奥硝唑血药浓度的高效液相色谱法测定及其国产与进口片剂的药动学与生物等效性研究英文.pdfVIP

　·药 　剂· Determination of ornidazole in plasma by HPLC and study on its pharma cokinetics and bioequivalence of domestic and imported tablets in 18 healthy volunteers 1 2 3 LI Qin , CHEN Jianzhong , GUO Ruichen ( 1. Marine Drug and Food Institute , Ocean University of China , Qing dao 26603 , Chi na ;2. Department of Pharmacy , Liaocheng People ’s Hospital of Shandong Province , Liaocheng 252000 , China ; 3. Institute of Clinical Phar ) macology , Qilu Hospital , Shandong University , Jinan 250012 , China ABSTRACT :OBJECTIVE　To establish a reversed HPLC method for the determination of ornidazole in human plasma , and study the phar macokinetics and bioequivalence of domestic and imported tablets in healthy volunteers.METHOD 　The drug was extracted from plasma with ( ) μ methanol and isopropanol 50 ∶50 , and then analyzed by HPLC with a C 5 m 250 ×4. 6mm column and UV detector set at 316nm. The 18 mixture of methanol and 0. 4 % glacial acetic acid (50 ∶50) was used as the mobile phase. The flow rate is 0. 8mL ·min - 1 . 1. 5g single oral dose of domestic and imported ornidazole tablets were given to 18 healthy volunteers in an open randomized crossover study. The pharmacoki netic parameters as well as relative bioavailability were measured. RESULTS 　The calibration curve was linear within the range of 2. 0～20. - 1 - 1 μ