正交试验优化注射用左卡尼汀调配条件  

Orthogonal optimization of the admixture technology about L-carnitine for injection

作　　者：吴妍[1] 曹教育[1] 吴凤芝[1] 李民[1] 刘圣[1] 马旖旎[1] 唐琪[2] 

机构地区：[1]安徽省立医院南区,安徽合肥230036 [2]安徽中医药大学,安徽合肥230012

出　　处：《安徽医药》2015年第9期1642-1646,共5页Anhui Medical and Pharmaceutical Journal

摘　　要：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,0~8h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1g药粉用8mL灭菌注射用水溶解,慢频次振荡1min,所得浓溶液与5%GS、0.9%NS配伍8h内含量较稳定,适宜配伍;与GNS配伍稳定性较差,6h含量下降超过10%;与10%GS配伍稳定性最差,2h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。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.

关 键 词：左卡尼汀 正交试验 调配 稳定性 

分 类 号：R942[医药卫生—药剂学]