CN211292844U - Two-chamber model experimental device for simulating in-vivo dissolution and transmembrane absorption processes of insoluble oral pharmaceutical preparation - Google Patents
Two-chamber model experimental device for simulating in-vivo dissolution and transmembrane absorption processes of insoluble oral pharmaceutical preparation Download PDFInfo
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Abstract
The utility model discloses a two-chamber model experimental device for simulating the process of dissolving out and transmembrane absorption in an insoluble oral medicinal preparation, and a two-chamber differential dissolving-out system consisting of an inner chamber porous filter membrane cup and an outer chamber dissolving-out cup is adopted as a core. The outer chamber dissolving cup sleeve is arranged outside the inner chamber porous filter membrane cup, a rotating basket is arranged in the inner chamber porous filter membrane cup, a medium input pipeline inserted in the inner chamber porous filter membrane cup is communicated with a dissolving medium source, a sampling needle inserted between the outer chamber dissolving cup and the inner chamber porous filter membrane cup is connected to a sample collection three-way valve through a liquid outlet main, two output ends of the sample collection three-way valve are respectively connected to a sample collector and a waste liquid collecting bottle, and a liquid inlet pump and a liquid outlet pump are respectively arranged on the medium input pipeline and the liquid outlet main. The utility model discloses can simulate dissolving out and the transmembrane absorption process of internal medicine of living beings, dissolve out the condition through the regulation, realize that the external correlation evaluation of dissolving out and internal absorption of different indissolvable medicines.
Description
Technical Field
The utility model belongs to the technical field of the medicine degree of dissolving out is experimental, especially, relate to a simulation indissolvable oral drug preparation is internal dissolves out and transmembrane absorption process's two-chamber model experimental apparatus.
Background
In combination with the biopharmaceutical classification system of drugs, in vitro dissolution examination is generally considered to be able to predict in vivo dissolution behavior and absorption conditions, reflect and control in vivo dissolution/release behavior of drugs, and further reflect in vivo absorption process of drugs. The dissolution determination conditions are selected mainly based on simulation results of gastrointestinal environment, and factors such as gastric pH, enzyme, surface tension, gastric juice volume, temperature, and intestinal pH and pressure are generally considered. In an in vitro dissolution test, different dissolution devices and dissolution media are selected to realize simulation of gastrointestinal tract environment. At present, the in vitro dissolution method of the pharmaceutical preparation mainly comprises a rotating basket method, a paddle method, a small cup method, a reciprocating cylinder method, a flow cell method and the like.
However, conventional dissolution processes such as paddle and basket methods encounter various problems and challenges in formulation quality screening and control, mainly manifested in: firstly, the traditional dissolution method is a closed dissolution system mode and cannot simulate physiological conditions such as gastrointestinal tract peristalsis, fluid dynamics and the like in vivo; secondly, in order to meet the conditions of the leakage groove, a surfactant with larger medium volume and higher concentration is often selected, which is not in accordance with the in vivo situation, the dissolution distinction degree of the pharmaceutical preparation is covered, and the in vitro dissolution curve cannot truly reflect the actual dissolution behavior in vivo. Celecoxib capsules (specification: 200mg) are classified as BCS class II drugs due to their poor water solubility (about 5 μ g/mL) and good permeability (logP of 3.5). The FDA recommends that the dissolution medium of the medicine is strong alkaline solution with pH of 12.0, and 1% of surfactant is added, which violates physiological conditions and masks the differentiation degree of real dissolution among various preparations. The traditional dissolution method does not consider an absorption mechanism, the drug release rate of the traditional dissolution method is obviously faster than the release/absorption process in vivo, the traditional dissolution method is not in accordance with the actual condition in vivo, the in vitro and in vivo correlation is difficult to establish, and the in vitro dissolution behavior is often similar while the in vivo BE is not equivalent.
In addition, when the flow cell method is adopted to carry out dissolution research on the celecoxib capsule, because the dosage of the medicament is large, the lower medium flow velocity scouring can not play a stirring role on the accumulated medicament, so that the medicament powder is easy to accumulate at the bottom of the flow cell and is adhered to the side wall of the flow cell, and the effective contact area with the dissolution medium is reduced. However, if a high concentration of surfactant is selected to increase dissolution, the adverse effect of the surfactant masks the resolution of dissolution between formulations. Therefore, the traditional basket method, paddle method and flow cell method all have certain inherent defects, the physiological process of the dissolution/release of the drug in the gastrointestinal tract cannot be simulated properly, and the in vitro discrimination and in vivo and in vitro correlation research of the insoluble drug preparation cannot be realized well.
