Oral simulated dissolution apparatus

Abstract

The utility model provides a kind of oral cavity simulation dissolution device, comprising: first heat preservation mechanism, extraction box, feed pump, collector and sample holder;Wherein, first heat preservation mechanism is used to heat release medium and maintain its temperature;Extraction box provides the space environment that test sample and release medium contact;Feed pump is used to pump the release medium in first heat preservation mechanism to extraction box at certain speed, and after release medium wet test sample, it dissolves out active ingredient, and flows to collector, for subsequent dissolution content detection;Sample holder is set in extraction box, for clamping test sample and providing certain extrusion force to test sample, and then simulate the pressure received in oral cavity;By controlling the temperature and flow rate of release medium, the pressure received by test sample, to restore the dissolution behavior of active ingredient of test sample in oral cavity;So as to improve the reliability and consistency of evaluating the dissolution behavior of active ingredient in oral delivery product.

Description

Technical Field

[0001] This utility model belongs to the field of oral delivery product dissolution detection technology, and in particular relates to an oral simulated dissolution device. Background Technology

[0002] Oral delivery products refer to products that directly enter the bloodstream through oral mucosal delivery systems. Traditional oral medications, such as tablets, suffer from several drawbacks. Firstly, the product may be degraded in the acidic environment of the stomach. Secondly, once the drug enters the intestines, it is absorbed into the bloodstream and enters the liver via the portal vein. During this process, most of the active pharmaceutical ingredient is typically metabolized into inactive chemical substances by enzymes that usually process foreign substances in food—a process known as first-pass metabolism. These factors significantly delay the therapeutic effect. Furthermore, oral delivery requires a much higher dosage than intravenous injection, increasing the risk of gastrointestinal side effects. Therefore, oral mucosal delivery is proposed to avoid these problems.

[0003] Nicotine pouches, as a novel nicotine ingestion product, have gained widespread attention in the market in recent years. They are small pouches containing nicotine, placed in the mouth, such as between the cheek and gums. The pouches are moistened by oral secretions, releasing nicotine to satisfy the user's nicotine cravings. Compared to traditional tobacco products, nicotine pouches are convenient to use, require no combustion, and may reduce the release of some harmful substances, making them a popular choice for many people who want to replace traditional smoking or control their nicotine intake.

[0004] With the increasing popularity of nicotine pouches, research on their release characteristics, release patterns, and influencing factors in the oral cavity has become particularly important. This research helps optimize nicotine pouch product design, improve product safety and efficacy, and better meet consumer needs. However, existing research methods often cannot realistically reproduce the complex environment of the oral cavity, such as temperature, humidity, saliva production, and oral movements. These factors all affect the release rate and amount of nicotine from the nicotine pouch. Due to the lack of suitable simulation devices, researchers find it difficult to accurately understand the release behavior of nicotine pouches in a real oral environment, which limits product development and improvement. Utility Model Content

[0005] The present invention aims to provide an oral cavity simulated dissolution device to solve the technical problem in the prior art that it is difficult to accurately evaluate the dissolution behavior of active ingredients in oral delivery products.

[0006] To solve the above-mentioned technical problems, this utility model provides an oral cavity simulated dissolution device, comprising: a first heat preservation mechanism, which is used to heat the release medium and maintain it within a preset temperature range, wherein the release medium is used to wet the test sample and extract active ingredients from the test sample;

[0007] An extraction chamber is configured to provide a spatial environment in which the release medium comes into contact with the test sample; the extraction chamber has an inlet and an outlet for the release medium to enter and flow out.

[0008] A feed pump is used to pump the release medium from the storage bottle into the extraction tank at a constant flow rate.

[0009] A collector, positioned at the sample outlet aligned with the extraction chamber, is used to receive the released medium after wetting the test sample;

[0010] A sample holder, detachably installed inside the extraction chamber, is configured to hold the test sample and provide a preset squeezing force when the release medium drips onto the test sample.

