本文關鍵詞： 頭孢噻肟鈉 穩(wěn)定性 酸堿　出處：《中國抗生素雜志》2017年08期 　論文類型：期刊論文

【摘要】：目的實驗考察頭孢噻肟鈉分別在酸性和堿性條件下的穩(wěn)定性及可能產生的降解產物,根據(jù)不同破壞條件下雜質峰面積的變化情況對雜質可能產生的來源進行分析。方法按溶液顏色比較法測定不同破壞程度時的色級,用UV方法測定不同破壞程度時頭孢噻肟鈉溶液的吸光度,以HPLC-UV測定雜質含量的變化。結果頭孢噻肟鈉水溶液在酸性和堿性條件下色級和吸光度均會發(fā)生變化,藥品主成分含量有所下降,雜質含量隨著破壞程度的加深而增加或降低,特別在堿性條件下變化更為明顯。結論頭孢噻肟鈉的穩(wěn)定性與pH有關,相比酸性條件下,堿性條件對頭孢噻肟的穩(wěn)定性影響更大,頭孢噻肟鈉在堿性條件下降解程度更深,主要降解產物為去乙酰頭孢噻肟。
[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.

【作者單位】： 河北科技大學化學與制藥工程學院;河北省藥物化工工程技術研究中心;華北制藥河北華民藥業(yè)有限公司;
【基金】：河北省食品藥品安全科技重點項目(No.ZD2015026) 河北省自然科學基金(No.B2015208106)
【分類號】：R927.1
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本文編號：1514560