Microneedle capsule for delivering an injectable drug and uses thereof

By designing microneedle capsules and utilizing the limiting mechanism and elastic components of intestinal degradable materials, oral delivery of injectable drugs is achieved, solving the problem of injectable drugs being difficult to take orally and improving patient compliance.

CN119424884BActive Publication Date: 2025-10-10BEIJING SHUIMU JINSHENG MEDICAL TECHNOLOGY SERVICES CO LTD
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Patent Information

Application Number
CN202411373904.9
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Filing Date
2024-09-29
Publication Date
2025-10-10
Estimated Expiration
2044-09-29

AI Technical Summary

Technical Problem

In existing technologies, injectable drugs are difficult to administer orally, resulting in poor patient compliance and frequent medical disputes.

Method used

A microneedle capsule is designed, which includes a capsule, a power device and an injection microneedle. The limiting mechanism and elastic component of the degradable material in the intestine are used to release the injection microneedle in the intestine and penetrate the intestinal wall to deliver the drug.

Benefits of technology

It realizes the oral delivery of injectable drugs, improves patient compliance, and avoids the discomfort and medical disputes caused by injections.

✦ Generated by Eureka AI based on patent content.

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Abstract

The application provides a microneedle capsule for delivering injection drugs and an application thereof, and relates to the technical field of medicines, and comprises a capsule, a power device arranged in the capsule, and a plurality of injection microneedles between the capsule and the power device; the power device comprises an elastic component and a limiting mechanism, the elastic component is arranged correspondingly to the plurality of injection microneedles; one end of the limiting mechanism is connected with the capsule, and the other end is connected with the elastic component; the limiting mechanism is used for limiting the elastic component to be in a contraction state, and the limiting mechanism is composed of a material which is degraded in an intestinal tract. The capsule is wrapped to be capable of being delivered to the intestinal tract, the limiting mechanism is degraded in the intestinal tract, the elastic component pushes the injection microneedles to move along the extension direction of the elastic component, the injection microneedles are punched out of the capsule, the injection microneedles are released, and the released injection microneedles penetrate the intestinal wall tissue subsequently, and the injection drugs carried by the injection microneedles are injected into the intestinal wall tissue. The technical problem that injection drugs are difficult to be administered by an oral mode in the prior art is solved.
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Description

Technical Field

[0001] The present invention relates to the field of medical technology, and in particular to a microneedle capsule for delivering injectable drugs and applications thereof. Background Art

[0002] Drugs can be administered via several routes: oral, intravenous (IV), intramuscular (IM), and subcutaneous (SC). Drugs can also be administered sublingually (sublingually), rectally (rectally), as eye drops, as nasal sprays, orally (inhalers), or topically (topically) or systemically (transdermally). Each route of administration has its own specific purpose and advantages and disadvantages. However, both drug developers and patients strongly prefer oral medications over injectables. Doctors, on the other hand, prefer prescribing oral medications over injectables, even if they are slightly less effective. This is partly because patients generally dislike injections, which often lead to numerous medical disputes. Furthermore, patients have poor disease self-management skills, often skipping injections or receiving repeated injections. Both of these situations can be very dangerous for patients with severe diabetes. Therefore, research into drug formulations and delivery methods has always been a key goal in pharmaceutical research. This can be broadly understood as converting currently injectable drugs, such as biologics, to more convenient oral administration. However, oral administration is limited to drugs that can survive the acidic environment of the stomach, the intestinal mucosa and epithelial barrier, and enzymatic degradation in the intestine and liver. According to Lipinski's famous "Rule of Five" (a rule of thumb for determining whether a pharmacologically or biologically active compound can be an oral drug), oral drugs generally need to meet the following conditions, such as a molecular weight generally less than 500 Da, being lipophilic, and not having many hydrogen bond donors or acceptors. This makes oral administration of proteins, genetic material, or other macromolecules impossible, so almost all biologics are administered by injection. Drug delivery researchers have been trying to orally administer biologics and other high-molecular-weight drugs for decades, but with little success.

[0003] In view of this, the present invention is proposed. Summary of the Invention

[0004] One of the purposes of the present invention is to provide a microneedle capsule for delivering injectable drugs, so as to solve the technical problem in the prior art that injectable drugs are difficult to be administered orally.