[0011] Optionally, the sample holder has a first clamping member and a second clamping member that are hinged and / or snap-fitted together, and the test sample is placed between the first clamping member and the second clamping member.

[0012] Optionally, the first clamping member and the second clamping member have a planar or concave surface, and when the first clamping member and the second clamping member are closed together, their respective planar or concave surfaces approach and abut each other.

[0013] Optionally, the first and second clamps are configured to provide a compressive force of 20-30g to the test sample.

[0014] Optionally, the sample holder is provided with a plurality of evenly distributed pores, which allow the release medium to flow in and out.

[0015] Optionally, the first insulation mechanism is configured to maintain the temperature range of the released medium at 36.5~37°C.

[0016] Optionally, it also includes a second heat preservation mechanism, which is disposed on the outer periphery of the extraction box to maintain the internal temperature of the extraction box within the range of 36.5~37℃.

[0017] Optionally, the second heat preservation mechanism is also disposed on the outer periphery of the delivery pipe to maintain the temperature of the release medium during the flow process.

[0018] Optionally, the flow rate of the release medium is configured to be 0.4~0.5 L / min.

[0019] Optionally, it also includes a storage bottle configured to contain the release medium.

[0020] This invention uses a first and a second heat-preserving mechanism to simulate the oral cavity temperature, allowing the test sample to undergo dissolution extraction within a constant temperature range, thus reducing the impact of temperature changes on dissolution behavior. Furthermore, by combining this with the sample holder, the pressure experienced by the test sample within the oral cavity can be simulated, further reproducing the dissolution behavior of the active ingredient in the oral cavity; thereby improving the reliability and consistency of the evaluation of the dissolution behavior of active ingredients in oral delivery products. Attached Figure Description

[0021] One or more embodiments are illustrated by way of example with reference numerals in the accompanying drawings. These illustrations do not constitute a limitation on the embodiments. Elements with the same reference numerals in the drawings are denoted as similar elements. Unless otherwise stated, the figures in the drawings do not constitute a limitation on scale.

[0022] Figure 1 This is a schematic diagram of the oral cavity simulated dissolution device provided in one embodiment of this application;

[0023] Figure 2 This is a schematic cross-sectional view of an oral cavity simulation dissolution device provided in an embodiment of this application;

[0024] Figure 3 for Figure 2 A magnified view of part A in the image;

[0025] Figure 4 This is a schematic diagram of the structure of a sample holder provided in one embodiment of this application;

[0026] Figure 5 This is a schematic diagram of the sample holder provided in another embodiment of this application.

[0027] The attached figures are labeled as follows:

[0028] 10. First insulation mechanism; 110. Box body; 111. Card seat; 120. Cover; 130. Circulation pump; 131. Circulation pipe;

[0029] 20. Storage bottle;

[0030] 30. Feed pump; 310. Conveying pipe;

[0031] 40. Extraction box; 410. Side wall; 420. Top cover; 430. Bottom wall; 440. Processing chamber; 450. Foot pad;

[0032] 50. Second insulation mechanism; 510. Pipeline heat circulation assembly; 511. First sleeve; 512. First water inlet; 513. First water outlet; 520. Extraction heat circulation assembly; 521. Second sleeve; 522. Second water inlet; 523. Second water outlet;

[0033] 60. Sample holder; 610. First clamping component; 620. Second clamping component; 630. Support foot; 640. Buckle; 6401. Locking component; 6402. Positioning component;

[0034] 70. Collector;

[0035] 80. Test sample. Detailed Implementation

[0036] To facilitate understanding of this utility model, the following section provides a more detailed description of it in conjunction with the accompanying drawings and specific embodiments. It should be noted that when an element is described as "connected" to another element, it can be directly on the other element, or one or more intermediate elements can exist between them. The terms "upper," "lower," "left," "right," "upper end," "lower end," "top," and "bottom," etc., used in this specification indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, and are only for the convenience of describing this utility model and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this utility model. Furthermore, the terms "first," "second," etc., are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0037] Unless otherwise defined, all technical and scientific terms used in this specification have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. The terminology used in this specification is for the purpose of describing particular embodiments only and is not intended to limit the scope of the invention.

