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通过述评角类动物药质量控制模式与方法的现状,针对角类动物药本身的特点进行分析,探索从生物鉴定的角度建立角类动物药质量控制模式和方法的可行性,并提出基于外观鉴别—物性鉴定—化学组分分析—生物效价检测序贯分析的角类动物药质量控制模式,为从根本上解决长期制约角类动物药发展的瓶颈问题,创建一套有效的内在质量控制方法提供新的理论依据与技术支撑。
By reviewing the status quo of quality control modes and methods of keratin drugs, the characteristics of keratin drugs themselves are analyzed, and the feasibility of establishing models and methods for quality control of keratin drugs from the perspective of biological identification is explored, and a method based on appearance identification is proposed. - Physical Characterization - Chemical Component Analysis - Bio-valence test sequential analysis of angular animal drug quality control model, in order to fundamentally solve the bottleneck problem of long-term restriction angle animal drug development, create an effective internal quality control method Provide new theoretical basis and technical support.