Study on the optimization of vacuum freeze drying technology of Amifostine

摘要

Amifostine is a new drug which is used to protect the normal cell and against the cancer and it is used to produce by vacuum freeze-drying. The purpose of this paper is to find the quantitive and qualitative relationship between crystal configuration and stability and provide optimal operating parameters for freeze-drying product of Amifostine. 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 the homogenous crystal configuration and product stability. Additive content obviously affects the eutectic point of solution and high additive content will decrease the eutectic point. In addition, the vacuum freeze-drying process is optimized by adjusting operating parameter of shelf temperature. The total time and cost of vacuum freeze drying are also decreased by the change of shelf temperature. In a word, the total time and cost of vacuum freeze drying are reduced through the changes of solution concentration, additive content and shelf temperature.