| The efficiency,rapidity and accuracy of drug testing are very important for acceleration of drug development.Dissolution Tester is widely used in the R&D and production of pharmaceutical enterprises.It is an essential key instrument in the R&D and production of solid drugs.In this thesis,a dissolution Tester has been chosen as the research object.According to the actual needs of the pharmaceutical R&D department,the research and Implementation Based on the extended function of dissolution instrument is carried out,and a set of p H dynamic control system of dissolution instrument is developed.The main work and innovations are as follows:Combined with the function and structure of the existing dissolution instrument in the laboratory,the technological requirements of the pharmaceutical R&D department for the p H regulation function of the dissolution instrument were comprehensively analyzed.By using the acid-base regulating model of human intestinal buffering,the change rule of p H was analyzed.The results showed that it was directly related to the dissolved amount of carbon dioxide in the buffer.The p H of buffer solution can be reduced by introducing carbon dioxide;the p H of buffer solution can be increased by replacing carbon dioxide with argon.Through the mixing of carbon dioxide and argon in different proportion,the p H value of the solution can be adjusted dynamically,and a biologically related dissolution method combined with quality control is put forward innovatively.The control algorithm of pH and process gas flow of the solution is presented,the system model based on PID control algorithm is established.A set of buffer p H automatic control system based on Siemens S7-200 PLC is designed.The control system includes hardware part and software part.Based on the WEILUN EB Pro configuration software,it can realize human-computer interaction and real-time monitoring of p H and gas flow,and meet the requirements of national GLP for software user management and data recording.The design function of the control system was verified by the dissolution test of Mycophenolate sodium enteric-coated tablets.The results show that the gas flow control and p H dynamic regulation meet the design function and use requirements.The research results have been used in drug research and development of enterprises,significantly accelerating the development process of related drugs. |
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