The Analysis of the Accelerated Degradation Test for Protein-type Biological Standard Substances / 中国药学杂志
Chinese Pharmaceutical Journal
;
(24): 2113-2117, 2018.
Artigo
em Chinês
| WPRIM
| ID: wpr-858122
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.
Texto completo:
DisponíveL
Índice:
WPRIM (Pacífico Ocidental)
Tipo de estudo:
Estudo prognóstico
Idioma:
Chinês
Revista:
Chinese Pharmaceutical Journal
Ano de publicação:
2018
Tipo de documento:
Artigo
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