环境温度及放置时间对注射用头孢菌素类抗生素有关物质检查结果的影响

摘要

目的 分析环境温度和放置时间对注射用头孢菌素类抗生素有关物质检查结果的影响.方法 注射用头孢曲松钠、注射用头孢呋辛钠、注射用头孢唑林钠3个品种各取3个批号,并分别制成有关物质检查供试品溶液,将供试品溶液分别放在4℃、25℃、35℃环境中放置一定时间,采用带控温模块的高效液相色谱仪测定注射用头孢菌类抗生素杂质含量,并观察杂质含量变化.结果 注射用头孢曲松钠、注射用头孢呋辛钠、注射用头孢唑林钠的杂质含量随着温度的升高、放置时间的加长而增加.在4℃环境中3种药物的放置时间均可达24 h以上,在25℃环境中注射用头孢曲松钠、注射用头孢唑林钠的放置时间基本可达24 h,在35℃环境下3种药物的放置时间均不足24 h,其中注射用头孢呋辛钠对温度的变化最敏感,在25℃、35℃环境下,其放置时间最短.结论 注射用头孢菌素类抗生素对温度变化的敏感度不一,且随着温度的升高和放置时间的延长,其杂质含量逐渐增加.在对注射用头孢菌素类抗生素有关物质进行检查时,需注意控制试验温度和放置时间,减轻环境温度和放置时间对检查结果的影响.%Objective To analyze the environmental temperature and placing time of cephalosporin class of antibiotics for injection related substances test results.Methods Ceftriaxone sodium for injection, cefuroxime sodium for injection, cefazolin sodium for injection, three varieties of cephalosporin antibiotics for injection clinical commonly used, three batches from each, were respectively made the change of impurities' content check, and the test solution were placed in the environment temperature on 4℃, 25℃ and 35℃ with a certain period of time. Determinating the impurities' content of fungi cephalosporin antibiotics by high performance liquid chromatograph with temperature control module.Results The impurities' contents of Ceftriaxone sodium for injection, cefuroxime sodium for injection and Cefazolin sodium for injection increased with the increasing of temperature and the extension of placing time . Under 4℃, three kinds of cephalosporin class of antibiotics for injection all can place over 24 h; Under 25℃, the placing time was up to 24 h both Ceftriaxone sodium for injection and Cefazolin sodium for injection; Under 35℃,t he placing time of three kinds of cephalosporin class of antibiotics for injection was shorter than 24h. Among three kinds of cephalosporin class of antibiotics, Cefuroxime sodium for injection was the most sensitive to changes in temperature, it's placing time was shortist under 25℃ and 35℃.Conclusion The cephalosporin class of antibiotics for injection had different sensitivity to temperature changing, and it's impurity content increased gradually with the increase of temperature and the extension of placing time.When checking the related substances of the cephalosporin class of antibiotics for injection, we need to pay attention to control test temperature and placing time, and reduce the impact of environmental temperature and placing time to the check result.