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Controllable-degradation lacrimal passage suppository and preparation method thereof

A lacrimal duct plug and collagen matrix technology, applied in medical science, surgery, etc., can solve problems such as difficulty in judging plugs, formation of packages, displacement and deterioration of the condition, avoiding ocular surface damage, simplifying the preparation method, and avoiding epiphora. Effect

Inactive Publication Date: 2015-10-21
SHAANXI BOYU REGENERATIVE MEDICINE CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

After the permanent lacrimal plug is implanted, there is a risk of granulation, and complications such as epiphora may occur, and surgery is required again
In addition, once the symptoms of this permanent lacrimal plug recur after surgery, it is difficult to judge whether it is caused by the displacement of the plug or the deterioration of the condition.
The canaliculus resistance core mentioned in Chinese patent 201310304213.9 has a cone-shaped end and a disc-shaped end. After implantation, the disc is exposed outside the canaliculus. Although this design can prevent the product from sliding into the lacrimal duct, However, it will also cause discomfort to the patient, and may also cause adverse conditions such as damage to the ocular surface.
However, the degradable lacrimal plug made of polymer materials may cause tissue inflammation during the degradation process after implantation.
The degradable lacrimal plug made of natural materials also has certain problems, such as easy slippage, complicated process, formation of wrapping, epiphora and other complications
Chinese patent 200810228181.8 describes a lacrimal embolus with sodium alginate as the main raw material. The formula and preparation process of this embolus are very complicated, and the requirements for equipment are high, so it is not suitable for large-scale production
In addition, the degradable products reported so far are all degraded within a specific period of time, and patients with different degrees of dry eye need to implant lacrimal plugs for treatment at different times
If treatment with products with a single degradation time will lead to some avoidable complications or other risks

Method used

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  • Controllable-degradation lacrimal passage suppository and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0035] Reference Methods Collagen was purified from bovine tendon and dissolved in 2% acetic acid solution to obtain a 1% collagen solution.

[0036] Cross-linking: EDC with a mass fraction of 0.01% was added to the above collagen solution, the cross-linking time was 24 hours at 25°C, and the stirring speed was 80r / min. Then, the purified water was used for repeated dialysis and vibration washing, and the liquid was changed every 8 hours, and the liquid was changed 3 times in total.

[0037] Homogenization: adding an appropriate amount of purified water to the obtained cross-linked collagen matrix for homogenization at 4°C until a fine and uniform gel-like substance with a viscosity of 800 mPa / s is formed.

[0038] Molding and freeze-drying: transfer the gel into a mold for freeze-drying to obtain a sample with a specified structure. There are 4 axial grooves evenly distributed on the surface of the A and B-type samples; The needle passes through the center of the C-type samp...

Embodiment 2

[0040] Reference Methods Collagen was purified from bovine tendon and dissolved in 2% acetic acid solution to obtain a 10% collagen solution.

[0041] Cross-linking: EDC with a mass fraction of 0.5% was added to the above collagen solution, the cross-linking time was 16 hours at 4°C, and the stirring speed was 300 r / min. Then, the purified water was used for repeated dialysis and vibration washing, and the liquid was changed every 4 hours, and the liquid was changed 6 times in total.

[0042] Homogenization: adding an appropriate amount of purified water to the obtained cross-linked collagen matrix for homogenization at 4°C until a fine and uniform gel-like substance with a viscosity of 1200 mPa / s is formed.

[0043] Forming freeze-drying: Transfer the gel into a mold for freeze-drying to obtain a sample with a specified structure. There are 10 axial grooves evenly distributed on the surface of the A and B-type samples; after freeze-drying, use a 0.5~0.7mm medical puncture Th...

Embodiment 3

[0045] The bovine cortical bone was cut and pulverized to obtain bone powder with a particle size of 0.05-0.1 mm, which was washed repeatedly to remove blood stains and other sundries. Degreasing, decalcification, and virus inactivation were performed according to the methods in the literature.

[0046] Swelling: soak in 0.3M hydrochloric acid solution at a mass ratio of 1:5 for 2 days, and then wash the swollen bone meal repeatedly with a large amount of purified water until the pH is 6-7. Remove the free water in the bone meal by suction filtration.

[0047] Homogenization: Add purified water at a mass ratio of 1:3, and homogenize at 4°C to form a fine and uniform gel.

[0048] Cross-linking: EDC with a mass fraction of 0.1% was added to the gelatinous collagen matrix, the cross-linking time was 10 hours at 4°C, and the stirring speed was 120 r / min. Then, the purified water was used for repeated dialysis and vibration washing, and the liquid was changed every 8 hours, and ...

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Abstract

The invention provides a controllable-degradation lacrimal passage suppository and a preparation method thereof. The lacrimal passage suppository is a novel slippage-preventing absorbable lacrimal passage suppository having multiple shapes and multiple degradation times and obtained with a cross-linked collagen matrix as a main raw material and through homogenization, freeze-drying molding and other processing steps. The multiple designed shapes not only all can be convenient to implant in surgery, but also can effectively prevent slippage; in addition, after implantation, the lacrimal passage suppository is swelled due to absorption of water, so that the stability of the product after implantation is more ensured, and the security is extremely high. In addition, with a specific micro-pore structure of the product, epiphora and other complications appearing after the product is implanted can be avoided. The method is simple in process and strong in operability. The prepared product can effectively relieve or treat xerophthalmia.

Description

technical field [0001] The invention relates to a lacrimal plug for treating dry eye and a preparation method thereof. In particular, it involves the preparation of a new type of absorbable lacrimal plug with simple process, anti-slip, avoiding epiphora, various shapes, and multiple degradation times, using collagen matrix as the main raw material. Background technique [0002] Dry eye, also known as dry eye disease, keratoconjunctival xerosis, etc., is a condition in which the tear film is unstable due to abnormal tear quality, quantity and dynamics caused by various reasons. It is a chronic disease that can damage the ocular surface. Or produce immune inflammation, the clinical manifestations are abnormalities on the ocular surface and discomfort symptoms such as dryness, foreign body sensation, pain, etc., among which dryness of the eyes is the most obvious symptom. Dry eye syndrome induces vision loss to a certain extent, and patients with severe disease even have the r...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61L31/04A61L31/14
Inventor 姚远
Owner SHAANXI BOYU REGENERATIVE MEDICINE CO LTD
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