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Tobramycin composition freeze-dried powder needle for injection

A technology of tobramycin and freeze-dried powder injection is applied in the field of medicine and medicine manufacturing, and can solve the problem of no chitosan-containing nanoparticles and the like

Inactive Publication Date: 2014-02-19
HAINAN WEI KANG PHARMA QIANSHAN
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] Chitosan nanoparticles are microparticles with a particle size of less than 100nm. As a drug carrier, they have slow-release and targeting effects and broad-spectrum antibacterial properties. They have certain inhibitory effects on the growth of various bacteria. There are no pharmaceutical dosage forms containing chitosan nanoparticles

Method used

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  • Tobramycin composition freeze-dried powder needle for injection
  • Tobramycin composition freeze-dried powder needle for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Embodiment 1, preparation of tobramycin composition freeze-dried powder for injection, in 1000 pieces.

[0031] Prescription:

[0032] Tobramycin 10g

[0033] Chitosan Nanoparticles 5g

[0034] Water for injection 2000mL

[0035] 2. Preparation process:

[0036] Weigh 100g of chitosan nanoparticles and slowly add to 2000mL of water for injection, and stir until dissolved while adding.

[0037] Add 200 g of Tobramycin and stir to dissolve until clear.

[0038] Adjust the pH to 8.0 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, and filter the liquid through 0.45 μm and 0.22 μm microporous membranes to detect the content of intermediates , calculated according to tobramycin 0.01g per bottle.

[0039] Fill according to the test requirements, put it into a freeze dryer after half-tamping, cool down to -40°C, keep warm for 2 hours, slowly heat up to -5°...

Embodiment 2

[0040] Embodiment 2, preparation of tobramycin composition freeze-dried powder for injection, in 1000 pieces.

[0041] 1. Prescription:

[0042] Tobramycin 10g

[0043] Chitosan Nanoparticles 6.5g

[0044] Water for injection 2000mL

[0045] 2. Preparation process:

[0046] Weigh 130g of chitosan nanoparticles and slowly add to 2000mL of water for injection, and stir until dissolved while adding.

[0047] Add 200 g of Tobramycin and stir to dissolve until clear.

[0048] Adjust the pH to 8.0 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, and filter the liquid through 0.45 μm and 0.22 μm microporous membranes to detect the content of intermediates , calculated according to tobramycin 0.01g per bottle.

[0049] Fill according to the test requirements, put it into a freeze dryer after half-tamping, cool down to -40°C, keep warm for 2 hours, slowly heat up t...

Embodiment 3

[0050]Embodiment 3, preparation of tobramycin composition freeze-dried powder for injection, in 1000 pieces.

[0051] Prescription:

[0052] Tobramycin 10g

[0053] Chitosan Nanoparticles 4g

[0054] Water for injection 2000mL

[0055] 2. Preparation process:

[0056] Weigh 80g of chitosan nanoparticles and slowly add to 2000mL of water for injection, and stir until dissolved while adding.

[0057] Add 200 g of Tobramycin and stir to dissolve until clear.

[0058] Adjust the pH to 8.0 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, and filter the liquid through 0.45 μm and 0.22 μm microporous membranes to detect the content of intermediates , calculated according to tobramycin 0.01g per bottle.

[0059] Fill according to the test requirements, put it into a freeze dryer after half-tamping, cool down to -40°C, keep warm for 2 hours, slowly heat up to -5°C~...

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Abstract

The invention provides a tobramycin composition freeze-dried powder needle for injection and belongs to the technical field of medicine and medicine preparation. The tobramycin composition freeze-dried powder needle for injection comprises the following raw materials in parts by weight: 0.46-0.62 part of tobramycin, 0.23-0.31 part of chitosan nanoparticle and 98.07-99.31 parts of water for injection. The tobramycin composition freeze-dried powder needle has the advantages as below: 1) the composition of tobramycin and chitosan nanoparticle which are in a proportion of 1:0.5 can improve the solubility of tobramycin in water, shorten the dissolving time, improve the dilution stability and is beneficial to clinical application; 2) the composition can remarkably improve the antibacterial effect of tobramycin, clinically reduce the use amount of tobramycin and reduce the adverse reaction of tobramycin; 3) the chitosan nanoparticle can replace mannitol to be used as a freeze-dried framework agent of freeze-dried powder needle and can eliminate the activity of mannitol to the human body; and 4) of the situation that medicine is decomposed after being heated can be avoided, the stability of medicine is maintained, the product is loose in texture, can be dissolved rapidly in water, and is good in stability and beneficial to storage.

Description

Technical field: [0001] The invention relates to the technical field of medicine and medicine manufacture, in particular to a freeze-dried powder injection of a tobramycin composition for injection. Background technique: [0002] The chemical name of tobramycin is O-3-amino-3-deoxy-α-O-glucopyranosyl-(1→6)-O-[2,6-diamino-2,3,6- Trideoxy-α-D-nucleo-hexapyranosyl-(1→4)]-2-deoxy-D-streptavidamine. [0003] This product is white or off-white powder, hygroscopic. Soluble in water, very slightly soluble in ethanol, almost insoluble in chloroform or ether. This drug belongs to aminoglycoside antibiotics, and its chemical structure is similar to gentamicin. Compared with other aminoglycoside antibiotics, it has a wider antibacterial spectrum, higher curative effect, and less toxicity. The formation of the 70S complex prevents mRNA from being translated into protein, leading to cell death. It is mainly effective against Gram-negative bacteria, such as Pseudomonas aeruginosa, Esch...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/702A61K47/36A61P31/04A61K31/722
Inventor 汪六一汪金灿程贤贵
Owner HAINAN WEI KANG PHARMA QIANSHAN
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