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Preparation technology of amoxicillin dispersible tablet

A technology for the preparation of amoxicillin, which is applied in the field of pharmaceutical synthesis, can solve problems such as critical raw material requirements, poor powder fluidity, and large differences in tablet weight, and achieve the effects of optimized formula, short disintegration time, and fast onset of action

Active Publication Date: 2019-03-08
SICHUAN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The technical problem to be solved by the present invention is: the existing powder direct compression method to prepare amoxicillin dispersible tablets has the disadvantages of poor powder fluidity, large difference in tablet weight, powder compression is easy to cause lobes and other weaknesses, and the requirements for raw materials are more critical, The present invention provides a kind of preparation technology of amoxicillin dispersible tablet that solves the above problems

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] The present embodiment provides a kind of preparation technology of amoxicillin dispersible tablet, concrete steps are:

[0028] In step 1, the original drug of amoxicillin and the auxiliary materials are respectively pulverized, the particle size of amoxicillin is 40-60 mesh, and the particle size of the auxiliary materials is 60-80 mesh;

[0029] Step 2, placing the pulverized amoxicillin original drug and auxiliary materials in a ball mill for ball milling and mixing to form a mixture, and the particle size of the mixture after ball milling is 80-100 mesh;

[0030] Step 3, adding ethanol to the mixture prepared in step 2, the ratio of the total mass of the mixture to the mass of the added ethanol is 5; after uniform stirring, tableting, drying, crushing, and sieving to obtain the primary molding material, the pressure of the tableting operation is 1.8MPa, the particle size of the sieved material is 40-60 mesh; when the material is dried, vacuum drying is used, the dr...

Embodiment 2

[0039] The present embodiment provides a kind of preparation technology of amoxicillin dispersible tablet, concrete steps are:

[0040] In step 1, the original drug of amoxicillin and the auxiliary materials are respectively pulverized, the particle size of amoxicillin is 40-60 mesh, and the particle size of the auxiliary materials is 60-80 mesh;

[0041] Step 2, placing the pulverized amoxicillin original drug and auxiliary materials in a ball mill for ball milling and mixing to form a mixture, and the particle size of the mixture after ball milling is 80-100 mesh;

[0042] Step 3, adding ethanol to the mixture prepared in step 2, the ratio of the total mass of the mixture to the mass of the added ethanol is 7; after uniform stirring, tableting, drying, crushing, and sieving to obtain the primary molding material, the pressure of the tableting operation is 2.1MPa, the particle size of the sieved material is 40-60 mesh; when the material is dried, vacuum drying is used, the dr...

Embodiment 3

[0051] The present embodiment provides a kind of preparation technology of amoxicillin dispersible tablet, concrete steps are:

[0052]In step 1, the original drug of amoxicillin and the auxiliary materials are respectively pulverized, the particle size of amoxicillin is 40-60 mesh, and the particle size of the auxiliary materials is 60-80 mesh;

[0053] Step 2, placing the pulverized amoxicillin original drug and auxiliary materials in a ball mill for ball milling and mixing to form a mixture, and the particle size of the mixture after ball milling is 80-100 mesh;

[0054] Step 3, adding ethanol to the mixture prepared in step 2, the ratio of the total mass of the mixture to the mass of the added ethanol is 7; after uniform stirring, tableting, drying, crushing, and sieving to obtain the primary molding material, the pressure of the tableting operation is 2.5MPa, the particle size of the sieved material is 40-60 mesh; when the material is dried, vacuum drying is used, the dry...

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Abstract

The invention discloses a preparation technology of an amoxicillin dispersible tablet. The preparation technology comprises the following steps: step 1, respectively smashing an amoxicillin active compound and an auxiliary material; step 2, carrying out ball milling and mixing on the smashed amoxicillin active compound and the smashed auxiliary material in a ball mill, thus preparing a mixture; step 3, adding ethanol in the mixture prepared in step 2, uniformly stirring, and tabletting, drying, crushing and screening, thus obtaining a primary forming material; step 4, mixing a dried material,a secondary disintegrating agent and a lubricating agent; step 5, tabletting. The auxiliary material comprises a primary disintegrating agent, filler and an adhesive. The preparation technology provided by the invention is adopted for producing the amoxicillin dispersible tablet, the stability and the tabletting and forming efficiency of the amoxicillin dispersible tablet can be favorably ensured,the disintegration time of the amoxicillin dispersible tablet is short, and the dissolution uniformity is good, so that a drug can take effect quickly and can be quickly absorbed, and the bioavailability of the drug can be increased.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical synthesis, in particular to a preparation process of amoxicillin dispersible tablets. Background technique [0002] Amoxicillin Dispersible Tablets is a new type of tablet prepared with amoxicillin as the raw material drug, which can be rapidly disintegrated in contact with water and form a uniform suspension, thus solving the problem of poor solubility of amoxicillin in water, which is beneficial to tissue Quickly absorbed, it has the characteristics of high gastrointestinal absorption rate and low side effects. Most of the amoxicillin dispersible tablets currently on the market adopt the traditional production process. First, a suitable binder is used for wet granulation, and the granules are dried and then compressed into tablets. However, the raw material of amoxicillin is very sensitive to heat and humidity. The traditional wet granulation production process has an impact on the produ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K47/26A61K47/36A61K47/02A61K47/38A61K31/43
CPCA61K9/2009A61K9/2018A61K9/2054A61K9/2059A61K9/2095A61K31/43
Inventor 朱玮刘焘周燕伟
Owner SICHUAN PHARMA