[0005] A second object of the present invention is to provide the use of the above-mentioned microneedle capsule in delivering injectable drugs in the intestine.

[0006] In a first aspect, the present invention provides a microneedle capsule for delivering an injectable drug, comprising a capsule, a power device disposed within the capsule, and a plurality of injection microneedles located between the capsule and the power device;

[0007] The power device includes an elastic component and a limiting mechanism, wherein the elastic component is correspondingly arranged with a plurality of injection microneedles; one end of the limiting mechanism is connected to the capsule, and the other end is connected to the elastic component;

[0008] The limiting mechanism is used to limit the elastic component to a contracted state, and the limiting mechanism is composed of a material that degrades in the intestine.

[0009] Furthermore, the capsule is provided with a plurality of microneedle emitting holes, and the plurality of microneedle emitting holes correspond one-to-one to the plurality of injection microneedles respectively.

[0010] Furthermore, the injection end of the injection microneedle is placed in the microneedle emission hole, and the non-injection end is connected to the elastic component.

[0011] Furthermore, a stopper is provided in the microneedle emission hole, the size of the stopper matches the size of the microneedle emission hole, and is located above the injection microneedle;

[0012] Preferably, the stopper is composed of a material that degrades in the intestine;

[0013] Preferably, the thickness of the limiting plug is ≤ 1 / 2 of the depth of the microneedle emitting hole.

[0014] In an optional embodiment, a limiting membrane is further provided between the injection microneedle and the limiting plug, and the limiting membrane is used to limit the displacement of the injection microneedle along the microneedle emission hole in a direction away from the elastic component;

[0015] The limiting film includes any one of a polyester film, a polyvinyl alcohol film or a polyimide film.

[0016] Furthermore, the elastic component includes a spring, two push plates arranged opposite to each other, and a plurality of push rods located on the push plates;

[0017] The two ends of the spring are respectively connected to two push plates arranged opposite to each other;

[0018] The push rods correspond to the injection microneedles one by one;

[0019] The push plate is connected to the limiting mechanism, and the end of the limiting mechanism away from the push plate is connected to the capsule;

[0020] Partition plates are provided on both sides of the push plate.

[0021] Furthermore, the limiting mechanism includes a limiting plate, both ends of the push plate are respectively connected to the limiting plates, and one end of the limiting plate away from the push plate passes through the capsule.

[0022] Further, the limiting mechanism comprises a limiting plate and a limiting strap, the limiting plate is connected with the lower end of the push plate, the spring is connected with the limiting plate, a limiting slot is arranged on the surface of the limiting plate opposite to the push plate, the limiting strap is sequentially threaded through the limiting slot on the limiting plate at one end of the spring, the strap hole at one end of the capsule, the limiting slot on the limiting plate at the other end of the spring and the strap hole at the other end of the capsule, and the two ends are connected after the above steps, the limiting strap and the limiting plate are matched with each other to limit the spring in the contracted state.

[0023] Further, the micro-needle emitting hole is provided with a guide tube in the direction of extending into the capsule, and the injection micro-needle is located in the guide tube.

[0024] Preferably, the vertical distance between the end surface of the guide tube opposite to the push plate is greater than or equal to the displacement distance of the injection micro-needle completely leaving the capsule.

[0025] Preferably, the injection micro-needle is a hollow structure, and the hollow structure contains an injection drug.

[0026] Preferably, the diameter of the needle of the injection micro-needle is 10-100 μm.

[0027] Preferably, the length of the injection micro-needle is 0.8-1.5 mm, and preferably 1 mm.

[0028] Preferably, the injection micro-needle comprises at least one of polylactic acid micro-needle, polycaprolactone micro-needle, chitosan micro-needle, collagen micro-needle, starch-based micro-needle or cellulose micro-needle.

[0029] Preferably, the size of the micro-needle capsule is suitable for passing through the small intestine and filling in the small intestine.

[0030] Preferably, the capsule comprises a supporting layer and an enteric layer, and the enteric layer is located on the inner side of the capsule.

[0031] In the second aspect, the application provides the use of the micro-needle capsule in any of the foregoing embodiments for delivering an injection drug in the intestinal tract.

