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Olopatadine hydrochloride gel eye drops and preparation method thereof

A technology of olopatadine hydrochloride and eye drops, which can be applied in pharmaceutical formulations, medical preparations with non-active ingredients, sensory diseases, etc., can solve the problem of low bioavailability of eye drops, poor patient acceptance, and physiological toxicity Reaction and other problems, to achieve the effect of reducing the frequency of medication, moderate viscosity, and reducing discomfort

Inactive Publication Date: 2016-12-28
JIANGSU JIBEIER PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, eye drops have problems such as low bioavailability, long-term administration, and easy to cause local or systemic physiological toxicity.
Long-term repeated use can easily lead to poor patient acceptance

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] Take about 6kg of water for injection, add 80g of carbomer under stirring, fully swell and filter to obtain a clear viscous solution. Take about 4 kg of water for injection, add 10 g of olopatadine hydrochloride, 1 g of benzalkonium chloride, and 50 g of sodium chloride, stir to dissolve, filter and sterilize through a microporous membrane, add carbomer to the viscous solution, and stir fully to dissolve uniform. Adjust the pH to 6-8 with 2mol / L hydrochloric acid or sodium hydroxide solution, sterilize with flowing steam, and pack aseptically to obtain the product.

Embodiment 2

[0020] Take about 6kg of water for injection, add 70g of carbomer under stirring, after fully swelling, filter to obtain a clear viscous solution. Take about 4 kg of water for injection, add 20 g of olopatadine hydrochloride, 1 g of benzalkonium chloride, and 50 g of sodium chloride, stir to dissolve, filter and sterilize through a microporous membrane, add carbomer to the viscous solution, and stir fully to dissolve uniform. Adjust the pH to 6-8 with 2mol / L hydrochloric acid or sodium hydroxide solution, sterilize with flowing steam, and pack aseptically to obtain the product.

Embodiment 3

[0022] Take about 6kg of water for injection, add 80g of carbomer under stirring, and after fully swelling, filter to obtain a clear viscous solution. Take about 4kg of water for injection, add olopatadine hydrochloride 10g, methylparaben 3g, and sodium chloride 50g, stir to dissolve, filter and sterilize through a microporous membrane, add carbomer to the viscous solution, stir fully to dissolve uniform. Adjust the pH to 6-8 with 2mol / L hydrochloric acid or sodium hydroxide solution, sterilize with flowing steam, and pack aseptically to obtain the product.

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PUM

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Abstract

The invention discloses an olopatadine hydrochloride gel eye drop and a preparation method thereof. The main raw material is olopatadine hydrochloride, and a gel matrix, an isotonic regulator, a preservative, water for injection and other auxiliary materials are added. Swell and stir evenly, adjust pH and sterilize, and then prepare 0.1%-0.2% olopatadine hydrochloride gel eye drops. The purpose of the invention is to provide a practical, convenient and reliable ophthalmic preparation for treating allergies for the clinic, and to solve the problems of short residence time and poor drug absorption of eye drops dosage forms in the eyes.

Description

technical field [0001] The invention relates to olopatadine hydrochloride gel eye drops and a preparation method thereof, belonging to the technical field of medicines. Background technique [0002] Olopatadine hydrochloride (Olopatadine hydrochloride), chemical name: Z-11-(3-dimethylaminopropenyl)-6,11-dihydrodibenzo[b,e]oxa-2-acetic acid Hydrochloride, chemical structural formula: [0003] Molecular formula: C 21 h 23 NO 3 • HCl, 373.87 [0004] Olopatadine hydrochloride is a powerful and safe anti-allergic drug of the third generation. It was developed by Kyowa Hakko, Japan, and was launched in the United States and Japan in 1997 and 2001, respectively. Alcon has developed it into 0.1% and 0.2% eye drops with trade names of Patanol and Pataday, respectively, for the treatment of allergic conjunctivitis. Olopatadine hydrochloride has the dual effects of inhibiting the release of histamine and selectively antagonizing H1 receptors, without the central nervous syste...

Claims

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Application Information

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IPC IPC(8): A61K31/335A61P27/14A61K47/38A61K47/36A61K47/32A61K47/34
Inventor 李海岛聂丽云王慧赵雷汪慧陈进吴修艮
Owner JIANGSU JIBEIER PHARMA
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