Non-steroidal anti-inflammatory eye drops and preparation method thereof

A technology of non-steroidal anti-inflammatory eye drops, which is applied in the field of medicine, can solve the problems of non-steroidal anti-inflammatory eye drops in terms of comfort and stability, and achieve significant economic benefits, strong targeting effect, and penetration powerful effect

Inactive Publication Date: 2018-11-02
广州君博医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] Aiming at the problem that the existing non-steroidal anti-inflammatory eye drops are insufficient in terms of medication comfort and stability, the object of the present invention is to

Method used

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  • Non-steroidal anti-inflammatory eye drops and preparation method thereof
  • Non-steroidal anti-inflammatory eye drops and preparation method thereof

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Example Embodiment

[0024] The present invention also provides a preparation method of the non-steroidal anti-inflammatory eye drops, which is characterized in that it comprises the following steps:

[0025] A. Disperse the prodrug of flurbiprofen with an appropriate amount of water for injection and use it for later use to obtain liquid A;

[0026] B. Disperse the thickener with an appropriate amount of water for injection and let it cool, then add the bacteriostatic agent, stir and filter, and add it to the liquid A obtained in step A) to obtain liquid B;

[0027] C. Dissolve the pH regulator with water for injection, slowly add it to liquid B, adjust the pH to 5.5-7.5, and obtain liquid C;

[0028] D. Dissolve the osmotic pressure regulator with water for injection, slowly add to the solution C obtained in step 3), adjust the osmolarity to 250-350 mOsmol / kg to obtain liquid D;

[0029] E. Add water for injection to liquid D to make the concentration of flurbiprofen prodrug in the eye drops 0.1-5 mg / ml, ...

Example Embodiment

[0032] Example 1-10

[0033] Table 1 Raw materials and ratio of eye drops

[0034]

Example Embodiment

[0035] Example 1

[0036] First, prepare the materials according to the formula shown in Table 1;

[0037] Step 1). Dissolve the flurbiprofen prodrug with 50% water for injection for use;

[0038] Step 2) Disperse the thickener with water for injection and let it cool, then add the bacteriostatic agent, stir and filter, and add to the flurbiprofen prodrug solution obtained in step 1);

[0039] Step 3), dissolve the pH regulator with water for injection, slowly add the flurbiprofen prodrug solution obtained in step 2), adjust the pH to 5.5 and stop;

[0040] Step 4), dissolve the osmotic pressure regulator with water for injection, slowly add to the solution obtained in step 3), adjust the osmolality to 250 mOsmol / kg and stop adding;

[0041] Step 5), add water for injection to 100ml, filter and dispense to obtain;

[0042] Thimerosal is used as a bacteriostatic agent, polyvinyl alcohol is used as a thickener, and a pH regulator is sodium hydroxide solution and / or hydrochloric acid solutio...

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Abstract

The invention discloses non-steroidal anti-inflammatory eye drops. Per 100mL of the eye drops include the following components: 0.01-0.5g of a flurbiprofen precursor drug, 0.0004-0.5g of a bacteriostatic agent, 0.1-0.5g of a thickener, a pH regulator, an osmotic pressure regulator, and the balance water for injection. The flurbiprofen precursor drug is flurbiprofen axetil or a pharmaceutically acceptable salt of flurbiprofen. The pH value of the eye drops is 5.5-7.5, and the osmotic pressure molar concentration of the eye drops is 250-350mOsmol/kg. The invention also provides a preparation method of the eye drops. The eye drops provided by the invention have the advantages of strong comfort, no irritation, good efficacy and the like, and the preparation method is easy for industrial production.

Description

technical field [0001] The invention relates to the field of medicine, in particular to a non-steroidal anti-inflammatory eye drop and a preparation method thereof. Background technique [0002] Flurbiprofen prodrugs are propionic acid non-steroidal anti-inflammatory drugs (NSAIDs), and its mechanism of action is to inhibit the activity of cyclooxygenase and block the synthesis of prostaglandins. Prostaglandins are mediators of certain intraocular inflammations, which can cause blood-aqueous barrier breakdown, vasodilation, increased vascular permeability, leukocyte chemotaxis, and miosis unrelated to cholinergic mechanisms. Clinical studies have shown that this product can inhibit the miosis during cataract surgery, and has no significant effect on intraocular pressure. Its analgesic effect is 10-20 times stronger than ketoprofen, indomethacin, and naproxen. It has powerful and balanced analgesic, anti-inflammatory, and antipyretic effects; it is safer to use, and the inci...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/192A61K31/222A61P27/02A61P29/00
CPCA61K9/0048A61K9/08A61K31/192A61K31/222A61K47/02A61K47/32A61P27/02A61P29/00
Inventor 谭上彬王延东崔明黄俊杰陈宇明
Owner 广州君博医药科技有限公司
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