Patent 201810071374.0 discloses an experimental device for simulating the dissolution and absorption processes of oral pharmaceutical preparations in vivo, which can simulate the dissolution and absorption processes of drugs in vivo and realize the synchronous evaluation of dissolution and absorption of drugs. However, the actual drug absorption is conducted through the membrane, so the above patent still has a certain difference with the actual drug dissolution and absorption in vivo. Based on this, it is urgently needed to develop a new dissolution device to dynamically simulate the in vitro dissolution conditions such as the digestive juice volume and the fluid dynamics characteristics of different digestive tract segments in a living body, solve the problem of accumulation of insoluble drugs in a flow cell, and simultaneously simulate the transmembrane permeation of different gastrointestinal tract segments to drugs to realize the synchronous evaluation of drug dissolution/release and absorption.
SUMMERY OF THE UTILITY MODEL
The present application is directed to solving at least one of the problems in the prior art. Therefore, an object of the present invention is to provide a two-chamber model experimental apparatus capable of preventing pipeline blockage and truly simulating the dissolution and transmembrane absorption processes of an insoluble oral pharmaceutical preparation in a living body, so as to be used for in vivo and in vitro correlation research of a drug and realize synchronous evaluation of dissolution and absorption behaviors of the drug.
In order to solve the technical problem, the following technical scheme is adopted in the application:
a two-chamber model experimental device for simulating the in-vivo dissolution and transmembrane absorption processes of an insoluble oral pharmaceutical preparation comprises an inner chamber porous filter membrane cup and an outer chamber dissolution cup, wherein the outer chamber dissolution cup is sleeved outside the inner chamber porous filter membrane cup, a rotating basket is arranged in the inner chamber porous filter membrane cup, a medium input pipeline inserted in the porous filter membrane cup is communicated with a dissolution medium source, a sampling needle inserted between the outer chamber dissolution cup and the inner chamber porous filter membrane cup is connected to a sample collection three-way valve through a liquid outlet main, two output ends of the sample collection three-way valve are respectively connected to a sample collector and a waste liquid collecting bottle, and a liquid inlet pump and a liquid outlet pump are respectively arranged on the medium input pipeline and the liquid outlet main.
In this embodiment, during the simulation test, the liquid inlet pump and the liquid outlet pump are adjusted to make the liquid inlet amount equal to the liquid outlet amount of the sampling needle, so as to ensure the medium diffusion balance in the inner porous filter membrane cup and the outer dissolution cup and the liquid level difference between the inner chamber and the outer chamber to be constant. The dissolution medium enters the inner chamber porous filter membrane cup from the medium input pipeline and dissolves out the medicine in the basket, the medicine solution is continuously filtered by the inner chamber porous filter membrane cup and then is diffused into the outer chamber dissolution cup, the sampling is carried out on the dissolution medium containing the dissolved medicine in the outer chamber dissolution cup in real time and quantitatively, the online sampling is completed through the sample collection three-way valve and the sample collector, and the transmembrane and absorption processes of the medicine in vivo are effectively simulated.
The flow rate of the liquid outlet main path is adjusted to output the dissolved medicine from the outer chamber dissolving cup in different speed processes in different time periods, so that the transmembrane permeation rate is simulated. The correlation between the drug dissolution and absorption processes and the in vivo and in vitro is realized by regulating and controlling the fast and slow relationship between the drug dissolution rate and the transmembrane absorption rate.
Furthermore, the medium input pipeline is divided into a plurality of medium conveying branches communicated with the medium storage bottle through a medium selector, and each medium conveying branch is provided with a liquid inlet control valve. According to different specific medicines, the medium selector can select different dissolution media to enter the inner chamber porous filter membrane cup at different time periods to dissolve the medicines.
Further, the inner chamber porous filter membrane cup comprises a porous steel cup and a filter membrane wrapped outside the porous steel cup. Specifically, the aperture of the microporous filter membrane is 0.1-10 microns, the aperture of the porous steel cup is 100-1200 meshes, the size diameter is 3-6 cm, the height is 10-12 cm, the porous steel cup can be filled with 100-500 mL of dissolution medium, and the rotary basket can be completely immersed in the dissolution medium and is suitable for dissolving the insoluble medicine.
