25％抗坏血酸注射液的稳定性考查及贮存期预测

Stability investigation of 25％ascorbic acid injection

本文研究了不同温度下新处方25%抗坏血酸注射液的颜色变化及浓度变化。采用经典恒温法及初均速法对药物进行稳定性加速试验,并结合Weibull概率分布拟合法计算贮存期,均达7年,表明新处方组合较为理想。

The stability behaviors of 25% ascorbicacid injection affected by excipients, metallicions and pH were studied with special attentionto the best formulation condition for the injec-tion. The shelflife of the injection was predictedto be about 7 years by the classical method,weibull probabillity paper method and initial av-erage rate method.