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Amoxicillin capsules and preparation method thereof

A technology of amoxicillin capsules and amoxicillin, which is applied in the field of pharmaceutical preparations, can solve the problems of uneven mixing of raw materials and disintegrants, increase the relative amount of co-solvents, and reduce the co-solvent effect of co-solvents, and achieve long-term effects. The effect of stable dissolution, simplified production configuration steps, and shortened preparation time

Active Publication Date: 2015-08-26
NORTH CHINA PHARMA COMPANY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Invention patent CN103735529A discloses a method for preparing amoxicillin dry granulation capsules. Dry granulation is adopted, and cross-linked povidone is added as a disintegrant during the granulation process. The addition of cross-linked povidone will cause capsules There are large individual differences in dissolution. In addition, crospovidone may also reduce the solubilizing effect of the co-solvent, and increase the relative addition of the co-solvent in a disguised form.
[0006] Currently commercially available amoxicillin capsules are often added with disintegrants such as crospovidone and sodium carboxymethyl starch for granulation to achieve rapid disintegration and rapid dissolution, but there are high polymer impurities, poor stability, Problems such as sudden release of capsules and large differences in individual dissolution rates caused by uneven mixing of raw materials and disintegrants

Method used

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  • Amoxicillin capsules and preparation method thereof
  • Amoxicillin capsules and preparation method thereof
  • Amoxicillin capsules and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Amoxicillin capsules, components and contents are configured according to Table 1:

[0031] Table 1 Composition and content of amoxicillin capsules

[0032] serial number

Element

Mass / g

parts by mass

purpose

1

Amoxicillin

250

100 copies

active ingredient

2

Sodium dodecyl sulfate

0.875

0.35 parts

Co-solvent

3

Talc powder

3.000

1.2 parts

Glidant

4

Magnesium stearate

3.000

1.2 parts

lubricant

[0033] The preparation method of amoxicillin capsule is divided into the following steps:

[0034] (A) Dry granulation: Amoxicillin is air-dried (inlet air temperature is less than 70°C) for 30 seconds and then added to a dry press (roller pressure 9MPa, roller speed 15r / min) for granulation, after granulation Machine sizing (rotating speed 120r / min), rotary vibrating sieve (20 mesh sieve) sieve, obtain amoxicillin heavy powder granule, wherein 82% of amoxi...

Embodiment 2

[0038] Amoxicillin capsules, components and contents are configured according to Table 2:

[0039] Table 2 Composition and Content of Amoxicillin Capsules

[0040] serial number

Element

Weight / g

quality score

purpose

1

Amoxicillin

250

100 copies

active ingredient

2

Sodium dodecyl sulfate

0.600

0.24 parts

Co-solvent

3

Talc powder

3.000

1.2 parts

Glidant

4

Magnesium stearate

1.475

0.59 parts

lubricant

[0041] The preparation method of amoxicillin capsule is divided into the following steps:

[0042] (A) Dry granulation: Amoxicillin is air-dried (inlet air temperature is less than 70°C) for 30 seconds into a dry press (roller pressure 7MPa, roller speed 8r / min) for granulation, after granulation Machine sizing (rotating speed 100r / min), rotary vibrating sieve (20 mesh sieve) sieving, obtain amoxicillin heavy powder granule, wherein 70% amoxicillin heavy...

Embodiment 3

[0046] Amoxicillin capsules, components and contents are configured according to Table 3:

[0047] Table 3 Composition and Content of Amoxicillin Capsules

[0048] serial number

Element

Weight / g

parts by mass

purpose

1

Amoxicillin

250

100 copies

active ingredient

2

Sodium dodecyl sulfate

0.60

0.24 parts

Co-solvent

3

Talc powder

3

1.2 parts

Glidant

4

Magnesium stearate

1.475

0.59 parts

lubricant

[0049] The preparation method of amoxicillin capsule is divided into the following steps:

[0050](A) Dry granulation: Amoxicillin is air-dried (inlet air temperature is less than 70°C) for 30 seconds into a dry press (roller pressure 11MPa, roller speed 12r / min) for granulation, and granulated by a granulator. Granules (rotating speed 160r / min), rotary vibrating sieve (20 mesh sieve) sieve, get amoxicillin heavy powder granules, wherein 55% amoxicillin heavy...

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Abstract

The present invention discloses amoxicillin capsules and a preparation method thereof, and belongs to the technical field of pharmaceutical preparations. The amoxicillin capsules comprise, by mass, 100 parts of amoxicillin, 0.1-1 part of sodium lauryl sulfate, 0.1-3 parts of talc powder, and 0.25-2.0 parts of magnesium stearate. According to the present invention, the raw material amoxicillin particle size and the proportion of the auxiliary material are adjusted so as to ensure the high amoxicillin dissolution, avoid the use of sodium carboxymethyl starch, cross-linked povidone and other disintegrating agents, and reduce the amoxicillin capsule volume; and the production preparation steps of the amoxicillin capsule drug are simplified, the production cost is reduced, the polymer impurity content in the amoxicillin capsules is reduced, and the production efficiency is improved.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to an amoxicillin capsule and a preparation method thereof. Background technique [0002] The chemical name of amoxicillin is (2S,5R,6R)-3,3-dimethyl-6-[(R)-(-)-2-amino-2-(4-hydroxyphenyl)acetamido] -7-Oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate, molecular formula C 16 h 19 N 3 o 5 S·3H 2 O, the molecular weight is 419.46. The properties of amoxicillin are off-white or white powder, crystalline, slightly bitter taste, insoluble in ethanol, slightly soluble in water, specific rotation in the range of +290°~+315°, and its chemical structural formula is: [0003] [0004] Amoxicillin is suitable for upper respiratory tract infections such as otitis media, sinusitis, pharyngitis, tonsillitis, etc. bacteria, Proteus mirabilis or Enterococcus faecalis, acute bronchitis, pneumonia and other lower respiratory tract infections ...

Claims

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Application Information

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IPC IPC(8): A61K9/48A61K31/43A61P31/04A61P13/02A61P15/00A61P13/00A61P11/00
Inventor 郝瑞霞王利杰严正人李树宾张丹丹赵川河王海燕马影影周捷刘丹武琳吴浩杨士宁甄长家刘亚红李兰涛张云龙程丽霞
Owner NORTH CHINA PHARMA COMPANY
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