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Cefoxitin sodium agent and preparation method thereof

A technology for cefoxitin sodium and injections, which is applied in pharmaceutical formulas, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., and can solve problems such as content decline, injection impurity content increase, and drug cost increase

Inactive Publication Date: 2013-09-04
张宏民
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the aseptic subpackaged powder of cefoxitin sodium has poor long-term storage stability, decreased content, and low bioavailability
[0007] Chinese patent 2010105926427 discloses a cefoxitin sodium liposome freeze-dried preparation and a preparation method thereof, the liposome preparation is prepared from cefoxitin sodium, neutral phospholipids, cholesterol, stabilizers, excipients and buffer salts As a result, the preparation not only has a complicated prescription, but also has too many types and dosages of pharmaceutical excipients, and its preparation process is relatively complicated, in which a large amount of pharmaceutical excipients are added, which leads to an increase in the impurity content in the injection, and greatly increases the hidden dangers of drug safety. Due to the increase in impurities , the content of related substances is difficult to meet the requirements of the Pharmacopoeia in the detection, and cannot be industrialized
In addition, the preparation yield of liposome is very low, which causes the cost of medicine to increase greatly, which is also another reason why the product cannot be industrialized.
[0008] Chinese patent application 2012102223575 discloses a cefoxitin liposome injection prepared by cefoxitin, soybean phosphatidylserine, cholesterol and poloxamer 188. Similarly, the preparation process of the preparation is relatively complicated, and a large amount of pharmaceutical excipients are added. As a result, the impurity content in the injection increases, and the potential safety hazard of the drug is greatly increased. Due to the increase in impurities, the content of related substances is difficult to meet the requirements of the Pharmacopoeia in the test, and it cannot be industrialized.
At present, no cefoxitin sodium liposome preparation has been approved by the State Food and Drug Administration for production

Method used

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  • Cefoxitin sodium agent and preparation method thereof
  • Cefoxitin sodium agent and preparation method thereof
  • Cefoxitin sodium agent and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Example 1 1000 cefoxitin sodium freeze-dried powder injections

[0027]

[0028]

[0029] In a clean area, take a small amount of sodium hydroxide and add it to a small amount of water for injection, stir to dissolve, and set aside; add the prescribed amount of cefoxitin sodium to an appropriate amount of water for injection, stir and dissolve as solution I; adjust the pH to about 6.6 with sodium hydroxide solution , to prepare solution II; add prescription amount of mannitol to solution II, stir and dissolve to obtain solution III. Weigh 2.4g of activated carbon and add an appropriate amount of water for injection and stir well, then add it to solution III, add water for injection to the full amount, stir and circulate for more than 15 minutes, first decarbonize by coarse filtration, and then fine filter through a 0.22μm filter membrane to obtain the essence The filtrate is tested for content, pH value, endotoxin, visible foreign matter and other items. After pas...

Embodiment 2

[0030] Example 2 1000 cefoxitin sodium freeze-dried powder injections

[0031]

[0032] In the clean area, first add the prescribed amount of cefoxitin sodium into an appropriate amount of water for injection, stir and dissolve, as solution I; adjust the pH to about 6.3 with hydrochloric acid, as solution II; add the prescribed amount of mannitol to solution II, Stir to dissolve as solution III. Take 20g of activated carbon and add an appropriate amount of water for injection and stir well, add it to solution III, add water for injection to the full amount, stir and circulate for more than 15 minutes, first decarbonize by coarse filtration, and then fine filter through a 0.22μm filter membrane, and take the fine filtrate for content, pH Value, endotoxin, visible foreign matter and other items are tested, and after passing the test, it is filled and freeze-dried, and the freeze-drying process is as follows: the shelf temperature is set at -35°C to -50°C for pre-freezing, and...

Embodiment 3

[0033] Example 3 1000 cefoxitin sodium freeze-dried powder injections

[0034]

[0035]

[0036] In the clean area, first add the prescribed amount of cefoxitin sodium into an appropriate amount of water for injection, stir and dissolve, and make it solution I; adjust the pH to about 6.5 with sodium hydroxide, and make it solution II; add the prescribed amount of manna to solution II Alcohol, stirred to dissolve, as solution III. Take 6g of activated carbon and add an appropriate amount of water for injection, stir well, add it to solution III, add water for injection to the full amount, stir and circulate for more than 15 minutes, first decarbonize by coarse filtration, and then fine filter through a 0.22μm filter membrane, and take the fine filtrate for content, pH Value, endotoxin, visible foreign matter and other items are tested, and after passing the test, it is filled and freeze-dried, and the freeze-drying process is as follows: the shelf temperature is set at -35°...

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Abstract

The invention relates to a cefoxitin sodium agent and preparation method thereof, especially relates to a cefoxitin sodium injection for treating microbe infection, preferably relates to a freeze-drying powder injection. The cefoxitin sodium injection of the present invention is mainly composed of cefoxitin and accessory mannitol. The solvent in the injection of the present invention is injection water; the excipient in the freeze-drying powder injection is mannitol, and sodium hydroxide or hydrochloric acid are used for adjusting pH valve.

Description

technical field [0001] The invention relates to an antibacterial drug and a preparation method thereof, in particular to a stable cefoxitin sodium injection and a preparation method thereof, belonging to the technical field of pharmaceutical preparations. Background technique [0002] Cefoxitin sodium, 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, molecular formula: C 16 h 16 N 3 NaO 7 S 2 , molecular weight 449.43, structural formula: [0003] [0004] Cefoxitin Sodium is a β-lactam antibiotic developed by Merck & Co. of the United States and launched in 1974. Cefoxitin kills bacteria by inhibiting the synthesis of bacterial cell walls, and because of its structural characteristics, it has high resistance to β-lactamase produced by bacteria, and its antibacterial effect and antibacterial spectrum are the same as those of second-generation cepha...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/546A61K47/26A61P31/04
Inventor 张宏民
Owner 张宏民
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