CN210355656U

CN210355656U - Enteric controlled release device for treating clostridium difficile infection

Info

Publication number: CN210355656U
Application number: CN201920655524.2U
Authority: CN
Inventors: 陈艾东; 张瑞; 孙硕; 刘实; 陈蕾
Original assignee: Nanjing Medical University
Current assignee: Nanjing Medical University
Priority date: 2019-05-06
Filing date: 2019-05-06
Publication date: 2020-04-21
Anticipated expiration: 2029-05-06

Abstract

The utility model discloses an enteric controlled release device for treating clostridium difficile infection, which relates to the technical field of medicine and comprises a capsule body and medicines in the capsule body; the utility model discloses it is convenient to dose, and the cure rate is high, and wherein excrement fungus liquid gets rid of residue and the ultracentrifuge after long-pending fungus through the centrifugation and pours into the capsule originally internally, reducible a lot of adverse reactions, and add the paracresol that alcaligenes faecalis decomposed clostridium difficile and is produced, destroys its microenvironment that relies on to survive, and then eliminates this fungus from the etiology. Meanwhile, the ZINPLAVA capable of locally and slowly releasing the exotoxin B of clostridium difficile is also used for relieving the damage to intestinal cells caused by the ZINPLAVA; the capsule body and the capsule cap are in threaded sealing connection, so that the probability of medicine overflow in the capsule body is reduced, the strength of the capsule body and the capsule cap can be increased through the first support and the second support, the probability of deformation or damage of the capsule body and the capsule cap is reduced, and the probability of medicine overflow in the capsule body is further reduced.

Description

Enteric controlled release device for treating clostridium difficile infection

Technical Field

The invention relates to the technical field of medicine, in particular to an enteric controlled release device for treating clostridium difficile infection.

Background

Clostridium difficile infection causes antibiotic-associated enteritis, which is a significant cause of complications and death in elderly hospitalized patients and is one of the most common nosocomial infections. The bacteria produce a large amount of exotoxins A and B, and the exotoxin A consists of intestinal toxins and cytotoxins. Exotoxins can bind to mucosal cells and cause bleeding. While exotoxin B is a cytotoxin, it cannot bind directly to mucosal cells in vivo, because exotoxin B can only bind to damaged cells, resulting in greater damage. Difficile also produces a special compound called p-cresol (p-cresol), which interferes with the normal intestinal probiotic flora and thus invisibly affects the function of the natural protective flora in the intestinal tract of the patient's body, destroying the microenvironment of the intestinal flora and further aggravating the disease. Currently, clinical routine vancomycin and metronidazole treatments have a remission rate of less than 31%, with up to 15-25% of patients relapsing.

Disclosure of Invention

1. Problems to be solved

Aiming at the problems in the prior art, the invention aims to provide an enteric controlled release device for treating clostridium difficile infection, which is convenient to administer and high in cure rate, wherein a fecal strain liquid is injected into a capsule body after being centrifuged to remove residues and ultracentrifugation accumulated bacteria, so that a lot of adverse reactions can be reduced, and alcaligenes faecalis added to decompose paracresol generated by clostridium difficile and destroy a microenvironment on which the clostridium difficile lives, so that the clostridium difficile is killed from the etiology. Meanwhile, the ZINPLAVA capable of locally and slowly releasing the toxin B against Clostridium difficile is also used for relieving the damage to intestinal cells caused by the ZINPLAVA, so that the problems mentioned in the background stories are solved.

