Azithromycin granule and preparation method thereof

A technology for azithromycin and granules, applied in the field of azithromycin granules and its preparation, can solve the problems of low dissolution and poor solubility of preparations, achieve good dissolution, improve poor solubility, and have high practical value

Inactive Publication Date: 2017-01-04
SHANGHAI HUA SURNAME PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The problem to be solved by the present invention is that, in order to overcome the poor solubility of azithromycin in the prior art and the low d

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Example Embodiment

[0027] Example 1

[0028] Azithromycin granules specifications: 0.1g

[0029] 1. Formula:

[0030] Azithromycin 100g, sucrose 400g, pregelatinized starch 125g, sodium starch glycolate 150g, mannitol 150g, steviol 75g, proper amount of ethanol, orange flavor 0.83g

[0031] 2. Preparation process:

[0032] After mixing azithromycin, sucrose, pregelatinized starch, sodium starch glycolate, mannitol, and stevia, use 80% ethanol solution to make soft material, and the soft material is passed through a 12-mesh sieve to make wet granules. The wet granules are boiled or in an oven After the granules are dried, collect the granules between 12 and 60 meshes, add orange flavor and mix uniformly, and pack the granules, each bag is about 1g (containing 0.1g azithromycin).

[0033] The finished azithromycin granules are tested according to the standards of the 2010 edition of the Chinese Pharmacopoeia, and they should all meet the requirements.

[0034] The inspection items include: character, identif...

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Abstract

The invention discloses an azithromycin granule and a preparation method thereof. The azithromycin granule comprises azithromycin and pharmaceutically acceptable carriers. The preparation method of the azithromycin granule comprises the following steps of uniformly mixing the azithromycin with the pharmaceutically acceptable carriers except for a wetting agent; and then adding the wetting agent into the mixture so as to prepare a soft material, and then performing sieving, boiling or drying. The azithromycin granule is good in dissolution rate, has relatively high practicability, and is capable of solving the problem that the azithromycin granule is low in medicine efficiency due to poor solubility.

Description

technical field [0001] The invention relates to azithromycin granules and a preparation method thereof. Background technique [0002] Azithromycin is a new generation of macrolide antibiotics, developed by Pliva Company in Croatia, and launched worldwide in 1988. Because of its broad antibacterial spectrum, long biological half-life, high tissue permeability, good chemical and biological stability, small adverse reactions, good tolerance, less frequency of medication (1 time / day), short course of treatment, etc., it is popular in the market. favor. At present, the drug has been widely used clinically for infections of the respiratory tract, skin soft tissue and genitourinary system. Compared with erythromycin, azithromycin is chemically stable in acid, and domestic azithromycin clinically commonly used dosage forms have been developed in addition to injections, and many dosage forms such as oral tablets and capsules have been developed. In recent years, with the developme...

Claims

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Application Information

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IPC IPC(8): A61K9/16A61K31/7052A61K47/26A61K47/46A61P31/04A61P11/00A61P17/00A61P19/04A61P13/00A61P15/00
Inventor 毕德忠张雷
Owner SHANGHAI HUA SURNAME PHARMA
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