香丹注射液与乳酸钠林格注射液的配伍稳定性研究  

Study on Compatible Stability of Xiangdan Injection and Sodium Lactate Ringer’s Injection

作　　者：昝珂[1] 陆静娴 祝清岚 周颖 郑成 ZAN Ke;LU Jingxian;ZHU Qinglan;ZHOU Ying;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(Traditional Chinese Patent Medicine),Hangzhou 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,杭州310052

出　　处：《中国现代应用药学》2021年第20期2564-2567,共4页Chinese Journal of Modern Applied Pharmacy

基　　金：浙江省基础公益研究计划项目(LGF19H280001)。

摘　　要：目的考察香丹注射液与乳酸钠林格注射液配伍的稳定性,为临床安全用药提供参考。方法按临床用药配伍使用量,制备香丹注射液与乳酸钠林格注射液的配伍溶液,考察配伍溶液的外观、pH值、不溶性微粒、紫外光谱及丹参素钠、原儿茶醛、咖啡酸、紫草酸、丹酚酸B和丹酚酸A的多指标含量。结果香丹注射液与乳酸钠林格注射液配伍6 h内,溶液性状、pH值、紫外光谱均无显著变化,不溶性微粒呈下降趋势,丹参素钠、原儿茶醛、咖啡酸和丹酚酸B的含量无显著性变化(<3%),紫草酸含量下降了17.41%,丹酚酸A的含量下降了78.64%。结论香丹注射液与乳酸钠林格注射液在配伍6 h内部分有效成分含量下降,建议减少配伍或配伍后尽快输注,以提高输液的有效性与安全性。OBJECTIVE To investigate the compatible stability of Xiangdan injection and SodiumLactate Ringer’s injection,and to provide reference for clinical safe medication.METHODS According to the amount of clinical application,Xiangdan injection was prepared with SodiumLactate Ringer’s injection.The appearance of the compatibility of solution,pH value,insoluble particles,ultraviolet spectrum and the contents of the salvianolic acid sodium,protocatechuic aldehyde,caffeic acid,lithospermic acid,salvianolic acid B,salvianolic acid A were determined.RESULTS The solution properties,pH value,UV spectrum had no change and particulate matter had decreased slightly within 6 h after the compatibility of SodiumLactate Ringer’s injection,and the content of lithospermic acid,salvianolic acid A had decreased by 17.41%and 78.64%respectively within 6 h after the compatibility of SodiumLactate Ringer’s injection,while the other contents had no change(<3%).CONCLUSION The content of effective components decreased within 6 h after Xiangdan injection and SodiumLactate Ringer’s injection compatibility.It is suggested not to infuse or infuse as soon as possible after compatibility to improve transfusion safety and effectiveness.

关 键 词：香丹注射液 乳酸钠林格注射液 配伍 稳定性 

分 类 号：R917.101[医药卫生—药物分析学]