康艾注射液与稀释液配伍的不溶性微粒的考察  

Study on the insoluble particles of Kangai Injection mixed with diluent

作　　者：王波 马萍 王辉 李丹 王道新 王丹丹 陈莲香 翁红 米广明 WANG Bo;MA Ping;WANG Hui;LI Dan;WANG Dao-xin;WANG Dan-dan;CHEN Lian-xiang;WENG Hong;MI Guang-ming(Changbaishan Pharmaceutical Co.,Ltd.,Jilin 132500)

机构地区：[1]长白山制药股份有限公司,吉林吉林132500

出　　处：《人参研究》2021年第3期32-34,共3页Ginseng Research

基　　金：国家中医药管理局项目,项目编号:ZYBZH-C-JL-23。

摘　　要：目的测定康艾注射液在静脉药物调配环境下稀释后,在不同时间及不同药物浓度中的不溶性微的变化。方法模拟临床输液调配操作过程,按康艾注射液说明书的要求对康艾注射液稀释后,采用2020版《中国药典》不溶性微粒检查法第一法(光阻法),测定不同时间段稀释液中不溶性微粒的数量。结果药物稀释后的不溶性粒数目受多种因素的影响,药物浓度增大,不溶性微粒数变化较少;输液稀释完毕后,放置时间越长,不溶性微粒数越多。结论在调配静脉输液时要根据临床规定用量,规定的稀释液种类使用;输液调配完毕后要尽快用于病人,减少输液的放置时间。Objective To determine the changes of insoluble micromolecules in Kangai injection at different time and concentration after being diluted in the environment of intravenous drug dispensing.Methods Simulated the clinical infusion dispense operation process,according to the requirements of Kangai injection instructions,after the dilution of Kangai injection,the number of insoluble particles in the diluent in different time periods was measured by the first method of insoluble particles test(photoresistance method)in the Chinese Pharmacopoeia 2020 edition.Results The number of insoluble particles after drug dilution was affected by many factors.The number of insoluble particles changed less with the increase of drug concentration.After the infusion was diluted,the longer the infusion was placed,the more insoluble particles were found Conclusion When dispensing intravenous infusion,the prescribed dosage and diluent type should be used according to clinical regulations.The infusion should be used for the patient as soon as possible after deployment to reduce the infusion placement time.

关 键 词：康艾注射液 稀释液 不溶性微粒 稳定性 光阻法 

分 类 号：R283.6[医药卫生—中药学]