Device for constructing subcutaneous environment in vitro for medicine dissolution and permeation

Abstract

The utility model discloses a device for constructing subcutaneous environment in vitro for medicine dissolution and permeation, which relates to the field of medicine detection devices and comprises an inner closed cavity, an outer closed cavity and a closed cover, a sliding groove is arranged on the closed cover, a sliding cover is connected onto the sliding groove in a sliding mode, and the top end of the inner closed cavity is connected between the sliding groove of the closed cover and the sliding cover in a clamping mode. The inner closed cavity extends into the outer closed cavity, the closed cover covers the top of the outer closed cavity, a plurality of through holes are formed in the closed cover, a first monitoring assembly and a reagent adding assembly are arranged in the through holes, a second monitoring assembly is arranged outside the outer closed cavity, and a biomimetic membrane is connected to the wall body of the inner closed cavity. The first monitoring assembly and the second monitoring assembly are used for monitoring release and permeation of injection medicine on the two sides of the biomimetic membrane. The device can reflect release and permeation of subcutaneous injection medicine in vitro, is simple to operate, has strong authenticity of experimental results, and provides better reference for sample analysis.

Description

Technical Field

[0001] The utility model relates to the field of drug detection devices, in particular to a device for constructing a subcutaneous environment in vitro for drug dissolution and penetration. Background Art

[0002] For solid drugs in conventional dosage forms, such as tablets, granules, and capsules, ordinary dissolution equipment can meet the quality detection and dissolution ability testing of drugs. However, for drugs that need to be subcutaneously injected, since they are liquid themselves, conventional dissolution equipment cannot correctly simulate the release of the drug under the skin. At the same time, subcutaneous injection will be accompanied by the drug entering the blood, and conventional dissolution equipment does not consider the situation of the drug entering the blood. Conventional dissolution equipment cannot meet the experimental requirements of subcutaneous drugs, whether it is simulating in vivo conditions or detecting drug penetration, and cannot correctly reflect the release and penetration of subcutaneously injected drugs in vitro.

[0003] Therefore, those skilled in the art urgently need to provide a device for constructing a subcutaneous environment in vitro for drug dissolution and penetration, which can reflect the release and penetration of subcutaneously injected drugs in vitro. Summary of the Utility Model

[0004] The purpose of the utility model is to provide a device for constructing a subcutaneous environment in vitro for drug dissolution and penetration, which can reflect the release and penetration of subcutaneously injected drugs in vitro.

[0005] To solve the above technical problems, the utility model adopts the following technical solutions:

[0006] A device for constructing a subcutaneous environment in vitro for drug dissolution and penetration of the utility model includes an inner closed cavity, an outer closed cavity, and a closed cover. A chute is provided on the closed cover, and a sliding cover is slidably connected to the chute. The top end of the inner closed cavity is snap-connected between the chute of the closed cover and the sliding cover. The inner closed cavity extends into the outer closed cavity and the closed cover is buckled on the top of the outer closed cavity. A plurality of through holes are provided on the closed cover, and a first monitoring component and a reagent adding component are arranged in the through holes. A second monitoring component is arranged outside the outer closed cavity. A biomimetic membrane is connected to the wall of the inner closed cavity. The first monitoring component and the second monitoring component are used to monitor the release and penetration of the injected drug on both sides of the biomimetic membrane.

[0007] Preferably, the first monitoring component includes an inner pH meter, an outer pH meter, and an optical fiber probe. The reagent adding component includes a liquid taking needle, a liquid adding needle, a carbon dioxide injection needle, and a sampling needle. The through holes include an inner pH meter port, an outer pH meter port, a sampling port, an optical fiber probe placement port, a carbon dioxide injection port, a liquid adding port, and a liquid taking port.

[0008] The internal pH meter extends into the internal pH meter port, the external pH meter extends into the external pH meter port, the liquid extraction needle and the liquid addition needle respectively extend into the liquid extraction port and the liquid addition port, the optical fiber probe extends into the optical fiber probe placement port, the carbon dioxide injection needle extends into the carbon dioxide injection port, and the sample injection needle extends into the sample injection port;

[0009] The bottom ends of the internal pH meter and the sample injection needle both extend into the internal closed cavity, and the bottom ends of the external pH meter, the carbon dioxide injection needle, the optical fiber probe, the liquid extraction needle and the liquid addition needle all extend into the external closed cavity.

[0010] Preferably, the four sides of the bottom of the internal closed cavity are all provided with a hollow structure, three sides of the bottom of the internal closed cavity are provided with transparent glass, and the other side of the bottom of the internal closed cavity is fixedly connected with a sandwich layer by screws, and a bionic membrane is vertically fixed in the sandwich layer.

[0011] Preferably, transparent glass structures are installed on the three outer wall surfaces in the middle of the external closed cavity by screws.

