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MG53 protein/MG53 mutant protein enteric capsule and preparation method thereof

An enteric-coated capsule and mutant technology, applied in the medical field, can solve the problems of being easily degraded and the active ingredients of drugs cannot be guaranteed, and achieve the effects of shortening the medication cycle, alleviating pain, and increasing the distribution area.

Pending Publication Date: 2019-03-29
MUDANJIANG YOUBO PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] In view of this, the present invention aims to propose a MG53 protein / MG53 mutant protein enteric-coated capsule to solve the problem that it is easily degraded under extreme conditions in the stomach and the active ingredients of the drug cannot be guaranteed

Method used

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  • MG53 protein/MG53 mutant protein enteric capsule and preparation method thereof
  • MG53 protein/MG53 mutant protein enteric capsule and preparation method thereof
  • MG53 protein/MG53 mutant protein enteric capsule and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0038] A MG53 protein / MG53 mutant protein enteric-coated capsule, including MG53 protein / MG53 mutant protein enteric-coated pellets and a blank enteric-coated capsule;

[0039] Configuration of MG53 protein / MG53 mutant protein enteric-coated pellets:

[0040]

[0041] making process:

[0042] S1. Weigh the pellet core, place it in a fluidized bed to preheat, the temperature is 40-55°C, and the time is 15-45min;

[0043] S2. Preparation of MG53 protein / MG53 mutant protein enteric-coated pellets: Weigh, take the lyophilized powder of MG53 or its mutant, add it to water and stir; add the binder to the lyophilized powder solution of MG53 or its mutant Stir to disperse evenly,

[0044] Adjust the parameters and apply the above-mentioned solution. The specific parameters are as follows:

[0045] Inlet speed 18~22m 3 / h·100g, air inlet temperature 43℃~48℃, material temperature 35℃~38℃, fan speed 1700~1900rpm, atomization pressure 0.2~0.23MPa, nozzle diameter 0.3mm.

[0046] ...

Embodiment 2

[0055] The difference between the present embodiment and the above-mentioned implementation is that the binder is: povidone (PVP), hypromellose (HPMC), carmellose sodium (CMC-Na), syrup; preferably , the present embodiment selects hypromellose, and the hypromellose has thickening ability, salt tolerance, low ash powder, pH stability, water retention, dimensional stability, excellent film-forming property, and extensive Enzyme resistance, dispersibility and cohesiveness and other characteristics.

Embodiment 3

[0057] The difference between this embodiment and the above-mentioned embodiments is that the pellet core is a microcrystalline cellulose pellet core, a sucrose pellet core, a starch pellet core, and the like. Preferably, the microcrystalline cellulose pellet core is selected in this implementation. The particle diameter of the pellet core is 100-1000 μm. Compared with sugar spherical particles, it has moderate water absorption, and the adhesion between particles is smaller, so it can be more easily coated with drugs and can effectively improve production efficiency.

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Abstract

The present invention provides an MG53 protein / MG53 mutant protein enteric capsule and a preparation method thereof, and belongs to the technical field of medicines. The MG53 protein / MG53 mutant protein enteric capsule comprises a MG53 protein / MG53 mutant protein enteric micro-pellet and a blank enteric capsule; the MG53 protein / MG53 mutant protein enteric micro-pellet comprises the following components: 25 parts by weight of freeze-dried powder of MG53 or MG53 mutant proteins, 100-120 parts by weight of pellet cores and 2-5 parts by weight of a binder; the enteric capsule micro-pellet has a moisture content of 1.5%-3%; and enteric coating weight gain is controlled at 25%-30%. The preparation method of the MG53 protein / MG53 mutant protein enteric capsule can ensure that the proteins do notdegrade, effectively ensure activity, avoid destruction of the MG53 proteins or MG53 mutant proteins by various proteases in digestive tract, delays to intestinal administration, enables distributionarea of medicines on intestinal surfaces to be increased, improves bioavailability of the medicines, and at the same time reduces stimulation of intestines.

Description

technical field [0001] The invention relates to the field of medical technology, in particular to an MG53 protein / MG53 mutant protein enteric-coated capsule and a preparation method thereof. Background technique [0002] MG53 is the skeletal muscle-specific protein mitsugumin53, referred to as MG53 or TRIM72. MG53 is a muscle-specific tripartitemotifamily (TRIM) family protein. The family proteins often contain three specific motif structures, which are called RING, B-BOX, and coiled coil domain (Coiled coil domain). Together, they bind to proteins that the cell no longer needs, marking them with ubiquitin for degradation. MG53 is also an important part of a cell membrane repair mechanism. [0003] In terms of medical applications, the efficacy of MG53 in the treatment of heart diseases caused by apoptosis, ulcerative colitis, etc. has been accepted and known in the frontier field of the industry. Inflammatory bowel disease (IBD) includes various intestinal inflammatory ...

Claims

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Application Information

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IPC IPC(8): A61K9/50A61K9/48A61K38/17A61K47/38A61K47/32A61P9/00A61P1/00
CPCA61K9/5078A61K9/5089A61K38/1709A61P1/00A61P9/00
Inventor 梁亚龙
Owner MUDANJIANG YOUBO PHARMA CO LTD
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