Ophthalmic composition as well as preparation method and application thereof

An ophthalmic composition and ocular technology, applied in the field of medicine, can solve the problems of prolonging the recovery time of patients, hyperemia, and many adverse reactions, and achieve the effects of increasing drug compliance, shortening recovery time, and improving therapeutic effects

Pending Publication Date: 2022-03-01
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

[0003] The existing pranoprofen eye drops have many adverse reactions after medication, mainly as: strong irritation, conjunctival hyperemia, etc., thereby affecting the compliance of patients with medication and prolonging 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

[0037] Add water for injection to prepare a total amount of 70wt% in the preparation tank, and start stirring. At a temperature of 70°C, after adding the pranoprofen, olopatadine and naphazoline of the prescription amount in the preparation tank to stir and dissolve evenly, add the osmotic pressure regulator (potassium chloride) of the prescription amount in the preparation tank ), pH regulator (boric acid), metal ion chelating agent (dicalcium edetate), thickener (polyvinylpyrrolidone) and preservative (benzalkonium chloride), stir and dissolve evenly, then add water for injection to set Fill to the full amount, then filter through a 0.22 μm filter membrane, and fill to prepare an ophthalmic composition with the following composition based on the total mass of the ophthalmic composition:

[0038]

[0039]

[0040] The mass ratio of pranoprofen, olopatadine and naphazoline is 1:1.25:0.25.

Embodiment 2

[0042] The preparation method of the ophthalmic composition of the present embodiment is the same as that of Example 1, the difference is that naphazoline is not added, and the ophthalmic composition of the following composition is obtained in terms of the total mass of the ophthalmic composition:

[0043]

[0044] The mass ratio of pranoprofen to olopatadine is 1:1.5.

Embodiment 3

[0046] The preparation method of the ophthalmic composition of this embodiment is the same as that of Example 1, except that, without adding olopatadine, an ophthalmic composition with the following composition based on the total mass of the ophthalmic composition is prepared:

[0047]

[0048]

[0049] The mass ratio of pranoprofen to naphazoline is 1:1.

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PUM

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Abstract

The present invention relates to an ophthalmic composition comprising pranoprofen and olopatadine and/or naphazoline. The invention also relates to a preparation method of the ophthalmic composition, which comprises the following steps: mixing the pranoprofen, the olopatadine and/or the naphazoline, the osmotic pressure regulator, the pH regulator, the metal ion chelating agent, the thickening agent, the preservative 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 external eye and/or anterior segment inflammation caused by gram-positive bacterium and/or gram-negative bacterium infection. When the ophthalmic composition provided by the invention is used as eye drops, the treatment effect on eye inflammation of a patient can be improved, and adverse effects of eye stimulation, conjunctival congestion, edema and the like after medication can be avoided, so that the medication 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] Pranoprofen (Pranoprofen) eye drops is an eye drop of the propionic acid non-steroidal anti-inflammatory drug Pranoprofen, and its mechanism of action is to reduce the biological activity of prostaglandins by inhibiting the activity of cyclooxygenase (COX) in the body. Synthetic, used for symptomatic treatment of outer eye and anterior segment inflammation (blepharitis, conjunctivitis, keratitis, scleritis, superficial scleritis, iridocyclitis, postoperative inflammation, etc.). [0003] Existing pranoprofen eye drops have many adverse reactions after medication, mainly as: strong irritation, conjunctival hyperemia, etc., thereby affecting the compliance of patients with medication and prolonging the recovery time of patients. [0004] In order to reduce adverse react...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/436A61K31/335A61K31/4174A61K9/08A61P27/02A61P31/04A61P29/00A61P7/10
CPCA61K31/436A61K31/335A61K31/4174A61K9/0048A61K9/08A61K47/38A61P27/02A61P31/04A61P29/00A61P7/10A61K2300/00
Inventor 尹传忠付欢郭欢张晓男胡雨薇胡梦琳王超
Owner 湖北远大天天明制药有限公司
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