主要基于生物热动力学表征的中药注射剂(注射用益气复脉冻干)质量评控方法的研究

Evaluation methods for quality volatility about Yiqi Fumai freeze-dried powder used for injection based on bio-thermodynamics exosyndrome

为建立包括生物指纹谱检测在内的中药注射剂质量波动性评价方法,该文以注射用益气复脉(冻干)为模式药,盲法记录样品的化学特征图谱、生物热活性指纹谱,选用Fischer判别对其进行辨识。结果表明化学特征图谱可较好辨识过期样品;生物热活性指纹谱可准确辨识特殊样品。初步建立了针对注射用益气复脉(冻干)质量波动性的评控方法,可作为现有质量控制方法的有益补充,并为其他中药注射剂质量波动性研究提供一定的技术参考。

Yiqi Fumai freeze-dried powder for injection was used as a model drug to establish an evaluation method mainly based on bio-thermodynamics profile detection.Fischer function was used to analyze the chemical and biological data.In general,chemical chromatogram can distinguish the expired sample and thermal spectrum of biological activity can distinguish special samples exactly.Thus,we established the evaluation method regarding the quality volatility of Yiqi Fumai freeze-dried powder for injection.The method can be used as a useful supplement in quality control as,and it could provide some technical information for quality control of other varieties of traditional Chinese medicine for injection.