A kind of bmp protein preparation and preparation method thereof
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A protein preparation and protein technology, applied in the field of protein stabilizers, can solve the problem of activity reduction and achieve the effect of no change in activity
Active Publication Date: 2020-09-22
FIRST HOSPITAL AFFILIATED TO GENERAL HOSPITAL OF PLA
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Problems solved by technology
[0004] The purpose of the present invention is to overcome the defects in the above-mentioned prior art, by providing a BMP protein preparation to solve the problem of rapid decrease in activity of BMP protein caused by short-term storage at room temperature and long-term exposure to the outside of the body during surgery
Method used
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Examples
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Effect test
Embodiment 1
[0018] A BMP protein preparation is composed of the following materials in parts by weight: 30 parts of BMP protein, 40 parts of glycerin, 15 parts of lecithin and 15 parts of trehalose.
[0019] Gently stir and mix the above components at low temperature, lose 8% of the activity within 10 days at room temperature, store at 0°C for 30 days, lose 5% of the activity, store at -80°C for 3 years , After thawing, the activity is lost by 15%.
Embodiment 2
[0021] A BMP protein preparation is composed of the following materials in parts by weight: 35 parts of BMP protein, 35 parts of gelatin, 18 parts of cephalin, and 12 parts of wakame polysaccharide.
[0022] Gently stir and mix the above components at low temperature, the activity will be lost by 7% within 10 days at room temperature, and the activity will be lost by 6% when stored at 0°C for 30 days, and stored at -80°C for 3 years , after thawing, the activity lost 16%.
Embodiment 3
[0024] A BMP protein preparation is composed of the following materials in parts by weight: 25 parts of BMP protein, 42 parts of sodium starch glycolate, 18 parts of cardiolipin, and 15 parts of isomaltooligosaccharide.
[0025] Gently stir and mix the above components at low temperature, the activity will lose 7% within 10 days at room temperature, store at 0°C for 30 days, lose 5% of the activity, and store at -80°C for 3 years , after thawing, the activity was lost by 14%.
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Abstract
The invention discloses a BMP protein preparation and a preparing method thereof. The preparation is prepared from BMP protein, an excipient, phospholipid and polysaccharide. The preparing method comprises the step that the BMP protein, the excipient, phospholipid and polysaccharide are evenly stirred with a glass stirring rod at 0 DEG C. The BMP protein preparation can be exposed under the normal temperature air condition for 10 days or longer in the orthopedic surgery treating process, and thus the smooth proceeding of surgery is ensured; the BMP protein preparation can be preserved for 30 days or longer under the low-temperature condition and can be preserved for years under the refrigerating condition with the activity unchanged.
Description
technical field [0001] The invention relates to a protein stabilizer, in particular to a preparation of bone morphogenetic protein BMP and a preparation method thereof. Background technique [0002] Bone morphogenetic protein (BMP) can induce animal or human mesenchymal cells to differentiate into bone, cartilage, ligament, tendon and nerve tissue. The clinical value of BMP is unlimited. In recent years, the safety and effectiveness of genetically recombined BMP-2 and BMP-7 have been fully confirmed. The US FDA also approved recombinant bone morphogenetic protein-2 for spinal fusion in July 2002. The safety and high-efficiency induction of osteogenic activity based on BMP has been confirmed by more and more experiments, and bone morphogenetic protein has entered the stage of large-scale clinical trials in some countries. [0003] As an effective protein for orthopedic therapy, its stability needs to be guaranteed. In the treatment, in order to achieve the effect, the bone...
Claims
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Application Information
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Patent Type & Authority Patents(China)
IPC IPC(8): A61K38/18A61K47/24A61K47/36A61P19/08
CPCA61K38/1875A61K47/24A61K47/36
Inventor 赵彦涛朱加亮韩丽伟别晓梅李晋衷鸿宾侯树勋
Owner FIRST HOSPITAL AFFILIATED TO GENERAL HOSPITAL OF PLA
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