[0032] Preferably, the injection drug comprises a drug preparation for injection.

[0033] Preferably, the injection drug comprises a biological preparation.

[0034] The present invention provides a microneedle capsule for delivering injectable drugs. The microneedles can carry the injectable drugs and are encapsulated to enable delivery to the intestines. In the intestines, the limiting mechanism degrades, contacting the limiting effect of the elastic component. The elastic component, under the elastic force of its contracted state, stretches, pushing the microneedles in the direction of their extension and out of the capsule, thereby releasing the microneedles. The released microneedles then penetrate the intestinal wall tissue and inject the injectable drugs they carry into the intestinal wall tissue. This solves the technical problem of the existing art that injectable drugs are difficult to administer orally. BRIEF DESCRIPTION OF THE DRAWINGS

[0035] In order to more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the specific embodiments or the description of the prior art. Obviously, the drawings described below are some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0036] Figure 1 This is a schematic diagram of the overall structure of a microneedle capsule for delivering injectable drugs provided in Example 1 of the present invention;

[0037] Figure 2 A schematic side view of the structure of a microneedle capsule for delivering injectable drugs provided in Example 1 of the present invention;

[0038] Figure 3 for Figure 2 Schematic diagram of the cross-sectional structure in the AA direction;

[0039] Figure 4 This is a schematic diagram of the top view of the microneedle capsule for delivering injectable drugs provided in Example 1 of the present invention;

[0040] Figure 5 for Figure 4 Schematic diagram of the cross-sectional structure in the middle BB direction;

[0041] Figure 6 for Figure 5 A in the middle is an enlarged structural diagram;

[0042] Figure 7 This is a schematic diagram of the overall structure of a microneedle capsule for delivering injectable drugs provided in Example 2 of the present invention;

[0043] Figure 8 A schematic side view of the structure of a microneedle capsule for delivering injectable drugs provided in Example 2 of the present invention;

[0044] Figure 9 for Figure 8 Schematic diagram of the cross-sectional structure in the CC direction;

[0045] Figure 10 This is a schematic diagram of the cross-sectional structure of the top view of the microneedle capsule for delivering injectable drugs provided in Example 2 of the present invention.

[0046] Icons: 10-capsule; 11-microneedle launching hole; 12-limiting plug; 13-limiting membrane; 14-guide tube; 15-support layer; 16-enteric layer;

[0047] 20-Microneedle injection;

[0048] 31-limiting mechanism; 311-limiting plate; 312-limiting lacing; 313-limiting groove; 314-lacing hole; 32-spring; 33-push plate; 34-push rod; 35-partition. DETAILED DESCRIPTION

[0049] Unless otherwise defined herein, scientific and technical terms used in conjunction with the present invention shall have the meanings commonly understood by those of ordinary skill in the art. The meaning and scope of the terms should be clear; however, in the event of any potential ambiguity, the definitions provided herein take precedence over any dictionary or external definitions. In this application, the use of "or" means "and / or" unless otherwise stated. In addition, the use of the term "including" and other forms is non-limiting.

[0050] The methods and techniques of the present invention are generally performed according to conventional methods well known in the art and as described in various general and more specific references that are cited and discussed throughout the present specification unless otherwise indicated.

[0051] In one aspect, the present invention provides a microneedle capsule for delivering an injectable drug, comprising a capsule 10, a power device disposed within the capsule 10, and a plurality of injection microneedles 20 disposed between the capsule 10 and the power device;

[0052] The power device includes an elastic component and a limiting mechanism 31, and the elastic component is correspondingly arranged with a plurality of injection microneedles 20; one end of the limiting mechanism 31 is connected to the capsule 10, and the other end is connected to the elastic component;

[0053] The limiting mechanism 31 is used to limit the elastic component to a contracted state, and the limiting mechanism is made of a material that degrades in the intestine.

