人血浆中头孢克洛的含量测定方法的研究  

Study on the determination of cefaclor in human plasma

作　　者：汤琤[1] 田洁[2] 黄民[1] 

机构地区：[1]中山大学临床药理研究所,广东广州510080 [2]深圳市第二人民医院,广东深圳518035

出　　处：《中国医院药学杂志》2006年第11期1353-1355,共3页Chinese Journal of Hospital Pharmacy

摘　　要：目的：改善头孢克洛在人血浆中的稳定性，以确保其血药浓度检测数据的准确度。方法：用HPLC法检测血药浓度。以磷酸二氢钾提供酸性环境，考察头孢克洛血浆样品在各种条件下的稳定性。结果：萃取回收率81．9%～87．1％，方法回收率99．9%-105．1％，日内RSD0．9％～4．9%，日间RSD1．0％～7．0%，血浆室温4h偏离度0．8％～2．9％，冻融3次偏离度1．0％～4．1％、冻存35d偏离度4．5％～0．03%、萃取液室温22h偏离度7．1％～4．0％。结论：各项指标均符合国家食品及药品监督管理局颁布的化学制剂人体生物利用度和生物等效性研究技术指导原则的要求。OBJECTIVE To improve stability of cefaclor in human plasma;so as to ensure its accuracy of plasma-concentration data. METHODS Cefaclor was separated and determined with a HPLC system. Stability of Cefaclor sample in plasma in variety of condition was observed after adding KH2PO4 to human plasma. RESULTS Extract recovery was 81.9%-87. 1%. Method recovery was 99. 9% - 105.2 %. Within-day Variation was 0. 9 % -4. 9% ;between-day was 1.0 %- 7.0%. Irrelevance plasma standing in room temperature for 4 h was 0. 8%-2. 9%; Freezing ＆ thawing three times was 1.0%-4. 1 %; Plasma freezing reservation for 35 d was 4. 5 %-0. 03%;Standing of extract in room temperature for 22 h was 7.1 %-4. 0%. CONCLUSION Each datum accords with the requirement of human bioavailability and pharmacokinetics study.

关 键 词：头孢克洛 稳定性 血药浓度 高效液相色谱法 

分 类 号：R927.2[医药卫生—药学]