[0012] Preferably, the second monitoring component includes a camera, a light source and a light receiving mechanism. The camera, the light source and the light receiving mechanism are placed outside the external closed cavity, and the camera, the light source and the light receiving mechanism are respectively arranged corresponding to the three outer wall surfaces in the middle of the external closed cavity.

[0013] Preferably, the light receiving mechanism faces the light source, and the camera faces the sandwich layer.

[0014] Compared with the prior art, the beneficial technical effects of the present utility model are:

[0015] (1) The present utility model constructs a closed environment to simulate the environment of subcutaneous injection of drugs into the subcutaneous tissue, and uses a special solvent and carbon dioxide in the constructed closed environment to simulate the subcutaneous tissue environment, so as to correctly reflect the release situation of the drug in the subcutaneous tissue.

[0016] (2) The present utility model fixes a bionic membrane on the outer wall of the internal closed cavity. The bionic membrane divides the closed environment into two parts inside and outside, and these two parts are used to simulate the process of the drug entering the blood from the subcutaneous tissue.

[0017] (3) The present utility model uses optical fiber technology and camera technology to record the release and penetration of the drug in real time, making the experimental operation simple and convenient. Description of the Drawings

[0018] The following further describes the present utility model with reference to the drawings.

[0019] Figure 1Schematic diagram of the three-dimensional structure of a device for in vitro construction of a subcutaneous environment for drug dissolution and penetration according to the present utility model;

[0020] Figure 2 Front view of a device for in vitro construction of a subcutaneous environment for drug dissolution and penetration according to the present utility model (light source, light receiving mechanism and camera omitted);

[0021] Figure 3 Side view of a device for in vitro construction of a subcutaneous environment for drug dissolution and penetration according to the present utility model (light source, light receiving mechanism and camera omitted);

[0022] Figure 4 Schematic diagram of the structure of the closed cover according to the present utility model;

[0023] Figure 5 Schematic diagram of the connection of a device for in vitro construction of a subcutaneous environment for drug dissolution and penetration according to the present utility model from another perspective (light source, light receiving mechanism and camera omitted);

[0024] Figure 6 Schematic diagram of the connection structure between the inner closed cavity and the closed cover according to the present utility model;

[0025] Figure 7 Schematic diagram of the structure of the inner closed cavity according to the present utility model.

[0026] Explanation of reference numerals: 1, inner closed cavity; 2, outer closed cavity; 3, inner pH meter port; 4, outer pH meter port; 5, sampling port; 6, optical fiber probe placement port; 7, liquid addition port; 8, liquid extraction port; 9, closed cover; 10, interlayer; 11, camera; 12, light source; 13, light receiving mechanism; 14, sliding cover; 15, carbon dioxide injection port; 16, inner pH meter; 17, outer pH meter; 18, optical fiber probe; 19, sampling needle; 20, liquid extraction needle; 21, liquid addition needle; 22, carbon dioxide injection needle. Detailed implementation manners

[0027] In order to make the technical problems, technical solutions and beneficial effects to be solved by the present utility model clearer and more understandable, the present utility model will be further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are only used to explain the present utility model and are not used to limit the present utility model.

[0028] As Figures 1-7As shown in the figure, a device for in vitro construction of a subcutaneous environment for drug dissolution and penetration includes an inner closed cavity 1, an outer closed cavity 2, and a closed cover 9. A chute is provided on the closed cover 9, and a sliding cover 14 is slidably connected to the chute. The top end of the inner closed cavity 1 is snap - connected between the chute of the closed cover 9 and the sliding cover 14. The inner closed cavity 1 extends into the outer closed cavity 2 and the closed cover 9 covers the top of the outer closed cavity 2. A plurality of through - holes are provided on the closed cover 9, and a first monitoring component and a reagent adding component are arranged in the through - holes. A second monitoring component is arranged outside the outer closed cavity 2. A biomimetic membrane is connected to the wall of the inner closed cavity 1. The first monitoring component and the second monitoring component are used to monitor the release and penetration of the injected drug on both sides of the biomimetic membrane.

[0029] Specifically, during use, the inner closed cavity 1 is vertically inserted into the chute from top to bottom. The chute has a supporting effect on the top of the inner closed cavity 1. Then, by moving the sliding cover 14 along the chute, the top of the inner closed cavity 1 is snap - connected between the chute of the closed cover 9 and the sliding cover 14.

[0030] Specifically, the chute is T - shaped.

[0031] The first monitoring component includes an inner pH meter 16, an outer pH meter 17, and an optical fiber probe 18. The reagent adding component includes a liquid - taking needle 20, a liquid - adding needle 21, a carbon dioxide injection needle 22, and a sampling needle 19. The through - holes include an inner pH meter port 3, an outer pH meter port 4, a sampling port 5, an optical fiber probe placement port 6, a carbon dioxide injection port 15, a liquid - adding port 7, and a liquid - taking port 8.

