非达霉素粗品中杂质的分离与鉴定

Isolation and identification of impurities in raw fidaxomicin

目的分离和鉴定非达霉素粗品中的杂质。方法采用制备液相色谱技术对非达霉素粗品中的杂质进行分离提纯,并通过核磁共振波谱和质谱分析鉴定杂质的结构。结果分离并鉴定了4个非达霉素杂质化合物,分别为非达霉素的有关化合物E、有关化合物K、有关化合物O和闰年霉素A4。结论杂质化合物与非达霉素骨架结构一致,属同系列化合物,由非达霉素发酵代谢过程产生,为非达霉素的质量控制和安全性评价提供了技术支持。

Objective To isolate and identify the impurities in raw fidaxomicin. Methods The liquid chromatography is adopted to isolate and purify the impurities in the raw fidaxomicin, and the nuclear magnetic resonance spectrum and mass spectrum analysis is used to identify the structure of impurities. Results The four fidaxomicin impurity compounds are isolated and purified, they are fidaxomicin related compound E, compound K, compound O and lipiarmycin A4 respectively. Conclusion The skeletal structure of impurity compounds is consistent with fidaxomicin, belongs to the same series compounds, produced by the fidaxomicin fermentation metabolic processes, which supports the technical support for the safety evaluation and the quality control of fidaxomicin.