Device for evaluating dissolving/absorbing process of medical solid preparation

Abstract

The invention provides a device for evaluating the dissolving / absorbing process of medical solid preparation, essentially consisting of a medicine dissolving room, a pH value adjusting room and a spreading pool, wherein the bottom of the medicine dissolving room is provided with a magnetic stir bar; the spreading pool consists of a feeding room, a receiving room and Caco-2 monolayer cell membraneor animal (such as rat) isolated intestine embedded between the feeding room and the receiving room; the medicine dissolving room, pH value adjusting room, the feeding room and the receiving room areconnected with each other by silicone tubes with inner diameter of 1.0mm-2.0mm; and the medicine dissolving room is provided with a medicine carrying device; a gap is remained between the medicine carrying device and the magnetic stir bar at the bottom of the medicine dissolving room; the top of the pH value adjusting room is provided with a stainless steel sieve mesh; and the silicone tube between the pH value adjusting room and the feeding room is internally additively provided with a Millipore filter. The device is applicable to wider solid preparation such as troche, soft capsule, hard capsule, and the like, solves the blocking problem caused by medical auxiliary materials, and truly simulate the affect of the pH change of gastrointestinal tract to the releasing rule of the medical solid preparation under the condition of human physiology.

Description

technical field [0001] The invention relates to a device for evaluating drug indexes, in particular to a device for evaluating the dissolution / absorption process of drug solid preparations. Background technique [0002] At present, the devices used to determine the dissolution of drugs mainly include blue turning method, paddle method, swinging cylinder method, flow cell method, disk sizing method, cylinder method, swinging disk method, rotating bottle method, diffusion chamber method, etc. The Caco-2 cell model is currently recognized as an ideal in vitro model for studying intestinal absorption of drugs at home and abroad. It is suitable for the early stage of new drug development and is used to study the absorption characteristics of drugs. [0003] There are few reports on drug dissolution / absorption dynamic evaluation systems in vitro. In 1999, Ginskin et al. established the drug dissolution / Caco-2 cell membrane system, which successfully predicted the absorption capac...

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Problems solved by technology

[0005] However, with the deepening of research, the existing drug dissolution / absorption dynamic bionic system has defects when evaluating solid preparations such as tablets and capsules: on the one hand, the position of the solid preparation in the dissolution chamber is not fixed and subject to Uneven force, for example, if a tablet sinks to the bottom of the dissolution chamber after being administered, the force on the tablet will be uneven. There is no force on the bottom side, and in this case, the tablet is easy to collide with the magnetic stirrer to generate a large mechanical force, which will cause the dissolution process of the tablet to be inconsistent with the dissolution process in the physiological environment of the human gastrointestinal tract; another On the one hand, during the dissolution process of pharmaceutical preparations, a large amount of excipients will also enter the pH adjustment chamber along with the dissolution liquid, which will easily accumulate at the glass fiber and cause pipeline blockage, making the test impossible to continue; if the pore size of the filter device increases, although it can solve the problem Blockage problem, but the tiny drug particles that have not been fully released flow out with the pH adjustment solution, resulting in drug loss

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