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Ophthalmic preparation of levofloxacin and prednisolone acetate and preparation method thereof

A technology of prednisolone acetate and levofloxacin is applied in the field of medicinal compositions for the treatment or prevention of bacterial keratitis, and in the field of ophthalmic preparations containing the active components levofloxacin and prednisolone acetate, which can solve the problem of difficult application of clinical and pharmaceutical products. Problems such as irritating gritty feeling

Active Publication Date: 2011-06-08
SHENYANG XINGQI PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] However, in the research on the ophthalmic combination preparation of levofloxacin and prednisolone acetate, it was found that the irritation of the drug, especially the gritty feeling, was strong and it was difficult to apply to clinical practice.

Method used

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  • Ophthalmic preparation of levofloxacin and prednisolone acetate and preparation method thereof
  • Ophthalmic preparation of levofloxacin and prednisolone acetate and preparation method thereof
  • Ophthalmic preparation of levofloxacin and prednisolone acetate and preparation method thereof

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Experimental program
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Effect test

Embodiment 1

[0096] The ophthalmic preparation of the present invention is prepared according to the following prescription ratio.

[0097] Levofloxacin 15g

[0098] Prednisolone Acetate 10g

[0099] Polysorbate 80 1.0g

[0100] Citric acid 5g

[0101] Edetate Disodium 0.1g

[0102] Hydroxypropyl Methyl Cellulose 5g

[0103] Glycerin 22g

[0104] Appropriate amount of sodium hydroxide

[0105] Add water for injection to 1000ml

[0106] Preparation method: (1) Take the prescribed amount of prednisolone acetate micropowder, put it in a clean glass plate, sterilize at 160°C for 3.5 hours, and set aside. (2) Swell the prescribed amount of hydroxypropyl methylcellulose with an appropriate amount of water for injection, overnight, and set aside; (3) Take about 600ml of water for injection at 50-60°C, and dissolve the prescribed amount of citric acid, levofloxacin, and editidine in turn. Add disodium nitrate and glycerin to the prepared hydroxypropyl methylcellulose solution, add water fo...

Embodiment 2

[0108] The ophthalmic preparation of the present invention is prepared according to the following prescription ratio.

[0109] Levofloxacin 15g

[0110] Prednisolone Acetate 10g

[0111] Polysorbate 80 1.0g

[0112] Citric acid 10g

[0113] Edetate Disodium 0.1g

[0114] Hydroxypropyl Methyl Cellulose 40g

[0115] Glycerin 22g

[0116] Appropriate amount of sodium hydroxide

[0117] Add water for injection to 1000ml

[0118] Preparation method: (1) Take the prescribed amount of prednisolone acetate micropowder, put it in a clean glass plate, sterilize at 160°C for 3.5 hours, and set aside. (2) Swell the prescribed amount of hydroxypropyl methylcellulose with an appropriate amount of water for injection, overnight, sterilize by autoclaving at 121°C for 30 minutes, pass through a 400-mesh sieve, and set aside; (3) Take about 400ml of water for injection at 50-60°C , dissolve the prescribed amount of citric acid, levofloxacin, edetate disodium, and glycerol in turn, adjus...

Embodiment 3

[0120] Prepare ophthalmic preparations according to the following prescription ratio.

[0121] Levofloxacin 10g

[0122] Prednisolone Acetate 10g

[0123] Polyoxyl 40 Hydrogenated Castor Oil 5g

[0124] Hydrochloric acid amount

[0125] Carbomer 5g

[0126] Edetate Disodium 0.1g

[0127] Glycerin 22g

[0128] Appropriate amount of sodium hydroxide

[0129] Add water for injection to 1000ml

[0130] Preparation method: (1) Take the prescribed amount of prednisolone acetate micropowder, put it in a clean glass plate, sterilize at 160°C for 3.5 hours, and set aside. (2) Swell the prescribed amount of carbomer with an appropriate amount of water for injection, leave overnight, and set aside. (3) Take levofloxacin, add about 600ml of water for injection at 50-60°C, add an appropriate amount of 1mol / L hydrochloric acid to dissolve; add the prescribed amount of edetate disodium and glycerin to dissolve, and filter at 0.22μm. (4) Grind prednisolone acetate and polysorbate 80 ...

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Abstract

The invention relates to an ophthalmic preparation of levofloxacin and prednisolone acetate and a preparation method thereof. Particularly, the invention relates to an ophthalmic preparation containing levofloxacin and prednisolone acetate with an effective amount for treatment and / or prevention, a high polymer material, a surfactant, a complexing agent and water. The invention also relates to anophthalmic preparation containing the ophthalmic preparation provided by the invention and a medicinal excipient mixed with the ophthalmic preparation provided by the invention before application, and a preparation method of the ophthalmic preparation. The ophthalmic preparation provided by the invention not only has a favorable effect of treating eye diseases, but also has very low stimulation to the eyes.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and relates to a pharmaceutical composition for treating or preventing bacterial keratitis, in particular to an ophthalmic preparation containing active ingredients levofloxacin and prednisolone acetate. Background technique [0002] Bacterial keratitis is a suppurative keratitis caused by bacterial infection, corneal epithelial defect and corneal stroma necrosis under the defect area, also known as bacterial corneal ulcer. Bacterial keratitis is a global eye disease that causes visual impairment. It is the first cause of corneal blindness in developing countries. Its condition is often critical. If it is not treated effectively, corneal ulcer perforation or even intraocular infection may occur. Eventually the eyeball shrinks. Even if it can be controlled by drugs, there will be extensive corneal scarring, corneal neovascularization or corneal staphyloma and corneal lipid degeneration ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/573A61K31/5383A61K47/30A61K47/38A61K47/32A61K47/34A61P27/02A61P31/04A61K47/10
Inventor 刘继东唐海杨宇春高坤
Owner SHENYANG XINGQI PHARM CO LTD
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