Composition of cefoxitin acid

Abstract

The invention relates to a cefoxitin acid composition which is characterized by comprising the combination of cefoxitin acid and arginine. The preparation method of the composition mainly comprises the following steps: weighing the aseptic raw material medicines of the cefoxitin acid and the arginine according to the proportion of a recipe in an aseptic environment, mixing evenly and then subpackaging. The composition solves the problem that the active component of the cefoxitin acid is not dissolved in water, also solves the problem that the original medicine of cefoxitin sodium is unstable,can effectively lower the impurity content and obviously enhance the stability of a product, thereby reducing the generation rate of side reactions, such as anaphylactic reactions, effectively; a safety testing result shows that compared with the original pharmaceutical preparation, the preparation has smaller local irritability and very important clinical application value.

Description

field of invention

[0001] The invention relates to a composition of antibiotic cefoxitin, which belongs to the field of pharmacy. Background technique

[0002] Cefoxitin Sodium (Cefoxitin Sodium) belongs to the cephalosporin antibiotics, and its mother nucleus is similar to cephalosporins. It is a semi-synthetic cephalosporin antibiotic created by Merck Company of the United States. It was developed by Japan's Daiichi Pharmaceutical Co., Ltd. in August 1979 The trade name of Cenomycin has been approved, and the advantage of this product is that it is stable to β-lactamase. Its chemical name is: (6R, 7S)-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.

[0003] Its structural formula is:

[0004]

[0005] Its active ingredient cefoxitin acid is almost insoluble in water, while its sodium salt is easily soluble in water. For the convenience of clinical injection, it is made into a ph...

Examples

Embodiment 1

[0014] In the aseptic batching workshop, weigh 35.5 kg of sterile cefoxitin acid API and 14.5 kg of arginine API, pour them into a high-efficiency three-dimensional motion mixer, and mix for about 1.5 hours at a speed of 5 rpm. After uniformity, the material is discharged and packaged separately, and the product is obtained.

Embodiment 2

[0016] In the aseptic batching workshop, weigh 35kg of sterile cefoxitin acid API and 15kg of arginine API, pour them into a high-efficiency three-dimensional motion mixer, and mix for about 1.5 hours at a speed of 5 rpm. , discharging, sub-packaging, that is to say.

field of invention

[0001] The invention relates to a composition of antibiotic cefoxitin, which belongs to the field of pharmacy. Background technique

[0002] Cefoxitin Sodium (Cefoxitin Sodium) belongs to the cephalosporin antibiotics, and its mother nucleus is similar to cephalosporins. It is a semi-synthetic cephalosporin antibiotic created by Merck Company of the United States. It was developed by Japan's Daiichi Pharmaceutical Co., Ltd. in August 1979 The trade name of Cenomycin has been approved, and the advantage of this product is that it is stable to β-lactamase. Its chemical name is: (6R, 7S)-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.

[0003] Its structural formula is:

[0004]

[0005] Its active ingredient cefoxitin acid is almost insoluble in water, while its sodium salt is easily soluble in water. For the convenience of clinical injection, it is made into a ph...

Examples

Embodiment 1

[0014] In the aseptic batching workshop, weigh 35.5 kg of sterile cefoxitin acid API and 14.5 kg of arginine API, pour them into a high-efficiency three-dimensional motion mixer, and mix for about 1.5 hours at a speed of 5 rpm. After uniformity, the material is discharged and packaged separately, and the product is obtained.

Embodiment 2

[0016] In the aseptic batching workshop, weigh 35kg of sterile cefoxitin acid API and 15kg of arginine API, pour them into a high-efficiency three-dimensional motion mixer, and mix for about 1.5 hours at a speed of 5 rpm. , discharging, sub-packaging, that is to say.

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