基于HPLC指纹图谱评价的当归补血汤传统汤剂与配方颗粒汤剂的成分差异分析

目的以当归补血汤为研究对象,比较其传统汤剂、自制配方颗粒汤剂与市售配方颗粒剂化学成分种类和含量的差异,为中药配方颗粒的临床应用提供科学依据。方法采用HPLC建立指纹图谱,从化学成分的种类、指标性成分含量、共有峰峰面积总和、指纹图谱的相似度4个方面进行评价。结果色谱峰数目由传统汤剂的15个共有色谱峰到配方颗粒的13个(A厂)、12个(自制)、11个(B厂)、9个(C厂)。指标成分的含量上,配方颗粒中阿魏酸含量与传统汤剂存在显著性差异(P0.05),其中阿魏酸含量:传统汤剂A厂配方颗粒汤剂自制配方颗粒汤剂B厂配方颗粒汤剂C厂配方颗粒汤剂;毛蕊异黄酮苷含量:自制配方颗粒汤剂传统汤剂A厂配方颗粒汤剂B厂配方颗粒汤剂C厂配方颗粒汤剂。配方颗粒汤剂中共有峰峰面积的总和均低于传统汤剂,若传统汤剂为1,其他(自制和A、B、C 3厂家)分别相当于0.95、0.66、0.40、0.47。自制配方颗粒汤剂以及A、B厂配方颗粒与传统汤剂相比相似度较高(0.97、0.96、0.98),C厂家稍低(0.85)。通过对当归补血汤主要色谱峰进行归属发现,其色谱峰基本均来自各单味药材,在本实验条件下,未见明显的新化学成分的产生,配方颗粒汤剂较传统汤剂有成分的消失。结论当归补血汤传统汤剂与配方颗粒汤剂相比,传统汤剂无论在指标成分的含量还是特征图谱中色谱峰的数量上均高于配方颗粒汤剂,两者存在一定的差异。这表明配方颗粒标识的临床当量与汤剂实际不符,应对中药配方颗粒的临床推荐当量进行校正,促进临床合理应用;同时也为国家中药配方颗粒质量的统一化管理提供科学的研究思路。

Analysis of ingredients difference between Danggui Buxue Decoction and formula granule decoction based on HPLC fingerprint evaluation

Objective Taking Danggui Buxue Decoction (DBD) as the research object, the differences of chemical composition types and content among traditional decoction, self-made granule decoction and marketable granule decoction were compared, in order to provide scientific basis for clinical application of Chinese medicine formul granules. Methods The fingerprint was established by HPLC. The value of the chemical composition, the content of the index components, the area of the common peak area, and the similarity of the fingerprint were evaluated, and the different dosage forms of the decoction of DBD were investigated. The effect of chemical composition on the chemical equivalence of traditional decoction and formula granules was compared. Results The number of chromatographic peaks ranged from 15 peaks of traditional decoction to 13 (factory A), 12 (self-made), 11 (factory B), and 9 (factory C). The content of ferulic acid in formula granules was significantly different from that in traditional decoction (P < 0.05). Among them, ferulic acid content was in order:traditional decoction > formula granule decoction of factory A > self-made formula granule decoction > formula granule decoction of factory B > formula granule decoction of factory C. Content of campanulin was in order:self-made formula granule decoction > traditional decoction > formula granule decoction of factory A > formula granule decoction of factory B > formula granule decoction of factory C. The total peak area of formula granule decoction was lower than that of traditional decoction. If the traditional decoction was 1, the others (self-made and factories A, B, C) were equivalent to 0.95, 0.66, 0.40 and 0.47, respectively. Comparing with traditional decoction, self-made formula granule decoction and formula granules from factories A and B had higher similarity (0.97, 0.96, 0.98), while that from factory C was slightly lower (0.85). The main chromatographic peaks of DBD were found to be from the single herbs and no new chemical components were found. The disappearance of ingredients in formula granule Decoction was found. Conclusion The content of index components and the number of chromatographic peaks of traditional decoction of DBD is higher than those in the formula granule decoction. There are some differences between them. This indicates that the clinical equivalence of formula granules is not consistent with the reality of decoction, so the recommended clinical equivalence of formula granules of traditional Chinese medicine should be corrected to promote rational clinical application, which can provide scientific research ideas for the unified management of the quality of formula granules of Chinese materia medica.