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Lotepredenol etabonate gernebcin suspension solution and method for preparing the same

A technology of loteprednol etabonate and tobramycin, which is applied in the field of ophthalmic pharmaceutical compositions, and can solve problems such as bubbles, easy generation of large quantities, and difficulty in filling

Inactive Publication Date: 2008-04-02
BEIJING D VENTUREPHARM TECH DEV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The amount of surfactant in the pharmaceutical composition disclosed in WO2005044231 is not less than 0.1%. During the experiment, the applicant found that when the amount of surfactant is greater than 0.1%, a large number of bubbles are likely to be generated during the homogenization process. Difficulty with filling

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019] Preparation Process:

[0020] Micronize loteprednol etabonate, weigh the prescribed amount of loteprednol etabonate, tyloxapol and water for injection with a total amount of 10% into a mortar, and grind them into a uniform emulsion to obtain solution 1; Prescribed amount of tobramycin, glucose, povidone, edetate disodium and sorbic acid, add water for injection 190ml, stir and dissolve to obtain solution 2. Use triethanolamine to adjust the pH value to 5.7-5.9, and filter through a 0.22-micron membrane; add solution 1 to solution 2, and milk the homogenizer for 10 minutes, add water for injection to the full amount, and adjust the pH value to 5.7-5.9 room, filling.

Embodiment 2

[0023] Preparation Process:

[0024] Micronize loteprednol etabonate, weigh the prescribed amount of loteprednol etabonate, tyloxapol and water for injection with a total amount of 10% into a mortar, and grind them into a uniform emulsion to obtain solution 1; Prescribed amount of tobramycin, sodium chloride, povidone, edetate disodium and urotropine, add water for injection 190ml, stir and dissolve to obtain solution 2. Use sodium hydroxide to adjust the pH value to 5.7-5.9, and filter through a 0.22 micron filter membrane; add solution 1 to solution 2, and milk the homogenizer for 10 minutes, add water for injection to the full amount, and adjust the pH value to 5.7-5.9 Between, filling.

Embodiment 3

[0027] Preparation Process:

[0028] Micronize loteprednol etabonate, weigh the prescribed amount of loteprednol etabonate, tyloxapol and water for injection with a total amount of 10% into a mortar, and grind them into a uniform emulsion to obtain solution 1; Prescribed amount of tobramycin, glycerin, povidone, edetate disodium and benzalkonium chloride, add water for injection 190ml, stir and dissolve to obtain solution 2. Use sulfuric acid to adjust the pH value to 5.7-5.9, and filter through a 0.22-micron membrane; add solution 1 to solution 2, and homogenize the milk for 10 minutes, add water for injection to the full amount, and adjust the pH value to 5.7-5.9 , filling.

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PUM

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Abstract

The invention discloses an eye use compound drug combination containing lotepredenol etabonate and tobramycin. The combination contains less than 0.1 percent of tetra chloro metlbond. The preparation method of the drug combination is simple and is suitable for industrial production.

Description

technical field [0001] The invention relates to a pharmaceutical composition for treating corticosteroid steroid-responsive inflammation caused by surface bacterial infection, in particular to a pharmaceutical composition based on loteprednol etabonate or its pharmacologically acceptable salt and tobramycin The ophthalmic pharmaceutical composition or its pharmacologically acceptable salt is the active substance, and the pharmaceutical composition exists in the form of suspension. technical background [0002] Bacterial keratitis and conjunctivitis are common and frequently-occurring diseases in clinical ophthalmology. Common bacterial species are Staphylococcus, Streptococcus, Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae and so on. In recent years, the weekly incidence of ophthalmic diseases in my country is about 1.7%. Tobramycin eye drops, an antibiotic drug currently on the market, is widely used in ophthalmology. Its mechanism of action is to inhibi...

Claims

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Application Information

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IPC IPC(8): A61K31/702A61K31/56A61P27/02A61P31/02
Inventor 孟凡静
Owner BEIJING D VENTUREPHARM TECH DEV
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