带鲁尔帽螺口注射器调配PIVAS静脉推注成品注射液的稳定性考察  

Stability study of a screw-port syringe with luer cap for the dispensing of PIVAS for intravenous bolus of finished product injections

作　　者：李国邦 林英坚 刘旦锋 莫旱春 刘萍 LI Guo-bang;LIN Ying-jian;LIU Dan-feng(Dongguan Kanghua Hospital,Dongguan 523080,China)

机构地区：[1]东莞康华医院,523080

出　　处：《中国实用医药》2024年第10期164-167,共4页China Practical Medicine

基　　金：东莞市社会科技发展一般项目(项目编号:202050715059679)。

摘　　要：目的 探讨静脉用药调配中心(PIVAS)应用带鲁尔帽螺口注射器调配静脉推注成品注射液的稳定性。方法 在PIVAS水平层流台应用带鲁尔帽螺口注射器调配注射用艾司奥美拉唑钠、注射用帕瑞昔布钠、盐酸氨溴索注射液,并静脉推注样品,采用正压法检测密封性;并于0、1、2、4、6、8、24 h检测样品液的pH值和性状的变化情况。结果 各样品注射液20 ml用带鲁尔帽螺口注射器在侧向力3 N、轴向力200 N和300 N的作用下30 s,均无出现渗漏现象。注射用艾司奥美拉唑钠、注射用帕瑞昔布钠、盐酸氨溴索注射液分别用一次性带鲁尔帽螺口注射器经20 ml 0.9%氯化钠注射液将其调配稀释,室温(实验条件25℃)条件下分别在0、1、2、4、6、8、24 h检测pH值,均表现稳定,未发生明显变化。注射用艾司奥美拉唑钠、注射用帕瑞昔布钠、盐酸氨溴索注射液分别用一次性带鲁尔帽螺口注射器经20 ml 0.9%氯化钠注射液将其调配稀释,室温(实验条件25℃)条件下分别在0、1、2、4、6、8、24 h时观察其澄明度和颜色变化,均表现为无色澄清状态,未发生颜色变化。结论 药物在PIVAS环境下用带鲁尔帽螺口注射器调配成静脉推注注射液,其稳定性和密封性是可以得到保障的。Objective To explore the stability of a screw-port syringe with luer cap for the dispensing of pharmacy intravenous admixture service(PIVAS)for intravenous bolus of finished product injections.Methods Application of screw-port syringe with luer cap for intravenous bolus samples of esomeprazole sodium for injection,parecoxib sodium for injection,ambroxol hydrochloride injection at the level of PIVAS laminar flow table;the sealing property was examined by positive pressure method;and the pH value of the sample solution and the changes of the traits were detected at the time points of 0,1,2,4,6,8,and 24 h.Results Each sample injection 20 ml was subjected to a lateral force of 3 N and axial forces of 200 N and 300 N for 30 s with a screw-port syringe with luer cap,and no leakage was observed.Esomeprazole sodium for injection,Parecoxib sodium for injection and ambroxol hydrochloride injection were diluted with 20 ml 0.9%sodium chloride injection using disposable screw syringes with luer cap,respectively.pH values were detected at 0,1,2,4,6,8 and 24 h at room temperature(experimental condition 25℃),and all showed stable results.No significant changes have taken place.Esomeprazole sodium for injection,parecoxib sodium for injection and ambroxol hydrochloride injection were diluted with 20 ml 0.9%sodium chloride injection using a disposable screw syringe with luer cap,respectively.Their clarity and color changes were observed at 0,1,2,4,6,8 and 24 h at room temperature(experimental condition 25℃),respectively.All showed colorless and clear state without color change.Conclusion The dispensing of the drug into an intravenous bolus injection with a screw-port syringe with luer cap within the PIVAS environment is secured for stability and sealing.

关 键 词：静脉用药调配中心 静脉推注 稳定性 

分 类 号：R942[医药卫生—药剂学]