[0038] First, the application scenarios and some concepts involved in the technical solution of this application need to be explained. The oral cavity dissolution simulation device is mainly used to evaluate the dissolution behavior of active ingredients in oral products, thereby understanding the consistency of dissolution of active ingredients during the R&D process or production quality control. Oral products refer to products that are held in the mouth during use, where their active substances dissolve under the moistening effect of saliva and are then absorbed through the oral mucosa. These active substances are generally not absorbed by the gastrointestinal tract, or are destroyed in the gastrointestinal environment, reducing their activity, or, after absorption through the gastrointestinal mucosa, require liver metabolism and transformation before entering the systemic circulation, resulting in a bioavailability of only about 10-30%. Absorption through the oral mucosa avoids the first-pass effect of the liver, resulting in higher bioavailability. Suitable candidates for oral products are the elderly and children. Compared to average, these two groups of patients usually receive more drug treatment and are generally unable to self-medicate. The active ingredients here include any substance that provides biological activity or effects to mammals. The active ingredient is a therapeutic active ingredient, which can also be a bioactive ingredient, a drug, a dietary supplement, or an active substance that needs to be replenished in a timely manner, such as nicotine or caffeine.

[0039] Please see Figure 1 and Figure 2 , Figure 1 This is a schematic diagram of the structure of an oral cavity simulation dissolution device provided in one embodiment of this application. Figure 2 This is a cross-sectional structural diagram of an oral cavity simulated dissolution device provided in an embodiment of this application. The oral cavity simulated dissolution device includes a first heat preservation mechanism 10, a feed pump 30, an extraction box 40, a sample holder 60, and a collector 70; wherein the sample holder 60 is disposed inside the extraction box 40.

[0040] Please continue reading. Figure 2 The first insulation mechanism 10 includes a housing 110, a cover 120, and a heating element (not shown in the figure). The cover 120 is connected to the housing 110, and the heating element is disposed inside the housing 110. The interior of the housing 110 is divided into upper and lower cavities by a partition plate, and the heating element is disposed in the lower cavity (not shown in the figure). A receiving cavity can be provided on the partition plate for dispensing and releasing the medium.

[0041] To reduce cleaning difficulty and prevent contamination of the release medium, the oral cavity simulation dissolution device also includes a storage bottle 20. A retainer 111 is provided on the partition plate for inserting and installing the storage bottle 20, thus enabling the first insulation mechanism 10 to load the storage bottle 20. Specifically, the storage bottle 20 is pre-filled with the release medium before being installed in the first insulation mechanism 10, so that the first insulation mechanism 10 can heat and maintain the temperature of the release medium. Furthermore, to maintain the stability of the release medium during the insulation process, the storage bottle 20 is made of a light-proof material, such as brown glass, aluminum foil, stainless steel, or plastics like polyvinyl chloride or high-density polyethylene.

[0042] Specifically, in this embodiment, the first heat preservation mechanism 10 is a hot circulating water bath. To simulate the human oral cavity environment, the first heat preservation mechanism 10 heats and maintains the temperature of the release medium between 36.5 and 37.3°C. The storage bottle 20 is a brown glass bottle, which is fixed inside the housing 110 of the first heat preservation mechanism 10 by a clip. To ensure that the release medium is fully heated and kept warm, the storage bottle 20 is mostly immersed in water. The release medium can be artificial saliva, real saliva, physiological saline, or water.

