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Cefuroxime sodium suspension powder injection

A technology of cefuroxime sodium and powder injection, which is applied in the field of a new dosage form of cefuroxime sodium, can solve problems such as poor stability, and achieve the effects of low cost, improved bioavailability and simple production process

Inactive Publication Date: 2011-02-02
HAINAN LINGKANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The object of the present invention is to provide a kind of stable cefuroxime sodium powder injection, specifically, through the combination of certain content surfactant, lyophilized support agent and active ingredient, adopt emulsification suspension technology to make cephalosporin of the present invention Suspension powder injection of Fuxin sodium has solved the problem of its poor stability and achieved satisfactory technical results

Method used

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  • Cefuroxime sodium suspension powder injection
  • Cefuroxime sodium suspension powder injection
  • Cefuroxime sodium suspension powder injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] The preparation of embodiment 1 cefuroxime sodium suspension powder injection

[0032] Prescription (100 bottles): Cefuroxime Sodium 75g

[0033] Cholesterol 187.5g

[0034] Tween-80 37.5g

[0035] Mannitol 300g

[0036] Sodium chloride 75g

[0037] Preparation Process

[0038] (1) Add 187.5g of cholesterol and 37.5g of Tween-80 into 2200ml of water for injection, then add 75g of cefuroxime sodium and mix evenly, heat and stir in a water bath at 70°C until it melts;

[0039] (2) Keeping the above liquid at 70-90°C for 10 minutes with a tissue masher to shear and stir at a speed of 10,000 r / min to obtain a primary emulsion, and then circulate and emulsify it through a high-pressure homogenizer for 5 times to obtain an emulsion;

[0040] (3) Add 300g of mannitol and 75g of sodium chloride to the emulsion, dissolve, filter, subpackage, and freeze-dry to obtain cefuroxime sodium freeze-dried suspension powder injecti...

Embodiment 2

[0048] The preparation of embodiment 2 cefuroxime sodium suspension powder injection

[0049] Prescription (100 bottles): Cefuroxime Sodium 100g

[0050] Cholesterol 500g

[0051] Tween-80 100g

[0052] Lactose 533g

[0053] Sucrose 267g

[0054] Preparation Process

[0055] (1) Add 500g of cholesterol and 100g of Tween-80 into 7500ml of water for injection, then add 100g of cefuroxime sodium and mix evenly, heat and stir in a water bath at 80°C until it melts;

[0056] (2) Heat the above liquid at 70-90°C and use a tissue masher to shear and stir for 20 minutes at a speed of 15000r / min to obtain a primary emulsion, and then circulate and emulsify it through a high-pressure homogenizer for 4 times to obtain an emulsion;

[0057] (3) Add 533g of lactose and 267g of sucrose to the emulsion, dissolve, filter, subpackage, and freeze-dry to obtain cefuroxime sodium suspension powder injection.

Embodiment 3

[0065] The preparation of embodiment 3 cefuroxime sodium suspension powder injection

[0066] Prescription (100 bottles): Cefuroxime Sodium 150g

[0067] Cholesterol 562.5g

[0068] Tween-80 112.5g

[0069] Trehalose 390g

[0070] Glycine 585g

[0071] Preparation Process

[0072] (1) Add 562.5g of cholesterol and 112.5g of Tween-80 into 6000ml of water for injection, then add 150g of cefuroxime sodium and mix evenly, heat and stir in a water bath at 90°C until it melts;

[0073] (2) Under the condition of keeping the above liquid at 70-90°C, shear and stir it with a tissue masher for 10 minutes at a speed of 13000r / min to obtain a primary emulsion, and then circulate and emulsify it through a high-pressure homogenizer for 5 times to obtain an emulsion;

[0074] (3) Add 390g trehalose and 585g glycine to the emulsion, dissolve, filter, subpackage, and freeze-dry to obtain cefuroxime sodium suspension powder injection. ...

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Abstract

The invention provides a cefuroxime sodium suspension powder injection. The cefuroxime sodium suspension powder injection comprises the following components by weight part: 1 part of cefuroxime sodium, 2 to 10 parts of surfactant and 3 to 18 parts of lyoprotectants. The cefuroxime sodium suspension powder injection is characterized in that the surfactant is a combination of cholesterol and tween-80 in a weight ratio of 6:1-4:1. The cefuroxime sodium suspension powder injection is prepared unexpectedly by using the emulsification and suspension technologies through specific surfactant after freezing and drying and solves the problem of poor stability of the cefuroxime sodium.

Description

technical field [0001] The invention relates to a new dosage form of cefuroxime sodium, in particular to cefuroxime sodium suspension powder injection and a preparation method thereof. Background technique [0002] Cefuroxime sodium, its chemical name is: (6R,7R)-7-[2-furyl(methoxyimino)acetamido]3-carbamoyloxymethyl-8-oxo-5-thia -1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid sodium salt, the molecular formula is: C 16 h 15 N 4 NaO 8 S, molecular weight: 446.37, structural formula: [0003] [0004] Cefuroxime sodium is a second-generation cephalosporin antibiotic, and its antibacterial activity against Gram-positive cocci is similar or slightly worse than that of the first-generation cephalosporins, but its β-lactamase against Staphylococcus and Gram-negative bacilli is comparable Stablize. The antibacterial activity against Staphylococcus aureus is worse than that of cefazolin, and 1-2 mg / L can inhibit all Staphylococcus aureus sensitive and resistant to penicill...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/19A61K31/546A61P31/04
Inventor 杨明贵
Owner HAINAN LINGKANG PHARMA CO LTD
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