Preparation method of cefditoren pivoxil granules

A technology for cefditoren pivoxil and granules, which is applied in the field of preparation of cefditoren pivoxil granules, can solve the problems of poor stability of amorphous raw materials, unstable light conditions, and cannot be stored for a long time, and achieves a reduction in the process Difficulty and risk, the effect of saving consumption and reducing production cost

Inactive Publication Date: 2022-04-12
BEIJING JIMEITANG MEDICINE RES CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

It has been verified that this process is feasible, but there are major problems: 1. The preparation workshop of the production line required by the crystal conversion process cannot meet the requirements, so it needs to be completed in the raw material workshop, so after each batch of crystal conversion, the amorphous raw materials are used in the preparation workshop. Full inspection is required (especially microbial inspection, which takes at least 7 days), and the production efficiency is low; 2. The stability of the amorphous raw material drug after crystal conversion is poor, and the conditions of high temperature, high humidity, and light are unstable, and it cannot be stored for a long time. With fresh preparation, short-term storage must also be in freezing conditions, which is not conducive to the production of preparations

Method used

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  • Preparation method of cefditoren pivoxil granules
  • Preparation method of cefditoren pivoxil granules
  • Preparation method of cefditoren pivoxil granules

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Example 1: The composition of the prescription is as follows, the information of the mixed organic solvent: acetone: ethanol: 1:2.

[0027]

[0028] Preparation Process:

[0029] 1) Material pretreatment: sucrose is pulverized through a 80-mesh sieve, and aspartame and crospovidone are all passed through an 80-mesh sieve to remove agglomerates;

[0030] 2) Adhesive configuration: Mix acetone and ethanol evenly in a ratio of 1:2, then add the prescribed amount of raw materials, hypromellose, and sodium chloride, and stir until completely dissolved;

[0031] 3) Granulation: Add the prescribed amount of sucrose, crospovidone, and aspartame into the fluidized bed, use the prepared binder for top-spray granulation, control the inlet air temperature at 50-80°C, and The wind frequency is 30-50HZ, the atomization pressure is 0.2-0.4Mpa, and the peristaltic pump speed is 20±3rpm;

[0032] 4) Drying: Control the air inlet temperature at 60-80°C, the air inlet frequency at 30...

Embodiment 2

[0035] Example 2: The composition of the prescription is as follows, the information of the mixed organic solvent: the ratio of acetone:ethanol is 1:1.

[0036]

[0037] Preparation Process:

[0038] 1) Material pretreatment: sucrose is pulverized and passed through an 80-mesh sieve, and both croscarmellose sodium and aspartame are passed through an 80-mesh sieve to remove agglomerates;

[0039] 2) Adhesive configuration: Mix acetone and ethanol evenly in a ratio of 1:1, then add the prescribed amount of raw materials, hydroxypropyl cellulose, and sodium chloride, and stir until completely dissolved;

[0040] 3) Granulation: Add the prescribed amount of sucrose, croscarmellose sodium, and aspartame into the fluidized bed, use the prepared binder for top spray granulation, and control the inlet air temperature at 60-90 ℃, air intake frequency 35-50HZ, atomization pressure 0.3-0.4Mpa, peristaltic pump speed 20±3rpm;

[0041] 4) Drying: Control the air inlet temperature at 6...

Embodiment 3

[0044] Example 3: The composition of the prescription is as follows, the information of the mixed organic solvent: the ratio of acetone:ethanol is 2:1.

[0045]

[0046] Preparation Process:

[0047] 1) Material pretreatment: sucrose is crushed and passed through an 80-mesh sieve, carboxymethyl starch sodium and sucralose are all passed through an 80-mesh sieve to remove agglomerates;

[0048] 2) Adhesive configuration: Mix acetone and ethanol evenly in a ratio of 2:1, then add the prescribed amount of raw materials, povidone K30, and sodium chloride, and stir until completely dissolved;

[0049] 3) Granulation: Add the prescribed amount of sucrose, carboxymethyl starch sodium, and sucralose into the fluidized bed, use the prepared binder for top-spray granulation, and control the inlet air temperature at 60-80°C and the air inlet frequency 30-50HZ, atomization pressure 0.2-0.4Mpa, peristaltic pump speed 20±3rpm;

[0050] 4) Drying: Control the air inlet temperature at 60...

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Abstract

The invention belongs to the technical field of medicines, and relates to a preparation method of cefditoren pivoxil granules, which is simple and stable in preparation process, and comprises the following steps of: adding a crystalline bulk drug, an adhesive and a part of flavoring agent into a mixed organic solvent as the adhesive in a granulation process, and performing top spray granulation on the adhesive, a filler, a disintegrating agent and a part of flavoring agent through a fluidized bed to obtain the cefditoren pivoxil granules. And mixing with spices to obtain the target granules. Compared with an original grinding process, the preparation process has low requirements on a production line and equipment, only a preparation workshop is needed in comparison with the original grinding process in which crystal transformation is needed in a raw material workshop, the dissolution curve of the prepared cefditoren pivoxil granules is matched with that of a reference preparation, and the stability of the cefditoren pivoxil granules is not inferior to that of the reference preparation.

Description

technical field [0001] The invention relates to a preparation method of cefditoren pivoxil granules. The preparation process is simple and stable. Compared with the original research process, it has lower requirements on the production line, equipment and technology. Compared with the original research process, it needs to be transformed in the raw material workshop. The present invention only needs the preparation production line, and the prepared cefditoren pivoxil granules The drug dissolution curve fits the reference preparation, and the stability is not inferior to the reference preparation. Background technique [0002] Cefditoren pivoxil (cefditorenpivoxil), is the third-generation oral cephalosporin antibiotics, developed by the Japanese Meiji Seika Company in 1994, for the treatment of infections caused by Gram-positive bacteria and Gram-negative bacteria, especially Gram-positive bacteria of the genus Staphylococcus, Streptococcus including Streptococcus pneumonia...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K47/38A61K47/32A61K31/546A61P31/04
Inventor 张龙杰刘晓明李利芳赵德千
Owner BEIJING JIMEITANG MEDICINE RES CO LTD
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