摘要
以6α-甲基-11β,17α-二羟基-1,4-孕甾二烯-3,20-二酮为起始原料,经碘代、酯化、醇解和单酯化4步反应得到琥珀酸甲泼尼龙,总摩尔收率46%,其HPLC纯度为99.86%;再经碱降解制备琥珀酸甲泼尼龙的杂质EP-B,并经MS、NMR确证其结构。杂质EP-B的制备可为琥珀酸甲泼尼龙原料和制剂的质量控制提供参考。
Starting with 6α-methyl-11β,17α-dihydroxy-1,4-pregnadiene-3,20-dione as a raw material,methylprednisolone hydrogen succinate was obtained through four steps of iodination,esterification,alcoholysis,and monoesterification,with a total molar yield of 46%and an HPLC purity of 99.86%.The impurity EP-B of methylprednisolone hydrogen succinate was prepared by further alkali degradation,and its structure was confirmed by MS and NMR spectroscopy.The preparation of impurity EP-B can provide references for the quality control of methylprednisolone hydrogen succinate raw materials and preparations.
作者
梁吉
LIANG Ji(Shanghai Pharmaceutical School,Shanghai 200135,China)
出处
《上海医药》
2026年第2期77-81,共5页
Shanghai Medical & Pharmaceutical Journal
关键词
琥珀酸甲泼尼龙
合成
杂质EP-B
结构确证
methylprednisolone hydrogen succinate
synthesis
impurity EP-B
structural confirmation