[0054] The injection microneedle 20 can carry an injection drug, and the capsule 10 can wrap the injection drug to enable delivery to the intestinal tract. In the intestinal tract, the limiting mechanism 31 degrades, thereby contacting the limiting effect on the elastic assembly. The elastic assembly is stretched by the elastic force of the elastic assembly in the contracted state, thereby pushing the injection microneedle 20 to move in the stretching direction of the elastic assembly, and the injection microneedle 20 is pushed out of the capsule 10, thereby achieving the purpose of releasing the injection microneedle 20. The released injection microneedle 20 then penetrates the intestinal wall tissue, and the injection drug carried by the injection microneedle 20 is injected into the intestinal wall tissue. The technical problem that injection drugs are difficult to be administered by oral administration in the prior art is solved.

[0055] The power device corresponds to the positions of the plurality of injection microneedles 20. The capsule 10 can accommodate a group of power devices and a plurality of corresponding injection microneedles 20, or can accommodate a plurality of groups of power devices and a plurality of corresponding injection microneedles 20.

[0056] The injection microneedle 20 is a hollow structure, and the hollow structure is pre-provisioned with an injection drug. The diameter of the needle of the injection microneedle 20 can be set to 10-100 μm. The length of the injection microneedle 20 can be set to 0.8-1.5 mm, and is preferably 1 mm.

[0057] The injection microneedle 20 includes at least one of a polylactic acid microneedle, a polycaprolactone microneedle, a chitosan microneedle, a collagen microneedle, a starch-based microneedle, or a cellulose microneedle. The injection microneedle 20 can be degraded in the small intestine after the injection of the pre-provisioned drug is completed.

[0058] In order to avoid the situation that the release of the injection microneedle 20 is blocked due to the action of the capsule 10, a microneedle launch hole 11 can be pre-provisioned on the capsule 10. In some specific embodiments, the capsule 10 is provided with a plurality of microneedle launch holes 11, and the plurality of microneedle launch holes 11 correspond to the plurality of injection microneedles 20 one by one.

[0059] In order to enable the injection microneedle 20 to be accurately released outside the capsule 10 along the microneedle launch hole 11 during the release process, in some specific embodiments, the injection end of the injection microneedle 20 is disposed in the microneedle launch hole 11, and the non-injection end is connected to the elastic assembly.

[0060] In some specific embodiments, a limiting plug 12 is provided in the microneedle launch hole 11. The limiting plug 12 has a size that matches the size of the microneedle launch hole 11, and is located above the injection microneedle 20. The limiting plug can prevent tissue fluid from entering the capsule 10 along the microneedle launch hole before reaching the intestinal tract.

[0061] When the microneedle capsule reaches the intestinal tract, in order to avoid the release of the injection microneedle 20 being hindered by the limiting plug 12, in some specific embodiments, the limiting plug 12 is composed of a material that degrades in the intestinal tract, degradation is achieved in the intestinal environment, forming a microneedle launching hole 11. The degradation rate of the limiting plug 12 is faster than the degradation rate of the limiting mechanism 31.

[0062] Experiments have found that the thickness of the limiting plug 12 affects the time of its degradation, in order not to affect the release of the injection microneedle, the thickness of the limiting plug 12 is ≤1 / 2 of the depth of the microneedle launching hole 11, to ensure that the microneedle launching hole 11 is in an unobstructed state when the limiting mechanism 31 is released from the limiting action.

[0063] In some specific embodiments, a limiting film 13 is further provided between the injection microneedle 20 and the limiting plug 12, which is used to limit the displacement of the injection microneedle 20 along the microneedle launching hole 11 away from the elastic component direction.

[0064] Among them, when the limiting plug 12 degrades, the limiting film 13 is exposed to the intestinal environment, the limiting film 13 is a thin film material with good biocompatibility and is difficult to dissolve in the small intestine environment, has a certain stability, and the limiting film 13 can keep the position of the injection microneedle 20 relatively stable.

[0065] Specifically, the limiting film 13 can be selected from any one of a polyester film, a polyvinyl alcohol film or a polyimide film, or other thin film materials with good biocompatibility and difficult to dissolve in the small intestine environment.

[0066] In some specific embodiments, the elastic component includes a spring 32, two oppositely arranged push plates 33, and a plurality of push rods 34 located on the push plate 33; the two ends of the spring 32 are respectively connected with the two oppositely arranged push plates 33; the push rod 34 corresponds to the injection microneedle 20 one by one; the push plate 33 is connected with the limiting mechanism 31, and the end of the limiting mechanism 31 away from the push plate 33 is connected with the capsule 10.

