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Azithromycin eye drops and preparation method thereof

A technology for azithromycin and eye drops, which is applied in pharmaceutical formulations, medical preparations containing active ingredients, organic active ingredients, etc., can solve the problems of prolonging the action time of the drug, difficult to control the dosage, and difficult to produce, and achieve a good biological phase. The effect of reducing the frequency of administration, improving the compliance

Inactive Publication Date: 2012-12-19
南京恒道医药科技股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although ophthalmic gel can prolong the action time of drugs and reduce the frequency of medication, it is difficult to produce, inconvenient to administer, and difficult to control the dose

Method used

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  • Azithromycin eye drops and preparation method thereof
  • Azithromycin eye drops and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] Prescription: Azithromycin: 1g Sodium Alginate: 1.5g

[0025] Citric acid: 0.2g Sodium citrate: 0.3g

[0026] EDTA-2Na: 0.05g Sodium hydroxide: appropriate amount

[0027] Benzalkonium bromide: 0.01g water for injection to 100ml

[0028] Preparation method:

[0029] (1) Weigh sodium alginate and place it in water for injection, stir until sodium alginate completely dissolves into a solution, and refrigerate;

[0030] (2) Take azithromycin, add a pH regulator and stir until the medicine is completely dissolved, add an osmotic pressure regulator, a stabilizer, a bacteriostat, and stir evenly;

[0031] (3) Mix the solutions of steps (1) and (2), stir evenly, and replenish to the required amount with an appropriate amount of water for injection;

[0032] (4) Aseptically subpackage after sterile filtration.

Embodiment 2

[0034] Prescription: Azithromycin: 1g Sodium Alginate: 2g

[0035] Citric acid: 0.2g Sodium citrate: 0.3g

[0036] EDTA-2Na: 0.10g Sodium hydroxide: appropriate amount

[0037] Benzalkonium bromide: 0.005g

[0038] Preparation method:

[0039] (1) Weigh sodium alginate and place it in water for injection, stir until sodium alginate completely dissolves into a solution, and refrigerate;

[0040] (2) Take azithromycin, add a pH regulator and stir until the medicine is completely dissolved, add an osmotic pressure regulator, a stabilizer, a bacteriostat, and stir evenly;

[0041] (3) Mix the solutions of steps (1) and (2), stir evenly, and replenish to the required amount with an appropriate amount of water for injection;

[0042] (4) Aseptically subpackage after sterile filtration.

Embodiment 3

[0044] Prescription: Azithromycin: 1g Sodium Alginate: 1.8g

[0045] Citric acid: 0.2g Sodium citrate: 0.3g

[0046] EDTA-2Na: 0.15g Sodium hydroxide: appropriate amount

[0047] Benzalkonium bromide: 0.001g

[0048] Preparation method:

[0049] (1) Weigh sodium alginate and place it in water for injection, stir until sodium alginate completely dissolves into a solution, and refrigerate;

[0050] (2) Take azithromycin, add a pH regulator and stir until the medicine is completely dissolved, add an osmotic pressure regulator, a stabilizer, a bacteriostat, and stir evenly;

[0051] (3) Mix the solutions of steps (1) and (2), stir evenly, and replenish to the required amount with an appropriate amount of water for injection;

[0052] (4) Aseptically subpackage after sterile filtration.

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Abstract

The invention relates to the field of medicinal preparations and specifically to Azithromycin eye drops which are characterized by containing Azithromycin, a matrix, a stabilizing agent, a pH value conditioning agent, an antiseptic and injection water, wherein the matrix is sodium alginate. The invention also discloses a preparation method for the eye drops. According to the invention, sodium alginate is used as the hydrophilic matrix, so good biocompatibility is obtained; the eye drops are in a form of a semi-colloidal preparation under the condition of in vitro storage; and the preparation has appropriate viscosity and does not run off when dropped into eyes, so the preparation can substantially prolong action time of drugs in the eyes, reduce administration frequency and improve compliance of patients.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to azithromycin eye drops and a preparation method thereof Background technique [0002] Azithromycin (C 38 h 72 N 2 o 12 ) is a new generation of macrolide antibiotics with a broad antibacterial spectrum. It has a good effect on the treatment of eye bacterial infections such as trachoma. Compared with the parent drug erythromycin, azithromycin has the advantages of relatively stable in acidic solution, high concentration in body tissues, long duration of action, broad antibacterial spectrum, and less side effects. Its antibacterial effect is stronger than roxithromycin and erythromycin. [0003] According to literature reports, oral formulations of azithromycin are suitable for the treatment of ocular infections such as conjunctivitis caused by chlamydia and other susceptible pathogens. And now the incidence of conjunctivitis in the crowd is very high, especially t...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/7052A61K47/36A61P27/02A61P31/04
Inventor 黄迎春刘伟
Owner 南京恒道医药科技股份有限公司
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