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Cefazedone sodium frozen powder injection and preparation method thereof

A technology of freeze-dried powder injection and cefazedone sodium, which is applied in the field of pharmaceutical preparations, can solve the problems of increasing substances and polymers and reducing safety, and achieves the effects of improving stability, improving safety, and stabilizing physical and chemical properties

Inactive Publication Date: 2012-07-04
湖南万健康品生物科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The compound injection powder also has the disadvantages of increased related substances and polymers after long-term storage, and reduced safety.

Method used

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  • Cefazedone sodium frozen powder injection and preparation method thereof
  • Cefazedone sodium frozen powder injection and preparation method thereof
  • Cefazedone sodium frozen powder injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0051] The preparation of embodiment 1 cefoxizone sodium freeze-dried powder injection

[0052] Cefoxizone Sodium 50g

[0053] Sorbitol 58g

[0054] Arginine 0.05g

[0055] Hydrochloric acid solution (0.05mol / l) appropriate amount

[0056] Add water for injection to 1000ml

[0057] Preparation Process:

[0058] Weigh the prescribed amount of cefazedone sodium, mannitol, and sodium bisulfite, pulverize and dissolve in an appropriate amount of water for injection cooled to below 30°C, then add an appropriate amount of activated carbon for needles, stir for 15 minutes, filter and decarbonize, and replenish Add water for injection to the full amount, stir evenly, adjust the pH to 4.0-6.0 with sodium hydroxide solution, then filter the liquid medicine through a microporous membrane of 1-8 μm to sterilize, and fill the filtrate into a vial after passing the test Each bottle is filled with about 2ml, then half-stoppered, put into a freeze-drying box to freeze-dry, fully stopper...

Embodiment 2

[0059] The preparation of embodiment 2 cefoxizone sodium freeze-dried powder injection

[0060] Cefoxizone Sodium 50g

[0061] Mannitol 32g

[0062] Sorbitol 16g

[0063] Glutathione 0.2g

[0064] Hydrochloric acid solution (0.05mol / l) appropriate amount

[0065] Add water for injection to 1000ml

[0066] Preparation process: with embodiment 1

Embodiment 3

[0067] The preparation of embodiment 3 cefoxizone sodium freeze-dried powder injection

[0068] Cefoxizone Sodium 50g

[0069] Mannitol 28.6g

[0070] Cysteine ​​Hydrochloride 0.8g

[0071] Citric acid solution (0.1mol / l) appropriate amount

[0072] Add water for injection to 1000ml

[0073] Preparation process: with embodiment 1

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Abstract

Belonging to the field of pharmaceutical preparation, the invention relates to cefazedone sodium frozen powder injection which comprises 45-90% of cefazedone, 5-52% of excipient, 0.02-5% of antioxygen; wherein the excipient is composed of one or more of mannitol, sorbic alcohol or lactose, the antioxygen is composed of one or more of arginine, cysteine hydrochloride or glutathione. The cefazedonesodium frozen powder injection features stable physical and chemical properties, controllable quality; in addition, polymer impurities of the cefazedone sodium frozen powder injection are obviously reduced in the process of storage, thus improving safety of using the injection.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and relates to a freeze-dried powder injection of cefazedone sodium and a preparation method thereof. Background technique [0002] Cefazedone Sodium (Cefazedone Sodium) is the first generation of cephalosporin antibiotics developed by Merck, Germany. It was first listed in Germany in 1979, and then listed in many countries. The largest selling first-generation cephalosporin on the market. Cefoxitone sodium is a semi-synthetic cephalosporin, which is a derivative of cephalosporin C. Similar to other cephalosporins, it acts as an antibacterial agent by inhibiting the biosynthesis of bacterial cell walls. Its effect on Gram-positive bacteria and Gram-negative bacteria such as Staphylococcus aureus, Streptococcus pyogenes, and Enterococcus is better than that of cefazolin and cephalothin. Cefoxitone sodium can be used for the treatment of respiratory system, urinary system, gastrointesti...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K31/546A61K47/42A61K47/18A61K47/26A61P31/04
Inventor 邹立兴黄攀峰
Owner 湖南万健康品生物科技有限公司
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