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Method for preparing cefoxitin sodium for injection

A technology for cefoxitin sodium and injection, applied in the direction of liquid cleaning methods, cleaning methods and utensils, chemical instruments and methods, etc., can solve the problem of uncontrollable parameter indicators, difficult parameter control requirements, and inability to play a good role at the same time control and other issues to achieve the effect of enhancing injection safety and improving quality

Active Publication Date: 2013-01-30
SICHUAN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

However, the method described in CN200910005009.0 is a method for conventionally prepared injection powder preparations. With this method, the acidity of the product, the clarity and color of the solution, the accelerated test of rubber stopper compatibility, related substances, and bacterial endotoxins , sterility, visible foreign matter, insoluble particles, content and other parameters, cannot be well controlled at the same time
To achieve better control of the above-mentioned various parameters, the process design of the whole preparation and the parameter control requirements in each process are difficult points. According to the preparation method recorded in the prior art, the above-mentioned parameters cannot be controlled. in a good range

Method used

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  • Method for preparing cefoxitin sodium for injection
  • Method for preparing cefoxitin sodium for injection
  • Method for preparing cefoxitin sodium for injection

Examples

Experimental program
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Effect test

Embodiment 1

[0028] The specific steps of the preparation method of cefoxitin sodium for injection of the present embodiment are as follows:

[0029] 1) Bottle washing process

[0030]Send qualified soda-lime glass molded injection bottles into the bottle washing track, first make the injection bottles enter the ultrasonic cleaning area and turn the bottle mouth downwards, and use ultrasonic waves for initial washing (the frequency selected in this embodiment is 40kHz, the experiment found that , Ultrasonic working frequency will produce noise within the range of human hearing. When the frequency is lower than 20kHz, not only the working noise is loud, but also may exceed the limit of safe noise specified in other regulations. Many existing cleaning uses 20-30kHZ Frequency, but in the cleaning process of injection bottles, the experiment found that the cleaning effect of 20-30kHZ frequency is poor, and it may also cause damage to the surface of injection bottles. Injection bottle surface ...

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Abstract

The invention relates to a method for preparing cefoxitin sodium for injection, comprising the steps of bottle washing, rubber plug treating, aluminium cap treating, cefoxitin sodium separate loading and capping to obtain cefoxitin sodium for the injection. The preparation method disclosed by the invention has the advantages that through the reasonable design of the process and the control of a plurality of parameters in the process, the pH value range of prepared cefoxitin sodium for the injection can be controlled between 6.7-7.0; the clarity, the visible foreign matter and the sterile determination of prepard cefoxitin sodium for the injection all meet the requirements; the impurity content, the endotoxin content and the quantity of insoluble particles are remarkably lower than the requirements established by the conventional standard; and the product quality is further increased and the injection safety of cefoxitin sodium for the injection is enhanced.

Description

technical field [0001] The invention belongs to the field of pharmacy, and in particular relates to a preparation method of cefoxitin sodium for injection. Background technique [0002] The main ingredient of cefoxitin sodium for injection is cefoxitin sodium, and its chemical name is: (6R, 7 S)-3-[(1-carbamoyloxy)methyl]-7-methoxy-8-oxo -7-[2-(2-Thienyl)acetamido]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid sodium salt. Cefoxitin sodium is mainly used clinically for the following infections caused by sensitive bacteria: upper and lower respiratory tract infections, urinary tract infections including uncomplicated gonorrhea, peritonitis and other intra-abdominal and pelvic infections, sepsis (including typhoid), gynecological Infection, bone, joint soft tissue infection, endocarditis, etc. Because this product is effective against anaerobic bacteria and stable to β-lactamase, it is especially suitable for aerobic and anaerobic mixed infections, as well as infecti...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/546A61P31/04G01N30/02G01N30/36B08B3/12A61L2/20A61L2/08F26B3/30
Inventor 周燕伟
Owner SICHUAN PHARMA
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