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Preservative-free multi-dose packaged anti-inflammatory eye drop and preparation method thereof

An eye drop and multi-dose technology, which is applied in the direction of medical preparations containing active ingredients, anti-inflammatory agents, and medical preparations with non-active ingredients, etc., can solve the problem of shortening the residence time of drugs, damaging eye health, and affecting Efficacy and other issues to achieve the effect of reducing the risk of drug contamination, avoiding bacterial invasion, and avoiding toxic and side effects

Active Publication Date: 2018-03-06
NKD PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At the same time, preservatives and stabilizers in eye drops can also cause eye irritation and damage eye health
If the eye drops are more irritating to the eyes, not only will tears flow, but also dilute the medicine, so that the medicine stays in the eyes for a shorter time, affecting the curative effect
However, if the drug stays in the eyes for too long, it will hinder the eyes and have adverse effects.
[0004] For preservative-free eye drops, single-dose packaging is usually used, but single-dose packaging requires a "blowing-filling-sealing" three-in-one equipment, which needs to be imported from abroad and is expensive
In addition, the single-dose package increases the number of packages, and it is discarded after one-time or one-day use, which will cause more medical waste

Method used

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  • Preservative-free multi-dose packaged anti-inflammatory eye drop and preparation method thereof
  • Preservative-free multi-dose packaged anti-inflammatory eye drop and preparation method thereof
  • Preservative-free multi-dose packaged anti-inflammatory eye drop and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] prescription

[0036]

[0037] Preparation:

[0038](1) accurately weigh gatifloxacin, sodium chloride, compound thickener in the above formula (the mass ratio of water-soluble polyethylene glycol succinimide succinate and trilysine acetate is 19:1), borax, add 300mL of water, stir to dissolve and mix evenly, adjust the pH of the solution to 6.3 with citric acid, and dilute to 1000mL with water for injection to obtain a drug solution;

[0039] (2) Filter the drug solution obtained in step 1 once through a 0.45 μm microporous membrane, and then once through a 0.22 μm microporous membrane;

[0040] (3) The liquid medicine obtained in step 2 is sterilized at 121° C. for 15 minutes by autoclaving, and then cooled;

[0041] (4) After testing the medicinal solution obtained in step 3, after passing the test, fill the medicinal solution into an eye drop bottle with a bacterial filtration device, 10 mL per bottle, and then seal it to obtain the finished product.

Embodiment 2

[0043] prescription

[0044]

[0045]

[0046] Preparation:

[0047] (1) Accurately weigh dexamethasone sodium phosphate, compound thickener (water-soluble polyethylene glycol succinimide succinate and trilysine acetate in a mass ratio of 10:1) in the above formula ), borax, mannitol, add 300mL of water, stir to dissolve and mix evenly, adjust the pH of the solution to 5.0 with hydrochloric acid, and set the volume to 1000mL with water for injection to obtain a drug solution;

[0048] (2) Filter the drug solution obtained in step 1 once through a 0.45 μm microporous membrane, and then once through a 0.22 μm microporous membrane;

[0049] (3) The liquid medicine obtained in step 2 is sterilized at 121° C. for 25 minutes by autoclaving, and then cooled;

[0050] (4) After testing the medicinal solution obtained in step 3, after passing the test, fill the medicinal solution into an eye drop bottle with a bacterial filtration device, 10 mL per bottle, and then seal it to o...

Embodiment 3

[0052] prescription

[0053]

[0054]

[0055] Preparation:

[0056] (1) Accurately weigh moxifloxacin hydrochloride, compound thickener (the mass ratio of water-soluble polyethylene glycol succinimide succinate and trilysine acetate is 40:1), glycerin, borax , add 300mL of water, stir to dissolve and mix evenly, adjust the pH of the solution to 9.0 with acetic acid, and then dilute to 1000mL with water for injection to obtain a drug solution;

[0057] (2) Filter the drug solution obtained in step 1 once through a 0.45 μm microporous membrane, and then once through a 0.22 μm microporous membrane;

[0058] (3) The liquid medicine obtained in step 2 is sterilized at 121° C. for 45 minutes by autoclaving, and then cooled;

[0059] (4) After testing the medicinal solution obtained in step 3, after passing the test, fill the medicinal solution into an eye drop bottle with a bacterial filtration device, 10 mL per bottle, and then seal it to obtain the finished product.

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Abstract

The invention relates to an eye drop and particularly relates to a preservative-free multi-dose packaged anti-inflammatory eye drop. A formula of the eye drop contains an anti-inflammatory drug, a compound thickening agent, an isoosmotic adjusting agent and a pH adjuster. By utilizing the compound thickening agent, the retention time of the drug on a cornea surface layer can be prolonged, so thatthe dose of the anti-inflammatory drug is reduced, and meanwhile, the anti-inflammatory effect of the eye drop is improved. The invention further provides a preparation method of the eye drop. The anti-inflammatory eye drop does not contain a preservative or a stabilizer, so that the stimulation of the eye drop to eyes is greatly reduced; by carrying out multi-dose packaging through an Aptar device bottle, the invasion of bacteria is avoided, the pollution risk of the drug is reduced, the service life of the multi-dose eye drop is prolonged, the wasting of the drug is avoided, and the productis relatively safe and reliable.

Description

technical field [0001] The invention relates to an eye drop, in particular to a preservative-free multi-dose packaged anti-inflammatory eye drop and a preparation method thereof. technical background [0002] In recent years, due to environmental pollution, working environment, eye hygiene and other factors, the number of eye disease patients with symptoms of dry eye or chronic conjunctivitis is increasing. Anti-inflammatory eye drops, as the most commonly used ophthalmic preparation, are simple and convenient to use, and have become a necessity for many people to relieve eye inflammation and other discomfort symptoms. At present, anti-inflammatory eye drops are mostly packaged in multi-dose for multiple use, and are used repeatedly. Once the preparation is opened, it is easy to be contaminated by tears and microorganisms in the air during use and storage, thereby causing potential safety hazards. In order to prevent ophthalmic preparations from being contaminated by micro...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K47/18A61K47/22A61K45/00A61K31/496A61K31/661A61K31/4709A61P29/00A61P27/02
CPCA61K9/0048A61K9/08A61K31/4709A61K31/496A61K31/661A61K45/00A61K47/183A61K47/22
Inventor 张志兵陶秀梅陈鹏尚丽霞
Owner NKD PHARMA CO LTD
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