异甘草酸镁注射液与注射用环磷腺苷葡胺配伍的稳定性  

Compatible Stability of Magnesium Isoglycyrrhizinate Injection and Meglumine Adenosine Cyclophosphate for Injection

作　　者：赵雯雯[1] 豆兴茹[1] 黄春燕[1] 陈明圆 李轶[1] ZHAO Wenwen;DOU Xingru;HUANG Chunyan;CHEN Mingyuan;LI Yi(Department of Pharmacy,the First Affiliated Hospital of Soochow University,Suzhou 215000,China)

机构地区：[1]苏州大学附属第一医院药学部

出　　处：《医药导报》2019年第10期1331-1334,共4页Herald of Medicine

基　　金：国家新药创制重大专项(2017ZX09304-021)

摘　　要：目的考察异甘草酸镁注射液与注射用环磷腺苷葡胺在不同溶媒中配伍的稳定性,为临床给药提供理论依据。方法按照临床配伍用药浓度,将异甘草酸镁注射液200 mg和注射用环磷腺苷葡胺180 mg溶于5种溶媒250 mL,分别考察在25和4℃的储存条件下,其24 h内外观、pH值、含量、不溶性微粒的变化。结果 25和4℃的储存条件下,5种配伍溶液在24 h内外观、pH值无明显改变,高效液相色谱(HPLC)法测定异甘草酸镁和环磷腺苷含量变化在(100±5)%,随着放置时间的延长,不溶性微粒数符合《中华人民共和国药典》的相关规定。结论在25和4℃储存条件下,两种药物24 h内稳定性良好,临床上可将两种药物配伍使用。Objective The stability of the compatibility of magnesium isoxalate injection with cyclic adenosine glucamine for injection in different solvents was investigated to provide a preliminary theoretical basis for clinical administration. Methods According to the concentration of clinical compatibility, 200 mg of magnesium isoglycyrrhizinate injection and 180 mg of meglumine adenosine cyclophosphate for injection were dissolved in 250 mL of five kinds of solvents, and the changes of appearance, pH,content and insoluble particles within 24 hours under storage conditions of 25 ℃ and 4 ℃ were examined. Results There were no significant changes in the appearance and pH of the five compatible solutions within 24 hours under storage conditions of 25 ℃and 4 ℃.The change of drug content was determined by HPLC with(100±5)% and the number of insoluble particles in accordance with the relevant provisions of the Chinese Pharmacopoeia with storage time increasing. Conclusion The stability of this clinical application compatibility program is good within 24 h and can be used clinically.

关 键 词：异甘草酸镁注射液 注射用环磷腺苷葡胺 配伍稳定性 

分 类 号：R975.5[医药卫生—药品] R969.2[医药卫生—药学]