注射用亚胺培南西司他丁钠用于儿童的分剂量及稳定性研究  

Study on manipulation and stability of Imipenem and cilastatin sodium for injection in children

作　　者：张先明[1] 朱增燕[1] 王文静 杜小换[1] ZHANG Xianming;ZHU Zengyan;WANG Wenjing;DU Xiaohuan(Dept.of Pharmacy,Children’s Hospital of Soochow University,Jiangsu Suzhou 215000,China)

机构地区：[1]苏州大学附属儿童医院药剂科,江苏苏州215000

出　　处：《中国药房》2025年第1期101-105,共5页China Pharmacy

基　　金：江苏省药学会-恒瑞医院药学基金立项课题(No.H202342)。

摘　　要：目的考察注射用亚胺培南西司他丁钠(ICS)的分剂量对其主药亚胺培南(IPN)含量一致性的影响以及不同浓度药液的稳定性,为儿童安全、有效使用ICS提供参考。方法3名操作员按照临床儿童常用的2种分剂量方式(以10 mL或20 mL的0.9%氯化钠注射液制成ICS初溶药液,自初溶药液中吸取所需药量)制备ICS供试液,平行处理后通过超高效液相色谱-串联质谱联用法测定IPN的含量,根据IPN含量变异系数(CV)<15%判断每组供试液的含量一致性。按照说明书配制ICS供试液X1,再将X1以0.9%氯化钠注射液按1∶1和1∶2体积比稀释后制得供试液X2和X3,分别置于室温[(23.0±0.5)℃]、30℃恒温水浴锅以及2~8℃冰箱内保存,以规定放置温度和时间下测得的IPN质量浓度与初始(0 h)质量浓度之比判断药液稳定性(比值≥90%则认为药液稳定)。结果每位操作员以2种分剂量方式制得的每组药液中,IPN含量的CV均小于15%,表明IPN的含量偏差较小。3个质量浓度水平的药液在室温6 h或冷藏18 h条件下均较稳定;在30℃放置6 h时,供试液X1和X2也可保持稳定,但供试液X3中IPN的质量浓度较0 h时的质量浓度下降约20%。结论ICS在儿童常用的2种分剂量方式下,其主药IPN的含量一致性较好。ICS药液的稳定性受浓度、温度和时间的影响,更低的浓度在更高的温度下会导致IPN的稳定性降低。临床应注意控制医嘱溶媒量以及配制和使用过程中的环境温度与时间。OBJECTIVE To evaluate the effect of manipulation of Imipenem and cisplatin sodium(ICS)for injection on the consistency of its main drug imipenem(IPN)content,and the stability of different concentrations of ICS solution,to provide a reference for the safe and effective use of ICS in children.METHODS Three operators prepared ICS solutions according to the two commonly used dosage methods for children(10 mL or 20 mL 0.9%Sodium chloride injection to prepare the initial ICS solution and draw the required dose from the initial suspension).The content of IPN was determined by ultra-high performance liquid chromatography-tandem mass spectrometry after parallel processing.The content consistency of solutions in each group was determined according to the coefficient of variation(CV)<15%of the IPN content.ICS test solution X1 was prepared according to the instructions,and then test solutions X2 and X3 were prepared by diluting X1 with 0.9%Sodium chloride injection in the volume ratios of 1∶1 and 1∶2,which were stored at room temperature[(23.0±0.5)℃],in a thermostatic water bath at 30℃,and in a refrigerator at 2-8℃.The stability of the drug solution was determined by the ratio of the IPN mass concentration measured at the specified temperature and time to the initial(0 h)mass concentration(if the ratio was≥90%,it was considered that the drug solution was stable).RESULTS CV of IPN content was<15%in each group of solutions prepared with two manipulation methods by each operator,indicating a small deviation in IPN content.The solutions at the three concentration levels were stable at room temperature for 6 h or refrigerated for 18 h.The test solutions X1 and X2 were also stable when placed at 30℃for 6 h,but the IPN concentration in test solution X3 decreased by about 20%compared with that of 0 h.CONCLUSIONS The consistency of the content of IPN is good in the two commonly used methods for ICS manipulation in children.The stability of ICS solution is affected by concentration,temperature and time.Lower concentrati

关 键 词：注射用亚胺培南西司他丁钠 亚胺培南 分剂量 儿童 稳定性 

分 类 号：R978.1[医药卫生—药品] R917[医药卫生—药学]