Furthermore, inert microspheres are filled in the inner cone bottom of the inner chamber porous filter membrane cup, so that the dissolution behavior under the eating condition can be simulated.
Furthermore, a top cover which can be opened and closed is arranged at the top opening end of the dissolution cup of the outer chamber, and one end of the rotary basket penetrates out of the top cover to be in transmission connection with the stirring pump, so that the dissolution medium in the porous filter membrane cup has different transverse rotating speeds, the influence of physiological peristalsis of the gastrointestinal tract in vivo on the dissolution of the medicine can be simulated, and the dissolution behavior of the medicine in the gastrointestinal tract can be simulated more truly.
Furthermore, a sample collection control valve is arranged on a pipeline between the sample collection three-way valve and the sample collector to realize timing sampling.
Furthermore, the device also comprises an external water bath and a constant temperature water bath, each medium storage bottle is preheated and insulated through the water bath, the outer chamber dissolution cup is placed in the constant temperature water bath to ensure that the dissolution medium in the inner chamber porous filter membrane cup is kept at a constant temperature, and the release medium is close to the physiological temperature of the gastrointestinal tract in vivo.
Compared with the prior art, the utility model discloses the beneficial effect who has lies in:
1. fresh dissolution media at a media source can continuously supplement fresh media and continuously take dissolved medicines away through a flow path mode that the fresh dissolution media enter a sample collector or a waste liquid collecting bottle through a media input pipeline, an inner chamber porous filter membrane cup, an outer chamber dissolution cup and a sample collecting three-way valve, wherein a liquid inlet of the media input pipeline is inserted into the inner chamber porous filter membrane cup, a sampling needle is inserted into the outer chamber dissolution cup, a liquid inlet and a liquid outlet are separated into two chambers, and a good uniform mixing effect is achieved through diffusion. In addition, the high-precision liquid outlet pump is matched, the inflow amount of a dissolving medium of the liquid inlet of the dissolving system is equal to the outflow amount of the dissolving medium of the liquid outlet, the balance of the total amount of the dissolving medium in the dissolving system is ensured, and the problem of pipeline liquid leakage caused by overhigh hydraulic pressure in a medium pipeline is effectively avoided.
2. The utility model provides an experimental apparatus for simulating the internal dissolution and transmembrane absorption process of an oral drug preparation is a two-chamber model differential dissolution system, which is composed of a porous steel cup wrapped by an internal microporous filter membrane and an outer chamber dissolution cup, wherein the dissolved drug is diffused into the outer chamber dissolution cup through the inner chamber porous filter membrane steel cup, and a liquid outlet branch of the drug dissolved out of the preparation is continuously taken out of the two-chamber model differential system in a differential form through a sample collection three-way valve, so that the internal transmembrane absorption process of the drug is simulated; different flow rates are set for the liquid outlet main passage at different time periods, so that the dissolved medicines are taken away from the outer chamber dissolving cup at different rates at different time periods, and the process of dissolving and absorbing the insoluble medicines in vivo can be effectively simulated.
3. The rotary basket is arranged in the inner chamber porous filter membrane cup, so that the transverse stirring effect in the dissolving process can be increased, the medicine is disintegrated, dissolved and diffused from the rotary basket to the outer dissolving cup, and compared with the method of only adopting longitudinal washing of a pipeline, the indissolvable medicine can be fully dissolved, and the indissolvable medicine cannot be accumulated at the bottom of the dissolving cup.
4. A dissolving-out medium with the volume of 100-500 mL is filled in the porous filter membrane cup, and the rotary basket can be completely immersed in the dissolving-out medium and is suitable for dissolving the insoluble medicine; moreover, different bionic dissolution media (different pH values, different surfactant concentrations and the like) are selected by the medium selector at different time periods, different transverse stirring effects and longitudinal scouring effects of the liquid inlet pipeline and the liquid outlet pipeline are applied to the dissolution medium in the porous filter membrane cup through the rotating speed of the rotary basket, gastrointestinal fluid, gastrointestinal peristalsis, gastrointestinal fluid dynamic characteristics and the like of different digestive tract parts in a living body can be simulated respectively, the dissolution behavior of the medicine is comprehensively regulated, the in-vitro dissolution process (first-order and zero-order dynamic processes and the like) and the dissolution rate constant of the medicine are consistent with the in-vivo process, and the in-vitro and in-vivo correlation of the medicine dissolution is realized.
