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Cefmetazole preparation used for injection and preparation method thereof

A technology of cefmetazole and cefmetazole acid, which is applied to the formulation and preparation of cefmetazole preparations, and can solve the problems of many impurities, low content, poor stability, etc.

Inactive Publication Date: 2009-11-11
张轶伦
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0014] The purpose of the present invention is to provide a new preparation that overcomes the shortcomings of existing cefmetazole sodium preparations for injection such as poor stability, low content, and many impurities, which can improve product quality and product stability, and better ensure clinical drug use Safety

Method used

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  • Cefmetazole preparation used for injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0035] Prescription of Cefmetazole for Injection:

[0036] Cefmetazole acid: 1000g (pure)

[0037] Anhydrous sodium carbonate: 150g

[0038]

[0039] Make 1000 pieces

[0040] Preparation Process:

[0041] Weigh the cefmetazole acid sterile powder and anhydrous sodium carbonate sterile powder according to the prescription amount, mix them evenly, and then pack them into aseptically treated vials, press the stopper, roll the cap, and pass the inspection. After packing.

[0042] The inspection results are shown in Table 3.

[0043] table 3

[0044] project

Embodiment 2

[0046] Prescription of Cefmetazole for Injection:

[0047] Cefmetazole acid: 1000g (pure)

[0048] Anhydrous sodium carbonate: 100g

[0049]

[0050] Make 1000 pieces

[0051] Preparation Process:

[0052] Weigh the cefmetazole acid sterile powder and anhydrous sodium carbonate sterile powder according to the prescription amount, mix them evenly, and then pack them into aseptically treated vials, press the stopper, roll the cap, and pass the inspection. After packing.

[0053] The inspection results are shown in Table 4.

[0054] Table 4

[0055] project

Embodiment 3

[0057] Prescription of Cefmetazole for Injection:

[0058] Cefmetazole acid: 1000g (pure)

[0059] Anhydrous sodium carbonate: 200g

[0060]

[0061] Make 1000 pieces

[0062] Preparation Process:

[0063] Weigh the cefmetazole acid sterile powder and anhydrous sodium carbonate sterile powder according to the prescription amount, mix them evenly, and then pack them into aseptically treated vials, press the stopper, roll the cap, and pass the inspection. After packing.

[0064] The inspection results are shown in Table 5.

[0065] table 5

[0066] project

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Abstract

The invention provides a new cefmetazole preparation used for injection. The preparation mixes evenly active ingredient cefmetazole acid asepsis powder and complex solubilizer anhydrous sodium carbonate asepsis powder which are respectively bottled in sterilized amoxicillin bottles according to labeled amount and are packaged to obtain the product of cefmetazole used for injection after tamponage, rolling of cover and full inspection; wherein the weight ratio between cefmetazole acid (pure) and anhydrous sodium carbonate is 1:0.1 to 1:0.2 with 1:0.15 being the better ratio, namely, 1g of cefmetazole acid (pure) asepsis powder is added into 0.1-0.2g of anhydrous sodium carbonate asepsis powder. The preparation is good in stability and safe in usage.

Description

technical field [0001] The invention relates to a formulation of cefmetazole preparation and a preparation method thereof, in particular to a formulation of injectable cefmetazole preparation and a preparation method thereof. Background technique [0002] Cefmetazole, chemical name: (6R,7S)-7-[2-[(cyanomethyl)thio]acetamido]-7-methoxy-3-[[(1-methyl-1H- Tetrazol-5-yl)thio]methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid. [0003] Chemical Structure: [0004] [0005] Cefmetazole is a second-generation cefamycin antibacterial drug developed by Japan Sankyo Company. The pharmacodynamic feature of the drug is that the concentration difference between MIC and MBC is small, so the bactericidal ability is strong, the initial bactericidal effect is superior, and the antibacterial effect is balanced, and it has good antibacterial function against Gram-positive and Gram-negative bacteria; usually Cephamycins have a strong effect on Gram-negative bacteria, and ...

Claims

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Application Information

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IPC IPC(8): A61K31/546A61K47/02A61P31/04A61K9/14
Inventor 张轶伦
Owner 张轶伦
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