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Faropenem sodium granules and preparation method thereof

A technology for faropenem sodium and granules, which is applied in the field of faropenem sodium granule components and the preparation of the faropenem sodium granules, can solve the problems of increased initial amount of substances, excessive increase of substances, poor formulation stability, and the like, and achieves reduction in volatilization, The effect of increasing stability and maintaining stability

Pending Publication Date: 2021-12-07
江苏睿实生物科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] However, faropenem sodium is sensitive to humidity and temperature, and the raw material drug is prone to produce high molecular polymers under hot and humid conditions, thereby inducing allergic reactions; at present, improper control of damp and heat in the production process of preparations leads to an increase in the initial amount of related substances in the product; faropenem Sodium granules have poor preparation stability, and related substances increase the risk of exceeding the limit during storage

Method used

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  • Faropenem sodium granules and preparation method thereof
  • Faropenem sodium granules and preparation method thereof
  • Faropenem sodium granules and preparation method thereof

Examples

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preparation example Construction

[0025] The invention provides a preparation method for preparing faropenem sodium granules, which specifically includes the following steps:

[0026] (1) Raw material premixing, weigh faropenem sodium, sucrose, mannitol, hydroxypropyl cellulose, aspartame, edetate calcium sodium, pigment yellow No. 5 and essence in the prescribed amount, and add them to the mixer Premix evenly; the raw materials are crushed and sieved in advance; the crushed and sieved process is to ensure that the average particle size is less than 150 μm after passing through a 100-120 mesh sieve; 380~420rpm, premixed propeller speed 180~220rpm

[0027] (2) Wet granulation, weigh the prescription amount of ultrapure water and add it dropwise at a constant speed to the raw materials in step (1), continue to mix evenly, and then perform wet granulation to obtain wet granules; the cutter speed of wet granulation is 1200~ 1900rpm, paddle speed 300~500rpm, paddle adding time 60~200s, granulation time 30~80s;

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Embodiment 1～4

[0034] The preparation method of the faropenem sodium granules, the main drug is ropenem sodium, the auxiliary materials are sucrose, mannitol, hydroxypropyl cellulose, calcium sodium edetate, aspartame, essence and tartrazine, and ultrapure water is used as the preparation method. granular adhesive. The present invention provides the specific components of four examples as shown in Table 1 below.

[0035] Table 1 Distribution ratio of faropenem sodium granules

[0036]

[0037] The preparation method of the faropenem sodium granules specifically includes the following steps:

[0038] (1) Raw material preparation: crush and sieve sucrose for later use, and sieve mannitol for later use; weigh faropenem sodium, sucrose, mannitol, hydroxypropyl cellulose, and aspartame in prescribed amounts, and pre- mix;

[0039](2), dissolving the prescribed amount of calcium sodium edetate and the pigment in water of the prescribed amount and making a solution for later use;

[0040] (3...

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Abstract

The invention provides a faropenem sodium granule. The faropenem sodium granule comprises the following raw material components: 12.25%-12.35% of faropenem sodium, 87.65%-87.75% of an auxiliary material and a proper amount of ultrapure water, wherein the ultrapure water accounts for 6.5%-8% of the total amount of raw materials; according to the preparation method of the faropenem sodium granules, the drying time of the raw materials is shortened, moisture in the raw materials is rapidly taken away by atomizing the raw materials, and the influence of high temperature and high humidity on the stability of the medicine is more effectively avoided. The fluidized bed drying method is adopted, the product drying efficiency is improved, meanwhile, the situation that the stability of the product is affected by damp heat is effectively avoided, and continuous production of the product is facilitated.

Description

technical field [0001] The invention relates to the technical field of preparation of faropenem sodium, in particular to a faropenem sodium granule component and a preparation method of the faropenem sodium granule. Background technique [0002] Faropenem is an atypical β-lactam antibiotic, which has a good affinity with penicillin-binding protein and good β-lactamase stability. Faropenem sodium is currently the first domestically marketed oral penem antibiotic. Its antibacterial activity is superior to the existing cephalosporin oral antibiotics, with better safety, wider antibacterial spectrum and stronger resistance to anaerobic bacteria. . [0003] Among them, faropenem sodium granules can be well manufactured in divided doses, and have advantages in taking, carrying, and storing; at the same time, the route of administration is convenient, the oral absorption effect is good, the antibacterial effect is not affected by food, and it has a high biological Utilization: Ap...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K31/431A61K47/38A61K47/10A61K47/26A61K47/18A61P31/04
CPCA61K31/431A61K9/1652A61K9/1623A61K9/1617A61P31/04A61K9/1682
Inventor 王炼李玉钦马婷婷梁志寿高慧丽
Owner 江苏睿实生物科技有限公司
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