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Emedastine fumarate aqueous pharmaceutical composition and preparation method thereof

A water-based and composition-based technology of mestin, which is applied in the direction of drug combination, drug delivery, and pharmaceutical formulations, can solve problems such as inapplicability, and achieve the effects of less preservative consumption, good long-term stability, and improved antibacterial efficacy

Active Publication Date: 2021-03-12
山东绅联药业股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This medicine should not be used to treat eye irritation caused by contact lenses

Method used

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  • Emedastine fumarate aqueous pharmaceutical composition and preparation method thereof
  • Emedastine fumarate aqueous pharmaceutical composition and preparation method thereof
  • Emedastine fumarate aqueous pharmaceutical composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Contains the following components:

[0027] Emedastine fumarate 0.1768 w / v%, edetate disodium 0.1 w / v%, sodium chloride 0.5 w / v%, polyhexamethylene biguanide 0.0001 w / v%, sodium hydroxide pH adjustment To 7.45, add water for injection to 100% volume;

[0028] Prepare emedastine fumarate eye drops according to the above ratio, comprising the following specific steps:

[0029] ① First add disodium edetate, stir to dissolve, then add polyhexamethylene biguanide, and keep stirring;

[0030] ② Add sodium chloride to the above solution and stir until dissolved;

[0031] ③ Add emedastine fumarate and continue to stir until it dissolves completely;

[0032] ④ Add sodium hydroxide dropwise to adjust the pH of the above solution to 7.45, and then add enough water for injection.

[0033] ⑤ Autoclaving after subpackaging.

Embodiment 2

[0035] Contains the following components:

[0036] Emedastine fumarate 0.1768 w / v%, edetate disodium 0.1 w / v%, sodium chloride 0.5 w / v%, polyhexamethylene biguanide 0.0002 w / v%, sodium hydroxide pH adjustment To 7.45, add water for injection to 100% volume;

[0037] The preparation method is the same as in Example 1.

Embodiment 3

[0039] Contains the following components:

[0040] Emedastine fumarate 0.1768 w / v%, edetate disodium 0.1 w / v%, sodium chloride 0.55 w / v%, polyhexamethylene biguanide 0.0001 w / v%, sodium hydroxide pH adjustment To 7.45, add water for injection to 100% volume;

[0041] The preparation method is the same as in Example 1.

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PUM

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Abstract

The invention relates to the technical field of ophthalmic medicine, in particular to an emedastine fumarate aqueous pharmaceutical composition and a preparation method thereof. Comprising the following components by weight fraction: Emedastine fumarate 15-18, osmotic pressure regulator 50-55, thickener 50-55, pH regulator 8-11, preservative 0.01-0.02; the above components The pH is 7.0 to 7.8 and the osmolarity is 250 to 290 mOsmol / kg. The present invention effectively solves the problem of compatibility between benzalkonium chloride and plastic bottles in the existing emedastine fumarate eye drops, and the related substances are obviously better than the existing emedastine fumarate eye drops, The long-term stability is better; and the amount of preservatives is less, more environmentally friendly, and low consumption; it also increases the number of contact lens patients and increases drug compliance.

Description

[0001] (1) Technical field [0002] The invention relates to the technical field of ophthalmic medicine, in particular to an emedastine fumarate aqueous pharmaceutical composition and a preparation method thereof. [0003] (2) Background technology [0004] The original product name of Emedastine Fumarate Eye Drops is EMADINE®, which is an ophthalmic drug developed by Alcon for the relief of allergic conjunctivitis. The bacteriostatic agent used in EMADINE® is 0.01% benzalkonium chloride. Benzalkonium chloride belongs to quaternary ammonium surfactant. Bacillus and bacterial spores are not effective. [0005] Benzalkonium chloride can cause allergic conjunctivitis, vision loss, contact dermatitis, etc. Patients with glaucoma, dry eye, infections and iritis who use eye drops containing benzalkonium chloride too often and for too long can cause damage. They have a higher incidence of endothelial injury, epithelial edema, and bullous keratopathy, and the severity of these disor...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/08A61K47/38A61K31/551A61K47/34A61P37/08A61P27/02
CPCA61K9/0048A61K9/08A61K31/551A61K47/34A61K47/38
Inventor 颜东高云兵张曼红刘建洋甄爱华
Owner 山东绅联药业股份有限公司