[0067] The limiting mechanism 31 is connected with the capsule 10 to achieve the limiting action on the push plate 33, so as to limit the spring 32 in a compressed state, and when the limiting mechanism 31 connected with the capsule 10 is degraded, the limiting action is lost. The spring 32 pushes the push plate 33 during extension, thereby driving the push rod 34 to move, so as to push the injection microneedle 20 connected with the push rod to the outside of the capsule 10, and release the injection microneedle.

[0068] Among them, the spring 32 is preferably a spring with tapered ends, which can occupy a smaller space in the compressed state and form a larger pushing distance. According to the situation, a spring with a constant diameter can also be selected, which can meet the pushing distance and force.

[0069] In some embodiments, the push plate 33 is provided with a partition 35 on both sides to prevent displacement of the push plate 33 and allow the push plate 33 to move outward within a certain range.

[0070] In some embodiments, the limiting mechanism 31 comprises a limiting plate 311, and both ends of the push plate 33 are connected with the limiting plate 311, and the end of the limiting plate 311 away from the push plate penetrates the capsule 10.

[0071] The limiting plate 311 is composed of a material that degrades in the intestinal tract. After the limiting plate 311 penetrates the capsule 10, it is exposed to the small intestinal environment and degrades, thereby separating from the capsule 10 and releasing the limiting effect on the push plate 33.

[0072] In some embodiments, the limiting mechanism 31 comprises a limiting plate 311 and a limiting strap 312. The limiting plate 311 is connected with the lower end of the push plate 33, and the spring 32 is connected with the limiting plate 311. The limiting plate 311 is provided with a limiting slot 313 on the surface opposite to the push plate 33. The limiting strap 312 penetrates the limiting slot 313 on the limiting plate 311 at one end of the spring, the strap hole 314 at one end of the capsule 10, the limiting slot 313 on the limiting plate 311 at the other end of the spring, and the strap hole 314 at the other end of the capsule 10, and is connected at both ends. The limiting strap 312 cooperates with the limiting plate 311 to limit the spring 32 in the contracted state. At this time, in order to keep the spring in the contracted state, the limiting strap 312 is in a tight state, and part of the limiting strap 312 at the strap hole is exposed to the small intestinal environment. The limiting strap 312 is composed of a material that degrades in the intestinal tract, and degrades to cause the limiting strap 312 at this position to break, thereby releasing the tight state of the limiting strap 312 and releasing the limitation.

[0073] In some embodiments, the micro-needle launching hole 11 is provided with a guide tube 14 in the direction extending into the capsule 10, and the injection micro-needle 20 is located in the guide tube 14. The guide tube 14 is provided to guide the release path of the injection micro-needle, and ensure that it is released along the preset path.

[0074] In some embodiments, the vertical distance between the end surface of the guide tube 14 opposite to the push plate 33 is greater than or equal to the displacement distance of the injection micro-needle 20 completely separated from the capsule 10, so as to ensure that the push rod can completely push the injection micro-needle 20 to the outside of the capsule 10 and complete the release.

[0075] In some embodiments, the size of the micro-needle capsule is suitable for passing through the small intestine and filling in the small intestine, and the injection micro-needle released is used to penetrate the small intestinal wall tissue and inject the preset drug into the tissue.

[0076] In some specific embodiments, the capsule 10 includes a support layer 15 and an enteric layer 16, with the enteric layer 16 located inside the capsule 10. The support layer 15 is composed of a material that is resistant to gastric acid and intestinal fluid, while the enteric layer is composed of a material that is resistant to gastric acid but degradable in the small intestine. After the injection microneedles 20 are released, intestinal fluid enters the capsule 10 through the degraded gaps, degrading the enteric layer 16 and reducing the size of the capsule 10, making it easier to expel from the body.

[0077] Among them, each structure inside the capsule 10 can be composed of materials that can be degraded in the intestine. Specifically, materials with different degradation rates can be selected in sequence according to the functions of each part. After the release is completed, the small intestinal fluid enters the capsule 10 and degrades, and finally the supporting layer 15 remains and is discharged from the body.

