头孢氨苄不稳定性对建立相应复方制剂质量标准的影响

The Influence of the Instability of Cefalexin on Establishment of the Quality Standard of the Corresponding Compound Preparation

关键词:  头孢氨苄  单硫酸卡那霉素  试剂纯度  不稳定性

Key words:  Cephalexin  Kanamycin monosulfate  purity of reagents  instability

摘要:

在兽用复方化学制剂头孢氨苄单硫酸卡那霉素乳房注入剂的注册检验过程中发现：当萃取所用的乙醚为国产分析纯试剂时，头孢氨苄会降解从而影响相应含量测定与降解物检查；在卡那霉素降解物检查项中，供试品溶液制备过程中的加热步骤会导致头孢氨苄降解从而干扰该项测定。针对上述两个问题进行研究后认为，申报方在标准中应对试剂纯度及卡那霉素降解物检查项中空白的配制方法作出详细规定。本实验在为完善该质量标准提供参考的同时，也可为同业人员制定含有不稳定主成分的兽用复方化学制剂的质量标准提供借鉴。

Abstract:

During the registration test of veterinary compound preparation intramammary infusions of cephalexin and kanamycin monosulfate, two problems were found: when the ether used for extraction was analytical reagent, cephalexin degraded that would interfere with the content determination of cephalexin and the inspection of degradation of cephalexin; during the inspection of degradation of kanamycin, the heating process during the preparation of test sample solution could lead to degradation of cephalexin that would interfere with the determination. In view of the above two questions, the corresponding suggestions were put forward—the applicant should make detailed provisions on the purity of the reagent and the preparation method of the blank in the examination of the degradation of kanamycin. This paper could provide reference not only for the applier to improve the quality standard, but also for the peers to establish quality standard for compound chemical preparation which contains unstable principal components.