【摘要】 目的建立复方头孢克洛片溶出度的测定方法。方法按2005年版《中国药典(二部)》附录溶出度测定法第一法,分别以水、稀盐酸、磷酸盐缓冲溶液等3种溶出介质进行溶出试验,采用高效液相色谱(HPLC)法测定溶出介质中头孢克洛的质量浓度。结果头孢克洛质量浓度在100～800μg/mL范围内与峰面积具有良好的线性关系,平均回收率为99.89%,RSD=1.11%(n=9);复方头孢克洛片45min时的溶出量大于标示量的90%。结论所建立的溶出度测定方法简单、准确、可靠,可作为复方头孢克洛片的质量控制方法。更多还原

【Abstract】 Objective To study and establish a method for testing the solubility of Compound Cefaclor Tablets.Methods According to Method 1 in Chinese Pharmacopeia (2005),Compound Cefaclor Tablets were dissolved in water,hydrochloric acid and the buffered solution of phosphate(PBS) as dissolution mediators respectively,and the concentration of cefaclor in dissolutions were determined with HPLC.Results The linear correlation of cefaclor was within the range of 100-800 μ g/mL.The average recovery rate was 99.89% and RSD was 1.11% .The solubility was more than 90% in 45 min.Conclusion The method is simple,accurate and reliable,which can be made as the standard to control the quality of Compound Cefaclor Tablets.更多还原