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Sclera external pressurized biologic composite materials and preparation method

A composite material and biological technology, applied in the field of medical biomaterials, can solve the problems of high residual concentration of crosslinking agent, uneven material hardness, failure to meet the requirements, etc., to achieve biocompatibility and mechanical strength, high surface hardness and Effect of impact resistance, good biocompatibility

Inactive Publication Date: 2010-09-15
HANGZHOU FIRST PEOPLES HOSPITAL
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

If the strength of the product is increased by increasing the concentration of the cross-linking agent and the substrate according to the ordinary method, the ultra-high viscosity of the hyaluronic acid substrate makes the cross-linking reaction not uniform, resulting in uneven hardness of the material, which is easy to crack from the weaker part. Moreover, the high residual concentration of the cross-linking agent makes the biocompatibility of the material poor and cannot meet the requirements

Method used

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  • Sclera external pressurized biologic composite materials and preparation method
  • Sclera external pressurized biologic composite materials and preparation method
  • Sclera external pressurized biologic composite materials and preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] Use 100g of pharmaceutical grade hyaluronic acid, add water to swell overnight at 4°C, prepare 10% sodium hyaluronate solution in 1000ml for use, prepare crosslinking reaction solution A according to the following formula, and its components and weight percentages:

[0037] BDDE (Butanediol Diglycidyl Ether) 30ml

[0038] Sodium hydroxide solution 0.5mol / L: 50ml

[0039] Distilled water to 500ml

[0040] Add the cross-linking reaction solution A into the hyaluronic acid solution, react at 40°C for 6 hours to obtain the preliminary cross-linking product, wash it repeatedly with distilled water for 4 times, then add the second-step cross-linking solution B, and the second-step cross-linking solution B The content of components and weight percent:

[0041] DVS (Diethylsulfone) 10ml

[0042] Sodium carbonate / sodium bicarbonate solution 0.8mol / L: 50ml pH=10

[0043]Distilled water to 500ml

[0044] Continue to react for 4 hours, wash with distilled water, then add 1000m...

Embodiment 2

[0050] Use 100g of pharmaceutical grade hyaluronic acid, add water to swell overnight at 16°C, prepare a 500ml solution of 20% sodium hyaluronate for use, prepare a cross-linking reaction solution A, and its components and weight percentages are as follows:

[0051] Formaldehyde solution 50ml

[0052] Sodium hydroxide solution 0.5mol / L: 40ml pH=12

[0053] 95% ethanol 20ml

[0054] Distilled water to 500ml

[0055] Add the cross-linking reaction solution A into the hyaluronic acid solution, and react at 4°C for 2 hours to obtain the preliminary cross-linking product, wash it repeatedly with distilled water, then add the cross-linking reaction solution B, the components and weight of the cross-linking reaction solution B Percent content:

[0056] Bissulfosuccinimide suberate (BS3) 5ml

[0057] 0.5N phosphate buffer solution 100ml pH=5.0

[0058] 95% ethanol 10ml

[0059] Distilled water to 500ml

[0060] Continue to react at 4°C for 3 hours, wash with distilled water, th...

Embodiment 3

[0066] Cut the cross-linked hyaluronic acid material prepared in Example 1 or 2 into rectangular strips with a size of 12mm×3.0mm×2.0mm, and sterilize with ethylene oxide for future use. The experiment used big-eared white rabbits with a body weight of 2-3KG and was anesthetized by intramuscular injection of 50.0 mg of ketamine. The eyelid was opened with the eyelid speculum, and the bulbar conjunctiva of the fornix, which was 7.0 mm away from the corneoscleral limbus, was cut with ophthalmic micro scissors, and the length was about 10 mm. Separate the superior rectus muscle and oblique muscle, and use 5-0 silk thread to make two mattress sutures with a distance of 7.0 mm on the sclera at a distance of 4.0 mm from the corneoscleral limbus at both ends of the muscle. The prepared material was placed under the muscle and mattress suture, the suture was ligated, both ends of the material were trimmed, and the bulbar conjunctiva was sutured continuously with 5-0 silk thread. B-ul...

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Abstract

The invention provides sclera external pressurized biologic composite materials which comprise 5-40 percent of pharmaceutical grade hyaluronic acid glucuronic acid, wherein the light transmittance of the pharmaceutical grade hyaluronic acid glucuronic acid is no more than 98 percent, the haemolysis is not detected, streptococcus haemolyticus is not detected, the total amount of the mycete and the saccharomycetes is no more than 10CFU / g, the mechanical tensile strengthen is larger than 3Mpa, the tearing strengthen is larger than 5kN / M, and the materials accord with the biologic safety requirements of three types of national medical devices. The invention takes hyaluronic acid as basic raw materials, carries out chemical crosslinking for more than two times with cross-linking agent to prepare crosslinking hyaluronic acid materials with high intensity, lowers toxic cross-linking agent residues through chemical reaction and is sterilized to prepare biologic materials which accord with three types of national medical devices. In the invention, through a composite crosslinking method, the sandwich type ultrahigh intensity crosslinking hyaluronic acid materials with higher surface rigidity and better interior elasticity are prepared, and the contradiction between the biocompatibility and the mechanical strength can be efficiently solved.

Description

technical field [0001] The invention belongs to medical biomaterials, and relates to a medical biocomposite material and a preparation method thereof. Background technique [0002] Rhegmatogenous retinal detachment is a kind of tissue atrophy caused by traction or insufficient blood supply of the retina, which leads to a tear in the retina, the main component of the eyeball, and the liquid in the eye enters between the retinal nerve layer and the pigment epithelium, causing the retina to lose its photosensitive function. A serious eye disease. Retinal detachment that has not been reset for a long time may cause loss of visual function, and may also be complicated by iridocyclitis, pupillary atresia, concurrent cataract, secondary glaucoma, and even eyeball atrophy. Rhegmatogenous retinal detachment is one of the main blinding diseases of myopic people. According to incomplete statistics, the annual incidence rate is 17 / 100,000. Nearly 200,000 people in the country are troub...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61L31/04A61L27/20
Inventor 张惠成胡勇平冯海黄鑫郝念
Owner HANGZHOU FIRST PEOPLES HOSPITAL
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