正交试验优化注射用左卡尼汀调配条件

摘要

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.%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。