香丹注射液与3种输液配伍后丹参素钠等6种有效成分的稳定性研究  

Compatible Stability of Six Effective Components including Sodium Danshensu in Xiangdan Injection Mixed with Three Infusions

作　　者：昝珂[1] 周颖 李文庭 谭春梅 祝清岚 马双成[1] 郑成 ZAN Ke;ZHOU Ying;LI Wenting;TAN Chunmei;ZHU Qinglan;MA Shuangcheng;ZHENG Cheng(National Institutes for Food and Drug Control,Beijing 102629,China;Zhejiang Institute for Food and Drug Control,NMPA Key Laboratory of Quality Evaluation of Traditional Chinese Medicine Hangzhou Zhejiang 310052,China)

机构地区：[1]中国食品药品检定研究院,北京102629 [2]浙江省食品药品检验研究院,国家药品监督管理局中成药质量评价重点实验室,浙江杭州310052

出　　处：《中国药物警戒》2021年第12期1134-1137,共4页Chinese Journal of Pharmacovigilance

基　　金：重大新药创制国家科技重大专项2018年度(2018-ZX09735-006);浙江省基础公益研究计划项目(LGF19H280001)。

摘　　要：目的研究香丹注射液与葡萄糖注射液、氯化钠注射液、葡萄糖-氯化钠注射液配伍后6种有效成分的稳定性。方法采用高效液相色谱法(HPLC)同时测定香丹注射液与葡萄糖注射液、氯化钠注射液、葡萄糖-氯化钠注射液配伍后放置不同时间丹参素钠、原儿茶醛、咖啡酸、紫草酸、丹酚酸B和丹酚酸A的含量变化。结果香丹注射液与氯化钠注射液配伍后,紫草酸、丹酚酸A含量逐渐下降;而咖啡酸逐渐上升;与葡萄糖-氯化钠注射液配伍后,丹酚酸A含量逐渐下降,咖啡酸含量逐渐上升;与葡萄糖注射液配伍后,只有丹酚酸A含量逐渐略微下降。结论香丹注射液最好与葡萄糖注射液配伍,并且尽快使用。Objective To study the stability of six effective components in Xiangdan injection after being mixed with glucose injection,sodium chloride injection and glucose sodium chloride injection,respectively.Methods The contents of sodium danshensu,protocatechuic aldehyde,caffeic acid,lithospermic acid,salvianolic acid B and salvianolic acid A in Xiangdan injection were determined by HPLC after they were mixed with glucose injection,sodium chloride injection and glucose sodium chloride injection,respectively.Results After mixture with sodium chloride injection,the contents of lithospermic acid and salvianolic acid A decreased gradually while caffeic acid increased gradually.After mixture with glucose sodium chloride injection,the contents of salvianolic acid A decreased and caffeic acid content increased gradually.Only the content of salvianolic acid A decreased slightly after it was mixed with glucose injection.Conclusion It is recommended that Xiangdan injection be used in compatibility with glucose injection and be used as soon as possible.

关 键 词：香丹注射液 输液 配伍 咖啡酸 紫草酸 丹酚酸A 

分 类 号：R972[医药卫生—药品]