Skin sample fixing structure and transdermal testing device

Through the combination of the fixing box structure and the transdermal testing device, the problem of waste and testing difficulties of skin samples is solved, and the efficient utilization and testing reliability of skin samples are achieved.

CN223071231UActive Publication Date: 2025-07-08CHINA INST FOR FOOD & DRUG CONTROL (MEDICAL DEVICE STANDARDS MANAGEMENT CENT OF THE STATE FOOD & DRUG ADMINISTRATION CHINA GENERAL INST FOR MEDICAL PROD INSPECTION)
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Patent Information

Application Number
CN202422241625.9
Authority / Receiving Office
CN · China
Patent Type
Utility models(China)
Current Assignee / Owner
Filing Date
2024-09-12
Publication Date
2025-07-08
Estimated Expiration
2034-09-12

AI Technical Summary

Technical Problem

In the prior art, skin samples are seriously wasted during skin permeability testing, especially ex vivo skin samples that are difficult to obtain, resulting in difficult testing.

Method used

The fixed box structure is adopted, including the upper and lower box, which is connected to the transdermal test device through the drug contact groove and the receiving liquid contact groove to fix the skin sample to avoid being restricted by the opening of the upper and lower pool body during clamping, and the sample utilization rate is increased by combining the support part and the limit part.

Benefits of technology

Effectively utilize skin samples, reduce waste, improve test reliability and stability, and solve the testing difficulties caused by the difficulty of sample acquisition.

✦ Generated by Eureka AI based on patent content.

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Abstract

The utility model relates to the technical field of transdermal absorption testing, and discloses a skin sample fixing structure and a transdermal testing device.The skin sample fixing structure comprises a fixing box, the fixing box comprises an upper half box and a lower half box, the upper half box and the lower half box are used for being spliced to clamp a skin sample, and a medicine contact groove penetrating through the upper half box in the height direction is formed in the upper half box; the lower half box is provided with a liquid receiving contact groove penetrating through the lower half box in the height direction. The skin sample penetration test box solves the problems that sample waste is caused, and a skin sample penetration test which is high in obtaining difficulty is difficult.
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Description

Technical Field

[0001] The utility model relates to the technical field of transdermal absorption testing, in particular to a skin sample fixing structure and a transdermal testing device. Background Art

[0002] In related industries such as cosmetics and pharmaceuticals, when testing products directly applied to the skin, such as skin care products and topical medications, it is usually necessary to test the skin penetration rate of the products.

[0003] In the prior art, the skin penetration rate is usually tested by using a receiving cell device. The receiving cell device generally includes an upper cell body, a lower cell body, and a clamping structure. The skin sample is located between the upper cell body and the lower cell body, and is positioned by pressing the upper cell body and the lower cell body. The clamping structure acts on the upper cell body and the lower cell body to make the upper cell body and the lower cell body abut against each other in the direction of approaching each other, so as to clamp the skin sample. The test product to be tested is added into the upper cell body, and the test product is brought into contact with the skin sample. The receiving liquid is added into the lower cell body. After a certain period of time, by detecting the concentration of the product in the receiving liquid, the skin penetration rate of the product can be measured.

[0004] However, in the above prior art, since the skin sample is clamped by the relative ends of the upper cell body and the lower cell body, the skin sample needs to be at least larger than the inner diameters of the upper cell body and the lower cell body, and the part clamped by the upper cell body and the lower cell body does not participate in the penetration of the product, resulting in waste of some samples. For some types of skin samples with difficult acquisition, such as human ex vivo skin samples, while the sample acquisition is difficult, the area of the sample itself is limited, which causes certain difficulties in testing with the receiving cell device in the prior art. Summary of the Utility Model

[0005] In view of this, the utility model provides a skin sample fixing structure and a transdermal testing device to solve the problems of sample waste and difficulties in the penetration test of skin samples with difficult acquisition.

[0006] In the first aspect, the utility model provides a skin sample fixing structure, including a fixing box, which includes an upper half box and a lower half box for clamping the skin sample by being spliced with each other. A drug contact groove penetrating through the upper half box in the height direction is formed on the upper half box, and a receiving liquid contact groove penetrating through the lower half box in the height direction is formed on the lower half box.

