注射用头孢噻肟钠的含量测定及体外抗菌活性检查  

Determination of cefotaxime sodium injection by HPLC and in vitro antibacterial activity assay

作　　者：张碧玫[1] 傅静[1] 

机构地区：[1]天津医科大学总医院药剂科,天津300052

出　　处：《中国现代应用药学》2006年第1期51-53,共3页Chinese Journal of Modern Applied Pharmacy

摘　　要：目的建立高效液相色谱法测定注射用头孢噻肟钠含量，并考察其体外抗菌活性。方法采用Kromasil C18色谱柱（4．6mm×250mm，5μm），甲醇一磷酸盐缓冲液（30：70）为流动相，头孢哌酮钠为内标物，流速为1mL·mini^-1，检测波长为254nm。采用微量稀释法测定其对不同菌株的MIC。结果头孢噻肟钠在5—50μg·mL^-1内呈现良好线性关系（r=0．9999，n=3）。回收率为98．2％-100．4％（RSD为0．82％，n=6）。测定三个不同厂家5批样品含量均符合中国药典2000版规定。MIC显示不同的临床意义。结论该内标法简便、快速、结果准确可靠，可用于头孢噻肟钠注射剂的含量测定，体外抗菌活性的测定为临床合理用药提供依据。OBJECTIVE To establish an HPLC method for the determination of eefotaxime sodium injection and to investigate in vitro antibacterial activity. METHODS Kromasil C,s column（4.6mm × 250mm,5 μm） was used. The Mobile phase was methanolphosphate buffer（30： 70,v/v） ,cefoperazone sodium was internal standard,the flow rate was 1mL · min^-1 and the detection wavelength was at 254nm. The MICs for different strains were determined by minor dilution method. RESULTS The linear range of cefotaxime sodium was 5 - 50 μg · mL^-1 （ r = 0.9999, n = 3 ）. The recovery was 98.2% - 100.4% （ RSD was 0.82%, n = 6）. 5 batches of samples of three different pharmaceutical plants were determined. Their contents accorded with Chinese Pharmacopeia （2000）. The results of MIC showed the different clinical significance. CONCLUSION This method was proved to be simple, accurate, quick and reliable, can be used for determination of eefotaxime sodium for injection. The in vitro antibacterial activity assay may provide basis for clinical drags rational utilization.

关 键 词：头孢噻肟钠 高效液相色谱法 体外抗菌活性 

分 类 号：R917.795.1[医药卫生—药物分析学]