| 吴 妍,曹教育,吴凤芝,等.正交试验优化注射用左卡尼汀调配条件[J].安徽医药,2015,19(9):1642-1646. |
| 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 |
| 投稿时间：2015-03-30 |
| DOI： |
| 中文关键词: 左卡尼汀 正交试验 调配 稳定性 |
| 英文关键词: L-carnitine orthogonal test deployment stability |
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| 中文摘要: |
| 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,0～8 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。 |
| 英文摘要: |
| Objective To optimize the admixture technology of L-carnitine for injection. Methods The L8(27)orthogonal test was designed 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,respectively.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 injection 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 injection has been optimized by the orthogonal test,which provides data support for admixture technology and promotes the rational clinical medication. |
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