初匀速法预测复方枸橼酸钠注射液的有效期

Prediction of the Shelf Life of Compound Sodium Citrate Injection by Initial Average Rate Stability Test

目的:以初匀速法预测复方枸橼酸钠注射液有效期。方法:采用7个温度对样品进行加速试验,考察葡萄糖降解反应初均速(V0)与开尔文温度的倒数(1/T)的关系,并计算反应活化能、药物反应速度常数及有效期。结果:回归方程为lgV0=18.15—6774.6×1/T(r=—0.9375),复方枸橼酸钠注射液的反应活化能为31.0Kcal·mol-1,20℃药物反应速度常数为1.1×10-5h-1,有效期为1.09y。结论:本方法操作简便,可准确预测复方枸橼酸钠注射液的有效期。

OBJECTIVE： To predict the shelf life of compound sodium citrate injection by initial average rate stability test. METHODS： The initial average rate stability test was performed at 7 different temperatures to investigate the relationship between the initial average rate （V0）of the glucose degradation reaction and Kelvin＇ s temperature （I/T）, and the activation energy of reaction, the drug reaction velocity constant and shelf life were computed as well. RESULTS： The regression equation was lgV0 = 18.15-6 774.6 × 1/T（r =-0.937 5）, the reaction activation energy was 31.0Kcal · mol^-1, the drug reaction velocity constant at 20℃ was 1.1 × 10^-5h^-1, and the shelf life was 1.09 years. CONCLUSION： The method is simple and it can accurately predicate the shelf life of compound sodium citrate injection.