基于药物体系的藁本质量评价研究

Quality reviewing of Gaoben(Rhizoma Ligustici) based on drug system

目的建立基于药物体系的藁本质量表征及其关联分析方法,为中药质量有效评价提供新模式。方法采用HPLC同时测定7批藁本饮片中阿魏酸、洋川芎内酯A、洋川芎内酯H、洋川芎内酯Ⅰ、藁本内酯等5种有效指标性成分的含量,分析基于有效指标性成分含量的质量表征;以洋川芎内酯Ⅰ含量为参比,对饮片进行有效指标性成分含量相对比值质量表征,并以批次4(已确定药效的饮片)为基准,作有效指标性成分含量相对比值的比值差,其绝对值之和表示为非关联系数δ,分析得关联度排序(δ/关联度)。结果基于有效指标性成分含量的质量表征:以阿魏酸含量排序为批次7>批次6>批次4>批次3>批次1>批次5>批次2,含量相差最大约2.2倍;以洋川芎内酯Ⅰ含量排序为批次7>批次4>批次3>批次6>批次1>批次5>批次2,含量相差最大约4.9倍;以苯酞类含量和排序为批次7>批次3>批次6>批次4>批次1>批次2>批次5,含量相差最大约3.6倍;批次7、3、4、6有效指标性成分总体含量较高。基于关键有效指标性成分含量相对比值的质量表征:批次4(0/100%)>批次7(1.21/79.8%)>批次3(1.36/77.3%)>批次6(1.83/69.5%)>批次5(2.18/63.7%)>批次1(2.28/62.0%)>批次2(9.14),即批次7、3的质量表征与批次4关联度较高。综合基于有效指标性成分含量及其相对比值的质量表征,以批次4为基准,可得批次7、3质量较优。结论基于有效指标性成分含量及其相对比值进行质量表征,并以具有确切药效的药材饮片为基准,进行质量表征关联度分析,以评价其质量整体关联性与应用有效性,这是中药质量评价提供一种新模式。

Objective To establish the quality representation of Gaoben （Rhizoma Ligustici ） and correlation analysis method based on drug system, and provide a new mode for quality evaluation of Chinese medicinal. Methods HPLC method was used for simultaneous determination of 5 effective in- dex components in 7 batches of Gaoben decocting pieces, including ferulic acid, senkyunolide A, senkyunolide H, senkyunolide I, and ligustilide, and then a correlation analysis was carried out;The quality representation based on the content relative ratio of key effective index components showed as follows： taking the content of senkyunolide I as reference, the quality representations of decocting pieces were dete^nined based on the content relative ratio of effective index components, and using batch 4 （decocting pieces with identified therapeutic effect） as baseline for getting the difference between these relative ratio of effective index components, and its sum of absolute value represented as non-correlation coefficient. Results The quality representation based on the content of effective index components showed as follows ： by the content of ferulic acid, the sorting was batch 7 〉 batch 6 〉 batch 4 〉 batch 3 〉 batch 1 〉 batch 5 〉 batch 2 and the maximum content difference was about 2.2 times ; by the content of senkyunolide I, the sorting was batch 7 〉 batch 4 〉 batch 3 〉 batch 6 〉 batch 1 〉 batch 5 〉 batch 2 and the maximum content difference was about 4.9 times; by the total content of phthalides, the sorting was batch 7 〉 batch 3 〉 batch 6 〉 batch 4 〉 batch 1 〉 batch 2 〉 batch 5 and the maximum content difference was about 3.6 times. The total content of effective index components was higher in batch 7, batch 3, batch 4 and batch 6. The sorting of the correlation degree （ ~/correlation degree） was analyzed as batch 4 （0/100%） 〉 batch 7 （ 1.21/79.8% ） 〉 batch 3 （ 1.36/77.3% ） 〉 batch 6 （ 1.83/69.5% ） 〉 batch 5 （2.18/63.7%） 〉 batch 1 （2.28/62.0%） 〉 batch 2 （9.14）. The results indicated that the correlation degree was higher between the quality representations of batch 7 or batch 3 and that of batch 4. Conclusion The analysis on the correlation degree of quality representation is conducted based on the content of effective index components and content relative ratio and taking decocting pieces with identified therapeutic effects as baseline for evaluating the overall correlation of quality and the effectiveness of application.