[0043] Please continue reading. Figure 1 The feed pump 30 is located on one side of the first insulation mechanism 10 and is connected to the storage bottle 20 and the extraction box 40 respectively through the delivery pipe 310 to pump out the release medium at a suitable temperature and deliver it into the extraction box 40. An opening is provided on the cover 120 of the first insulation mechanism 10, through which the delivery pipe 310 extends into the storage bottle 20. Specifically, in this embodiment, the feed pump 30 is a peristaltic pump, whose working principle is similar to "peristalsis" in nature. Its core is that a motor drives a rotor to rotate, and rollers or pressure rollers mounted on the rotor alternately squeeze the elastic hose inside the pump head. When the roller squeezes the hose, the hose cavity is closed, and the fluid inside is forced forward by pressure; when the roller leaves the hose, the hose quickly returns to its original shape under its own elasticity, creating a negative pressure inside the hose, thereby drawing in new fluid. This cycle repeats continuously, achieving continuous fluid delivery. Its advantages lie in the fact that the fluid flows only within the hose, without contacting other parts of the pump body, effectively preventing fluid contamination; and its rotational speed is stable and adjustable, with flow rate proportional to rotational speed, thus enabling high-precision flow control with high repeatability and stability. Therefore, choosing a peristaltic pump for delivering the release medium maximizes the replication of the saliva secretion process in the oral cavity. Furthermore, the flow rate of the release medium is controlled between 0.4 and 0.5 L / min.

[0044] Please continue reading. Figure 1-3The extraction chamber 40 is located on the side near the output of the feed pump 30. The extraction chamber 40 includes a side wall 410, a top cover 420, and a bottom wall 430. The side wall 410, top cover 420, and bottom wall 430 together form a processing chamber 440. The top cover 420 and bottom wall 430 are arranged opposite each other. The top cover 420 has a sample inlet for the delivery pipe 310 from the output end of the sample pump to be introduced into the extraction chamber. The bottom wall 430 has a sample outlet for the dissolved sample to flow out to the collector 70. The bottom of the extraction chamber is also provided with several feet 450, with space between the feet 450 for the collector 70 to be placed.

[0045] Please continue to refer to Figure 3 The sample holder 60 and extraction box 40 are disposed in the processing chamber 440. Specifically, an installation groove (not shown in the figure) is provided on the bottom wall 430. The installation groove allows the sample holder 60 to be fixed to the bottom of the extraction box 40 by plugging in. There is no limit to the number of installation grooves, as long as they are compatible with the sample holder 60. The sample holder 60 is installed directly above the liquid outlet at the bottom of the extraction box 40 and the collector 70. During device testing, the test sample 80 is placed in the sample holder 60, and the delivery tube 310 extends from the sample inlet and faces the test sample 80, about 5 mm away from the test sample 80.

[0046] To further facilitate the placement and removal of the sample holder 60, the extraction box 40 is designed to consist of two detachable parts, which can be assembled through threaded connections, rotational snap-fits, or sleeve connections. Specifically, in this embodiment, refer to... Figures 1-2 As can be seen, the extraction box 40 is a cylindrical tube, and the side wall 410 can be separated into upper and lower parts from the middle. The two parts are assembled together by rotating and snapping. One part of the side wall 410 is closed with the top cover 420, and the other part of the side wall 410 is integrally formed with the bottom wall 430. Therefore, the sample holder 60 can be placed either by opening the top cover 420 or by disassembling the side wall 410.

[0047] Please refer to Figure 4 , Figure 4This is a schematic diagram of the sample holder 60 in one embodiment of this application. The sample holder 60 includes a first clamping member 610 and a second clamping member 620. The test sample 80 is placed between the first clamping member 610 and the second clamping member 620 to support the test sample 80 while applying a certain squeezing force to the test sample 80, thereby simulating the pressure experienced by the product in the oral cavity. Specifically, in this embodiment, both the first clamping member 610 and the second clamping member 620 have uniformly spaced holes and are hinged together by a torsion spring. When the sample holder 60 is opened, the first clamping member 610 and the second clamping member 620 rotate around a pivot, causing the torsion spring to undergo torsional deformation and generate torsional elastic potential energy. Once the sample holder 60 is released, the torsion spring attempts to return to its original state, thereby causing the sample holder 60 to close and generating a squeezing force to clamp the test sample 80. To facilitate the release medium's passage through the sample holder 60 to wet the test sample 80 and smoothly flow into the collector 70, the sample holder 60 is provided with a plurality of evenly distributed pores. Specifically, in this embodiment, the first clamping member 610 and the second clamping member 620 each include an integrally formed clamping plate and a clamping handle. The clamping plates of the first clamping member 610 and the second clamping member 620 are parallel to each other, and the clamping handles of the first clamping member 610 and the second clamping member 620 form an angle with each other. The pores for the release medium to flow through are formed on the two clamping plates.

