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Cefathiamidine freeze-dried powder injection and preparing method thereof

A technology of cefathiamidine and freeze-dried powder injection, applied in the field of cefathiamidine freeze-dried powder injection and its preparation, can solve the problems of low product yield, frequent temperature changes, unstable moisture control, etc., and achieve consistent color and appearance The effect of plumping and improving the dissolution rate

Active Publication Date: 2008-07-30
SHANDONG LUOXIN PARMACEUTICAL GROUP STOCK CO LTD +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] In the prior art, the freeze-drying process of cefathione freeze-dried powder requires frequent temperature changes, the yield of the final product is low, and the moisture control is unstable

Method used

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  • Cefathiamidine freeze-dried powder injection and preparing method thereof
  • Cefathiamidine freeze-dried powder injection and preparing method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0038] Dissolve 40 g of cefathiamidine finished product in 50 mL of water for injection, heat to 50° C. and stir to dissolve, add 1 g of activated carbon and stir for 30 minutes to decolorize, then sterile filter and wash. Put the final filtrate into the tray of the freeze dryer, quickly cool down to -41°C, keep freezing at -41°C for 4 hours, then continue to cool down to -60°C, vacuumize, and gradually raise the temperature to -20°C within 6 hours ℃, maintain -20 ℃ and vacuum dry for 8 hours, continue to raise the temperature, rise to 25 ℃ within 2 hours, maintain 25 ℃ and vacuum dry until the vacuum degree does not change, to obtain 39.2g of cefathiamidine freeze-dried powder injection, the water content is 0.37% , yield 98%.

Embodiment 2

[0040] Dissolve 40 g of cefathiamidine finished product in 50 mL of water for injection, heat to 40°C and stir to dissolve, add 0.8 g of activated carbon and stir for 30 minutes to decolorize, then sterile filter and wash. Put the final filtrate into the feed tray of the freeze dryer, quickly cool down to -35°C, keep it frozen at -35°C for 5 hours, then continue to cool down to -50°C, vacuumize, and gradually raise the temperature to -18°C within 5 hours ℃, maintain -18 ℃ vacuum drying for 9 hours, continue to heat up, rise to 30 ℃ within 4 hours, maintain 30 ℃ vacuum drying until the vacuum degree does not change, obtain cefathiamidine freeze-dried powder injection 39.4, moisture is 0.40%, Yield 98.5%.

Embodiment 3

[0042] Dissolve 40 g of cefathiamidine finished product in 50 mL of water for injection, heat to 60°C and stir to dissolve, add 1.1 g of 769 type activated carbon and stir for 30 minutes to decolorize, then sterile filter and wash. Put the final filtrate into the tray of the freeze dryer, quickly cool down to -30°C, keep it frozen at -30°C for 3 hours, then continue to cool down to -55°C, vacuumize, and gradually raise the temperature to -15°C within 7 hours ℃, maintain -15 ℃ and vacuum dry for 7 hours, continue to heat up, rise to 28 ℃ within 2 hours, maintain 28 ℃ and vacuum dry until the vacuum degree does not change, to obtain cefathiamidine freeze-dried powder injection 39.1, the water content is 0.36%, Yield 98.2%.

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Abstract

The invention which discloses a preparation method of cephathiamidine freeze-dried powder injection is characterized in that the cephathiamidine is dissolved in the temperature of 40 to 60 DEG C and after the color removal through activated carbon and filtration, the hot solution is rapidly cooled to minus 41 to minus 30 DEG C in a freeze drier; the temperature is reduced to minus 60 to minus 50 DEG C and the vacuum is pumped and the temperature rises to 20 to 30 DEG C gradually; the obtained cephathiamidine freeze-dried powder injection has the average yield of more than 98 percent, water content of less than 0.4 percent, stable quality of drugs, uniform crystallization and color and plump appearances.

Description

technical field [0001] The invention relates to the field of freeze-dried preparations, in particular to cefathiamidine freeze-dried powder injection and a preparation method thereof. Background technique [0002] Cephathiamidine is a β-lactam antibiotic, chemical name: (6R,7R)-3[(acetyl)methyl]-7-[α-(N,N'-diisopropylamidinesulfur Base)-acetamido]8-oxo-5-thia-1-azabicyclo[4,2,0]oct-2-ene-2-carboxylic acid betaine, its chemical structure is as follows: [0003] [0004] Cefathiamidine is currently the only self-developed cephalosporin in my country. It has the advantages of broad antibacterial spectrum, strong bactericidal power, high blood concentration, wide tissue distribution, and few side effects. After being absorbed by the body, it is distributed in various organs and tissues of the body, with the highest distribution in bile. It is not metabolized in the body and is mainly excreted through the kidneys and urine. It has a strong effect on Staphylococcus aureus, St...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/54A61P31/04
Inventor 刘保起李明华孙松
Owner SHANDONG LUOXIN PARMACEUTICAL GROUP STOCK CO LTD
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