[0078] According to another aspect of the present invention, there is also provided the use of the above-mentioned microneedle capsule in delivering injectable drugs in the intestine;

[0079] Among them, the injectable drugs include pharmaceutical preparations that are administered by injection; specific injectable drugs may include biological preparations, such as insulin.

[0080] The following will clearly and completely describe the technical solutions of the present invention in conjunction with the embodiments. Obviously, the embodiments described are only some embodiments of the present invention, not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of the present invention.

[0081] Example 1

[0082] Combine Figures 1 to 6 To illustrate, a microneedle capsule for delivering an injectable drug includes a capsule 10, a power device disposed within the capsule 10, and injection microneedles 20 located between the capsule 10 and the power device. In this embodiment, two groups of power devices and 36 corresponding injection microneedles 20 are provided, with the 36 corresponding injection microneedles 20 in each group being evenly spaced and relatively arranged. The capsule 10 includes a support layer 15 and an enteric layer 16, which is located on the inner side of the capsule 10.

[0083] The power device includes an elastic component and a limiting mechanism 31. The limiting mechanism 31 is used to limit the elastic component to a contracted state.

[0084] The capsule 10 is provided with microneedle-launching holes 11, each corresponding to an injection microneedle 20. The injection end of each microneedle 20 is positioned within the microneedle-launching hole 11, while the non-injection end is connected to an elastic component. A stopper 12 is positioned within the microneedle-launching hole 11. The stopper 12 is sized to match the microneedle-launching hole 11 and positioned above the injection microneedle 20. The stopper 12 is made of a material that degrades in the intestines and is half the depth of the microneedle-launching hole 11.

[0085] A limiting membrane 13 is further provided between the injection microneedle 20 and the limiting plug 12 .

[0086] The elastic component includes a spring 32, two push plates 33 arranged opposite to each other, and a plurality of push rods 34 located on the push plates 33; both ends of the spring 32 are connected to the two push plates 33 arranged opposite to each other;

[0087] The push rods 34 correspond to the injection microneedles 20 one by one; partitions 35 are provided on both sides of the push plate 33 .

[0088] The limiting mechanism 31 includes a limiting plate 311 . Both ends of the push plate 33 are respectively connected to the limiting plates 311 . An end of the limiting plate 311 away from the push plate passes through the capsule 10 .

[0089] A guide tube 14 is provided extending from the microneedle emitting hole 11 into the capsule 10, and the injection microneedle 20 is located in the guide tube 14. The vertical distance between the opposite end surfaces of the guide tube 14 and the push plate 33 is equal to the displacement distance of the injection microneedle 20 completely out of the capsule 10.

[0090] The injection microneedle 20 is a hollow structure, in which the thymosin solution is pre-filled; the needle tip of the injection microneedle 20 has a diameter of 30 μm and a length of 1 mm.

[0091] In this embodiment, the size of the microneedle capsule is suitable for passing through the small intestine and filling the small intestine.

[0092] Example 2

[0093] Combine Figures 7 to 10 For illustration, unlike Example 1, the needle tip of the injection microneedle 20 is made of nearly 100% compressed freeze-dried insulin. It is able to penetrate the intestinal wall, which dissolves the needle tip. The remaining portion of the capsule is excreted from the body through the intestine.

[0094] The limiting mechanism 31 includes a limiting plate 311 and a limiting lacing 312. The limiting plate 311 is connected to the lower end of the push plate 33. The spring 32 is connected to the limiting plate 311. A limiting slot 313 is provided on the surface of the limiting plate 311 opposite the push plate 33. The limiting lacing 312 sequentially passes through the limiting slot 313 on the limiting plate 311 at one end of the spring, the lacing hole 314 at one end of the capsule 10, the limiting slot 313 on the limiting plate 311 at the other end of the spring, and the lacing hole 314 at the other end of the capsule 10, and then connects the two ends. The limiting lacing 312 cooperates with the limiting plate 311 to limit the spring 32 in the contracted state. The limiting lacing 312 is made of a material that degrades in the intestines.

