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Radiation-sterilization-resistant protein composition

A composition and protein technology, applied in the field of protein composition, can solve the problems of strong toxicity, adverse effects on the human body, and no sterilization of enzyme-containing nanofibers.

Active Publication Date: 2015-01-07
KM生物医药股份公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the activity of proteins such as physiologically active proteins is reduced by heat or radiation sterilization
Ethylene oxide sterilization may not only produce by-products through chemical reactions, but also has strong toxicity, and residual gas may have adverse effects on the human body, etc.
Sterilization with chemical sterilants has the following problems: the need to consider protein resistance to sterilants, changes in pH, changes in ionic strength, or changes in temperature
However, there is no description in this document about sterilizing enzyme-containing nanofibers

Method used

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  • Radiation-sterilization-resistant protein composition
  • Radiation-sterilization-resistant protein composition
  • Radiation-sterilization-resistant protein composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0069] Disperse fibrinogen freeze-dried powder (Boluhelu (registered trademark, the same below) for tissue adhesion: vial (vial) 1) in 2-propanol, and then dissolve hydroxypropyl cellulose (6-10mPa·s , manufactured by Wako Pure Chemical Industries, Ltd.) to 16 wt%, to prepare a spinning solution containing fibrinogen-containing particles / hydroxypropyl cellulose=20 (9.2 as fibrinogen) / 100 (w / w). At a temperature of 22°C and a humidity of 26% or less, spinning is performed by electrospinning to obtain a sheet-like fiber molded body. The inner diameter of the nozzle is 0.8 mm, the voltage is 11 kV, the flow rate of the spinning solution is 1.2 mL / hour, and the distance from the nozzle to the plate is 15 cm. The average fiber diameter of the obtained fiber molded product was 0.86 mu m with an average thickness of 137 mu m. The obtained sheet was sterilized by electron beam at 20 kGy. Cut the sterilized sheet into 0.5cm×0.5cm, use 62.5 mu Protein was extracted with L normal...

Embodiment 2

[0071] Freeze-dried fibrinogen powder (for tissue bonding: vial 1) was dispersed in 2-propanol, and then hydroxypropyl cellulose (6-10 mPa·s, manufactured by Wako Pure Chemical Industries, Ltd.) was dissolved to 16 wt%, A spinning solution of fibrinogen freeze-dried powder / hydroxypropyl cellulose=40 (18 based on fibrinogen) / 100 (w / w) was prepared. At a temperature of 22°C and a humidity of 26% or less, spinning is performed by electrospinning to obtain a sheet-like fiber molded body. The inner diameter of the nozzle is 0.8 mm, the voltage is 12.5 kV, the flow rate of the spinning solution is 1.2 mL / hour, and the distance from the nozzle to the plate is 15 cm. The average fiber diameter of the obtained fiber molded product was 0.43 mu m with an average thickness of 152 mu m. The obtained sheet was sterilized by electron beam at 20 kGy. Cut the sterilized sheet into 0.5cm×0.5cm, use 62.5 mu Protein was extracted with L normal saline, and ELISA assay was carried out. As ...

Embodiment 3

[0073] Freeze-dried fibrinogen powder (for tissue bonding: vial 1) was dispersed in 2-propanol, and then hydroxypropyl cellulose (6-10 mPa·s, manufactured by Wako Pure Chemical Industries, Ltd.) was dissolved to 16 wt%, A spinning solution of fibrinogen freeze-dried powder / hydroxypropyl cellulose=100 (46 based on fibrinogen) / 100 (w / w) was prepared. At a temperature of 22°C and a humidity of 26% or less, spinning is performed by electrospinning to obtain a sheet-like fiber molded body. The inner diameter of the nozzle is 0.8 mm, the voltage is 12.5 kV, the flow rate of the spinning solution is 1.2 mL / hour, and the distance from the nozzle to the plate is 15 cm. The average fiber diameter of the obtained fiber molded body was 0.35 mu m, with an average thickness of 191 mu m. The obtained sheet was sterilized by electron beam at 20 kGy. Cut the sterilized sheet into 0.5cm×0.5cm, use 62.5 mu Protein was extracted with L normal saline, and ELISA assay was carried out. As a...

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Abstract

A protein composition exhibiting radiation-sterilization resistance, and including, as an additive, a mixture comprising glycine, phenylalanine and histidine, and / or a cellulose-ester derivative.

Description

technical field [0001] The present invention relates to a radiation-resistant protein composition comprising a specific amino acid group and / or a cellulose ether derivative. Background technique [0002] In recent years, the importance of natural and synthetic proteins as medicines has increased. In addition, when used for medical use, the product must be sterilized. As sterilization methods, heat sterilization using an autoclave, ionizing radiation sterilization using gamma rays or electron beams, gas sterilization using ethylene oxide gas, and plasma sterilization using hydrogen peroxide are known. Sterilization, chemical sterilization using glutaraldehyde preparations, separation sterilization using filters, etc. However, the activity of proteins such as physiologically active proteins is reduced by heat or radiation sterilization. Ethylene oxide sterilization may not only produce by-products through chemical reactions, but also has strong toxicity, and the residual ga...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/00A61K9/70A61K38/48A61K47/38A61L15/44A61P7/04
CPCA61K47/38A61L15/44A61L29/049A61L31/143A61K9/70A61K38/48A61K38/00A61L17/10A61L28/0026A61L15/225A61L27/26A61L31/041A61L27/505A61K9/7007A61P5/00A61P7/04C08L1/00C08L89/00A61K38/16A61K47/12A61K38/1709A61K38/465A61K38/47A61K38/4833C12Y302/01021
Inventor 景山由佳子藤永贤太郎山口鲇子秋山佑介加藤宗一郎木村由妃子本多勧佐竹真兼子博章A.石割平岛正树
Owner KM生物医药股份公司