[0007] Beneficial effects: By providing a fixing box, the upper half box and the lower half box of the fixing box are used to jointly clamp the skin sample. The medicine contact groove on the upper half box communicates with the upper cell body of the transdermal test device, enabling the skin sample to contact the medicine. At the same time, the receiving liquid contact groove on the lower half box communicates with the lower cell of the transdermal test device, enabling the skin sample to contact the receiving liquid, thus realizing transdermal testing. Since the fixing box is used to directly clamp the skin sample between the upper cell and the lower cell, and the skin sample is fixed by the fixing box, the size of the skin sample is no longer limited by the size of the openings of the upper cell and the lower cell, and the contact area with the skin sample during the fixation of the skin sample is reduced, improving the utilization rate of the skin sample and solving the problem of difficult penetration testing of skin samples that are difficult to obtain due to sample waste.

[0008] In an alternative embodiment, a support portion is provided at the receiving liquid contact groove on the lower half box, and the support portion is used to support the skin sample and prevent the skin sample from sagging downward.

[0009] Beneficial effects: By providing a support portion on the lower half box, the support portion supports the lower side of the skin, preventing the skin from sagging under the action of gravity and the pressure of the medicine above. At the same time, due to the effective support of the skin sample, the force required to clamp and tension the skin sample is reduced, and the clamping area of the box body on the edge of the skin sample can be further reduced, thereby further improving the utilization rate of the skin sample.

[0010] In an alternative embodiment, the support portion includes a central frame and a plurality of connecting bars, one end of each connecting bar is connected to the lower half box, and the other end is connected to the central frame.

[0011] Beneficial effects: Through the arrangement of the central frame and the connecting bars, it is ensured that there is sufficient exposed area under the support portion for the skin sample, so that it can fully contact the receiving liquid, avoiding affecting the reliability of the transdermal test results.

[0012] In an alternative embodiment, the connecting bars are arc-shaped, and a plurality of the connecting bars are arranged in a vortex shape, and the rotation direction of the vortex shape formed by the plurality of connecting bars is the same as the rotation direction of the stirring structure of the transdermal test device in the working state.

[0013] Beneficial effects: By setting the connecting bars to be arc-shaped and arranging a plurality of connecting bars in a vortex shape, and making the rotation direction of the vortex the same as the rotation direction of the stirring structure, during the transdermal test, the stirring device stirs the receiving liquid and forms a receiving liquid swirl in the lower cell body. Through the vortex arrangement of the connecting bars, the interference with the flow direction of the receiving liquid swirl can be reduced, thereby reducing the disturbance of the receiving liquid swirl to the box body and the skin sample, improving the stability of the skin sample fixation, and contributing to improving the test reliability.

[0014] In an optional embodiment, a limiting portion is provided on the upper half box at the medicine contact groove, and the limiting portion is used to limit the upper side of the skin sample and prevent the skin sample from bulging upward.

[0015] Beneficial effect: By setting a limiting part, the upper side of the skin sample is limited. During the test, the limiting part is located on the upper side of the skin sample, thereby preventing the skin sample from tilting upward under the disturbance of the receiving liquid on the lower side to form bubbles and other situations that affect the test results.

[0016] In an optional embodiment, the limiting portion includes two limiting bars arranged in a cross shape, and both ends of the limiting bars are respectively connected to the upper half box.

[0017] Beneficial effect: By using two cross-shaped limiting strips as the limiting part, it is possible to limit the skin sample and ensure that the skin sample has sufficient contact area with the medicine.

[0018] In the second aspect, the utility model also provides a transdermal testing device, including: a lower pool body, used to hold a receiving liquid, the top of the lower pool body having an opening; an upper pool body, suitable for being placed on the upper side of the lower pool body, the top and bottom of the upper pool body having openings, and when the upper pool body is placed on the upper side of the lower pool body, the bottom opening of the upper pool body is arranged opposite to the top opening of the lower pool body, and a rotating stirring structure for stirring the receiving liquid is provided at the bottom of the lower pool body; the above-mentioned skin sample fixing structure is arranged between the upper pool body and the lower pool body, and when the test is carried out, the upper pool body and the lower pool body clamp the fixing box.