2. Technical scheme

In order to achieve the purpose, the invention provides the following technical scheme:

an enteric controlled release device for treating clostridium difficile infection comprises a capsule body and medicines in the capsule body, wherein an enteric coating wraps the outer surface of the capsule body, the medicines are arranged in the capsule body, the medicines are dissolved and released in an intestinal tract through the enteric coating, and the medicines in the capsule body achieve the purpose of treating clostridium difficile infected surfaces; the capsule body comprises a capsule body, a conical guide port, a capsule cap, a positioning ring, a first support, a buffer bin, a thickening ring, a second support, an internal thread and an external thread, wherein the capsule cap is arranged on one side of the capsule body in a matched mode, the internal thread is arranged at an opening of the capsule body, the external thread is arranged at an opening of the capsule cap, and the capsule body is connected with the capsule cap through the external thread and the internal thread; the capsule body is internally and integrally formed with a first support for increasing the strength of the capsule body, and the capsule cap is internally and integrally formed with a second support for increasing the strength of the capsule cap.

As a further scheme of the invention: the capsule comprises a capsule body and a support, wherein the capsule body is internally and integrally formed with a first main rod with one open end, the opening of the first main rod is communicated with the outside, the first main rod is integrally formed with a plurality of first branch rods which are evenly distributed and open at two ends, the first branch rods are communicated with the first main rod, and the opening at one end, far away from the first main rod, of each branch rod penetrates through the capsule body and is communicated with the outside.

As a further scheme of the invention: the second support is composed of a second main rod and a second branch rod, the second main rod with one open end is integrally formed in the capsule cap, the opening of the second main rod is communicated with the outside, the second main rod is integrally formed with two branch rods which are symmetrically arranged and have two open ends, the second branch rod is communicated with the second main rod, and the opening of one end, far away from the second main rod, of the second branch rod penetrates through the capsule cap and is communicated with the outside.

As a further scheme of the invention: the conical guide opening is integrally formed at the opening of the capsule body, the capsule body and the capsule cap are combined conveniently through the conical guide opening, the conical guide opening plays a role of a reinforcing rib, and the probability of deformation of the opening of the capsule cap is reduced.

As a further scheme of the invention: the outer surface of the capsule cap is integrally formed with a thickened ring and a positioning ring, and the positioning ring is arranged close to the opening of the capsule cap.

As a further scheme of the invention: the outer surface integrated into one piece of the capsule body has a plurality of evenly distributed surge bins, and the surge bins are hollow structures and play a role in buffering and damping.

As a further scheme of the invention: the capsule body is a gelatin capsule, and the medicines in the capsule body comprise Alcaligenes faecalis, ZINPLAVA for resisting Clostridium difficile exotoxin B and fecal bacteria liquid, wherein the fecal bacteria liquid is injected into the capsule body after residues are removed through centrifugation and bacteria are accumulated through ultracentrifugation.

Compared with the prior art, the invention has the beneficial effects that:

1. the invention has convenient administration and high cure rate, and the liquid dung is injected into the capsule body after the centrifugal removal of residues and the ultracentrifugation of accumulated bacteria, which can reduce a lot of adverse reactions, and the alcaligenes faecalis added to decompose paracresol generated by clostridium difficile and destroy the microenvironment where the clostridium difficile lives, thereby eliminating the bacteria from the etiology. Meanwhile, the ZINPLAVA capable of locally and slowly releasing the exotoxin B of clostridium difficile is also used for relieving the damage to intestinal cells caused by the ZINPLAVA;

2. the capsule body and the capsule cap are in threaded sealing connection, so that the probability of medicine overflow in the capsule body is reduced, the strength of the capsule body and the capsule cap can be increased through the first support and the second support, the probability of deformation or damage of the capsule body and the capsule cap is reduced, and the probability of medicine overflow in the capsule body is further reduced;

3. the first bracket and the second bracket also play a role of a spoiler, so that Alcaligenes faecalis and Clostridium difficile exotoxin B ZINPLAVA in the capsule body are better mixed with the liquid dung, the capsule body and the capsule cap are conveniently combined through the conical guide opening, and the conical guide opening plays a role of a reinforcing rib, so that the probability of deformation of the opening of the capsule cap is reduced.

Drawings

Fig. 1 is a front view structural schematic diagram of an enteric controlled release device for treating clostridium difficile infection.

