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Viscoelastic agent for ophthalmology

A viscoelastic and ophthalmological technology, applied in medical science, medical formula, surgery, etc., can solve problems such as intraocular lens turbidity, and achieve the effects of improving storage stability, improving stability, and improving storage and transportation performance

Active Publication Date: 2018-09-28
EYEBRIGHT MEDICAL TECH BEIJING
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Furthermore, viscoelastics are known to have a number of drawbacks in their use, such as clouding of the intraocular lens after cataract surgery

Method used

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  • Viscoelastic agent for ophthalmology

Examples

Experimental program
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Effect test

Embodiment approach

[0038] According to another embodiment of the present invention, the viscoelastic agent comprises or consists of the following components:

[0039] - Sodium Hyaluronate: 1.5%-2.5% w / v;

[0040] - Boric acid: 0.7%-0.85% w / v;

[0041] - Borax: 0.04%-0.07% w / v;

[0042] - Sodium chloride: 0.3%-0.7% w / v;

[0043] - The balance is water.

[0044] The viscoelastic agent of the present invention is a viscoelastic agent suitable for ophthalmology, especially, a viscoelastic agent suitable for intraocular.

[0045] The present invention also relates to an ophthalmic implement comprising a viscoelastic as described above.

[0046] The present invention also relates to an ophthalmic implant comprising a viscoelastic as described above.

[0047] The present invention also relates to the method for preparing the viscoelastic agent of the present invention, comprising the steps of:

[0048] - Dissolving pH buffers and osmolarity regulators to obtain sterile buffers,

[0049] - adding...

Embodiment 1

[0055] The viscoelastic agents of the present invention having formulations 1-6 were prepared according to the following steps according to Table 1 below. Firstly, the pH buffer agent and the osmotic pressure regulator powder are dispersed and dissolved with water for injection, and then filtered and sterilized through a 0.22 μm water-based filter membrane to obtain a sterile buffer solution. In a dynamic 100-level environment, add the viscoelastic material calculated and weighed according to the corresponding formula into the sterile buffer solution, shake and mix well, and then stand at 2-8°C to remove air bubbles. Fill the mixed and bubble-free feed solution into the prefilled syringe through the prefilled syringe filling machine under the protection of the oRABS aseptic isolation system.

[0056] Table 1

[0057]

Embodiment 2

[0058] Example 2 Moist heat sterilization of formula 1-6 and shear viscosity before and after sterilization

[0059] Put the viscoelastic agent of formula 1-6 encapsulated in the pre-filled syringe in a pressure-compensated humid-heat sterilizer, set the sterilization temperature at 121°C and F0=8, and use a rheometer before and after sterilization ( Manufacturer TA, model DHR-1) to test, record 0.25s -1 The viscosity data at the shear rate are shown in Table 2.

[0060] Table 2

[0061]

[0062] As shown in Example 2, the viscoelastic agent of the present invention can withstand moist heat sterilization, and after conventional terminal moist heat sterilization, the viscoelastic agent of the present invention still has excellent viscosity, including pH buffering based on boric acid and / or borate The viscoelastic agent of the agent still has the required viscoelasticity and so on.

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Abstract

The invention relates to a viscoelastic agent which is suitable for the ophthalmic surgery. The problem can be solved that the artificial lens after the ophthalmic surgery such as cataract surgery isturbid. The viscoelastic agent has biological safety and comprises a viscoelastic substance, a pH buffering agent based on borate, an osmotic pressure conditioning agent and water.

Description

technical field [0001] The invention relates to the technical field of medical biomaterials, and provides a gel substance used in clinical ophthalmic microsurgery, in particular, relates to a viscoelastic agent suitable for use in eye surgery. Background technique [0002] Cataract is the eye disease with the highest probability of blindness in the world, which leads to a significant reduction in vision and quality of life of patients. At present, the only effective treatment for cataract is surgery. After years of development, phacoemulsification combined with intraocular lens implantation has become the most commonly used cataract surgery. In order to improve surgical quality, create surgical space, stabilize intraocular pressure, and reduce damage to corneal endothelial cells during surgical operations, viscoelastic is a necessary auxiliary material for cataract surgery. It plays a certain role in filling, supporting, lubricating and protecting during ophthalmic surgery....

Claims

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Application Information

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IPC IPC(8): A61L31/04A61L31/14
CPCA61L31/042A61L31/044A61L31/14A61L31/145A61L2400/06C08L5/08C08L89/00
Inventor 魏永吉解江冰
Owner EYEBRIGHT MEDICAL TECH BEIJING
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