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目的采用生物检定统计法设计建立乙型肝炎人免疫球蛋白乙肝表面抗体(抗-HBs)效价的测定方法。方法按照欧洲药典(EP8.0)规定,用生物检定统计法斜率比模型中随机区组设计实验、数据统计分析、结果计算,通过与国际标准品比较计算供试品抗-HBs效价。结果每次独立实验可靠性检验符合欧洲药典(EP8.0)的要求,置信限范围为80%-120%,线性相关系数均>0.99,重复性RSD为1.92%,人员和时间因素在α=0.05水平上对方法的影响无统计学意义。结论乙型肝炎人免疫球蛋白抗-HBs效价生物检定统计法测定结果稳定、可靠,操作简便、快速、无污染,可用于乙型肝炎人免疫球蛋白抗-HBs效价的检测。
Objective To establish a method for the determination of hepatitis B surface immunoglobulin hepatitis B surface antigen (anti-HBs) titer by bioassay. Methods According to the European Pharmacopoeia (EP8.0), randomized block design experiments, statistical analysis and calculation of results were performed in the slope ratio model of bioassay. The titer of anti-HBs was calculated by comparing with international standards. Results The reliability of each independent experiment meets the requirements of the European Pharmacopoeia (EP8.0). The confidence limits ranged from 80% to 120%. The linear correlation coefficients were both> 0.99. The repeatability RSD was 1.92% 0.05 level on the impact of the method was not statistically significant. Conclusion The bioassay results of the anti-HBs titer of hepatitis B immunoglobulin are stable, reliable, easy to operate, rapid and non-polluting. It can be used to detect the anti-HBs titer of hepatitis B human immunoglobulin.