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Boletic acid ketotifen eye drops containing sodium hyaluronate and its preparing process

A technology of ketotifen fumarate and sodium hyaluronate, applied to medical preparations containing active ingredients, pharmaceutical formulas, organic active ingredients, etc., can solve problems such as inconvenient use and poor reducibility, and achieve the effect of preventing spillage and loss

Inactive Publication Date: 2007-03-07
SHANGHAI SINE PHARMA LAB
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Due to the poor reducibility of this type of gel, it is also inconvenient to use, because it must be used and stored at low temperature

Method used

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  • Boletic acid ketotifen eye drops containing sodium hyaluronate and its preparing process

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preparation example Construction

[0033] The preparation method of the ketotifen fumarate eye drops of the present invention is very simple, and can be produced by adopting a conventional eye drop production process, and simple physical mixing is enough.

[0034] The using method of ketotifen fumarate eye drops of the present invention is as follows:

[0035] Eye drops, 1-2 drops at a time, 3 times a day.

[0036] Because the ketotifen fumarate eye drop of the present invention is added with sodium hyaluronate, its antiallergic effect is more durable, and the ocular surface is moistened and comfortable at the same time.

[0037] The present invention also provides a method for preparing the eye drops, which comprises mixing 0.25-1200 parts by weight of ketotifen fumarate, 1-1200 parts by weight of sodium hyaluronate, 100-3000 parts by weight of isotonic The regulator and the pharmaceutically acceptable carrier adjust the pH value of the ketotifen fumarate eye drop to 4.0-7.5.

[0038] The present invention als...

Embodiment 1

[0049] 100ml water for injection contains:

[0050] Ketotifen 50mg

[0051] Sodium Hyaluronate 150mg

[0052] Sodium chloride 840mg

[0053] Benzalkonium Chloride 10mg

[0054] Preparation Process:

[0055] 1. Add sodium hyaluronate to 25ml of water for injection, and swell at room temperature to obtain a fully swollen sodium hyaluronate solution.

[0056] 2. Sodium chloride and benzalkonium chloride were dissolved in 50ml of water for injection, then added into the fully swollen sodium hyaluronate solution, stirred evenly to obtain a mixed solution, and left to stand for use.

[0057] 3. Add ketotifen fumarate to the mixed solution obtained in step 2, and stir evenly to obtain a solution.

[0058] 4. Adjust the pH of the solution obtained in step 3 to 5.2 with hydrochloric acid.

[0059] 5. Add 25ml of water for injection to the solution obtained in step 4, stir evenly and filter and fill.

Embodiment 2

[0061] 100ml water for injection contains:

[0062] Ketotifen Fumarate 80mg

[0063] Sodium Hyaluronate 300mg

[0064] Boric acid 1500mg

[0065] Borax 300mg

[0066] Methylparaben 30mg

[0067] Preparation Process:

[0068] 1. Add sodium hyaluronate to 25ml of water for injection, and swell at room temperature to obtain a fully swollen sodium hyaluronate solution.

[0069] 2. Dissolve boric acid, borax, and benzalkonium chloride in 50ml of water for injection, then add it into the fully swollen sodium hyaluronate solution, stir evenly to obtain a mixed solution, and set aside.

[0070] 3. Add ketotifen fumarate to the mixed solution obtained in step 2 to dissolve, and stir evenly to obtain a solution.

[0071] 4. Add 25ml of water for injection to the solution obtained in step 3, stir evenly and filter and fill. The resulting eye drops had a pH of 4.5.

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Abstract

The invention relates to a gutta which comprises boletic acid at 0.25-1200 deals, hyaluronic acid soda at 1-1200 deals, osmotic regulation adjuster at 100-3000 deals, and acceptable carrier. Wherein, the pH value of said invention is 4.0-7.5. The invention can avoid overflow to keep drug at needed part. And it can humidify cornea.

Description

technical field [0001] The invention relates to sodium hyaluronate-containing ketotifen fumarate eye drops and a preparation method thereof. Background technique [0002] Ketotifen fumarate is an antiallergic drug that has a strong histamine H1 receptor antagonism and inhibits the release of allergic reaction mediators. The antihistamine effect of ketotifen fumarate is about 10 times stronger than that of chlorpheniramine, and has a longer curative effect. It can inhibit the release of histamine and slow-response allergic substances from mast cells in the peribronchial mucosa, and also inhibit the release of histamine and slow-response allergic substances from eosinophils in the blood, thereby producing anti-allergic effects. It can significantly reduce nasal mucosal edema, thereby reducing or disappearing symptoms of allergic rhinitis such as nasal itching, sneezing, runny nose and nasal congestion. It can also be used for allergic rhinitis and allergic bronchial asthma. ...

Claims

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Application Information

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IPC IPC(8): A61K31/4535A61P27/02A61P37/08
Inventor 朱正鸣乌旭琼张冬梅夏凌云陈佩丽杨毅静
Owner SHANGHAI SINE PHARMA LAB
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