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Diclofenac sodium eye-drop preparation

A technology of diclofenac sodium and ophthalmic preparations, which is applied in the field of diclofenac sodium ophthalmic preparations, and can solve the problems of strong irritation of diclofenac sodium

Active Publication Date: 2017-06-09
JIANGSU HANCHEN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] The biggest side effect of diclofenac sodium is strong irritation, which is difficult for patients to accept, but its clinical efficacy is worthy of recognition, and has been proved by a large number of clinical trials

Method used

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  • Diclofenac sodium eye-drop preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0057] 1) According to the process prescription configuration, stir and dissolve 1g of diclofenac sodium with 100ml of water for injection, add 50mg of sodium diacetate, stir until completely dissolved, and obtain solution A;

[0058] 2) Add 50g of poloxamer to solution A in step 1), continue to stir for 30 minutes, add water for injection to 800ml, add boric acid to 10g, borax to 7.6g, after the dissolution is complete, adjust the pH with sodium hydroxide or hydrochloric acid value to about 7.5-8.5 (preferably 8.0), add 1 L of water for injection, and then filter through a 0.22 μm microporous filter element, and carry out intermediate detection during the configuration process. After the detection is qualified, the ophthalmic preparation is obtained.

Embodiment 2

[0060] 1) According to the process prescription configuration, stir and dissolve 1g of diclofenac sodium with 100ml of water for injection, add 50mg of sodium diacetate, stir until completely dissolved, and obtain solution A;

[0061] 2) Add 50g of poloxamer to solution A in step 1), continue to stir for 30 minutes, add water for injection to 800ml, add boric acid to 10g, borax to 7.6g, after the dissolution is complete, adjust the pH with sodium hydroxide or hydrochloric acid value to about 7.0, add 1L of water for injection, and then filter through a 0.22 μm microporous filter element, and carry out intermediate detection during the preparation process. After passing the test, the ophthalmic preparation is obtained.

Embodiment 3

[0063] 1) According to the process prescription configuration, stir and dissolve 1g of diclofenac sodium with 100ml of water for injection, add 50mg of sodium diacetate, stir until completely dissolved, and obtain solution A;

[0064] 2) Add 50g of poloxamer to solution A in step 1), continue to stir for 30 minutes, add water for injection to 800ml, add boric acid to 10g, borax to 7.6g, after the dissolution is complete, adjust the pH with sodium hydroxide or hydrochloric acid value to 9, add 1L of water for injection, and then filter through a 0.22 μm microporous filter element, and carry out intermediate detection during the configuration process. After the detection is qualified, the ophthalmic preparation is obtained.

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Abstract

The invention provides a diclofenac sodium eye-drop preparation, and belongs to the field of preparations. The diclofenac sodium eye-drop preparation consists of the following components: containing effective constituent diclofenac sodium, using 1 mg / ml of the iclofenac sodium as a measurement standard, 2 to 30 mg / ml of buffer salt, 20 to 100 mg / ml of a cosolvent, 20 to 200 [mu]g / ml of a bacteriostatic agent and an appropriate amount of a pH conditioning agent and the balance of water for injection, wherein the pH value is 7.0 to 9.0. The eye-drop preparation comprises eye drops, so that the stimulation of the diclofenac sodium for eyes can be effectively reduced, and the stability of the diclofenac sodium is strengthened.

Description

technical field [0001] The invention belongs to the field of preparations, in particular to a diclofenac sodium ophthalmic preparation. [0002] technical background [0003] Diclofenac sodium ophthalmic preparations, especially eye drops, diclofenac sodium belongs to non-steroidal anti-inflammatory drugs. Due to the unique properties of anti-inflammatory and analgesic drugs, the preparations made of such drugs have strong irritation. Related The mechanism is not yet clear. According to a large number of clinical reports, about 15% of patients experience transient tingling in the eyes when using diclofenac sodium eye drops. At present, NSAIDS (non-steroidal anti-inflammatory drugs) commonly used in ophthalmology include Punanpuling eye drops, Anhela eye drops, Ocofen eye drops, indomethacin eye drops, diclofenac sodium eye drops Wait. [0004] Punan Puling Eye Drops: Animal experiments and clinical studies have proved that 0.1% Punan Puling Eye Drops has a good anti-inflamm...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/196A61K47/12A61P29/00A61P27/02
CPCA61K9/0048A61K9/08A61K31/196A61K47/12
Inventor 孙先法顾姣姣何鹏华朱松张炜峰
Owner JIANGSU HANCHEN PHARMA
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