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目的依据《欧洲药典》8.0版规定的生物统计检定法原理,建立检测人凝血因子Ⅷ(FⅧ)活性的显色法。方法采用斜率比模型中随机区组设计显色法实验,进行数据统计分析及结果计算。以FⅧ国际标准品及FⅧ原液、成品为测试样品,确定其线性范围,并验证其重复性、中间精密度、专属性;用《中国药典》三部(2010版)规定的一期法和建立的方法进行比较。结果当FⅧ效价在0~17.85 IU/L范围内时,标准品和样品的线性相关系数(r)均大于0.99;重复性相对标准偏差(RSD)为2.1%;2位实验人员测定结果经t检验,差异无统计学意义(P>0.05);该方法置信限范围为80%~120%。两种方法检测结果差异无统计学意义(P>0.05)。结论该方法操作简便、快速,测定结果稳定、准确,检测水平符合《欧洲药典》要求,可用于FⅧ活性检测。
OBJECTIVE To establish a colorimetric method for the determination of the activity of human factor Ⅷ (FⅧ) based on the principle of biometric assay as defined in the European Pharmacopoeia, version 8.0. Methods Randomized block design of slope ratio model was used to design the colorimetric experiment. The data were statistically analyzed and the results were calculated. To F Ⅷ international standards and F Ⅷ liquid, the finished product for the test sample to determine the linear range, and to verify its repeatability, intermediate precision, specificity; with “Chinese Pharmacopoeia” three (2010 version) of the first phase of the law and the establishment of Method of comparison. Results The linear correlation coefficient (r) between standard and sample was greater than 0.99 when the F Ⅷ titer was in the range of 0 ~ 17.85 IU / L. The relative standard deviation of repeatability (RSD) was 2.1%. The results of two experiments t test, the difference was not statistically significant (P> 0.05); The confidence limits of this method ranged from 80% to 120%. There was no significant difference between the two methods (P> 0.05). Conclusion The method is simple and rapid, the method is stable and accurate, and the detection level meets the requirements of the European Pharmacopoeia. It can be used for the detection of FⅧ activity.