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Cefmetazole sodium crystal compound, preparation method thereof and sterile powder for injection containing cefmetazole sodium crystal compound

A technology of cefmetazole sodium and crystal compound, which is applied in the field of chemical pharmacy, can solve the problems of poor uniformity of mixed powder, high cost, slow reconstitution, etc., and achieves the effects of adjusting crystal particle size, qualified product quality, and changing crystal morphology.

Inactive Publication Date: 2014-02-26
HAINAN HERUI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, common aseptic subpackaged preparations for injection have large particle size, resulting in poor uniformity of the mixed powder, slow reconstitution, and poor clarity after reconstitution, poor fluidity during the subpackage process, and large differences in filling volume. However, the aseptic freeze-dried powder prepared by ultra-low temperature freeze-forming technology has the following disadvantages: uneven freeze-dried powder, poor color, difference in pure loading, problems in clarity, low purity of the prepared product, stable substance The sex problem has not been completely solved, and it is still not easy to store for a long time, etc., and the process of freeze-dried powder injection is more complicated and the cost is higher
[0011] However, the above-mentioned method only purifies the raw material cefmetazole sodium by recrystallization to improve its purity, and the above-mentioned recrystallization process is faced with a small average particle size of the cefmetazole sodium product and an uneven particle size distribution. The knot is one of the important factors that cause the unqualified quality of cefmetazole sodium products, and it also directly affects other quality indicators of the product.

Method used

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  • Cefmetazole sodium crystal compound, preparation method thereof and sterile powder for injection containing cefmetazole sodium crystal compound
  • Cefmetazole sodium crystal compound, preparation method thereof and sterile powder for injection containing cefmetazole sodium crystal compound
  • Cefmetazole sodium crystal compound, preparation method thereof and sterile powder for injection containing cefmetazole sodium crystal compound

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0044] [Example 1] Preparation of Cefmetazole Sodium Crystals

[0045] 1) Prepare the crude product solution: dissolve 20 kg of the crude product of cefmetazole sodium in 10 L of water, control the temperature at about 20° C., add 0.01% of the weight of the crude product of cefmetazole sodium for decolorization, and filter to obtain 2.0 kg / L of cefmetazole sodium aqueous solution;

[0046] 2) Crystal nucleation process: control the temperature of the cefmetazole sodium aqueous solution at about 20°C, add 50L of absolute ethanol to the aqueous solution at a rate of 10ml / min under stirring at a stirring speed of 130r / min, and turbidity appears , to obtain a cloudy solution;

[0047] 3) Crystal growth process: place the turbid solution obtained in step 2) at a frequency of 3.5kHz and an intensity of 0.6W·cm -2 Under the ultrasonic field, the temperature of the solution is controlled at about 20°C, and a mixed solution of 70L of acetone and tetrahydrofuran is added dropwise at a...

Embodiment 2-10

[0051]

[0052] The X-ray powder diffraction pattern obtained by measuring the cefmetazole sodium crystals prepared in Examples 2-10 using Cu-K α rays is consistent with that of Example 1.

preparation Embodiment 1

[0053] [Preparation Example 1] Cefmetazole Sodium Composition Sterile Powder for Injection

[0054] Specification: 1.0g (in C 15 h 17 N 7 o 5 S 3 count)

[0055] prescription:

[0056] Cefmetazole sodium crystal 1000g prepared by embodiment 1 (in C 15 h 17 N 7 o 5 S 3 count)

[0057] A total of 1000 bottles were made

[0058] Preparation:

[0059] Get the cefmetazole sodium crystal 1000g prepared by embodiment 1 (in C 15 h 17 N 7 o 5 S 3 Calculated), under aseptic conditions, it is divided into 1000 bottles of antibiotic glass bottles, and the amount of each bottle is 1.0g (in C 15 h 17 N 7 o 5 S 3 meter), stoppering, capping, light inspection, inspection qualified, labeling, packaging to obtain the sterile powder of cefmetazole sodium composition for injection.

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Abstract

The invention relates to a cefmetazole sodium crystal compound, a preparation method thereof and sterile powder for injection containing the crystal compound. The cefmetazole sodium crystal compound is a novel crystal form of cefmetazole sodium. The X-ray powder diffraction of the crystal form measured with a Cu-Kalpha ray shows characteristic peaks when 2theta is 6.8 degrees, 11.4 degrees, 12.0 degrees, 12.6 degrees, 14.8 degrees, 15.8 degrees, 18.0 degrees, 19.4 degrees, 20.1 degrees, 21.7 degrees, 23.4 degrees, 25.6 degrees, 28.0 degrees, 29.0 degrees and 30.6 degrees. The cefmetazole sodium crystal compound provided by the invention has high stability, and is non-hygroscopic basically. The sterile powder for injection has qualified quality and high stability.

Description

technical field [0001] The invention relates to the field of chemical pharmacy, in particular to a cefmetazole sodium crystalline compound, a preparation method thereof and a sterile powder for injection containing the compound. 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 Sodium is white, off-white powder or block, odorless, bitter, easy to induce moisture, 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 ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C07D501/57C07D501/12A61K31/546A61K9/14A61P31/04
Inventor 朱正兵张金花
Owner HAINAN HERUI PHARMA
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