摘要
目的选择合适的抗氧剂解决硫普罗宁注射剂在储存过程中杂质含量超标的问题。方法首先通过单因素实验,以60℃高温放样后杂质的增长量为指标,从常用的药用抗氧剂中筛选最适宜的抗氧剂。然后利用正交实验考察抗氧剂用量、EDTA-2Na用量和p H对药品稳定性的影响,确定最佳处方组成。结果最适宜的抗氧剂为盐酸赖氨酸,最佳处方组成为硫普罗宁2.5 g,盐酸赖氨酸0.15 g,EDTA-2Na 0.01 g,p H=5.0。结论优化后的处方在相同条件下稳定性明显优于原处方。
Objective To improve the stability of tiopronin injection by selecting appropriate antioxidants. Methods Single factor experiment was used to select suitable antioxidants. The optimal formulation was determined by orthog- onal experiment with L9 （3^4）. Results The suitable antioxidant was lysine hydrochloride and the optimal formulation was as follows： tiopronin 2.5 g, lysine hydrochloride 0.15 g, EDTA-2Na 0.01 g, and pH=5.0. Conclusion The opti- mized formulation is stable.
出处
《中南药学》
CAS
2015年第7期739-740,779,共3页
Central South Pharmacy
关键词
硫普罗宁
注射剂
处方优化
正交实验
抗氧剂
tiopronin
injection
formulation optimization
orthogonal experiment
antioxidant
