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Hydrogel lacrimal passage suppository and preparation method thereof

A hydrogel lacrimal duct and hydrogel technology, which is applied in suppository delivery, pharmaceutical formulations, preparations for in vivo tests, etc., can solve the problems of short maintenance time, increase in diameter, frequent replacement, etc., and achieve mild process conditions, The effect of reducing air bubbles and reducing breakage

Active Publication Date: 2020-10-16
NKD PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, such degradable lacrimal plugs that are currently available on the market not only increase in diameter but also increase in length after encountering tears, requiring a deeper implantation position, which has the disadvantages of easy slipping after implantation, short maintenance time, and frequent replacement.

Method used

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  • Hydrogel lacrimal passage suppository and preparation method thereof
  • Hydrogel lacrimal passage suppository and preparation method thereof
  • Hydrogel lacrimal passage suppository and preparation method thereof

Examples

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preparation example Construction

[0060] The invention provides a method for preparing a hydrogel lacrimal plug, comprising:

[0061] 1. Preparation of hydrogel prepolymer

[0062] The polymer was dissolved in the buffer salt system, and placed in a low-temperature centrifuge for defoaming treatment to obtain the first uniform solution (solution I),

[0063] Then add the cross-linking agent and the color developing agent into the buffer salt system to obtain the second mixed solution (solution II).

[0064] 2. Preparation and molding of wet gel

[0065] Mix the first homogeneous solution and the second mixed solution evenly, pressurize and inject into the mold (tubular mold) and let stand to form a hydrogel.

[0066] 3. Preparation of dry gel

[0067] The hydrogel is taken out after drying at room temperature for a suitable time (preliminary dehydration to obtain a wet hydrogel), and then placed at room temperature for a period of time (further dehydration), and then uniformly stretched to a fixed length at...

Embodiment 1

[0071] The preparation of embodiment 1 hydrogel lacrimal plug

[0072] 1. Add 7500mg of four-armed polyethylene glycol succinimide propionate (molecular weight: 20000±1000Da) into 20mL of 0.015M borate buffer, stir to dissolve, and place in a centrifuge for low-temperature centrifugation for defoaming treatment. Setting conditions: rotation speed 2000r / min, temperature 5°C, time 2min, to obtain the first uniform solution (Solution I).

[0073] Dissolve 100mg trilysine acetate, 50mg polyethyleneimine (molecular weight 10000Da) and 10mg N-hydroxysuccinimide fluorescein in 10mL 0.015M borate buffer to obtain the second mixed solution (Solution II) .

[0074] 2. Mix the first uniform solution and the second mixed solution evenly.

[0075] 3. Pour the mixed solution into a silicone tube with an inner diameter of 1.7 mm, let it stand for 1 min, and form a hydrogel after chemical crosslinking.

[0076] 4. Dry the hydrogel at room temperature and normal pressure for 2 hours, take o...

Embodiment 2

[0079] Embodiment 2 Preparation of hydrogel lacrimal plug

[0080] 1. Add 2500mg of eight-armed polyethylene glycol maleimide (molecular weight 20000±1000Da) to 20mL of 0.015M borate buffer solution, stir to dissolve, and place it in a centrifuge for defoaming treatment. The setting conditions of the centrifuge are: speed 2000r / min, temperature 5°C, time 2min, the first homogeneous solution (Solution I) was obtained.

[0081] 100mg trilysine acetate, 50mg polyethyleneimine (molecular weight 10000Da) and 10mg N-hydroxysuccinimide fluorescein were dissolved in 10mL of 0.015M borate buffer to obtain the second mixed solution (Solution II ).

[0082] 2. Add the second mixed solution to the first solution, stir and mix evenly.

[0083] 3. Pour the mixed solution into a silicone tube with an inner diameter of 1.7 mm, let it stand for 1 min, and form a hydrogel after chemical crosslinking.

[0084] 4. Dry the hydrogel at room temperature and normal pressure for 2 hours, take out t...

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Abstract

The invention provides a hydrogel lacrimal passage suppository and a preparation method thereof. The hydrogel lacrimal passage suppository is a hydrogel suppository of which the size can pass througha lacrimal point; the hydrogel lacrimal passage suppository comprising a dehydrated hydrophilic polymer hydrogel (xerogel) of which the cross-sectional width expands to at least 2 times after absorbing physiological water, and thus the suppository is enlarged and can be deployed in a lacrimal duct. The hydrogel lacrimal passage suppository can be used as a drug delivery system. The gel is taken out after being subjected to primary drying to a proper state under the room temperature condition and then placed at the room temperature, the production process condition is mild, the tensile propertyof the prepared gel is greatly improved, the breakage probability in a stretching process is reduced, and the production efficiency is improved. The lacrimal passage suppository product does not contain bubbles, is smooth in appearance, uniform and stable in quality and good in in-vivo compliance, can have a degradation cycle of more than 180 days, and can be used for instruments for treating xerophthalmia, improve the ocular surface environment and relieve xerophthalmia symptoms.

Description

technical field [0001] The invention relates to the technical fields of polymer materials and medicine, in particular to a hydrogel lacrimal duct suppository and a preparation method thereof. Background technique [0002] Dry eye syndrome refers to a tear secretion disorder eye disease caused by various factors, with dry eyes as the main symptom, often accompanied by itching, foreign body sensation, burning sensation in both eyes, or photophobia, blurred vision, vision fluctuations, etc. Performance. Dry eye will reduce the quality of life of patients, affect the work and life of patients, and cause blindness in severe cases. Therefore, the prevention and treatment of dry eye has become a top priority. [0003] The more common methods for the clinical treatment of dry eye are artificial tears, punctal closure and lacrimal embolism. Among them, the treatment method of artificial tears needs longer treatment time, and is easy to relapse, and can only treat mild dry eye synd...

Claims

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Application Information

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IPC IPC(8): A61K9/02A61K9/06A61K45/00A61K47/10A61K49/00A61P27/02A61F9/007A61F9/00
CPCA61K9/02A61K9/06A61K47/10A61K9/0051A61K45/00A61P27/02A61K49/0054A61K49/0073A61F9/0017A61F9/007
Inventor 黄果徐小雨陶秀梅陈鹏
Owner NKD PHARMA CO LTD
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