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Tissue sealant and preparation method and application thereof

A sealant and tissue technology, applied in the field of biodegradable polymer materials, can solve the problems of unsatisfactory effect, high irritation, high hardness, etc.

Active Publication Date: 2015-12-23
NKD PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] At present, hydrogel has been widely used as a sealant for wound tissue in clinical operations, especially in ophthalmic surgery. Most of the commonly used ophthalmic tissue sealants are natural materials. For example, absorbable gelatin, fibrin sealant and mussel mucin adhesive, etc., but these substances are of animal origin, and there is a risk of animal virus transmission; followed by fully synthetic biopolymer materials, such as α-cyanoacrylic acid Esters such as isobutyl ester, n-octyl ester and their derivatives, etc., but due to the disadvantages of non-degradable, short setting time, strong irritation, and high hardness, the effect in clinical application is not ideal, so it is necessary to carry out Improve

Method used

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  • Tissue sealant and preparation method and application thereof
  • Tissue sealant and preparation method and application thereof

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Experimental program
Comparison scheme
Effect test

preparation example Construction

[0069] In the preparation of the medical tissue sealant of the present invention, the first component and the second component are mixed through a mixing tool to undergo covalent cross-linking to form a hydrogel. The reaction mechanism is: the NHS of the hydrophilic component (the first component) and the NH of the nucleophilic component (the second component) 2 Covalent bonding, polymerization reaction occurs, and a hydrogel is formed. A small amount of by-products have good biocompatibility, are non-toxic and non-irritating, and are excreted from the body with the degradation of the gel. The reaction is as follows:

[0070]

[0071] Where R1, R3 are any one of H, CH3, CH2CH3, CH2CH2CH3, including R1, R3 are the same structure, etc.; R2 is OCCH2CO, OCCH2CH2CO, OCCH2CH2CH2CO, etc.; R4 is NH or S; R5 is OC(CH2) n CO, polyethylene glycol, etc.

[0072] The medical tissue sealant provided by the present invention satisfies the following characteristic indicators:

[0073] 1)...

Embodiment

[0087] Embodiment one hydrophilic component is the derivative of PEG

[0088] The nucleophilic component is trilysine, the hydrophilic component is PEG derivatives, the solvent is PBS buffer with pH=7.4, and the gel test is carried out according to the following procedure.

[0089] Dissolve trilysine containing nucleophilic functional groups in 5 μL of PBS buffer solution with pH=7.4 to obtain solution A; dissolve PEG derivatives containing hydrophilic functional groups and chromogenic reagent in solution A, mix and stir thoroughly , about 15s, observe the situation of gel formation respectively.

[0090] The formula of 0.1M PBS buffer solution with pH=7.4: weigh 4.005g of sodium chloride as reagent A; weigh 0.1g of potassium chloride as reagent B; weigh 1.7907g of disodium hydrogen phosphate dodecahydrate as reagent C; Weigh 0.135g of potassium dihydrogen phosphate as reagent D; put the four substances of reagents A, B, C and D in a 500mL volumetric flask in turn, and then d...

Embodiment 2

[0099] Embodiment two nucleophilic components are three lysine derivatives

[0100] The nucleophilic component is trilysine derivative, the hydrophilic component is 2-arm-PEG-NHS, the solvent is PBS buffer solution with pH=7.4, and the gel preparation test is carried out according to the following procedure.

[0101] Dissolve the trilysine derivative containing nucleophilic functional groups in 70 μL of PBS buffer solution with pH = 7.4 to obtain a solution; immediately dissolve 2-arm-PEG-NHS containing hydrophilic functional groups in the solution and mix well Stir for about 5 seconds and observe the formation of gel.

[0102] The situation of hydrogel composed of different three lysine derivatives and the hydrophilic component PEG derivative 2-arm-PEG-NHS is as follows The table below Show:

[0103]

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Abstract

The invention relates to a tissue sealant and a preparation method and application thereof. The sealant mainly comprises hydrophilic raw material, nucleophilic raw material, a marker and physiological thinner, wherein the hydrophilic raw material mainly refers to the derivatives of polyethylene glycol and the nucleophilic raw material mainly refers to polyamino acid. The preparation method includes: physically mixing the hydrophilic raw material, the nucleophilic raw material, the marker and the physiological thinner through a mixing tool, and performing covalent cross-linking to form hydrogel. The tissue sealant has the advantages that the sealant mainly used for sealing small wounds after eye surgery is good in tissue cohesive force and film-forming property, good in biocompatibility, capable of promoting epithelization healing and preventing seepage leakage, simple in preparation method, capable of being quantified to form a stable production line, and good in clinical application value.

Description

technical field [0001] The invention belongs to the field of biodegradable polymer materials, in particular to a medical tissue sealant or hydrogel formed by in-situ cross-linking and its preparation method and application. Background technique [0002] Cataracts are a progressive blurring of the lens, usually as a result of aging, but there may be other factors as well. Statistics show that about 3.3 million people in the United States undergo cataract surgery each year. Cataract surgery is a process in which the lens is removed and replaced with an artificial lens to restore vision. During cataract surgery, the ophthalmologist will make a small incision on the cornea through which the patient's own lens is removed. Since the incision is small (usually within 3mm) in most cases of implanting an intraocular lens, it is important to use the intraocular lens The incision tissue will heal itself after it is placed, however, many factors are not stable for the time leading to t...

Claims

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Application Information

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IPC IPC(8): A61L24/00A61L24/04
Inventor 徐小雨陶秀梅牟昳尚丽霞
Owner NKD PHARMA CO LTD
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