Device for evaluating dissolving/absorbing process of medical solid preparation

A solid preparation and absorption process technology, which is applied in the field of devices for evaluating the dissolution/absorption process of pharmaceutical solid preparations, and can solve problems such as pipeline blockage, test inability to continue, uneven force, etc.

Inactive Publication Date: 2010-02-03
TIANJIN UNIV OF TRADITIONAL CHINESE MEDICINE
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

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

Method used

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  • Device for evaluating dissolving/absorbing process of medical solid preparation
  • Device for evaluating dissolving/absorbing process of medical solid preparation
  • Device for evaluating dissolving/absorbing process of medical solid preparation

Examples

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Embodiment 1

[0038] A device for evaluating the dissolution / absorption process of solid drug preparations, mainly composed of a drug dissolution chamber 1, a pH adjustment chamber 2 and a diffusion pool, wherein the bottom of the drug dissolution chamber 1 is provided with a magnetic stirrer 7, and the diffusion pool is composed of a supply chamber 3 , a receiving chamber 4 and a rat isolated intestinal tube 10' fitted between the two, each chamber is sequentially connected by a silicone tube 5 with an inner diameter of 1.0mm, and a drug-loading basket 6 is also provided in the drug dissolution chamber. There is a distance between the drug-loaded basket 6 and the magnetic stirrer 7 at the bottom of the drug dissolution chamber 1, the upper end of the drug-loaded basket 6 is fixedly connected to the upper end of the drug dissolution chamber 1, and the central axis of the drug-loaded basket 6 is connected to the drug dissolution chamber 1. The positions of the central axes coincide, and the d...

Embodiment 2

[0040] A device for evaluating the dissolution / absorption process of solid drug preparations, mainly composed of a drug dissolution chamber 1, a pH adjustment chamber 2 and a diffusion pool, wherein the bottom of the drug dissolution chamber 1 is provided with a magnetic stirrer 7, and the diffusion pool is composed of a supply chamber 3 , the receiving chamber 4 and the Caco-2 monolayer cell membrane 10 embedded between the two, each chamber is connected in turn by a silicone tube 5 with an inner diameter of 2.0 mm, and a metal clip is also provided in the drug dissolving chamber 1 6', the two ends of the metal sheet clip 6' are fixed on the side wall of the drug dissolution chamber 1, and its center coincides with the midpoint of the central axis of the drug dissolution chamber 1. The metal sheet clip 6' is made of strong acid-resistant, strong-resistant Alkali, high temperature resistant stainless steel material.

Embodiment 3

[0042] A device for evaluating the dissolution / absorption process of solid drug preparations, mainly composed of a drug dissolution chamber 1, a pH adjustment chamber 2 and a diffusion pool, wherein the bottom of the drug dissolution chamber 1 is provided with a magnetic stirrer 7, and the diffusion pool is composed of a supply chamber 3 , the receiving chamber 4 and the Caco-2 monolayer cell membrane 10 embedded between the two, each chamber is connected in turn by a silicone tube 5 with an inner diameter of 1.5 mm, and a drug-loading basket is also provided in the drug dissolution chamber 1 6. There is a distance between the drug-loaded basket 6 and the magnetic stirrer 7 at the bottom of the drug dissolution chamber 1, the upper end of the drug-loaded basket 6 is fixedly connected to the upper end of the drug dissolution chamber 1, and the central axis of the drug-loaded basket 6 is in line with the drug dissolution chamber. The central axis of chamber 1 coincides with each ...

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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...

Claims

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Application Information

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IPC IPC(8): G01N33/15
Inventor 何新
Owner TIANJIN UNIV OF TRADITIONAL CHINESE MEDICINE
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