经典名方枳实薤白桂枝汤物质基准的量值传递研究

Research on quantitative transmitting of classical prescription Zhishi Xiebai Guizhi Decoction substance benchmarks

目的 建立经典名方枳实薤白桂枝汤(Zhishi Xiebai Guizhi Decoction,ZXGD)基准样品的HPLC特征图谱并对其进行多成分含量测定,研究ZXGD物质基准量值传递规律,为复方制剂研究奠定基础。方法 制备20批ZXGD基准样品,建立其特征图谱,明确其特征峰并对其进行特征峰的归属;对ZXGD基准样品进行多成分含量测定,分析主要成分从饮片-物质基准的传递规律。结果 20批ZXGD基准样品的特征图谱相似度均大于0.93,共匹配得到11个特征峰,分别来自于方中枳实(峰1、3~5、9)、厚朴(峰2、10、11)、桂枝(峰6~8);各指标性成分的含量范围及饮片-基准样品的平均转移率分别为辛弗林0.46%~0.85%和103.80%,橙皮苷0.58%~1.07%和42.36%,肉桂酸0.025%~0.047%和105.53%,桂皮醛0.09%~0.17%和5.40%,厚朴酚与和厚朴酚0.005 6%~0.010 3%和0.23%。结论 采用HPLC特征图谱和多成分含量测定对ZXGD物质基准的量值传递规律进行研究,该方法科学合理,且明确了饮片-物质基准的传递规律,实现了对经典名方ZXGD开发研究的全过程质量控制。

Objective To establish the HPLC characteristic map of the reference samples of the classical prescription Zhishi Xiebai Guizhi Decoction (ZXGD,枳实薤白桂枝汤) and to determine the content of its multi-components,to study the transfer rule of the substance benchmark value of ZXGD,for the follow-up study of Chinese medicine compound preparations lay the foundation.Methods Twenty batches of ZXGD reference samples were prepared,and their characteristic map was established,its characteristic peaks was clarified and assigned to the characteristic peaks;Multi-component content determination on the reference samples of ZXGD was carried out,and the transfer law of main components were analyzed from the decoction pieces to the substance benchmark.Results The similarities of the characteristic maps of the 20 batches of ZXGD reference samples were all greater than 0.93,and a total of 11characteristic peaks were matched,which were from Zhishi (Aurantii Fructus Immaturus,peaks 1,3—5,9),Houpo (Magnoliae Officinalis Cortex,peaks 2,10,11),Guizhi (Cinnamomi Ramulus,peaks 6—8);The content range of each index component and the average transfer rate of decoction pieces-reference samples were 0.46%—0.85%and 103.80%for synephrine,respectively,hesperidin0.58%—1.07%and 42.36%,cinnamic acid 0.025%—0.047%and 105.53%,cinnamaldehyde 0.09%—0.17%and 5.40%,magnolol and honokiol 0.005 6%—0.010 3%and 0.23%.Conclusion The HPLC characteristic map and multi-component content determination are used to study the quantity value transfer law of ZXGD.The whole process quality control of the development and research of classical prescription ZXGD.