Cefepime hydrochloride medicine composition, powder-injection thereof and preparation method thereof

A technology of cefepime hydrochloride and composition, which is applied in the field of drug invention, can solve problems such as pH stability and uneven packaging, and achieve the effects of uniform product quality, reduced usage, and good pH stability

Inactive Publication Date: 2013-06-12
SHENZHEN SALUBRIS PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0014] In order to overcome the problems of pH stability, uneven packaging and pH stability in the transportation process of cefepime hydrochloride for injection in the prior art, the present invention provides a method with good pH stability in the packaging process. , a cefepime hydrochloride pharmaceutical composition with good packaging uniformity, good pH stability during transportation, and small gastrointestinal side effects

Method used

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  • Cefepime hydrochloride medicine composition, powder-injection thereof and preparation method thereof
  • Cefepime hydrochloride medicine composition, powder-injection thereof and preparation method thereof
  • Cefepime hydrochloride medicine composition, powder-injection thereof and preparation method thereof

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Effect test

Embodiment 1

[0035] Embodiment 1: prescription and technology of cefepime hydrochloride pharmaceutical composition

[0036] Cefepime Hydrochloride 100kg

[0037] L-Arginine 40kg

[0038] Hydroxypropyl-β-cyclodextrin 10kg

[0039]Preparation method: respectively crush cefepime hydrochloride, L-arginine and hydroxypropyl-β-cyclodextrin, pass through a 28-mesh sieve, weigh 100 kg of cefepime hydrochloride and 40 kg of L-arginine after sieving 10kg of hydroxypropyl-beta-cyclodextrin, mixed evenly to obtain the cefepime hydrochloride pharmaceutical composition.

Embodiment 2

[0040] Embodiment 2: prescription and technology of cefepime hydrochloride pharmaceutical composition

[0041] Cefepime Hydrochloride 100kg

[0042] L-Arginine 40kg

[0043] Hydroxypropyl-β-cyclodextrin 8kg

[0044] Preparation method: 1) remove the outer package from the raw and auxiliary materials, crush cefepime hydrochloride and L-arginine respectively, and pass through a 28-mesh sieve; 2) take 100 kg of cefepime hydrochloride and 40 kg of L-arginine after sieving, respectively, Mix evenly and add to the coating machine; 3) Dissolve 8kg of hydroxypropyl-β-cyclodextrin in an appropriate amount of ethanol, and spray the resulting solution evenly into the particles of the mixture of cefepime hydrochloride and L-arginine in a fine mist The surface of the layer is dried in a fluidized bed to obtain the cefepime hydrochloride pharmaceutical composition.

Embodiment 3

[0045] Embodiment 3: the prescription of cefepime hydrochloride pharmaceutical composition

[0046] Cefepime Hydrochloride 100kg

[0047] L-Arginine 40kg

[0048] Hydroxypropyl-β-cyclodextrin 12kg

[0049] The preparation method is as follows: 1) remove the outer package from the raw and auxiliary materials, crush cefepime hydrochloride and L-arginine respectively and pass through a 28-mesh sieve; 2) take 100 kg of cefepime hydrochloride and 40 kg of L-arginine after sieving respectively , mixed evenly and added to the coating machine; 3) Dissolve 12kg of hydroxypropyl-β-cyclodextrin in an appropriate amount of ethanol, and spray the resulting solution evenly into the mixture of cefepime hydrochloride and L-arginine in a fine mist The particle layer surface is dried in a fluidized bed to obtain the cefepime hydrochloride pharmaceutical composition.

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PUM

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Abstract

The invention relates to a cefepime hydrochloride medicine composition, a powder-injection thereof and a preparation method thereof. The medicine composition comprises the following ingredients: cefepime hydrochloride, L-arginine and hydroxypropyl-beta-cyclodextrin, wherein the weight of the L-arginine is 40% of that of the cefepime hydrochloride, and the weight of the hydroxypropyl-beta-cyclodextrin is 10% of that of the cefepime hydrochloride. The medicine composition is good in mixing uniformity, has small pH value change in subpackaging and transportation processes, is small in gastrointestinal tract side effect, and greatly improves the stability and safety of the medicine.

Description

technical field [0001] The invention belongs to the field of pharmaceutical inventions, and in particular relates to a cefepime hydrochloride pharmaceutical composition, its powder injection and a preparation method thereof. Background technique [0002] Cefepime (BMY-28142, CFPM) is a fourth-generation injectable cephalosporin antibiotic developed by Bristol-Myerssquibb. Enter Chinese market. [0003] Cefepime hydrochloride, chemical name: 1-(6R,7R)-7-2-(2-amino-4-thiazolyl)-glyoxalamido-2-carboxy-8-oxo-5-thia-1 - Azabicyclo 4.2.0 Oct-2-en-3-ylmethyl-1-methylpyrrolium inner salt. The currently used cefepime hydrochloride contains a molecule of water. Its chemical structural formula is as follows: [0004] [0005] Cefepime hydrochloride is a fourth-generation cephalosporin antibiotic. Compared with the third-generation cephalosporin antibiotics, it has a wider antibacterial spectrum, stronger antibacterial activity, and is more stable to the β-lactamase produced by ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/546A61K47/40A61K9/14A61P31/04
Inventor 陈碧陈伟
Owner SHENZHEN SALUBRIS PHARMA CO LTD
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