[0095] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit it. Although the present invention has been described in detail with reference to the above embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the above embodiments, or replace some or all of the technical features therein with equivalents. However, these modifications or replacements do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. A microneedle capsule for delivering injectable drugs, characterized in that: It comprises a capsule (10), a power device placed in the capsule (10), and a plurality of injection microneedles (20) located between the capsule (10) and the power device; The power device comprises an elastic component and a limiting mechanism (31), wherein the elastic component is arranged corresponding to a plurality of injection microneedles (20); one end of the limiting mechanism (31) is connected to the capsule (10), and the other end is connected to the elastic component; The limiting mechanism (31) is used to limit the elastic component to a contracted state, and the limiting mechanism is composed of a material that degrades in the intestine; The capsule (10) is provided with a plurality of microneedle emission holes (11), and the plurality of microneedle emission holes (11) correspond one-to-one to the plurality of injection microneedles (20); The injection end of the injection microneedle (20) is placed in the microneedle emission hole (11), and the non-injection end is connected to the elastic component; A stopper (12) is provided in the microneedle emission hole (11), the size of the stopper (12) matches the size of the microneedle emission hole (11), and is located above the injection microneedle (20); the stopper (12) is made of a material that degrades in the intestine; the thickness of the stopper (12) is ≤ 1 / 2 of the depth of the microneedle emission hole (11); A limiting membrane (13) is further provided between the injection microneedle (20) and the limiting plug (12), and the limiting membrane (13) is used to limit the displacement of the injection microneedle (20) along the microneedle emission hole (11) in a direction away from the elastic component; The elastic component includes a spring (32), two push plates (33) arranged opposite to each other, and a plurality of push rods (34) located on the push plates (33); the two ends of the spring (32) are respectively connected to the two push plates (33) arranged opposite to each other; the push rods (34) correspond one to one with the injection microneedles (20); the push plates (33) are connected to the limiting mechanism (31), and the end of the limiting mechanism (31) away from the push plates (33) is connected to the capsule (10); partitions (35) are provided on both sides of the push plates (33); The injection microneedle (20) is a hollow structure, and the hollow structure contains an injectable drug.

2. The microneedle capsule according to claim 1, characterized in that The limiting mechanism (31) comprises a limiting plate (311), both ends of the push plate (33) are respectively connected to the limiting plate (311), and the end of the limiting plate (311) away from the push plate passes through the capsule (10).

3. The microneedle capsule according to claim 1, characterized in that The limiting mechanism (31) includes a limiting plate (311) and a limiting lace (312), wherein the limiting plate (311) is connected to the lower end of the push plate (33), and the spring (32) is connected to the limiting plate (311). A limiting groove (313) is provided on the surface of the limiting plate (311) opposite to the push plate (33). The limiting lace (312) sequentially passes through the limiting groove (313) on the limiting plate (311) at one end of the spring, the lace hole (314) at one end of the capsule (10), the limiting groove (313) on the limiting plate (311) at the other end of the spring, and the lace hole (314) at the other end of the capsule (10), and then the two ends are connected. The limiting lace cooperates with the limiting plate to limit the spring (32) to a contracted state.

4. The microneedle capsule according to claim 2 or 3, characterized in that A guide tube (14) is provided in the direction in which the microneedle emission hole (11) extends into the capsule (10), and the injection microneedle (20) is located in the guide tube (14).

5. The microneedle capsule according to claim 4, characterized in that The vertical distance between the end faces of the guide tube (14) and the push plate (33) facing each other is greater than or equal to the displacement distance of the injection microneedle (20) completely separating from the capsule (10).

6. The microneedle capsule according to claim 4, characterized in that The needle tip diameter of the injection microneedle (20) is 10-100 μm.

7. The microneedle capsule according to claim 4, characterized in that The length of the injection microneedle (20) is 0.8-1.5 mm.

8. The microneedle capsule according to claim 4, characterized in that The size of the microneedle capsule is suitable for passing through the small intestine and filling the small intestine.

9. The microneedle capsule according to claim 4, characterized in that The capsule (10) comprises a supporting layer (15) and an enteric layer (16), wherein the enteric layer (16) is located on the inner side of the capsule (10).

10. Use of the microneedle capsule according to any one of claims 1 to 9 in the preparation of a product for the intestinal delivery of injectable drugs.

11. The use according to claim 10, characterized in that The injectable drugs include drug preparations that are administered by injection.

12. The use according to claim 10, characterized in that The injectable drugs include biological preparations.

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