两种抗人T淋巴细胞免疫球蛋白原料和成品中淋巴细胞毒效价检测方法的相关性分析  被引量:1

Correlation of two methods for determination of lymphocytotoxicity titer in raw materials and final products of anti-human T lymphocyte immunoglobulin

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作  者:邹浩勇 薛红刚 殷文曲 程文进 余健 王智 郭晓东 张智 ZOU Hao-yong;XUE Hong-gang;YIN Wen-qu;CHENG Wen-jin;YU Jian;WANG Zhi;GUO Xiao-dong;ZHANG Zhi(Wuhan Zhongsheng Yujin Biomedical Co.,Ltd.,Wuhan 430207,Hubei Province,China)

机构地区:[1]武汉中生毓晋生物医药有限责任公司,湖北武汉430207

出  处:《中国生物制品学杂志》2022年第6期724-728,共5页Chinese Journal of Biologicals

基  金:武汉市国际科技合作计划(2015030809020360)。

摘  要:目的建立一种简易的流式细胞术检测猪抗人T淋巴细胞免疫球蛋白原料和成品中的淋巴细胞毒效价,并分析其与《中国药典》方法的相关性。方法用《中国药典》方法中的淋巴细胞毒试验检测500倍和1000倍稀释的人外周血免疫的猪血浆,在《中国药典》方法的基础上将用0.5%的台盼蓝染色镜检改为用5μg/mL的PI溶液进行流式细胞术分析;用两种方法检测不同稀释倍数的猪抗人T淋巴细胞免疫球蛋白成品;用相同的评判标准对两种方法检测猪血浆和免疫球蛋白成品的结果进行对比及相关性分析。结果《中国药典》方法检测500倍和1000倍稀释的免疫后猪血浆的合格率分别为52.9%和17.6%,流式细胞术检测的合格率分别为100%和94.1%;《中国药典》方法检测不同稀释倍数成品的结果低于流式细胞术,但二者结果的趋势一致;两种方法检测500倍和1000倍稀释原料的结果在95%置信区间的相关系数(r)分别为0.632和0.611,P均小于0.01,极显著相关。《中国药典》方法检测500倍和1000倍稀释原料的r为0.737,而流式细胞术为0.919。两种方法检测成品的r为0.910,P为0.0007,也极显著相关。结论建立的简易流式细胞术可更准确地应用于猪抗人T淋巴细胞免疫球蛋白原料和成品中淋巴细胞毒效价的定性检测。Objective To develop a simple flow cytometry to determine lymphocytotoxicity titer in raw materials and final products of anti-human T lymphocyte immunoglobulin,and analyze its correlation with the method in Chinese Pharmacopoeia.Methods The 500-and 1000-fold diluted porcine plasma immunized with human peripheral blood were determined by lymphocytotoxicity test in Chinese Pharmacopoeia.Based on the method in Chinese Pharmacopoeia,flow cytometry with 5μg/mL PI solution was adopted instead of microscopy with 0.5%Trypan blue staining.The two methods were used to determine the final products of porcine anti-human T lymphocyte immunoglobulin at various dilutions.The determination results by the two methods were compared according to the same evaluation criteria,of which the correlation was analyzed.Results The qualification rates of 500-and 1000-fold diluted porcine plasma determined by the method in Chinese Pharmacopoeia were 52.9%and 17.6%,while those by flow cytometry were 100%and 94.1%,respectively.The lymphocytotoxicity titers of final products at various dilutions determined by the method in Chinese Pharmacopoeia were lower than those by flow cytometry,of which the trends were in agreement.Correlation coefficients(r)of 95%confidence intervals of determination results of 500-and 1000-fold diluted raw materials by the two methods were 0.632 and 0.611 respectively(each P<0.01),indicating an extremely significant correlation.The r value of 500-and 1000-fold diluted raw materials determined by the method in Chinese Pharmacopoeia was 0.737,while that by flow cytometry was 0.919.However,the r and P values of determination results of final products by the two methods were0.910 and 0.0007 respectively,which also indicated an extremely significant correlation.Conclusion The developed simple flow cytometry is more accurate for qualitative detection of lymphocytotoxicity titer in raw materials and final products of porcine anti-human T lymphocyte immunoglobulin.

关 键 词:流式细胞术 猪抗人T淋巴细胞免疫球蛋白 淋巴细胞毒 效价 

分 类 号:R-331[医药卫生]

 

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