Fig. 2 is a schematic sectional structure diagram of an enteric controlled-release device for treating clostridium difficile infection.

Fig. 3 is a partially enlarged view of a portion a in fig. 2.

In the figure: the capsule comprises a capsule body 1, a conical guide opening 2, a capsule cap 3, a positioning ring 4, a first support 5, a first branch rod 501, a first main rod 502, a buffer bin 6, a thickening ring 7, a second support 8, a second main rod 801, a second branch rod 802, internal threads 9 and external threads 10.

Detailed Description

The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.

Referring to fig. 1 to 3, in the embodiment of the invention, an enteric controlled release device for treating clostridium difficile infection comprises a capsule body and medicines in the capsule body, wherein an enteric coating is wrapped on the outer surface of the capsule body 1, the medicines are arranged in the capsule body, the medicines are dissolved and released in an intestinal tract through the enteric coating, and the medicines in the capsule body achieve the purpose of treating clostridium difficile infected surfaces; the capsule body comprises a capsule body 1, a conical guide opening 2, a capsule cap 3, a positioning ring 4, a first support 5, a buffer bin 6, a thickening ring 7, a second support 8, an internal thread 9 and an external thread 10, wherein the capsule cap 3 is arranged on one side of the capsule body 1 in a matching mode, the internal thread 9 is arranged at an opening of the capsule body 1, the external thread 10 is arranged at an opening of the capsule cap 3, the capsule body 1 is connected with the capsule cap 3 through the external thread 10 and the internal thread 9 in a threaded connection mode, the capsule body 1 is guaranteed to be in threaded sealing connection with the capsule cap 3, and the probability of medicine overflow in the capsule body is reduced; a first support 5 for increasing the strength of the capsule body 1 is integrally formed in the capsule cap 3, and a second support 8 for increasing the strength of the capsule body is integrally formed in the capsule body 3, so that the probability of deformation or damage of the capsule body 1 and the capsule cap 3 is reduced in the process of storing and transporting the capsule body, and the probability of medicine overflow in the capsule body is further reduced.

The support I5 comprises a branch rod I501 and a main rod I502, the capsule body 1 is internally and integrally formed with the main rod I502 with an opening at one end, the opening of the main rod I502 is communicated with the outside, the main rod I502 is integrally formed with a plurality of branch rods I501 which are uniformly distributed and have openings at two ends, the branch rods I501 are communicated with the main rod I502, the opening of one end of the branch rod I501, which is far away from the main rod I502, penetrates through the capsule body 1 and is communicated with the outside, the support II 8 comprises a main rod II 801 and a branch rod II 802, the capsule cap 3 is internally and integrally formed with a main rod II 801 with an opening at one end, the opening of the main rod II 801 is communicated with the outside, the main rod II 801 is integrally formed with two symmetrically arranged branch rods II 802 with openings at two ends, the branch rods II 802 are communicated with the main rod II 801, the opening of one end of the branch rod II 802, which is far away from the main rod II 801, penetrates through, and the first branch rod 501, the first main rod 502, the second main rod 801 and the second branch rod 802 also play the role of a spoiler, so that the Alcaligenes faecalis and the ZINPLAVA for resisting the clostridium difficile exotoxin B in the capsule body are better mixed with the liquid dung.

The conical guide opening 2 is integrally formed at the opening of the capsule body 1, the capsule body 1 and the capsule cap 3 are combined conveniently through the conical guide opening 2, and the conical guide opening 2 plays a role of a reinforcing rib, so that the deformation probability of the opening of the capsule cap 3 is reduced.

The outer surface integrated into one piece of capsule cap 3 has thickening ring 7 and holding ring 4, and holding ring 4 is close to the opening setting of capsule cap 3, and when rotating capsule cap 3, the working part of operation machinery acts on thickening ring 7, reduces the probability that capsule cap 3 damaged through thickening ring 7, and plays the effect of instruction through holding ring 4, makes things convenient for detection personnel or detects machinery and knows whether firm (promptly through the distance judgement between holding ring 4 and the toper direction mouth 2) the threaded connection between capsule body 1 and capsule cap 3.

