Airbag with directional adjusting function and application thereof

Abstract

The invention provides an air bag with a directional adjusting function and application thereof, and relates to the technical field of biomedical materials. The air bag with the directional adjusting function comprises a main air bag body, an auxiliary air bag body and an air channel communicated with the main air bag body and the auxiliary air bag body, the auxiliary air bag body is provided with an air generating assembly capable of inflating the air bag bodies, the air channel is provided with a supporting body containing area, and the length of the inflated air bag body is larger than the width of the specific position of the intestinal tract. The air bag with the directional adjustment function in the embodiment of the invention can be used for directionally adjusting the micro-robot, so that the medicine loaded on the micro-robot can directionally act on the intestinal wall, and the usability of oral administration of biological agents or some other special preparations is improved.

Description

Technical Field

[0001] The present invention relates to the technical field of biomedical materials, and in particular to an airbag with directional adjustment function and application thereof. Background Art

[0002] The presence of abundant digestive enzymes and mucosal barriers in the gastrointestinal tract makes the oral availability of biologic drugs such as peptides, proteins, nucleic acids and antibodies low, and they usually need to be administered by injection, which leads to poor patient compliance. In particular, patients with chronic diseases have to undergo frequent therapeutic injections, which further reduces patient compliance. How to overcome the difficulties of oral administration of biological drugs and improve patient compliance remains a huge challenge.

[0003] Micro medical robots have the advantages of low invasiveness, versatility, high safety, practicality and intelligence in gastrointestinal drug delivery, and can be applied to the oral delivery of biological drugs. However, it is difficult for existing micro medical robots to direct drugs to the intestinal wall, resulting in low drug availability; although some micro medical robots with magnetic drive can stably move in the gastrointestinal tract to drive the direction of microneedles, long-term use can easily lead to magnetic substances retained in the body, leading to intestinal obstruction. Therefore, a device for oral delivery of biological agents that can control direction has very important clinical significance. Summary of the invention

[0004] The purpose of the present invention includes providing an airbag with directional adjustment function and its application, which can overcome the problem that the existing micro medical robot is difficult to directional adjust or is easy to partially remain in the body.

[0005] The embodiments of the present invention can be implemented as follows:

[0006] In the first aspect, the present invention provides an airbag with a directional adjustment function, comprising a main airbag, a secondary airbag and a gas channel connecting the main airbag and the secondary airbag, the secondary airbag is provided with a gas generating component capable of inflating the airbag, the gas channel is provided with a support body placement area, and the length of the airbag after inflation is greater than the width of a specified position of the intestine.

[0007] In an optional embodiment, the gas generating assembly includes a primary auxiliary airbag for containing a first reactant and a secondary auxiliary airbag for containing a second reactant, the auxiliary airbag and the secondary auxiliary airbag are separated by a second isolation device, and the secondary auxiliary airbag and the primary auxiliary airbag are separated by a first isolation device, and the first reactant and the second reactant can react and generate gas.

[0008] In an optional embodiment, the airbag is further provided with a soluble exhaust valve;

[0009] and / or, the first isolation device can be dissolved or released under a first preset condition, the second isolation device can be dissolved or released under a second preset condition, and the soluble exhaust valve can be dissolved or released under a third preset condition;

[0010] And / or, the first isolation device, the second isolation device and the third isolation device are dissolved or released in sequence.

[0011] In an optional embodiment, the material of the airbag is at least one of PU, PVC, PA, PE and PET;

[0012] and / or, after the first reactant and the second reactant react to generate gas, the length of the airbag along the axial direction is 40-50 mm, and the length perpendicular to the axial direction is 5-20 mm;

[0013] In a second aspect, the present invention provides a directional adjustment component for a temporary implant in the body, comprising a gel capsule and an airbag as described in any one of the aforementioned embodiments, wherein the main airbag and the auxiliary airbag are respectively arranged at two ends of the gel capsule, and the main airbag and the auxiliary airbag are connected through a gas channel penetrating the gel capsule;

[0014] The gel capsule is filled with water-swellable gel particles, and the outer surface of the gel capsule is provided with a drug-loading area and a water inlet area provided with a water inlet hole. The water inlet area is at least partially arranged in the non-drug-loading area of ​​the gel capsule, and the size of the water inlet hole is smaller than the size of the gel particles before absorbing water.