5. The porous steel cup is wrapped by the microporous filter membrane in the differential dissolution system of the two-chamber model, the problem of tightness is avoided, the cross-sectional area of filtration is increased, the filtration is thorough, no residue exists, the pipeline blockage is avoided, the collected sample can be detected on line, and the treatment is not needed.
Drawings
Fig. 1 is a schematic structural view of the present invention;
FIG. 2 is a graph of the in vivo average cumulative absorption fraction of celecoxib reference and test formulations analyzed in the application examples;
FIG. 3 is a differential dissolution curve of each celecoxib reference formulation and test formulation in an application example;
FIG. 4 is a cumulative dissolution curve of each celecoxib reference formulation and test formulation in an application example;
FIG. 5 shows F of celecoxib reference preparation in application exampledis(％)-Fabs(vii) regression curves and correlation coefficients for (%);
wherein: 1-water bath; 2-a media storage bottle; 3-a medium conveying branch; 4-a liquid inlet control valve; 5-a media selector; 6-high-precision liquid inlet pump; 7-medium input line; 8-an external chamber dissolution cup; 9-inner chamber porous filter membrane cup; 10-inert microspheres; 11-a rotating basket; 12-a drug; 13-a sampling needle; 14-high precision liquid outlet pump; 15-medium outlet line; 16-sample collection three-way valve; 17-a sample collection control valve; 18-a header pipe; 19-waste liquid bottle.
Detailed Description
The technical solutions in the embodiments of the present invention will be described clearly and completely with reference to the accompanying drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only some embodiments of the present invention, not all embodiments. Based on the embodiments in the present invention, all other embodiments obtained by a person skilled in the art without creative efforts belong to the protection scope of the present invention.
Example 1
Referring to fig. 1, a two-chamber model experimental device for simulating the in vivo dissolution and transmembrane absorption processes of an insoluble oral drug preparation comprises an inner chamber porous filter membrane cup 9 and an outer chamber dissolution cup 8, wherein the top part of the inner chamber porous filter membrane cup 9 is opened, the outer chamber dissolution cup 8 is sleeved outside the inner chamber porous filter membrane cup 9, the inner chamber porous filter membrane cup 9 is provided with percolation holes communicated with the outer chamber dissolution cup 8, a basket 11 filled with a drug 12 (oral drug preparation) is arranged inside the inner chamber porous filter membrane cup 9, a sampling needle 13 inserted between the outer chamber dissolution cup 8 and the inner chamber porous filter membrane cup 9 is used for conveying dissolution media in the outer chamber dissolution cup 8 to a sample collection three-way valve 16 in real time through a main liquid outlet path 15, the sample collection three-way valve 16 is divided into two liquid outlet branches respectively communicated with a sample collection device 18 and a waste liquid collection bottle 19, a medium input pipeline 7 inserted in the inner chamber porous filter membrane cup 9 is connected with a medium selector 5, and the medium selector 5 is connected with a medium storage bottle Different bionic dissolution media such as artificial gastric juice, artificial intestinal juice and the like) are communicated, a liquid inlet pump 6 and a liquid outlet pump 14 are respectively arranged on a medium input pipeline 7 and a liquid outlet main pipeline 15, and the flow of a liquid inlet of the medium input pipeline 7 is equal to the collection amount of a sampling needle 13 so as to ensure the stability of the content of the dissolution media in the inner porous filter membrane cup 9 and the outer dissolution cup 8.
