Amoxicillin and clavulanate potassium dry suspension and preparation method thereof

A technology of potassium amoxicillin-clavulanate and potassium clavulanate, which is applied in the direction of pharmaceutical formulas, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., which can solve the problem of high cost and meet market demand , The preparation method is simple and feasible, and the effect of excellent quality stability

Active Publication Date: 2022-06-28
LUNAN PHARMA GROUP CORPORATION
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the patent only compares the dissolution in pH5.0 buffer solution and the single dose weight of the drug is about 1.2g / bag, which is costly

Method used

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  • Amoxicillin and clavulanate potassium dry suspension and preparation method thereof
  • Amoxicillin and clavulanate potassium dry suspension and preparation method thereof
  • Amoxicillin and clavulanate potassium dry suspension and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0048]

[0049]

[0050] Preparation:

[0051] 1. Drying: xanthan gum, maltodextrin (pass 80 mesh sieve first), aspartame, microcrystalline cellulose-carboxymethyl cellulose sodium,

[0052] Dry at 105°C for 4 hours, and control the moisture content of auxiliary materials to be ≤2.0%;

[0053]2. Mixing and sieving: the ambient temperature is 18~26℃, and the ambient humidity is less than or equal to 35%. First, mix succinic acid and xanthan gum and pass through an 80-mesh sieve, then add aspartame to mix and pass through an 80-mesh sieve, and then add malt. The dextrin is mixed through an 80-mesh sieve, and then microcrystalline cellulose-carboxymethyl cellulose sodium is added and mixed through an 80-mesh sieve to obtain mixed powder I; amoxicillin, potassium clavulanate and colloidal silicon dioxide are mixed through an 80-mesh sieve. Mesh sieve to get mixed powder II; finally, mix mixed powder I and II through an 80-mesh sieve and mix evenly;

[0054] 3. Total mixing...

Embodiment 2

[0058]

[0059] Preparation method: Refer to Example 1.

Embodiment 3

[0061]

[0062] Preparation method: Refer to Example 1.

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Abstract

The invention belongs to the technical field of pharmaceutical preparations, and discloses a prescription composition and a preparation method of an amoxicillin and potassium clavulanate dry suspension, and the prescription of the amoxicillin and potassium clavulanate dry suspension is formed by mixing amoxicillin, potassium clavulanate, a flavoring agent, a thickening agent, a stabilizer, a pH regulator, a diluent, a suspending aid and an aromatic. And powder is directly filled. The amoxicillin and clavulanate potassium dry suspension prepared by the preparation method disclosed by the invention is high in dissolution rate and high in stability.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a prescription composition of amoxicillin-clavulanate potassium dry suspension and a preparation process 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, its chemical structural formula is: [0003] [0004] The chemical name of potassium clavulanate is: (Z)-(2R,5R)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]heptane Potassium alkane-2-carboxylate, its chemical structural formula is: [0005] [0006] Amoxicillin is a white or off-white crystalline powder, slightly soluble in water, and almost insoluble in ethanol. Solubility in various pH dissolution media (37°C): pH1.2: 30.7mg / ml, pH4.0: 3.8mg / ml, pH 6.8: 4.9mg / ml, water: 3.6mg / ml, it can be seen that the solubility of amoxicillin...

Claims

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Application Information

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Patent Type & AuthorityApplications(China)
IPC IPC(8): A61K9/14A61K47/36A61K47/38A61K47/26A61K47/04A61K31/43A61K31/424A61P31/04
CPCA61K9/146A61K9/145A61K9/143A61K31/43A61K31/424A61P31/04A61K2300/00Y02A50/30
Inventor李宝杰赵伟陈赫
OwnerLUNAN PHARMA GROUP CORPORATION