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Azithromycin for suspension and its preparing method

A technology of azithromycin and dry suspension, which is applied in the field of dry suspension of azithromycin for medicine and its preparation, which can solve the problems of difficult to effectively cover up the bitter taste of the drug and poor dissolution of the drug, and achieve wide application, tight packaging and stable good sex effect

Active Publication Date: 2006-08-09
HAINAN PULIN PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] The purpose of the present invention is to overcome the problems that existing azithromycin tablets and capsules are not suitable for children, the elderly and patients with dysphagia, and that granules and dry suspensions are difficult to effectively cover the bitter taste of the drug and the dissolution rate of the drug is poor. An oral azithromycin dry suspension that is not only suitable for adults but also especially suitable for children, the elderly and patients with dysphagia, has better stability, good absorption, fast onset and high bioavailability, and this dosage form is not like The absorption of capsules is affected by eating, which greatly improves the patient's compliance with medication

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0039] Preparation:

[0040] (1) Prepare 10% Eudragit E100 (butyl methacrylate: dimethylaminoethyl methacrylate: methyl methacrylate 25:50:25 copolymer) solution;

[0041] (2) Azithromycin, sucrose, mannitol, and sodium phosphate are passed through an 80-mesh sieve and mixed in the top spray of the fluidized bed, the inlet air temperature is 40°C, and the pressure is 0.25 MPa;

[0042] (3) Spray Eudragit E100 (butyl methacrylate: dimethylaminoethyl methacrylate: methyl methacrylate 25: 50: 25 copolymer) solution;

[0043] (4) Top spray drying, the inlet temperature is 50°C, and the drying time is 70 minutes;

[0044] (5) Granulation: Weigh the remaining sucrose and mannitol to mix the alcoholic solution to granulate, dry the granules, screen the granules obtained, and select a 30-mesh sieve;

[0045] (6) Mixing: Manually mix the coating raw materials, sucrose and mannitol granules according to the same increasing method, and then mix the remaining raw and auxiliary ma...

Embodiment 2

[0048] Preparation:

[0049] (1) No. IV acrylic resin solution of preparation 10%;

[0050] (2) Azithromycin, sucrose, mannitol, and sodium phosphate are passed through an 80-mesh sieve and mixed in the top spray of a fluidized bed, the inlet air temperature is 40°C, and the pressure is 0.5 MPa;

[0051] (3) spray No. IV acrylic resin solution;

[0052] (4) Top spray drying, the inlet air temperature is 50°C, and the drying time is 100 minutes;

[0053] (5) Granulation: Weigh the remaining sucrose and mannitol and mix them evenly to granulate the alcoholic solution, dry the granules, screen the obtained granules, and select a 50-mesh sieve;

[0054] (6) Mixing: Mix the coating materials, sucrose and mannitol granules in an equal increment method, and then mix with the remaining raw and auxiliary materials in the same way and dry.

Embodiment 3

[0056] time min

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PUM

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Abstract

The present invention relates to a dried suspension preparation of medicinal azithromycin and its preparation method. Said dried suspension preparation includes (by wt%) 0.1-20% of azithromycin, 1-10% of lubricant flow aid, 0.1-10% of pH value regulating agent, 10-40% of high-molecular adhesive, 50-85% of sweetener and 0.5-15% of aromatic corrective.

Description

technical field [0001] The invention relates to a dry suspension of azithromycin for medicine and a preparation method thereof. Background technique [0002] Azithromycin is the most commonly used anti-infective drug clinically, and it has a good therapeutic effect on infections caused by a variety of sensitive strains. Erythromycin (Ery) has been used clinically for decades. However, because of its instability to acid, low blood concentration, large dose, and toxicity to the liver, relevant scientists have developed a series of new macrolide derivatives by modifying its chemical structure. Azithromycin (Azithromycin, Azi) has the advantages of acid stability, long half-life, high drug concentration in tissues and cells at the infection site, significant curative effect, good safety and tolerance. [0003] Azithromycin achieves its antibacterial effect by inhibiting the surface of ribosomal 50s subunit protein. It has antibacterial activity again...

Claims

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Application Information

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IPC IPC(8): A61K9/16A61K9/14A61K31/7052A61P31/04
Inventor 范敏华
Owner HAINAN PULIN PHARMA
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