Study on the optimization of vacuum freeze drying technology ofAmifostine

摘要

Amifostine is a new drug which is used to protect the normal cell and against the cancer and it is used toproduce by vacuum freeze-drying. The purpose of this paper is to find the quantitive and qualitative relationshipbetween crystal configuration and stability and provide optimal operating parameters for freeze-drying product ofAmifostine. This paper focuses on the optimization of vacuum freeze-drying processing techniques of Amifostine.The optimal solution concentration is 0.10*103 kg/m3 or so and the one of additive content is between 5% and 12%for the injection of Amifostine. High solution concentration and low additive content are satisfied to thehomogenous crystal configuration and product stability. Additive content obviously affects the eutectic point ofsolution and high additive content will decrease the eutectic point. In addition, the vacuum freeze-drying process isoptimized by adjusting operating parameter of shelf temperature. The total time and cost of vacuum freeze dryingare also decreased by the change of shelf temperature. In a word, the total time and cost of vacuum freeze dryingare reduced through the changes of solution concentration, additive content and shelf temperature.