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Injection ceftaroline fosamil composition sterile powder and preparation method thereof

A technology of ceftaroline axetil and sterile powder, which is applied in the direction of powder delivery, medical preparations containing non-active ingredients, medical preparations containing active ingredients, etc., and can solve the problem of reduced antibacterial activity of ceftaroline axetil and poor stability of aqueous solution, etc. problem, to achieve stable solution and good dissolution effect

Inactive Publication Date: 2017-07-14
REYOUNG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The object of the present invention is to provide a kind of sterile powder of ceftaroline axetil composition for injection, which solves the problems that ceftaroline axetil antibacterial activity decreases and its aqueous solution stability is poor due to the enhancement of bacterial drug resistance, and has good dissolving effect, The characteristics of good solution stability, the present invention also provides its preparation method

Method used

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  • Injection ceftaroline fosamil composition sterile powder and preparation method thereof
  • Injection ceftaroline fosamil composition sterile powder and preparation method thereof
  • Injection ceftaroline fosamil composition sterile powder and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0046] With L-arginine as a solubilizer and stabilizer, the sterile powder of the ceftaroline axetil composition for injection is made of the following components by weight:

[0047] Ceftaroline fexetil monoacetic acid monohydrate 600g (calculated as ceftaroline fexetil monoacetic acid anhydrate)

[0048] Avibactam sodium 500g (calculated as Avibactam)

[0049] L-Arginine 261g

[0050] The preparation method is as follows:

[0051] Crush L-arginine under sterile conditions not exceeding 20°C, pass through a 60-mesh sieve, weigh 261g of L-arginine and 600g of ceftaroline fexetil monoacetic acid monohydrate, and put them into a three-dimensional mixer , mixed for 30 minutes, then weighed 500g of avibactam sodium, put it into a three-dimensional mixer, mixed for 30 minutes, put the mixed powder into a sterile bag, transferred to the subpackaging workshop for subpackaging, plugging and capping, Batch of 1000 pieces.

Embodiment 2

[0053] With L-arginine as a solubilizer and stabilizer, the sterile powder of the ceftaroline axetil composition for injection is made of the following components by weight:

[0054] Ceftaroline fexetil monoacetic acid monohydrate 600g (calculated as ceftaroline fexetil monoacetic acid anhydrate)

[0055] Avibactam Sodium 600g (calculated as Avibactam)

[0056] L-Arginine 350g

[0057] The preparation method is as follows:

[0058] Crush L-arginine under sterile conditions not exceeding 20°C, pass through a 60-mesh sieve, weigh 350g of L-arginine and 600g of ceftaroline fexetil monoacetic acid monohydrate, and put them into a three-dimensional mixer , mixed for 30 minutes, then weighed 600g of avibactam sodium, put it into a three-dimensional mixer, mixed for 30 minutes, put the mixed powder into a sterile bag, transferred to the subpackaging workshop for subpackaging, plugging and capping, Batch of 1000 pieces.

Embodiment 3

[0060] With L-arginine as a solubilizer and stabilizer, the sterile powder of the ceftaroline axetil composition for injection is made of the following components by weight:

[0061] Ceftaroline fexetil monoacetic acid monohydrate 800g (calculated as ceftaroline fexetil monoacetic acid anhydrate)

[0062] Avibactam Sodium 800g (calculated as Avibactam)

[0063] L-Arginine 600g

[0064] The preparation method is as follows:

[0065] Crush L-arginine under sterile conditions not exceeding 20°C, pass through a 60-mesh sieve, weigh 600g of L-arginine and 800g of ceftaroline fexetil monoacetic acid monohydrate, and put them into a three-dimensional mixer , mixed for 30 minutes, then weighed 800g of avibactam sodium, put it into a three-dimensional mixer, mixed for 30 minutes, put the mixed powder into a sterile bag, and transferred it to the subpackaging workshop for subpackaging, plugging and capping. Batch of 1000 pieces.

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Abstract

The invention relates to injection ceftaroline fosamil composition sterile powder and a preparation method thereof, and belongs to the technical field of medicine synthesis and preparations. The sterile powder comprises ceftaroline fosamil or pharmaceutically acceptable salts or solvent compounds of the ceftaroline fosamil, avibactam or pharmaceutically acceptable salts of the avibactam, and free arginine or pharmaceutically acceptable salts of the free arginine. The preparation method comprises the following steps: firstly, in a low-temperature sterile environment, crushing and screening the free arginine or the pharmaceutically acceptable salts of the free arginine, mixing with the ceftaroline fosamil or pharmaceutically acceptable salts or solvent compounds of the ceftaroline fosamil, further mixing with the avibactam or pharmaceutically acceptable salts of the avibactam, performing vacuum packaging with sterile aluminum plastic bags, sub-pacakaging in sterile penicillin bottles, and performing plugging and cover rolling. By adopting the injection ceftaroline fosamil composition sterile powder provided by the invention, the problems of effective dissolution and sufficient chemical stability maintenance are solved, the stability of an obtained product is not less than that of an original product, and the powder has the characteristics of being good in dissolution effect and stable in solution.

Description

technical field [0001] The invention relates to a sterile powder of a ceftaroline axetil composition for injection and a preparation method thereof, belonging to the technical field of drug synthesis and preparation. Background technique [0002] The trade name of ceftaroline fosamil is Teflaro, which was developed by Takeda Pharmaceutical Company of Japan, and Forest Laboratories of the United States obtained the market authorization in the United States, and was listed in the United States for the first time in March 2011. As a β-lactam drug, ceftaroline axetil has a higher affinity for penicillin-binding protein PBPs, which inhibits the synthesis of bacterial cell walls and kills bacteria. And has broad-spectrum antibacterial activity, the drug against Staphylococcus aureus [including methicillin-resistant Staphylococcus aureus (MRSA), moderately vancomycin-resistant Staphylococcus aureus (VISA), heterogeneous drug-resistant VISA (hVISA) and Gram-positive bacteria such a...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/675A61K31/551A61K31/198A61K9/14A61K47/18A61P31/04
CPCA61K31/675A61K9/0019A61K9/145A61K31/198A61K31/551A61K2300/00
Inventor 苗得足胡清文李宇婷于志波
Owner REYOUNG PHARMA
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