摘要
目的考察辅料和温度对穿琥宁注射液的影响,预测其在室温下的贮存期。方法建立HPLC法测定穿琥宁注射液含量,采用经典恒温加速实验方法考察注射液不同处方的稳定性,筛选最佳处方,并预测其在室温下的贮存期。结果与结论筛选出含0.05%EDTA-2Na的最佳处方,其室温下的贮存期为3.45年。
Objective： To investigate the influence of vehicle and temperature on potassium dehydroandrographolide succinate injection and to predict its shelf life. Methods： A HPLC method was adopted for the assay. The classical isothermal accelerated stability test was conducted to observe the stability of the injection with varied formulations, to screen out the best formulation and to predict its shelf life. Results and Conclusion： The best formulation containing 0.05 % EDTA-2Na was selected and its shelf life of 3.45 years was predicted.
出处
《药学进展》
CAS
2005年第12期560-562,共3页
Progress in Pharmaceutical Sciences
关键词
穿琥宁注射液
高效液相色谱法
处方
稳定性
贮存期
Potassium dehydroandrographolide succinate injection
HPLC
Formulation
Stability
Selflife
