Awsn Injection Developed

To investigate the pyrolytic degradation kinetics of sodium ferulate aqueous solution. The HPLC method was used to determine the contents of the sodium ferulate under different pH, ionic strength and dielectric constant condions. With comparative regression analysis of linear fit, the pyrolytic degradation kinetics orders of sodium ferulate solution were determined as 1. The pHm of the sodium ferulate aqueous solution is about 6. The higher ionic strength and dielectric constant conditions can increase the degrade rate. It was found that the pyrolytic degradation kinetics of sodium ferulate solution followed apparent first-order kinetics. The degrade rate was affected by pH remarkably and showed positive correlation with ionic strength and dielectric constant.Drug-excipients were one of the most important factors which would influence the stability of sodium ferulate formulation. Based on the pyrolytic degradation kinetics of sodium ferulate aqueous solution. We selected several pH, oxidation-resistants, EDTAn buffers, nonaqueous solvents as the influential factors.A HPLC method for determing the content and of sodium ferulate injection. The linear ranger was 3. 54~15. 95 μ g/ml, A = 100316C-46640, R2 = 0.9999; The recovery were 99. 51 ± 0.55%, 100. 00 ± 0. 50%, 99. 27±0.42% respectively; The intra-day precision were 0. 06±0. 69%, 0. 10±0. 96%, 0.09 ±0. 72%respectively; Samples and maintain their stability in 8 hous.Classic isothermal kinetic method and Multivariate linear model were used to predict the expiration date of the injection, and compared the characteristics of these two different methods at the same time. It was found that the pyrolytic degradation kinetics of sodium ferulate injection followed apparent first-order kinetics. The expiration date of the injection calculated by two different methods were 1.76, 1.90 years. The expiration date of the injection calculated by two different methods almost the same, Multivariate linear model can be used for a convenient method to predict the expiration date of the injection.