The Analysis of the Accelerated Degradation Test for Protein-type Biological Standard Substances / 中国药学杂志

ABSTRACT

OBJECTIVE: To establish a weighted least square method for the accelerated degradation analysis of protein-type biological standard substances.METHODS: A mathematical model was proposed to estimate the parameters of degradation rate constants k at the elevated temperatures based on the Arrhenius or Eyring equation and chemical reaction principles under the suitable assumptions. Hence, it is probably to predict the stability of biological standard at the normal condition by solving the model.RESULTS: According to the experimental data of recombinant human granulocyte colony-stimulating factor and interferon α-2a, the preliminary numerical experiments were also performed and the results confirm the reliability of the method in the paper.CONCLUSION: The same methodology may be applied in the pharmaceutical industry where it is necessary to predict the viable shelf-life of biological products.