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Preparation process of ceftezole sodium for injection sterilize powder-injection for injection

A technology for ceftazole sodium and sterile powder injection, which is applied in the field of preparation of ceftazole sodium sterile powder injection for injection, can solve problems such as uncontrollable clarity, and achieves the advantages of enhancing injection safety and improving product quality. Effect

Inactive Publication Date: 2017-08-29
SICHUAN PHARMA
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0006] The technical problem to be solved by the present invention is that the conventional method for preparing ceftezole sodium injection powder cannot control the clarity of the product solution, the accelerated test of rubber stopper compatibility, bacterial endotoxin, sterility, visible foreign matter, insoluble particles, content, etc. Various parameter indicators are within a good range, the purpose is to provide the preparation process of ceftezole sodium sterile powder for injection, through the reasonable summation of each process technology and the reasonable control of parameters in the process, the determination of the above parameters all meet the requirements , and further increased the product quality

Method used

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  • Preparation process of ceftezole sodium for injection sterilize powder-injection for injection

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Embodiment

[0025] The preparation process of Ceftezole Sodium Sterile Powder for Injection of the present invention, the specific steps are as follows:

[0026] (1) Raw material preparation process: first use drinking water to clean the surface of the ceftezole sodium powder barrel / bag, then wipe and disinfect with 0.2% bromogeramine or 2% lysol; 35m / s, filter purification efficiency ≥ 0.6μm dust ≥ 99.99%; enter the C-class clean area and use 1% peracetic acid for aerosol spray disinfection for 15min, the mist particles include 90% of the particles with a diameter of 15μm; again in the transfer window Perform air shower treatment for 10 minutes, the nozzle wind speed is 50m / s, the filter purification efficiency is ≥ 0.2μm dust ≥ 99.99%, and finally enters the material temporary storage room in the B-level clean area for temporary storage.

[0027] (2) Cleaning process of soda-lime glass molded injection bottles: firstly, the qualified injection bottles are sprayed and cleaned with circul...

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Abstract

The invention discloses a preparation process of a ceftezole sodium for injection sterilize powder-injection for injection. The preparation process successively comprises the following steps of: a raw material preparation step, a soda-lime glass moulded injection bottle cleaning step, a rubber plug cleanings step, an aluminum cover cleaning step and a sterile packaging step. By reasonably designing the step processes and reasonably controlling the parameters in the processes, the parameters which are tested meet the demand, and the quality of a product is further up-regulated, and the injection safety of the ceftezole sodium for injection is enhanced.

Description

technical field [0001] The invention belongs to the technical field of medicine and chemical industry, and in particular relates to a preparation process of ceftezole sodium sterile powder for injection. Background technique [0002] Ceftezole sodium for injection, the main ingredient of this product is ceftezole sodium, without excipients. Chemical name: (6R,7R)-3-[[(1,3,4-thiazol-2-yl)sulfur]methyl]-7-[(1H-4azol-1-yl)acetamido]-8 -Oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid sodium salt, molecular formula: C 13 h 11 N 8 NaO 4 S 3 ,Chemical Structure: [0003] [0004] For sepsis, pneumonia, bronchitis, bronchiectasis (in case of infection), secondary infection of chronic respiratory diseases, lung abscess, peritonitis, pyelonephritis, cystitis, urethritis. [0005] The usage of ceftezole sodium for injection is intravenous injection, intravenous drip or intramuscular injection, and it is administered by intravenous injection, intravenous drip or intr...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/14A61K31/546A61P31/04A61P11/00A61P43/00A61P13/12A61P13/10A61P13/02B65B3/00B65B55/24B65B7/28
CPCA61K31/546A61K9/0019A61K9/14B65B3/003B65B3/006B65B7/28B65B7/2821B65B55/24
Inventor 刘焘唐丽陈玉红
Owner SICHUAN PHARMA
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