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Atropine sulfate in situ forming eye gel

A technology of atropine sulfate and gel, which is applied in the direction of medical preparations of non-active ingredients, sensory diseases, active ingredients of heterocyclic compounds, etc., can solve skin flushing, rash, erythema, long time of peak action, and large loss of eye drops To achieve the effect of enriching drug dosage forms, reducing absorption, reducing side effects and poisoning reactions

Inactive Publication Date: 2008-12-24
肖正连
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, clinically there are problems such as large loss of eye drops instilled into the eye, short residence time, and too long time to reach the peak effect.
In addition, 1% atropine sulfate eye drops can easily flow into the lacrimal sac for absorption, which can cause skin flushing, rash, erythema, dry mouth, heart palpitations and other side effects. In severe cases, symptoms of poisoning may occur, especially children are prone to poisoning.

Method used

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  • Atropine sulfate in situ forming eye gel
  • Atropine sulfate in situ forming eye gel

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] Prescription: 5 grams of atropine sulfate, 400 milliliters of hydrochloric acid (0.05mol / L)

[0024] Sodium Citrate 8.5g 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 atropine sulfate, dissolve phenylethyl alcohol in ethanol, add dropwise to the above solution while stirring, add sodium citrate, stir for more than 30 minutes, then add hydrochloric acid and stir , filter through a microporous membrane (0.22 μm), and then heat the filtrate to 40°C, add sodium chloride, methylcellulose, PEG-1000 and PEG-400 while hot, and stir to room temperature (18-25°C), 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: 10 grams of atropine sulfate, 200 ml of sulfuric acid (0.05mol / L)

[0030] Sodium Citrate 8.6g Methylcellulose 5.0g Benzyl Alcohol 0.5g

[0031] Ethanol 5ml Sodium Chloride 5.0g PEG-1000 70g

[0032] Appropriate amount of water for injection

[0033] Preparation method: heat water for injection to boil, cool to 80°C, add atropine sulfate, dissolve benzyl alcohol in ethanol, add dropwise to the above solution while stirring, add sodium citrate, stir for more than 30 minutes, add sulfuric acid and stir , 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), add water for injection Make up the weight to 1000 ml, stir to form a uniform gel, and aseptically dispense it.

Embodiment 3

[0035] Prescription: 1 g of atropine sulfate, 200 ml of sodium hydroxide (0.1mol / L)

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

[0037] Ethanol 5ml Sodium Chloride 25.0g PEG-4000 100g

[0038] Appropriate amount of water for injection

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

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Abstract

The invention discloses an instant atropine sulphate eye gel and a preparation method thereof. According to the invention, 1000ml of the instant atropine sulphate eye gel contains 1g to 20g of atropine sulphate, 0.05g to 1g of preservative, 1.0g to 7.5g of osmotic pressure adjusting agent, and 30g to 150g of gel stroma, and the rest includes acid-alkali buffer and water for injection. The invention, through the optimization of accessories and the improvement of the technique, enriches the pharmaceutical dosage form of the atropine sulphate, greatly prolongs the time for which the medicine stays in the eyes, and not only improves the curative effect and shortens the time for reaching the function peak, but also reduces the amount of the medicine flowing into and absorbed by dacryocysts and relieves the side effect and toxic reaction of the atropine sulphate.

Description

【Technical field】 [0001] The invention belongs to the technical field of chemical medicines, and in particular relates to an instant ophthalmic gel of atropine sulfate. 【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 wil...

Claims

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Application Information

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IPC IPC(8): A61K31/46A61K9/00A61K47/34A61P27/02A61K47/10A61K47/32A61K47/38
Inventor 肖正连
Owner 肖正连
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