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Medicinal composition containing diclofenac sodium and preparation method thereof

A technology of diclofenac sodium and a composition is applied in the field of pharmaceutical compositions containing diclofenac sodium and its preparation, which can solve the problems such as no solution, eye irritation, etc., and achieve increased compliance, simple operation, and easy conditions. Effect

Inactive Publication Date: 2013-01-16
JIANGSU HANCHEN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] However, during the use of non-steroidal anti-inflammatory drugs, due to their drug structure, they cause obvious stinging sensation to the eyes. So far, there is no good solution for this type of eye drops on the domestic market.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0014] A pharmaceutical composition containing diclofenac sodium, the pharmaceutical composition is an ophthalmic preparation with a pH value of 6.5-8.5, with diclofenac sodium being 1 mg / ml as a metering basis, the pharmaceutical composition contains 50 mg / ml of stabilizer, 80mg / ml co-solvent, 30mg / ml buffer, 45μg / ml preservative, pH regulator and water for injection, the stabilizer is sulfobutyl-β-cyclodextrin and its derivatives, the buffer It is boric acid, the preservative is benzalkonium chloride, the cosolvent is poloxamer, and the pH regulator is sodium hydroxide.

[0015] The preparation method of the above-mentioned pharmaceutical composition containing diclofenac sodium, the method comprises:

[0016] (1) Take 0.1 ml of water for injection, add 1 mg of diclofenac sodium, stir to dissolve completely, add 50 mg of sulfobutyl-β-cyclodextrin, and stir for 20 minutes to obtain the clathrated diclofenac sodium solution;

[0017] (2) Add 80 mg of poloxamer to the cla...

Embodiment 2

[0019] A pharmaceutical composition containing diclofenac sodium, the pharmaceutical composition is an oral liquid with a pH value of 6, with diclofenac sodium being 1 mg / ml as the metering basis, the pharmaceutical composition contains 100 mg / ml of sulfobutyl-β- Cyclodextrin, 40mg / ml buffer, 50μg / ml preservative and water for injection, the buffer is boric acid and borax in a weight ratio of 2:1, and the preservative is benzalkonium chloride.

Embodiment 3

[0021] A pharmaceutical composition containing diclofenac sodium, the pharmaceutical composition is an ophthalmic preparation with a pH value of 6.5-8.5, taking diclofenac sodium as 1 mg / ml as a metering basis, the pharmaceutical composition contains 150 mg / ml of stabilizer, 60mg / ml co-solvent, 35mg / ml buffer, 48μg / ml preservative, pH regulator and water for injection, the stabilizer is sulfobutyl-β-cyclodextrin and its derivatives, the buffer It is boric acid, the preservative is benzalkonium chloride, the cosolvent is poloxamer, and the pH regulator is sodium hydroxide.

[0022] The preparation method of the above-mentioned pharmaceutical composition containing diclofenac sodium, the method comprises:

[0023] (1) Take 0.1ml of water for injection, add 1mg of diclofenac sodium, stir to dissolve completely, add 150mg of sulfobutyl-β-cyclodextrin, and stir for 40min to obtain the clathrated diclofenac sodium solution;

[0024] (2) Add 60 mg of poloxamer to the clathrated dicl...

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PUM

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Abstract

The invention discloses a medicinal composition containing diclofenac sodium which is characterized in that the medicinal composition is an ophthalmic preparation with a pH value of 6.5 to 8.5; and 1mg / ml of diclofenac sodium is taken as a measuring standard, the medicinal composition contains 10 to 200mg / ml of a stabilizing agent, 10 to 100mg / ml of a cosolvent, 5 to 50mg / ml of a buffering agent, 45 to 50 mu g / ml of a preservative, a pH regulator and water for injection. The stabilizing agent is sulfobutylether-beta-cyclodextrin and a derivative of sulfobutylether-beta-cyclodextrin; the buffering agent is boric acid and / or borax; the preservative is benzalkonium chloride; the cosolvent is poloxamer; and the pH regulator is either sodium hydroxide or hydrochloric acid. The invention has the advantages that the medicinal composition provided by the invention is simple to operate and conditions are easy to implement. With the adoption of the medicinal composition containing diclofenac sodium obtained by the preparation method provided by the invention, irritation of diclofenac sodium eye drops is remarkably reduced and compliance of the patients is increased.

Description

technical field [0001] The invention relates to a pharmaceutical composition containing diclofenac sodium and a preparation method thereof. Background technique [0002] When ocular trauma occurs, the stimulation of the trauma will disturb the cell membrane and activate phospholipase A2. Under the action of phospholipase A2, arachidonic acid will be released from the phospholipids of the cell membrane. There are two metabolic pathways of arachidonic acid, one of which is the formation of ring peroxides (PGG2 and PGH2) under the catalysis of cyclooxygenase, and then converted into prostaglandins (PGE2, PGF2, PGD2), prostacyclin (PGI2) and thromboxane A2 (TXA2). When the eye is subjected to physical and chemical trauma or surgery, anterior chamber puncture, laser irradiation and stimulation of the trigeminal nerve, it will lead to the synthesis of prostaglandins in the eye tissue. Prostaglandins are the most powerful ocular inflammatory substances among the natural substance...

Claims

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Application Information

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IPC IPC(8): A61K31/196A61P27/02
Inventor 程浩文袁社平孙先法
Owner JIANGSU HANCHEN PHARMA
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