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Cefmenoxime hydrochloride composition powder injection and manufacturing method thereof

A technology of cefmenoxime hydrochloride and its composition, which is applied in the field of cefmenoxime hydrochloride composition powder injection and its preparation, can solve problems such as accelerated drug decomposition and molecular rearrangement of cefmenoxime, and achieve quality improvement, rapid dissolution and stability sex high effect

Active Publication Date: 2009-11-04
SHANDONG LUOXIN PARMACEUTICAL GROUP STOCK CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, L-arginine has certain pharmacological and physiological effects, and its safety as an adjuvant for other drugs has yet to be verified experimentally.
In addition, arginine has a hydroxyl group, and long-term storage can easily lead to molecular rearrangement of cefmenoxime, thereby accelerating the decomposition of the drug

Method used

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  • Cefmenoxime hydrochloride composition powder injection and manufacturing method thereof
  • Cefmenoxime hydrochloride composition powder injection and manufacturing method thereof
  • Cefmenoxime hydrochloride composition powder injection and manufacturing method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0060] 250g of cefmenoxime hydrochloride and 66g of anhydrous sodium carbonate were respectively passed through a 200 mesh sieve, then mixed uniformly and pulverized using a ball mill filled with nitrogen, nitrogen protection during the pulverization process, pulverization until the particle size of cefmenoxime hydrochloride was 500 mesh, after pulverization, use The three-dimensional mixer is mixed, and the speed of the mixer is 60 rpm, and the mixture is mixed for 25 minutes. After the mixing is completed, it is divided into 1000 bottles of sterilized vials and stoppered.

[0061] Or recrystallize cefmenoxime hydrochloride before powder injection preparation: dissolve cefmenoxime hydrochloride with an HPLC content of 99.5% in 10 times aseptically treated acetone at 40°C, adjust the stirring speed to 80 rpm, and slowly drop 1 times sterilized water for injection, the dropping time is 3.2min, after dropping, adjust the stirring speed to 47 rpm, cool down to -5°C, let it stand o...

Embodiment 2

[0063] 500 g of cefmenoxime hydrochloride and 132 g of anhydrous sodium carbonate were passed through a 200 mesh sieve respectively, then mixed uniformly and pulverized using a ball mill filled with nitrogen, nitrogen protection during the pulverization process, pulverization until the particle size of cefmenoxime hydrochloride was 500 mesh, after pulverization, use The three-dimensional mixer is used for mixing, the speed of the mixer is 50 rpm, and the mixture is mixed for 30 minutes. After the mixing is completed, it is divided into 1000 bottles of sterilized vials and corked.

[0064] Or recrystallize cefmenoxime hydrochloride before powder injection preparation: dissolve cefmenoxime hydrochloride with an HPLC content of 99.5% in 10 times aseptically treated acetone at 40°C, adjust the stirring speed to 80 rpm, and slowly drop 1 times sterilized water for injection, the dropping time is 4.5min, after dropping, adjust the stirring speed to 47 rpm, lower the temperature to 0°...

Embodiment 3

[0066] 1000g of cefmenoxime hydrochloride and 264g of anhydrous sodium carbonate were passed through a 200 mesh sieve respectively, then mixed uniformly and pulverized using a ball mill filled with nitrogen, nitrogen protection during the pulverization process, pulverization until the particle size of cefmenoxime hydrochloride was 500 mesh, after pulverization, use The three-dimensional mixer is used for mixing, the speed of the mixer is 50 rpm, and the mixture is mixed for 25 minutes. After the mixing is completed, it is packed into 1000 sterilized vials and corked.

[0067] Or recrystallize cefmenoxime hydrochloride before powder injection preparation: dissolve cefmenoxime hydrochloride with an HPLC content of 99.5% in 10 times aseptically treated acetone at 40°C, adjust the stirring speed to 80 rpm, and slowly drop 1 times sterilized water for injection, the dropping time is 6.3min, after dropping, adjust the stirring speed to 47 rpm, cool down to 0°C, let it stand overnight...

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Abstract

The invention relates to a cefmenoxime hydrochloride composition powder injection, which comprises the following components: 100-150 parts of cefmenoxime hydrochloride, 30-35 parts of natrium carbonicum calcinatum, preferably 125 parts of cefmenoxime hydrochloride and 33 parts of natrium carbonicum calcinatum. The grain size of the cefmenoxime hydrochloride is 400-600 meshes, which is preferably 500 meshes. The manufacturing method of the cefmenoxime hydrochloride composition powder injection comprises the steps as follows: 100-150 parts of cefmenoxime hydrochloride and 30-35 parts of natrium carbonicum calcinatum are respectively sieved, evenly mixed and pulverized until the grain size of the cefmenoxime hydrochloride is 400-600 meshes and is preferably 500 meshes; the obtained powder is sub-packaged into sterilized vials and is plugged. The cefmenoxime hydrochloride composition powder injection prepared by the invention has the advantages of fine quality, rapid dissolution and good stability after being prepared into solution.

Description

technical field [0001] The invention relates to the field of medicine, in particular to a cefmenoxime hydrochloride composition powder injection and a preparation method thereof. Background technique [0002] Cefmenoxime is a third-generation sporin developed by Japan's Takeda Pharmaceutical Company. It was first launched in Japan in 1983 and entered the latest editions of European and American pharmacopoeias. Cefmenoxime is a third-generation cephalosporin, and its Gram-positive bacterial spectrum is wider than that of the second-generation cephalosporins. The effective rates of various bacteria are: 89.6% for Gram-positive bacteria, 83.2% for Gram-negative bacteria, and 93.6% for anaerobic bacteria. Highly effective against Pseudomonas aeruginosa. [0003] Cefmenoxime achieves its bactericidal effect by inhibiting the biosynthesis of bacterial cell walls. In vitro tests have shown that this product has effects on both Gram-positive and Gram-negative bacteria. This prod...

Claims

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Application Information

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IPC IPC(8): A61K31/546A61K47/02A61K9/14A61P31/04C07D501/36C07D501/12
Inventor 李明华李明杰武玉梅
Owner SHANDONG LUOXIN PARMACEUTICAL GROUP STOCK CO LTD
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