Cefmetazole sodium medicament and preparation method thereof

A technology for cefmetazole sodium and medicine, which is applied to the field of cefmetazole sodium medicine and its preparation, can solve the problems of poor clarity, slow reconstitution, poor uniformity of mixed powder, etc., and achieves reduction of difference in loading and irritation. , the effect of improving liquidity

Active Publication Date: 2010-01-13
SHANDONG LUOXIN PARMACEUTICAL GROUP STOCK CO LTD +1
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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
Although the above-mentioned problems of some sterile powders for injection have been solved by using ultrafine pulverization technology, due to the high manufacturing cost of equipment, large one-time investment, high energy consumption, and energy utilization rate of only about 2%, it is generally considered to be higher than other pulverization The method is several times, and the cost of crushing is too high
Thereby its application is subject to certain restrictions, and the sterile powder for cefmetazole sodium injection prepared by ultrafine pulverization technology has the disadvantages of low purity and poor clarity

Method used

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  • Cefmetazole sodium medicament and preparation method thereof
  • Cefmetazole sodium medicament and preparation method thereof
  • Cefmetazole sodium medicament and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0068] Specification: 0.25g (in C 15 h 17 N 7 o 5 S 3 count)

[0069] prescription:

[0070] Cefmetazole sodium 250g (in C 15 h 17 N 7 o 5 S 3 count)

[0071] A total of 1000 bottles were made

[0072] Preparation Process:

[0073] (1) Pretreatment

[0074] a) In a class 10,000 clean area, add cefmetazole sodium into the water for injection, slowly raise the temperature to 40°C, stir to dissolve, add medicinal charcoal, stir, filter while hot to remove charcoal, then filter through a filter membrane, and cool to room temperature, add ethanol and mix evenly, stir and crystallize for 12 hours to obtain a crystallization solution;

[0075] b) transfer the crystallization solution to a sterile room, filter, wash with ethanol, filter, and dry to obtain a sterile powder of cefmetazole sodium;

[0076] (2) Aseptic packaging

[0077] The cefmetazole sodium aseptic powder obtained in the last step is subpackaged to antibiotic glass bottles under aseptic conditions, and ...

Embodiment 2

[0079] Specification: 0.5g (in C 15 h 17 N 7 o 5 S 3 count)

[0080] prescription:

[0081] Cefmetazole sodium 500g (in C 15 h 17 N 7 o 5 S 3 count)

[0082] A total of 1000 bottles were made

[0083] Preparation Process:

[0084] (1) Pretreatment

[0085] a) In a class 10,000 clean area, add cefmetazole sodium into the water for injection, slowly raise the temperature to 40°C, stir to dissolve, add medicinal charcoal, stir, filter while hot to remove charcoal, then filter through a filter membrane, and cool to room temperature, add ethanol and mix evenly, stir and crystallize for 35 hours to obtain a crystallization solution;

[0086] b) transfer the crystallization solution to a sterile room, filter, wash with ethanol, filter, and dry to obtain a sterile powder of cefmetazole sodium;

[0087] c) extruding and pre-crushing the sterile cefmetazole sodium powder obtained in the previous step with a ball mill, and pulverizing it into a fine powder that all passes ...

Embodiment 3

[0091] Specification: 1.0g (in C 15 h 17 N 7 o 5 S 3 count)

[0092] prescription:

[0093] Cefmetazole sodium 1000g (in C 15 h 17 N 7 o 5 S 3 count)

[0094] A total of 1000 bottles were made

[0095] Preparation Process:

[0096] (1) Pretreatment

[0097] a) In a class 10,000 clean area, add cefmetazole sodium into the water for injection, slowly raise the temperature to 40°C, stir to dissolve, add medicinal charcoal, stir, filter while hot to remove charcoal, then filter through a filter membrane, and cool to room temperature, add ethanol and mix evenly, stir and crystallize for 20 hours to obtain a crystallization solution;

[0098] b) transfer the crystallization solution to a sterile room, filter, wash with ethanol, filter, and dry to obtain a sterile powder of cefmetazole sodium;

[0099] c) extruding and pre-crushing the sterile cefmetazole sodium powder obtained in the previous step with a ball mill, and pulverizing it into a fine powder that all passes...

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Abstract

The invention relates to a cefmetazole sodium medicament and a preparation method thereof. The cefmetazole sodium medicament contains 100 percent of cefmetazole sodium which is preprocessed by sterile refining. Because the cefmetazole sodium is preprocessed by sterile refining, the powder fluidity of the cefmetazole sodium medicament is improved to be beneficial to separated packing, reduce the packing difference caused in the separated packing process and have simpler process and easy operation. The cefmetazole sodium sterile powder for injection prepared by the method has uniform color, high purity, almost no impurity, reduced stimulation, good solubility, faster redissolution, better clarity after redissolution and more stable quality and can be stored for a long time.

Description

technical field [0001] The invention relates to a cefmetazole sodium medicine and a preparation method thereof, belonging to the field of pharmaceutical preparations. 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 cepha...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/546C07D501/12A61P31/04
Inventor 李明华陈雨吕金辉
Owner SHANDONG LUOXIN PARMACEUTICAL GROUP STOCK CO LTD
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