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Roxithromycin injection and preparation process thereof

A technology of roxithromycin and roxithromycin aspartate is applied in the field of preparation of roxithromycin aspartate freeze-dried powder injection and solution injection, can solve problems such as incompatibility and waste, and achieves Effective bacteriostatic concentration, suitable pH value, good application prospect and significance effect

Inactive Publication Date: 2011-09-14
SHENYANG PHARMA UNIVERSITY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

According to literature reports, when roxithromycin is administered orally, the medicine absorbed through the gastrointestinal tract only accounts for 50% of the dosage, and the rest is all excreted, causing a lot of waste, and the oral dosage form is not suitable for some patients who cannot be administered orally. Patients with abnormal drug or gastrointestinal absorption function, as well as some patients with serious conditions are not suitable

Method used

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  • Roxithromycin injection and preparation process thereof
  • Roxithromycin injection and preparation process thereof
  • Roxithromycin injection and preparation process thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0015] Embodiment 1: the preparation of roxithromycin aspartate for injection:

[0016] The prescription consists of: (calculated on the basis of 100 sticks)

[0017] Roxithromycin 15.0g

[0018] Aspartic Acid 2.4g

[0019] Mannitol 5.0g

[0020] Water for injection 200mL

[0021] Weigh the mannitol of the prescribed amount, add water for injection to make a solution with a concentration of about 15%, and set aside. Weigh the prescribed amount of roxithromycin and aspartic acid, put them in a 250mL beaker, add about 120mL of water for injection and the above-mentioned mannitol solution, stir at room temperature until completely dissolved, add 0.16g of activated carbon for needles, and Stir for 20 minutes, filter, wash the charcoal cake twice with the remaining water for injection, combine the original solution of the washing liquid, pass through a 0.22 μm microporous membrane filter for sterilization, pack aseptically according to the predetermined dose, and freeze-dry to ...

Embodiment 2

[0022] Embodiment 2: the preparation of roxithromycin aspartate injection:

[0023] The prescription consists of: (calculated on the basis of 100 sticks)

[0024] Roxithromycin 15.0g

[0025] Aspartic Acid 2.4g

[0026] Water for injection 200mL

[0027] Weigh the prescribed amount of roxithromycin and aspartic acid, place in a 250mL beaker, add about 160mL of water for injection, stir at room temperature until fully dissolved, add 0.16g of activated carbon for needles, stir at 40°C for 20 minutes, filter After that, the charcoal cake was washed twice with the remaining water for injection, and the stock solution of the lotion was combined and filtered through a 0.45 μm microporous membrane, divided into ampoules according to the predetermined dose, and sterilized by circulating steam at 100°C for 30 minutes.

Embodiment 3

[0028] Embodiment 3: the preparation of roxithromycin aspartate infusion:

[0029] The prescription consists of: (calculated on the basis of 100 sticks)

[0030] Roxithromycin 15.0g

[0031] Aspartic Acid 2.4g

[0032] Sodium chloride 90.0g

[0033] Water for injection 10000mL

[0034] Weigh the prescribed amount of roxithromycin, aspartic acid and sodium chloride, put them in a 10000mL beaker, add about 8000mL of water for injection, stir at room temperature until completely dissolved, add 80.0g of activated carbon for needles, and stir at 40°C After 20 minutes, filter, wash the charcoal cake twice with the remaining water for injection, combine the original solution of the lotion and filter through a 0.45 μm microporous membrane, pack it into infusion bottles according to the predetermined dose, and sterilize it at 115°C for 30 minutes. .

[0035] The following test data can illustrate the benefits of the present invention:

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Abstract

The invention relates to an eritrocina injection, wherein the invention has high solubility, used in vein injection. The eritrocina and aspartic acid will react in water and room temperature to generate soluble salt, while they react in equal mol number; the injection contains 50-500mg eritrocina, and the solution can be made into injection or powder via added supporter. The invention has quick drug release, high stability and quick treatment.

Description

technical field [0001] The present invention relates to a kind of roxithromycin injection, more specifically, relate to the lyophilized powder injection of roxithromycin aspartate and the solution type injection, the present invention also provides roxithromycin aspartate freeze-dried Preparation method of powder injection and solution injection. Background technique [0002] Roxithromycin (RXM) is a new type of macrolide antibiotic that was put into clinical practice in the early 1990s. Its chemical name is (9E)-[O-[(2-methoxyethoxy)methyl]oxime Base] erythromycin, which introduces an oxime ether side chain at the 9-position of erythromycin, thus improving its acid resistance and stability. Its antibacterial spectrum is similar to that of erythromycin, and it has strong antibacterial effect on Gram-positive bacteria, and it also has good antibacterial effect on Gram-negative bacteria such as meningococcus, gonorrhoeae, influenza bacillus, pertussis bacillus, Brucella, etc....

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/7048A61K9/08A61K9/19A61P31/04A61K31/198
Inventor 何仲贵方金玲刘晓红
Owner SHENYANG PHARMA UNIVERSITY
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