Method and system for separating plasma protein from blood product by using diatomite
A technology for separating plasma and blood products, applied in the field of biopharmaceuticals, can solve the problems of inability to carry out thorough cleaning and disinfection, inability to accurately control the amount of addition, cumbersome operation, etc., to avoid pollution risks, protect structure and activity, and reduce pollution.
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Embodiment 1
[0075] Three batches of human plasma protein were selected, the batch numbers were 20160610, 20160611, 20160612, and the above three batches of samples were processed using the method of the embodiment of the present invention, and the steps are as follows:
[0076] (1) After the raw plasma is collected by breaking the bag, it is centrifuged at 0 to 4 degrees. After the centrifugal plasma is made of component I+II+III, according to the weight of the component I+II+III product obtained after production, Calculate the amount of diatomaceous earth according to 20g / Kg component I+II+III product (W / W).
[0077] (2) Prepare qualified diatomaceous earth for dry baking according to the amount of diatomaceous earth, and dry baking at 250°C for 1 hour. Accurately weigh the dried and roasted diatomaceous earth and prepare it according to the diatomaceous earth: component I+II+III balance liquid ratio (1:3.5). Dissolve the diatomaceous earth in the mixing tank to obtain a homogeneous diatomace...
Embodiment 2
[0081] Collect the three batches of component I+II+III reaction solutions of the corresponding batch of Example 1, and use the method of the embodiment of the present invention to process the above three batches of samples respectively, and the steps are as follows:
[0082] (1) After the reaction solution of Example 1 has been prepared for component IV, the amount of diatomaceous earth is calculated based on the weight of the component IV product obtained after the preparation at 15 g / kg of the component IV product (W / W).
[0083] (2) Prepare qualified diatomite for dry-baking according to the amount of diatomite, and dry-baked at 230°C for 1 hour. Accurately weigh the dried and roasted diatomaceous earth and prepare it according to the ratio of diatomaceous earth: component IV balance solution (1:4). Dissolve the diatomaceous earth in the mixing tank to obtain a diatomaceous earth homogeneous solution. The mass-liquid transportation program is added to the reaction tank through t...
Embodiment 3
[0087] Collect the three batches of component IV reaction solutions corresponding to the batches of Example 2, and use the method of the embodiment of the present invention to process the above three batches of samples respectively. The steps are as follows:
[0088] (1) The preparation of component V is completed, and the filter press is separated to obtain the precipitate of component V. The obtained component V precipitate is dissolved in a 4% ethanol solution at -1 to 0°C, and the ratio of component V precipitate to 4% ethanol solution is 1:3. The component V solution is obtained, and the pH value of the component V solution is adjusted to the range of 4.0-4.6 to obtain the component V product. Calculate the amount of diatomaceous earth based on the weight of the obtained component V product and the obtained component V product (W / W) at 2.5 g / kg.
[0089] (2) Prepare qualified diatomaceous earth for dry baking according to the amount of diatomaceous earth, and dry baking at 20...
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Abstract
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