目的 构建养胃颗粒浸膏的物理指纹图谱，建立其质量一致性评价方法。方法 构建由密度、pH值、固含量、表面张力、接触角、平均粒径、电导率、动力黏度8个物理参数组成的物理指纹图谱，基于物理指纹图谱进行一致性评价，结合多元统计分析方法进行统计分析及异常样品判断。结果 17批次养胃颗粒浸膏的物理指纹图谱存在差异，主要体现在平均粒径、电导率和动力黏度3个指标上；经主成分分析得出物理参数间的相关性关系，由DModX控制图诊断出1批异常样品，贡献图分析得到异常波动原因。结论 构建了养胃颗粒浸膏的物理指纹图谱，展现了浸膏的物理质量属性及其差异，证明基于物理指纹图谱的养胃颗粒浸膏质量一致性评价方法的可行性。

Objective To establish physical fingerprints of Yangwei Granule (养胃颗粒) extracts and evaluate quality consistency. Methods Physical fingerprints were constructed with density, pH value, solid content, surface tension, contact angle, average size, conductivity and dynamic viscosity. The quality consistency of the extracts was evaluated based on physical fingerprints, and statistical analysis and abnormal sample identification were implemented with multi-statistical analysis methods. Results Differences of physical fingerprints and parameters existed in 17 batches of Yangwei Granule extracts, mainly reflected in average size, conductivity and dynamic viscosity. Principal component analysis showed correlations among the physical parameters. A batch of abnormal sample was diagnosed by DModX control chart, and the cause of abnormal fluctuation was analyzed by contribution chart. Conclusion Physical fingerprints were successfully constructed and directly exhibited physical properties and the differences of different batches of extracts, which demonstrated the feasibility of evaluating the quality consistency of Yangwei Granule extracts by physical fingerprints.

R283.6

国家科技重大专项“重大新药创制”（2018ZX09201011-002）