The outer surface integrated into one piece of capsule body 1 has a plurality of evenly distributed surge bins 6, and surge bins 6 are hollow structure, and surge bins 6 play the cushioning effect.

The capsule body is a gelatin capsule, and the medicines in the capsule body comprise alcaligenes faecalis, ZINPLAVA resisting clostridium difficile exotoxin B and a coprogous liquid, wherein the coprogous liquid is injected into the capsule body after being centrifuged to remove residues and ultracentrifuged to accumulate bacteria, paracresol generated by clostridium difficile is decomposed by the alcaligenes faecalis to destroy the microenvironment where clostridium difficile lives, so that the bacteria is eliminated from the etiology, and the ZINPLAVA resisting clostridium difficile exotoxin B is locally and slowly released to relieve the damage to intestinal cells caused by the ziNPLAVA, and the most effective means for treating clostridium difficile infection at present is coprogging, and long-term follow-up studies of a first multi-center large sample in 2012 indicate that the cure rate of treating clostridium difficile infection by coprogging is as high as 98%. A random control clinical test in 2013 shows that the curative effect of the coprophila transplantation treatment is obviously better than that of an antibiotic group (the remission rate is 94% vs 23% -31%). For severe clostridium difficile infection, 84 percent of patients are relieved of symptoms after receiving the fecal strain transplantation for the first time, and have no relapse within 90 days, and 92 percent of patients can still be cured after receiving the fecal strain transplantation treatment again when the relapse occurs.

Centrifuging the mixed liquid of the fecal bacteria treated by PBS to remove residues, ultracentrifuging supernatant for bacteria accumulation, injecting flora into the capsule body, and adding the probiotic alcaligenes faecalis which is subjected to purification culture in the process. The bacterium can decompose paracresol which is generated by clostridium difficile and inhibits the growth of other bacteria, and is favorable for establishing the intestinal microenvironment of the transplantation flora. Meanwhile, the controlled-release microcapsules are filled in the capsules, the microcapsules are filled with ZINPLAVA for resisting Clostridium difficile exotoxin B, the exotoxin B is extremely destructive to intestinal cells, and the controlled-release microcapsules continuously release the ZINPLAVA, so that the controlled-release microcapsules can play a good role in reducing the damage of toxins to the cells in the local part of intestinal morbidity. The enteric capsule device is convenient to take, prevents gastric acid from damaging the transplanted flora, releases a large amount of flora with treatment effect in the diseased part, and simultaneously releases alcaligenes faecalis to decompose paracresol generated by clostridium difficile to destroy the living microenvironment of the clostridium difficile. In this process, the controlled release microcapsules will release the ZINPLAVA continuously locally in the disease, to counteract the destructive effect of exotoxin B on the intestinal cells.

In the description of the present invention, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "front", "rear", and the like indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings, only for the convenience of description of the present invention and for simplicity of description, rather than to indicate or imply that the device or element so referred to must have a particular orientation, be constructed and operated in a particular orientation, therefore, the present invention should not be construed as being limited thereto, and it should be noted that the terms "mounted" and "connected" should be interpreted broadly, for example, as being able to be fixedly connected, detachably connected, or integrally formed, mechanically connected or indirectly connected through an intermediate, and the specific meaning of the terms in the invention can be understood through specific situations.

It will be evident to those skilled in the art that the invention is not limited to the details of the foregoing illustrative embodiments, and that the present invention may be embodied in other specific forms without departing from the spirit or essential attributes thereof. The present embodiments are therefore to be considered in all respects as illustrative and not restrictive, the scope of the invention being indicated by the appended claims rather than by the foregoing description, and all changes which come within the meaning and range of equivalency of the claims are therefore intended to be embraced therein. Any reference sign in a claim should not be construed as limiting the claim concerned.