[0019] Beneficial effect: by clamping the fixing box between the upper pool body and the lower pool body, the skin sample is fixed by the fixing box, so that the size of the skin sample is no longer limited by the relative opening area of ​​the upper pool body and the lower pool body, thereby achieving the effect of saving skin samples and avoiding waste.

[0020] In an optional embodiment, a step groove is provided on the side wall of the top opening of the lower pool body, and the step groove is adapted to the shape of the fixing box. When the test is in progress, the fixing box is located in the step groove, and the step groove and the upper pool body jointly press against the fixing box.

[0021] Beneficial effects: By setting the step groove, it is convenient to accommodate and limit the fixing box, so as to keep the skin sample in the correct position during the test, and it also helps to improve the sealing performance between the fixing box and the upper pool body, and between the fixing box and the lower pool body.

[0022] In an alternative embodiment, a step groove is provided on the side wall at the bottom opening of the upper pool body. The step groove is adapted to the shape of the fixed box. In the state of the test in progress, the fixed box is located in the step groove, and the step groove and the lower pool body jointly press against the fixed box.

[0023] Advantageous effects: The step groove can also be provided at the bottom opening of the upper pool body, so as to realize the limitation of the fixed box, providing a solution different from that of opening the step groove at the top of the lower pool body.

[0024] In an alternative embodiment, a clamping member is further included. A first clamping edge is provided on the circumferential side wall at the bottom end of the upper pool body, and a second clamping edge is provided on the circumferential side wall at the top end of the lower pool body. The clamping member is adapted to clamp the first clamping edge and the second clamping edge so that the upper pool body and the lower pool body are pressed against each other.

[0025] Advantageous effects: Through the arrangement of the clamping member, the first clamping edge and the second clamping edge of the upper pool body and the lower pool body are clamped, so that the upper pool body and the lower pool body are pressed against each other, and jointly provide reliable limitation for the fixed box, and the upper half box and the lower half box of the fixed box are squeezed in the direction of approaching each other, so as to clamp the skin sample. Description of the Drawings

[0026] In order to more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the following will briefly introduce the drawings required for use in the description of the specific embodiments or the prior art. Obviously, the following drawings are some embodiments of the present invention. For those of ordinary skill in the art, other drawings can be obtained based on these drawings without creative efforts.

[0027] Figure 1 It is a schematic diagram of the overall structure of a transdermal test device according to an embodiment of the present invention;

[0028] Figure 2 It is a schematic diagram of the structure of the upper half box in a skin sample fixing structure according to an embodiment of the present invention;

[0029] Figure 3 It is a schematic diagram of the structure of the lower half box in a skin sample fixing structure according to an embodiment of the present invention;

[0030] Figure 4 It is a schematic diagram of the overall structure of another transdermal test device according to an embodiment of the present invention.

[0031] Description of the Reference Numerals:

[0032] 100, Fixed box; 101, upper half box; 1011, drug contact groove; 102, lower half box; 1021, receiving liquid contact groove; 200, support part; 201, central frame; 202, connecting bar; 300, limiting part; 301, limiting bar; 400, upper cell body; 401, first clamping edge; 500, lower cell body; 501, second clamping edge; 600, rotating stirring structure; 700, step groove. Detailed implementation manners

[0033] To make the objectives, technical solutions and advantages of the embodiments of the present utility model clearer, the technical solutions in the embodiments of the present utility model will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present utility model. Apparently, the described embodiments are some but not all of the embodiments of the present utility model. Based on the embodiments of the present utility model, all other embodiments obtained by those of ordinary skill in the art without creative efforts shall fall within the protection scope of the present utility model.

[0034] The following combines Figures 1 to 4 , and describes the embodiments of the present utility model.

[0035] According to an embodiment of the present utility model, on the one hand, a skin sample fixing structure is provided, which includes a fixed box 100. The fixed box 100 includes an upper half box 101 and a lower half box 102 that are used to be joined together to clamp the skin sample. A drug contact groove 1011 that penetrates the upper half box 101 in the height direction is formed on the upper half box 101, and a receiving liquid contact groove 1021 that penetrates the lower half box 102 in the height direction is formed on the lower half box 102.

