of the State Food and Drug Administration,the absorbance was measured at 237 nm using ultraviolet visible method to calculate the degree of release.Results:The standard substance was stable with RSD of 0.65%;the influence error of membrane on 2 h release rate was 5.1%~9.4%;when the temperature difference is 1℃,the average difference of absorbance is 2.3%.Conclusion:The standard substance should not be considered in normal test;temperature only needs to be considered when the inspection result is edge;filter membrane is the main factor affecting the results of release,so the influence of filter membrane must be considered in the test.
作者
刘景宜
LIU Jingyi(Luoyang Food and Drug Inspection Institute,Luoyang Henan 471023,China)
出处
《药品评价》
CAS
2021年第8期467-470,共4页
Drug Evaluation
关键词
硝苯地平缓释片Ⅰ
药物释放
滤膜
温度
溶出仪
紫外可见分光光度法
Nifedipine sustained release tablet I
Drug liberation
Filter membrane
Temperature
Dissolution apparatus
Ultraviolet visible spectrodiometer
