Method for preparing cefmenoxime hydrochloride freeze-dried powder injection

A technology of cefmenoxime hydrochloride and freeze-dried powder injection, which is applied in the field of preparation of cefmenoxime hydrochloride freeze-dried powder injection, can solve the problems of complex preparation, unstable quality, high cost, etc., and achieve the effect of improving stability and dissolution speed

Inactive Publication Date: 2010-06-09
海南澳合医药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] In the prior art, cefmenoxime hydrochloride is made into liposome freeze-dried powder, which has the disadvantages of complicated preparation and high cost
However, powder injection sub-packages have the disadvantages of low degree of sterility control, low yield, and unstable quality.

Method used

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  • Method for preparing cefmenoxime hydrochloride freeze-dried powder injection
  • Method for preparing cefmenoxime hydrochloride freeze-dried powder injection
  • Method for preparing cefmenoxime hydrochloride freeze-dried powder injection

Examples

Experimental program
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Effect test

Embodiment 1

[0026] Dissolve 40 g of cefmenoxime hydrochloride finished product and 4 g of arginine in 100 ml of fresh water for injection, stir to dissolve, add 1 g of activated carbon, stir for decolorization for 30 minutes, and filter aseptically. Put the filtrate into a lyophilizer after subpackaging, quickly cool down to -40°C, keep at -40°C for 3 hours, vacuumize, gradually increase the temperature to -20°C within 8 hours, and maintain -20°C for 8 hours in vacuum , continue to heat up to 25° C. within 2 hours, maintain 25° C. and dry in vacuum until the degree of vacuum does not change, to obtain cefmenoxime hydrochloride freeze-dried powder injection.

Embodiment 2

[0028] Dissolve 40 g of cefmenoxime hydrochloride finished product and 10 g of arginine in 100 ml of fresh water for injection, stir to dissolve, add 2.5 g of activated carbon, stir for 30 minutes to decolorize, and filter aseptically. Put the filtrate into a lyophilizer after subpackaging, quickly cool down to -30°C, keep at -30°C for 5 hours, vacuumize, gradually increase the temperature to -15°C within 6 hours, and maintain -20°C for 8 hours in vacuum , continue to heat up to 30 DEG C within 4 hours, maintain 30 DEG C and vacuum-dry until the vacuum degree does not change, to obtain cefmenoxime hydrochloride freeze-dried powder injection.

Embodiment 3

[0030] Dissolve 40 g of cefmenoxime hydrochloride finished product and 20 g of arginine in 100 ml of freshly prepared water for injection, stir to dissolve, add 2 g of activated carbon, stir for decolorization for 30 minutes, and filter aseptically. Put the filtrate into a lyophilizer after subpackaging, quickly cool down to -35°C, maintain -40°C for 4 hours, vacuumize, gradually increase the temperature to -20°C within 8 hours, and maintain -15°C for 10 hours in vacuum , continue to heat up to 25°C within 3 hours, maintain 25°C and vacuum-dry until the degree of vacuum does not change, to obtain cefmenoxime hydrochloride freeze-dried powder injection.

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Abstract

The invention discloses a method for preparing a cefmenoxime hydrochloride freeze-dried powder injection, which comprises the following steps of: dissolving cefmenoxime hydrochloride and arginine together; quickly cooling and freezing solution decolorized by activated carbon in a freeze dryer; vacuumizing; and gradually raising the temperature to room temperature. The obtained cefmenoxime hydrochloride freeze-dried powder injection has the advantages of over 98 percent of average yield, less than 0.5 percent of moisture content, stable medicament quality and full appearance.

Description

technical field [0001] The invention relates to the field of freeze-dried preparations, in particular to a preparation method of cefmenoxime hydrochloride freeze-dried powder injection. Background technique [0002] Cephathiamidine hydrochloride (Cephathiamidine) is a β-lactam antibiotic, which has the advantages of broad antibacterial spectrum, strong bactericidal power, high blood concentration, wide tissue distribution, and few side effects. Clinically, it is mainly used for sepsis; secondary infection of burns and surgical trauma; pneumonia, bronchitis, bronchiectasis combined with infection, secondary infection of chronic respiratory diseases; empyema; cholecystitis, liver abscess; peritonitis; pyelonephritis, bladder inflammation; Bartholinitis, endometritis, adnexitis, pelvic inflammatory disease; meningitis. [0003] Patent 03117380.2 discloses a preparation method of cefmenoxime hydrochloride powder injection, by adding arginine to cefmenoxime hydrochloride to aid ...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/546A61K47/18A61P31/04
Inventor 吴秋萍
Owner 海南澳合医药有限公司
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