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A kind of thermosensitive gel eye drop and its preparation method and application

An eye drop, temperature-sensitive technology, applied in the field of medicine, can solve the problems of poor control of preparation irritation, poor patient compliance, etc., achieve good antibacterial and anti-inflammatory effects, increase adhesion, and reduce the frequency of administration

Active Publication Date: 2019-01-15
SOUTHWEST UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the current ophthalmic thermosensitive gel technology is not mature enough. For example, the irritation of the preparation is not well controlled, which leads to poor patient compliance.

Method used

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  • A kind of thermosensitive gel eye drop and its preparation method and application

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] Example 1 Neomycin Sulfate, Dexamethasone Sodium Phosphate Thermosensitive Gel Eye Drops I

[0026] Take about 70% of the prescription amount of water for injection, add 0.01% benzalkonium bromide, 0.9% sodium chloride, 0.1% disodium edetate and stir to dissolve; then add 1.5% neomycin sulfate, 0.15% dexamethasone Methasone sodium phosphate, stirred to dissolve, cooled at 3-5°C for 1-2h; added 19% poloxamer 407 and 2% poloxamer 188, stirred and mixed, dilute to the specified volume with water for injection, mixed Mix well, and cool at 3-5°C for 18-24h until a clear solution without bubbles is formed. Wherein each component weight percent is as shown in the table below:

[0027] components

[0028] Quality inspection: This product is a colorless clear liquid with a pH of 6.04; it is a liquid at room temperature and becomes a uniform and fine semi-solid when heated to 35.3°C; the differential reaction of neomycin sulfate and dexamethasone sodium phosphate is po...

Embodiment 2

[0029] Example 2 Neomycin Sulfate, Dexamethasone Sodium Phosphate Thermosensitive Gel Eye Drops II

[0030] Take about 70% of the prescription amount of water for injection, add 0.01% benzalkonium bromide, 0.9% sodium chloride, 0.1% disodium edetate, 0.5% sodium hyaluronate (molecular weight 11000Da), and 2% glycerin; Then add 1.5% neomycin sulfate, 0.15% dexamethasone sodium phosphate, stir to dissolve, and cool at 3-5°C for 1-2h; add 18% poloxamer 407 and 1% poloxamer 188. Stir and mix evenly, dilute to the specified volume with water for injection, mix evenly, and cool at 3-5°C for 18-24h until a transparent solution without bubbles is formed. Wherein each component weight percent is as shown in the table below:

[0031]

[0032] Quality inspection: This product is a colorless clear liquid with a pH of 5.97; it is a liquid at room temperature and becomes a uniform and fine semi-solid when heated to 35.8°C; the differential reaction of neomycin sulfate and dexamethasone ...

Embodiment 3

[0033] Example 3 Neomycin sulfate, dexamethasone sodium phosphate ophthalmic thermosensitive gel eye drops III

[0034] Take about 70% of the prescription amount of water for injection, add 0.08% sorbic acid, 0.9% sodium chloride, 0.1% disodium edetate, 0.5% polylysine, 2.0% propylene glycol, and stir to dissolve; then add 1.5% % Neomycin Sulfate, 0.15% Dexamethasone Sodium Phosphate, stir to dissolve, then cool at 3-5°C for 1-2h; add 20% Poloxamer 407 and 1% Poloxamer 188, stir and mix , dilute to the specified volume with water for injection, mix well, and cool at 3-5°C for 18-24h until a transparent solution without bubbles is formed. Wherein each component weight percent is as shown in the table below:

[0035] components

[0036] Quality inspection: This product is a colorless clear liquid with a pH of 6.05; it is a liquid at room temperature and becomes a uniform and delicate semi-solid when heated to 35.1°C; the differential reaction of neomycin sulfate and d...

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Abstract

The invention discloses thermo-sensitive type gel eye drops, as well as a preparation method and application thereof. The eye drops comprise prescription active ingredients, gel matrix, a preservative, a metal ion chelating agent, an isoosmotic adjusting agent and water for injection, wherein the prescription active ingredients comprise neomycin sulfate and dexamethasone sodium phosphate; the gel matrix comprises poloxamer 407 and poloxamer 188; the preservative comprises benzalkonium bromide; the metal ion chelating agent is ethylene diamine tetraacetic acid; and the isoosmotic adjusting agent is sodium chloride. Preferably, the eye drops also comprise a moisturizing agent and a bioadhesive material. The eye drops, disclosed by the invention, have the following advantages: (1) administration is facilitated, the medicine liquid has adhesion, retention and sustained release effects on the surface of retina, the administration frequency can be reduced, the medicine loss can be reduced and the compliance of a patient can be improved; (2) the eye drops are simple in preparation process, low in cost and suitable for large-scale production; and (3) the eye drops have good antibacterial and anti-inflammatory effects, low irritability and high safety.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a temperature-sensitive gel eye drop and its preparation method and application. Background technique [0002] Ophthalmic preparations refer to preparations that are directly used in the eyes to exert preventive effects. Currently clinically used ophthalmic preparations are mainly eye drops, ophthalmic ointments, and ophthalmic gels, and most of the eye drops are drug solutions. In recent years, with the development of biopharmaceuticals and the in-depth study of pharmacokinetics after ophthalmic administration, it has been found that solutions have problems such as short residence time and low bioavailability. When the eye drops are instilled into the eye, only 1%-10% of the drug reaches the eye to play a role due to the blinking of the eyelids and the secretion of tears, and it is necessary to increase the number of administrations to improve bioavailability or st...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/7036A61K9/08A61K47/34A61K47/10A61K47/26A61K47/36A61P27/02A61P27/06A61P27/12A61P31/00A61K31/661
CPCA61K9/0048A61K9/08A61K31/661A61K31/7036A61K47/10A61K47/26A61K47/34A61K47/36A61K2300/00
Inventor 罗雷张琪罗永煌
Owner SOUTHWEST UNIV
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