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Cefdinir composition capsule and preparation method thereof

A technology of cefdinir and its composition, which is applied in the field of cefdinir composition capsules and its preparation, can solve the problems of low stability, low weight loss on drying, influence on the safety and effectiveness of cefdinir, and inconvenience in production, and achieve effective It is conducive to safe use and long-term storage, to reduce or prevent digestive system diseases, and to improve the effect of stable performance

Active Publication Date: 2014-05-14
SHANDONG LUOXIN PHARMA GRP CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the excipients used in the cefdinir capsules disclosed in this patent have low stability (such as labeled amount, related substances, weight loss on drying, etc.) in a high-temperature and high-humidity environment, and the dissolution rate after coating is also unstable.
In addition, this patent uses mannitol etc. as fillers. Since both cefdinir and mannitol have poor fluidity, it is difficult to control the loading amount, which brings inconvenience to production and is not conducive to the realization of industrial production.
The above factors still affect the safety and effectiveness of cefdinir

Method used

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  • Cefdinir composition capsule and preparation method thereof
  • Cefdinir composition capsule and preparation method thereof
  • Cefdinir composition capsule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] Embodiment 1: prepare cefdinir composition capsule of the present invention

[0028]

[0029]

[0030] A total of 1000 capsules were made

[0031] Mix cefdinir through a 120 mesh sieve with polacrilin potassium and croscarmellose sodium that pass through a 100 mesh sieve respectively, and then mix them with microcrystalline cellulose, talcum powder and succinic acid that pass through a 100 mesh sieve respectively Mix evenly to get the mixture, add 95% ethanol solution and soft material made of 2-hydroxyethyl methacrylate to the mixture, wet granulate with 20 mesh sieve, blow dry the granules at about 65°C, granulate with 20 mesh sieve, Add magnesium stearate for total mixing, and fill No. 2 capsules.

Embodiment 2

[0032] Embodiment 2: preparation cefdinir composition capsule of the present invention

[0033]

[0034] A total of 1000 capsules were made

[0035] Mix cefdinir through a 120 mesh sieve with polacrilin potassium and croscarmellose sodium that pass through a 100 mesh sieve respectively, and then mix them with microcrystalline cellulose, talcum powder and succinic acid that pass through a 100 mesh sieve respectively Mix evenly to get the mixture, add 95% ethanol solution and soft material made of 2-hydroxyethyl methacrylate to the mixture, wet granulate with 20 mesh sieve, blow dry the granules at about 65°C, granulate with 20 mesh sieve, Add magnesium stearate for total mixing, and fill No. 2 capsules.

Embodiment 3

[0036] Embodiment 3: preparation cefdinir composition capsule of the present invention

[0037]

[0038]

[0039] A total of 1000 capsules were made

[0040]Mix cefdinir through a 120 mesh sieve with polacrilin potassium and croscarmellose sodium that pass through a 100 mesh sieve respectively, and then mix them with microcrystalline cellulose, talcum powder and succinic acid that pass through a 100 mesh sieve respectively Mix evenly to get the mixture, add 95% ethanol solution and soft material made of 2-hydroxyethyl methacrylate to the mixture, wet granulate with 20 mesh sieve, blow dry the granules at about 65°C, granulate with 20 mesh sieve, Add magnesium stearate for total mixing, and fill No. 2 capsules.

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Abstract

The invention relates to the field of pharmaceutical preparations and particularly discloses a cefdinir composition capsule and a preparation method thereof. Pharmaceutical effective ingredients of the cefdinir composition capsule disclosed by the invention comprise cefdinir, microcrystalline cellulose, potassium polacrilin, cross-linked sodium carboxymethyl cellulose, talcum powder, 95% ethanol, magnesium stearate, methyl-2-hydroxyethyl acrylate and succinic acid. According to the cefdinir composition capsule, cefdinir, microcrystalline cellulose, potassium polacrilin, cross-linked sodium carboxymethyl cellulose, talcum powder, 95% ethanol, magnesium stearate, methyl-2-hydroxyethyl acrylate and succinic acid preferably serve as the pharmaceutical effective ingredients of the cefdinir composition capsule, and the stability, fluidity and dissolution of cefdinir are improved through mutual synergism, so that the use safety and long-term storage of clinical drugs are facilitated.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a cefdinir composition capsule and a preparation method thereof. Background technique [0002] Cefdinir, the English name is CefdinirCapsules, the chemical name is (6R, 7R)-7-[[(2-amino-4-thiazolyl)-(oximino)acetyl]amino]-3-vinyl-8- Oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid has the following chemical structure: [0003] [0004] Cefdinir belongs to the semi-synthetic, broad-spectrum oral third-generation cephalosporins, which produce antibacterial effects by inhibiting the synthesis of bacterial cell walls. This product has antibacterial activity against Gram-positive bacteria and negative bacteria, and is stable to most β-lactamases, so many microorganisms resistant to penicillins and cephalosporins are sensitive to this product. Clinically used for the treatment of tonsillitis, sinusitis, otitis media, acute bronchitis, pneumonia, abdominal cavity...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/48A61K47/38A61K47/12A61K47/14A61K31/546A61P31/04
Inventor 宋丽丽赵树楷刘召英张园李俊广
Owner SHANDONG LUOXIN PHARMA GRP CO LTD