[0015] In an optional embodiment, a gel capsule disintegration opening is further provided in the drug-loading area, and the size of the gel capsule disintegration opening is larger than the size of the gel particles after swelling due to water absorption.

[0016] In an optional embodiment, the material of the gel capsule is at least one of PVA, PU, ​​PVC, and silica gel;

[0017] and / or, the volume of the gel particles increases by more than 30 times after absorbing water;

[0018] And / or, in a direction perpendicular to the axis, the length of the expanded gel capsule is 15-30 mm and is 5-10 mm greater than the length of the inflated air bag.

[0019] In a third aspect, the present invention provides a swallowable device, comprising a directional adjustment component for a temporary in vivo implant as described in any one of the aforementioned embodiments, wherein the drug-carrying area of ​​the directional adjustment component for a temporary in vivo implant is covered with a water-swellable microneedle substrate, and a microneedle array for loading drugs is provided on the microneedle substrate.

[0020] In an optional embodiment, the material of the microneedle substrate is at least one of PVA, PVP and PAM;

[0021] And / or, the preparation method of the microneedle substrate comprises: solidifying a raw material liquid on the surface of the gel capsule to form the microneedle substrate;

[0022] And / or, the surface of the microneedle substrate is provided with water absorption holes;

[0023] And / or, the microneedle comprises a microneedle bottom and a microneedle tip, and the drug is loaded on the microneedle tip;

[0024] And / or, the drug comprises at least one of growth hormone, parathyroid hormone, antibody, chemotherapeutic agent, insulin, glucagon-like peptide, immunosuppressant, vaccine or antiparasitic agent.

[0025] In an optional embodiment, the invention further comprises a capsule for wrapping the swallowable device.

[0026] The beneficial effects of the airbag with directional adjustment function, the directional adjustment component for temporary implant in the body and the swallowable device provided by the embodiments of the present invention include:

[0027] The airbag with directional adjustment function in the present application can be used to perform directional adjustment on the microrobot, so that the drugs loaded on the microrobot can act on the intestinal wall in a directional manner, thereby improving the availability of oral administration of biological agents or some other special agents. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings required for use in the embodiments will be briefly introduced below. It should be understood that the following drawings only show certain embodiments of the present invention and therefore should not be regarded as limiting the scope. For ordinary technicians in this field, other related drawings can be obtained based on these drawings without paying creative work.

[0029] Figure 1 It is a schematic diagram of the structure of the airbag in this application (inflated);

[0030] Figure 2 It is a schematic diagram of the partial structure of the airbag in this application;

[0031] Figure 3 It is a schematic diagram of the partial structure of the airbag in this application;

[0032] Figure 4 It is an exploded view of the directional adjustment component in this application (inflated and water-absorbed);

[0033] Figure 5 An exploded view of the swallowable device in this application (not inflated and not filled with water);

[0034] Figure 6 It is a schematic diagram of the structure of the swallowable device in this application (not inflated and not filled with water);

[0035] Figure 7 It is a schematic diagram of the structure of the swallowable device in this application (water absorption and inflation);

[0036] Figure 8 The in vivo mechanism of action of the swallowable device in this application;

[0037] Fig. 9 Schematic diagram of the structure of the microneedle and microneedle substrate in this application;

[0038] Fig.10 Schematic diagram of the structure of the microneedle in this application;

[0039] Fig.11 Schematic diagram of the structure of the capsule in this application.

[0040] Icons: 100-swallowable device; 105-main airbag; 106-soluble exhaust valve; 120-auxiliary airbag; 101-first-level auxiliary airbag; 102-first isolation device; 104-second-level auxiliary airbag; 103-second isolation device; 130-gas channel; 113-gas; 107-gel capsule; 112-gel particles; 108-water inlet; 111-gel capsule disintegration port; 110-microneedle base; 109-microneedle array; 109B-microneedle bottom; 109A-microneedle tip; 109D-drug; 1-capsule. DETAILED DESCRIPTION

[0041] In order to make the purpose, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are part of the embodiments of the present invention, not all of the embodiments. Generally, the components of the embodiments of the present invention described and shown in the drawings here can be arranged and designed in various different configurations.

