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Experimental device for simulating release and absorption process of suppository or transdermal patch in body

A transdermal patch and absorption process technology, applied in the field of drug release test, can solve the problems of poor biological correlation, inability to simulate, and inability to truly simulate the actual physiological conditions of the biological cavity or skin, to achieve enhanced release and increased flow speed effect

Inactive Publication Date: 2018-08-10
HUNAN HUIZE BIO PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the conventional release mode is mostly a closed release system and uses a relatively large amount of release medium, which can only investigate the in vitro release of drugs and cannot simulate the in vivo absorption process, such as vaginal tablets for inspection equipment
Moreover, there is a big difference between this kind of device and the actual release / absorption environment in the organism, and objectively there are many structural and performance defects, which make it impossible to truly simulate the actual physiological conditions of the organism's cavity or skin, and thus cannot reflect The real release and absorption of pharmaceutical dosage forms such as suppositories or transdermal patches on organisms, poor biological correlation

Method used

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  • Experimental device for simulating release and absorption process of suppository or transdermal patch in body

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] see figure 1, an experimental device for simulating the in vivo release and absorption process of suppositories or transdermal patches, comprising a release pool 10 with an open top, and liquid inlets and liquid outlets are symmetrically arranged on the opposite side walls of the release pool 10, and the liquid inlet The outlet is connected with the outlet of the confluence valve 7 through the liquid inlet 9, and the liquid outlet is connected with the diverter valve 19 through the liquid outlet 17. The diverter valve 19 divides two liquid outlets, one of which passes through three The through valve 23 communicates with the sample collector 25 and the waste liquid collection bottle 27 respectively (X flow path), and the other liquid outlet branch communicates with one of the inlets of the confluence valve 7 to form a circulation loop 20 (Y flow path), and the confluence valve 7 The other inlet is communicated with the release medium source through the medium input pipel...

Embodiment 2

[0030] The difference from Embodiment 1 is that a sample collection control valve 24 is provided on the pipeline between the three-way valve 23 and the sample collector 25 , and a filter structure is provided on the sample collector 25 . The medium input pipeline 6 divides a plurality of medium delivery branches 3 through the medium selector, which are respectively connected with the medium storage bottles 2 containing different release mediums, and each medium delivery branch 3 is provided with a liquid inlet control valve 4 . As preferably, the content of the release medium in the release pool 10 is 5-50ml, and the real liquid volume of the biological cavity or skin site can be simulated by the smaller release pool 10 (5-50ml), which can provide a closer approach to the release of the drug. The release medium volume and sink conditions for the actual situation of the organism. In this embodiment, different artificial release fluids are selected and switched online through th...

Embodiment 3

[0032] The difference from Example 2 is that the experimental device of the simulated suppository or transdermal patch in vivo release and absorption process of the present embodiment also includes a water bath 1, and each medium storage bottle 2 (No. 1-2 bottles are equipped with different The release medium) is preheated and kept warm through the water bath 1, and the temperature is kept at 37°C ± 0.5°C to ensure that the release medium is close to the physiological temperature of the human cavity or skin (it can also be set differently according to the different parts of the drug). preheating temperature to more properly simulate physiological temperature). Preferably, at least part of the pipe periphery of the circulation loop 20 is provided with an insulation cover 21, and the insulation cover 21 is heated by a high-precision heater to insulate the flowing medium in the circulation loop (the temperature setting is consistent with the temperature of the water bath) , to en...

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Abstract

The invention discloses an experimental device for simulating a release and absorption process of a suppository or a transdermal patch in the body. A liquid inlet and a liquid outlet are formed at twoopposite side walls of a release pool, respectively, wherein the liquid inlet communicates with an outlet of a flow collecting valve via a liquid inlet main pipe, and the liquid outlet communicates with a flow dividing valve via a liquid outlet main pipe. Two liquid outlet branch pipes are led out from the flow dividing valve, wherein one liquid outlet branch pipe communicates with a sample collector and a waste liquid collecting bottle via a three-way valve, and the other liquid outlet branch pipe communicates with one inlet of the flow collecting valve. The other inlet of the flow collecting valve communicates with a release medium source via a medium input pipe. A liquid inlet pump is located on the liquid inlet main pipe, and a liquid outlet pump is located on the liquid outlet main pipe. The release pool is internally provided with a biomimetic penetration plate, the bottom of which contacts a release medium in the release pool. A suppository or a transdermal patch is placed on the biomimetic penetration plate, and the flow of the liquid inlet is equal to the flow of the liquid outlet. The device is simple in structure and can truly simulate and reflect the release and absorption process of a suppository or a transdermal patch in the living body.

Description

technical field [0001] The invention belongs to the technical field of drug release test, in particular to an experimental device for simulating the release and absorption process of a suppository or a transdermal patch on a body (organism). Background technique [0002] In vitro release testing, as a method of checking the drug properties of suppositories or transdermal patches, plays an important role in the development and quality control of pharmaceutical preparations. Suppositories or transdermal patches are a major type of pharmaceutical dosage form used in clinical practice. Accurate evaluation and control of their release / absorption behavior can effectively guarantee the safety and effectiveness of clinical medication. The ultimate goal of drug release inspection is to reflect and control the release process of drugs on organisms, and then predict the in vivo absorption of drugs. However, the conventional release mode is mostly a closed release system and uses a rel...

Claims

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Application Information

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IPC IPC(8): G01N33/15
CPCG01N33/15
Inventor 程泽能赵悦清
Owner HUNAN HUIZE BIO PHARMA CO LTD
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