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Brimonidine tartrate in situ forming eye gel

A technology of brimonidine tartrate and brimonidine ophthalmic technology is applied in the field of brimonidine tartrate ophthalmic ready-to-use gel, and can solve the problem of limiting the curative effect of brimonidine tartrate ophthalmic solution to be widely used, the retention time is short, and the The problem of large loss of eye drops, etc., achieves the effect of enriching the drug dosage form, prolonging the residence time, and having no adverse irritant reactions.

Inactive Publication Date: 2009-01-28
肖正连
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Brimonidine tartrate eye drops is a commonly used ophthalmic preparation, but clinically there is a large loss of eye drops instilled into the eye and a short residence time. These problems limit the curative effect of brimonidine tartrate eye drops and more widely used

Method used

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  • Brimonidine tartrate in situ forming eye gel
  • Brimonidine tartrate in situ forming eye gel
  • Brimonidine tartrate in situ forming eye gel

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] Prescription: 1 gram of brimonidine tartrate, 400 milliliters of hydrochloric acid (0.05mol / L)

[0024] Sodium Citrate 8.7g Methylcellulose 5.0g Phenylethyl Alcohol 0.5g

[0025] Ethanol 5ml Sodium Chloride 1.0g PEG-1000 20g

[0026] PEG-400 5g water for injection appropriate amount

[0027] Preparation method: Heat water for injection to boil, cool to 80°C, add brimonidine tartrate, dissolve phenylethyl alcohol in ethanol, add dropwise to the above solution while stirring, add sodium citrate, stir for more than 30 minutes, then add Stir after hydrochloric acid, filter through a microporous membrane (0.22 μm), heat the filtrate to 40°C, add sodium chloride, methylcellulose, PEG-1000 and PEG-400 while hot, and stir to room temperature (18-25 ℃), add water for injection to make up the weight to 1000 milliliters, stir to make it form a uniform gel, and aseptically pack it.

Embodiment 2

[0029] Prescription: 1.2 grams of brimonidine tartrate, 200 milliliters of sulfuric acid (0.05mol / L)

[0030] Sodium Citrate 8.7g Methylcellulose 5.0g Benzyl Alcohol 0.5g

[0031] Ethanol 5ml Sodium Chloride 2.0g PEG-1000 70g

[0032] Appropriate amount of water for injection

[0033] Preparation method: heat water for injection to boil, cool to 80°C, add brimonidine tartrate, dissolve benzyl alcohol in ethanol, add dropwise to the above solution while stirring, add sodium citrate, stir for more than 30 minutes, then add Stir after sulfuric acid, filter through a microporous membrane (0.22μm), heat the filtrate to 40°C, add sodium chloride, methylcellulose and PEG-1000 while hot, stir to room temperature (18-25°C), and then Add water for injection to make up the weight to 1000 ml, stir to make it form a uniform gel, and aseptically pack it.

Embodiment 3

[0035] Prescription: 1.3 grams of brimonidine tartrate, 200 milliliters of sodium hydroxide (0.1mol / L)

[0036] Boric acid 5.6g Methylcellulose 5.0g Sodium benzoate 0.5g

[0037] Ethanol 5ml Sodium Chloride 5.0g PEG-4000 100g

[0038] Appropriate amount of water for injection

[0039] Preparation method: Heat water for injection to boil, cool to 80°C, add brimonidine tartrate, add sodium citrate, sodium hydroxide and sodium benzoate, stir for more than 30 minutes, then add boric acid and stir, pass through a microporous membrane (0.22μm) filtered, the filtrate was heated to 40°C, PEG-4000 and methylcellulose were added while it was hot, stirred to room temperature (18-25°C), added water for injection to make up the weight to 1000 ml, stirred to form Uniform gel, aseptically dispensed.

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Abstract

The invention discloses a brimonidine tartrate eye drops ophthalmic gel and a preparation method thereof; every 1000ml of brimonidine tartrate eye drops ophthalmic gel contains 1-4g of brimonidine tartrate eye drops, 0.05g of preservative, 1.0-7.5g of osmoregulation agent, 30-150g of gel stroma, and rest amount of acid-base buffering agent and water used for injection. Due to the optimization and technique improvement of the auxiliary materials, the medicine dosage forms of the brimonidine tartrate eye drops are enriched, detention time of the medicine in the eyes are greatly prolonged, the healing effect is improved, and no pessimal stimulation response exists.

Description

【Technical field】 [0001] The invention belongs to the technical field of traditional Chinese medicines, in particular to a brimonidine tartrate ophthalmic instant gel. 【Background technique】 [0002] Ophthalmic instant gel is also called ophthalmic in-situ gel or ophthalmic in-situ gel. Its preparation is liquid when placed at room temperature. Gel-like, it can stay in the eye for a long time, so as to prolong the treatment time, enhance the treatment effect and reduce the loss of medicine. [0003] Instant ophthalmic gel is not yet a very mature pharmaceutical preparation, and instant ophthalmic gel, which depends on the principles of temperature, pH value and ionic strength, is not yet mature in commercialization, because the dosage form is not only It requires fine technology, appropriate excipients, and the proper matching of drugs, processes and excipients in ophthalmic ready-to-use gels. Otherwise, it cannot be placed in a liquid state at room temperature, and it will...

Claims

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Application Information

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IPC IPC(8): A61K31/498A61K9/00A61K47/32A61K47/34A61K47/38A61P27/06A61K47/10
Inventor 肖正连
Owner 肖正连
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