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生物制品生物活性/效价测定方法验证指导原则浅析 被引量:4
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作者 王鸣人 陈钢 +2 位作者 赵宇豪 邵泓 段徐华 《中国药品标准》 CAS 2022年第3期241-245,共5页
《中国药典》2020年版三部“生物制品生物活性/效价测定方法验证指导原则”(通则9401)是国内首个适用于生物制品生物活性/效价测定方法验证的指导原则,弥补了国内缺少针对生物活性方法验证指导原则的空白。为正确理解和执行该指导原则,... 《中国药典》2020年版三部“生物制品生物活性/效价测定方法验证指导原则”(通则9401)是国内首个适用于生物制品生物活性/效价测定方法验证的指导原则,弥补了国内缺少针对生物活性方法验证指导原则的空白。为正确理解和执行该指导原则,推动国内生物活性/效价测定方法验证工作的规范化,本文从该指导原则的新增背景、起草过程、国内外药典比较和主要内容解读等几方面进行了阐述,并对未来该通则内容的完善进行了初步展望,旨在为广大从业人员提供指导性建议及参考。 展开更多
关键词 《中国药典》 生物活性/效价测定方法 验证
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以EV71抗原检测方法验证浅析生物制品生物效价检测方法学验证
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作者 刘正玲 李娅娴 +6 位作者 赵勇 杜宋婷 王汉慧 蒋曦 贺凌煜 袁明翠 常亚军 《中国药品标准》 CAS 2023年第2期168-173,共6页
目的:本文以对生物制品生物效价检测进行规范的《中国药典》2020年版新增9401指导原则为标准进行EV71抗原检测方法的验证,进一步浅析生物制品生物活性/效价检测的方法学验证。方法:依据《中国药典》2020年版9401指导原则,结合EV71抗原... 目的:本文以对生物制品生物效价检测进行规范的《中国药典》2020年版新增9401指导原则为标准进行EV71抗原检测方法的验证,进一步浅析生物制品生物活性/效价检测的方法学验证。方法:依据《中国药典》2020年版9401指导原则,结合EV71抗原检测方法特点及验证目的对其进行专属性、相对准确度、精密度、线性和范围5个方面进行方法学验证。结果:EV71抗原检测方法专属性强,6个效价水平几何变异系数为4.7%~13.0%,均小于15%,相对偏倚为-6.05%~9.03%,均在±15%范围内,定量范围为225%~31%,线性回归相关系数为0.999 5,5方面验证均符合要求,且适用于该检测方法的使用。结论:本原则可具体指导生物学检测方法验证,在对不同检测方法进行验证时,根据检测目的、方法的原理、方法的技术特点、被检物的成分等设计具体方案。 展开更多
关键词 中国药典2020年版 生物制品 生物活性/效价 方法学验证 EV71抗原检测
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山西省不同品种马铃薯凝集素质量分数分析
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作者 岳新丽 湛润生 +2 位作者 李建 陈云 王春珍 《中国农学通报》 2019年第36期38-41,共4页
为研究山西省不同品种(品系)马铃薯凝集素的质量分数,通过对马铃薯凝集素粗提液进行大孔树脂柱层析法提纯,获得马铃薯凝集素溶液,然后采用测定吸光度与凝集活性效价的方法,评定了山西省大同市不同品种(品系)马铃薯凝集素质量分数高低。... 为研究山西省不同品种(品系)马铃薯凝集素的质量分数,通过对马铃薯凝集素粗提液进行大孔树脂柱层析法提纯,获得马铃薯凝集素溶液,然后采用测定吸光度与凝集活性效价的方法,评定了山西省大同市不同品种(品系)马铃薯凝集素质量分数高低。结果表明,大孔树脂柱层析法提纯马铃薯凝集素效果良好,滤液可以用于后续的分析测定。根据吸光值和凝血效果综合评定,不同品种(品系)马铃薯凝集素质量分数顺序为:‘05-32-7’>‘同薯23号’>‘晋薯27号’>‘同薯30号’>‘晋薯23号’。 展开更多
关键词 马铃薯凝集素 大孔树脂柱层析 凝血活性效价 山西 质量分数
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基于基因修饰细胞系的生物检定法研究进展 被引量:2
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作者 于雷 周勇 王军志 《中国药品标准》 CAS 2022年第2期101-107,共7页
以药物的作用机制为基础,采用细胞与分子生物学技术构建特定基因修饰细胞系并开发相应的检测方法,可用于相关产品的生物检定。这种基于基因修饰细胞系的生物检定法在药物的质量控制领域具有广泛的应用前景。本文探讨了基因修饰细胞系的... 以药物的作用机制为基础,采用细胞与分子生物学技术构建特定基因修饰细胞系并开发相应的检测方法,可用于相关产品的生物检定。这种基于基因修饰细胞系的生物检定法在药物的质量控制领域具有广泛的应用前景。本文探讨了基因修饰细胞系的构建策略及检测方法的基本原理,并概述了基于基因修饰细胞系的生物检定法在重组蛋白类、疫苗类、基因治疗类等不同产品质量评价中的研究进展及应用情况。 展开更多
关键词 基因修饰细胞系 生物检定法 细胞法 报告基因法 活性/效价测定
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Enhanced degradation of carbon tetrachloride by surfactant-modified zero-valent iron
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作者 MENG Ya-feng GUAN Bao-hong WU Zhong-biao WANG Da-hui 《Journal of Zhejiang University-Science B(Biomedicine & Biotechnology)》 SCIE CAS CSCD 2006年第9期702-707,共6页
Sorption of carbon tetrachloride (CT) by zero-valent iron (ZVI) is the rate-limiting step in the degradation of CT, so the sorption capacity of ZVl is of great importance. This experiment was aimed at enhancing th... Sorption of carbon tetrachloride (CT) by zero-valent iron (ZVI) is the rate-limiting step in the degradation of CT, so the sorption capacity of ZVl is of great importance. This experiment was aimed at enhancing the sorption of CT by ZVI and the degradation rate of CT by modification of surfactants. This study showed that ZVI modified by cationic surfactants has favorable synergistic effect on the degradation of