[0036] In this embodiment, by providing the fixed box 100, and clamping the skin sample jointly by the upper half box 101 and the lower half box 102 of the fixed box 100, and connecting the drug contact groove 1011 on the upper half box 101 to the upper cell body 400 of the transdermal test device, the skin sample can be in contact with the drug. At the same time, the receiving liquid contact groove 1021 on the lower half box 102 is connected to the lower cell of the transdermal test device, so that the skin sample can be in contact with the receiving liquid, realizing transdermal testing. Since the fixed box 100 is used to clamp the skin sample directly between the upper cell body and the lower cell body instead of the skin sample, and the skin sample is fixed by the fixed box 100, the size of the skin sample is no longer limited by the size of the openings of the upper cell body and the lower cell body, and the contact area with the skin sample during the fixation of the skin sample is reduced, improving the utilization rate of the skin sample, and solving the problem of difficult penetration testing of skin samples with large acquisition difficulty due to sample waste.

[0037] Specifically, in the above embodiments, no specific connection form between the upper half box 101 and the lower half box 102 is restricted. The upper half box 101 and the lower half box 102 can be connected to form an integral box body by being clamped to each other through matching edges, or can be simply butted and formed into an integral body by the limitation and pressing of the upper cell body 400 and the lower cell body 500 of the transdermal test device.

[0038] In one embodiment, a support portion 200 is provided on the lower half box 102 at the position of the receiving liquid contact groove 1021. The support portion 200 is used to support the skin sample and prevent the skin sample from sagging towards the lower cell body 500.

[0039] It should be noted that no specific form of the support portion 200 is restricted in this embodiment. In some embodiments not shown, the support portion 200 can be grid-shaped or in other forms, as long as it can support the skin sample while ensuring that the skin sample can contact the receiving liquid.

[0040] In this embodiment, by providing the support portion 200 on the lower half box 102, the support portion 200 supports the lower side of the skin, preventing the skin from sagging under the action of gravity and the pressure of the medicine above. At the same time, due to the effective support for the skin sample, the force required to clamp and tension the skin sample is reduced, and the area of the box body clamping the edge of the skin sample can be further reduced, thereby further improving the utilization rate of the skin sample.

[0041] In one embodiment, the support portion 200 includes a central frame 201 and a plurality of connecting bars 202. One end of the connecting bar 202 is connected to the lower half box 102, and the other end is connected to the central frame 201.

[0042] Specifically, both the central frame 201 and the connecting bars 202 are hard wire structures. The wire structure can be composed of metal wires, such as iron wires, aluminum wires, etc., or can be made of polymer materials.

[0043] In this embodiment, through the arrangement of the central frame 201 and the connecting bars 202, it is ensured that there is sufficient exposed area under the support portion 200 for the skin sample, so that it can fully contact the receiving liquid, avoiding affecting the reliability of the transdermal test results.

[0044] In one embodiment, the connecting bars 202 are arc-shaped, and a plurality of connecting bars 202 form a vortex arrangement, and the rotation direction of the vortex arrangement formed by the plurality of connecting bars 202 is the same as the rotation direction of the stirring structure of the transdermal test device in the working state.

[0045] In this embodiment, by setting the connecting strip 202 to be arc-shaped and arranging a plurality of connecting strips 202 in a vortex shape, the rotation direction of the vortex type is the same as that of the stirring structure. During the transdermal test, the stirring device stirs the receiving liquid and forms a receiving liquid vortex in the lower cell body 500. Through the vortex arrangement of the connecting strips 202, the interference with the flow direction of the receiving liquid vortex can be reduced, thereby reducing the disturbance of the receiving liquid vortex to the cell body and the skin sample, improving the stability of the skin sample fixation, and contributing to improving the test reliability.

[0046] In one embodiment, a limiting portion 300 is provided on the upper half box 101 at the medicine contact groove 1011. The limiting portion 300 is used to limit the upper side of the skin sample and prevent the skin sample from protruding upward towards the upper cell body 400.

