Deproteinized calf blood extract composition as well as injection and preparation method thereof
A calf blood and protein-removing technology, applied in the field of medicine, can solve problems such as poor process reproducibility, incomplete protein removal, and reduced medicinal value, so as to achieve good process repeatability and ensure safety and stability , which is conducive to the effect of large-scale production
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Embodiment 1
[0073] The preparation method of embodiment 1 calf blood deproteinized extract
[0074] A preparation method of calf blood deproteinized extract, comprising the steps of:
[0075] a) Slowing calf blood at 35°C for 20 minutes to obtain slowed calf blood;
[0076] b) adding hydrochloric acid solution to the slowed calf blood obtained in step a) for acid precipitation, adjusting the pH to 4.0 to obtain acidified calf blood; the hydrochloric acid solution is purified water with a mass fraction of 37% Hydrochloric acid is prepared according to the volume ratio of 1:1;
[0077] c) Freeze the acidified calf blood obtained in step b) at -25°C for 24 hours, then raise the temperature to 60°C at a rate of 1°C / min, and keep the temperature at 60°C for 1 hour. After the blood is thawed, centrifuge for 12 minutes at a centrifuge speed of 15,000 rpm, collect the supernatant, and set aside;
[0078] d) adding NaOH solution with a mass fraction of 20% to the supernatant obtained in step c)...
Embodiment 2
[0083] Embodiment 2 powder injection
[0084] prescription:
[0085] Calf blood deproteinized extract 4000g
[0086] Lyoprotectant 200g
[0087] Water for injection 4000g
[0088] The lyoprotectant is composed of trehalose and PEG in a weight ratio of 3:1;
[0089] Preparation method:
[0090] a) Prepare the dosing container: rinse the dosing container with water for injection and set aside;
[0091] b) Concentrated preparation: weigh the deproteinized calf blood extract of the prescribed amount, add water for injection according to the relative density of 1.0560 for concentrated preparation, and use a hollow fiber column with a cut-off molecular weight of 5000 Daltons to deproteinize the calf blood extract. Perform pre-filtration, and then use a membrane with a cut-off molecular weight of 5,000 Daltons to perform ultrafiltration on the deproteinized calf blood extract into a dilute tank to obtain a concentrated solution for use;
[0092] c) Dilute preparation: add water...
Embodiment 3
[0110] Embodiment 3 powder injection
[0111] prescription:
[0112] Calf blood deproteinized extract 4000g
[0113] Lyoprotectant 200g
[0114] Water for injection 4000g
[0115] The lyoprotectant is composed of trehalose and PEG in a weight ratio of 3:1;
[0116] Preparation method:
[0117] a) Prepare the dosing container: rinse the dosing container with water for injection and set aside;
[0118] b) Concentrated preparation: Weigh the calf blood deproteinized extract of the prescribed amount, add water for injection according to the relative density of 1.0580 for concentrated preparation, and use a hollow fiber column with a cut-off molecular weight of 5000 Daltons to deproteinize the calf blood deproteinized extract. Perform pre-filtration, and then use a membrane with a cut-off molecular weight of 5,000 Daltons to perform ultrafiltration on the deproteinized calf blood extract into a dilute tank to obtain a concentrated solution for use;
[0119] c) Dilute preparat...
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