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Children amoxicillin-potassium clavulanate composition

A technology of amoxicillin-clavulanate potassium and its composition, which is applied in the field of freeze-dried orally disintegrating tablets of children's amoxicillin-clavulanate potassium composition and its preparation, to maintain porosity, good stability, and high safety Effect

Active Publication Date: 2012-07-04
HAINAN WEI KANG PHARMA QIANSHAN
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

And there is no amoxicillin-clavulanate potassium orally disintegrating tablet on the market at present, in view of this, propose the present invention

Method used

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  • Children amoxicillin-potassium clavulanate composition
  • Children amoxicillin-potassium clavulanate composition
  • Children amoxicillin-potassium clavulanate composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0045] Taking 120mg / tablet as an example to prepare children's amoxicillin-clavulanate potassium composition freeze-dried orally disintegrating tablets,

[0046] Prescription: 1000 tablets

[0047]

[0048] Preparation Process:

[0049] Dissolve the prescribed amount of amoxicillin clavulanate potassium in the prescribed amount of tert-butanol (solution a), stir and dissolve at room temperature, continue to stir, and dissolve the prescribed amount of mannitol and sucralose in the prescription for purification 70%-80% of the total water in purified water (solution b); then dissolve the prescribed amount of gelatin and xanthan gum in the purified water of 20%-30% of the prescribed water amount (solution c), and heat until completely dissolved ; Combine the above two solutions of b and c to form solution d, and stir evenly, and then cool the mixed solution to about 5°C. Mix the two solutions a and d, stir well, and adjust the pH value to 6.0-6.5 with sodium bicarbonate. Ac...

Embodiment 2

[0051] Taking 120mg / tablet as an example to prepare children's amoxicillin-clavulanate potassium composition freeze-dried orally disintegrating tablets,

[0052] Prescription: 1000 tablets

[0053]

[0054] Preparation Process:

[0055] Dissolve the prescribed amount of amoxicillin clavulanate potassium in the prescribed amount of tert-butanol (solution a), stir and dissolve at room temperature, continue to stir, and dissolve the prescribed amount of mannitol and sucralose in the prescription for purification 70%-80% of the total water in purified water (solution b); then dissolve the prescribed amount of gelatin and xanthan gum in the purified water of 20%-30% of the prescribed water amount (solution c), and heat until completely dissolved ; Combine the above two solutions of b and c to form solution d, and stir evenly, and then cool the mixed solution to about 5°C. Mix the two solutions a and d, stir well, and adjust the pH value to 6.0-6.5 with sodium bicarbonate. Ac...

Embodiment 3

[0057] Taking 120mg / tablet as an example to prepare children's amoxicillin-clavulanate potassium composition freeze-dried orally disintegrating tablets,

[0058] Prescription: 1000 tablets

[0059]

[0060] Preparation Process:

[0061] Dissolve the prescribed amount of amoxicillin clavulanate potassium in the prescribed amount of tert-butanol (solution a), stir and dissolve at room temperature, continue to stir, and dissolve the prescribed amount of mannitol and sucralose in the prescription for purification 70%-80% of the total water in purified water (solution b); then dissolve the prescribed amount of gelatin and xanthan gum in the purified water of 20%-30% of the prescribed water amount (solution c), and heat until completely dissolved ; Combine the above two solutions of b and c to form solution d, and stir evenly, and then cool the mixed solution to about 5°C. Mix the two solutions a and d, stir well, and adjust the pH value to 6.0-6.5 with sodium bicarbonate. Ac...

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Abstract

The invention discloses a children amoxicillin-potassium clavulanate composition, relating to the technical field of medicinal preparations. The children amoxicillin-potassium clavulanate composition comprises the following components: 24wt% of amoxicillin-potassium clavulanate (7:1), 24-72wt% of mannitol, 2-4wt% of gelatin, 0.2-1.0wt% of xanthan gum and 0.1-0.15wt% of sucralose. The invention further discloses a freeze-dried orally disintegrating tablet of the children paracetamol prepared from the composition, wherein the freeze-dried orally disintegrating tablet comprises simple components, is taken without water and chewing, disintegrates in the oral cavity of a human body within 2 seconds, has the advantages of high effect-taking speed, fewer intestinal tract residue, absorption sufficiency, low side effect and good mouthfeel, and is particularly suitable for being taken by infants and babies. Furthermore, a freeze-drying preparation method is characterized in that a tertiary butanol-water cosolvent is used as a dissolvent, so that the sublimation period of a medicine can be quickened, a freeze-drying period is shortened, the dissolution of amoxicillin and the stability of medicine are enhanced, and the crystallization of the medicine is promoted.

Description

technical field [0001] The present invention relates to the technical field of pharmaceutical preparations, in particular to a pediatric amoxicillin-clavulanate potassium composition and a pediatric amoxicillin-clavulanate potassium composition freeze-dried orally disintegrating tablet made from the composition and a preparation method thereof . Background technique [0002] Amoxicillin and clavulanate potassium are suitable for lower respiratory tract infection, otitis media, and sinusitis caused by β-lactamase-producing Haemophilus influenzae and Moraxella catarrhalis; β-lactamase-producing Staphylococcus aureus and enzyme-producing intestinal Bacteriaceae bacteria such as Escherichia coli, Klebsiella caused by urinary tract and skin and soft tissue infections; it can also be used for mild and moderate infections caused by Enterococcus. This product can also be used for the above-mentioned various infections caused by non-enzyme-producing strains of the above-mentioned ba...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/43A61K47/42A61P31/04A61K31/424
Inventor 李祖红汪六一汪金灿
Owner HAINAN WEI KANG PHARMA QIANSHAN
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