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Recombinant human interleukin-1 receptor antagonist in-situ gel

A receptor antagonist and in situ gel technology, applied in the field of medicine, can solve problems such as inaccurate dosage, poor fluidity, difficulty in meeting the needs and recognition of the market and patients

Active Publication Date: 2010-12-15
HAINAN ZHONGSEN BIOTECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Some antibacterial drug ophthalmic gels developed now are viscous liquids with poor fluidity. Although they can prolong the residence time in local tissues to a certain extent, the gels need to be squeezed out when they are used. Uncomfortable application in the eye and prone to inaccurate dosing
This gel is inconvenient to use and the dosage is inaccurate, so it is difficult to meet the needs and acceptance of the market and patients

Method used

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  • Recombinant human interleukin-1 receptor antagonist in-situ gel
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  • Recombinant human interleukin-1 receptor antagonist in-situ gel

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] Example 1. Recombinant human interleukin-1 receptor antagonist in situ gel No. 1

[0025] Take 15g of poloxamer 407, 15g of poloxamer 188, and 0.1g of gellan gum, add 50mL of boric acid buffer to fully swell into a uniform solution. Add 3mL IL-1ra receptor antagonist stock solution and 0.3g chlorobutanol. Mix evenly and divide for use. The in situ gel has dual functions of temperature sensitivity and ion sensitivity, and is a flowing liquid at room temperature ( figure 1 ), 5min at 37°C to form a gel ( figure 2 ). The in situ gel can be used in various administration routes and modes mentioned in the specification.

Embodiment 2

[0026] Example 2. Recombinant human interleukin-1 receptor antagonist in situ gel No. 2

[0027] Weigh 10 g of polyethylene glycol monomethyl ether / polylactic acid-glycolic acid copolymer (mPEG-PLGA) and 3 g of carbomer in 50 mL of water, stir and place it in a refrigerator at 4 °C with continuous shaking until mPEG- After PLGA swells, shake well to make a homogeneous solution. Add 3mL IL-1ra receptor antagonist stock solution, mix evenly, and dispense for use. The in-situ gel has dual effects of pH sensitivity and temperature sensitivity, and is a flowing liquid at room temperature, and becomes a gel within 5 minutes after intranasal administration. The in situ gel can be used in various administration routes and modes mentioned in the specification.

Embodiment 3

[0028] Example 3. Recombinant human interleukin-1 receptor antagonist in situ gel No. 3

[0029] Take 15g of poloxamer 407 and 15g of poloxamer 188, 0.1g of gellan gum, 2.5g of chitosan and add 50mL of water to fully swell to form a uniform solution. Add 3mL IL-1ra receptor antagonist stock solution, mix evenly, and dispense for use. The in-situ gel has dual functions of temperature sensitivity and ion sensitivity. At the same time, chitosan acts as an absorption accelerator. It is a flowing liquid at room temperature and forms a gel within 5 minutes after spraying into the nasal cavity. The in situ gel can be used in various administration routes and modes mentioned in the specification.

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Abstract

The invention discloses a recombinant human interleukin-1 receptor antagonist in-situ gel, which comprises a recombinant human interleukin-1 receptor antagonist and an in-situ gel material, wherein the in-situ gel material is one or more of a temperature-sensitive in-situ gel material, a pH-sensitive in-situ gel material and an ionic strength-sensitive in-situ gel material. The in-situ gel is flowable liquid at room temperature, has the advantages of easy access (injection, eye drop, nasal drop, spray, lung inhalation and the like), accurate dosage, and capacities of forming high-viscosity hardly flowing gel in short time when contacting tissues, prolonging the residence time in the tissues, increasing the medicament adsorption and fully exerting medicinal effects. The in-situ gel has the advantages of adhesiveness, slow release, and capacities of greatly improving the medicinal bioavailability and achieving possible sustained-release long-acting effect.

Description

technical field [0001] The invention relates to the field of medicine, in particular to the recombinant human interleukin-1 receptor antagonist in situ gel. Background technique [0002] Interleukin-1 (interleukin-1 for short, IL-1, including IL-1α and IL-1β) is a cytokine with a wide range of functions, which plays an important role in regulating the body’s immune and inflammatory responses, but excessive IL-1 often causes the disturbance of normal host function, and reducing the synthesis and effect of IL-1 has become a means of treating many diseases. Interleukin-1 receptor antagonist (Interleukin-1 receptor antagonist, IL-1ra) is an isomer of IL-1 naturally occurring in the body, with a molecular weight of about 17KD, and has a high affinity with the IL-1 receptor in the body. Endogenous IL-1ra is very important for maintaining the balance and stability of the tissue's own internal environment and maintaining the health of the body. IL-1ra can block the inflammatory re...

Claims

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Application Information

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IPC IPC(8): A61K9/00A61K38/20A61P29/00A61P27/02A61P11/06A61P37/08A61P11/02A61P19/02A61P19/04
Inventor 佟丽咸洪军齐健马川
Owner HAINAN ZHONGSEN BIOTECH CO LTD
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