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Cefepime hydrochloride composition sterile powder for injection

A technology of cefepime hydrochloride and sterile powder, which is used in powder delivery, antibacterial drugs, medical preparations containing active ingredients, etc. to improve the uniformity of mixing and the uniformity of packaging

Active Publication Date: 2011-06-29
SHANDONG LUOXIN PHARMA GRP CO LTD +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

And the uniformity of mixing cefepime hydrochloride and L-arginine directly affects the packing uniformity of cefepime hydrochloride powder injection, resulting in low packing rate

Method used

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  • Cefepime hydrochloride composition sterile powder for injection
  • Cefepime hydrochloride composition sterile powder for injection
  • Cefepime hydrochloride composition sterile powder for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] [embodiment 1] the preparation of cefepime hydrochloride crystal

[0041] 1) under water bath and stirring conditions, cefepime hydrochloride is dissolved in water to obtain an aqueous solution of cefepime hydrochloride;

[0042] 2) adding activated carbon to the aqueous solution of cefepime hydrochloride obtained in step 1), stirring, suction filtration, and getting the filtrate;

[0043] 3) adjust the stirring speed, and add the mixed solution of precooled ethanol and ether to the filtrate;

[0044] 4) After adding the mixed solution of ethanol and ether, add an ice-water bath to cool down, and stir to grow crystals;

[0045] 5) suction-filtering the crystallization feed liquid, washing, and vacuum-drying to obtain cefepime hydrochloride crystals.

[0046] The bulk density of gained cefepime hydrochloride crystal is 0.3g / cm 3 .

Embodiment 2

[0047] [embodiment 2] the preparation of cefepime hydrochloride crystal

[0048] 1) Dissolve 50 g of cefepime hydrochloride in 100 ml of water at a water bath temperature of 50° C. under stirring conditions to obtain an aqueous solution of cefepime hydrochloride;

[0049] 2) Add 0.5 g of activated carbon to the aqueous solution of cefepime hydrochloride obtained in step 1), stir, suction filter, and get the filtrate;

[0050] 3) Adjust the stirring speed to 250r / min, and add a mixed solution of ethanol and ether that has been pre-cooled to 5°C and has a volume ratio of 1:1 to the filtrate;

[0051] 4) After adding the mixed solution of ethanol and ether, add an ice-water bath to cool down to 0°C, and stir to grow the crystal;

[0052] 5) suction-filtering the crystallization feed liquid, washing, and vacuum-drying to obtain cefepime hydrochloride crystals.

[0053] The bulk density of gained cefepime hydrochloride crystal is 0.5g / cm 3 .

Embodiment 3

[0054] [embodiment 3] the preparation of cefepime hydrochloride crystal

[0055] 1) Dissolve 50 g of cefepime hydrochloride in 75 ml of water at a water bath temperature of 60° C. under stirring conditions to obtain an aqueous solution of cefepime hydrochloride;

[0056] 2) Add 0.45 g of activated carbon to the aqueous solution of cefepime hydrochloride obtained in step 1), stir, suction filter, and get the filtrate;

[0057] 3) Adjust the stirring speed to 400r / min, and add a mixed solution of ethanol and ether that has been pre-cooled to 10°C in a volume ratio of 1:2 to the filtrate;

[0058] 4) After adding the mixed solution of ethanol and ether, add an ice-water bath to cool down to 5°C, and stir to grow crystals;

[0059] 5) suction-filtering the crystallization feed liquid, washing, and vacuum-drying to obtain cefepime hydrochloride crystals.

[0060] The bulk density of gained cefepime hydrochloride crystal is 0.4g / cm 3 .

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Abstract

The invention relates to cefepime hydrochloride composition sterile powder for injection. The cefepime hydrochloride composition sterile powder for injection consists of cefepime hydrochloride serving as a raw material and L-arginine serving as an auxiliary material, wherein the content of the L-arginine serving as the auxiliary material is 83.5 percent of that of the cefepime hydrochloride serving as the raw material and the amount of the cefepime hydrochloride is calculated by cefepime; and the cefepime hydrochloride is cefepime hydrochloride crystal with the bulk density of between 0.3 to 0.5 g / cm<3>. The bulk density of the cefepime hydrochloride crystal in the medical composition is close to that of the L-arginine and fits for the L-arginine, so mixing uniformity of the cefepime hydrochloride raw powder and the L-arginine is greatly improved. Thus, the packaging uniformity of cefepime hydrochloride powder injection is improved.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and in particular relates to a cefepime hydrochloride composition sterile powder for injection. Background technique [0002] Cefepime (Cefepim, BMY-28142, CFPM) is a fourth-generation cephalosporin for injection developed by Bristol-Myerssquibb. It was first launched in Sweden in 1993 and entered the Chinese market in 1998. [0003] Name: Cefepime Hydrochloride for Injection (English Name: Cefepime Hydrochloride for Injection) Molecular Formula: C 19 h 25 ClN 6 o 5 S 2 ·HCl·H 2 o [0004] Molecular weight: 571.50 [0005] Chemical name: 1-[[(6R,7R)-7-[2-(2-Amino-4-thiazolyl)-glyoxylamido]-2-carboxy-8-oxo-5-thia-1 -Azabicyclo[4,2,0]oct-2-en-3-yl]methyl]-1-methylpyrrolidine chloride, 72-(Z)-(0-methyloxime)hydrochloride-hydration thing [0006] Chemical Structure: [0007] [0008] Cefepime hydrochloride for injection is a fourth-generation cephalosporin antibiotic. Compare...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/14A61K31/546A61P31/04
Inventor 李明华范丽刘明霞
Owner SHANDONG LUOXIN PHARMA GRP CO LTD
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