头孢克洛缓释胶囊体外释放度方法的研究

Studies on Release Rate in vitro Method of Cefaclor Release Capsule

目的建立头孢克洛缓释胶囊体外释放度的测定方法。方法采用溶出度第一法,以水900m L为溶出介质,转速为100r·min-1,取样时间为1、2、4、6、8、10、12h。结果头孢克洛在40.4~202μg·m L-1范围内线性关系良好（r=0.9999）;平均回收率为98.8%（RSD=0.91%）,3批样品释放平稳,12h平均溶出度均在95%以上。结论本方法便捷、准确、重现性好,可用于头孢克洛缓释胶囊的质量控制。

OBJECTIVE To study on release rate in vitro method of cefaclor release capsule. METHODS The dissolution of cefaclor release capsule was determined by dissolution test method 1. Water 900mL was taken as solvent with the rotating speed at 100r · min-l, and the sampling time was 1,2,4,6,8,10,12h. RESULTS The linear range of cefaclor was 40. 4 - 202μg · mL-1 （ r = 0. 9999 ） , with average recovery rate at 98.8% （ RSD = 0. 91% ）. The dissolutions of three groups of samples were smooth, the 12h average dissolutions were above 95% . CONCLUSION The method is simple, accurate and reproducible, and can be used for the quality control of this preparation.