摘要
泊沙康唑作为治疗抗真菌感染,现有文献及合成工艺优化,虽然有的文献报道可以工业化生产,但是没有作为原料药(API)参照QBD理念,充分考虑作为API的要求去设计工艺,也没有杂质谱的分析。泊沙康唑(posaconazole)是2006年9月15日由美国FDA批准的一种广谱三唑类抗真菌药,用于难治性疾病或其他药物耐药所引起的真菌感染(如曲霉菌病、结核菌病和镰刀菌病等),该药由美国Scher. ing-Plough公司研制上市,商品名为Noxafil。本文主要介绍作为原料药,而非化工品适合于工业化生产的工艺研究,及其作为原料药在药物申报阶段,从起始原料开始至API的杂质谱的分析与控制。
As a therapeutic antifungal infection,posaconazole is optimized in the existing literature and synthetic process.Although some literature reports it can be industrialized,it does not refer to the QBD concept as a drug substance(API),and no fully considers the design process as an API requirement.There is no analysis of the impurity spectrum.Posaconazole is a broad-spectrum triazole antifungal drug approved by the US FDA on September 15,2006 for fungal infections caused by refractory diseases or other drug resistance.(such as Aspergillosis,Tuberculosis and Fusarium),the drug is made by Scher.ing-Plough company is on the market,the trade name is Noxafil.This paper mainly introduces the process research as a raw material drug,not a chemical product suitable for industrial production,and as a raw material drug in the drug declaration stage,from the starting material to the analysis and control of the impurity spectrum of the API.
作者
郭彦飞
蓸卫
包玉盛
刘婷婷
Guo Yanfei;Cao Wei;Bao Yusheng;Liu Tingting(Nanjing Heron Pharmaceutical Science and Technology Co.,Ltd.,Nanjing 211100,China)
出处
《山东化工》
CAS
2018年第23期47-51,55,共6页
Shandong Chemical Industry
关键词
泊沙康唑
治疗真菌感染
合成工艺
杂质谱分析
Posaconazole
treatment of fungal infection
synthesis process research
impurity spectrum analysis