双定性双定量相似度法评价银杏达莫注射液的高效液相色谱指纹图谱

建立了色谱指纹图谱的双定性双定量相似度评价法,并应用于银杏达莫注射液的高效液相色谱（HPLC）指纹图谱的评价。采用反相HPLC,以芦丁为参照物峰,确定了41个共有峰,建立了银杏达莫注射液的对照指纹图谱。以双定性相似度S和S′、双定量相似度C和P评价银杏达莫注射液的HPLC指纹图谱，分别考察在大峰缺失和小峰缺失两种情况下,4个相似度指标的变化特征。S能反映化学成分的分布比例,受大峰影响严重,无法反映小峰的丢失; S′对所有指纹峰等权,反映小峰缺失灵敏,二者构成双定性相似度。C能反映样品共有峰的总体含量,但受大峰影响严重,无法反映小峰的缺失; P对所有峰积分值等权,能较好地反映小峰的变动,二者构成双定量相似度。因此,由S与S′、C与P构成的双定性双定量相似度法能同时监测大峰和小峰的变动与缺失,能准确地解决色谱指纹图谱的宏观定性和定量评价问题。同时还提出了方向余弦作为对照指纹图谱的特征指纹的概念和分解相似度的概念,以此考察了各指纹峰对相似度贡献的大小及其在不同程度缺失时4种相似度的变化情况。所建立的HPLC对照指纹图谱可用于银杏达莫注射液的质量控制。

Quality Assessment on High Performance Liquid Chromatographic Fingerprints of Ginkgo Leaf Extract and Dipyridamole Injection by Double Qualitative Similarities and Double Quantitative Similarities

A novel method of double qualitative similarities and double quantitative similarities was established for the evaluation of chromatographic fingerprints and it has been applied on the quality assessment of the high performance liquid chromatographic (HPLC) fingerprint of ginkgo leaf extract and dipyridamole injection. The chromatographic fingerprints containing 41 co-possessing peaks were obtained by choosing rutin peak as the referential peak. The chromatographic fingerprints were evaluated by the double qualitative similarity parameters (S and S') and the double quantitative similarity parameters (C and P). A variety of characteristics were investigated when big peaks and small peaks were missing. S can clearly reflect the distribution of chemical constituents, and C can reflect the total content of the co-possessing peaks of the sample, but both of them were significantly influenced by the big peaks and not by the missing of small peaks. S' and P are of equally weighing to all fingerprint peaks, and they can reflect sensitively the missing of small peaks . The double qualitative similarities (S and S') and the double quantitative similarities (C and P) can be combined to provide accurate qualitative and quantitative assessments for the quality of traditional Chinese medicine with regarding to the changes or lacks of both big peaks and small peaks. Meanwhile, the concepts of direction cosine and decomposition value of similarity were firstly put forward to describe the characteristics of chromatographic fingerprints, by which the contribution of each common peak to total similarity and the change of similarity under the missing of different peaks were quantified. The HPLC fingerprints can be used in the quality control of ginkgo leaf extract and dipyridamole injection.