Cefditoren pivoxil tablet and preparation method thereof

A technology of cefditoren pivoxil and cefditoren, which is applied in the direction of pharmaceutical formulations, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., can solve the problem of sensitivity to light, temperature, humidity, and unfavorable clinical absorption , poor stability and other issues, to achieve the effect of high dissolution rate, simple and flexible operation, and stable quality

Active Publication Date: 2021-02-05
SHENZHEN LIJIAN PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Cefditoren pivoxil has two states of crystalline form and amorphous form. Crystalline cefditoren pivoxil has strong stability, but poor solubility, which is not conducive to clinical absorption; amorphous cefditoren pivoxil has better solubility, Oral absorption is significantly better than that of crystalline cefditoren pivoxil; however, wh

Method used

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  • Cefditoren pivoxil tablet and preparation method thereof
  • Cefditoren pivoxil tablet and preparation method thereof
  • Cefditoren pivoxil tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0061] A cefditoren pivoxil tablet, in parts by weight, comprises the following raw materials:

[0062] Cefditoren pivoxil 100 parts,

[0063] 30 parts of premix,

[0064] Mannitol 60 parts,

[0065] Chitosan 35 parts,

[0066] 10 parts of hydroxypropyl cellulose,

[0067] Glycine 2.5 parts,

[0068] 2.5 parts of talcum powder,

[0069]The premix comprises 66% of low-viscosity polyvinyl alcohol 1788, 10% of trehalose, 10% of lecithin, 8% of mannitol and 6% of titanium dioxide in terms of mass percentage.

[0070] The preparation method of above-mentioned cefditoren pivoxil tablet:

[0071] A. Preparation of acidic hypromellose solution:

[0072] Take about 7L of 1mol / L hydrochloric acid solution, add hypromellose E610g, stir to dissolve completely,

[0073] Cool to 0-5°C and set aside;

[0074] B. At 0-5°C, stir and disperse 1 kg of crystalline cefditoren pivoxil in the acidic hypromellose solution prepared in A until completely dissolved;

[0075] C, the solution th...

Embodiment 2

[0082] A cefditoren pivoxil tablet, in parts by weight, comprises the following raw materials:

[0083] Cefditoren pivoxil 100 parts,

[0084] 30 parts of premix,

[0085] Mannitol 50 parts,

[0086] Chitosan 40 parts,

[0087] 15 parts of hydroxypropyl cellulose,

[0088] Glycine 2 parts,

[0089] 2 parts talcum powder;

[0090] The premix comprises 66% of low-viscosity polyvinyl alcohol 1788, 10% of trehalose, 10% of lecithin, 8% of mannitol and 6% of titanium dioxide in terms of mass percentage.

[0091] The preparation method is the same as in Example 1.

Embodiment 3

[0093] A cefditoren pivoxil tablet, in parts by weight, comprises the following raw materials:

[0094] Cefditoren pivoxil 100 parts,

[0095] 30 parts of premix,

[0096] Mannitol 80 parts,

[0097] Chitosan 20 parts,

[0098] 8 parts of hydroxypropyl cellulose,

[0099] Glycine 5 parts,

[0100] 3 parts talcum powder;

[0101] The premix comprises 66% of low-viscosity polyvinyl alcohol 1788, 10% of trehalose, 10% of lecithin, 8% of mannitol and 6% of titanium dioxide in terms of mass percentage.

[0102] The preparation method is the same as in Example 1.

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Abstract

The present invention discloses a cefditoren pivoxil tablet. The cefditoren pivoxil tablet comprises the following raw materials in parts by weight: 90-120 parts of cefditoren pivoxil, 20-40 parts ofa premix, 50-80 parts of mannitol, 20-40 parts of chitosan, 8-15 parts of hydroxy propyl cellulose, 2-5 parts of glycine and 2-5 parts of talcum powder. The premix comprises the following components in percentage by mass: 60-80% of low-viscosity polyvinyl alcohol, 5-10% of trehalose, 5-10% of lecithin, 5-10% of mannitol and 5-10% of titanium dioxide. The present invention also discloses a preparation method of the cefditoren pivoxil tablet. The prepared cefditoren pivoxil tablet improves quality stability while ensuring a dissolution rate.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a cefditoren pivoxil tablet and an application thereof. Background technique [0002] Cefditoren Pivoxil (Cefditoren Pivoxil), chemical name: (-)-(6R,7R)-2,2-dimethylpropionyloxymethyl 7-[(Z)-2-(2-amino-4 -Thiazolyl)-2-methoxyiminoacetamido]-3-[(Z)-2-(4-methyl-5-thiazolyl)ethenyl]-8-oxo-5-thia- 1-Azabicyclo[4.2.0]oct-2-ene-2-carboxylate, developed by Meiji Seika Co., Ltd., was first listed on April 1, 1994; it can treat various infectious diseases such as Respiratory tract, skin infection, urinary tract infection, etc. [0003] Cefditoren pivoxil has two states of crystalline form and amorphous form. Crystalline cefditoren pivoxil has strong stability, but poor solubility, which is not conducive to clinical absorption; amorphous cefditoren pivoxil has better solubility, Oral absorption is significantly better than that of crystalline cefditoren pivoxil; how...

Claims

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Application Information

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IPC IPC(8): A61K9/28A61K47/38A61K47/36A61K47/32A61K47/26A61K47/24A61K47/18A61K47/02A61K31/546A61P31/04
CPCA61K9/2009A61K9/2013A61K9/2018A61K9/2027A61K9/205A61K9/2054A61K9/28A61K31/546A61P31/04
Inventor 宋珊珊高春花陈达红
Owner SHENZHEN LIJIAN PHARM CO LTD
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