Method for inactivating viruses in process of preparing antitoxin and antiserum

Method for inactivating viruses in process of preparing antitoxin and antiserum

  • CN 102,532,306 A
  • Filed: 01/09/2012
  • Published: 07/04/2012
  • Est. Priority Date: 01/09/2012
  • Status: Active Application
First Claim
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1. the method for an inactivation of viruses in preparing toxinicide, antiserum(antisera) is characterized in that comprising the following steps:

  • A, with behind 2~

    4 times of volumes of blood plasma raw material dilution, regulate diluent pH value to 2.8~

    4.0;

    B, in the diluent of every 100ml steps A, add 0.1~

    1.0g gastric enzyme, in 29~

    31 ℃

    of digestion 1~

    3 hour down, perhaps in 20~

    22 ℃

    of digestion 20~

    22 hours down, Digestive system;

    C, in the Digestive system of every 100ml step B, add 14~

    16g ammonium sulfate, and regulate pH of mixed value to 4.8~

    5.6, heating mixed solution to 57~

    59 ℃

    , and keeping 30 minutes are cooled to below 45 ℃

    , separate, supernatant;

    D, the supernatant of step C is diluted to contained protein concentration is 10~

    50 g/L;

    In this diluent, add organic solvent and stain remover;

    The organic solvent that in every 100ml diluent, contains 0.25~

    1.35g;

    The stain remover that contains 1.00~

    1.35g in every 100ml diluent, constant temperature is 4~

    6 hours in 24~

    37 ℃

    of water-baths, gets mixed solution;

    E, in the mixed solution of every 100ml step D, add 15~

    25 g ammonium sulfate, left standstill 90~

    180 minutes, divide the supernatant of leaving away, throw out;

    F, the throw out of step e is diluted to protein content is lower than 20 g/L, adjustment diluent pH value is 7.7~

    7.9, and adds the amount of 0.6~

    1.0g alum by every 100ml diluent, in diluent, adds alum, leave standstill 60~

    120 minutes after, mistake filters supernatant;

    G, with the supernatant of step F filter membrane with 3~

    50,000 molecular weight;

    When being concentrated into 1/5th volumes;

    2~

    5 times the PB that in liquid concentrator, add 20mM, pH value and be 6.0~

    8.0, add-on is the raw blood plasma volume of steps A replaces, concentrates;

    Be lower than 1.0 g/L until ammonium sulfate content, get liquid concentrator;

    H, with the liquid concentrator of step F, behind ion exchange chromatography, must collect liquid, after carrying out degerming to collecting liquid, filter by routine, packing gets toxinicide, the antiserum(antisera) goods of inactivation of viruses.

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