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

A technology of absorption process and pharmaceutical preparations, applied in the direction of testing pharmaceutical preparations, material inspection products, etc., can solve the problems of low sensitivity, weak stirring effect, difficult to overcome drug cohesion, etc., to avoid pipeline leakage and enhance liquid. The effect of flow scouring

Inactive Publication Date: 2018-05-29
HUNAN HUIZE BIO PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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

Method used

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

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] See figure 1 , An experimental device that simulates the dissolution and absorption process of oral pharmaceutical preparations in vivo, including a dissolution tank 15 with an open top. Specifically, the bottom end of the dissolution tank 15 is tapered with a filter plate inside. The space enclosed by the filter plate and the conical bottom end of the dissolution tank 15 is filled with inert microspheres 11, and the inside of the dissolution tank 15 is located in the filter. A drug basket 12 containing drugs 13 (oral drug preparations) is suspended above the plate, and a liquid inlet 10 is provided at the lowest position of the conical bottom end of the dissolution tank 15. The liquid inlet 10 passes through the main liquid inlet 9 and The outlet of the merging valve 7 is connected, and the liquid outlet connector 17 inserted from the top of the dissolution tank 15 transports the dissolution medium in the dissolution tank 15 to the diverter valve 21 through the effluent...

Embodiment 2

[0033] The difference from Embodiment 1 is that the medium input pipeline 6 in this embodiment is divided into a plurality of medium conveying branches 3 connected to the medium storage bottle 2 through the medium selector 5, and each medium conveying branch 3 is provided There is an inlet control valve 4, and each medium storage bottle 2 is equipped with different bionic dissolution media. In addition, in this embodiment, the content of the dissolution medium in the dissolution tank 15 is 5-60 ml.

[0034] In this embodiment, a micro stirrer is also provided above the drug basket 12 in the dissolution tank 15, and an openable and closable top cover is provided on the top open end of the dissolution tank 15. Specifically, in this embodiment, the micro-agitator includes a stirring paddle 14 and a high-precision stirring pump 16. One end of the stirring paddle 14 is connected to the high-precision stirring pump 16 after passing through the top cover. By adjusting the rotation spee...

Embodiment 3

[0037] The difference from Example 2 is that the experimental device for simulating the dissolution and absorption process of oral pharmaceutical preparations in this example also includes a water bath 1, and each medium storage bottle 2 is preheated and insulated through the water bath 1, so that each dissolution medium It is close to the biological temperature (37°C). Preferably, a sample collection control valve 26 is provided on the pipeline between the sample collection three-way valve 25 and the sample collector 27. An in-line filter 18 is provided at the connection between the liquid outlet connector 17 and the liquid outlet main line 19; a fine filtration membrane structure with better filtering effect (smaller pore size) is provided on the sample collector 27. Preferably, an insulation jacket 23 is provided around part of the pipeline of the circulation loop 22, and the insulation jacket 23 is heated by a high-precision heater to keep the flowing medium in the circulat...

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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...

Claims

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Application Information

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