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A kind of cefdinir capsule and preparation method thereof

A technology of dini capsules and cefdinir, which is applied in the field of medicine, can solve problems such as increased dissolution rate, and achieve the effects of increased dissolution rate, excellent fluidity, and ensuring safety

Active Publication Date: 2017-02-22
石药集团中诺药业(石家庄)有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Existing patent CN103908442A discloses a kind of cefdinir capsule, by pulverizing cefdinir principal agent granules, make the finished medicine particle size d (0.5) in 10~25 microns, the cefdinir capsule disclosed in the technology increases to a certain extent The dissolution rate of the drug was improved, but in this method, the dissolution rate was only significantly increased after adding crospovidone and croscarmellose sodium.

Method used

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  • A kind of cefdinir capsule and preparation method thereof
  • A kind of cefdinir capsule and preparation method thereof
  • A kind of cefdinir capsule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Example 1 Preparation of the cefdinir crystal form of the present invention

[0027] Add 2 g of cefdinir crude product into a 50 ml three-necked flask, add 23 ml of trityl methyl ether, stir, heat to reflux and dissolve, then add 5 ml of cyclopropane and let it stand for 10 minutes, then slowly cool down to 5°C, stir and crystallize for 4 hours, filtered, washed with 20ml of N,N-dimethylaniline, and vacuum-dried at 80°C to obtain 1.92g of dry crystal form cefdinir, with a yield of 96%.

[0028] The X-ray powder diffraction pattern of cefdinir crystal form is 15.2±0.2°, 18.2±0.2°, 22.0±0.2°, 22.4±0.2°, 23.9±0.2°, 24.9±0.2°, 28.5±0.2° at reflection angle 2θ ° has a characteristic absorption peak, such as figure 1 shown.

[0029] Its DSC spectrum has endothermic peaks around 69°C, 228°C and 281°C, such as figure 2 shown.

Embodiment 2

[0030] Example 2 Preparation of cefdinir capsules according to the present invention, specification: 100mg (calculated as cefdinir)

[0031] prescription:

[0032]

[0033] Preparation:

[0034] (1) Pretreatment of raw and auxiliary materials: Cefdinir and sodium citrate are pulverized into superfine powder and sieved with a superfine pulverizer respectively to obtain cefdinir and cefdinir with a particle size of d (0.5) within 20 to 35 microns. Sodium citrate for later use;

[0035] Pass direct-pressed mannitol, polyoxyl (40) stearate, low-substituted hydroxypropyl cellulose, silicon dioxide, and magnesium stearate through a 60-mesh sieve for subsequent use;

[0036] (2) Weighing and mixing: Weigh cefdinir, sodium citrate, direct pressure mannitol, polyoxyl (40) stearate, low-substituted hydroxypropyl cellulose, and silicon dioxide according to the prescription and add them to the hopper for mixing In the machine, the humidity of the environment is controlled to be below ...

Embodiment 3

[0038] Example 3 Preparation of Cefdinir Capsules according to the present invention, specification: 100mg (calculated as Cefdinir)

[0039] prescription:

[0040]

[0041] Preparation:

[0042] (1) Pretreatment of raw and auxiliary materials: Cefdinir and potassium citrate are pulverized into superfine powder and sieved with a superfine pulverizer respectively to obtain cefdinir and cefdinir with a particle size of d (0.5) within 20 to 35 microns. Sodium citrate for later use;

[0043] Pass direct-pressed mannitol, polyoxyl (40) stearate, low-substituted hydroxypropyl cellulose, silicon dioxide, and magnesium stearate through a 60-mesh sieve for subsequent use;

[0044] (2) Weighing and mixing: weigh cefdinir, potassium citrate, direct pressure mannitol, polyoxyl (40) stearate, low-substituted hydroxypropyl cellulose, and silicon dioxide according to the prescription and add them to the hopper for mixing In the machine, the humidity of the environment is controlled to b...

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Abstract

The invention relates to a cefdinir capsule and a preparation method thereof and belongs to the technical field of medicines. The capsule comprises cefdinir, a filling agent, a disintegrating agent and the like. The preparation process is simple and convenient, auxiliary materials are low in toxicity, and the probability that related substances exceed the standard due to the fact that main materials are damaged due to addition of other auxiliarymaterials is reduced. The cefdinir capsule is good in dissolution, high in powder-mixing flowability and forming capacity and high in content, contains a few related substances and is prone to industrial production.

Description

technical field [0001] The invention relates to a capsule and a preparation method thereof, in particular to a cefdinir capsule and a preparation method thereof, belonging to the technical field of medicine. Background technique [0002] Cefdinir (Cefdinir) was first listed in Japan in 1991, with a trade name of Cefzon; authorized Abbott in the United States, and was approved by the FDA in December 1997, with a trade name of Omnicef. Fujisawa Pharmaceutical was approved in my country in 1999 , Trade name: Quan Ze Fu. In 2001, Jinkang Pharmaceutical of Tianjin Pharmaceutical Group obtained the production approval for capsules. [0003] Cefdinir belongs to the third-generation oral cephalosporins. Cefdinir has high antibacterial activity against Gram-positive bacteria and good stability against β-lactamase. Among the original drug-type oral cephalosporins, it is the strongest variety against Gram-positive bacteria, especially the strongest anti-staphylococcus activity, even ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/48A61K31/546A61K47/12A61K47/34A61P31/04A61K47/38
Inventor 刘晶晶马慧丽杜淑朋董朝蓬姚振江董珊红陈洁李冬梅王晓霞
Owner 石药集团中诺药业(石家庄)有限公司