In this embodiment, fresh dissolution media at the media source can continuously supplement fresh media and continuously take dissolved drugs away in a flow path mode that the fresh dissolution media enter the sample collector 18 or the waste liquid collecting bottle 19 through the media input pipeline 7, the inner chamber porous filter membrane cup 9, the outer chamber dissolution cup 8 and the sample collecting three-way valve 16, wherein a liquid inlet of the media input pipeline 7 is inserted into the inner chamber porous filter membrane cup 9, the sampling needle 13 is inserted into the outer chamber dissolution cup 8, a liquid inlet and a liquid outlet are separated into two chambers, a good uniform mixing effect is achieved through diffusion, and the transmembrane and absorption processes in a drug body are effectively simulated. In addition, the high-precision liquid outlet pump is matched, the inflow amount of a dissolving medium of the liquid inlet of the dissolving system is equal to the outflow amount of the dissolving medium of the liquid outlet, the balance of the total amount of the dissolving medium in the dissolving system is ensured, and the problem of pipeline liquid leakage caused by overhigh hydraulic pressure in a medium pipeline is effectively avoided.
In addition, the rotary basket is arranged in the inner chamber porous filter membrane cup, so that the transverse stirring effect in the dissolution process can be increased, the medicine is disintegrated, dissolved and diffused in the rotary basket to the outer chamber dissolution cup, and compared with the method of simply adopting longitudinal washing of a pipeline, the indissolvable medicine can be fully dissolved, and the indissolvable medicine cannot be accumulated at the bottom of the dissolution cup.
Example 2
Referring to fig. 1, different from the experimental apparatus of embodiment 1, in the experimental apparatus of this embodiment, an openable top cover (not shown) is disposed on an open end of a top portion of an outer-chamber dissolution cup 8, and one end of a rotary basket 11 penetrates out of the top cover to be in transmission connection with a stirring pump, so that dissolution media in an inner-chamber porous filter membrane cup 9 have different transverse rotation speeds, which can simulate the influence of physiological peristalsis of a gastrointestinal tract in vivo on dissolution of a drug, and more truly simulate dissolution behavior of the drug in the gastrointestinal tract.
In the embodiment, the rotating basket 11 rotates and stirs in the porous filter membrane cup 9 by adjusting the rotating speed of the stirring pump, different transverse rotating speeds and mechanical stirring effects are provided for the dissolution medium, physiological peristalsis of gastrointestinal tracts in vivo can be simulated, and the medium input pipeline 7 has a longitudinal scouring effect on the medicine 12, so that the dissolution medium is more suitable for solving the problem of accumulation of insoluble high-dose medicines. If the medicine is difficult to dissolve/release, the longitudinal flow of media in the inner chamber porous filter membrane cup 9 and the outer chamber dissolving cup 8 needs to be enhanced by adjusting the flow rate of sampling and transfusion, the sampling speed simulates the transmembrane absorption process, the larger the sampling speed is, the larger the transmembrane rate is, the faster the medicine is dissolved/released, and the correlation with the human body is realized.
Referring to fig. 1, it should be noted that, in practical applications, in order to reduce drug accumulation and simulate food friction, and more truly approach physiological structural conditions, the inner bottom surface of the inner porous filter membrane cup 9 may be designed to be an inverted cone, and the inner bottom of the inverted cone is filled with inert microspheres 10.
Example 3
Referring to fig. 1, unlike example 1, the experimental apparatus of this example shows a specific structure formation of the inner chamber porous filter membrane cup 9: the inner chamber porous filter membrane cup 9 comprises a porous steel cup and a filter membrane wrapped outside the porous steel cup.
In this embodiment, the sizes of the porous steel cup and the outer chamber dissolution cup 8 can be adjusted, but the lowest dissolution medium volume needs to immerse the rotating basket 11, and the material, the aperture and the thickness of the filter membrane can also be selected according to actual needs, for example, in this embodiment, the aperture of the microporous filter membrane is 0.1-10 μm, the thickness is 0.45 μm, the size of the opening on the porous steel cup is 100-1200 meshes, the size diameter is 3-6 cm, the height is 10-12 cm, and the aperture of the porous steel cup is 1200 meshes, which can effectively play a primary filtration role, the filter membrane wrapped outside plays a secondary filtration role, the filtration area is large, and the problem that the traditional flow cell pipeline is easy to block can be solved. 100-500 mL of dissolution medium can be filled in the porous filter membrane cup, and the rotary basket can be completely immersed in the dissolution medium, so that the device is suitable for dissolving insoluble medicines.
Preferably, a sample collection control valve 17 is arranged on a pipeline between the sample collection three-way valve 16 and the sample collector 18 so as to realize timing sampling.
