当归补血不同制剂高效液相特征图谱比较

Comparison of High-performance Liquid Chromatography Profiles of Different Formulations of Danggui Buxue

目的:比较当归补血汤剂、配方颗粒、口服液3种不同制剂多种成分差异及不同制剂方法对制剂中化学成分的影响。方法:对9批当归补血制剂采用5%甲醇水为溶剂制备样品溶液,应用Lab Alliance高效液相色谱仪,Kromasil C18(4.6 mm×250 mm,5μm)色谱柱,UV检测器进行测定。以甲醇-0.4%甲酸水溶液为流动相进行梯度洗脱,流速1 mL·min-1,检测波长280 nm。通过HPLC特征图谱比较,并利用中药指纹图谱信息数字化处理技术,分析当归补血汤剂、配方颗粒、口服液3种不同制剂中特征峰、主要成分和未知成分的差异。结果:9批当归补血制剂的HPLC特征图谱共有色谱峰特征明显,样品中共检测到15个共有峰,不同剂型的当归补血制剂相似度有一定差别,配方颗粒和口服液色谱峰的数目和面积均有不同程度减少,各种成分比例具有较大差异。结论:与汤剂相比,当归补血配方颗粒和口服液在制剂过程当中,化学成分受到不同程度的损失,可能影响其临床疗效。本研究建立的HPLC特征图谱方法快速、高效,为当归补血制剂的质量研究提供了有效手段。

Objective：To compare the formulations of Danggui Buxue decoction,granule,oral liquid of 3 different preparation of various composition differences,which is used for the contradistinction of affects for chemical compositions of different pharmaceutical technologies.Method：9 samples of formulations of Danggui Buxue were extracted by 5% methanol-water solution.Sample solutions were determined by Lab Alliance high performance liquid chromatograph instrument equipped with Kromasil C18column and UV detector,and gradient eluted with methanol-0.4% formic acid aqueous solution as mobile phase.The flow rate was set to 1 mL ·min^-1,and the wavelength for detection was set to 280 nm.Through the comparison of HPLC characteristic spectrum,and the use of traditional Chinese medicine fingerprint digital information processing technology of Danggui Buxue Decoction,difference analysis on granules,specific,main components and unknown components was performed.Result：It had obvious characteristics for the common peaks of the HPLC chromatographic profiles for the formulations of Danggui Buxue.15 common peaks were detected.The similarity indexes had some differences between different formulations of Danggui Buxue preparations.The amount and areas of peaks in dispensing granules and oral liquor had different degrees of reduction,the proportion of various components with different.Conclusion：Compared with the decoction,chemical compositions in Danggui Buxue dispensing granules and oral liquor are subject to varying degrees of loss in preparation process,and may affect the clinical efficacy.The HPLC chromatographic profiles method appeared to be simple,accurate and can be used for the quality researches of the formulations of Danggui Buxue.