Cefpiramide sodium composition freeze-dried injection for injection

A technology of cefpiramide sodium and freeze-dried powder injection, which can be used in freeze-dried delivery, powder delivery, medical preparations containing active ingredients, etc., and can solve the problems of diarrhea, white turbidity of injection, flocculent, epileptic seizures, etc.

Inactive Publication Date: 2014-02-05
HAINAN WEI KANG PHARMA QIANSHAN
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] In clinical application, it was found that single cefpiramide sodium has poor activity against Pseudomonas aeruginosa and anaerobic bacteria, and it is very common to use it in combination with other anti-infective drugs. White turbidity and flocs appear, frequent medication can lead to nausea, vomiting, diarrhea, seizures, etc.

Method used

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  • Cefpiramide sodium composition freeze-dried injection for injection

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] Embodiment 1, preparation of cefpiramide sodium composition freeze-dried powder for injection, in 1000 pieces.

[0030] Prescription:

[0031] Cefpiramide Sodium 1000g

[0032] Chitosan Nanoparticles 800g

[0033] Water for injection 2000ml

[0034] 2. Preparation process:

[0035] The chitosan nanoparticle that weighs 800g is slowly added in the water for injection of 2000ml, stirs while adding, until dissolving.

[0036] Add 1000 g of cefpiramide sodium and stir to dissolve until clear.

[0037] Adjust the pH to 5.1 with buffer salts of sodium dihydrogen phosphate and disodium hydrogen phosphate, add 0.1% activated carbon and stir for 30 minutes, filter out the activated carbon, and filter the liquid through 0.45 μm and 0.22 μm microporous membranes to detect the content of intermediates , according to cefpiramide sodium 1.0g per bottle to calculate the filling volume.

[0038] Fill according to the test requirements, put it into a freeze dryer after half-tampin...

Embodiment 2

[0039] Embodiment 2, preparation of cefpiramide sodium composition freeze-dried powder for injection, in 1000 pieces.

[0040] 1. Prescription:

[0041] Cefpiramide Sodium 1000g

[0042] Chitosan Nanoparticles 865g

[0043] Water for injection 2000ml

[0044] 2. Preparation process:

[0045] The chitosan nanoparticle that weighs 865g is slowly added in the water for injection of 2000ml, stirs while adding to dissolve.

[0046] Add 1000 g of cefpiramide sodium and stir to dissolve until clear.

[0047] Adjust the pH to 5.1 with buffer salts of sodium dihydrogen phosphate and disodium hydrogen phosphate, add 0.1% activated carbon and stir for 30 minutes, filter out the activated carbon, and filter the liquid through 0.45 μm and 0.22 μm microporous membranes to detect the content of intermediates , according to cefpiramide sodium 1.0g per bottle to calculate the filling volume.

[0048] Fill according to the test requirements, put it into a freeze dryer after half-tamping, ...

Embodiment 3

[0049] Embodiment 3, preparation of cefpiramide sodium composition freeze-dried powder for injection, in 1000 pieces.

[0050] 1. Prescription:

[0051] Cefpiramide Sodium 1000g

[0052] Chitosan Nanoparticles 757g

[0053] Water for injection 2000ml

[0054] 2. Preparation process:

[0055] The chitosan nanoparticle that takes by weighing 757g is slowly added in the water for injection of 2000ml, stirs while adding, until dissolving.

[0056] Add 1000 g of cefpiramide sodium and stir to dissolve until clear.

[0057] Adjust the pH to 5.1 with buffer salts of sodium dihydrogen phosphate and disodium hydrogen phosphate, add 0.1% activated carbon and stir for 30 minutes, filter out the activated carbon, and filter the liquid through 0.45 μm and 0.22 μm microporous membranes to detect the content of intermediates , according to cefpiramide sodium 1.0g per bottle to calculate the filling volume.

[0058]Fill according to the test requirements, put it into a freeze dryer afte...

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PUM

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Abstract

The invention provides a cefpiramide sodium composition freeze-dried injection for injection, and relates to the technical field of medicines and medicine preparation. The cefpiramide sodium composition freeze-dried injection for injection comprises the following raw material components in parts by weight: 7.26-9.17 parts of cefpiramide sodium, 5.78-7.67 parts of chitosan nanoparticles and 81.38-87.10 parts of water for injection. The cefpiramide sodium composition freeze-dried injection for injection has the advantages that 1) the in vitro antimicrobial activity spectrum is wider and covers Gram-positive bacteria and Gram-negative bacteria (comprising Pseudomonas aeruginosa), the characteristics that the G+ bacterial and Pseudomonas aeruginosa resistance of the third and fourth generation cephalosporin and the activity of anaerobic bacteria are poor, and research and development direction of cephalosporin is met; 2) the injection is good in stability, thus greatly reducing the risk that the product quality is greatly reduced in production and circulation links (particularly commercial circulation; 3) the activity is enhanced, so that the medication period of the patient is shortened, and the probability of adverse reaction caused by accumulation of cefpiramide sodium is reduced; 4) the chitosan nanoparticles can replace mannitol as a freeze-dried skeleton agent of the freeze-dried injection, so that the activity of mannitol on human body is eliminated.

Description

Technical field: [0001] The invention relates to the technical field of medicine and medicine manufacture, in particular to a cefpiramide sodium composition freeze-dried powder for injection. Background technique: [0002] Cefpiramide sodium is a semi-synthetic third-generation cephalosporin antibiotic. This product is characterized by broad antibacterial spectrum and bactericidal power, and is quite stable to β-lactamase. Clinically, it is mainly used for pharyngitis, tonsillitis, acute and chronic bronchitis, pneumonia, pulmonary suppurative disease, meningitis and gynecological infection caused by sensitive bacterial infection. The mechanism of action has strong affinity with 1A, 1B and 3 of penicillin-binding protein (PBP), inhibiting the synthesis of bacterial cell walls, thereby exerting a bactericidal effect. [0003] In clinical application, it was found that single cefpiramide sodium has poor activity against Pseudomonas aeruginosa and anaerobic bacteria, and it i...

Claims

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Application Information

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IPC IPC(8): A61K31/722A61K9/19A61P31/04A61P31/10A61P31/12A61K31/546
Inventor 汪六一汪金灿胡维维
Owner HAINAN WEI KANG PHARMA QIANSHAN
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