[0042] Therefore, the following detailed description of the embodiments of the present invention provided in the accompanying drawings is not intended to limit the scope of the invention claimed for protection, but merely represents selected embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0043] It should be noted that similar reference numerals and letters denote similar items in the following drawings, and therefore, once an item is defined in one drawing, further definition and explanation thereof is not required in subsequent drawings.

[0044] In the description of the present invention, it should be noted that if the terms "upper", "lower", "inside", "outside", etc. appear to indicate an orientation or position relationship, they are based on the orientation or position relationship shown in the accompanying drawings, or are the orientation or position relationship in which the product of the invention is usually placed when used. They are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on the present invention.

[0045] In addition, the terms “first”, “second”, etc., if used, are merely used to distinguish between the descriptions and should not be understood as indicating or implying relative importance.

[0046] It should be noted that, in the absence of conflict, the features in the embodiments of the present invention may be combined with each other.

[0047] The embodiment of the present invention provides an airbag with directional adjustment function, such as Figure 1 As shown, it includes a main airbag 105, a secondary airbag 120 and a gas channel 130 connecting the main airbag 105 and the secondary airbag 120, the secondary airbag 120 is provided with a gas 113 generating component capable of inflating the airbag, the gas channel 130 is provided with a support body placement area, the length of the airbag after inflation is greater than the width of the specified position of the intestine, and the length of the airbag after inflation is greater than the width of the specified position of the intestine.

[0048] The airbag with directional adjustment function in the embodiment of the present application can be used to directional adjust the microrobot, so that the drug 109D loaded on the microrobot can act on the intestinal wall in a directional manner, thereby improving the availability of oral administration of biological agents or some other special agents. Specifically, after the airbag in the embodiment of the present application enters the body, the gas 113 generating component can generate gas 113 and release it into the airbag when the preset conditions such as pH reaches a specified range, and fill the airbag. After the airbag is filled, since its length is greater than the width of the intestine at the position where the drug 109D acts, the axis of the airbag will be set along the direction of the intestinal wall, thereby realizing the self-orientation of the airbag, which is conducive to the drug 109D loaded on the microrobot to act on the intestinal wall in a directional manner.

[0049] It should be noted that the airbag in the present application includes a main airbag 105, a secondary airbag 120 and a gas channel 130, and the overall shape is similar to a dumbbell. Under the same conditions, compared with the cylinder or capsule 1, it can use less gas 113 to achieve a longer length, which is beneficial to enhance the directional adjustment function of the airbag; a support can be set on the support area to prevent the gas channel 130 from bending due to a small diameter, and the support area can also be used to load drugs 109D.

[0050] In an optional embodiment, if Figure 2As shown, the gas 113 generating component includes a first-level auxiliary airbag 101 for containing a first reactant and a second-level auxiliary airbag 104 for containing a second reactant. The auxiliary airbag 120 is separated from the second-level auxiliary airbag 104 by a second isolation device 103, and the second-level auxiliary airbag 104 is separated from the first-level auxiliary airbag 101 by a first isolation device 102. The first reactant and the second reactant can react to generate gas 113.

[0051] After the airbag enters the body and reaches a designated area of ​​the intestine, such as the colon, the first soluble isolation device dissolves, the first reactant and the second reactant contact and react to generate gas 113, and then the gas 113 dissolved in the second soluble isolation device enters the auxiliary airbag 120 and the main airbag 105 in turn to expand the airbag, so that the volume and length of the balloon gradually increase, and can remain parallel to the direction of the intestine in the colon area.

[0052] It should be noted that the first soluble isolation device and the second soluble isolation device can separate the two side capsules by means of wires, rings, clamps, etc., wherein the separation standard of the first soluble isolation device is that liquid cannot pass through, and the separation standard of the second soluble isolation device can be that solids as the second reactant cannot pass through or only a small amount can pass through without affecting the expansion of the capsule. In some embodiments, the second reactant can be a solid and the first reactant can be a liquid.

[0053] The first reactant and the second reactant may include an acid and a base, but it should be noted that since they act on the intestines, the first reactant and the second reactant need to be safe and edible, and the generated gas 113 also needs to not affect human health. For example, the acid may be citric acid, and the base may be sodium bicarbonate or potassium bicarbonate, etc.

