存储温度对不同厂家盐酸阿糖胞苷稳定性影响  

Effect of storage temperature on stability of cytarabine hydrochloride from different manufacturers

作　　者：张玉倩 解伟伟 李德强[1] 王可欣 刘剑[1] 靳怡然[1] ZHANG Yuqian;XIE Weiwei;LI Deqiang;WANG Kexin;LIU Jian;JIN Yiran(Department of Pharmacy,the Second Hospital of Hebei Medical University,Hebei Province,Shijiazhuang 050000,China)

机构地区：[1]河北医科大学第二医院药学部,石家庄市050000

出　　处：《临床合理用药杂志》2023年第4期4-7,共4页Chinese Journal of Clinical Rational Drug Use

基　　金：河北省药学会医院药学科研课题项目(2020-Hbsyxhqn0002)。

摘　　要：目的观察存储温度对进口及国产注射用盐酸阿糖胞苷稳定性的影响。方法将进口及国产注射用盐酸阿糖胞苷在冷藏及常温条件下放置一定时间后,用5%葡萄糖注射液溶解,采用高效液相色谱法测定阿糖胞苷浓度变化。色谱柱为Diamonsil C_(18)柱(250 mm×4.6 mm,5μm),流动相为磷酸盐缓冲液(取0.0106 mol/L磷酸二氢钾溶液与0.0104 mol/L磷酸氢二钾溶液等体积混合)—甲醇(90∶10),流速为1 ml/min,检测波长为254 nm,柱温为35℃,进样量为10μl;用pH计测定溶液pH变化。结果国药一心制药有限公司的注射用盐酸阿糖胞苷在冷藏条件下含量变化无显著性差异,但在常温放置15 d后下其含量开始下降,到30 d其含量下降10%;5%葡萄糖注射液中pH在2 d后开始有上升的趋势,当其放置4个月其pH值上升到4.5左右,而0.9%氯化钠注射液的pH值无显著变化。结论进口的注射用盐酸阿糖尿苷相比国产阿糖胞苷更稳定,存储温度对含量变化影响较小。Objective To investigate the effect of storage temperature on the stability of imported and domestic cytarabine hydrochloride for injection.Methods The imported and domestic cytarabine hydrochloride for injection was placed under refrigeration and room temperature for a certain period of time,it was dissolved with 5%glucose injection,and the change of cytarabine concentration was determined by high performance liquid chromatography.The chromatographic column was Diamonsil C_(18) column(250 mm×4.6 mm,5μm),and the mobile phase was phosphate buffer(take 0.0106 mol/L potassium dihydrogen phosphate solution and 0.0104 mol/L dipotassium hydrogen phosphate solution in equal volume)-methanol(90∶10),the flow rate was 1 ml/min,the detection wavelength was 254 nm,the column temperature was 35℃,the injection volume was 10μl;the pH change of the solution was measured with a pH meter.Results There was no significant difference in the content change of cytarabine hydrochloride for injection of Sinopharm Yixin Pharmaceutical Co.,Ltd.under cold storage conditions,but its content began to decline after 15 days at room temperature,and declined by 10%after 30 days;The pH of 5%glucose injection began to increase after 2 days,when it was placed for 4 months,its pH value rose to about 4.5,while the pH of 0.9%sodium chloride injection did not change significantly.Conclusion The imported arabinosine hydrochloride for injection is more stable than the domestic cytarabine,and the storage temperature has less influence on the content change.

关 键 词：盐酸阿糖胞苷 高效液相色谱法 存储温度 稳定性 

分 类 号：R979.1[医药卫生—药品]