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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, when using amorphous cefditoren pivoxil to prepare pharmaceutical preparations, it is sensitive to light, temperature and humidity and has poor stability, and is easily converted into crystalline cefditoren pivoxil Tolenpimate requires strict control of the processing time of each step in the production process and the ambient temperature and humidity

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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