摘要
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 explore the analysis method of related substances of cefradine capsules and discuss limit and influence factors. Methods The exploratory research method was used to assay the related substances of 380 batches of national drug evaluation testing samples that produced by 95 enterprises. Results The assay method of related substances in Chp2010 could not effectively separate impurities and identify 7-ADCA and dihydrogen benzene glycosides acid; The single impurity limit value was too high, which could not control the level of 4＇,5＇-double hydrogen cefradine and other single impurity, These above problem was solved, and the factors affecting the related substances were discussed. Conclusion The quality standard in Chp2010 should reduce limit value according to actual samples; the manufacturer should select high-quality raw materials, avoid unreasonable wet granulation process, and strengthen packing material sealing to maximize the related substances control level.
出处
《中国抗生素杂志》
CAS
CSCD
北大核心
2014年第1期36-39,44,共5页
Chinese Journal of Antibiotics
关键词
头孢拉定胶囊
有关物质
影响因素
Cefradine capsule
The related substances
Influence factors
