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Medicine composition for ophthalmology department

A composition and ophthalmology technology, applied in the direction of drug combination, drug delivery, boron compound active ingredients, etc., can solve the problems of cyclodextrin deposition instability, irritation and lack of stability, etc., to ensure chemical stability, Ease of treatment and long-lasting effects

Active Publication Date: 2008-01-23
SHENYANG XINGQI PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In July 1995, Ruosu Pharmaceutical Co., Ltd. Takeuchi Masashi and others applied for the patent of "anti-inflammatory eye drops" with the authorization notification number CN 1087169C. It uses diclofenac sodium as the main drug in a wide range of concentrations. Diclofenac sodium, A patent for an invention made by using γ-cyclodextrin (γ-CyD), polyvinylpyrrolidone (PVP) in combination with benzethonium chloride or benzalkonium chloride as a preservative and adjusting the pH to 7.0-8.5 , its purpose is to reduce the irritation and strong eye pain effect of eye drops, but the disadvantage of this invention is that it uses strong acid and strong base to adjust the pH value and there is a hidden danger of instability of cyclodextrin deposition in the preparation during storage
[0004] Another patent application for diclofenac sodium eye drops with the application number 99123788.9 proposed by the inventor in November 1999, the prescription is: 1 g of diclofenac sodium, 0.6 g of tromethamine, 6 g of borax, 15 g of boric acid, and 0.04 g of mercuric sulfate. g, polyvinylpyrrolidone (PVP) 138, the eye drops of this invention have made some progress in the treatment of anterior uveitis and the control of inflammatory reactions after inner eye surgery, but there are still deficiencies in terms of irritation and stability place

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] The following ophthalmic pharmaceutical compositions were prepared in the following proportions.

[0024] Diclofenac Sodium 1.0g

[0025] Borax 3.0g

[0026] Boric acid 1.5g

[0027] Tromethamine 2.0g

[0028] Sodium chloride 7.1g

[0029]

[0030] Add water for injection to 1000.0ml

[0031] Preparation Process

[0032] Take about 50% of the prescribed amount of water for injection, dissolve diclofenac sodium, add borax, boric acid, tromethamine, and sodium chloride in turn after fully dissolved, heat to 100°C and boil for 15 minutes, cool down, and make up the full amount with water for injection.

Embodiment 2

[0034] prescription:

[0035] Diclofenac Sodium 0.5g

[0036] Borax 3.0g

[0037] Boric acid 1.58

[0038] Sodium Hyaluronate 1.0g

[0039] Thimerosal 0.04g

[0040] Tromethamine 0.3g

[0041] Sodium chloride 6.3g

[0042]

[0043] Add water for injection to 1000.0ml

[0044] Take the prescribed amount of sodium hyaluronate, add an appropriate amount of water for injection, and prepare a 0.1% solution, place it at 2-10°C for more than 12 hours, and set aside; take about 50% of the prescribed amount of water for injection, dissolve diclofenac sodium, and dissolve it completely Add borax, boric acid, tromethamine and sodium chloride in sequence, heat to 100°C and boil for 15 minutes, cool down to 35-40°C, add sodium hyaluronate solution, add thimerosal dissolved in advance, make up to full amount with water for injection, that is Obtain the composition of the present invention, its pH value is 8.2.

Embodiment 3

[0046] prescription:

[0047] Diclofenac Sodium 2.0g

[0048] Borax 11.5g

[0049] Boric acid 4.5g

[0050] Sodium Hyaluronate 0.2g

[0051] Thimerosal 0.04g

[0052] Tromethamine 1.2g

[0053] Sodium chloride 3.0g

[0054]

[0055] Add water for injection to 1000.0ml

[0056] According to above-mentioned prescription, operate with the same method of embodiment 2, promptly obtain composition of the present invention, its pH value is 8.8.

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PUM

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Abstract

The invention provides a medicinal composition for ophthalmology department which comprises diclofenac sodium 0.05-0.2%, trometamol 0.02-0.2%, borax 0.3-3.0%, boracic acid 0.1-1.0%, sodium hyaluionate 0.01-0.1%, thiomersal 0.001-0.01%, the component ratio being weight / volume percentage, the pH of the composition aqueous solution is 6.5-9.0.

Description

[technical field] [0001] The invention relates to an anti-inflammation ophthalmic pharmaceutical composition for topical use on the eye with diclofenac sodium as an active ingredient. The composition has good drug stability and less irritation. [Background technique] [0002] Diclofenac and its salts are non-steroidal anti-inflammatory analgesics derived from phenylacetic acid, used as a substitute for corticosteroids for the treatment of eye diseases. Side effects from corticosteroids, as well as some adverse effects and increased intraocular pressure. Because of its strong blocking effect on the biosynthesis of prostaglandins, it is used to prevent postoperative inflammation and postoperative complications during cataract surgery; when diclofenac and its salts are used in the eye, almost without exception Stimulate the mucous membranes and eyes and show strong eye pain: At the same time, there are also changes in the appearance and internal quality of the preparations to ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/196A61K31/133A61K33/22A61K33/28A61P27/02A61K9/08
Inventor 刘继东
Owner SHENYANG XINGQI PHARM CO LTD
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