基于功效和谱效关系的多基原枳实品质研究

The quality evaluation system about Chinese medicinal materials of varied original species is not perfect now. This quality evaluation system bring out the quality difference and unstable effect of Chinese medicinal materials. The current situation result in hidden trouble of clinical medication. Establish of quality evaluation system that have correlation with clinical effect is one of the key problems in Chinese medicine. The quality of Zhi shi from different original species is varied. Now the quality evaluation system can not insure the effectiveness and safety of Zhi Shi. And scientific basis for improving the quality evaluation system of Zhi Shi has not been studied well. Effective components of regulating qi will be studied based on traditional efficacy by grey relational analysis, multiple linear regression analysis and some other methods which used in the study of fingerprint-effect relationship. And the absorbed effective components in plasma will be studied by the technologies of HPLC-MS and others. The quality of Zhi shi from varied original species will be evaluated by the methods of similarity analysis taking absorbed effective components of genuine medicinal materials and effective components of regulating qi as standards. The work is hoped to provide scientific basis for improve the quality evaluation system of Zhi Shi to correspond the cilinacal characteristics more. This work can provide scientific basis for improving effectiveness, safety and stability of clinical usage about Zhi Shi. The study will provide references for studying effective substance and quality evaluation of other medicinal materials from varied original species.

针对多基原药材评价体系不完善，导致其易出现品质差异进而引起药效不稳定给中医临床用药带来隐患的现状，研究建立与临床功效相关的评价标准是中医药界亟待解决的关键问题之一。多基原中药枳实质量差异大，现行质量标准还不能完全保证其用药的安全有效。但目前仍缺乏完善其质量评价体系的科学依据。项目拟以传统功效为指导，利用谱效关系研究中的灰色关联度、多元线性回归等分析方法，研究枳实"理气"药效组分群；利用HPLC-MS等分析技术研究其入血药效组分群。在明确"理气"药效组分群基础上利用仪器分析方法进行定量分析以其平均值拟合标准药效组分群图谱，将其和道地药材入血药效组分群图谱共同做为对照标准，采用相似度分析的方法评价目前临床使用的枳实饮片的原料药材的品质。项目以期为完善枳实的质量评价体系使其更符合临床用药特点以保证其使用的安全、有效和稳定提供部分科学依据，为研究其他多基原中药的药效物质基础和质量评价提供参考。

研究建立与临床功效相关的评价标准是中医药界亟待解决的关键问题之一。中药枳实质量差异大，现行质量标准还不能完全保证其用药的安全有效。但目前仍缺乏完善其质量评价体系的科学依据。.利用谱效关系的研究方法确定了枳实理气药效组分，并补充了评价标准。建立了酸橙枳实HPLC指纹图谱；利用药理学中胃肠平滑肌运动实验方法、体外抗氧化方法和常规药理学实验方法检测了枳实样品的DPPH清除率、ABTS清除率、大鼠离体肠平滑肌运动、小鼠肠推进、功能性消化不良模型大鼠胃排空、肠推进、胃动素和胃泌素的分泌8个功效指标。应用“R语言”软件中偏最小二乘回归分析将HPLC指纹图谱和“理气”功效指标进行关联分析，确定枳实13个“理气”药效组分色谱峰，指认了其中7个药效组分，分别为新橙皮苷、橙皮苷、柚皮苷、芸香柚皮苷、野漆树苷、川陈皮素和辛弗林。以10批道地药材13个共有药效组分峰的各自峰面积平均值拟合标准指纹图谱和对照药材13个共有峰图谱分别为标准。相关系数大于0.74的样品均为正品，小于0.74的样品均为伪品。样品与标准通过“R语言”软件中灰色关联度分析计算出的相关系数可以很好地将酸橙枳实的正品与伪品区别开，并可根据相关系数的大小进行样品质量评价。.项目为完善枳实的质量评价体系使其更符合临床用药特点以保证其使用的安全、有效和稳定提供了部分科学依据。