氟康唑氯化钠注射液的质量评价

Quality assessment of fluconazole and sodium chloride injection

目的对国产氟康唑氯化钠注射液的质量状况进行评价。方法采用法定标准检验结合探索性研究,对检验结果进行统计分析。结果按法定标准检验158批样品,合格率为100%。探索性研究采用文献报道的有关物质测定方法,对样品进行检测,合格率为95.4%;采用LC/MS对主要杂质进行结构确认,并进行来源分析;氟康唑氧化降解杂质为主要杂质,部分企业的原料和制剂中存在未知的弱极性杂质,优化后的有关物质系统可对其同步控制。结论国产氟康唑氯化钠注射液的整体质量较好,各企业产品存在不同程度的质量差异。原料工艺控制水平是影响本品质量的关键因素,相关企业应对原料进行优选并提高生产工艺控制水平。现行标准无法有效控制弱极性杂质,pH值及渗透压摩尔浓度的限度范围有待规范,标准亟待修订。

Objective To evaluate the quality of fluconazole and sodium chloride injection.Methods The statutory standard tests combined with exploratory researches were used to evaluate the quality by statistical analysis of the results.Results According to the statutory standards for the examination of the 158 batches of samples,the qualified rate was 100%.Analysis methods of related substances were developed,and the qualified rate was 95.4%according to the exploratory researches standards.The structures and sources of impurities were confirmed by using LC/MS;fluconazole oxidative degradation impurity was the major impurity.Some unknown nonpolar impurities existed in fluconazole raw materials and preparations,which can be detected and controlled by this method.Conclusion The overall quality of fluconazole and sodium chloride injection was good,but differences in the level of impurities,the pH value,and osmolarity was found between generic products and innovative drugs.The quality of raw materials was the key to the quality of products,the domestic enterprises should optimize the raw materials and production processes to improve the product quality;the current statutory standards should be unified and further improved.