基于指纹图谱-药效学-药动学的天麻超微粉品质评价研究

天麻系我国传统名贵中药材，列贵州“十大地道药材”之首，系贵州“八大中药产业链”之一，在10余个贵州名优中药品种中均以生粉入药。课题组前期对黔产天麻化学成分、质量控制、不同粒径与药效相关性等进行了系统研究，发现天麻超微粉在有效成分溶出率、镇静镇痛及神经保护作用方面均明显优于天麻普通粉。为进一步阐明以天麻超微粉用药的科学性，本课题将以色谱联用技术建立多维特征指纹图谱，对比研究不同粒径天麻粉的药效差异并开展基于谱效关系分析的效应物质研究；考察天麻超微粉和普通粉在动物体内吸收分布特性、药动学参数以及安全性指标的变化情况，同时从PK-PD角度揭示体内与药效直接相关的物质，从而阐明天麻超微粉的体内过程特征、生物利用度及其应用安全性，实现对天麻整体质量的多指标分析控制并建立基于体内直接作用物质的天麻及其超微粉质量标准，为天麻超微粉在天麻相关产品中的深度开发利用提供科学依据。

Gastrodia elata is a precious traditional Chinese herb. It also ranks first among the ten authentic medicinal herbs of Guizhou Province and has fallen into the list of the eight major TCM industrial chains of the provincial government. Its powder has been used directly in more than 10 TCM products such as Quantianma Capsules. Our previous investigations showed that its ultrafine powder surpassed the ordinary powder in the active ingredients dissolution rate, analgesic effect and nerve protection. In order to further clarify the rationale for the use of Gastrodia elata ultrafine powder, the current project plans to establish a multi-dimensional characteristic fingerprint of Gastrodia elata for its overall quality control by using UPLC/Q-TOF MS. The study also will focus on the effects of the sizes of ultrafine powder on the pharmacological effects and the spectrum-effect relationship. Investigations on the differences of absorption, distribution, pharmacokinetic parameters, and safety index between the ultrafine powder and ordinary powder will also be carried out. PK-PD correlations will be studied to reveal the substances effective in vivo. The research will build a quality standard of Gastrodia elata and its ultrafine powder based on the direct effective substances and will provide scientific basis for the development of the related products of Gastrodia elata ultrafine powder.