中药效应近红外谱的构建及应用——以大黄配方颗粒为例

Construction and application of effect-related near-infrared spectroscopy for traditional Chinese medicines——Exemplification by rhubarb dispensing granules

中药配方颗粒的质量一致性是保障其临床疗效稳定性的重要因素。本研究以大黄配方颗粒为示例,结合近红外光谱和生物活性效价探索构建中药效应近红外谱。建立大黄配方颗粒的近红外检测方法,并采集不同批次的近红外光谱信息;基于复方地芬诺酯片致小鼠便秘模型测定不同批次大黄配方颗粒致泻生物效价(动物实验经中国人民解放军第三○二医院动物福利伦理委员会批准,批准号:IACUC-2019-0010);采用超高效液相色谱法同时测定大黄配方颗粒中芦荟大黄素等10种蒽醌类化学成分的含量。对近红外光谱和生物活性效价进行相关性分析,初步筛选出与活性高度相关的5个特征波段:4011~4390 cm^-1、4859~5461 cm^-1、7012~7493 cm^-1、10992~11312 cm^-1、11871~12489 cm^-1。本研究筛选发现的基于近红外光谱的活性波段可实现大黄配方颗粒质量波动的快速、在线检测,提高大黄配方颗粒的质量可控性。本文的研究模式对中药配方颗粒的质量控制亦具有一定的参考价值。

Consistency in quality of traditional Chinese medicine granules is an important factor to ensure reproducible clinical efficacy.In this study rhubarb dispensing granules were utilized to construct an efficacious near-infrared spectroscopy(eNIRS)assay by combining NIRS and biopotency.A NIR method for assaying rhubarb dispensing particles was established,and information on different batches was collected.The diarrhea-inducing biopotency of rhubarb dispensing granules was determined based on a constipation model induced by diphenoxylate in mice.The animal protocol was approved by the Animal Ethic Committee of 302 Hospital of Chinese PLA People's Liberation Army(ID:IACUC-2019-0010).Ten anthraquinones were determined in rhubarb dispensing granules by UPLC.The correlation between NIR and biopotency was analyzed and five characteristic bands that correlated highly with bioactivity were identified,including 4011-4390,4859-5461,7012-7493,10992-11312 and 11871-12489 cm^-1.There were some differences in the main bands of different chemical constituents.In summary,five active bands based on NIRS were identified and found to be able to achieve rapid on-line detection of rhubarb dispensing granule quality.This research model may also provide reference for quality control of other Chinese medicine dispensing granules.