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为了建立和验证重组人血小板源生长因子(PDGF-BB)生物学活性方法,通过检测细胞为ATCC的小鼠Balb/c3T3成纤维细胞,分板血清浓度为1.2%、分板数为0.6*10~5个/m L,参考2010版《中国药典》,进行了线性、专属性、精密度、准确度、耐用性等方面的方法验证,结果发现线性、精密度、专属性、范围、耐用性均符合要求,因此证明PDGF-BB的生物学活性方法简单、有效、稳定。
To establish and validate the biological activity of recombinant human platelet-derived growth factor (PDGF-BB), by assaying mouse Balb / c3T3 fibroblasts with ATCC cells, the serum concentration of the plate was 1.2% and the number of sub-plates was 0.6 * 10 ~ 5 / m L, with reference to the 2010 edition of the “Chinese Pharmacopoeia”, the method validation of linearity, specificity, precision, accuracy, durability and the like, the results found that linearity, precision, specificity, range, durability All meet the requirements, thus proving that the biological activity of PDGF-BB is simple, effective and stable.