缩宫素中醋酸含量对有关物质的影响

Effect of acetic acid content in oxytocin on related substances

目的:研究缩宫素中醋酸含量对缩宫素有关物质的影响。方法:采用液相色谱和质谱法对6批醋酸含量不同的缩宫素进行稳定性研究,分析有关物质种类、降解趋势和降解量。结果:鉴别出缩宫素降解产生的4种主要有关物质为杂质Ac-Oxy、Oxy[Trisulfide]、Oxy[Cis-dimer]和Oxy[Trans-dimer]。这4种杂质的降解趋势和降解量与缩宫素中醋酸含量密切相关,缩宫素中醋酸含量越高,得到的成品杂质数量和总杂含量越低,稳定性试验过程越不易降解产生杂质;但杂质Ac-Oxy降解速度越快,降解量越高。结论:缩宫素中醋酸含量的变化,对缩宫素成品质量和储存期间稳定性、杂质降解趋势和降解量都具有重要影响。

Objective:To study the effect of acetic acid content in oxytocin on related substances.Methods:Stability of six batches of oxytocin with different acetic acid contents was studied by liquid chromatography and mass spectrometry to analyze some kinds of substances,their degradation trend and degradation amount.Results:Four main substances related to the degradation of oxytocin were identified as impurities Ac-Oxy,Oxy[Trisulfide],Oxy[Cis-dimer]and Oxy[Trans-dimer].Their degradation trend and degradation amount were closely related to the acetic acid content in oxytocin,the higher the acetic acid content in oxytocin,the lower the amount of impurities and total impurity content in oxytocin,and the less likely it is to degrade and produce impurities during the stability test process.However,the faster degradation rate of impurity Ac-Oxy,the higher the degradation amount.Conclusion:The change of acetic acid content in oxytocin has an important effect on the quality of oxytocin,the stability during storage,the tendency of impurity degradation and the amount of degradation.