国产头孢克肟口服固体制剂有关物质研究

Studies on impurities in domestic oral solid preparation of cefexime

目的对国产头孢克肟口服固体制剂有关物质进行分析，对其中的主要有关物质来源、结构进行初步研究。方法建立HPLC方法对头孢克肟口服固体制剂有关物质进行了考察，采用LC-Q-TOF／MS技术对主要杂质结构进行了初步鉴定。结果国产头孢克肟口服固体制剂共检出20个有关物质，其中，杂质7、14、16、17是主要杂质。486批样品的有关物质最大单个杂质含量在0．1％～4．1％之间，总杂质含量在0．1％～9．8％之间。结论制剂中的有关物质来源于原料及降解反应，建议企业优化生产工艺，严格控制原料的质量及生产、运输和贮存环境。

Objective To analyze the related substances of domestic oral solid preparation of cefexime, and study the source and structure of major impurities. Methods An HPLC method was established to study the impurities in oral solid preparation of cefexime. LC-Q-TOF/MS technique was used to identify the structure of the impurities. Results There were 20 impurities detected in domestic oral solid preparation of cefexime, the major impurities were impurity 7, 14, 16 and 17. In 486 batches of samples, the largest content of single impurity range from 0.1% to 4.1%, the total content of impurity range from 0.1% to 9.8%. Conclusion The study found that the impurities came from raw material and degradation reaction. The domestic enterprise should further optimize the productive technology, strengthen the quality of raw materialand and the environment of production, transportation and storage.