Control system and method for simulating gastrointestinal dynamic parameters and dissolution instrument

Abstract

The invention discloses a control system and method for simulating gastrointestinal dynamic parameters and a dissolution tester, and belongs to the field of medicine research and development equipment, the control system comprises a dissolution cup, a main control system, a solution parameter control system, a parameter determination system, at least two plunger pumps, a simulated gastric juice solution bottle and a simulated intestinal juice solution bottle, the parameter measuring system measures the current parameter value of the dissolution medium in the dissolution cup, and the master control system controls the plunger pump to operate by comparing the deviation between the current parameter value and the parameter set value, so that the current parameter value of the dissolution medium changes along with the adjustment of the parameter set value, and the dynamic adjustment of the dissolution medium parameter is realized. Therefore, the dynamic change process of gastrointestinal tract internal parameters of a human body or an experimental animal under physiological conditions or pathological conditions can be simulated, meanwhile, the dissolution process of a medicine in the body can be better reflected in a medicine dissolution experiment, and the device has the characteristics of intelligence, automation, convenience and the like; the method is helpful for optimizing the prescription of innovative medicines and evaluating and researching the consistency of imitated medicines.

Description

technical field [0001] The invention relates to the field of drug research and development equipment, in particular to a control system, method and dissolution apparatus for simulating gastrointestinal dynamic parameters. Background technique [0002] The drug research process is complicated and the cycle is long. At present, the dissolution of the drug in the body is mainly simulated by the dissolution apparatus. However, the dissolution medium conditions in the dissolution vessel are usually fixed, and it is difficult to simulate the dynamic change process of the pH value in the gastrointestinal tract. The obtained dissolution data is consistent with the human body. There may be some differences in actual data, which is not conducive to the prediction of bioequivalence of pH-sensitive generic drugs and the formulation process design of innovative drugs. At present, the in vitro gastrointestinal tract simulation devices seen in scientific research reports are difficult to b...

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Problems solved by technology

[0002] The drug research process is complicated and the cycle is long. At present, the dissolution of the drug in the body is mainly simulated by the dissolution apparatus. However, the dissolution medium conditions in the dissolution vessel are usually fixed, and it is difficult to simulate the dynamic change process of the pH value in the gastrointestinal tract. The obtained dissolution data is consistent with the human body. There may be some differences in the actual data, which is not conducive to the bioequivalence prediction of pH-sensitive generic drugs and the formulation process design of innovative drugs

At present, the in vitro gastrointestinal tract simulation device seen in scientific research reports has harsh experimental conditions, complex structure, high cost, and cumbersome operation, making it difficult to be widely used in industrial production

Usually, the pH of the gastrointestinal tract has a certain change curve under the physiological conditions of the human body, but the traditional dissolution apparatus cannot dynamically adjust the solution parameters, making it difficult to simulate the changes in the environmental parameters of the human gastrointestinal tract

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