[0048] To improve the installation stability of the sample holder 60, the connection between the sample holder 60 and the extraction box 40 can be achieved through snap-fit, adhesive, plug-in, threaded connection, or other methods. For example, in one embodiment, a groove can be formed at the bottom of the extraction box 40, and a support foot 630 adapted to the groove is provided at the bottom of the sample holder 60. The sample holder 60 is fixed in position by inserting a flange into the groove. In another embodiment, double-sided adhesive tape, preferably a residue-free and easy-to-remove tape, can be applied to the bottom of the sample holder 60 to achieve fixation and removal within the extraction box 40. The connection method between the sample holder 60 and the extraction box 40 is not limited here, as long as it achieves both fixed position and easy removal of the sample holder 60.

[0049] Please refer to Figure 5 , Figure 5This is a schematic diagram of the sample holder 60 according to another embodiment of this application. The sample holder 60 includes a first clamping member 610, a second clamping member 620, a support foot 630, and a buckle 640. The first clamping member 610 and the second clamping member 620 are hinged on one side by a pivot and locked on the other side by the buckle 640. Specifically, the buckle 630 includes a positioning member 6402 and a locking member 6401. The locking member 6401 is integrally formed with the first clamping member 610, and the positioning member 6402 is integrally formed with the second clamping member 620. The support foot 630 is located at the bottom of the second clamping member 620. In order to improve the installation stability without affecting the flow direction of the dissolved sample, the support foot 630 is arranged around the perimeter away from the center of the second clamping member 620. When using the sample holder 60, the locking member 6401 and the positioning member 6402 need to be unlocked first. Then, the first clamping member 610 is rotated away from the second clamping member 620 via the pivot. The test sample 80 is then placed on the second clamping member 620. The first clamping member 610 is then rotated. Finally, the sample holder 60 is closed and locked by inserting the locking member 6401 into the positioning member 6402. Thus, the bottom surface of the first clamping member 610 and the top surface of the second clamping member 620 apply a compressive force to the test sample 80.

[0050] Specifically, both the first clamping member 610 and the second clamping member 620 have concave surfaces, which are hemispherical. When the two concave surfaces approach each other, they almost overlap, so the test sample 80 will be subjected to compressive force when placed between the two concave surfaces. To simulate the real scene of the human oral cavity, the first clamping member 610 and the second clamping member 620 provide a compressive force of 20~30g to the test sample 80. Due to the spherical design, the release medium can gather at the apex of the concave surface and drip down to the collector 70, thereby improving the collection efficiency of the dissolved sample.

[0051] To further enhance the simulation effect of this device, the sample holder 60 can also be connected to an external air pump, and the opening and closing of the sample holder 60 can be controlled by the intelligent control module at regular intervals to squeeze the test sample 80 at a certain frequency, so as to simulate the effect of holding the sample in the mouth.

[0052] Please continue to refer to Figure 1 In another embodiment of this application, the oral cavity simulated dissolution device further includes a second heat preservation mechanism 50. The second heat preservation mechanism 50 is used to heat and keep the release medium output from the feed pump 30 at a constant temperature, while maintaining the temperature of the release medium during the extraction process, thereby fully simulating the oral cavity environment. The second heat preservation mechanism 50 is connected to the first heat preservation mechanism 10 through a circulation pipe 131. The circulation pump 130 of the first heat preservation mechanism 10 delivers the heating medium that has reached a preset temperature to the second heat preservation mechanism 50, and uses the temperature difference of the heating medium to perform heat exchange, so as to achieve a temperature range of 36.5-37°C during the extraction process of the release medium.

