生脉注射液物理指纹图谱的建立及其质量评价

目的建立生脉注射液的物理指纹图谱,评价其质量。方法构建由8个物理参数(电导率、p H值、浊度、折光率、固含物、相对密度、运动黏度、渗透压摩尔浓度)组成的对照物理指纹图谱,以雷达图直观展现,运用相关系数法计算样品指纹图谱与对照指纹图谱的相似度。结果相同品种不同生产厂家的产品物理指纹图谱及参数有较大差异,某些公司同一产品不同规格、不同批次间质量也不稳定,主要体现在渗透压摩尔浓度、电导率和浊度3个指标上。结论物理指纹图谱法可用于评价生脉注射液的质量,同时也可为中药注射剂质量再评价研究提供一定的思路。

Establishment of physical fingerprint of Shengmai Injection and its quality evaluation

Objective To establish the physical fingerprint of Shengmai Injection and evaluate its quality.Methods The physical fingerprint was visually showed by the radar map consisting of eight indexes (conductivity, pH, turbidity, refractive index, solid content, relative density, kinematic viscosity, and osmolality). Correlation coefficient method was used to calculate the similarity between the fingerprints and the control fingerprints.Results The products physical fingerprints and parameters of the same species from different manufacturers were quite different. In some companies, the quality of the same product was also unstable among different batches and specifications, mainly reflected in the three indicators of osmolality, conductivity, and turbidity.Conclusion Physical fingerprints can be used to evaluate the quality of Shengmai Injection and provide some ideas for the quality re-evaluation of Chinese medicine injection.