| 摘要 |
FIELD: medicine, in particular production of lyophilized diagnosis reagent, namely, control plasma with normal level of prothrombin complex. ^ SUBSTANCE: claimed method includes donor blood sampling, plasma separation by centrifugation, blending of donor's plasma, pool centrifugation, followed by canning and lyophilization of finished product. Method is characterized that after the second centrifugation pool is blended with buffer HEPES to finished concentration of 0.004±0.0005 M, then frost and quenched at -38°C or less for 4-6 h. Lyophilization is carried out for 17±1 h at product starting temperature not more than -(54±14°C); during 10±1 h temperature is increased to the positive value; and lyophilization is finished at +(12±3)°C. Diagnosis reagent of present invention is useful in calculation of prothrombin index according to the formula %-PI and/or plotting of calibration curve for calculation of prothrombin complex factor activity. ^ EFFECT: diagnosis reagent containing normal level of prothrombin complex and being stable for one year. ^ 1 ex, 2 tbl, 1 dwg |
