CAJ | 학술논문

目的：优选注射用左卡尼汀最佳调配方法。方法采用L8（27）正交试验优选注射用左卡尼汀的最佳溶解溶媒、溶媒量、振荡时间和振荡频次；考察左卡尼汀浓溶液与5％葡萄糖注射液（5％GS）、10％葡萄糖注射液（10％GS）、葡萄糖氯化钠注射液（GNS）以及0．9％氯化钠注射液（0．9％NS）配伍后成品输液在室温（23℃）条件下，0～8 h内左卡尼汀含量、pH、外观以及不溶性微粒数变化情况，判断其成品输液稳定性。结果注射用左卡尼汀最佳调配方法为每1 g药粉用8 mL灭菌注射用水溶解，慢频次振荡1 min，所得浓溶液与5％GS、0．9％NS配伍8 h内含量较稳定，适宜配伍；与GNS配伍稳定性较差，6 h含量下降超过10％；与10％GS配伍稳定性最差，2 h含量下降近40％；各成品输液pH、外观和不溶性微粒数变化均符合药典要求。结论正交试验优选出了最佳调配方案，为注射用左卡尼汀静脉用药调配技术提供了数据支持，促进了临床合理用药。
목적：우선주사용좌잡니정최가조배방법。방법채용L8（27）정교시험우선주사용좌잡니정적최가용해용매、용매량、진탕시간화진탕빈차；고찰좌잡니정농용액여5％포도당주사액（5％GS）、10％포도당주사액（10％GS）、포도당록화납주사액（GNS）이급0．9％록화납주사액（0．9％NS）배오후성품수액재실온（23℃）조건하，0～8 h내좌잡니정함량、pH、외관이급불용성미립수변화정황，판단기성품수액은정성。결과주사용좌잡니정최가조배방법위매1 g약분용8 mL멸균주사용수용해，만빈차진탕1 min，소득농용액여5％GS、0．9％NS배오8 h내함량교은정，괄의배오；여GNS배오은정성교차，6 h함량하강초과10％；여10％GS배오은정성최차，2 h함량하강근40％；각성품수액pH、외관화불용성미립수변화균부합약전요구。결론정교시험우선출료최가조배방안，위주사용좌잡니정정맥용약조배기술제공료수거지지，촉진료림상합리용약。
Objective To optimize the admixture technology of L-carnitine for injection.Methods The L8(27)orthogonal test was de-signed to optimize the solvent,the amount of the solvent,the shaking time and the shaking frequency.Then the concentrated solution was diluted by 5%glucose injection,10%glucose injection,sodium chloride and dextrose injection and 0.9%sodium chloride injection,re-spectively.The L-carnitine content,pH value,appearance and insoluble particles of the products within 8 hours were measured under room temperature(23℃)so as to investigate their stability.Results The best deployment process was dissolving the powder(1 g)in 8 mL sterile water for injection and shaking for 1 minute with low frequency.The content of L-carnitine in the 5% glucose injection and 0.9%sodium chloride injection were stable within 8 hours,which declined more than 10%in the sodium chloride and dextrose injec-tion within 6 hours,and nearly 40%in the 10%glucose injection within 2 hours.The changes of pH value,appearance and insoluble particles of the products were tolerable according to the pharmacopeia.Conclusions The best deployment process of L-carnitine for in-jection has been optimized by the orthogonal test,which provides data support for admixture technology and promotes the rational clini-cal medication.