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Preparation method of ceftezole sodium lyophilized powder for injection

The technology of ceftizole sodium and injection is applied in the field of ceftazole sodium freeze-dried powder injection and preparation thereof, and can solve the problems of easy aggregation into lumps, freeze-dried powder injection easy to shrink into agglomerates, easy to produce precipitation and the like, Achieve the effects of good stability, high clinical safety, and low content of related substances

Inactive Publication Date: 2015-06-03
成都创屹远景科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Due to its strong hygroscopicity, ceftezole sodium is easy to agglomerate when exposed to the air, causing the prepared freeze-dried powder to easily shrink into agglomerates, and it is easy to produce precipitation when prepared into an injection after dissolving

Method used

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  • Preparation method of ceftezole sodium lyophilized powder for injection
  • Preparation method of ceftezole sodium lyophilized powder for injection
  • Preparation method of ceftezole sodium lyophilized powder for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0021] Ceftezole Sodium: 42g

[0022] Citric acid: 4.3g

[0023] Vitamin B1: 8.5g

[0024] Polysorbate 40: 48g

[0025] Mannitol: 50g

[0026] PH regulator: appropriate amount

[0027] Water for injection: 2000ml

[0028] Process:

[0029] 1. Take the prescribed amount of citric acid and vitamin B1, add 50% water for injection, heat to 50-55°C, stir to dissolve, take the prescribed amount of ceftezole sodium into the solution, stir to dissolve and continue to stir for 15 minutes .

[0030] 2. Take the prescribed amount of polysorbate 40 and mannitol, add 40% water for injection, stir for 15 minutes, and adjust the pH to 3.7-4.0 with hydrochloric acid.

[0031] 3. Combine solutions 1 and 2, adjust the pH to 6.4-6.5 with a pH regulator (sodium hydroxide solution), add water for injection to the full amount, add 0.15% activated carbon for needles, stir for 25 minutes, filter for decarburization, intermediate Inspection, after passing the test, use a 0.22 μm filter membran...

Embodiment 1

[0033] Ceftezole Sodium: 42g

[0034] Vitamin B1: 8.5g

[0035] Polysorbate 40: 48g

[0036] Mannitol: 50g

[0037] PH regulator: appropriate amount

[0038] Water for injection: 2000ml

[0039] The preparation method is the same as in Example 1.

Embodiment 2

[0041] Ceftezole Sodium: 42g

[0042] Citric acid: 4.3g

[0043] Polysorbate 40: 48g

[0044] Mannitol: 50g

[0045] PH regulator: appropriate amount

[0046] Water for injection: 2000ml

[0047] The preparation method is the same as in Example 1.

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Abstract

The invention discloses a preparation method of ceftezole sodium lyophilized powder for injection, and relates to a ceftezole sodium injection. The ceftezole sodium lyophilized powder is prepared from the following raw materials: 42 g of ceftezole sodium, 4.3 g of citric acid, 8.5 g of vitamin B1, 48 g of polysorbate 40, and 200 ml of water for injection; in the preparation method, the pH value is adjusted to be 6.4-6.5.

Description

technical field [0001] The invention relates to ceftezole sodium freeze-dried powder injection and a preparation method thereof. Background technique [0002] Ceftezole sodium, also known as Yitixin, its chemical name is: (6R,7R)-3-[(1,3,4-thiadiazol-2-yl)thiomethyl]-8-oxo- 7-[2-(1H-tetrazol-1-yl)acetamido]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate sodium, English alias: 5-Thia- 1-azabicyclo[4,2,0]oct-2-ene-2-carboxylic sodium or sodium(6S,7R)-8-oxo-7-[(1H-tetrazol-1-yacetyl)amino]-3-[ (1,3,4-thiadiazol-2-ylsulf anyl)methyl]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate. This product is white to light yellow crystalline powder, odorless and hygroscopic. Ceftezole sodium is a semi-synthetic cephalosporin derivative, and its mechanism of action is to exert antibacterial activity by inhibiting the synthesis of bacterial cell walls. Ceftezole sodium has antibacterial activity against the following bacteria: Aerobic Gram-positive bacteria: Staphylococcus aureus, S...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/546A61K47/22A61P31/04A61P11/00A61P29/00A61P13/12A61P13/10A61P13/02
Inventor 刘颖
Owner 成都创屹远景科技有限公司
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