CAJ | 학술논문

目的：研究丹参注射液与多巴胺注射液在5％的葡萄糖注射液中的配伍稳定性。方法采用HPLC法考察2药在5％的葡萄糖注射液中配伍后，于5、25、35℃避光和光照条件下，6 h内丹参注射液中4个主成分：丹参素钠、原儿茶醛、迷迭香酸及丹酚酸B和多巴胺注射液中的盐酸多巴胺的含量变化；并考察配伍前后配伍液外观、性状、pH及不溶性微粒的变化。结果在避光条件下，6 h内配伍液的外观、pH值均无明显变化，不溶性微粒均符合中国药典的要求，配伍液中丹参素钠、原儿茶醛、迷迭香酸、丹酚酸B和盐酸多巴胺的百分含量均在99％以上（相对于0 h）；在光照条件下，随着温度的升高，放置时间的延长，配伍液中盐酸多巴胺的含量没有明显下降，而丹参素钠、原儿茶醛、迷迭香酸及丹酚酸B的含量下降较明显，配伍液pH值也有一定程度的降低，不溶性微粒则无明显变化。结论丹参注射液与多巴胺注射液在5％的葡萄糖注射液中在6h内、于避光环境中可配伍使用；光照及温度可能是影响丹参注射液与多巴胺注射液配伍稳定性的主要因素。
목적：연구단삼주사액여다파알주사액재5％적포도당주사액중적배오은정성。방법채용HPLC법고찰2약재5％적포도당주사액중배오후，우5、25、35℃피광화광조조건하，6 h내단삼주사액중4개주성분：단삼소납、원인다철、미질향산급단분산B화다파알주사액중적염산다파알적함량변화；병고찰배오전후배오액외관、성상、pH급불용성미립적변화。결과재피광조건하，6 h내배오액적외관、pH치균무명현변화，불용성미립균부합중국약전적요구，배오액중단삼소납、원인다철、미질향산、단분산B화염산다파알적백분함량균재99％이상（상대우0 h）；재광조조건하，수착온도적승고，방치시간적연장，배오액중염산다파알적함량몰유명현하강，이단삼소납、원인다철、미질향산급단분산B적함량하강교명현，배오액pH치야유일정정도적강저，불용성미립칙무명현변화。결론단삼주사액여다파알주사액재5％적포도당주사액중재6h내、우피광배경중가배오사용；광조급온도가능시영향단삼주사액여다파알주사액배오은정성적주요인소。
Objective To study compatibility stability of Danshen injection combined with dopamine injection in 5% glucose injection. Methods The relative contents of tanshinol sodium, protocatechuic aldehyde, rosmarinic acid,salvianolic acid B in Danshen injection and Dopamine hydrochloride in dopamine injection were determined by HPLC in 6h after the compatibility in the above infusion at 5 ℃,25℃,35 ℃ under dark and light,and the changes in pH value,appearance and insoluble particles were also observed.ResuIts There were no significant changes in appearance and pH value at 5℃,25℃,35 ℃ under dark,insoluble particles were in line with Chinese Pharmacopoeia,and the relative content of tanshinol sodium, protocatechuic aldehyde, rosmarinic acid,salvianolic acid B and Dopamine hydrochloride were above 99%(compared with 0h) in 6h.In the light conditions,as the temperature raised,the extension of storage time,the relative content of Dopamine hydrochloride was not significantly decreased,but the content of tanshinol sodium, protocatechuic aldehyde, rosmarinic acid and salvianolic acid B had declined,while pH value also had a certain degree of reduction,the insoluble particles had no obvious change.ConcIusion The mixture of Danshen injection and dopamine injection in 5%glucose injection is stable under dark conditions in 6h, illumination and temperature maybe the main factor affecting the stability of Danshen injection combined with dopamine injection.