新鱼腥草素钠注射液中化学成分的研究(Ⅰ)

 目的研究新鱼腥草素钠(sodium New Houttuyfonate)注射液中的二聚物,为控制新鱼腥草素钠注射液的质量提供科学依据。方法采用HPLC、UPLC-MS及重量法3种方法测定了新鱼腥草素钠注射液中主成分的含量;制备了其有关物质二聚物,并通过波谱数据及原子吸收分光光度法鉴定了其化学结构,还测定了该化合物在制剂中的含量。结果用HPLC及UP-LC-MS测定2批新鱼腥草素钠注射液,发现主成分含量均仅不到2%,而用现标准含测重量法测定,含量为98%以上;二聚物鉴定为2-(1′-羰基十二烷基)-5-羟-2,4-十六二烯醛钠盐,UPLC-MS测定6批注射液及1批冻干粉针中该二聚物含量在0%～4%之间,而在原料的水溶液中含量较高为12%。结论实验说明新鱼腥草素钠注射液不稳定,现标准的含测方法不能全面反映药品质量。注射液中所含有一个二聚物为新化合物,其在水中对热不稳定。

Studies on Chemical Constituents of Sodium New Houttuyfonate Injection(Ⅰ)

OBJECTIVE To investigate the dimer of Sodium New Houttuyfonate Injection for controling the quality of Sodium New Houttuyfonate Injection.METHODS The major ingredient content of Sodium New Houttuyfonate Injection was determined by HPLC,UPLC-MS and weighting method.This chemosynthetic dimer substance was elucidated by spectra analysis and atomic absorption spectrophotometry.Meanwhile the dimer was determined by UPLC-MS for its content in the preparations.RESULTS The major ingredient content in Sodium New Houttuyfonate Injection by HPLC and UPLC-MS method were only less than 2%,but more than 98% by weighting method.The structure of the dimer was identified as monosodium salt of 2-(1'-carbonyl lauryl)-5-hydroxy-2,4-hexadecadienal.The dimer contents in Sodium New Houttuyfonate Injection by UPLC-MS method were in the range of 0%～4%.CONCLUSION Sodium New Houttuyfonate Injection is unstable.The official standard can not fully reflect the quality of the drug.There is a dimer which is reported firstly in Sodium New Houttuyfonate Injection,and the dimer was proved to dissolve in the water and unstable to heat.