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目的对头孢拉定胶囊有关物质分析方法、限度及影响因素进行探讨。方法采用探索性研究方法,对95家生产企业380批次国家药品评价抽验样品进行有关物质的测定。结果解决了药典标准有关物质方法杂质分离不佳,不能有效识别7-氨基乙酰氧基头孢烷酸(7-ADCA)、双氢苯苷氨酸;单个杂质限度值过高,无法控制4’,5’-双氢头孢拉定的水平,也无法控制除4’,5’-双氢头孢拉定外其它单个杂质的问题,并对有关物质影响因素进行了初步探讨。结论药典有关物质标准较为宽泛,应根据样品实际下调限度值;各生产厂家应选用优质原料、避免不合理的湿法制粒生产工艺、加强包装材料密封性,最大限度提高有关物质控制水平。
Objective To investigate the methods, limits and influential factors of cephradine capsule-related substances. Methods Exploratory research methods were used to determine the related substances in 380 batches of national drug evaluation samples from 95 manufacturing enterprises. As a result, the method of the Pharmacopoeia standard related to substance separation is poor, which can not effectively identify 7-aminoacetoxycephalosporanic acid (7-ADCA) and dihydrophenylalanine; single impurity limit value is too high to control 4 ’ 5’-dihydropterralradine level, but also can not control the 4 ’, 5’-dihydrocephalosporin other single impurity problems, and the influencing factors of the substances were discussed. Conclusion The relevant Pharmacopoeia standards are more broadly based, and the actual cut-off value should be based on the samples. All manufacturers should use high-quality raw materials to avoid unreasonable wet granulation production process, enhance the tightness of packaging materials and maximize the control of related substances.