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Production method of sterile stable azithromycin eye drops

A technology for azithromycin and its production method, which is applied in the direction of antibacterial drugs, pharmaceutical formulations, medical preparations containing active ingredients, etc., and can solve the problem of harsh storage conditions, difficult access to eye drop enterprises, and restrictions on the application of azithromycin eye drops, etc. problem, to achieve the effect of improving stability and security

Inactive Publication Date: 2013-07-24
WUHAN NUOAN PHARMACY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Because of its harsh storage conditions, it is not easy for domestic enterprises to produce eye drops, which limits the application of azithromycin eye drops in China

Method used

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  • Production method of sterile stable azithromycin eye drops
  • Production method of sterile stable azithromycin eye drops
  • Production method of sterile stable azithromycin eye drops

Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0017] The preparation method of the special solvent can be according to the conventional preparation method, adding the pH regulator and additives into the water for injection, dissolving and then sterilizing.

[0018] The osmotic pressure regulator can be conventional various osmotic pressure regulators used in eye drops, for example, it can be at least one of glycerol, sodium chloride, potassium chloride, boric acid, borax, mannitol or sorbitol kind.

[0019] The preservative can be conventional various preservatives used in eye drops, for example, it can be in benzalkonium chloride, benzalkonium bromide, methylparaben, ethylparaben, chlorobutanol at least one.

[0020] The surfactant can be various conventional surfactants used in eye drops, for example, it can be at least one of polysorbate-80, polysorbate-60 and polysorbate-20.

[0021] The antioxidant may be various conventional antioxidants used in eye drops, for example, may be at least one of disodium edetate, sodi...

Embodiment 1

[0027] Azithromycin freeze-dried powder formula:

[0028]

[0029] Special solvent formula:

[0030]

[0031] Preparation:

[0032] (1) Get the azithromycin and citrate of prescription quantity, join in the water for injection of prescription quantity, stir and make to dissolve, then adjust pH value to 6.0~6.5 with sodium hydroxide, 0.22 μm filter membrane sterile filtration, press each 2ml sterile aliquots, prepared into sterile freeze-dried powder according to the freeze-drying process.

[0033] (2) Take 60% of the prescription amount of water for injection, slowly add the polycarbophil of the prescription amount, swell the liquid, stir to make it even, and sterilize it by autoclaving at 121°C for 30 minutes; take another 40% of the prescription amount of water for injection, Add mannitol, sodium citrate, sodium chloride, benzalkonium chloride, disodium edetate, and poloxamer in sequence, stir to dissolve, filter aseptically with a 0.22 μm filter membrane; then mix t...

Embodiment 2

[0035] Azithromycin freeze-dried powder formula:

[0036]

[0037] Special solvent formula:

[0038]

[0039] Preparation:

[0040] (1) Get the azithromycin and citrate of prescription quantity, join in the water for injection of prescription quantity, stir and make to dissolve, then adjust pH value to 6.0~6.5 with sodium hydroxide, 0.22 μm filter membrane sterile filtration, press each 2ml sterile aliquots, prepared into sterile freeze-dried powder according to the freeze-drying process.

[0041] (2) Take 60% of the prescription amount of water for injection, slowly add the polycarbophil of the prescription amount, swell the liquid, stir to make it even, and sterilize it by autoclaving at 121°C for 30 minutes; take another 40% of the prescription amount of water for injection, Add mannitol, sodium citrate, sodium chloride, benzalkonium chloride, disodium edetate, polysorbate-80 successively, stir to dissolve, filter aseptically with a 0.22 μm filter membrane; then mix...

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PUM

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Abstract

The invention discloses a production method of sterile stable azithromycin eye drops. The sterile stable azithromycin eye drops comprise a sterile solid drug packaged individually and a special-purpose solvent for dissolving the sterile solid drug. The sterile solid drug contains an active component and pharmaceutically acceptable auxiliary materials. The active component is azithromycin. According to the production method, the active component azithromycin and the pharmaceutically acceptable auxiliary materials are prepared into sterile freeze-dried powder and the sterile freeze-dried powder is dissolved in the special-purpose sterile solvent in clinical use. The production method can improve stability of the azithromycin eye drops, realize production of the sterile stable azithromycin eye drops, and improve safety of the sterile stable azithromycin eye drops in use.

Description

technical field [0001] A method for producing sterile and stable azithromycin eye drops. Background technique [0002] Eye infection is a common ophthalmic disease. Clinical bacterial research results show that local infection is often caused by bacteria. Antibacterial drugs such as chloramphenicol, aminoglycosides, fluoroquinolones, and macrolide antibiotics are commonly used in clinical treatment. However, chloramphenicol, aminoglycosides, and fluoroquinolones all have certain side effects and are limited in clinical use, while macrocyclic ester antibacterials have unique advantages in the treatment of eye diseases due to their small adverse reactions. Macrocyclic ester antibiotics are broad-spectrum antibiotics, which are effective against a variety of Gram-negative and positive bacteria, mycoplasma, chlamydia, spirochete and rickettsia. The main adverse reactions are gastrointestinal reactions, abdominal discomfort, nausea, and vomiting Wait. At present, the domestic u...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K9/19A61K31/7052A61P31/04A61P27/02
Inventor 肖学成袁文才肖思芮
Owner WUHAN NUOAN PHARMACY
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