Studies On Freeze-drying Process Of Temozolomide For Injection

In this thesis,we study the freeze-drying process of temozolomide for injection,including the temperature and time of pre-freezing,the temperature of primary drying and secondary drying,time and vacuum degree.By optimizing the product freezing,drying and other issues to solve the unqualifiedproduct appearance and performance problems during the production process.Based on a large number of experimental researches,the freeze-drying process is:1)control the temperature of the feed plate of the freeze dryer at 5℃ before feeding and let the freeze dryer stand for 0.5 hour after all products in;2)pre-freezing process,cool the plate temperature to-50℃ with a constant speed within 2.5 hours and keep for 4 hours at this temperature;3)primary drying process,reduce the pressure of freeze-drying chamber to 26Pa±2Pa,raise rapidly the plate temperature from-50℃ to-10℃ and maintain 2 hours;raise rapidly the plate temperature from-10℃ to 0℃ and maintain 29 hours;raise rapidly the plate temperature from 0℃ to 5℃ and maintain 8 hours;raise rapidly the plate temperature from 5℃ to 10℃ and maintain 9.5 hours;4)secondary drying process,maintain the pressure of freeze-drying chamber at 26Pa±2Pa,raise rapidly the plate temperature from 10℃ to 35℃ and maintain 13 hours.Products obtained from above freeze-drying process are: good appearance,no shrinking,no bubbling,uniform color,porosity,firm structure,fast speed of re-dissolution and low residual water.This study provides experimental data for the study of the freeze-drying process of temozolomide,which has important theoretical significance and application value for the production and early market of temozolomide.