Microsphere injection of ceftriaxone sodium/tazobactam sodium drug composition

A technology of ceftriaxone sodium and tazobactam sodium, which is applied in the field of medicine, can solve problems such as easy deterioration and decomposition, quality decline, and poor stability, and achieve the effects of simple preparation process, improved stability, and improved encapsulation efficiency

Inactive Publication Date: 2010-08-18
HAINAN MEIDA PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This patent is relatively simple, and the raw and auxiliary materials are directly mixed, sieved, and packaged, but the stability is poor, and when it is decomposed by light and heat, the aqueous solution is quickly hydrolyzed and oxidized, and it is easy to deteriorate, which affects the efficacy and quality of the medicine.
[0006] CN101537009A discloses an easy-to-mix ceftriaxone sodium / tazobactam sodium pharmaceutical composition, but it also has poor stability and is easily deteriorated and decomposed when exposed to light and heat, resulting in a decline in quality and affecting the curative effect
The microspheres of the ceftriaxone sodium / tazobactam sodium pharmaceutical composition have not been reported so far

Method used

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  • Microsphere injection of ceftriaxone sodium/tazobactam sodium drug composition
  • Microsphere injection of ceftriaxone sodium/tazobactam sodium drug composition
  • Microsphere injection of ceftriaxone sodium/tazobactam sodium drug composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0060] The preparation of embodiment 1 ceftriaxone sodium / tazobactam sodium injection

[0061] Prescription: (100 bottles)

[0062] Ceftriaxone Sodium 75g

[0063] Tazobactam Sodium 25g

[0064] PLA 62.5g

[0065] PEG600 50g

[0066] Sodium Glycocholate 75g

[0067] Trehalose 200g

[0068] making process:

[0069] (1) 75g of ceftriaxone sodium, 25g of tazobactam sodium, 50g of PEG600 and 200g of trehalose were dissolved in 1000ml of water for injection to obtain an aqueous phase;

[0070] (2) 62.5g PLA and 75g sodium glycocholate were dissolved in 800ml of chloroform and N,N-dimethylformamide mixed solvent with a volume ratio of 4:1 to obtain an oily phase;

[0071] (3) Slowly drop the water phase obtained above into the oil phase under stirring conditions, control the dropping speed to 5ml / min, stir for 10min after dropping, then transfer to a high-speed homogenizer and stir at a high speed for 3 times at a speed of 15000r / min, each 10min, to obtain a uniform white e...

Embodiment 1

[0074] Preparation of Comparative Example 1 Ceftriaxone Sodium / Tazobactam Sodium Injection

[0075] Prescription: (100 bottles)

[0076] Ceftriaxone Sodium 75g

[0077] Tazobactam Sodium 25g

[0078] PLA 62.5g

[0079] PEG600 50g

[0080] Sodium Glycocholate 75g

[0081] Except for the absence of trehalose, the same prescription and process as in Example 1 were used to prepare the ceftriaxone sodium / tazobactam sodium injection of Comparative Example 1.

Embodiment 2

[0082] The preparation of embodiment 2 ceftriaxone sodium / tazobactam sodium injection

[0083] Prescription: (100 bottles)

[0084] Ceftriaxone Sodium 150g

[0085] Tazobactam Sodium 50g

[0086] PLA 350g

[0087] PEG600 250g

[0088] Sodium Glycocholate 300g

[0089] Trehalose 750g

[0090] making process:

[0091] (1) 150g of ceftriaxone sodium, 50g of tazobactam sodium, 250g of PEG600 and 750g of trehalose were dissolved in 5000ml of water for injection to obtain an aqueous phase;

[0092] (2) 350g PLA and 300g sodium glycocholate were dissolved in 3000ml of chloroform and N,N-dimethylformamide mixed solvent with a volume ratio of 4:1 to obtain an oily phase;

[0093] (3) Slowly drop the water phase obtained above into the oil phase under stirring conditions, control the dropping speed to be 10ml / min, stir for 30min after dropping, then transfer to a high-speed homogenizer for high-speed stirring for 5 times at a speed of 15000r / min, each 5min, to obtain a uniform ...

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Abstract

The invention discloses microsphere injection of a ceftriaxone sodium / tazobactam sodium drug composition, which comprises ceftriaxone sodium, tazobactam sodium, PLA, sodium glycocholate, PEG600 and trehalose. In the preferential technical scheme, the microsphere injection comprises 3 parts of ceftriaxone sodium, 1 part of tazobactam sodium, 2.5-7 parts of PLA, 3-6 parts of sodium glycocholate, 2-5 parts of PEG600 and 8-15 parts of trehalose. Compared with the prior art, the invention has the advantages of good stability, high encapsulation efficiency, preparation process suitable for industrial production and proper slow-release effect.

Description

technical field [0001] The invention relates to a ceftriaxone sodium / tazobactam sodium pharmaceutical composition microsphere injection, which belongs to the technical field of medicine. Background technique [0002] The main antibacterial ingredient of this product is ceftriaxone sodium. Ceftriaxone sodium is a third-generation cephalosporin antibiotic, which plays a bactericidal effect by inhibiting the synthesis of bacterial cell walls. , Klebsiella pneumoniae, Bacillus influenzae and indole-positive Proteus have strong effects, especially the most effective against Haemophilus. Clinically, it is mainly used for various infections caused by sensitive bacteria, such as respiratory tract infection, biliary tract infection, pyelonephritis, urinary tract infection, peritonitis, sepsis and skin soft tissue, bone, joint and other infections. Another component of this product is the β-lactamase inhibitor tazobactam sodium, which inhibits the β-lactamase produced by a variety o...

Claims

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Application Information

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IPC IPC(8): A61K31/546A61K31/431A61K9/16A61P31/04
Inventor 王明
Owner HAINAN MEIDA PHARMA
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