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Single-tank bionic system device and medicine dissolving solution as well as evaluation method using device and solution

A bionic system and dissolving solution technology are applied in the field of single-cell bionic system device and drug dissolving solution and evaluation. Reduce, avoid the loss of small particles of the preparation, and facilitate the effect of micro-measurement

Active Publication Date: 2011-11-23
TIANJIN UNIV OF TRADITIONAL CHINESE MEDICINE
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

However, with the deepening of research, the existing drug dissolution / absorption dynamic bionic system cannot evaluate delayed-release preparations: on the one hand, delayed-release preparations stay in the drug dissolution chamber and are not easy to disintegrate, and cannot simulate the migration of preparations from the stomach to the intestinal disintegration, release process, so it is difficult to predict its in vivo process; on the other hand, there is a stagnation volume in the pH adjustment chamber, which results in a retention time of the drug detected on the dissolution side of the drug diffusion cell and a decrease in the apparent concentration, which is not convenient for trace In addition, a large amount of auxiliary materials will also enter the pipeline with the eluate, and accumulate in the silicone tube to cause pipeline blockage, so that the test cannot continue

Method used

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  • Single-tank bionic system device and medicine dissolving solution as well as evaluation method using device and solution
  • Single-tank bionic system device and medicine dissolving solution as well as evaluation method using device and solution
  • Single-tank bionic system device and medicine dissolving solution as well as evaluation method using device and solution

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0055] Such as figure 1 As shown, a single-cell biomimetic system device for evaluating delayed-release preparations is mainly composed of a drug dissolution chamber 1, a pH regulator 2, a replaceable microporous filter 10, and a drug diffusion cell. The drug dissolution chamber 1, The pH regulator 2 and the drug diffusion cell are made of transparent plexiglass material, wherein the bottom of the drug dissolution chamber 1 is provided with a magnetic stirrer 7, and a drug carrier is arranged in the drug dissolution chamber 1, and the drug carrier and the drug dissolution chamber There is a distance between the magnetic stirrers 7 at the bottom, and the stainless steel screen 8 is placed above the drug carrier; the filler in the pH regulator 2 is a non-absorptive filler 9; the drug diffusion pool is composed of the supply chamber 3, receiving The chamber 4 and the biofilm tissue 11 embedded between them are composed; the drug dissolution chamber 1, the pH regulator 2, the micr...

Embodiment 2

[0057] Such as figure 1 As shown, a single-cell bionic system device for evaluating delayed-release preparations has a similar structure to the single-cell bionic system device for evaluating delayed-release preparations described in Example 1, wherein the drug dissolution chamber 1, pH The regulator 2, the microporous filter 10 and the drug diffusion cell are sequentially connected by a silicone tube 5 with an inner diameter of 2.0mm, and the drug dissolution chamber 1, the pH regulator 2 and the receiving chamber 4 are respectively provided with injection holes, and the The supply chamber 3 and the receiving chamber 4 are also provided with an air inlet and a sampling hole, wherein the drug carrier is a drug-loaded basket 6 made of stainless steel material resistant to strong acid, strong alkali and high temperature, and the non-absorbent The permanent filler 9 is glass microspheres, the microporous filter 10 is a glass fiber filter membrane with a pore size of 0.8 μm, and t...

Embodiment 3

[0059] Such as figure 1 As shown, a single-cell bionic system device for evaluating delayed-release preparations has a similar structure to the single-cell bionic system device for evaluating delayed-release preparations described in Example 1, wherein the drug dissolution chamber 1, pH The regulator 2, the microporous filter 10 and the drug diffusion cell are sequentially connected by a silicone tube 5 with an inner diameter of 1.5mm, and the drug dissolution chamber 1, the pH regulator 2 and the receiving chamber 4 are respectively provided with sampling holes, and the The supply chamber 3 and the receiving chamber 4 are also provided with an air inlet and a sampling hole, wherein the drug carrier is a drug-loaded basket 6 made of stainless steel material resistant to strong acid, strong alkali and high temperature, and the non-absorbent The permanent filler 9 is sea sand, the microporous filter 10 is a quartz fiber filter membrane with a pore size of 0.57 μm, and the biofil...

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Abstract

The invention provides a single-tank bionic system device and medicine dissolving solution as well as an evaluation method using the device and the solution. The device mainly consists of a medicine dissolving chamber, a pH adjuster, a microporous filter and a medicine diffusion cell; each 1000ml of a medicine dissolving solution A contains 7.8894g of NaCl, 9.008g of D-Glucose, 0.2797g of CaCl2, 0.0975g of MgSO4, 1.9524g of MES (fatty acid methyl ester sulfonate), 5.0mL of HCL (1mM) and the balance of water; and each 1000ml of a medicine dissolving solution B contains 0.7977g of KCl, 0.1198g of KH2PO4, 7.8894g of NaCl, 0.0965g of NaH2PO4, 9.762g of MES the Tris pH value of which is adjusted at 6.8-7.8 and the balance of water. By utilizing the device and the evaluation method, the release and absorption law of a delayed-release preparation can be evaluated.

Description

technical field [0001] The invention relates to a device, a drug solution and a drug evaluation method for evaluating the release and transmembrane characteristics of drug preparations, especially a single-cell bionic system device, drug solution and evaluation method for delayed-release preparations. method. Background technique [0002] The existing drug dissolution / absorption dynamic bionic system (patent authorization number: ZL 200920098448.6), which consists of a drug dissolution chamber, a pH adjustment chamber and a drug diffusion cell, is used to simulate the dissolution rate of drugs in vivo and the evaluation of cell penetration effects. However, with the deepening of research, the existing drug dissolution / absorption dynamic bionic system cannot evaluate delayed-release preparations: on the one hand, delayed-release preparations stay in the drug dissolution chamber and are not easy to disintegrate, and cannot simulate the migration of preparations from the stomac...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/15
Inventor 何新李自强刘韦鋆朱新冰顾慧
Owner TIANJIN UNIV OF TRADITIONAL CHINESE MEDICINE
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