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METHOD FOR PRODUCING POSITIVE CONTROL STANDARD SAMPLE OF HUMAN IMMUNOGLOBULIN TO DETERMINE ANTICOMPLEMENTARY ACTIVITY OF PREPARATIONS OF HUMAN IMMUNOGLOBULIN, AND STANDARD SAMPLE OF HUMAN IMMUNOGLOBULIN TO DETERMINE ANTICOMPLEMENTARY ACTIVITY OF PREPARATIONS OF HUMAN IMMUNOGLOBULIN
METHOD FOR PRODUCING POSITIVE CONTROL STANDARD SAMPLE OF HUMAN IMMUNOGLOBULIN TO DETERMINE ANTICOMPLEMENTARY ACTIVITY OF PREPARATIONS OF HUMAN IMMUNOGLOBULIN, AND STANDARD SAMPLE OF HUMAN IMMUNOGLOBULIN TO DETERMINE ANTICOMPLEMENTARY ACTIVITY OF PREPARATIONS OF HUMAN IMMUNOGLOBULIN
FIELD: biotechnology.;SUBSTANCE: group of inventions relates to biotechnology, specifically to human immunoglobulin standard samples used to determine anticomplementary activity of human immunoglobulins, and methods for their preparation. Group of inventions discloses a method of producing a positive control standard sample of human immunoglobulin comprising thermal treatment of sample in a water bath, cooling thermally treated sample at a temperature of (22±3) °C, anticomplementary activity determination of positive control sample; and a standard sample of human immunoglobulin containing a positive control, produced by disclosed method, and negative control with anticomplementary activity in range of 10-45 %.;EFFECT: group of inventions can be used to assess quality of human immunoglobulin preparations and enables to determine anticomplementary activity to improve reliability of results.;2 cl, 4 dwg, 11 ex
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机译：领域：发明领域本发明涉及生物技术，尤其涉及用于确定人免疫球蛋白的抗互补活性的人免疫球蛋白标准样品及其制备方法。一组发明公开了一种生产人免疫球蛋白阳性对照标准样品的方法，该方法包括在水浴中对样品进行热处理，在（22±3）°C的温度下冷却热处理的样品，确定阳性对照样品的抗互补活性;以及通过公开的方法生产的人免疫球蛋白标准样品，该样品包含阳性对照和抗互补活性在10-45％范围内的阴性对照。效果：该组发明可用于评估人免疫球蛋白制剂的质量，并能够确定抗互补活性以提高结果的可靠性。; 2 cl，4 dwg，11 ex
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