中国实用医药
中國實用醫藥
중국실용의약
CHINA PRACTICAL MEDICAL
2009年
16期
44-46
,共3页
乳酸氟罗沙星分散片%高效液相色谱法%药动学
乳痠氟囉沙星分散片%高效液相色譜法%藥動學
유산불라사성분산편%고효액상색보법%약동학
Fleroxacin dispersible tablets%HPLC%Pharmacokinetics
目的 建立乳酸氟罗沙星分散片人体血药浓度的HPLC测定法,研究其药动学.方法 血浆样品加入内标,用二氯甲烷提取, HPLC进行分析.色谱柱为HypersiLODS2,流动相为甲醇-10 mmol/L的磷酸二氢钠-5 mmol/L四丁基溴化铵溶液(磷酸调PH3.0,1:1)(35:65),内标为加替沙星.结果 在51.31～3284.00 ng/ml内氟罗沙星与内标峰面积的比值与浓度的线性关系良好.批内RSD<6.7%,批间RSD<4.5%;提取回收率为96.29%～98.98%.乳酸氟罗沙星分散片(以氟罗沙星计)的消除半衰期为(14.24 1.26)h;峰质量浓度为(2307.80 419.83)ng/mL;达峰时间为(0.7 0.1)h.结论 本试验所建立的HPLC方法简便、快速、灵敏,可用于乳酸氟罗沙星分散片的人体动力学研究.
目的 建立乳痠氟囉沙星分散片人體血藥濃度的HPLC測定法,研究其藥動學.方法 血漿樣品加入內標,用二氯甲烷提取, HPLC進行分析.色譜柱為HypersiLODS2,流動相為甲醇-10 mmol/L的燐痠二氫鈉-5 mmol/L四丁基溴化銨溶液(燐痠調PH3.0,1:1)(35:65),內標為加替沙星.結果 在51.31～3284.00 ng/ml內氟囉沙星與內標峰麵積的比值與濃度的線性關繫良好.批內RSD<6.7%,批間RSD<4.5%;提取迴收率為96.29%～98.98%.乳痠氟囉沙星分散片(以氟囉沙星計)的消除半衰期為(14.24 1.26)h;峰質量濃度為(2307.80 419.83)ng/mL;達峰時間為(0.7 0.1)h.結論 本試驗所建立的HPLC方法簡便、快速、靈敏,可用于乳痠氟囉沙星分散片的人體動力學研究.
목적 건립유산불라사성분산편인체혈약농도적HPLC측정법,연구기약동학.방법 혈장양품가입내표,용이록갑완제취, HPLC진행분석.색보주위HypersiLODS2,류동상위갑순-10 mmol/L적린산이경납-5 mmol/L사정기추화안용액(린산조PH3.0,1:1)(35:65),내표위가체사성.결과 재51.31～3284.00 ng/ml내불라사성여내표봉면적적비치여농도적선성관계량호.비내RSD<6.7%,비간RSD<4.5%;제취회수솔위96.29%～98.98%.유산불라사성분산편(이불라사성계)적소제반쇠기위(14.24 1.26)h;봉질량농도위(2307.80 419.83)ng/mL;체봉시간위(0.7 0.1)h.결론 본시험소건립적HPLC방법간편、쾌속、령민,가용우유산불라사성분산편적인체동역학연구.
Objective To develop a method for determining of Fleroxacin Lactate Dispersible Tablets in plasma. Methods After being mixed with the internal standard fleroxacin, plasma samples were extracted with Dichlormethane and separated by HPLC on HypersiLODS2 with a mobile phase of methanol-10 mmoL/LNaH2PO4-tetrabutylammoniu bromide(phosphoric acid PH3.0,1:1))(35:65).In the clinical trial,a single dose of 200 mg was administered orally to 19 healthy volunteers,and the pharmacokinetic parameters of fleroxacin were calculated. Results Calibration curve for fleroxacin was linear over the range of 51.31-3284.00 ng/ml.The RSDs of intra- and inter-run were less than 6.7% and 4.5%,respectively.The extraction recovery of fleroxacin in plasma was 96.29%-98.98%.The main pharmacokinetic parameters t1/2 ,tmax and ρmax of fleroxacin in human were (14.24 1.26)h, (0.7 0.1)h and (2307.80 419.83)ng/ml,respectively.Conclusion The assay is proved to be sensitive,accurate and convenient.It can be applied to study the pharmacokinetics of fleroxacin lactate dispersible tablets formulation in human .
