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Cefmetazole sodium composition powder injection for injection

A technology of cefmetazole sodium and its composition, which is applied in the field of chemical pharmacy, can solve the problems of uneven particle size distribution and small particle size, and achieve the effect of qualified product quality and good stability

Active Publication Date: 2011-06-22
SHANDONG LUOXIN PHARMA GRP CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0012] The object of the present invention is to provide a kind of sterile powder of cefmetazole sodium composition for injection, which contains cefmetazole sodium crystal in the sterile powder of cefmetazole sodium composition for injection, and the crystal particle size is relatively large and the particle size distribution is uniform , so as to well solve the above problems caused by the small particle size and uneven particle size distribution

Method used

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  • Cefmetazole sodium composition powder injection for injection
  • Cefmetazole sodium composition powder injection for injection
  • Cefmetazole sodium composition powder injection for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0060] [Example 1] Preparation of Cefmetazole Sodium Crystals

[0061] a) At room temperature, 14kg of cefmetazole sodium was dissolved in 10L of water to obtain a 0.4kg / L aqueous solution of cefmetazole sodium;

[0062] b) Add 70L of absolute ethanol at a rate of 10ml / min to the above-mentioned cefmetazole sodium aqueous solution under stirring at a stirring speed of 250r / min, and turbidity occurs;

[0063] c) Add a mixed solution of 70L acetone and isopropanol (the volume ratio of acetone and isopropanol is 1:2) to the above cloudy solution with a flow rate of 5ml / min under stirring at a stirring speed of 120r / min ), a large number of crystals are precipitated;

[0064] d) Cultivate crystals at a temperature of 22° C. for 20 minutes, filter, wash the filter cake three times with absolute ethanol, and dry in vacuum to obtain 13.3 kg of cefmetazole sodium crystals.

[0065] The main particle size of the obtained cefmetazole sodium crystal is 80 μm, and the characteristic pea...

Embodiment 2

[0066] [Example 2] Preparation of Cefmetazole Sodium Crystals

[0067] a) At room temperature, 16kg of cefmetazole sodium was dissolved in 10L of water to obtain a 0.6kg / L aqueous solution of cefmetazole sodium;

[0068] b) Add 75L of absolute ethanol at a rate of 15ml / min to the above-mentioned cefmetazole sodium aqueous solution under stirring at a stirring speed of 300r / min, and turbidity occurs;

[0069] c) Add the mixed solution of 150L acetone and isopropanol (the volume of acetone and isopropanol is 1:4) to the above-mentioned turbid solution under stirring at a stirring speed of 180r / min with a flow rate of 8ml / min , a large number of crystals precipitated;

[0070] d) Cultivate crystals at a temperature of 28° C. for 30 minutes, filter, wash the filter cake three times with absolute ethanol, and dry in vacuum to obtain 15.4 kg of cefmetazole sodium crystals.

[0071] The main particle size of the obtained cefmetazole sodium crystals was 120 μm, and the X-ray powder ...

Embodiment 3

[0072] [Example 3] Preparation of Cefmetazole Sodium Crystals

[0073] a) At room temperature, 15kg of cefmetazole sodium was dissolved in 10L of water to obtain a 0.5kg / L aqueous solution of cefmetazole sodium;

[0074] b) Add 73L of absolute ethanol at a rate of 12ml / min to the above aqueous solution of cefmetazole sodium under stirring at a stirring speed of 280r / min, and turbidity occurs;

[0075] c) Add a mixed solution of 219L acetone and isopropanol (the volume ratio of acetone and isopropanol is 1:3) to the above cloudy solution with a flow rate of 6ml / min under stirring at a stirring speed of 160r / min ), a large number of crystals are precipitated;

[0076] d) Cultivate crystals at a temperature of 25° C. for 25 minutes, filter, wash the filter cake three times with absolute ethanol, and dry in vacuum to obtain 14.4 kg of cefmetazole sodium crystals.

[0077] The main particle size of the obtained cefmetazole sodium crystals was 100 μm, and the X-ray powder diffract...

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Abstract

The invention relates to cefmetazole sodium composition sterile powder for injection, which comprises 99.0 to 99.9 weight percent of cefmetazole sodium and 0.1 to 1.0 percent of sodium benzoate. The cefmetazole sodium is cefmetazole sodium crystal and the primary granularity of the cefmetazole sodium ranges from 80 to 120 mu m. The cefmetazole sodium composition sterile powder for injection provided by the invention contains the cefmetazole sodium crystal, and has the advantages of large crystal granularity, uniform granularity distribution, qualified quality, and high stability.

Description

technical field [0001] The invention relates to the field of chemical pharmacy, in particular to a cefmetazole sodium composition powder for injection. Background technique [0002] The chemical name of cefmetazole is (6R, 7S)-7-[2-[(cyanomethyl)thio]acetamido]-7-methoxy-3-[[(1-methyl-1H-tetra Azol-5-yl)thio]methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid sodium salt, the molecular formula is C 15 h 16 N 7 NaO 5 S 3 , the molecular mass is 493.52, and the chemical structural formula is as follows: [0003] [0004] Cefmetazole is white, off-white powder or block, odorless, bitter, easy to induce moisture, and easily soluble in water. [0005] Other names of cefmetazole include cefmetazole sodium, thiocyanate, cefmetazol, etc. Cefmetazole is a broad-spectrum, high-efficiency, and low-toxicity antibiotic. Its antibacterial spectrum is similar to that of cefoxitin, and its performance is similar to that of the second-generation cephalosporins. It ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/14A61K31/546C07D501/57A61P31/04
Inventor 李明华李明杰陈雨
Owner SHANDONG LUOXIN PHARMA GRP CO LTD
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