注射用盐酸柔红霉素在葡萄糖注射液中的稳定性分析  

Analysis of the stability of daunorubicin hydrochloride for injection in glucose injection

作　　者：林杰[1] 刘淑梅[2] 罗继名[3] 梁欣荃[4] Lin Jie;Liu Shumei;Luo Jiming(Intravenous drug distribution center,Chenzhou No.1 People's Hospital,Chenzhou,Hunan 423000,China)

机构地区：[1]郴州市第一人民医院静脉药物配置中心,湖南郴州423000 [2]郴州市第一人民医院制剂中心,湖南郴州423000 [3]郴州市第一人民医院临床药学科,湖南郴州423000 [4]郴州市第一人民医院血液内科,湖南郴州423000

出　　处：《湘南学院学报（医学版）》2020年第3期6-9,共4页Journal of Xiangnan University（Medical Sciences）

基　　金：郴州市静脉药物配置技术研发中心(yfzx201911);湖南省教育厅课题(19C1722)。

摘　　要：目的分析注射用盐酸柔红霉素在葡萄糖溶液中的稳定性,为临床使用葡萄糖注射液溶解盐酸柔红霉素提供可靠依据。方法将注射用盐酸柔红霉素与5%葡萄糖配伍后在室温不避光条件下放置,采用高效液相色谱法测定配伍液中柔红霉素含量的变化。色谱柱:4.6 mm×250 mm,5μm;检测波长254 nm;流动相:水-乙腈(62∶38),以峰面积作为含量指标,外标法测定主要含量。结果试验条件下6 h内配伍液颜色无明显变化,柔红霉素浓度在12.22~195.6μg·mL-1范围内,浓度与峰面积呈现良好线性关系(r^2=0.9999),盐酸柔红霉素含量为99.3%~100.7%,无明显变化。结论在试验条件下,注射用盐酸柔红霉素在5%葡萄糖注射液中配伍稳定,提示盐酸柔红霉素可以配伍葡萄糖注射液。Objective To analyze the stability of Daunorubicin Hydrochloride for injection in Glucose solution and to provide a reliable basis for clinical use of Glucose injection to dissolve daunorubicin hydrochloride.Methods Daunorubicin hydrochloride for injection was mixed with 5%glucose and placed at room temperature under light condition.The content of daunorubicin in the mixed solution was determined by HPLC.The Column was 4.6 mm×250 mm,5μm,the detection wavelength was 254 nm and the mobile phase was water-acetonitrile(62∶38).The peak area was taken as the content index,and the main content was determined by external standard method.Results Under the experimental conditions,there was no significant change in the color of the blend solution within 6 h.The concentration of daunorubicin was within the range of 12.22~195.6μg·mL-1,and the concentration showed a good linear relationship with the peak area(r^2=0.9999).The content of daunorubicin hydrochloride was 99.3%~100.7%with no significant change.Conclusion The compatibility of Daunorubicin Hydrochloride for injection in glucose injection was stable under the experimental conditions,which suggested that daunorubicin hydrochloride could be compatible with glucose injection.

关 键 词：高效液相色谱法 柔红霉素 葡萄糖 配伍 稳定性 

分 类 号：R965.3[医药卫生—药理学]