[0032] The inner pH meter 16 extends into the inner pH meter port 3, the outer pH meter 17 extends into the outer pH meter port 4, the liquid - taking needle 20 and the liquid - adding needle 21 respectively extend into the liquid - taking port 8 and the liquid - adding port 7, the optical fiber probe 18 extends into the optical fiber probe placement port 6, the carbon dioxide injection needle 22 extends into the carbon dioxide injection port 15, and the sampling needle 19 extends into the sampling port 5.

[0033] The bottom ends of the inner pH meter 16 and the sampling needle 19 both extend into the inner closed cavity 1, and the bottom ends of the outer pH meter 17, the carbon dioxide injection needle 22, the optical fiber probe 18, the liquid - taking needle 20, and the liquid - adding needle 21 all extend into the outer closed cavity 2.

[0034] Specifically, according to the actual drug administration principle, a subcutaneous environment is constructed using a closed structure, which can effectively reflect the dissolution and penetration of subcutaneously injected drugs in the in-vivo environment. An internal pH meter and an external pH meter are used to monitor the experimental environment in real time to ensure the stability of the experimental environment. A fiber optic probe structure is adopted to record and analyze the release and penetration of samples in real time, effectively reducing the data analysis steps and improving the experimental efficiency. A camera, a light source, and a light receiving mechanism are used to record the morphological changes of the sample during the experiment, improving the authenticity of the experiment and providing a reference for sample analysis.

[0035] The four sides of the bottom of the inner closed cavity 1 are all set as hollow structures, among which three sides of the bottom of the inner closed cavity 1 are provided with transparent glass, and the other side of the bottom of the inner closed cavity 1 is fixedly connected with a sandwich layer 10 by screws, and a biomimetic membrane is vertically fixed in the sandwich layer 10.

[0036] Three outer wall surfaces in the middle of the outer closed cavity 2 are all installed with transparent glass structures by screws, so that the situation inside the outer closed cavity 2 can be observed.

[0037] The second monitoring component includes a camera 11, a light source 12, and a light receiving mechanism 13. The camera 11, the light source 12, and the light receiving mechanism 13 are placed outside the outer closed cavity 2, and the camera 11, the light source 12, and the light receiving mechanism 13 are respectively arranged corresponding to the three outer wall surfaces in the middle of the outer closed cavity 2.

[0038] The light receiving mechanism 13 faces the light source 12, and the camera 11 faces the sandwich layer 10.

[0039] Specifically, the light source 12 and the light receiving mechanism 13 are placed on both sides of the outer closed cavity 2. The light source 12 faces the right observation window of the outer closed cavity 2, the light receiving mechanism 13 faces the left observation window of the outer closed cavity 2, and the camera 11 faces the front observation window of the outer closed cavity 2.

[0040] The use process of the present utility model includes the following steps:

[0041] S1: Six screws are used to fix a quartz glass on each hollow surface of the outer closed cavity 2. A total of three quartz glasses close the three hollow surfaces of the outer closed cavity 2, and experimental observations can be carried out.

[0042] S2: A sandwich layer 10 is provided on the front surface of the inner closed cavity 1, and a biomimetic membrane is placed in parallel in the sandwich layer 10. The four corners of the biomimetic membrane are fixed to the front surface of the inner closed cavity 1 by screws;

[0043] S3: The inner closed cavity 1 with the biomimetic membrane is suspended directly below the closing cover 9 through the sliding groove of the closing cover 9, and then the sliding cover 14 covers the inner closed cavity 1 through the sliding groove of the closing cover 9. The assembled inner closed cavity 1 is vertically placed inside the outer closed cavity.

[0044] S4: Vertically place the combined inner closed cavity 1 and outer closed cavity 2 in the middle of the camera 11, light source 12, and light receiving mechanism 13, with the front of the outer closed cavity 2 facing the camera 11, the left side of the outer closed cavity 2 facing the light receiving mechanism 13, and the right side of the outer closed cavity 2 facing the light source 12.

[0045] S5: Place the inner pH meter 16, outer pH meter 17, an optical fiber probe 18, and a carbon dioxide injection needle 22 into the reserved inner pH meter port 3, outer pH meter port 4, optical fiber probe placement port 6, and carbon dioxide injection port 15 on the closing cover 9. The liquid addition port 7 and liquid sampling port 8 are fixed on the closing cover 9. When performing sampling and liquid addition operations, place the liquid addition needle 21 and liquid sampling needle 20 into the liquid addition port 7 and liquid sampling port 8.

[0046] S6: According to the experimental requirements, add the experimental solution into the outer closed cavity 2 through the liquid addition port 7, and add the experimental sample into the inner closed cavity 1 through the sample injection port 5.

