摘要
为了控制磺达肝癸钠注射液的质量,合成了磺达肝癸钠注射液的3个有关物质。分别为甲基-O-(2-脱氧-6-O-磺酸基-2-氨基-α-D-吡喃葡萄糖)-(1→4)-O-(β-D-吡喃葡萄糖醛酸)-(1→4)-O-(2-脱氧-3,6-O-二磺酸基-2-氨基-α-D-吡喃葡萄糖)-(1→4)-O-(2-O-磺酸基-α-L-吡喃艾杜糖醛酸)-(1→4)-2-脱氧-6-O-磺酸基-2-磺酰胺基-α-D-吡喃葡萄糖苷八钠盐(IP1)、甲基-O-(4-脱氧-2-磺酰基-α-L-吡喃-己-4-烯糖酸)-(1→4)-2-脱氧-6-O-磺酸基-2-磺酰胺基-α-D-吡喃葡萄糖苷四钠盐(IP2)、甲基-O-(2-脱氧-6-O-磺酸基-2-磺酰胺基-α-D-吡喃葡萄糖)-(1→4)-O-(β-D-吡喃葡萄糖醛酸)-(1→4)-O-(2-脱氧-3,6-O-二磺酸基-2-氨基-α-D-吡喃葡萄糖)-(1→4)-O-(2-O-磺酸基-α-L-吡喃艾杜糖醛酸)-(1→4)-2-脱氧-6-O-磺酸基-2-磺酰胺基-α-D-吡喃葡萄糖苷九钠盐(IP3)。所得的产物经1HNMR、13CNMR和HRMS等确证了结构,可以作为质量研究的对照物。
To conduct the quality control of fondaparinux sodium injection, three related substances were synthesized, including methyl O-(2-deoxy-6-O-sulfo-2-amino-α-D-glucopyranosyl)-(1→4)-O-(β-D-glucopyranosyluronate)-(1→4)-O-(2-deoxy-3,6-di-O-sulfo-2-amino-α-D-glucopyranosyl-(1→4)-O-(2-O-sulfo-α-L-idopyranosyluroate)-(1→4)-(2-deoxy-6-O-sulfo-2-(sulfoamino)-α-D-glucopyranoside),octasodium salt(IP1), methyl-O-(4-deoxy-2-O-sulfo-α-L-threo-hex-4-enopy ranosyluronate)-(1→4)-O-(2-deoxy-6-O-sulfo-2-sulfamino-α-D-glucopyranoside), tetrasodium salt(IP2), methyl O-(2-deoxy-6-O-sulfo-2-(sulfoamino)-α-D-glucopyranosyl)-(1→4)-O-(β-D-glucopy ranosyluronate)-(14)-O-(2-deoxy-3,6-di-O-sulfo-2-amino-α-D-glucopyranosyl-(1→4)-O-(2-O-sulfo-α-L-idopyranosyluronate)-(1→4)-(2-deoxy-6-O-sulfo-2-(sulfoamino)-α-D-glucopyranoside), nonasodium salt(IP3). Their structures were confirmed by 1H NMR, 13C NMR and HRMS.
作者
干浩
徐珊珊
周喜泽
李振重
GAN Hao;XU Shanshan;ZHOU Xize;LI Zhenzhong(Tianjin Chase Sun Pharmaceutical Co.,Ltd.,Tianjin 301700;Hubei Enoray Biopharmaceutical Co.,Ltd.,Huangmei 435501)
出处
《中国医药工业杂志》
CAS
CSCD
北大核心
2019年第11期1280-1284,共5页
Chinese Journal of Pharmaceuticals
关键词
磺达肝癸钠
有关物质
杂质合成
抗血栓药物
质量控制
fondaparinux sodium
related substances
synthesis of impurities
anticoagulant
quality control