[0053] In another embodiment of this application, see [reference] Figure 1 The second heat preservation mechanism 50 includes a pipeline heat circulation group 510 and an extraction heat circulation group 520. The pipeline heat circulation group 510 is installed on the outer periphery of the conveying pipe 310 between the feed pump 30 and the extraction box 40, and is used to heat and maintain the temperature of the released medium in this section of the conveying pipe 310. The extraction heat circulation group 520 is installed on the outer periphery of the extraction box 40, and is used to heat and maintain the temperature inside the extraction box 40.

[0054] Please continue reading. Figures 1-2 Specifically, in this embodiment, the pipe heat circulation assembly 510 includes a first sleeve 511, a first inlet nozzle 512, and a first outlet nozzle 513, with the first inlet nozzle 512 and the first outlet nozzle 513 respectively located at the two relatively far ends of the double-layered hollow pipe body. The extraction heat circulation assembly 520 includes a second sleeve 521, a second inlet nozzle 522, and a second outlet nozzle 523, with the second inlet nozzle 522 and the second outlet nozzle 523 respectively located at the two relatively far ends of the double-layered hollow pipe body. Both the first sleeve 511 and the second sleeve 521 are double-layered hollow pipe bodies made of glass; the first inlet nozzle 512, the first outlet nozzle 513, the second inlet nozzle 522, and the second outlet nozzle 523 are made of blown glass. To achieve heat circulation in the second insulation mechanism 50, the outlet of the circulation pump 130, the first inlet 512, the first outlet 513, the second inlet 522, the second outlet 523, and the inlet of the circulation pump 130 of the first insulation mechanism 10 are connected in sequence through the circulation pipe 131, thereby realizing the circulation supply of heat source.

[0055] In other embodiments, the extraction heat circulation assembly 520 or the pipeline heat circulation assembly 510 can be a soft plastic bag that fits more closely to the outer walls of the delivery pipe 310 and the extraction box 40, thereby improving heat exchange efficiency. The extraction heat circulation assembly 520 or the pipeline heat circulation assembly 510 can be replaced by an insulation layer that covers the outer periphery of the delivery pipe 310 and the extraction box 40 to reduce heat loss of the released medium during the circulation process.

[0056] To further improve the installation stability of the extraction heat circulation assembly 520, an annular groove (not shown in the figure) is provided on the outer periphery of the lower section of the extraction box 40 to support the bottom of the extraction heat circulation assembly 520. In other embodiments, a slot adapted to the extraction heat circulation assembly 520 may also be provided on the outer periphery of the extraction box 40 for the installation and fixation of the extraction heat circulation assembly 520; the specific method is not limited here.

[0057] Continue reading Figure 1 The collector 70 is a container with an opening for collecting samples leached from the release medium. The material of the collector 70 is not limited; it can be made of glass or plastic. Specifically, in this embodiment, the collector 70 serves as the sample injector for the detection device, facilitating direct transfer to the detection device for subsequent sample leaching content testing.

[0058] The principle of this oral cavity simulation dissolution device in nicotine bag products is as follows: The nicotine bag is placed in the extraction box 40. The first heat preservation mechanism 10 heats the artificial saliva water bath to 37°C and then delivers it to the extraction box 40 at a certain flow rate through the feed pump 30, so that the artificial saliva flows through the nicotine bag and dissolves the nicotine from the nicotine bag. The dissolved artificial saliva is collected using the collector 70, and the amount of nicotine dissolved is measured by the instrument.

[0059] The specific steps include:

[0060] S1: Use a liquid guide tube to connect the circulation pump 130 in the first heat preservation mechanism 10 with the pipeline heat circulation group 510 and the extraction heat circulation group 520 in the second heat preservation mechanism 50, start the first heat preservation mechanism 10, and set the temperature to 37°C to form a water bath heating internal circulation and external circulation.

[0061] S2: Place the brown storage bottle 20 containing the release medium (artificial saliva) on the card holder 111 inside the first heat preservation mechanism 10 and fix it, then heat the release medium.

