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Preparation method of oxacillin sodium and oxacillin sodium for injection

A technology of oxacillin sodium and crystal seed is applied in the field of oxacillin sodium preparation, and can solve the problems of poor fluidity of oxacillin sodium powder, low yield of injection oxacillin sodium sub-packaging, etc. Achieve uniformity and improve uniformity

Inactive Publication Date: 2021-02-02
SICHUAN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] The technical problem to be solved by the present invention is: the fluidity of the existing oxacillin sodium powder is poor, resulting in a low yield of sub-package of injection oxacillin sodium

Method used

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  • Preparation method of oxacillin sodium and oxacillin sodium for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] 1. Condensation:

[0038] Prepare the buffer first: add 840L high-purity water to the crystallization tank, control the temperature of the water at 26-27°C, start stirring, then add 3.5kg sodium dihydrogen phosphate and 0.33kg ammonium chloride to dissolve, and add 18kg6- APA was stirred until completely dissolved to obtain a clear and transparent solution, then 20 kg of acid chloride was added, and the pH was adjusted to 6.8-7.0 with NaOH solution, and the reaction was carried out for 2 hours.

[0039] 2. Acidification extraction:

[0040] After the condensation reaction is completed, add activated carbon, stir and filter, add 240L butyl acetate to the filtrate, add dropwise H 2 SO 4 , adjust PH=2.0 left and right, stir, stand and separate layers, collect the upper layer filtrate, then add 80L butyl acetate to the upper layer filtrate, again use H 2 SO 4 Adjust the pH to about 2.0, stir, and let stand for the second time to separate layers, collect the upper layer ...

Embodiment 2

[0056] 1. Condensation:

[0057]Prepare the buffer first: add 840L high-purity water to the crystallization tank, control the temperature of the water at 26-27°C, start stirring, then add 3.5kg sodium dihydrogen phosphate and 0.33kg ammonium chloride to dissolve, and add 18kg6- APA was stirred until completely dissolved to obtain a clear and transparent solution, then 20 kg of acid chloride was added, and the pH was adjusted to 6.8-7.0 with NaOH solution, and the reaction was carried out for 2 hours.

[0058] 2. Acidification extraction:

[0059] After the condensation reaction is completed, add activated carbon, stir and filter, add 240L butyl acetate to the filtrate, add dropwise H 2 SO 4 , adjust PH=2.0 left and right, stir, stand and separate layers, collect the upper layer filtrate, then add 80L butyl acetate to the upper layer filtrate, again use H 2 SO 4 Adjust the pH to about 2.0, stir, and let stand for the second time to separate layers, collect the upper layer f...

Embodiment 3

[0073] The difference between this embodiment and Example 2 is that oxacillin sodium seed crystals are added in the crystallization process, and the introduction of crystal seeds is beneficial to ensure the number and uniformity of crystal nuclei, and ensure the uniformity of the particle size of the grown crystals. Specifically, the extract is added to a crystallization tank, and a seed crystal is added, and then sodium acetate solution is added for a crystallization reaction.

[0074] The preparation method of the oxacillin sodium seed crystal is as follows: the sodium acetate solution with a concentration of 10-12% is slowly added dropwise to the extract solution, the dropping speed is 2L / min, and the dropping speed is such that the crystallization temperature is controlled at 40- 50°C, react for 8-10min, wash the crystals, and dry.

[0075] The added amount of the seed crystal is 2% based on oxacillin sodium.

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Abstract

The invention discloses a preparation method of oxacillin sodium and oxacillin sodium for injection, and solves the problem that the split charging yield of the oxacillin sodium for injection is low due to poor fluidity of the existing oxacillin sodium powder. The method comprises the following steps of: adding crystallized and dried oxacillin sodium intermediate powder into a ball milling tank, and carrying out ball milling to obtain oxacillin sodium dry powder. The method has the advantages that the flowability of the oxacillin sodium dry powder is good, the yield of the obtained oxacillin sodium for injection is high, and the like.

Description

technical field [0001] The invention relates to the technical field of oxacillin sodium preparation, in particular to a preparation method of oxacillin sodium and oxacillin sodium for injection. Background technique [0002] Oxacillin sodium is a spectrum penicillin antibiotic, a semi-synthetic isoxazole antibiotic that has been on the market since 1972. [0003] Oxacillin sodium is used for various infections caused by penicillin-resistant Staphylococcus, such as sepsis, respiratory infection, meningitis, soft tissue infection, etc., as well as mixed infections caused by Streptococcus pyogenes or Streptococcus pneumoniae and penicillin-resistant cocci. [0004] The original drug of oxacillin sodium is white powder or crystalline powder; colorless or odorless, bitter in taste, soluble in water and ethanol, insoluble in ether and acetone, slightly soluble in chloroform. [0005] The drug is enzyme-resistant and acid-resistant, and can be taken orally or injected. At present,...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07D499/16C07D499/18C07D499/76A61K9/14A61K31/431A61P31/04
CPCA61K9/0019A61K9/14A61K31/431A61P31/04C07B2200/13C07D499/16C07D499/18C07D499/76
Inventor 王静赵永龙周燕伟
Owner SICHUAN PHARMA
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