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A kind of lacrimal canaliculus slow-release hydrogel implant and preparation method thereof

An implant and hydrogel technology, applied in the field of medicine, can solve the problems of difficulty in maintaining a stretched state, poor tensile properties of silicone tubes, and difficulties in industrialized production, and achieve high stretching efficiency, small batch-to-batch variation, and productivity. big effect

Active Publication Date: 2021-03-16
NKD PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

However, due to the preparation of the silicone tube internal stretching method, the stretchability of the silicone tube is poor, and the two ends are easy to break during the drying process and it is difficult to maintain the stretched state, and the xerogel is bent after the silicone tube retracts, and the bent xerogel is not easy to take out. And cutting, there are problems such as large differences between batches, making industrial production very difficult

Method used

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  • A kind of lacrimal canaliculus slow-release hydrogel implant and preparation method thereof
  • A kind of lacrimal canaliculus slow-release hydrogel implant and preparation method thereof
  • A kind of lacrimal canaliculus slow-release hydrogel implant and preparation method thereof

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preparation example Construction

[0053] A preparation method of a lacrimal canalicular slow-release hydrogel implant of the present invention, comprising the following steps:

[0054] (1) Micronize the active ingredient raw material to obtain active ingredient micropowder, and dissolve the color developing agent in borax buffer;

[0055] (2) Dissolving the polyethylene glycol derivative with borax buffer solution, then adding the active ingredient micropowder, and stirring to form a uniform active ingredient suspension;

[0056] (3) Trilysine acetate is dissolved in borax buffer solution, then added to the active ingredient suspension, stirred and mixed evenly;

[0057] (4) Pour the mixed suspension into the silica gel tube, let it stand, and form a hydrogel after chemical crosslinking;

[0058] (5) The hydrogel is vacuum-dried to a constant weight, and then taken out and placed in a high-humidity environment, which absorbs moisture to increase in weight and become soft;

[0059] (6) After moisture absorpti...

Embodiment 1

[0066] Embodiment 1: the preparation of dexamethasone implant

[0067] (1) The dexamethasone raw material is air-pulverized, and the average particle size of the obtained micropowder is 3.2 μm, wherein 90% of the particles are less than 5 μm;

[0068] (2) Add 2000mg of 4-arm polyethylene glycol succinimidyl propionate (PEG-SPA, molecular weight 10K) to 20mL of 0.015M borax buffer, stir to dissolve, then add 0.5mL of Tween with a concentration of 1mg / mL 80 aqueous solution, then add 230 mg active ingredient micropowder, and stir to form a uniform suspension;

[0069] (3) Dissolve 70mg of trilysine acetate in 5mL of 0.015M borax buffer, then add it to the active ingredient suspension, stir and mix evenly;

[0070] (4) Inject the mixed suspension into the silica gel tube, let it stand, and form a hydrogel after chemical crosslinking;

[0071] (5) The hydrogel is vacuum-dried to a constant weight, and then placed in a 92.5% RH high-humidity environment to absorb moisture and inc...

Embodiment 2

[0073] Embodiment 2: the preparation of cyclosporine implant

[0074] (1) The cyclosporine raw material is air-pulverized, and the average particle size of the obtained micropowder is 5.5 μm, wherein 90% of the particles are smaller than 10 μm;

[0075] (2) Add 3000mg of 8-arm polyethylene glycol succinimidyl glutarate (molecular weight 15K) to 15mL of 0.005M borax buffer, stir to dissolve, then add 1mL of Povidone K30 aqueous solution with a concentration of 0.7mg / mL , then add 175mg active ingredient micropowder, stir to form a homogeneous suspension;

[0076] (3) Dissolve 100mg trilysine acetate in 10mL of 0.005M borax buffer, then add it to the active ingredient suspension, stir and mix evenly;

[0077] (4) Inject the mixed suspension into the silica gel tube, let it stand, and form a hydrogel after chemical crosslinking;

[0078] (5) The hydrogel is vacuum-dried to a constant weight, and then placed in a 92.5% RH high-humidity environment to absorb moisture and gain 40%...

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Abstract

The invention relates to an active ingredient preparation, in particular to a lacrimal canalicular slow-release hydrogel implant, comprising a polyethylene glycol derivative, bio-hydrogel, and activeingredient particles; the lacrimal canalicular slow-release hydrogel implant is based on the polyethylene glycol derivative, bio-hydrogel, with the active ingredient particles distributed evenly; thelacrimal canalicular slow-release hydrogel implant is prepared via a stretching apparatus. The invention also discloses a preparation method of the lacrimal canalicular slow-release hydrogel implant.The lacrimal canalicular slow-release hydrogel implant can be produced on large scale by controlling hydrogel prescriptions and stretching process parameters. The bio-hydrogel allows easy insertion into lacrimal ductile so as to provide noninvasive implanting; patient compliance is improved.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a lacrimal duct slow-release hydrogel implant and a preparation method thereof. Background technique [0002] Many eye diseases, such as cataracts, glaucoma, ocular infectious inflammation, dry eye, macular degeneration, retinopathy, ocular surface allergies and other diseases, will even lead to blindness if not treated in time and effectively. For the treatment of these eye diseases, eye drops are one of the important ways of ophthalmic medication, but because the corneal sac contains only 20 μL of liquid, and the volume of 1 drop of eye drops is about 50-60 μL, coupled with the corneal tissue barrier and tear dilution, eye drops After entering the eye, the absorption amount is less than 10% (Research Progress of Ophthalmic Active Ingredient Preparations, Food and Drugs, Volume 14, Issue 5, 2012); in addition, eye drops are frequently administered, generally prescri...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/06A61K9/00A61K47/22A61K47/18A61K31/573A61K38/13A61P27/02
CPCA61K9/0051A61K9/06A61K31/573A61K38/13A61K47/183A61K47/22A61P27/02
Inventor 张志兵陶秀梅陈鹏尚丽霞
Owner NKD PHARMA CO LTD
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