头孢克洛胶囊的溶出方法和API溶液稳定性研究  

Studies on Dissolution Profiles of Cefaclor Capsules and Stabilities of API Solution

作　　者：杜金松 柳世萍 DU Jin-song;LIU Shi-ping(NCPC HebeiHuaminPharmaceutical Co.,Ltd.,Hebei Shijiazhuang 052165,China)

机构地区：[1]华北制药河北华民药业有限责任公司,河北石家庄052165

出　　处：《中国药物评价》2018年第5期329-332,共4页Chinese Journal of Drug Evaluation

摘　　要：目的:筛选确定头孢克洛胶囊的溶出方法,并进行头孢克洛溶液稳定性研究。方法:以头孢克洛胶囊为参比制剂,紫外分光光度计264 nm波长下,比较其在不同条件下的溶出曲线。结果:转篮法50 r·min-1条件下制剂呈现更好的溶出行为,水和p H 4. 0介质溶出趋势显著,p H 1. 2和p H 6. 8介质呈现快速溶出,p H 6. 8介质中终溶出量低于90%,可能有降解现象。溶液稳定性实验证明,头孢克洛在p H 6. 8介质中15 min就已经开始降解,2 h后降解量达46%,其他介质中未见明显降解。结论:在头孢克洛胶囊仿制药质量和疗效一致性评价中,可首选转篮法50 r·min-1作为溶出曲线测定方法,鉴于其在p H 6. 8介质中有降解,样品测定时,不宜长时间放置。Objective： To select the dissolution test method for thecefaclor capsulesand research the stabilities ofcefaclorsolution. Methods： We compared the dissolution profilesof cefaclor capsules, measured by UV （264 nm） in different conditions. Results： The Ceclor shows a better dissolution trend with the Rotating Basketsmethod （50 r · min -1 ） than others. It performs significant dissolution trendin the mediumsof water and pH 4. 0, and high solubility in the mediums of pH 1.2 and pH 6. 8. Butin the pH6. 8 medium, the ceclorshowsless than 90% dissolution at lastbecause ofdegraded probably. The results ofsolution stabilities of API indicates thatcefaclor is already degraded in 15 min only in pH 6. 8 medium, and can reach 46% degradationafier 2 h. No significant degradation was found in other mediums. Conclusion： We preferred the Rotating Baskets method（50 r · min -1 ） as the dissolution profilesmethod of cefaclor capsules in the Quality and Efficacy Agreement Evaluation of Generic Drug. And thesamples should not be placed for a long time because of its degradation in pH6. 8 medium.

关 键 词：头孢克洛胶囊 溶出曲线 溶液稳定性 

分 类 号：R927.11[医药卫生—药学]