[0062] S3: Place the test sample 80 (nicotine bag) in the holder and install the holder at the bottom of the extraction box 40;

[0063] S4: Connect the storage bottle 20, the feed pump 30 and the extraction box 40 through the conveying pipe 310;

[0064] S5: When the preset temperature of the first heat preservation mechanism 10 is 37℃, start the circulation pump 130; set the flow rate of the feed pump 30 to 0.4L / min, turn on the feed pump 30, and deliver the artificial saliva to the extraction box 40, so that the artificial saliva flows through the nicotine bag and dissolves the nicotine from the nicotine bag; place the collector 70 below the extraction box 40 and directly opposite the sample outlet of the extraction box 40 to receive the sample dissolved by the artificial saliva.

[0065] This invention can reproduce to the greatest extent possible various factors in oral movement during the use of nicotine pouches, such as oral temperature, saliva volume, saliva flow rate, and the pressure of the palate and gums. This allows researchers to conduct a comprehensive and systematic study on the release of nicotine from the pouch under controlled conditions, providing a more accurate basis for the research and development and improvement of nicotine pouch products.

[0066] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of this utility model, and not to limit it; under the concept of this utility model, the technical features of the above embodiments or different embodiments can also be combined, the steps can be implemented in any order, and there are many other variations of the different aspects of this utility model as described above. For the sake of brevity, they are not provided in detail; the above test sample uses a nicotine bag for illustration, and it should be understood that this utility model is applicable to all products delivered orally; although the utility model has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some of the technical features; and these modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of this utility model.

Claims

1. An oral cavity simulated dissolution device, characterized in that, include: A first heat preservation mechanism is used to heat the release medium and maintain it within a preset temperature range. The release medium is used to wet the test sample and extract the active ingredient from the test sample. An extraction chamber is configured to provide a spatial environment in which the release medium comes into contact with the test sample; the extraction chamber has an inlet and an outlet for the release medium to enter and flow out. A feed pump is used to pump the release medium from the storage bottle into the extraction tank at a constant flow rate. A collector, positioned at the sample outlet aligned with the extraction chamber, is used to receive the released medium after wetting the test sample; A sample holder, detachably installed inside the extraction chamber, is configured to hold the test sample and provide a preset squeezing force when the release medium wets the test sample.

2. The oral cavity simulated dissolution device according to claim 1, characterized in that, The sample holder has a first clamping member and a second clamping member that are hinged and / or snap-fitted together, and the test sample is placed between the first clamping member and the second clamping member.

3. The oral cavity simulated dissolution device according to claim 2, characterized in that, The first clamping member and the second clamping member have a flat or concave surface. When the first clamping member and the second clamping member are closed together, their respective flat or concave surfaces approach each other and abut.

4. The oral cavity simulated dissolution device according to claim 2 or 3, characterized in that, The first and second clamps are configured to provide a compressive force of 20-30g to the test sample.

5. The oral cavity simulated dissolution device according to any one of claims 1 to 3, characterized in that, The sample holder is provided with a number of evenly distributed pores, which allow the release medium to flow in and out.

6. The oral cavity simulated dissolution device according to any one of claims 1 to 3, characterized in that, The first insulation mechanism is configured to maintain the temperature of the released medium at 36.5~37°C.

7. The oral cavity simulated dissolution device according to any one of claims 1 to 3, characterized in that, It also includes a second heat preservation mechanism, which is located on the outer periphery of the extraction box and is used to maintain the internal temperature of the extraction box at 36.5~37℃.

8. The oral cavity simulated dissolution device according to claim 7, characterized in that, The second heat preservation mechanism is also provided on the outer periphery of the delivery pipe to maintain the temperature of the released medium during the flow process.

9. The oral cavity simulated dissolution device according to any one of claims 1 to 3, characterized in that, The flow rate of the release medium is configured to be 0.4~0.5 L / min.

10. The oral cavity simulated dissolution device according to claim 1, characterized in that, It also includes a storage bottle configured to contain the release medium.

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