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Azithromycin ophthalmic instant molding gel and preparation method thereof

A technology of azithromycin and gel, which is applied in the field of azithromycin ophthalmic ready-to-use gel, which can solve the problems of inconvenient administration and difficult dose control, and achieve the effects of reducing the number of administrations, good biocompatibility, and prolonging the action time

Inactive Publication Date: 2009-06-03
CHINA PHARM UNIV
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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 the drug and reduce the frequency of medication, it is inconvenient to administer and the dose is not easy to control

Method used

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  • Azithromycin ophthalmic instant molding gel and preparation method thereof
  • Azithromycin ophthalmic instant molding gel and preparation method thereof
  • Azithromycin ophthalmic instant molding gel and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] Azithromycin API 0.5g

[0041] Carbomer 974P NF 0.4g

[0042] Poloxamer 407 21.0g

[0043] Poloxamer 188 6.0g

[0044] Mannitol 1.3g

[0045] Ethylparaben 0.01g

[0046] Sodium hydroxide 2.5ml

[0047] Water for injection to 100ml

[0048] Preparation method: Weigh carbomer 934P NF into 50ml water for injection, stir magnetically for 30min until the carbomer swells completely to form a solution, add azithromycin raw material, stir magnetically for 1.5h until the drug is completely dissolved, add mannitol, benzalkonium chloride Ammonium was added to the solution, magnetically stirred for 10 minutes, poloxamer was added and magnetically stirred evenly, placed in a refrigerator at 4°C for 24 hours to completely dissolve, 1M sodium hydroxide was used to adjust the pH to 5.6-6.0, and finally supplemented with an appropriate amount of water for injection to required amount. After sterile filtration (membrane filter pore size 0.2 μm), aseptically dispense.

Embodiment 2

[0050] Azithromycin API 0.8g

[0051] Carbomer 934P NF 0.6g

[0052] Poloxamer 407 23.0g

[0053] Poloxamer 188 5.0g

[0054] Sodium chloride 0.3g

[0055] Benzalkonium Chloride 0.01g

[0056] Sodium hydroxide 2.8ml

[0057] Water for injection to 100ml

[0058] The preparation method is the same as in Example 1.

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PUM

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Abstract

The invention relates to the field of pharmaceutical preparation, in particular relates to an azithromycin ophthalmic instant molding gel. The azithromycin ophthalmic instant molding gel is characterized in that the azithromycin ophthalmic instant molding gel comprises azithromycin, a temperature sensing substrate, carbomer, a permeation pressure conditioning agent and water for injection, wherein the temperature sensing substrate comprises poloxamer 407 and poloxamer 188. The invention further discloses a preparation method thereof. The invention uses the poloxamer 407 and the poloxamer188 as the temperature sensing substrate with good biocompatibility. The preparation is flowable fluid preparation under the condition of invitro storage; the preparation forms gel when the external environment of dropping in ocular region is changed, so as not to flow in ocular region; therefore, the pharmic action time is remarkably prolonged, time administer drug is reduced and the adaptability of the patient is improved.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to an instant azithromycin ophthalmic gel, and also discloses 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 acid, high concentration in body tissues, long duration of action, broad antibacterial spectrum, and small 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 ver...

Claims

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Application Information

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IPC IPC(8): A61K9/00A61K31/7052A61K47/34A61P31/04A61P27/02
Inventor 平其能操锋张晓林
Owner CHINA PHARM UNIV
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