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Pharmaceutical composition containing cefmetazole sodium compound, and preparation method thereof

A technology of cefmetazole sodium and cefmetazole acid, applied in the field of medicine, can solve the problems of instability of cefmetazole sodium, high side effects and allergic rate

Active Publication Date: 2011-10-05
福建亿懿兴华生物技术开发有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, cefmetazole sodium made by this method is unstable during storage, so the side effects and allergies are relatively high during use.

Method used

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  • Pharmaceutical composition containing cefmetazole sodium compound, and preparation method thereof
  • Pharmaceutical composition containing cefmetazole sodium compound, and preparation method thereof
  • Pharmaceutical composition containing cefmetazole sodium compound, and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] Prescription: (100 bottles)

[0019] Cefmetazole Acid 25g

[0020] Sodium carbonate 2.53g

[0021] Mannitol 0.1g

[0022] Preparation Process

[0023] 1) Dissolve the prescribed amount of cefmetazole acid, sodium carbonate and mannitol in water for injection, add water to 1000ml, and stir at 150r / min to make the reaction complete;

[0024] 2) Add activated carbon to the above-mentioned fully reacted solution and stir, adjust the pH to 6 with sodium hydroxide, filter to remove carbon, then filter through a filter membrane, and fill;

[0025] 3) Cool down the above-mentioned filled solution rapidly to freezing in a freeze dryer, maintain freezing at -40°C for 3 hours, vacuumize, slowly heat up to below the eutectic point, and vacuum-dry until the vacuum degree is maintained at 5-10pa Continue to heat up while heating up to 25° C. within 2 hours, and maintain until the degree of vacuum no longer changes to obtain a freeze-dried powder. Example 2

Embodiment 2

[0026] Prescription: (100 bottles)

[0027] Cefmetazole Acid 25g

[0028] Sodium carbonate 2.53g

[0029] Mannitol 0.2g

[0030] 1) Dissolve the prescribed amount of cefmetazole acid, sodium carbonate and mannitol in water for injection, add water to 1000ml, and stir at 190r / min to make the reaction complete;

[0031] 2) Add activated carbon to the above-mentioned fully reacted solution and stir, adjust the pH to 6 with sodium hydroxide, filter to remove carbon, then filter through a filter membrane, and fill;

[0032] 3) Rapidly cool down the above-mentioned filled solution to freezing in a freeze dryer, maintain freezing at -30°C for 5 hours, vacuumize, slowly raise the temperature to below the eutectic point, and vacuum-dry until the vacuum degree is maintained at 5-10pa Continue to heat up while heating up to 30° C. within 4 hours, and maintain until the degree of vacuum no longer changes to obtain a freeze-dried powder.

Embodiment 3

[0034] Prescription: (100 bottles)

[0035] Cefmetazole Acid 25g

[0036] Sodium carbonate 2.53g

[0037] Mannitol 0.3g

[0038] Preparation Process

[0039] 1) Dissolve the prescribed amount of cefmetazole acid, sodium carbonate and mannitol in water for injection, add water to 1000ml, and stir at 160r / min to make a complete reaction;

[0040] 2) Add activated carbon to the above-mentioned fully reacted solution and stir, adjust the pH to 6 with sodium hydroxide, filter to remove carbon, then filter through a filter membrane, and fill;

[0041] 3) Cool down the above-mentioned filled solution rapidly to freezing in a freeze dryer, maintain freezing at -35°C for 4 hours, vacuumize, slowly raise the temperature to below the eutectic point, and vacuum-dry until the vacuum degree is maintained at 5-10pa Continue to heat up while heating up to 30° C. within 3 hours, and maintain until the degree of vacuum no longer changes to obtain a freeze-dried powder.

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Abstract

The invention provides a pharmaceutical composition containing a cefmetazole sodium compound. The pharmaceutical composition is prepared from cefmetazole acid, sodium carbonate and mannitol. The invention also provides a preparation method of the pharmaceutical composition containing the cefmetazole sodium compound. The preparation method comprises the following steps of: adding the active component cefmetazole acid sterile powder, the cosolvent sodium carbonate and the excipient mannitol to water for injection, adding active carbon and stirring, regulating the pH to be 6 by sodium hydroxide, filtering to remove the active carbon, finely filtering by a filter membrane, filling and lyophilizing. Because a proper amount of excipient mannitol is added to the pharmaceutical composition prepared by the method, the lyophilized powder is more stable in quality and can be stored for a long term. The cefmetazole acid and the sodium carbonate directly react to obtain the cefmetazole sodium, thereby shortening the process flow.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a pharmaceutical composition containing an active ingredient of cefmetazole acid and a preparation method thereof. Background technique [0002] Cefmetazole sodium (Cefmetazole), also known as cyanazole-methoxycephalosporin, cefmetazol, vanguard metabolite, vanguard dense forest, cefmethoxazole, is a second-generation cephalosporin, widely Spectrum β-lactamases have better stability. Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Shigella, Salmonella and other negative bacilli have good sensitivity to this product. Staphylococcus aureus, Group A hemolytic streptococcus, and Brahamella catarrh are highly sensitive to this product. It is used for respiratory system infection, biliary tract infection, urinary system infection, obstetrics and gynecology bacterial infection, skin and soft tissue infection and other diseases caused by sensitive bacteria. Prevention of i...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/546A61K9/19A61K47/02A61K47/10A61P31/04
Inventor 罗诚
Owner 福建亿懿兴华生物技术开发有限公司
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