Closed-loop sampling system for flow-cell-process drug dissolution and use method thereof

Abstract

The invention discloses a closed-loop sampling system for flow-cell-process drug dissolution and a use method thereof. The closed-loop sampling system comprises a constant-temperature water area system, a flow cell system, a lifting mechanism, a circulating heating system, a solvent monitoring system, a solvent circulating system and a sampling system, wherein the constant-temperature water area system comprises a constant-temperature water tank rack, a constant-temperature water tank, a solvent cup holder, a solvent cup and a solvent cup cover; the flow cell system is arranged at the top endof the constant-temperature water area system; the lifting mechanism is arranged on one side of the constant-temperature water tank rack; the circulating heating system comprises a heating device anda water circulating pump; the circulating inlet end of the solvent monitoring system communicates with the heating device, and the circulating outlet end of the solvent monitoring system respectivelycommunicates with the solvent cup and a flow cell; the solvent circulating system comprises a solvent circulating pump and a pulse valve; and the sampling system comprises a sampling mechanism, a sampling pipeline, a sampling valve and a sampling pump. The system is compact in structure, the heating efficiency of the heating device is high, water area temperature distribution is uniform, water temperature control is accurate, and temperature and pressure of a solvent are monitored.

Description

technical field [0001] The invention relates to the technical field of application of medical experimental equipment, in particular to a closed-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 sim...

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

Images