[0047] In this embodiment, by providing the limiting portion 300 to limit the upper side of the skin sample. During the test, the limiting portion 300 is located on the upper side of the skin sample, thereby avoiding the situation that the skin sample warps upward to form bubbles under the disturbance of the receiving liquid below, which affects the test results.

[0048] In one embodiment, the limiting portion 300 includes two limiting strips 301 arranged in a cross shape. The two ends of the limiting strip 301 are respectively connected to the upper half box 101.

[0049] Specifically, the limiting strip 301 is a hard filamentous structure, and the hard filamentous structure can be composed of a metal wire or other wire materials.

[0050] In this embodiment, by using the two cross-shaped limiting strips 301 as the limiting portion 300, not only can the skin sample be limited, but also the skin sample can have a sufficient contact area with the medicine.

[0051] According to an embodiment of the present invention, on the other hand, a transdermal test device is also provided, including: a lower cell body 500 for containing a receiving liquid, and the top of the lower cell body 500 has an opening; an upper cell body 400 adapted to be placed on the upper side of the lower cell body 500, and the top and bottom of the upper cell body 400 have openings. When the upper cell body 400 is placed on the upper side of the lower cell body 500, the bottom opening of the upper cell body 400 is opposite to the top opening of the lower cell body 500, and a rotary stirring structure 600 for stirring the receiving liquid is provided at the bottom of the lower cell body 500; the above-mentioned skin sample fixing structure is arranged between the upper cell body 400 and the lower cell body 500, and when the test is in progress, the upper cell body 400 and the lower cell body 500 clamp and fix the cassette 100.

[0052] Specifically, the stirring structure can be a magnetic stirrer bar cooperating with a magnetic stirrer, and in some embodiments not shown, it can also be a stirring paddle blade connected to a motor.

[0053] In this embodiment, the fixing box 100 is clamped by the upper pool body 400 and the lower pool body 500, and the skin sample is fixed by the fixing box 100, so that the size of the skin sample is no longer restricted by the relative opening area of the upper pool body 400 and the lower pool body 500, achieving the effect of saving the skin sample and avoiding waste.

[0054] In one embodiment, a step groove 700 is provided on the side wall at the top opening of the lower pool body 500. The step groove 700 is adapted to the shape of the fixing box 100. In the state of the test, the fixing box 100 is located in the step groove 700, and the step groove 700 and the upper pool body 400 jointly press against the fixing box 100.

[0055] In this embodiment, by providing the step groove 700, it is convenient to accommodate and limit the fixing box 100, to keep the skin sample in the correct position during the test, and at the same time it also helps to improve the sealing performance between the fixing box 100 and the upper pool body 400, and between the fixing box 100 and the lower pool body 500.

[0056] In one embodiment, a step groove 700 is provided on the side wall at the bottom opening of the upper pool body 400. The step groove 700 is adapted to the shape of the fixing box 100. In the state of the test, the fixing box 100 is located in the step groove 700, and the step groove 700 and the lower pool body 500 jointly press against the fixing box 100.

[0057] In this embodiment, the step groove 700 can also be provided at the bottom opening of the upper pool body 400, so as to realize the limitation of the fixing box 100, providing a scheme different from that of the step groove 700 provided at the top of the lower pool body 500.

[0058] In one embodiment, it further includes a clamping member (not shown in the figure). A first clamping edge 401 is provided on the circumferential side wall at the bottom end of the upper pool body 400, and a second clamping edge 501 is provided on the circumferential side wall at the top end of the lower pool body 500. The clamping member is adapted to clamp the first clamping edge 401 and the second clamping edge 501 so that the upper pool body 400 and the lower pool body 500 are pressed against each other.

[0059] Specifically, the clamping member can be a horseshoe-shaped clip or other types of jigs, as long as it can clamp the first clamping edge 401 and the second clamping edge 501 to press the upper pool body 400 and the lower pool body 500 tightly.

