注射用阿洛西林钠在5%木糖醇注射液中的稳定性考察

Study on Stability of Azlocillin Sodium For Injection in 5% Xylitol Injection

关键词:  高效液相色谱法  经典恒温加速法  多元线性模型  阿洛西林钠  稳定性

Key words:  classical isothermal accelerated tests  multiple linear model  azlocillin sodium  stability

摘要:

目的研究注射用阿洛西林钠在5%木糖醇注射液中的稳定性。方法用高效液相色谱法测定阿洛西林钠的含量,用经典恒温加速法和多元线性模型研究温度对阿洛西林钠在5%木糖醇注射液中稳定性的影响。结果各温度下阿洛西林钠百分含量的对数(lgC)与时间(t)具有线性关系,符合一级动力学反应。用经典恒温加速法和多元线性模型预测阿洛西林钠在5%木糖醇注射液的有效期分别为5.09d,5.59d。结论2种方法预测得到的有效期基本一致。在25℃,注射用阿洛西林钠在5%木糖醇注射液应在5d内稳定。

Abstract:

OBJECTIVE To study the stability of azlocillin sodium in 5% xylitol injection.METHODSThe content of azlocillin sodium was determined by HPLC and the effect of temperature on the stability of azlocillin sodium in 5% xylitol injection was detected by classic isothermal accelerated tests and multiple linear model. RESULTSThere was a linearity between the azlocillin contents in the 5% xylitol injection in logarithm (lgC) and time (t) at each temperature.It responded to the first order kinetic reaction. The expiration dates of azlocillin sodium 5% xylitol injection detected by classic isothermal accelerated tests and multiple linear model were 5.09 days and 5.59 days, respectively.CONCLUSIONIts expiration dates are the same calculated by 2 different methods. Azlocillin sodium in 5% xylitol injection was stable within 5d at room temperature (25 ℃).