胸腺肽注射液两种工艺的稳定性考察研究

Study on Stability of Two kinds of Technics of Thymosin Injection

目的:研究胸腺肽注射液的生产工艺,选择出最佳的工艺处方及条件,并考察其质量的稳定性。方法:采用加速稳定性试验考察,时间为6个月,在试验期间的第1个月、2个月、3个月、6个月末各取样一次,按稳定性重点考察项目(外观、pH值、含量%、胸腺肽α1、生物活性)检测。结果:胸腺肽在氯化钠的环境下,含量和活性比较稳定。结论:处方2的工艺条件稳定性好,工艺条件简单,适合大规模生产操作。

Objective：To study the product technic of thymosin injection,To chose the best prescription and condition, and invest,gat the quality stability of thymosin injection.Methods：to investigate the stability of accelerat experiment,The whole period is 6 months,Take a sample at the end of day of the first month、the second month、the third month、and the sixth month.According to the stability investigation item,test its external（appearance、pH、assay、Tal and creature activity） .Results：The assay and activity of thymosin is stabler in the sodium chloride liquid.Conclusion：The second technic prescription and condition is simple and good,and suits to the large -scale production.