Phacolysin eye in-situ gel

A facolin and gel technology, applied in the field of facolin ophthalmic ready-to-use gel, can solve the problems of expensive pharmaceutical excipients, complicated implementation process, etc. Effect

Inactive Publication Date: 2009-01-07
肖正连
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the patent uses poloxamer 407 and 188, which are very expensive pharmaceutical excipients, and the implementation process of the invention is also relatively complicated, so further research and development of a new ophthalmic instant gel process is required

Method used

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  • Phacolysin eye in-situ gel
  • Phacolysin eye in-situ gel
  • Phacolysin eye in-situ gel

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] Prescription: Facolin 50mg Hydrochloric acid (0.05mol / L) 400ml

[0023] Sodium citrate 7.5 g Methyl cellulose 5.0 g Phenyl alcohol 0.5 g

[0024] Ethanol 5ml Sodium chloride 2.5g PEG-1000 20g

[0025] PEG-400 5g water for injection appropriate amount

[0026] Preparation method: Heat the water for injection to a boil, cool to 80°C, add facolin, dissolve phenethyl alcohol in ethanol, add dropwise to the above solution while stirring, and add sodium citrate, stir for more than 30 minutes, then add hydrochloric acid Stir, filter through a microporous membrane (0.22μm), and then heat the filtrate to 40℃, add sodium chloride, methylcellulose, PEG-1000 and PEG-400 while it is hot, and stir to room temperature (18-25℃) , Then add water for injection to make up the weight to 1000 ml, stir to form a uniform gel, and get it aseptically.

Embodiment 2

[0028] Prescription: facolin 100 mg sulfuric acid (0.05 mol / L) 200 ml

[0029] Sodium citrate 7.5 g methyl cellulose 5.0 g benzyl alcohol 0.5 g

[0030] Ethanol 5ml Sodium chloride 1.0g PEG-1000 70g

[0031] Water for injection

[0032] Preparation method: Heat the water for injection to a boil, cool to 80°C, add facolin, benzyl alcohol dissolved in ethanol, add dropwise to the above solution while stirring, and add sodium citrate, stir for more than 30 minutes, and then add sulfuric acid Stir, filter through a microporous membrane (0.22μm), heat the filtrate to 40°C, add sodium chloride, methylcellulose and PEG-1000 while it is hot, stir to room temperature (18-25°C), and then add injection Make up the weight to 1000 ml with water, stir to form a uniform gel, and then aseptically pack it.

Embodiment 3

[0034] Prescription: facolin 150 mg sodium hydroxide (0.1 mol / L) 200 ml

[0035] Boric acid 5.6 g Methyl cellulose 5.0 g Sodium benzoate 0.5 g

[0036] Ethanol 5ml Sodium chloride 3.0g PEG-4000 100g

[0037] Water for injection

[0038] Preparation method: Heat the water for injection to a boil, cool to 80℃, add Facorin, add sodium citrate, sodium hydroxide and sodium benzoate, stir for more than 30 minutes, add boric acid and stir, pass through a microporous membrane (0.22 μm) filter, and then heat the filtrate to 40°C, add PEG-4000 and methyl cellulose while it is hot, stir to room temperature (18-25°C), add water for injection to make up the weight to 1000 ml, stir to form a uniform The gel can be obtained aseptically.

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Abstract

The invention discloses a phacoline eye gel and a preparation method thereof. The phacoline eye gel contains the following components (per 1,000 mL) phacoline 50-150 mg, antiseptic 0.05-1 g, osmotic pressure regulator 1.0-7.5 g, gel matrix 30-150 g, and acid/base buffer and water for injection in balancing amount. The inventive phacoline eye gel optimizes adjuvants and improves production process, so as to enrich the phacoline dosage forms, remarkably prolong the retention time of the phacoline in eyes, improve the therapeutic effect, reduce eye drop frequency, and prevent the occurrence of cataract and glaucoma. In addition, the eye gel has reduced fluidity and can reduce the drug absorption in lacrimal passage and nasopharyngeal mucosa, so as reduce systematic side effects.

Description

【Technical Field】 [0001] The invention belongs to the technical field of chemical medicine, and specifically relates to a facolin 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. When it is dropped into the eye, it turns into Gel-like, can stay in the eye for a long time, so as to extend the treatment time, enhance the treatment effect and reduce the loss of medicine. [0003] The ready-to-use ophthalmic gel is not a very mature pharmaceutical preparation at present. The ready-to-use ophthalmic gel that relies on the principles of temperature, pH and ionic strength is not yet mature in commercialization. This is because the dosage form is It requires fine craftsmanship, proper excipients, and proper matching of the medicine in the ready-to-use ophthalmic gel with the crafts and excipients. Otherwise, it will not be placed in a l...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/498A61K9/00A61K47/32A61K47/34A61K47/38A61P27/12A61K47/10
Inventor 肖正连
Owner 肖正连
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