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Amoxicillin particle and preparation process thereof

A technology of amoxicillin and granules, which is applied in the field of amoxicillin granules and its preparation technology, can solve the problems of easily decomposed allergic polymer impurities, poor stability, etc., to avoid penicillin allergic reactions, improve stability, curative effect and The effect of security assurance

Active Publication Date: 2011-04-06
HAINAN SIMCERE PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The purpose of the present invention is to solve the problem of poor stability of amoxicillin in production and easy decomposition to produce allergic polymer impurities. By adding a low-moisture and volatile binder solution when making soft materials, and using low-temperature drying and other technologies , so as to provide an amoxicillin granule preparation, which ensures the stability of the drug during the production process and storage

Method used

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  • Amoxicillin particle and preparation process thereof
  • Amoxicillin particle and preparation process thereof
  • Amoxicillin particle and preparation process thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0042]

[0043] Preparation Process:

[0044] (1) Weigh Amoxicillin.

[0045] (2) Mix and pulverize auxiliary materials such as citric acid, sodium citrate, tartrazine, sodium carboxymethylcellulose and sucrose, and pass through an 80-mesh sieve.

[0046](3) Prepare an adhesive solution, which is prepared in proportion to 1.0wt% sodium carboxymethylcellulose in 95% ethanol solution and 66.52wt% syrup.

[0047] (4) Mix amoxicillin and auxiliary materials, add binder solution, place in the hopper of a high-efficiency wet granulator, close the material box, turn on the paddle and the cutter to mix at low speed for 5 minutes, stop stirring, and add 95% Proper amount of ethanol, turn on the paddle stirring and cutter, stir at a slow speed for 120 seconds, stop the stirring, add 1% sodium carboxymethyl cellulose slurry, and when the high-speed stirring reaches 60 seconds, add syrup from the observation port, and stir at a high speed From 180 seconds to 240 seconds, use the clea...

Embodiment 2

[0053]

[0054]

[0055] Preparation Process:

[0056] (1) Weigh Amoxicillin.

[0057] (2) Mix and pulverize auxiliary materials such as citric acid, sodium citrate, tartrazine, sodium carboxymethylcellulose and sucrose, and pass through an 80-mesh sieve.

[0058] (3) Prepare an adhesive solution, which is prepared in proportion to 1.0% carboxymethylcellulose sodium in 95% ethanol solution and 70.0% syrup.

[0059] (4) Mix amoxicillin and auxiliary materials, add binder solution, place in the hopper of a high-efficiency wet granulator, close the material box, turn on the paddle and the cutter to 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 1.0% sodium carboxymethyl cellulose slurry, and when the high-speed stirring reaches 60 seconds, add syrup from the observation port, and stir at a high speed From 180 seconds to 240 seconds, u...

Embodiment 3

[0065]

[0066] Preparation Process:

[0067] (1) Weigh Amoxicillin.

[0068] (2) Mix and pulverize auxiliary materials such as citric acid, sodium citrate, tartrazine, sodium carboxymethylcellulose and sucrose, and pass through an 80-mesh sieve.

[0069] (3) Prepare an adhesive solution, which is prepared in proportion to 1.0% carboxymethylcellulose sodium in 95% ethanol solution and 65% syrup.

[0070] (4) Mix amoxicillin and auxiliary materials, add binder solution, place in the hopper of a high-efficiency wet granulator, close the material box, turn on the paddle and the cutter to 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 1.0% sodium carboxymethyl cellulose slurry, and when the high-speed stirring reaches 60 seconds, add syrup from the observation port, and stir at a high speed From 180 seconds to 240 seconds, use the cleaned...

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Abstract

The invention discloses an amoxicillin particle and a preparation process thereof. In the preparation process of the amoxicillin particle, a low-moisture volatile adhesive solution and a cold drying technology are adopted. The invention has the advantages that the stability of the amoxicillin particle is enhanced; and within the 36-month valid period of the amoxicillin particle, the safety and validness of the amoxicillin particle in clinical use are ensured, and no penicillin anaphylaxis is generated.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a stable amoxicillin granule preparation 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] The chemical name of amoxicillin is: 6-[2-amino-2-(4-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-aza Bicyclo[3.2.0]heptane-2-carboxylic acid trihydrate, 6-[2-Amino-2-(4-hydroxyphenyl)-acetyl]amino-3, 3-dimethyl-7-oxo-4-thia-1 -azabicyclo[3.2.0]heptane-2-carboxylic acidtrihydrate, whose structural formula is: [0004] [0005] Molecular formula: C16H19N3O5S 3H2O Molecular weight: 419.46 [0006] Due to the instability of the...

Claims

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Application Information

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IPC IPC(8): A61K9/16A61K31/43A61K47/38A61P31/04
Inventor 罗兴洪周进东周静赵耀军任晋生
Owner HAINAN SIMCERE PHARMA CO LTD
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