摘要
目的:探讨骨肽类制剂的基本特性、质控模式、生物活性评价方法的研究现状,建立科学合理的质量评价模式。方法:通过对骨肽类制剂体内外生物活性评价方法的汇总和梳理,探讨适宜的骨肽类制剂的质量评价方法。结果与结论:旨在介绍一种能反映骨肽类制剂药效的生物活性测定研究思路,与主要活性成分理化分析方法相结合,从而使现有质量标准的评价更全面更合理。
Objective:To explore the research status of basic characteristics,quality control mode and biological activity evaluation methods of bone peptide preparations,and establish a scientific and reasonable quality evaluation mode.Methods:The suitable quality evaluation methods of bone peptide preparations were discussed by summarizing and screening the biological activity evaluation methods of bone peptide preparations in vivo and in vitro.Results and Conclusion:The purpose of this paper is to introduce a research method of biological activity determination that can reflect the efficacy of bone peptide preparations and to combine it with the physical and chemical analysis methods of main active ingredients,so as to make the evaluation of the current quality standards more comprehensive and reasonable.
作者
杨泽岸
张媛
吴彦霖
高华
Yang Zean;Zhang Yuan;Wu Yanlin;Gao Hua(National Institutes for Food and Drug Control,Beijing 102600,China)
出处
《中国药事》
CAS
2019年第4期380-384,共5页
Chinese Pharmaceutical Affairs
关键词
骨肽类制剂
生物活性测定
质量标准
bone peptide preparation
biological activity determination
quality standard
