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Amoxicillin granules and preparation technology of same

A technology of amoxicillin and granules, applied in the field of amoxicillin granule preparation and preparation thereof, can solve the problems of large amount of solvent and high safety risk of high-concentration ethanol, and achieves reduction of polymer impurities, improvement of production safety, and improvement of solubility. Effect

Active Publication Date: 2013-03-20
NANJING CHANGAO PHARM CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In patent CN102000033B, more than 90% ethanol and syrup are used for granulation, and the drying temperature is controlled between 55-65°C. However, due to the large amount of solvent, the safety risk of high-concentration ethanol is extremely high

Method used

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  • Amoxicillin granules and preparation technology of same
  • Amoxicillin granules and preparation technology of same
  • Amoxicillin granules and preparation technology of same

Examples

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Effect test

reference example 1

[0017] Example 1 in the patent CN102000033B.

[0018]

[0019] Preparation Process:

[0020] (1) Weigh Amoxicillin.

[0021] (2) Mix and grind citric acid, sodium citrate, lemon yellow and sucrose through an 80-mesh sieve.

[0022] (3) Prepare the binder solution, and prepare 1.0wt% sodium carboxymethylcellulose in 95% ethanol and 66.52wt% syrup in proportion.

[0023] (4) Mix amoxicillin and excipients, add binder solution, place in the hopper of a high-efficiency wet granulator, close the material box, turn on the paddle and cutter and mix at low speed for 5 minutes, stop stirring, and add 95% Appropriate amount of ethanol, turn on the paddle stirring and cutter, stir at a slow speed for 120 seconds, stop stirring, add 1% sodium carboxymethyl cellulose slurry, and stir at a high speed for 60 seconds, add syrup from the observation port, and stir at a high speed From 180 seconds to 240 seconds, use the cleaned and disinfected material barrel to receive the wet granules,...

reference example 2

[0028]

[0029] Preparation Process

[0030] (1) Weigh amoxicillin, lactose, mannitol, stevioside, sucrose, and sodium carboxymethylcellulose for subsequent use;

[0031] (2) Configuration of adhesive solution:

[0032] Put povidone K30, ethyl paraben, tartrazine, and sweet orange essence into 80 g of purified water and stir to dissolve to prepare a binder solution.

[0033] (3) Put amoxicillin, lactose, mannitol, sucrose, sodium carboxymethyl cellulose, and stevioside into the wet granulator, turn on the motor of the stirring paddle, and stir for 10 minutes; open the cover and add the adhesive solution, the granulation time is about 3 minutes.

[0034] (4) After the granulation is completed, open the discharge piston, and move the stirring paddle to discharge the wet granules. The wet granules are granulated with a wet granulator (the mesh number of the screen is 16 mesh).

[0035] (5) Start the blower to suck the material into the boiling dryer. The air inlet tempera...

Embodiment 1

[0039]

[0040] Preparation Process

[0041] (1) Weigh amoxicillin, lactose, mannitol, stevioside, sucrose, and sodium carboxymethylcellulose for subsequent use;

[0042] (2) Configuration of adhesive solution:

[0043] Put povidone K30, ethyl paraben, tartrazine, and sweet orange essence into 80 g of purified water and stir to dissolve to prepare a binder solution.

[0044] (3) Put amoxicillin, lactose, mannitol, sucrose, sodium carboxymethyl cellulose, and stevioside into the wet granulator, turn on the motor of the stirring paddle, and stir for 10 minutes; open the cover and add the adhesive solution, the granulation time is about 3 minutes.

[0045] (4) After the granulation is completed, open the discharge piston, and move the stirring paddle to discharge the wet granules. The wet granules are granulated with a wet granulator (the mesh number of the screen is 16 mesh).

[0046] (5) Start the blower to suck the material into the boiling dryer. The air inlet tempera...

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Abstract

The invention discloses amoxicillin granules and a preparation technology of the same. The amoxicillin granules are prepared by taking a pure water solution of povidone as a binding agent solution for granulation, wherein the dosage ratio of the povidone to the amoxicillin is (1:25)-(1:10) by weight percent. With the preparation technology, the production safety is improved, and the solubility and the stability of the amoxicillin granules are improved greatly.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to amoxicillin granule preparations and a preparation process thereof. Background technique [0002] Amoxicillin, also known as amoxicillin, is a semi-synthetic broad-spectrum penicillin. Enterococcus, Salmonella, Salmonella typhi and Proteus all have antibacterial effects. Because of its strong acid resistance, broad antibacterial spectrum and definite curative effect, it is widely used in clinic. [0003] Due to the instability of the β-lactam structure in the molecule of penicillin antibiotics, amoxicillin is prone to intermolecular polymerization and forms sensitizing polymer impurities, making the allergic reaction of its preparations a clinical problem that cannot be ignored. The problem. For oral amoxicillin, when the high molecular impurity (polymer) in the preparation is less than 0.2%, penicillin allergic reaction will generally not occur...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K31/43A61K47/32A61P31/04
Inventor 吴小涛吴苏敏宋祥珍薛晓兵朱月刘经辉曹芳李纬黄海燕杨晓兵
Owner NANJING CHANGAO PHARM CO LTD
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