香丹注射液中吐温80的含量测定  

Determination of the Content of Twain80in Xiangdan Injection

作　　者：巩晓宇[1] 严俊珍[1] 邱凤邹[1] 陈秋燕[1] 陆燕萍[1] GONG Xiaoyu;YAN Junzhen;QIU Fengzou;CHEN Qiuyan;LU Yanping(Longgang District People's Hospital of Shenzhen&The Second Affiliated Hospital of the Chinese University of Hong Kong,Shenzhen 518172,China)

机构地区：[1]深圳市龙岗区人民医院&香港中文大学(深圳)附属第二医院,广东深圳518172

出　　处：《中国民族民间医药》2022年第3期38-40,45,共4页Chinese Journal of Ethnomedicine and Ethnopharmacy

摘　　要：目的:建立香丹注射液中吐温80含量测定的方法,用于该类药品的质量控制和安全性评价。方法:采用高效液相色谱法,凝胶色谱柱,柱温为30℃;以0.02 mol/L醋酸铵溶液-乙腈(90∶10)为流动相,流速为0.6 mL/min;Alltech蒸发光散射检测器,漂移管温度120℃,氮气流速2.0 L/min,进样量10μL。结果:样品色谱图中吐温80无干扰,分离度符合要求,吐温80浓度在0.505~5.05 mg/mL范围内,线性关系良好(R^(2)=0.9991),加样回收实验表明,平均加样回收率96.7%, RSD=2.0%。结论:通过高效液相色谱法结合凝胶色谱柱建立的方法准确可靠,可以准确有效的检测香丹注射液中吐温80的含量,评价药品的安全性,控制药品质量。ObjectiveTo establish a method for the determination of Xiangdan injection Twain 80 content,for the drug quality control and safety evaluation.MethodsThe gel chromatography column,the column temperature is 30 DEG C;to 0.02 mol/L ammonium acetate solution and acetonitrile(90∶10)as mobile phase.The flow rate was 0.6 ml/min;Alltech evaporative light scattering detector,the drift tube temperature of 120 DEG C,nitrogen flow rate 2.0 L/min,into 10 mu l of sample volume.ResultsThe Twain80 concentration in the range of 0.505-5.05 mg/mL,a good linear relationship(R^(2)=0.9991),the average recovery rate was96.7%,RSD=2.0%.ConclusionThe established method is accurate and reliable,and can effectively detect Xiangdan injection of Tween 80 in the content and evaluation of drug safety and control the quality of drugs.

关 键 词：吐温80 HPLC 含量测定 

分 类 号：R284[医药卫生—中药学]