Cefdinir capsule and preparation method thereof

A technology for cefdinir and dinicapsules, which is applied in the directions of capsule delivery, pharmaceutical formulations, medical preparations with inactive ingredients, etc. Sensitivity, improving efficacy and safety, and improving the effect of in vitro release

Active Publication Date: 2011-05-18
JIANGSU YABANG QIANGSHENG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Due to the strong polarity and hydrophilicity of the silanol group, the micro-powdered silica gel of the disintegrating agent is conducive to the penetration of water into the tablet, and can significantly increase the dissolution rate of insoluble drugs; at the same time, the micro-powdered silica gel may also absorb moisture in the environment, thus making The related substances of the prepared tablets increase, and the therapeutic effect is poor or even adverse reactions occur.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] prescription:

[0032] Cefdinir 50g

[0033] Lactose 80g

[0034] Hydroxypropyl Cellulose 10g

[0035] PEG 6000 10g

[0036] Magnesium Stearate 2g

[0037] Opadry AMB 1.5%

[0038]

[0039] A total of 1000 capsules were made

[0040] Preparation Process:

[0041] (1) Weighing and dosing: Weigh the prescribed amount of cefdinir and other excipients, and prepare Opadry AMB with pure water for dispersion and stirring;

[0042] (2) Mixing: Mix cefdinir and lactose through a 200-mesh sieve, then shear and mix with hydroxypropyl cellulose, PEG 6000 and magnesium stearate in a wet mixer;

[0043] (3) Dry granulation: use the dry granulation machine to granulate, sieve the granules of 10-40 mesh, and return the remaining materials to the granulator to continue granulation;

[0044] (4) Fluidized bed coating: the granules obtained in step (3) are put into a top-spray fluidized bed, and the pre-prepared coating solution is sprayed onto the gr...

Embodiment 2

[0047] prescription:

[0048] Cefdinir 100g

[0049] Lactose 120g

[0050] Hydroxypropyl Cellulose 18g

[0051] PEG 6000 15g

[0052] Magnesium Stearate 2g

[0053] Opadry AMB 1.5%

[0054]

[0055] A total of 1000 capsules were made

[0056] Preparation Process:

[0057] The preparation method of Cefdinir capsules is the same as in Example 1.

Embodiment 3

[0059] prescription:

[0060] Cefdinir 50g

[0061] Mannitol 70g

[0062] Croscarmellose Sodium 10g

[0063] PEG 6000 10g

[0064] Magnesium Stearate 2g

[0065] Opadry AMB 1.5%

[0066]

[0067] A total of 1000 capsules were made

[0068] Preparation Process:

[0069] The preparation method of Cefdinir capsules is the same as in Example 1.

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PUM

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Abstract

The invention relates to a Cefdinir capsule and a preparation method thereof. Each Cefdinir capsule contains equivalently 50-100mg of Cefdinir and also comprises a filling agent, a disintegrating agent, a solubilizer, a lubricating agent and a coating agent. The method of mixing and screening raw materials and hydrophilic excipients, granulating by adopting a material dry method and then coating with a moistureproof film coat is adopted in the invention, thus the drug in vitro release degree is improved, the activity of the Cefdinir is avoided from reducing in a high-moisture environment and the related substances of the Cefdinir are avoided from increasing, and the treatment effect, the stability and the safety of the drug are improved.

Description

technical field [0001] The invention relates to a cephalosporin antibiotic cefdinir capsule and a preparation method thereof, belonging to the field of pharmaceutical preparations. Background technique [0002] Cefdinir was developed by Japan's Fujisawa Pharmaceutical Co., Ltd., and was first launched in Japan in 1991. In 2002, it was represented by Xi'an Janssen and introduced into the Chinese market. The trade name is "Quanzefu". [0003] Cefdinir belongs to the third-generation oral cephalosporin, which is an oral cephalosporin developed on the basis of cefixime. Its chemical structure is characterized by replacing the hydroxymethoxyimino group on the 7-position side chain of cefixime with imino. Compared with cefixime, ceftibuten, cefpodoxime, and cefaclor, cefdinir had no effect on G + Bacteria have strong antibacterial activity; while for G - Bacteria, its antibacterial activity is similar to that of cefixime, obviously superior to that of cefaclor. Cefdinir can be...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/48A61K31/546A61K47/32A61K47/36A61K47/38A61P31/04
Inventor 陈再新谢瑞丽毛白杨赵晓红王勇军葛育红盖海涛张潍郭雯
Owner JIANGSU YABANG QIANGSHENG PHARMA
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