The Freeze-drying Process Optimization And New Technology Development Of Cardiomyopeptidin For Injection

Cardiomyopeptidin is a kind of biological drug used in the perioperative period of cardiac surgery,and the main ingredient of it can help to repair myocardial damage.With more and more people getting heart disease in C hina,the demand of cardiomyopeptidin also increases.In the production of cardiomyopeptidin for injection,Vacuum Freeze-Drying is a key technology.This paper aims to optimize the original freeze drying process and develop a new routing,which can improve quality of the drug and reduce cost of the production.O n the other hand,the research systematically investigated the freeze drying process of a kind of biological drug,it is full of practical and academic meaning.The freeze drying process of cardiomyopeptidin faces many difficulties such as long cycle of freeze drying(78 hours)and large deviation of quality in group(more tha n 2%)which reduce the efficiency of product.In the research,we conducted rigorous experiments to investigate many factors which may influence the freeze drying process by a miniature freeze dryer.After investigating all kinds of factors of preparation of solution,freezing stage,and drying stage,we get an initiatorily optimized freeze drying process which cuts down the cycle from 78 hours to 45 hours and reduces the deviation of quality in group.During the research,we found four most important factors: filling quantity,feeding method,duration time of low speed stage,duration time of high speed stage.Then,we conducted an orthogonal test of vacuum degree,air stir,duration time of low speed stage,duration time of high speed stage,and get a furtherly optimized process.Then,we successfully applied this optimized process to a larger scale retest(300 pieces per time),aiming to measure the stability of the process and to furtherly adjust it.Last,we applied the adjusted optimal process to the amplification of industrial production(more than 10000 pieces per time)and successfully solved the problems as mentioned above.The research above focuses on the optimization of the original freeze drying process,but it is so complicated that the parameters change frequently which may increases the deviation of quality.In the paper we added the annealing technology to the original freeze drying process.With the best conditions of annealing: temperature of annea ling at-9℃ for 80 min,duration time before annealing is 150 min,and duration time after annealing is 180 min,the original process is thoroughly simplified and the cycle of process is cut down to 40 hours with qualified moisture and good appearance.Meanwhile,the most confused problem called freeze layer is completely solved owing to annealing technology.