头孢噻肟钠酸碱稳定性研究

发布时间：2018-02-16 03:31

  本文关键词： 头孢噻肟钠 稳定性 酸碱　出处：《中国抗生素杂志》2017年08期 　论文类型：期刊论文

【摘要】：目的实验考察头孢噻肟钠分别在酸性和碱性条件下的稳定性及可能产生的降解产物,根据不同破坏条件下杂质峰面积的变化情况对杂质可能产生的来源进行分析。方法按溶液颜色比较法测定不同破坏程度时的色级,用UV方法测定不同破坏程度时头孢噻肟钠溶液的吸光度,以HPLC-UV测定杂质含量的变化。结果头孢噻肟钠水溶液在酸性和碱性条件下色级和吸光度均会发生变化,药品主成分含量有所下降,杂质含量随着破坏程度的加深而增加或降低,特别在碱性条件下变化更为明显。结论头孢噻肟钠的稳定性与pH有关,相比酸性条件下,碱性条件对头孢噻肟的稳定性影响更大,头孢噻肟钠在碱性条件下降解程度更深,主要降解产物为去乙酰头孢噻肟。
[Abstract]:Objective to study the degradation products of cefotaxime sodium were stable in acidic and alkaline conditions and possible, according to the analysis of changes in source area of different failure condition of impurity peaks on the possible impurities. Methods different color grade damage when measured by solution color comparison method to determine the absorbance of cefotaxime sodium the solution of different damage degree with UV method, change of impurity content was determined by HPLC-UV. The results of cefotaxime sodium in acidic and alkaline conditions the color and absorbance are changed, the drug containing principal component decreased, with the damage degree of impurity content increased or decreased, especially in alkaline conditions. The change is more obvious. Conclusion the stability of cefotaxime sodium and pH, compared to acidic conditions, effects of alkaline conditions on the stability of cefotaxime more, cefotaxime sodium The degradation degree of the main degradation product is deacetyl cefotaxime under the alkaline condition.

【作者单位】： 河北科技大学化学与制药工程学院;河北省药物化工工程技术研究中心;华北制药河北华民药业有限公司;
【基金】：河北省食品药品安全科技重点项目(No.ZD2015026) 河北省自然科学基金(No.B2015208106)
【分类号】：R927.1
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本文编号：1514560