基于异功散基准样品物理化学特征图谱及多成分含量测定的制剂提取工艺研究

Study on the Extraction Process of Preparations Based on Physical and Chemical Characteristic Chromatograms and Multicomponent Content Determination of Yigong Powder Reference Samples

    摘要
  • 摘要:
    目的 建立15批异功散基准样品（Yigong powder，YP）的物理、化学指纹图谱，对其5个指标成分进行含量测定，并优选YP最优制剂提取工艺。
    方法 制备15批YP基准样品提取液，以折光率、电导率、干膏率、表面张力、密度及pH值6个物理参数建立其物理指纹图谱并进行相似度评价；通过HPLC法建立化学指纹图谱并进行相似度评价，测定人参皂苷Rg1+Re、橙皮苷、甘草苷、甘草酸的含量并计算其转移率；以物理-化学指纹图谱相似度、物性参数及指标性成分转移率限度建立YP基准样品提取液质量标准，采用AHP-熵权法建立异功散综合评分体系，并筛选YP最佳提取工艺。
    结果 15批YP基准样品提取液的物理指纹图谱、化学指纹图谱相似度均大于0.9；以指标成分人参皂苷Rg1+Re、甘草苷、甘草酸、橙皮苷转移率的80%~120%、干膏率的70%~130%、物性参数中pH、n、ρ、σ平均值的90%~110%为限度以及物理、化学指纹图谱相似度建立质量标准；以表面张力、电导率、干膏率、pH以及橙皮苷、甘草苷、甘草酸、人参皂苷Rg1+Re转移率建立综合评分体系；依据质量标准及综合评分确定YP的最佳提取工艺为：加入12倍量水，提取时间60 min。
    结论 基于化学成分与物理属性建立的YP基准样品提取液质量标准，可以有效表征其质量，建立的复方制剂提取工艺稳定可靠，为YP基准样品到复方制剂的质量一致性评价提供参考。

     

    Abstract:
    OBJECTIVE To establish the physical and chemical fingerprints of 15 batches of Yigong Powder (YP), determine the content of 5 index components, and optimize the extraction process of YP.
    METHODS Fifteen batches of YP reference sample extracts were prepared, and their physical fingerprints were established with six physical parameters of refractive index, conductivity, dry extract rate, surface tension, density and pH value, and the similarity was evaluated. The chemical fingerprint was established by HPLC and the similarity was evaluated. The content of ginsenoside Rg1 + Re, hesperidin, liquiritin and glycyrrhizic acid was determined and the transfer rate was calculated. The quality standard of YP reference sample extract was established by physical-chemical fingerprint similarity, physical parameters and index component transfer rate limit. The comprehensive scoring system of YP was established by AHP-entropy weight method, and the optimal extraction process of YP was screened.
    RESULTS The similarity of physical fingerprint and chemical fingerprint of 15 batches of YP reference sample extract was greater than 0.9. The quality standard was established with the transfer rate of ginsenoside Rg1 + Re, liquiritin, glycyrrhizic acid and hesperidin of 80 % -120 %, the dry extract rate of 70% -130%, the average value of pH, n, ρ and σ in the physical parameters of 90 % -110 % as the limit and the similarity of physical and chemical fingerprints. A comprehensive scoring system was established based on surface tension, conductivity, dry paste rate, pH, and transfer rates of hesperidin, liquiritin, glycyrrhizic acid, ginsenoside Rg1 and Re. According to the quality standard and comprehensive score, the optimum extraction process of YP was determined as follows: adding 12 times the amount of water and extracting for 60 min.
    CONCLUSION The quality standard of YP reference sample extract based on chemical composition and physical properties can effectively characterize its quality. The established extraction process of compound preparation is stable and reliable, which provides a reference for the quality consistency evaluation of YP reference sample to compound preparation.

     

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