Title:
METHOD FOR PREPARING LOW-ENDOTOXIN COLLAGEN
Document Type and Number:
WIPO Patent Application WO/2023/143391
Kind Code:
A1
Abstract:
Provided are a low-endotoxin collagen comprising a low-endotoxin collagen solution and a low-endotoxin collagen freeze-dried product, and a preparation method therefor. The method comprises the steps of loading a sample, rebalancing, washing impurities and eluting; and carrying out freeze drying on the collagen solution to obtain the low-endotoxin collagen freeze-dried product. The collagen has a purity of 99% or more and an endotoxin content of less than 0.01 EU/mg. When the collagen is clinically used as a collagen injection at a concentration of 4 mg/mL, the content of the endotoxin in the collagen injection is less than 0.04 EU/mL, which is much lower than the endotoxin limit value of 0.5 EU/mL specified by the pharmaceutical industry standard YY0954-2015.
Inventors:
FAN DAIDI (CN)
SHI JINGJING (CN)
GU JUAN (CN)
DUAN ZHIGUANG (CN)
XU RU (CN)
YAN JIANYA (CN)
LIU LIN (CN)
SHI JINGJING (CN)
GU JUAN (CN)
DUAN ZHIGUANG (CN)
XU RU (CN)
YAN JIANYA (CN)
LIU LIN (CN)
Application Number:
PCT/CN2023/073213
Publication Date:
August 03, 2023
Filing Date:
January 19, 2023
Export Citation:
Assignee:
SHAANXI GIANT BIOTECHNOLOGY CO LTD (CN)
International Classes:
A61L27/24; A61L27/50; C07K1/14; C07K1/18; C07K1/34; C07K1/36
Foreign References:
CN109400698A | 2019-03-01 | |||
CN109535222A | 2019-03-29 | |||
US20020147315A1 | 2002-10-10 | |||
CN112778412A | 2021-05-11 | |||
CN114452444A | 2022-05-10 | |||
JP2004300077A | 2004-10-28 | |||
JP2009173678A | 2009-08-06 |
Attorney, Agent or Firm:
BEIJING TANGSONG IP FIRM (CN)
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