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Lysostaphin freeze dried powder used for preventing and treating trauma surface infestation

A technology of lysostaphin and freeze-dried powder, which is applied in freeze-dried delivery, powder delivery, antibacterial drugs and other directions, can solve the problems of vancomycin not being used externally, high liver and kidney toxicity of patients, and toxic and side effects.

Active Publication Date: 2007-02-14
SHANGHAI HI TECH UNITED BIO TECHCAL RES
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, in recent years, it has been reported that MRSA is less sensitive to vancomycin under the selective pressure of vancomycin.
Moreover, vancomycin has strong toxic and side effects, and is highly toxic to the liver and kidneys of patients. In addition, vancomycin cannot be used externally.
At present, SD-Ag, sulfamethone, and chlorhexidine are commonly used in burns, scalds, and trauma wounds. These drugs are highly irritating to damaged skin and basically have no effect on MRSA

Method used

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  • Lysostaphin freeze dried powder used for preventing and treating trauma surface infestation
  • Lysostaphin freeze dried powder used for preventing and treating trauma surface infestation
  • Lysostaphin freeze dried powder used for preventing and treating trauma surface infestation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] Embodiment 1 Preparation of lysostaphin freeze-dried powder

[0037] 1. Composition and ratio

[0038]Lysostaphin 0.4%; human serum albumin 10%; glycine 30%; mannitol 10%; potassium dihydrogen phosphate 15%; disodium hydrogen phosphate 30%.

[0039] 2. Preparation of semi-finished products

[0040] Weigh solid KH 2 PO 4 and Na 2 HPO 4 .12H 2 O, prepare 0.2mol / L phosphate buffer A (pH value 6.5 phosphate buffer, concentration is 0.2M). According to the formulation prescription, weigh the required glycine and mannitol, measure the required volume of human serum albumin, add it to the solution of part A, stir and dissolve, and obtain solution B. Measure the stock solution of recombinant lysostaphin, add it to solution B, make the biological activity of recombinant lysostaphin in the final solution be 400U / ml, add A solution to the final volume, and what is obtained at this time is the recombinant lysostaphin Semi-finished solution.

[0041] 3. Microf...

Embodiment 2

[0047] Example 2 Repeated Dosing Toxicity Test of Rabbit Subcutaneous Injection External Recombinant Lysostaphin

[0048] 1. Purpose of the experiment

[0049] The purpose of this experiment is to observe the nature, degree, development and recovery of toxic reactions in rabbits through subcutaneous injection of recombinant lysostaphin for external use, so as to provide reference materials for clinical safety drug dosage design and clinical toxicity monitoring.

[0050] 2. Experimental method

[0051] 24 New Zealand white rabbits, weighing 2.5-3.0kg. There are 3 dosage groups for recombinant lysostaphin for external use, and the dosages are 100, 20 and 4ml.kg -1 (equivalent to 241936, 48387 and 9677U·m-2), the solvent control group (0.9% sodium chloride injection), the subcutaneous injection volume is 1ml.kg -1 . Administered continuously 7 days a week for a total of 4 weeks.

[0052] 3. Experimental results

[0053] After administration, the general behavior and...

Embodiment 3

[0056] Example 3 Skin irritation test of transdermally administered topical recombinant lysostaphin in rabbits

[0057] 1. The purpose of the experiment:

[0058] To observe the local irritation reaction of intact skin and broken skin of rabbits after contacting externally applied recombinant lysostaphin, and to provide experimental data for the safety evaluation of its clinical use.

[0059] 2. Experimental method:

[0060] In the test, two test groups were established: intact skin (group I) and damaged skin peptide (group II), with 4 animals in each group, half male and half male, and each animal had a hairless area of ​​10 × 6 cm on the back of each animal with electric hair removal scissors. Prepare the skin once every other day during the medication period. Use a sterile needle to cut the epidermis of the skin in the shape of a "well" (1 cm apart) in the hair removal area for damaged skin to ooze blood. The drug concentration is based on the maximum dilution con...

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Abstract

A freeze-dried powder-injection of staphylococcus lysozyme for preventing and the infection of straphylococcus, especially the Staphylococcus aureus, to the wound caused by burn, scald, etc and the skin mucosa of eye and nose is composed of staphylococcus lysozyme, bovine serum albumin, glycine, mannitol, and phosphate. Its preparing process is also disclosed.

Description

technical field [0001] The invention relates to a freeze-dried biological preparation, in particular to a freeze-dried powder of lysostaphin. Background technique [0002] Long before antibiotics became widely available in the 1930s, Staphylococcus aureus infected most of the people who came into contact with it. In 1929, penicillin was discovered to treat Staphylococcus aureus infection, and drug-resistant strains were produced in the late 1950s; in 1956, vancomycin, which had a good effect on penicillin-resistant Staphylococcus, was invented. Later, due to its high toxicity, Applications were limited; by the 1960s less toxic methicillin and cephalosporin antibiotics were on the market, but the first methicillin-resistant Staphylococcus aureus (MRSA) strain was found in Europe in 1961. [0003] In recent years, the MRSA infection rate has increased significantly compared with the past. The United States was 2.4% in 1986, rose to 29% in 1991, and has an upward trend in rec...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/43A61K9/19A61P31/04A61P17/02
Inventor 黄青山莫云杰
Owner SHANGHAI HI TECH UNITED BIO TECHCAL RES
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