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目的:对四个不同厂家生产的硝苯地平缓释片(Ⅰ)的体外释放度进行考察,以反映其内在品质差别。方法:分别以pH 1.2盐酸溶液、pH 4.0醋酸盐溶液、pH 6.8的磷酸盐溶液和水为释放介质,采用紫外分光光度法测定市售硝苯地平缓释片(Ⅰ)的体外释放度,释放曲线采用相似因子f2法进行比较。结果:四厂家产品释放度均符合我国药品标准,但不同厂家、不同释放介质中释放曲线不完全相似。结论:四厂家产品质量存在差异,我国的释放度测定标准有待提高。
OBJECTIVE: To investigate the in vitro release of nifedipine sustained-release tablets (I) produced by four different manufacturers to reflect the difference of intrinsic quality. Methods: The in vitro release of nifedipine sustained-release tablets (Ⅰ) was measured by ultraviolet spectrophotometry with pH 1.2 hydrochloric acid solution, pH 4.0 acetate solution, pH 6.8 phosphate solution and water as the release media, The release curve was compared using the similar factor f2 method. Results: The release degree of the products of four factories accord with the standards of Chinese medicines, but the release curves of different manufacturers and different release media are not completely similar. Conclusion: There are differences in product quality among the four manufacturers, and the standard for the determination of release in China needs to be improved.