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Rupatadine fumarate eye drops and preparation method thereof

A technology for rupatadine fumarate and eye drops, which is applied in pharmaceutical formulations, medical preparations containing active ingredients, drug delivery, etc., to achieve the effects of small systemic side effects, no toxic side effects, and simple preparation methods

Active Publication Date: 2010-12-29
HAICHANG CONTACT LENSES +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] So far, the research and application of rupatadine dosage forms mainly focus on oral and nasal drops, and rupatadine eye drops have not been marketed at home and abroad.

Method used

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  • Rupatadine fumarate eye drops and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] Rupatadine Fumarate 5.0g

[0034] Hypromellose 1.0g

[0035] Polyvinylpyrrolidone 4.0g

[0036] Sodium dihydrogen phosphate 0.39g

[0037] Disodium hydrogen phosphate 7.16g

[0038] Sodium chloride 2.55g

[0039] Benzalkonium chloride 0.05g

[0040] Polysorbate-80 0.04g

[0041] Water for injection to 1000mL

[0042] Preparation method A:

[0043] 1) Weigh the prescribed amount of thickener and disperse it with 1 / 4 to 1 / 3 of the total amount of water for injection, stir for 2-12 hours to make it fully swell, and obtain solution a for later use;

[0044] 2) Weigh the prescription amount of rupatadine fumarate, sodium dihydrogen phosphate, disodium hydrogen phosphate, sodium chloride and benzalkonium chloride respectively, add appropriate amount of water for injection to dissolve (heating and dissolving if necessary), and dissolve them Stir and mix to obtain solution b for later use, and the amount of water for injection is equivalent to 1 / 3 to 1 / 2 of the total am...

Embodiment 2

[0049] Rupatadine Fumarate 4.0g

[0050] Hypromellose 2.0g

[0051] Sodium dihydrogen phosphate 0.39g

[0052] Disodium hydrogen phosphate 7.16g

[0053] Sodium chloride 2.59g

[0054] Benzalkonium chloride 0.05g

[0055] Polysorbate-80 0.03g

[0056] Water for injection to 1000mL

Embodiment 3

[0058] Rupatadine Fumarate 3.0g

[0059] Hypromellose 2.0g

[0060] Sodium dihydrogen phosphate 0.39g

[0061] Disodium hydrogen phosphate 7.16g

[0062] Sodium chloride 2.63g

[0063] Benzalkonium Bromide 0.05g

[0064] Polysorbate-80 0.02g

[0065] Water for injection to 1000mL

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Abstract

The invention relates to rupatadine fumarate eye drops. The eye drops are prepared from rupatadine fumarate serving as a primary medicament, and a thickening agent, buffer salt, an isotonic agent, a bacteriostatic agent and a solubilizer serving as auxiliary materials. A preparation method A comprises the following steps of: dissolving the thickening agent by using a certain amount of water, and dissolving the primary medicament, the buffer salt, the isotonic agent, the bacteriostatic agent and the solubilizer by using a certain amount of water for injection; and mixing the two kinds of solution, and adding a proper amount of water for injection to reach the needed concentration. A preparation method B comprises the following steps of: stirring the thickening agent, the rupatadine fumarate, the buffer salt, the bacteriostatic agent, the isotonic agent, the solubilizer and the water for injection for a long time until the solution is clarified; and supplying the water for injection to fix the volume. The rupatadine fumarate eye drops have the advantages of simple preparation method and use for treating ocular surface allergic diseases, and have the characteristics of obvious curative effect, no irritation, no toxic or side effect, high stability and the like.

Description

technical field [0001] The invention relates to an eye drop and a preparation method thereof, in particular to a rupatadine fumarate eye drop and a preparation method thereof, and belongs to the technical field of medicine preparation. Background technique [0002] Rupatadine fumarate (Rupatadine fumarate), the chemical name is 8-chloro-6,11-dihydro-11-[1-[(5-methyl-3-pyridyl)methyl]-4-piper Pyridylidene]-5H-benzo[5,6]cyclohepta[1,2-b]pyridine fumarate is an antihistamine and antiplatelet activating factor (PAF) developed by Uriach Pharmaceutical Company of Spain A dual-action antiallergic drug indicated for seasonal and perennial allergic rhinitis. [0003] [0004] Studies have shown that allergic and inflammatory diseases are multifactorial and complex processes resulting from the production and release of many different mediators. Histamine is the most inflammatory mediator contained in the early stage of allergic reaction and when the symptoms of such diseases appe...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/4545A61P27/02A61P37/08
Inventor 邹志红王伟王其远高启合
Owner HAICHANG CONTACT LENSES
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