Preparation of pancreatic enzyme granules and enteric film coating of the study and simulation of accelerated test
Abstract
In the first part of the experiment, the pancreatic enzymes (Pancreatin) to contain amylase (Amylase) lipase (Lipa-
se) and protein particles of the preparation of their experimental system to study.
The results showed that pancreatic enzyme tablets ingredients in traditional style Granulation Line, the No Tax Agents, directly to the water as adhesive, adhesive
Together, with its blade granulator granulation (Ram Extruder Granulator), helps to retain activity, while the Progressive
Nirvana-style traditional step granulation method in the
manufacturing process to improve, then to reduce the granulation of the mechanical break pregnant, and to
Enzyme obtained by this method particles are able to maintain activity of more than 90 percent, this flow of particles into the layer granulator
(Fluid-Bed Granulator) in order to rubber-soluble polymer (Eudragit L30 D) for coating studies, found
Fixed conditions and coating materials, coating amount of the more drying time between discernment is longer allow the formation of a more complete film coating
All in for enteric film coating of the dissolution test, to prevent sabotage of acid into the membrane enzyme activity, and eventually
To this the experimental products and commercial goods to a dissolution test for comparison of dissolution activity.
The second part to accelerate computer simulation experiment, this experiment PASCAL computer simulation in three temperatures (40, 50,
60. C) or five temperatures (40, 50, 60, 70, 80. C) and the
experimental period of three months or six months, consisting of
Accelerate the experimental design, computer-related factors according to the setting of the constants (and activation energy storage on the frame) to simulate the difference with experiment
(2.5%, 5.0%, 7.0%) of the data, then simulate the application of two kinds of experimental data, Zhao sexual relationship to assess their requirements
Have the storage rack and the activation energy of the accuracy of two kinds of solution thus Zhao Xing Liao relationship of Liaoning in the real application of viability by
The results showed that the difference between the control
experiment at room temperature storage rack of forecast accuracy has a great influence, and experimental design
Account in the choice of the number of test temperature and test the length of the period covered if sufficient amount of drug units significantly
Change in estimate will be more super-close to the theoretical value, while the linear regression method than the traditional method.
