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

doi:10.19803/j.1672-8629.2021.12.07

中国药物警戒 ›› 2021, Vol. 18 ›› Issue (12): 1134-1137.
DOI: 10.19803/j.1672-8629.2021.12.07

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

昝珂¹, 周颖, 李文庭², 谭春梅², 祝清岚², 马双成^1,*, 郑成^2#

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

收稿日期:2021-05-08 出版日期:2021-12-15 发布日期:2021-12-16
通讯作者: ^*马双成，男，博士，研究员，中药质量控制。E-mail：masc@nifdc.org.cn. ^#为共同通信作者。
作者简介:昝珂,男,博士,副研究员,中药质量研究。^△为并列第一作者。

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

ZAN Ke¹, ZHOU Ying, LI Wenting², TAN Chunmei², ZHU Qinglan², MA Shuangcheng^1,*, ZHENG Cheng^2#

¹National Institutes for Food and Drug Control, Beijing 102629, China;
²Zhejiang Institute for Food and Drug Control, NMPA Key Laboratory of Quality Evaluation of Traditional Chinese Medicine Hangzhou Zhejiang 310052, China

Received:2021-05-08 Online:2021-12-15 Published:2021-12-16

摘要/Abstract

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。

关键词: 香丹注射液, 输液, 配伍, 咖啡酸, 紫草酸, 丹酚酸A

Abstract: 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.

Key words: Xiangdan injection, infusion, compatibility, caffeic acid, lithospermic acid, salvianolic acid A

中图分类号:

R972R961

昝珂, 周颖, 李文庭, 谭春梅, 祝清岚, 马双成, 郑成. 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[J]. 中国药物警戒, 2021, 18(12): 1134-1137.

ZAN Ke, ZHOU Ying, LI Wenting, TAN Chunmei, ZHU Qinglan, MA Shuangcheng, ZHENG Cheng. Compatible Stability of Six Effective Components including Sodium Danshensu in Xiangdan Injection Mixed with Three Infusions[J]. Chinese Journal of Pharmacovigilance, 2021, 18(12): 1134-1137.

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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

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