Example 4
Referring to fig. 1, the experimental apparatus of this embodiment is different from embodiment 1 in that it further includes an external water bath 1 and a constant temperature water bath (not shown in the figure), each media storage bottle 2 is placed in the external water bath 1, and is preheated and insulated by the external water bath 1, and the outer dissolution cup 8 is placed in the constant temperature water bath to ensure that the dissolution media in the inner porous filter membrane cup 9 is kept at a constant temperature, so that the release media is close to the physiological temperature of the gastrointestinal tract in vivo.
Application example
The experimental device for simulating the in vivo dissolution/transmembrane absorption process of the drug related to the research is added with the stirring and flow path flushing effects of the rotary basket, simulates the fluid dynamics of in vivo digestive juice, the gastrointestinal peristalsis effect and the like, and enables the dissolution and absorption to be related in vivo and in vitro.
And (3) carrying out atrioventricular model fitting on the in-vivo data of the celecoxib capsule, and analyzing an in-vivo absorption curve (shown in figure 2) by adopting a corresponding method (a Wagner-Nelson method or a Loo-Riegelman method) according to different atrioventricular models. Fitting the absorption curve in the dynamic process to obtain the rate constant ka. Based on the absorption curve and the absorption rate constant of the Xilebao, the differential dissolution devices of the two-chamber system are adjustedParameters including medium volume, medium pH, liquid flow rate, rotating basket rotating speed, etc. make the in vitro dissolution rate of the reference preparation consistent with the in vivo absorption rate, on the basis, the dissolution rate research of the test preparations of a plurality of manufacturers is carried out, and differential release curves and accumulated release curves are respectively shown in figures 3 and 4. Linear regression of the absorption fraction and the degree of release, R2>0.9, the slope is close to 1, and the in vitro correlation is good (FIG. 5).
The above examples are merely illustrative of the present invention clearly and are not intended to limit the embodiments. Other variations and modifications will be apparent to persons skilled in the art in light of the above description. Nor is it intended to be exhaustive of all embodiments. And obvious changes and modifications may be made without departing from the scope of the present invention.
Claims (9)
1. A two-chamber model experimental device for simulating the in-vivo dissolution and transmembrane absorption processes of an insoluble oral pharmaceutical preparation is characterized in that: the sampling device comprises an inner chamber porous filter membrane cup and an outer chamber dissolution cup, wherein the outer chamber dissolution cup is sleeved outside the inner chamber porous filter membrane cup, a rotating basket is arranged in the inner chamber porous filter membrane cup, a medium input pipeline inserted in the inner chamber porous filter membrane cup is communicated with a dissolution medium source, a sampling needle inserted between the outer chamber dissolution cup and the inner chamber porous filter membrane cup is connected to a sample collection three-way valve through a liquid outlet main, two output ends of the sample collection three-way valve are respectively connected to a sample collector and a waste liquid collecting bottle, and a liquid inlet pump and a liquid outlet pump are respectively arranged on the medium input pipeline and the liquid outlet main.
2. The assay device of claim 1, wherein: the medium input pipeline is divided into a plurality of medium conveying branches communicated with the medium storage bottle through a medium selector, and each medium conveying branch is provided with a liquid inlet control valve.
3. The assay device according to claim 1 or 2, wherein: the inner chamber porous filter membrane cup comprises a porous steel cup and a filter membrane wrapped outside the porous steel cup.
4. The assay device of claim 3, wherein: the aperture of the filter membrane is 0.1-10 mu m, and the aperture of the porous steel cup is 100-1200 meshes.
5. The assay device according to claim 1 or 2, wherein: and inert microspheres are filled in the inner cone bottom of the inner chamber porous filter membrane cup.
6. The assay device according to claim 1 or 2, wherein: the content of the dissolution medium in the inner chamber porous filter membrane cup is 100-500 mL.
7. The assay device according to claim 1 or 2, wherein: the top opening end of the outer chamber dissolving-out cup is provided with a top cover which can be opened and closed, and one end of the rotary basket penetrates out of the top cover to be in transmission connection with the stirring pump.
8. The assay device according to claim 1 or 2, wherein: and a sample collection control valve is arranged on a pipeline between the sample collection three-way valve and the sample collector.
9. The assay device of claim 2, wherein: the device also comprises an external water bath and a constant-temperature water bath, wherein each medium storage bottle is arranged in the external water bath, and the outer chamber dissolving cup is arranged in the constant-temperature water bath.
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