复方磺胺甲噁唑片降解杂质分析  

Analysis of Degradable Impurities in Compound Sulfamethoxazole Tablets

作　　者：张名坚 颜文革 张用钊 林芳 周珍辉 ZHAN Min-jian;YAN Wen-ge;ZHANG Yong-zhao;LIN Fang;ZHOU Zhen-hui(Teyi Pharmaceutical Group Co.,Ltd.,Taishan 529200,China)

机构地区：[1]特一药业集团股份有限公司,广东台山529200

出　　处：《精细化工中间体》2024年第1期49-54,共6页Fine Chemical Intermediates

摘　　要：通过考察复方磺胺甲噁唑片的降解途径以及降解产物,有效地进行药物杂质分析,提高药品质量控制水平。取复方磺胺甲噁唑片、空白辅料、空白辅料加甲氧苄啶和空白辅料加磺胺甲噁唑四种组分的样品分别进行破坏试验,考察各样品在光、热、酸、碱、氧化条件下的降解情况。主要降解杂质有在氧化破坏条件下产生磺胺甲噁唑氧化杂质1和2、甲氧苄啶杂质F,光照破坏条件下产生较大的磺胺甲噁唑杂质C、D。通过降解杂质的研究,可以有效规避制剂处方工艺和储存等环节产生降解杂质的风险,还可以采用实验中液相色谱条件同时监测复方磺胺甲噁唑片中各降解杂质,提升质量标准。By examining products and pathways from the degradation of compound sulfamethoxazole tablets,effective impurity analysis of drugs can be carried out to improve the level of drug quality control.Samples of compound sulfamethoxazole tablets,blank excipients,blank excipients with trimethoprim,and blank excipients with sulfamethoxazole were taken for destruction tests to investigate the degradation of each sample under light,heat,acid,alkali,and oxidation conditions.The main impurities from degradation included sulfamethoxazole oxidation impurities 1 and 2 under oxidative damage conditions,trimethoprim impurity F,and larger sulfamethoxazole impurities C and D under light damage conditions.By studying the impurities from degradation,the risk of impurities from degradation in formulation processes and storage can be effectively avoided.The liquid chromatography conditions in this experiment can also be used to simultaneously monitor the impurities from degradation in compound,and improve quality standards.

关 键 词：磺胺甲噁唑 甲氧苄啶 降解杂质 

分 类 号：R943[医药卫生—药剂学]