[0054] In an optional embodiment, if Figure 3 As shown, the airbag is also provided with a soluble exhaust valve 106;

[0055] and / or, the first isolation device 102 can be dissolved or released under a first preset condition, the second isolation device 103 can be dissolved or released under a second preset condition, and the soluble exhaust valve 106 can be dissolved or released under a third preset condition;

[0056] And / or, the first isolation device 102, the second isolation device 103 and the third isolation device are dissolved or released in sequence.

[0057] The airbag remains parallel to the direction of the intestine so that after the drug 109D loaded on the microneedle robot acts on the inner wall of the intestine, the soluble exhaust valve 106 dissolves, the gas 113 in the airbag is released, and the volume gradually decreases, which is conducive to the airbag and the microneedle robot using it to quickly pass through the intestine and be excreted from the body, and can shorten the retention time of the microneedle robot in the body.

[0058] In an optional embodiment, the material of the airbag is at least one of polyurethane (PU), polyvinyl chloride (PVC), polyamide (PA), polyethylene (PE) and polyethylene terephthalate (PET);

[0059] And / or, after the first reactant and the second reactant react to generate the gas 113, the length of the airbag along the axial direction is 40-50 mm, and the length perpendicular to the axial direction is 5-20 mm.

[0060] If the axial length is too short, the airbag cannot have the function of directional adjustment, so it needs to have a certain length; the length of the airbag perpendicular to the axial direction, that is, the diameter, will affect the strength, drug loading capacity, and the force between the drug 109D loaded on the microneedle robot and the inner wall of the intestine, so it should not be too small.

[0061] The present invention also provides a directional adjustment component for a temporary implant in vivo, such as Figure 4-7 As shown, it can also be called a micro robot, comprising a gel capsule 107 and the airbag described in any one of the aforementioned embodiments, the main airbag 105 and the auxiliary airbag 120 are respectively arranged at two ends of the gel capsule 107, and the main airbag 105 and the auxiliary airbag 120 are connected through a gas channel 130 that runs through the gel capsule 107;

[0062] The gel capsule 107 is filled with water-swellable gel particles 112. The outer surface of the gel capsule 107 is provided with a drug loading area and a water inlet area provided with a water inlet hole 108. The water inlet area is at least partially arranged in the non-drug loading area of ​​the gel capsule 107. The size of the water inlet hole 108 is smaller than the size of the gel particles 112 after absorbing water.

[0063] In this embodiment, the gel capsule 107 can expand after absorbing water, so that on the one hand it can play a supporting role for the capsule body, and on the other hand its surface can load microneedles or drugs 109D. After expansion, the diameter of the gel capsule 107 can be larger than the diameter of the air bag, and when it acts on the inner wall of the intestine, it is easier for the drug 109D to act on the intestinal mucosa.

[0064] It should be noted that a plurality of water inlet holes 108 are provided on the water inlet area, and the arrangement of the water inlet holes 108 may be in an array or other manners. Since the drug-loading area may be covered by microneedles or the loaded drugs 109D later, the water inlet holes 108 are at least partially arranged in the non-drug-loading area, so that water can smoothly enter the gel capsule 107 under the drug-loading condition.

[0065] In an optional embodiment, a gel capsule disintegration opening 111 is further provided in the drug loading area, and the size of the gel capsule disintegration opening 111 is larger than the size of the gel particles 112 after swelling due to water absorption.

[0066] A gel capsule disintegration opening 111 is provided in the drug loading area. When the loaded drug 109D or microneedles are present, the gel capsule disintegration opening 111 is covered, and the gel particles 112 therein are blocked in the gel capsule 107. When the loaded drug 109D or microneedles are separated, the gel capsule disintegration opening 111 is exposed, and the gel therein will leak out from the gel capsule disintegration opening 111, thereby reducing the volume of the gel capsule 107, thereby facilitating the directional regulation component to quickly pass through the intestine and be discharged from the body.

[0067] In an optional embodiment, the material of the gel capsule 107 is at least one of PVA (polyvinyl alcohol), PU (polyurethane), PVC (polyvinyl chloride), and silica gel.

[0068] In an optional embodiment, the volume of the gel particles 112 increases by more than 30 times after absorbing water, so that the directional adjustment component can provide sufficient support for the airbag and at the same time the directional adjustment component can have a sufficient diameter to interact with the intestinal wall.

