NGF and hydroxypropyl-beta-cyclodextrin inclusion compound ophthalmic gel and preparation method thereof

A technology of ophthalmic gel and cyclodextrin, which is applied in the direction of medical preparations with non-active ingredients, medical preparations containing active ingredients, and drug combinations, etc. It can solve the problems of poor patient compliance, inaccurate dosage, and crusting of eyelids, etc. problem, to achieve stable drug release, prolonged action time, and less irritating effects

Inactive Publication Date: 2016-07-27
XIAMEN EYE CENTER OF XIAMEN UNIVERSITY CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Eye ointment, longer residence time, but poor patient compliance due to inaccurate dosing, blurred vision and lid crusting, and usually only used at bedtime

Method used

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  • NGF and hydroxypropyl-beta-cyclodextrin inclusion compound ophthalmic gel and preparation method thereof
  • NGF and hydroxypropyl-beta-cyclodextrin inclusion compound ophthalmic gel and preparation method thereof
  • NGF and hydroxypropyl-beta-cyclodextrin inclusion compound ophthalmic gel and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] Each 1000g of NGF eye gel contains:

[0032]NGF 200mg, hydroxypropyl-β-cyclodextrin 400mg, carbomer 3g, mannitol 15g, 10% sodium hydroxide solution 10-50g, benzalkonium bromide 0.1g, distilled water to 1000g.

[0033] Take the prescribed amount of carbomer, add appropriate amount of distilled water to swell; in addition, dissolve the prescribed amount of NGF, hydroxypropyl-β-cyclodextrin, mannitol, benzalkonium bromide, etc. in distilled water, stir to dissolve, and pass through 0.3 μm micro After sterilizing and filtering with a pore filter membrane, add the filtrate to the carbomer matrix, adjust the pH to 6.5-8.5 with 10% sodium hydroxide solution, add distilled water to 1000 g, and stir to form a uniform gel. After irradiation and disinfection, samples are taken to measure the pH value and content, and after passing the test, aseptic filling is performed to obtain the product gel.

Embodiment 2

[0035] Each 1000g of NGF eye gel contains:

[0036] NGF 200mg, hydroxypropyl-β-cyclodextrin 500mg, methylcellulose 5g, mannitol 10g, 10% sodium hydroxide solution 10-50g, benzalkonium chloride 0.075g, distilled water to 1000g.

[0037] Take the prescribed amount of methylcellulose, add appropriate amount of distilled water, and swell; in addition, dissolve the prescribed amount of NGF, hydroxypropyl-β-cyclodextrin, mannitol, etc. in distilled water, stir to dissolve, pass through a 0.30μm microporous membrane After sterilization and filtration, add the filtrate to the methylcellulose matrix, adjust the pH to 7-8.5 with 10% sodium hydroxide solution, add distilled water to 1000 g, and stir to form a uniform gel. After irradiation and disinfection, samples are taken to measure the pH value and content, and after passing the test, aseptic filling is performed to obtain the product gel.

Embodiment 3

[0039] Each 1000g of NGF eye gel contains:

[0040] NGF400mg, hydroxypropyl-β-cyclodextrin 400mg, carbomer 3g, mannitol 15g, 10% sodium hydroxide solution 10-50g, benzalkonium bromide 0.1g, distilled water added to 1000g.

[0041] Take the prescribed amount of carbomer, add appropriate amount of distilled water to swell; in addition, dissolve the prescribed amount of NGF, hydroxypropyl-β-cyclodextrin, mannitol, benzalkonium bromide, etc. in distilled water, stir to dissolve, and pass through 0.3 μm micro After sterilizing and filtering with a pore filter membrane, add the filtrate to the carbomer matrix, adjust the pH to 6.5-8.5 with 10% sodium hydroxide solution, add distilled water to 1000 g, and stir to form a uniform gel. After irradiation and disinfection, samples are taken to measure the pH value and content, and after passing the test, aseptic filling is performed to obtain the product gel.

[0042] The stability and animal experiment results of the prepared NGF hydrox...

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Abstract

The invention discloses NGF and hydroxypropyl-beta-cyclodextrin inclusion compound ophthalmic gel and a preparation method thereof.The ophthalmic gel comprises NGF, hydroxypropyl-beta-cyclodextrin and an ophthalmic gel base material, wherein the content of NGF is 30-400 micrograms / ml, the content of hydroxypropyl-beta-cyclodextrin is 10-80 g / ml, and the remaining constituent is the ophthalmic gel base material.The preparation method comprises the steps of mixing NGF, hydroxypropyl-beta-cyclodextrin and the ophthalmic gel base material with water, and conducting stirring, so that gel is formed; adjusting the pH value to 6.5-8.5, adding sufficient water, adjusting the concentration of NGF to 30-400 micrograms / ml, and stirring the mixture to be uniform, so that the NGF and hydroxypropyl-beta-cyclodextrin ophthalmic gel is obtained.The ophthalmic gel has the advantages of being good in biocompatibility, good in medicine stability, low in irritation, high in medicine atrium permeability and the like.

Description

technical field [0001] The invention relates to an ophthalmic drug, in particular to an NGF hydroxypropyl-β-cyclodextrin inclusion complex ophthalmic gel and a preparation method thereof. Background technique [0002] NGF (NerveGrowth Factor, NGF) is the first neurotrophic factor to be discovered and the most thoroughly studied at present. It is a nerve cell growth regulator with dual biological functions of neuron nutrition and neurite growth. Development, differentiation, growth, regeneration, and expression of functional properties are all important regulators. At present, NGF can be extracted from tissues such as male mice, human placenta brain, human placenta and snake venom, and can also be prepared by genetic engineering. In the existing technology, NGF is the only biologically active molecule found so far that not only acts as a trophic factor on normal nerve cells of the central and peripheral nerves, but also regulates the repair function of damaged nerves. It ca...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K47/48A61K9/06A61K38/18A61P27/02A61P25/00
CPCA61K38/185A61K9/0048A61K9/06
Inventor 吴仁毅胡倩倩黄昌泉吕洁璇汪耀
Owner XIAMEN EYE CENTER OF XIAMEN UNIVERSITY CO LTD
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