Experimental apparatus for simulating in-vivo dissolution and absorption process of oral drug preparation

Abstract

The invention discloses an experimental apparatus for simulating an in-vivo dissolution and absorption process of an oral drug preparation. The experimental apparatus comprises a dissolution pool, wherein a drug basket frame is arranged inside the dissolution pool in a suspending manner, a liquid inlet on the bottom of the dissolution pool is communicated with an outlet of a confluence valve by virtue of a liquid inlet main path, a liquid outlet connector inserted in the dissolution pool transports a dissolution medium in the dissolution pool to a distribution valve in real time by virtue of aliquid outlet main path, the distribution valve is divided into two liquid outlet branches, one liquid outlet branch is separately communicated with a sample collector (for implementing the online automatic sample collection) and a waste liquid collection bottle by virtue of a sample collection three-way valve, the other liquid outlet branch is communicated with one inlet of the confluence valveto form a circulating loop, another inlet of the confluence valve is communicated with a dissolution medium source by virtue of a medium input pipeline, the liquid inlet main path and the liquid outlet main path are respectively provided with a liquid inlet pump and a liquid outlet pump, and the flow rate of the liquid inlet is the same with an output amount of the liquid outlet connector. By adopting the experimental apparatus, the dissolution and absorption process of a drug in a living body can be simulated, and the synchronous evaluation of the dissolution and absorption of the drug can berealized.

Description

Technical field [0001] The invention belongs to the technical field of drug dissolution testing, and particularly relates to an experimental device that simulates the dissolution and absorption process of oral drug preparations in vivo (in vivo). Background technique [0002] In vitro dissolution testing is a method of testing the properties of drugs, and it plays an important role in the development and quality control of pharmaceutical preparations, especially for slow and controlled release preparations or some rapid-release preparations with slow dissolution. The ultimate goal of drug dissolution inspection is to reflect and control the dissolution / release behavior of the drug in the body, and then reflect the in vivo absorption process of the drug to ensure the safety and effectiveness of the drug. However, the conventional dissolution modes, such as the basket method or the paddle method, have many structural and performance defects, and cannot fully simulate all the physio...

AI Technical Summary

Problems solved by technology

No matter what concentration of surfactant or medium flow rate is selected, it is difficult to release the drug, which means that the release behavior of the drug is less sensitive to the surfactant concentration and medium flow rate in the ordinary flow cell release mode. , the reason for the analysis may be that the dissolution mode of the ordinary flow cell method only uses the longitudinal medium flow as the agitation effect, and this agitation effect is very weak, it is difficult to overcome the cohesion of the drug and destroy the hydrogel structure formed on the surface of the drug preparation , cannot effectively simulate the physiological peristalsis and food friction of the gastrointestinal tract in the body to promote the drug dissolution / release process

Therefore, the traditional basket and paddle dissolution / release modes as well as the common flow-through cell method have some inherent defects, which cannot properly simulate the physiological process of drug dissolution / release in the gastrointestinal tract, and cannot be well realized. For some special pharmaceutical preparations, such as the above-mentioned nifedipine extended-release tablets (60mg), the release studies have poor in vivo correlation

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