骨肽原液促UMR106细胞增殖法的建立及验证  

Establishment and validation of UMR106 cell proliferation induced by bone peptide

作　　者：吴彦霖 张媛 杨泽岸 胡文言 高华 WU Yan-lin;ZHANG Yuan;YANG Ze-an;HU Wen-yan;GAO Hua(Division of Pharmacology,Institute for Chemical Drug Control,National Institutes for Food and Drug Control,Beijing 102629,China;China Biochemical Pharmaceutical Industry Association,Beijing 100068,China)

机构地区：[1]中国食品药品检定研究院化学药品检定所药理室,北京102629 [2]中国生化制药工业协会,北京100068

出　　处：《中国药理学通报》2020年第9期1324-1328,共5页Chinese Pharmacological Bulletin

基　　金：国家药典委员会国家药品标准提高研究项目(No 2018H001)。

摘　　要：目的建立骨肽原液促UMR106细胞增殖法并进行方法学验证,确定方法的限值和判定标准,为建立骨肽原液的生物活性测定方法提供研究数据。方法1)选取2个厂家的骨肽原液进行UMR106细胞增殖方法建立;2)选用1批样品进行方法学验证;3)选取13个厂家39批的骨肽原液进行方法限值和判定标准的确定。结果1)建立了骨肽原液致UMR106细胞增殖方法;2)重复性、中间精密度和耐用性结果符合方法学验证的要求;3)13个厂家39批骨肽原液中:8个厂家的骨肽原液促UMR106细胞增殖率≥150%,5个厂家的骨肽原液促UMR106细胞增殖率<150%。结论骨肽原液促UMR106细胞增殖方案:以1.0 g·L^-1骨肽原液药物浓度作为限值剂量,增殖率≥150%作为符合规定的判定标准。Aim To establish and validate UMR106 cell proliferation induced by bone peptide,and to determine the limits and criteria of the method,in order to provide research data for the determination of bioactivity of bone peptide solution.Methods 1)UMR106 cell proliferation method was established by selecting bone peptide solution from 2 manufacturers.2)1 batch of samples were selected for methodological verification;3)39 batches of bone peptide solution from 13 manufacturers were selected to determine the method limit and determination standard.Results 1)The proliferation of UMR106 cells induced by bone peptide was established.2)The results of repeatability,intermediate precision and durability met the requirements of methodology validation;3)There were 8 manufacturers which promoted the proliferation rate of UMR106 cells not less than 150%,and 5 manufacturers which promoted the proliferation rate of UMR106 cells less than 150%in 39 batches of bone peptide solution from 13 manufacturers.Conclusions The standard for bone peptide induced UMR106 cell proliferation:the limit concentration of bone peptide is 1.0 g·L^-1,and the proliferation rate is not less than 150%.

关 键 词：骨肽 成骨 UMR106 生物活性测定法 方法学验证 质量标准 

分 类 号：R-332[医药卫生] R329.28