Furthermore, it should be understood that although the present description refers to embodiments, not every embodiment may contain only a single embodiment, and such description is for clarity only, and those skilled in the art should integrate the description, and the embodiments may be combined as appropriate to form other embodiments understood by those skilled in the art.

Claims

1. An enteric controlled release device for treating clostridium difficile infection comprises a capsule body and medicines in the capsule body, and is characterized in that an enteric coating wraps the outer surface of the capsule body (1), the medicines are arranged in the capsule body, the medicines are dissolved and released in an intestinal tract through the enteric coating, and the medicines in the capsule body achieve the purpose of treating clostridium difficile infected surfaces; the capsule comprises a capsule body (1), a conical guide opening (2), a capsule cap (3), a positioning ring (4), a first support (5), a buffer bin (6), a thickening ring (7), a second support (8), an internal thread (9) and an external thread (10), wherein the capsule cap (3) is arranged on one side of the capsule body (1) in a matched mode, the internal thread (9) is formed in an opening of the capsule body (1), the external thread (10) is formed in an opening of the capsule cap (3), and the capsule body (1) is connected with the capsule cap (3) through the external thread (10) and the internal thread (9) in a threaded mode; a first support (5) for increasing the strength of the capsule body is integrally formed in the capsule body (1), and a second support (8) for increasing the strength of the capsule cap is integrally formed in the capsule cap (3).

2. The enteric controlled release device for treating clostridium difficile infection of claim 1, wherein the first bracket (5) comprises a first branch rod (501) and a first main rod (502), the first main rod (502) with an open end is integrally formed in the capsule body (1), the open end of the first main rod (502) is communicated with the outside, the first main rod (502) is integrally formed with a plurality of first branch rods (501) which are uniformly distributed and open at two ends, the first branch rods (501) are communicated with the first main rod (502), and an open end of the first branch rods (501), which is far away from the first main rod (502), penetrates through the capsule body (1) and is communicated with the outside.

3. The enteric controlled release device for treating clostridium difficile infection of claim 1, wherein the second bracket (8) is composed of a second main rod (801) and a second branch rod (802), the second main rod (801) with an opening at one end is integrally formed in the capsule cap (3), the opening of the second main rod (801) is communicated with the outside, the second main rod (801) is integrally formed with two symmetrically arranged second branch rods (802) with openings at two ends, the second branch rods (802) are communicated with the second main rod (801), and the opening at one end of the second branch rods (802) far away from the second main rod (801) penetrates through the capsule cap (3) and is communicated with the outside.

4. The enteric controlled release device for treating clostridium difficile infection of claim 1, wherein a conical guide port (2) is integrally formed at the opening of the capsule body (1), the capsule body (1) and the capsule cap (3) are conveniently combined through the conical guide port (2), and the conical guide port (2) plays a role of a reinforcing rib to reduce the probability of deformation of the opening of the capsule cap (3).

5. An enteric controlled release device for the treatment of clostridium difficile infection according to claim 1, wherein the outer surface of the capsule cap (3) is integrally formed with a thickened ring (7) and a positioning ring (4), the positioning ring (4) being disposed near the opening of the capsule cap (3).

6. The enteric controlled release device for treating clostridium difficile infection of claim 1, wherein a plurality of uniformly distributed buffer bins (6) are integrally formed on the outer surface of the capsule body (1), the buffer bins (6) are of a hollow structure, and the buffer bins (6) play a role in buffering and damping.

7. The enteric controlled-release device for treating clostridium difficile infection of claim 1, wherein the capsule body is a gelatin capsule, and the drugs in the capsule body comprise alcaligenes faecalis, ZINPLAVA resisting clostridium difficile exotoxin B and fecal bacteria liquid, wherein the fecal bacteria liquid is injected into the capsule body after being centrifuged to remove residues and ultracentrifuged to accumulate bacteria.