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

作　　者：张萍 牛明 谭鹏 韩延忠[1,3] 张定堃 孙磊[4] 房吉祥[1] 崔园园 马艳芹 马双成 周永峰[1] ZHANG Ping;NIU Ming;TAN Peng;HAN Yan-zhong;ZHANG Ding-kun;SUN Lei;FANG Ji-xiang;CUI Yuan-yuan;MAYan-qin;MA Shuang-cheng;ZHOU Yong-feng(The Fifth Medical Center of PLA General Hospital,China Military Institute of Chinese Medicine,Beijing 100039,China;Sichuan Academy of Traditional Chinese Medicine,State Key Laboratory of Quality Evaluation of Traditional Chinese Medicine,Chengdu 610041,China;Pharmacy College,Chengdu University of Traditional Chinese Medicine,Chengdu 611137,China;National Institutes for Food and Drug Control,Beijing 100050,China)

机构地区：[1]中国人民解放军总医院第五医学中心,全军中医药研究所,北京100039 [2]四川省中医药科学院国家中医药管理局中药质量生物评价重点研究室,四川成都610041 [3]成都中医药大学药学院,四川成都611137 [4]中国食品药品检定研究院,北京100050

出　　处：《药学学报》2019年第12期2162-2168,共7页Acta Pharmaceutica Sinica

基　　金：国家重点研发计划(2018YFC1707000);首都卫生发展科研专项(首发2018-2-5031);成都市科技局技术创新研发项目(2016-HM01-00312-SF)

摘　　要：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.

关 键 词：大黄配方颗粒 近红外 生物效价 效应近红外谱 

分 类 号：R917[医药卫生—药物分析学]