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目的建立头孢地尼片溶出度方法,更好地控制产品质量。方法参照头孢地尼片质量标准及日本橙皮书相关溶出曲线方法,溶出介质为盐酸溶液,体积为900ml,50转/分,测定波长为254nm,进行滤膜吸附、溶液稳定性、准确度、重复性、线性及均一性试验考察。结果滤膜对主成分无吸附,溶液在6小时内稳定、准确度试验的回收率为99.3%(RSD为1.1%)、在0.02mg/ml~0.204mg/ml线性关系良好、重复性试验的相对标准偏差为1.5%。结论方法学研究结果表明所建立方法可行。
Objective To establish a method of dissolution of cefdinir tablets to better control product quality. Methods According to the quality standard of cefdinir and the related dissolution curve method of Japanese orange book, the dissolution medium was hydrochloric acid solution with a volume of 900 ml and a rotation speed of 50 rpm and a detection wavelength of 254 nm. Adsorption, solution stability, accuracy, Repeatability, linearity and homogeneity test investigation. Results The filter did not adsorb to the main component and the solution was stable within 6 hours. The recovery of the accuracy test was 99.3% (RSD 1.1%) and the linearity was good at 0.02 mg / ml to 0.204 mg / ml. The reproducibility The relative standard deviation was 1.5%. Conclusion The methodological study results show that the method is feasible.