Method for preparing cefepime dihydrochloride and L-arginine mixed powder

A technology of cefepime hydrochloride and arginine, which is applied in the field of medicine and can solve the problems of density, powder fluidity, powder mixing uniformity, etc.

Active Publication Date: 2008-08-13
QILU ANTIBIOTICS PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Physical mixing requires special mixing equipment, and the density and powder fluidity of cefepime hydrochloride and L-arginine will affect the uniformity of mixing powder

Method used

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  • Method for preparing cefepime dihydrochloride and L-arginine mixed powder
  • Method for preparing cefepime dihydrochloride and L-arginine mixed powder

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preparation example Construction

[0011] A preparation method of cefepime hydrochloride and L-arginine mixed powder is characterized in that cefepime hydrochloride and L-arginine are dissolved to obtain a uniform product through freeze-drying process, and the specific steps are as follows:

[0012] (1) temperature control 0~20 ℃, cefepime hydrochloride and L-arginine by weight ratio (1.65-1.70): 1 make the aqueous solution of 20-30%wt, adjust feed liquid pH to 4.0-6.0, Filter with a 0.22 μm filter membrane into a freeze-drying box;

[0013] (2) Cool down to -45~-55℃ or lower within 2-3 hours, and keep it for 2-3 hours;

[0014] (3) Turn on the vacuum and reach a pressure of 0.10mbar to 0.30mbar for vacuum drying. Raise the set temperature to -10~0°C and keep it for at least 2 hours, then raise the set temperature to 10~20°C and keep it for at least 10 hours To ensure complete sublimation of water;

[0015] (4) Heating up to 30-45°C and drying until the moisture content is less than 3.0%wt.

[0016] The cefe...

Embodiment 1

[0021] Control the temperature at 0-5°C, add 35g of cefepime hydrochloride to 200ml of water for injection, dissolve and add 20.72g of L-arginine to adjust the pH of the feed solution to 4.42, and filter it through a 0.22μm filter membrane into a freeze-drying box. Cool down to -55°C in 2-3 hours and keep for 2 hours. Turn on the vacuum and reach 0.10-0.30mbar for vacuum drying, raise the set temperature to -10°C and keep it for 3 hours, then raise the set temperature to 15°C and keep it for 12 hours to completely sublimate the water. The temperature was raised to 45°C and dried for 3 hours, and the moisture was detected to be 2.17%, and the temperature was lowered to 20°C to obtain 54.21 g of the product.

Embodiment 2

[0023] Control the temperature at 10-15°C, add 14g of cefepime hydrochloride monohydrate to 70ml of water for injection, add 8.48g of L-arginine after dissolving to adjust the pH of the feed solution to 5.85, and filter it through a 0.22μm filter membrane into a freeze-drying box . Cool down to -50°C in 2-3 hours and keep for 3 hours. Turn on the vacuum and reach 0.10-0.30mbar for vacuum drying, raise the set temperature to 0°C and keep it for 2 hours, then raise the set temperature to 20°C and keep it for 10 hours to ensure the water sublimation is complete. Raise the temperature to 40°C and dry for 4 hours to detect that the moisture content is 1.96%, then cool down to 20°C to obtain 21.69 g of the product.

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Abstract

The invention relates to a method for preparing a mixture powder of cefepime hydrochloride and L-arginine. The cefepime hydrochloride is dissolved in the water used for injection and then added with the L-arginine. The pH value of the solution is adjusted within a range from 4.0 to 6.0 and then the solution is filtered through a 0.22 micron filter membrane. The product, namely the powder mixed with cefepime hydrochloride and L-arginine, can be obtained after freeze drying. Such powder prepared through the method of freeze drying is good in homogeneity, quick in dissolution velocity and stable in content of product, water content, pH value and other major quality indexes.

Description

technical field [0001] The invention relates to a method for preparing mixed powder of cefepime hydrochloride and L-arginine, in particular to a powder mixed product of cefepime hydrochloride and L-arginine prepared by a freeze-drying method, and belongs to the technical field of medicine. Background technique [0002] Cefepime hydrochloride is the fourth-generation cephalosporin for injection, developed by Boomer-Squibb Company of the United States. It has broad antibacterial spectrum, strong antibacterial effect, high stability to β-lactamase, and good drug tolerance. . Clinically used to treat severe infections, its chemical structure is as follows: [0003] [0004] Cefepime hydrochloride is highly acidic, and it will cause pain when injected directly into the human body. In practical application, cefepime hydrochloride is often mixed with L-arginine at a ratio of about 5:3 to make mixed powder, and the pH value of the aqueous solution after dissolution is between 3...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/546A61K47/16A61P31/04
Inventor 杜海生范美菊王勇进
Owner QILU ANTIBIOTICS PHARMA
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