Open-loop sampling system for medicine dissolution through flow cell method and use method

Abstract

The invention discloses an open-loop sampling system for medicine dissolution through a flow cell method and a using method. A constant-temperature water area system comprises a constant-temperature water tank rack, a constant-temperature water tank and a solvent cup holder. A flow cell system is arranged at the top end of the constant-temperature water area system and comprises a flow cell rack,a flow cell and a glass tube; a lifting mechanism is arranged on one side of the constant-temperature water tank rack; a circulating heating system comprises a heating device and a water circulating pump; a solvent monitoring system is arranged at the top end of the heating device; a solvent switching system is arranged on one side of the constant-temperature water area system; a solvent mixing system comprises a solvent mixing seat, a solvent mixer and a solvent suction pump; a solvent circulating system comprises a solvent circulating pump and a pulse valve; a sampling system comprises a sampling mechanism, a sampling pipeline and a sampling valve. According to the invention, an open type solvent sampling process can be carried out on a solvent, the heating device of the solvent is stably fixed, the heating efficiency is high, the temperature is accurately controlled, the pH value of the solvent can be switched and adjusted, and the real dissolution environment of human gastrointestinal tracts is simulated.

Description

technical field [0001] The invention relates to the technical field of application of medical experimental equipment, in particular to an open-loop sampling system for drug dissolution by a flow cell method and a use method thereof. Background technique [0002] The rapid development of pharmaceutical technology, accompanied by the birth of a large number of new drugs and the current requirements for the in vitro and in vivo correlation (IVIVC) of the dissolution test method, the traditional dissolution test methods (paddle method, basket method, etc.) Encountered many new problems, such as the determination of trace pharmaceutical preparations, the formulation of new pharmaceuticals such as patches and microspheres, and how to solve the in vivo and in vitro correlations of immediate-release preparations. As a new test method for dissolution concentration, the flow cell method mainly relies on the continuous flushing of preparations with flowing solvents, which can well simu...

AI Technical Summary

Problems solved by technology

[0005] 1. When controlling the temperature of the solvent in the solvent cup, a separate heating water tank is used to heat the water area of ​​the solvent cup. The water area heating system and the dissolution system of the flow pool use two sets of devices. During the test of the system, the solvent needs to be The inlet and outlet pipelines of the cup and the inlet and outlet of the dissolution system of the flow cell should be plugged and fixed. At the same time, the inlet and outlet pipelines of the circulating water of the heating system and the circulation water inlet and outlet pipelines of the dissolution system of the flow tank should also be plugged and fixed. The test operation process is very complicated. Inconvenient; and the overall equipment of this structure occupies a large area, and the structure is not compact enough

[0006] 2. When heating the water area of ​​the solvent cup, the heating wire is directly placed in the heating water tank of the solvent cup, and the water area in the water tank is directly and locally heated. The temperature distribution in the water tank is uneven, resulting in the replacement of the water area and the solvent in the solvent cup. The heat temperature is difficult to control; and during the circulation of the solvent, it is not possible to continuously control the temperature of the solvent at multiple points to ensure that the solvent and the drug are at the best temperature for the drug dissolution test

[0007] 3. When the drug is subjected to the open-loop dissolution test, the solvent bottle is used to store the solvent due to the large flow of the solvent. The pH of the solvent stored in the solvent bottle is a fixed value, and it is impossible to quickly switch the solvent conveniently, so as to quickly measure different pH values. The dissolution rate of the solvent under the value, in order to achieve the drug dissolution effect of simulating the real internal environment of the human body

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