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Cefcapene pivoxil granules and preparation method thereof

A technology of cefcapene axetil and granules, which is applied to pharmaceutical formulations, medical preparations without active ingredients, and medical preparations containing active ingredients, etc. Problems such as poor stability, to achieve good business prospects, improved appearance, and high production efficiency

Pending Publication Date: 2021-02-26
湖北凌晟药业股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0011] Based on this, the object of the present invention is to provide a kind of cefcapene pivoxil granule, aims to solve the problems such as cefcapene pivoxil preparation insufficient dissolution or unsuitable release speed, poor stability, bad taste etc.

Method used

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  • Cefcapene pivoxil granules and preparation method thereof
  • Cefcapene pivoxil granules and preparation method thereof
  • Cefcapene pivoxil granules and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] This embodiment provides a cefcapene pivoxil granule, which is composed of the components in weight percentage in Table 1.

[0042] The raw material proportioning of table 1 embodiment 1

[0043]

[0044] The consumption of essence in table 1 is that 1% is relative to the weight of cefcapene pivoxil granules, and the consumption 5% of coating agent is relative to the weight of granules containing medicine, and the consumption 14.6% of cefcapene pivoxil is relative to core weight. The weight ratio of cefcapene pivoxil to the cefcapene pivoxil granule is 13.77%, which is 10% when converted into cefcapene. The consumption notation of other embodiment and comparative example is the same.

[0045] The preparation method of the cefcapene pivoxil granule of the present embodiment may further comprise the steps:

[0046] (1) Cefcapene axetil is pulverized to a particle size of 176 μm in d90 and 83 μm in d50, and other materials are passed through a 60-mesh sieve.

[0047...

Embodiment 2

[0053] This embodiment provides a cefcapene pivoxil granule, which is composed of the components in weight percentage in Table 2.

[0054] The raw material ratio of table 2 embodiment 2

[0055]

[0056] The preparation method of the cefcapene pivoxil granule of the present embodiment may further comprise the steps:

[0057] (1) Cefcapene axetil is pulverized to a particle size of 174 μm in d90 and 66 μm in d50, and other materials are passed through a 60-mesh sieve.

[0058] (2) cefcapene axetil, croscarmellose calcium, sucralose, sorbitol, colloidal silicon dioxide, tartaric acid, sunset yellow lake are placed in the wet mixing granulator, stirred and mixed evenly, Add water under the conditions of stirring speed 200rpm and shearing speed 2000rpm for 15min to make soft material.

[0059] (3) Put the soft material in an extrusion spheronizer, and prepare granules under the conditions of a screen aperture of 0.7 mm, a roller speed of 5 rpm, a turntable speed of 800 rpm, a...

Embodiment 3

[0064] This embodiment provides a cefcapene pivoxil granule, which is composed of the components in weight percentage in Table 3.

[0065] The raw material ratio of table 3 embodiment 3

[0066]

[0067] The preparation method of the cefcapene pivoxil granule of the present embodiment may further comprise the steps:

[0068] (1) Cefcapene axetil is pulverized to a particle size of 153 μm in d90 and 52 μm in d50, and other materials are passed through a 60-mesh sieve.

[0069] (2) Cefcapene axetil, sodium carboxymethyl starch, lactose, xylitol, xanthan gum, lactic acid, and lemon yellow starch are placed in a wet mixing granulator, stirred and mixed evenly, at a stirring speed of 130rpm, shearing Add water under the condition of cutting speed 800rpm, stir and shear for 15min to make soft material.

[0070] (3) Put the soft material in an extrusion spheronizer, and prepare granules under the conditions of a sieve aperture of 0.4 mm, a roller speed of 20 rpm, a turntable spe...

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Abstract

The invention provides cefcapene pivoxil granules. The cefcapene pivoxil granules comprise medicine-containing granules and essence, wherein the medicine-containing granules consist of a core part anda coating layer wrapping the core part; the cefcapene pivoxil granules comprise the following components in percentage by weight: 97-99% of the medicine-containing granules and 1-3% of the essence, wherein the medicine-containing granules comprise the following components in percentage by weight: 0.5-5% of the coating layer and the balance of the core part, and the coating layer consists of a coating agent; and the core part comprises the following components in percentage by weight: 14-15% of cefcapene pivoxil, 10-30% of a disintegrating agent, 30-70% of a flavoring agent, 4-10% of a suspending agent and 1-10% of a pH regulating agent, wherein the pH regulating agent is one or more of citric acid, malic acid, tartaric acid and lactic acid. The cefcapene pivoxil granules prepared by the preparation method disclosed by the invention are good in solubility, appropriate in release speed, good in stability and good in taste.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a cefcapene pivoxil granule and a preparation method thereof. Background technique [0002] Cefcapene Pivoxil Hydrochloride Hydrate (Cefcapene Pivoxil Hydrochloride Hydrate) is an oral cephalosporin antibiotic, which has the advantages of broad antibacterial spectrum and strong antibacterial activity. Its molecular formula is C 23 h 29 N 5 o 8 S 2 ·HCl·H 2 O, with a relative molecular weight of 622.11, is a white to pale yellowish white crystalline powder or a block with a slight peculiar smell, easily soluble in N,N-dimethylformamide, methanol, ethanol (99.5%), slightly soluble in water. Its structural formula is as follows: [0003] [0004] Cefcapene pivoxil hydrochloride hydrate is referred to as cefcapene pivoxil for short. When it is absorbed, it is hydrolyzed by intestinal wall esterase to generate antibacterial active cefcapine. Cefcapene play...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/50A61K31/546A61K47/38A61P31/04
CPCA61K31/546A61K9/5042A61K9/5047A61P31/04
Inventor 何健吕萌郑丹金联明金大俊门万辉邹菁
Owner 湖北凌晟药业股份有限公司
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