[0069] In an optional embodiment, in a direction perpendicular to the axis, the length of the gel capsule 107 after expansion is 15-30 mm and is 5-10 mm greater than the length of the air bag after inflation.

[0070] The present invention also provides a swallowable device 100, such as Figure 5-7 As shown, it includes a directional adjustment component for a temporary in vivo implant as described in any of the aforementioned embodiments, wherein the drug-carrying area of ​​the directional adjustment component for a temporary in vivo implant is covered with a water-swellable microneedle substrate 110, and a microneedle array 109 for loading drugs 109D is arranged on the microneedle substrate 110.

[0071] The directional adjustment component quickly forms an orientation in the colon area, keeping the drug-carrying area and the microneedle base 110 always parallel to the direction of the intestine. The peristaltic contraction wave of the intestine can squeeze the microneedles on the microneedle base 110 against the inner wall of the intestine, and the microneedles penetrate the mucosa, so that the drug 109D carried by the microneedle base 110 acts on the inner wall of the intestine. Since the microneedle base 110 absorbs water in the intestine, the adhesion between the microneedle base 110 and the gel capsule 107 gradually decreases. After the microneedle penetrates the mucosa, while the microneedle is fixed, the intestine continues to peristaltic contract, so that the microneedle base 110 and the gel capsule 107 are separated. At this time, the gel capsule disintegration port 111 located in the drug-carrying area is exposed, so that the gel will leak out from the gel capsule disintegration port 111. The directional adjustment component can quickly pass through the intestine and be discharged from the body. Figure 8 shown.

[0072] The microneedle substrate 110 is responsible for supporting and fixing the microneedle array 109 and providing reliable support for the precise insertion of the microneedle array 109 into the tissue. The shape of the microneedle can be selected as needed.

[0073] In an optional embodiment, the material of the microneedle substrate 110 is at least one of PVA (polyvinyl alcohol), PVP (polyvinyl pyrrolidone), and polyacrylamide (PAM).

[0074] In an optional embodiment, the preparation method of the microneedle substrate 110 includes: solidifying the raw material liquid on the surface of the gel capsule 107 to form the microneedle substrate 110; the microneedle substrate 110 and the gel capsule 107 prepared in this way have a certain adhesion force, so that the microneedle substrate 110 and the gel capsule 107 will not fall off before the microneedle penetrates the mucosa, and can fall off after the microneedle penetrates the mucosa.

[0075] In an optional embodiment, water absorption holes are provided on the surface of the microneedle substrate 110 to increase the water absorption rate of the microneedle substrate 110 .

[0076] In an optional embodiment, if Fig. 9 As shown, the microneedle includes a microneedle bottom 109B and a microneedle tip 109A, and the drug 109D is loaded on the microneedle tip 109A;

[0077] In an optional embodiment, the material of the microneedle is a degradable material; the microneedle array 109 is used for drug loading and intestinal tract puncture, and can be composed of one or more of a degradable material such as polyethylene glycol diacrylate, polylactide-co-lactide, PCL, hyaluronic acid, PVA, hydroxypropyl cellulose and chitosan, and is prepared by a molding process. The specific structure of the microneedle may include a barb or no barb, and the shape can also be selected according to needs, such as Fig.10 shown.

[0078] In an alternative embodiment, the drug 109D comprises at least one of growth hormone, parathyroid hormone, an antibody, a chemotherapeutic agent, insulin, a glucagon-like peptide, an immunosuppressant, a vaccine, or an antiparasitic agent.

[0079] In an optional embodiment, if Fig.11 As shown, it also includes a capsule 1 for wrapping the swallowable device 100, which facilitates oral administration and greatly increases the drug loading capacity while preventing the directional adjustment component from being exposed to gastric juice.

[0080] It should be noted that, in the embodiments of the present application, the first preset condition, the second preset condition, and the third preset condition may be the same or different, and are usually the pH of a specified position in the intestine. If the first preset condition, the second preset condition, and the third preset condition are the same, the dissolution time may also be adjusted by adjusting the material of the corresponding structure. For example, the first soluble isolation device dissolves faster than the second soluble isolation device, thereby achieving the purpose of dissolving the first soluble isolation device first and the second soluble isolation device later. Specifically, in some embodiments, the first soluble isolation device dissolves about 1 minute after the capsule 1 is dissolved, the second soluble isolation device dissolves about 5 minutes after the capsule 1 is dissolved, and the soluble exhaust valve 106 dissolves 10-20 minutes after the capsule 1 is dissolved.

