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Azithromycin eye drops and preparing process thereof

A technology for azithromycin and eye drops, which is applied in pharmaceutical formulations, medical preparations containing active ingredients, drug delivery, etc. It can solve problems affecting the normal flora of the gastrointestinal tract and achieve clarity, stability, and dosage less, stable performance

Inactive Publication Date: 2008-01-16
陕西省眼科研究所
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Large doses of azithromycin not only cause serious side effects, but also affect the normal flora in the gastrointestinal tract

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] Azithromycin 3.0g (calculated as 1000 units per mg of azithromycin)

[0020] Lactobionic acid (solvent) 2.9g Ethylparaben 0.3g

[0021] Disodium hydrogen phosphate 12.0g Sodium dihydrogen phosphate 5.2g

[0022] Sodium Chloride 2.2g Sodium Hyaluronate 0.5g

[0023] Glycerol 30mL (ml)

[0024] Add 1000mL (milliliter) of water for injection.

[0025] Its preparation process:

[0026] (1) Call azithromycin according to the prescription, add a small amount of water for injection to make azithromycin into a suspension, then add cosolvent-lactobionic acid to completely dissolve azithromycin, then add stabilizer-glycerol to prepare solution 1, set aside;

[0027] (2) Take water for injection, add pH regulator-disodium hydrogen phosphate and sodium dihydrogen phosphate, preservative-ethylparaben, isotonic agent-sodium chloride, viscous agent-sodium hyaluronate, adjust the pH value 6.0-7.5, make solution 2, set aside;

[0028] (3) Combine solution 1 and solution 2, add wat...

Embodiment 2

[0031] Azithromycin 3.0g (calculated as 1000 units per mg of azithromycin)

[0032] Fumaric acid 0.5g Ethylparaben 0.3g

[0033] Disodium hydrogen phosphate 12.0g Sodium dihydrogen phosphate 5.2g

[0034] Sodium Chloride 2.2g Sodium Hyaluronate 0.5g

[0035] Glycerol 30mL

[0036] Add 1000mL of water for injection.

[0037] Preparation process: In the process of the above-mentioned embodiment 1, the lactobionic acid is replaced by fumaric acid, and the operation is the same.

Embodiment 3

[0039] Azithromycin 3.0g (calculated as 1000 units per mg of azithromycin)

[0040] Maleic acid 0.5g Ethylparaben 0.3g

[0041] Disodium hydrogen phosphate 12.0g Sodium dihydrogen phosphate 5.2g

[0042] Sodium Chloride 2.2g Sodium Hyaluronate 0.5g

[0043] Glycerol 30mL

[0044] Add 1000mL of water for injection.

[0045] Preparation process: In the process of the above-mentioned embodiment 2, fumaric acid is replaced by maleic acid, and the same method is operated.

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PUM

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Abstract

The invention discloses azithromycin eye drops and the preparation. The eye drops is a stable ophthalmic preparation made by azithromycin or axithromycin salt as the active ingredient which is assisted by a stabilizer, a pH regulator, an antiseptic, an isotonic agent and a pasting agent; wherein the optimized stabilizer is propanetriol, the pH regulator is sodium phosphate buffer, the antiseptic is Ethyl p-hydroxybenzoate, the isotonic agent is sodium chloride and the pasting agent is sodium hyaluronate. Compared with oral delivery, the invention has the advantages of less dose, small side effect on a whole body, direct absorption at the ocular region, quick achieving effective antibacterial concentration and quick developing treating function; and compared with ophthalmic gel or ophthalmic ointment, the invention has the advantages of convenient application and good tolerance for a patient; thus the reasonable preparation process and stable performance of the invention guarantees the clarity and stability of eye drops.

Description

technical field [0001] The invention relates to an eye drop and a preparation method thereof, in particular to an azithromycin eye drop and a preparation method thereof. Background technique [0002] Azithromycin preparations are now a mature variety for clinical application. Its raw materials, tablets, and capsules have been included in the 2000 and 2005 editions of the Chinese Pharmacopoeia. Currently, the approved production forms include dispersible tablets, granules, injections, infusions, and dry suspensions. and dry syrup etc. So far, my country's SFDA has issued 25 API production numbers, 194 preparation production numbers, and more than 150 brands of different specifications and dosage forms. However, its eye drops have always been in the blank field. Through years of experiments, our institute has successfully solved its stability problem and formulated azithromycin eye drops suitable for clinical application. [0003] Azithromycin (Azithromycin, C 38 h 72 N 2...

Claims

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Application Information

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IPC IPC(8): A61K31/7052A61K9/08A61P27/02A61P31/00
Inventor 朱秀萍王养正潘士印
Owner 陕西省眼科研究所
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