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Ophthalmic composition as well as preparation method and application thereof

An ophthalmic composition and ocular technology, applied in the field of medicine, can solve problems such as conjunctival hyperemia and edema, affect patients' medication compliance, and prolong patients' recovery time, so as to increase medication compliance, reduce eye irritation, improve The effect of the treatment effect

Pending Publication Date: 2022-03-04
湖北远大天天明制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The existing moxifloxacin eye drops are prone to adverse reactions such as conjunctival hyperemia, edema, and eye irritation after medication, which affects the compliance of patients with medication and prolongs the recovery time of patients

Method used

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  • Ophthalmic composition as well as preparation method and application thereof
  • Ophthalmic composition as well as preparation method and application thereof
  • Ophthalmic composition as well as preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] Add and prepare a total amount of 50wt% water for injection into the preparation tank, and start stirring. At a temperature of 70°C, add moxifloxacin, menthol, N-succinyl carboxymethyl chitosan, and surfactant (polysorbate 80) into the preparation tank and stir to dissolve evenly, then pour into the preparation tank Add prescription amount of osmotic pressure regulator (sodium chloride), pH regulator (boric acid), metal ion chelating agent (ethylenediaminetetraacetic acid disodium) and preservative (benzalkonium chloride), stir and dissolve evenly, and then Add water for injection to make up to full volume, then filter through a 0.22 μm filter membrane, fill it, and prepare an ophthalmic composition with the following composition based on the total mass of the ophthalmic composition:

[0037]

[0038]

[0039] The mass ratio of moxifloxacin, menthol, and N-succinylcarboxymethyl chitosan is 1:0.6:0.04.

Embodiment 2

[0041] The preparation method of the ophthalmic composition of the present embodiment is the same as that of Example 1, except that N-succinylcarboxymethyl chitosan is not added, the osmotic pressure regulator is potassium chloride, and the pH regulator is dihydrogen phosphate Sodium, the metal ion chelating agent are dicalcium edetate, the surfactant is tyloxapol and the preservative is benzalkonium bromide, and the ophthalmic composition of the following composition is obtained in terms of the total mass of the ophthalmic composition:

[0042]

[0043] The mass ratio of moxifloxacin to menthol is 1:0.58.

Embodiment 3

[0045] The preparation method of the ophthalmic composition of the present embodiment is the same as that of Example 1, except that menthol is not added, the osmotic pressure regulator is glycerin, the metal ion chelating agent is citric acid, the surfactant is polyethylene glycol and antiseptic The agent is methylparaben, and the ophthalmic composition of the following composition is obtained in terms of the total mass of the ophthalmic composition:

[0046]

[0047] The mass ratio of moxifloxacin to N-succinylcarboxymethyl chitosan is 1:0.025.

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Abstract

The invention relates to an ophthalmic composition. The ophthalmic composition comprises moxifloxacin and menthol and / or N-succinyl carboxymethyl chitosan. The invention also relates to a preparation method of the ophthalmic composition, which comprises the following steps: mixing the moxifloxacin, the menthol and / or the N-succinyl carboxymethyl chitosan, the osmotic pressure regulator, the pH regulator, the metal ion chelating agent, the surfactant and the water for injection to obtain the ophthalmic composition. The invention also relates to an application of the ophthalmic composition in preparation of a medicine for treating ocular inflammation, and the ocular inflammation comprises bacterial conjunctivitis caused by gram-positive bacterium and / or gram-negative bacterium infection. As eye drops, the ophthalmic composition provided by the invention not only can improve the treatment effect on bacterial conjunctivitis of a patient, but also can avoid adverse effects such as eye stimulation, conjunctival congestion and edema after administration, so that the administration compliance of the patient is improved, and the recovery time of the patient is shortened.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to an ophthalmic composition and its preparation method and application. Background technique [0002] Moxifloxacin is the fourth generation of fluoroquinolone antibiotics. Its original manufacturer is Bayer in Germany. Its antibiotics are wider than the previous three generations of quinolones. Moxifloxacin eye drops are currently used to treat Gram-positive bacteria (such as: Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus viridans, etc.), Gram-negative bacteria (such as: Haemophilus influenzae, Jones Bacterial conjunctivitis caused by Actinobacillus, etc.) and Chlamydia trachomatis. The existing moxifloxacin eye drops are prone to adverse reactions such as conjunctival hyperemia, edema, and eye irritation after medication, thereby affecting the compliance of patients with medication and prolonging the recovery time of patients. [0003] In order to r...

Claims

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Application Information

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IPC IPC(8): A61K31/722A61K9/08A61P27/02A61P29/00A61P31/02A61P31/04A61K31/045A61K31/4709
CPCA61K31/4709A61K31/045A61K31/722A61K9/0048A61K9/08A61K47/26A61P27/02A61P29/00A61P31/04A61P31/02A61K2300/00
Inventor 付欢王超尹传忠张晓男徐玉梅郭欢陈足智
Owner 湖北远大天天明制药有限公司
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