[0081] The above description is only a specific implementation mode of the present invention, but the protection scope of the present invention is not limited thereto. Any changes or substitutions that can be easily conceived by a technician familiar with the technical field within the technical scope disclosed by the present invention should be covered within the protection scope of the present invention.

Claims

1. An airbag with directional adjustment function, characterized in that: It includes a main airbag, a secondary airbag and a gas channel connecting the main airbag and the secondary airbag. The secondary airbag is provided with a gas generating component capable of inflating the airbag. The gas channel is provided with a support body placement area. The length of the airbag after inflation is greater than the width of a specified position of the intestine.

2. The airbag with directional adjustment function according to claim 1, characterized in that: The gas generating assembly includes a primary auxiliary airbag for containing a first reactant and a secondary auxiliary airbag for containing a second reactant. The auxiliary airbag is separated from the secondary auxiliary airbag by a second isolation device, and the secondary auxiliary airbag is separated from the primary auxiliary airbag by a first isolation device. The first reactant and the second reactant can react to generate gas.

3. The airbag with directional adjustment function according to claim 2, characterized in that: The airbag is also provided with a soluble exhaust valve; and / or, the first isolation device can be dissolved or released under a first preset condition, the second isolation device can be dissolved or released under a second preset condition, and the soluble exhaust valve can be dissolved or released under a third preset condition; And / or, the first isolation device, the second isolation device and the third isolation device are dissolved or released in sequence.

4. The airbag with directional adjustment function according to claim 2, characterized in that: The material of the airbag is at least one of PU, PVC, PA, PE and PET; And / or, after the first reactant and the second reactant react to generate gas, the length of the airbag along the axial direction is 40-50 mm, and the length perpendicular to the axial direction is 5-20 mm.

5. A directional adjustment component for a temporary implant in the body, characterized in that: It comprises a gel bag and an air bag as claimed in any one of claims 1 to 4, wherein the main air bag and the auxiliary air bag are respectively arranged at two ends of the gel bag, and the main air bag and the auxiliary air bag are connected through a gas channel penetrating the gel bag; The gel capsule is filled with water-swellable gel particles, and the outer surface of the gel capsule is provided with a drug-loading area and a water inlet area provided with a water inlet hole. The water inlet area is at least partially arranged in the non-drug-loading area of ​​the gel capsule, and the size of the water inlet hole is smaller than the size of the gel particles before absorbing water.

6. The directional adjustment component for a temporary implant in the body according to claim 5, characterized in that: The drug-loading area is also provided with a gel capsule disintegration opening, and the size of the gel capsule disintegration opening is larger than the size of the gel particles after swelling by absorbing water.

7. The directional adjustment component for a temporary implant in the body according to claim 5, characterized in that: The material of the gel capsule is at least one of PVA, PU, ​​PVC and silica gel; and / or, the volume of the gel particles increases by more than 30 times after absorbing water; And / or, in a direction perpendicular to the axis, the length of the expanded gel capsule is 15-30 mm and is 5-10 mm greater than the length of the inflated air bag.

8. A swallowable device, characterized in that: It comprises the directional adjustment component for temporary in vivo implants as claimed in any one of claims 5 to 7, wherein the drug-carrying area of ​​the directional adjustment component for temporary in vivo implants is covered with a water-swellable microneedle substrate, and a microneedle array for loading drugs is arranged on the microneedle substrate.

9. The swallowable device according to claim 8, characterized in that The material of the microneedle substrate is at least one of PVA, PVP and PAM; And / or, the preparation method of the microneedle substrate comprises: solidifying a raw material liquid on the surface of the gel capsule to form the microneedle substrate; And / or, the surface of the microneedle substrate is provided with water absorption holes; And / or, the microneedle comprises a microneedle bottom and a microneedle tip, and the drug is loaded on the microneedle tip; And / or, the drug comprises at least one of growth hormone, parathyroid hormone, antibody, chemotherapeutic agent, insulin, glucagon-like peptide, immunosuppressant, vaccine or antiparasitic agent.

10. The swallowable device according to claim 8, characterized in that Also included is a capsule for encapsulating the swallowable device.

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