Dog intravenous injection albumin, its preparing method and dog intravenous injection albumin preparation
An albumin and preparation technology, which is applied to the canine intravenous albumin preparation, its preparation, the field of canine intravenous albumin injection, can solve the problem that albumin cannot be used for intravenous injection, etc., and achieves low cost, stable performance, and good finished product purity. Effect
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Embodiment 1
[0037] Example 1: Extraction of canine albumin by rivanol method
[0038] 1) Melt slurry and adjust pH
[0039] Melt 200,000 ml of plasma that meets the raw material requirements quickly at 37°C, and put it into a reaction tank under a sterile environment; slowly add Na at a concentration of 1% while stirring 2 CO 3 , adjust the pH to 8.5±0.1.
[0040] 2) Complexation and dissociation
[0041] In the stirring state, add 2% rivanol equal volume (200,000 milliliters) to the blood plasma in the reaction tank, stop stirring after adding, and let it stand for 2 hours.
[0042] Take out the supernatant after complexation in the reaction tank for the separation of immunoglobulin, and leave the precipitated part in the tank; start the agitator, and use the PP6 pump to add NaCl, HCl solution and sodium octanoate solution into the tank successively; the mixture is stirred More than 2 hours or overnight;
[0043] Add 0.6% NaCl, 0.2% sodium octanoate and 4% 0.5 mol HCl at a final con...
Embodiment 2
[0050] Embodiment 2: adopt low-temperature ethanol method to extract canine albumin
[0051] Described low-temperature ethanol method comprises the following steps:
[0052] 1).Melting slurry and adding ethanol
[0053]Melt 200,000 ml of plasma that meets the raw material requirements quickly at 37°C, and put it into a reaction tank under a sterile environment; gradually cool down to 0°C while stirring, and adjust the pH to 7.2 with an acetate buffer with a pH of 4 ±0.2; while stirring, add 53.3% ethanol pre-cooled at -15°C--20°C until the final concentration of ethanol volume is 8% (add ethanol slowly, based on 100,000 ml of plasma, add 400-500ml per minute, 2 -3 hours to complete the addition), the temperature was maintained at -2°C--3°C, after the addition was completed, continue to stir for 1 hour, and let it stand for 2 hours.
[0054] 2). Centrifuge to remove impurities
[0055] Use G142 continuous centrifuge, 13000r, centrifuge several times, discard the precipitate ...
Embodiment 3
[0065] Example 3: Preparation of albumin preparation for dog intravenous injection--intravenous injection solution with albumin content of 1% to 25%
[0066] The albumin solution with a concentration of 1 to 20% extracted in Example 1 and Example 2 is followed by the following operations to obtain an albumin preparation for intravenous injection:
[0067] 5) Inspection and addition of reagents:
[0068] Take the concentrated sample and submit it for inspection to determine the content of albumin; add sodium octanoate at 0.16mmol / g albumin; add NaCl at 160mmol / L albumin solution; adjust to pH 7.0±0.2.
[0069] 6) Inactivation:
[0070] Put the albumin solution into a stainless steel milk jug and seal it. Each batch of products must be heated at 60±0.5°C for 10 hours. The inactivation treatment can be carried out before sterile filtration or within 24 hours after aliquoting.
[0071] 7) Batch:
[0072] Products mixed in the same manufacturing process and in the same contain...
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