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Azithromycin eye drops and preparation method thereof

A technology of azithromycin and eye drops, applied in pharmaceutical formulations, medical preparations containing active ingredients, organic active ingredients, etc., can solve problems such as aging, and achieve the effects of low toxicity, long treatment time, and few systemic side effects

Inactive Publication Date: 2014-09-24
SHANGHAI MODERN PHARMA ENG INVESTIGATION CENT
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, using temperature-sensitive materials as ophthalmic gel bases may present aging issues during transportation and storage

Method used

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  • Azithromycin eye drops and preparation method thereof
  • Azithromycin eye drops and preparation method thereof
  • Azithromycin eye drops and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] formula:

[0042]

[0043] Preparation Process:

[0044] Weigh citric acid according to the prescription amount, add water for injection to dissolve, the weight dosage of water for injection is 20% of the total weight of water for injection, then add the prescription amount of azithromycin to make it completely dissolved, then add poloxamer 407, at 4 ℃ Let it swell completely and set aside;

[0045] Take the deacetylated gellan gum, mannitol and benzalkonium chloride of the prescribed amount, add water for injection to dissolve, the weight dosage of water for injection is 70% of the total weight of water for injection, keep warm at 40°C, and set aside;

[0046] Combine them, adjust the pH to 6 with 1 mol / L trishydroxymethylaminomethane, supplement the remaining amount of water for injection, stir evenly, filter through a 0.22 μm microporous membrane, and pack in separate packages to obtain the product.

Embodiment 2

[0048]

[0049] Preparation Process:

[0050] Weigh citric acid according to the prescription amount, add water for injection to dissolve, the weight dosage of water for injection is 30% of the total weight of water for injection, then add the prescription amount of azithromycin to make it completely dissolved, then add poloxamer 407, at 4 ℃ Let it swell completely and set aside;

[0051] Take the deacetylated gellan gum, mannitol and benzalkonium bromide of the prescription, add water for injection to dissolve, the weight dosage of water for injection is 60% of the total weight of water for injection, keep warm at 40°C, and set aside;

[0052] Combine them, adjust the pH to 6.5 with 1 mol / L trishydroxymethylaminomethane, add the remaining amount of water for injection, stir evenly, filter through a 0.22 μm microporous membrane, and pack in separate packages to obtain the product.

Embodiment 3

[0054]

[0055]

[0056] Preparation Process:

[0057] Weigh citric acid according to the prescription amount, add water for injection to dissolve, the weight dosage of water for injection is 20% of the total weight of water for injection, then add the prescription amount of azithromycin to make it completely dissolved, then add poloxamer 407, at 4 ℃ Let it swell completely and set aside;

[0058] Take the deacetylated gellan gum, mannitol and benzalkonium chloride of the prescribed amount, add water for injection to dissolve, the weight dosage of water for injection is 70% of the total weight of water for injection, keep warm at 40°C, and set aside;

[0059] Combine them, adjust the pH to 5.5 with 1 mol / L trishydroxymethylaminomethane, add the remaining amount of water for injection, stir evenly, filter through a 0.22 μm microporous membrane, and pack in separate packages to obtain the product.

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Abstract

The invention discloses azithromycin eye drops and a preparation method thereof, the azithromycin eye drops comprise the following components by weight: 0.5-2.0% of azithromycin or azithromycin salt, 0-1.5% of cosolvent, 0.2-10% of poloxamer 407, 0.1-1.5% of deacetylated gellan gum, 0.1-9% of osmotic pressure regulator, 0.001-2% of antiseptic; pH value is adjusted to 5.5-7.5 by a pH conditioning agent, and injection water is the balance. The azithromycin eye drops contain ion sensitive and temperature sensitive gel matrix, and has dual gelling characteristic, compared with usage of a single matrix, the azithromycin eye drops have better characteristic, preparation technology is reasonable, stability of the azithromycin eye drops can be guaranteed, metering is easily and accurately controlled, little loss can be avoided, the therapeutic time of the medicine can be maintained for a longer time, the side effect is less, the azithromycin eye drops have good biocompatibility without influence of eyesight, and the survivability of the patients is good.

Description

technical field [0001] The invention relates to eye drops and a preparation method thereof, in particular to azithromycin eye drops and a preparation method thereof. Background technique [0002] Azithromycin (Azithromycin, C 38 h 72 N 2 o 12 , molecular weight 748.99) is a new generation of macrolide antibiotics, which is relatively mature in clinical application at present. Compared with the parent raw material erythromycin, it is more stable to acids, has a broad antibacterial spectrum, long half-life, and is convenient to take. Much lower than erythromycin, less adverse reactions. [0003] The mechanism of the antibacterial effect of azithromycin is to interfere with the synthesis of proteins by binding to the 50S ribosomal subunit of sensitive microorganisms. Azithromycin has a broad antibacterial spectrum and can inhibit a variety of Gram-positive bacteria, mycoplasma, chlamydia, spirochaete and rickettsia, etc. [0004] There are a variety of microorganisms in t...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/7052A61K47/34A61P31/04A61P27/02A61K47/10
Inventor 陈中亚陶涛赵雁印玺璟高大林谢双李丹丹柴旭煜王威
Owner SHANGHAI MODERN PHARMA ENG INVESTIGATION CENT
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