[0047] S7: After the liquid addition operation is completed, inject carbon dioxide into the outer closed cavity 2 through the carbon dioxide injection port 15 to simulate the subcutaneous environment in the body.

[0048] S8: After the environment construction is completed, monitor the drug content in the closed cavity through the placed optical fiber probe 18. At the same time, the light source 12 emits light that passes through both sides of the transparent outer closed cavity 2 and inner closed cavity 1, the light receiving mechanism 13 receives the transmitted light, and the camera 11 records the morphological changes of the drug in the closed cavity.

[0049] It should be noted that in this article, relational terms such as first and second are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any actual relationship or order between these entities or operations. Moreover, the term "comprising", "including" or any other variant thereof is intended to cover non-exclusive inclusion, so that a process, method, article or device comprising a series of elements not only includes those elements, but also includes other elements not expressly listed, or also includes elements inherent to such process, method, article or device.

[0050] The above-described embodiments are only descriptions of the preferred modes of the present invention, and do not limit the scope of the present invention. Without departing from the design spirit of the present invention, various deformations and improvements made by those of ordinary skill in the art to the technical solutions of the present invention shall fall within the protection scope determined by the claims of the present invention.

Claims

1. A device for constructing a subcutaneous environment in vitro for drug dissolution and penetration, characterized in that: The invention comprises an inner closed cavity (1), an outer closed cavity (2) and a closed cover (9), wherein a slide groove is provided on the closed cover (9), a slide cover (14) is slidably connected to the slide groove, the top end of the inner closed cavity (1) is snap-connected between the slide groove of the closed cover (9) and the slide cover (14), the inner closed cavity (1) extends into the outer closed cavity (2) and the closed cover (9) is buckled on the top of the outer closed cavity (2), a plurality of through holes are provided on the closed cover (9), a first monitoring component and a reagent adding component are provided in the through holes, a second monitoring component is provided outside the outer closed cavity (2), a bionic membrane is connected to the wall of the inner closed cavity (1), and the first monitoring component and the second monitoring component are used to monitor the release and penetration of the injected drug on both sides of the bionic membrane.

2. The device for constructing a subcutaneous environment in vitro for drug dissolution and penetration according to claim 1, characterized in that: The first monitoring component comprises an inner pH meter (16), an outer pH meter (17) and an optical fiber probe (18); the reagent adding component comprises a liquid collection needle (20), a liquid adding needle (21), a carbon dioxide injection needle (22) and an injection needle (19); the through hole comprises an inner pH meter port (3), an outer pH meter port (4), an injection port (5), an optical fiber probe placement port (6), a carbon dioxide injection port (15), a liquid adding port (7) and a liquid collection port (8); The inner pH meter (16) extends into the inner pH meter port (3), the outer pH meter (17) extends into the outer pH meter port (4), the liquid collection needle (20) and the liquid addition needle (21) extend into the liquid collection port (8) and the liquid addition port (7) respectively, the optical fiber probe (18) extends into the optical fiber probe placement port (6), the carbon dioxide injection needle (22) extends into the carbon dioxide injection port (15), and the injection needle (19) extends into the injection port (5); The bottom ends of the inner pH meter (16) and the injection needle (19) extend into the inner closed cavity (1), and the bottom ends of the outer pH meter (17), the carbon dioxide injection needle (22), the optical fiber probe (18), the liquid collection needle (20) and the liquid addition needle (21) extend into the outer closed cavity (2).

3. The device for constructing a subcutaneous environment in vitro for drug dissolution and penetration according to claim 2, characterized in that: The four sides of the bottom of the inner closed cavity (1) are all arranged as hollow structures, wherein three sides of the bottom of the inner closed cavity (1) are arranged with transparent glass, and the other side of the bottom of the inner closed cavity (1) is fixedly connected with an interlayer (10) by means of screws, and a bionic membrane is vertically fixed in the interlayer (10).

4. The device for constructing a subcutaneous environment in vitro for drug dissolution and penetration according to claim 3, characterized in that: Transparent glass structures are mounted on the three outer wall surfaces in the middle of the outer closed cavity (2) by means of screws.

5. The device for constructing a subcutaneous environment in vitro for drug dissolution and penetration according to claim 4, characterized in that: The second monitoring component comprises a camera (11), a light source (12) and a light receiving mechanism (13); the camera (11), the light source (12) and the light receiving mechanism (13) are placed outside the outer closed cavity (2); the camera (11), the light source (12) and the light receiving mechanism (13) are respectively arranged corresponding to three outer wall surfaces in the middle of the outer closed cavity (2).

6. The device for constructing a subcutaneous environment in vitro for drug dissolution and penetration according to claim 5, characterized in that: The light receiving mechanism (13) faces the light source (12), and the camera (11) faces the interlayer (10).

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