CT. The CT degradation rate of ZVI modified by cetyl pyridinium bromide (CPB) was higher than that of the unmodified ZVI by 130%, and the CT degradation rate of ZVI modified by cetyl trimethyl ammonium bromide (CTAB) was higher than that of the unmodified ZVI by 81%. This study also showed that the best degradation effect is obtained at the near critical micelle concentrations (CMC) and that high loaded cationic surfactant does not have good synergistic effect on the degradation due to its hydrophilicity and the block in surface reduction sites. Furthermore degradation of CT by ZVI modified by nonionic surfactant has not positive effect on the degradation as the ionic surfactant and the ZVI modified by anionic surfactant has hardly any obvious effects on the degradation. 展开更多
关键词 Enhanced degradation SORPTION SURFACTANTS Synergistic effect Zero-valent iron (ZVI)
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马立克氏病疫苗中加入庆大霉素对其效价的影响 被引量:1
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作者 胡瑜 刘魁之 《养禽与禽病防治》 2001年第10期36-37,共2页
关键词 雏鸡 马立克氏病疫苗 庆大霉素 活性效价
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Chemical Availability of Cd, Pb and Zn in Anthropogenically Polluted Soil: Assessing the Geochemical Reactivity and Oral Bioaccessibility 被引量:4
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作者 Christophe WATERLOT Francis DOUAY Aurélie PELFRENE 《Pedosphere》 SCIE CAS CSCD 2017年第3期616-629,共14页
The most recent in vitro tests used to determine metal bioaccessiblility are generally time-consuming and expensive. This study aimed at determining potential relationships between the concentrations of metals extract... The most recent in vitro tests used to determine metal bioaccessiblility are generally time-consuming and expensive. This study aimed at determining potential relationships between the concentrations of metals extracted using single-extraction methods and the concentrations of bioaccessible metals assessed by a harmonised in vitro test, the Unified BARGE Method (UBM). A total number of 27 soil samples were collected from kitchen gardens and lawns with various physicochemical parameters and contamination levels. Significant relationships were obtained between Cd, Pb and Zn extracted in gastric and gastrointestinal phases and using single extractions. The best relationhips were established using acetic and citric acids for Cd, whereas for Pb, citric acid and ethylenedi- aminetetraacetic acid (EDTA) were identified as the best extractants. These relationships were improved by means of a linear multiple regression with a downward stepwise procedure involving agronomic parameters (soil cation exchange capacity and assimilated P). This method highlighted the fact that the cation exchange capacity and P contents in soils were the two main parameters that controlled the human bioaccessibility of Cd, Pb and Zn in the gastric phase. Besides, the metal concentrations extracted with the acetic and citric acids correlated well with the metal concentrations in the gastric and gastrointestinal phases, suggesting that the bioaceessible metals were mainly in a soluble form, weakly bound to the organic matter and associated with the carbonates and the Fe and Mn oxides/hydroxides in soils. 展开更多
关键词 gastric phase gastrointestinal phase linear multiple regression single extractant urban soil
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