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Biapenem composition freeze-dried powder for injection

A technology of biapenem and freeze-dried powder injection, which is applied in the field of freeze-dried powder injection of biapenem composition for injection, can solve the problems of no chitosan-containing nanoparticles, etc., achieves stability and solubility, reduces Adverse reactions, the effect of enhancing the antibacterial effect

Inactive Publication Date: 2014-01-29
HAINAN WEI KANG PHARMA QIANSHAN
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Chitosan nanoparticles are microparticles with a particle size not greater than 100nm. As a drug carrier, they have sustained-release and targeting effects, but there is no clinically available pharmaceutical dosage form containing chitosan nanoparticles.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] Example 1. Preparation of freeze-dried powder injection of biapenem composition for injection, counted in 1000 vials.

[0032] 1. Prescription:

[0033] Biapenem 200g

[0034] Chitosan Nanoparticles 100g

[0035] Water for injection 2000ml

[0036] 2. Preparation process:

[0037] The chitosan nanoparticle that takes by weighing 100g is slowly added in the water for injection of 2000ml, stirs while adding, until dissolving.

[0038] Add 200 g of biapenem and stir to dissolve until clear.

[0039] Adjust the pH to 5.0 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, filter the liquid through 0.45 μm and 0.22 μm microporous membranes, and detect the content of intermediates. The filling volume is calculated as 0.2 g per bottle based on biapenem.

[0040] Fill according to the test requirements, put it into a freeze dryer after half-tamping, cool down ...

Embodiment 2

[0041] Example 2: Preparation of biapenem composition freeze-dried powder for injection, counted in 1000 vials.

[0042] 1. Prescription:

[0043] Biapenem 200g

[0044] Chitosan Nanoparticles 130g

[0045] Water for injection 2000ml

[0046] 2. Preparation process:

[0047] The chitosan nanoparticle that takes by weighing 130g is slowly added in the water for injection of 2000ml, stirs while adding to dissolve.

[0048] Add 200 g of biapenem and stir to dissolve until clear.

[0049] Adjust the pH to 5.0 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, filter the liquid through 0.45 μm and 0.22 μm microporous membranes, and detect the content of intermediates. The filling volume is calculated as 0.2 g per bottle based on biapenem.

[0050] Fill according to the test requirements, put it into a freeze dryer after half-tamping, cool down to -40°C, keep warm...

Embodiment 3

[0051] Example 3: Preparation of freeze-dried powder injection of biapenem composition for injection, counted in 1000 vials.

[0052] 1. Prescription:

[0053] Biapenem 200g

[0054] Chitosan Nanoparticles 80g

[0055] Water for injection 2000ml

[0056] 2. Preparation process:

[0057] The chitosan nanoparticle that takes by weighing 80g is slowly added in the water for injection of 2000ml, stirs while adding to dissolve.

[0058] Add 200 g of biapenem and stir to dissolve until clear.

[0059] Adjust the pH to 5.0 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, filter the liquid through 0.45 μm and 0.22 μm microporous membranes, and detect the content of intermediates. The filling volume is calculated as 0.2 g per bottle based on biapenem.

[0060] Fill according to the test requirements, put it into a freeze dryer after half-tamping, cool down to -40°C, ...

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PUM

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Abstract

The invention provides a biapenem composition freeze-dried powder for injection, and belongs to the field of medicine and medicine preparation technology. The biapenem composition freeze-dried powder comprises following raw material ingredients, by weight, 1 part of biapenem, 0.2 to 10 parts of chitosan nanoparticle, and 91.18 to 93.08 parts of injection water. Advantages of the biapenem composition freeze-dried powder are that: the chitosan nanoparticle is used as a freeze-dried skeleton agent of the freeze-dried powder injection instead of mannitol, so that active effects of mannitol on human bodies are avoided, problems of stability and solubility are solved at the same time, antibacterial effect of biapenem is improved significantly, dosage of biapenem in clinic is reduced, and adverse reaction of biapenem is reduced. The biapenem composition freeze-dried powder is successfully developed, and is capable of providing novel ideas for clinical application of biapenem.

Description

Technical field: [0001] The invention relates to the technical field of medicine and medicine manufacture, in particular to a biapenem composition freeze-dried powder for injection. Background technique: [0002] The chemical name of Biapenem is (-)6-[[(4R,5S,6S)-2-carboxy-6-[(1R)-1-hydroxyethyl]-4-methyl-7- Oxo-1-azabicyclo[3.2.0]hept-2-en-3-yl]thio]-6,7-dihydro-5H-pyridine[1,2-a][1,2,4] Triazol-4-ium inner salt. [0003] Biapenem was developed by Japan Lederle Company and American Cyamide Company, and was jointly listed in Japan in March 2002 by Japan Lederle Company and Japan Meiji Co., Ltd. [0004] Biapenem is a new type of 1β-methyl carbapenem antibiotics with a broad antibacterial spectrum and good bactericidal effect on Gram-negative bacteria, Gram-positive bacteria, aerobic bacteria and anaerobic bacteria; Lambert-negative bacteria, especially the activity against Pseudomonas aeruginosa is stronger than imipenem; the antibacterial activity against aerobic Gram-po...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/4196A61K47/36A61K31/722A61P31/04
Inventor 汪六一汪金灿饶经纬
Owner HAINAN WEI KANG PHARMA QIANSHAN
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