注射用氟罗沙星的质量控制标准及安全性  

Quality control and safety evaluation of fleroxacin for injection

作　　者：孙进[1] 何仲贵[1] 

机构地区：[1]沈阳药科大学药学院,辽宁沈阳110016

出　　处：《沈阳药科大学学报》2005年第6期425-428,共4页Journal of Shenyang Pharmaceutical University

摘　　要：目的 对注射用氟罗沙星的质量控制标准和安全性进行研究.方法 采用RP HPLC法,色谱柱为Diamonsil C18柱(200 mm×6 mm,5 μm),流动相为0.4 mol·L-1枸橼酸甲醇乙睛(体积比为10∶4∶1,用三乙胺调节pH值至4),检测波长为286 nm,流速1.0 mL·min-1,柱温为室温.以溶血性及血管刺激性作为评价指标,考察制剂安全性.结果 本分析条件下,氟罗沙星与内标物分离度大于1.5,与其主要杂质分离度不低于1.5;注射用氟罗沙星质量浓度在0.04～0.2 g·L-1内无溶血现象,分别静滴质量浓度为0.2、1 g·L-1的氟罗沙星10 mL·kg-1,2组家兔耳缘处无明显刺激性.结论 注射用氟罗沙星安全、有效,且质量可控.Objective To develop quality control and to study safety of fleroxacin for injection. Methods Chromatographic condition included the Diamonsil C18 column （200 mm×4.6 mm, 5μm） and mobile phase consisting of citric acid-methanol-acetonitrile （ V： V ： V = 10 ： 4 ： 1, pH = 4 adjusted by triethylamine）. The detection wavelength was set at 286 nm, the flow rate was 1.0 mL·min^-1, the column temperature was room temperature. Safety evaluation included the stimulation and haemolysis test. Results The resolution from its impurities was higher than 1.5 using the developed analytic condition. In vitro, fleroxacin for injection with concentration ranging of 0.04-0.2 g·L^-1didn＇t cause haemolysis within 4 h. Stimulation was not found in rabbits＇ ear-rim auricular vein after given 0.2 and 1 g·L^-1 fleroxacin for injection, respectively. Conclusions The fleroxacin for injection is safe, effective and quality-control.

关 键 词：氟罗沙星 粉针 反相高效液相色谱法 溶血作用 刺激性 

分 类 号：R917[医药卫生—药物分析学]