The Freeze-drying Process Optimization And Application Of Cardiomyopeptidin

Cardiomyopeptidin is a class of drugs used in the perioperative period of cardiac surgery for the purpose to accelerat the renovatation process of myocardial damage. Based on the current situation of the numbers of the heart disease patients increased year by year, which stimulates the demand for Cardiomyopeptidin. This paper focus on the optimization for the original freeze drying process of Cardiomyopeptidin for the purpose of improving the quality of Cardiomyopeptide, reducing the costs and increasing production capacity which will leads to the popularity of clinical Cardiomyopeptidin drugs with high quality and common price and Have important meaning in clinical application.As This paper all knows, the previous freeze-dried process presented three problems as follows:long cycle of lyophilization(78 hours), existence of frozen layer and large deviation of quality in group(greater than 2%). So this paper conducted a detailed research to the quantity of sublimation water, the degree of the vacuum, the methods of refrigeration and the stage of primary drying on the basis of the original technology of freeze drying. This paper draw the relationship curve of temperature and sublimation water volume and the results shoThis paperd that the maximum sublimation water volume in the first sublimation stage at the range of temperature from-15? to -5?.This paper innovatived the process of freeze drying according to more than 50 times preliminary tests(25 pieces per time) and retests(300 pieces per time) and to further shortened the time of the freeze drying cycle for 15 hours and optimized the times to 60 hours which was successful used in the amplification of industrial production in the Zhenao Company(17647 pieces with 500 mg per piece) with more than 2.3% amount of qualified quantity and qualified water content which corroborated the feasibility of this methods. But this shorten time freeze drying process have a certain optimization on the existence of frozen layer and the large deviation of quality in group but can not completely resolved these problems.So This paper innovatively added the annealing process and to optimizing solve the conditions problems frozen layer and deviation of quality. This paper added the annealing process during the freeze drying annealing stage and investigate the temperature, time and freezing maintenance time before and after the time for freeze drying to ensure the best optimal conditions:annealing lasted for 80 min at -9? after 90 min freeze drying and continue to freeze drying for 240 min which completely solved the existence of frozen layer and the large deviation of quality in group and moreover with a satisfied better results of active effect to shorten the freeze drying cycle. even shortening the freeze drying cycle to 55 hours.