[0060] In this embodiment, through the setting of the clamping member, the first clamping edge 401 and the second clamping edge 501 of the upper pool body 400 and the lower pool body 500 are clamped, so that the upper pool body 400 and the lower pool body 500 are pressed against each other, and jointly and reliably limit the fixing box 100, and squeeze the upper half box 101 and the lower half box 102 of the fixing box 100 in the direction of approaching each other, so as to clamp the skin sample.

[0061] Although embodiments of the present utility model have been described in conjunction with the accompanying drawings, those skilled in the art can make various modifications and variations without departing from the spirit and scope of the present utility model, and such modifications and variations all fall within the scope defined by the appended claims.

Claims

1. A skin sample fixation structure, characterized in that, Comprising: A fixed box (100), including an upper half box (101) and a lower half box (102) for fitting together to clamp a skin sample. A medicine contact groove (1011) penetrating the upper half box (101) in the height direction is formed on the upper half box (101), and a receiving liquid contact groove (1021) penetrating the lower half box (102) in the height direction is formed on the lower half box (102).

2. The skin sample fixation structure according to claim 1, characterized in that, A support portion (200) is provided at the receiving liquid contact groove (1021) on the lower half box (102), and the support portion (200) is used for supporting the skin sample and preventing the skin sample from sagging downward.

3. The skin sample fixation structure according to claim 2, characterized in that, The support portion (200) includes a central frame (201) and a plurality of connecting bars (202). One end of each connecting bar (202) is connected to the lower half box (102), and the other end is connected to the central frame (201).

4. The skin sample fixing structure according to claim 3, characterized in that, The connecting bars (202) are arc-shaped, and the plurality of connecting bars (202) are arranged in a spiral shape. The spiral direction of the spiral arrangement formed by the plurality of connecting bars (202) is the same as the rotation direction of the stirring structure of the transdermal test device in the working state.

5. The skin sample fixation structure according to any one of claims 1 to 4, characterized in that, A limiting portion (300) is provided at the medicine contact groove (1011) on the upper half box (101), and the limiting portion (300) is used for limiting the upper side of the skin sample and preventing the skin sample from bulging upward.

6. The skin sample fixing structure according to claim 5, characterized in that The limiting portion (300) includes two limiting bars (301) arranged in a cross shape. Both ends of each limiting bar (301) are connected to the upper half box (101).

7. A transdermal test device, characterized in that, Comprising: A lower cell body (500) for containing a receiving liquid, and the top of the lower cell body (500) has an opening; An upper cell body (400) adapted to be placed on the upper side of the lower cell body (500). The top and bottom of the upper cell body (400) have openings. When the upper cell body (400) is placed on the upper side of the lower cell body (500), the bottom opening of the upper cell body (400) is oppositely arranged with the top opening of the lower cell body (500), and a rotary stirring structure (600) for stirring the receiving liquid is provided at the bottom of the lower cell body (500); The skin sample fixing structure according to any one of claims 1 to 6 is provided between the upper cell body (400) and the lower cell body (500). During the test, the upper cell body (400) and the lower cell body (500) clamp the fixed box (100).

8. The transdermal test device according to claim 7, characterized in that, A step groove (700) is provided on the side wall at the top opening of the lower cell body (500). The step groove (700) is adapted to the shape of the fixed box (100). During the test, the fixed box (100) is located in the step groove (700), and the step groove (700) and the upper cell body (400) jointly press against the fixed box (100).

9. The transdermal test device according to claim 7, characterized in that, A step groove (700) is provided on the side wall at the bottom opening of the upper pool body (400). The step groove (700) is adapted to the shape of the fixed box (100). In the state of the test in progress, the fixed box (100) is located in the step groove (700), and the step groove (700) and the lower pool body (500) jointly clamp the fixed box (100).

10. The transdermal test device according to claim 8 or 9, characterized in that, It further includes a clamping member. A first clamping edge (401) is provided on the circumferential side wall at the bottom end of the upper pool body (400), and a second clamping edge (501) is provided on the circumferential side wall at the top end of the lower pool body (500). The clamping member is adapted to clamp the first clamping edge (401) and the second clamping edge (501) so that the upper pool body (400) is in tight contact with the lower pool body (500).