基于质量源于生产的广藿香质量标志物的确立  

Establishment of quality markers for Pogostemonis Herba based on quality by production

作　　者：荆文光 郭晓晗 李楚 程显隆[1] 马双成[1] 魏锋[1] JING Wen-guang;GUO Xiao-han;LI Chu;CHENG Xian-long;MA Shuang-cheng;WEI Feng(National Institutes for Food and Drug Control,Beijing 100050,China;School of Chinese Materia Medica,Beijing University of Chinese Medicine,Beijing 102488,China)

机构地区：[1]中国食品药品检定研究院,北京100050 [2]北京中医药大学中药学院,北京102488

出　　处：《中草药》2021年第15期4496-4506,共11页Chinese Traditional and Herbal Drugs

基　　金：国家重点研发计划“中药材净切制关键技术与智能设备研究及应用”(2019YFC1711500)。

摘　　要：目的建立基于质量源于生产(quality by production,Qb P)的广藿香质量标志物(Q-Marker),为规范广藿香饮片生产,合理提升广藿香饮片质量提供依据。方法对广藿香饮片生产过程中的质量风险点和饮片质量进行分析,发现饮片加工过程中存在广藿香叶加入不足的不规范生产现象,致使广藿香饮片质量下降。采用GC法同时测定广藿香饮片中挥发性成分百秋李醇和广藿香酮的含量,利用指纹图谱结合化学计量学对不同比例广藿香叶的样品中差异性成分进行筛选。结果百秋李醇含量与饮片中广藿香叶比例呈显著正相关,可作为控制饮片中广藿香叶比例的关键标志物之一。正交偏最小二乘-判别分析(OPLS-DA)结果显示,黄酮类成分对不同广藿香叶比例的饮片样品划分具有显著影响。通过同时测定雷杜辛黄酮醇和藿香黄酮醇2种主要黄酮类成分的含量并结合方差分析,结果显示雷杜辛黄酮醇和藿香黄酮醇含量在不同广藿香叶比例样品中具有显著性差异(P<0.05),并与广藿香叶比例呈显著性正相关,亦可作为广藿香生产规范性的Q-Marker。考虑饮片加工过程中广藿香叶的损失,以15%广藿香叶比例为标准,建议百秋李醇不低于0.24%,雷杜辛黄酮醇和藿香黄酮醇总量不低于0.045%。结论基于Qb P理念,确立百秋李醇、藿香黄酮醇和雷杜辛黄酮醇为广藿香生产规范化Q-Marker,为广藿香质量标准提升和保障饮片质量提供实验依据。Objective To establish quality markers(Q-Marker)for Guanghuoxiang(Pogostemonis Herba,PH)based on quality by production(QbP)and provide a basis for standardizing the production so as to reasonably improve the quality of PH pieces.Methods Based on the analysis of the production process and the quality of PH pieces,an irregular production phenomenon of insufficient Pogostemon cablin leaves(PCL)proportion during the processing was obviously discovered,which led to the deterioration of the quality of PH pieces.The GC method was performed to simultaneously determine the content of the patchouli alcohol and pogostone,meanwhile,the non-volatile components in PH were also screened by fingerprints combining with chemometrics.Results The content of patchouli alcohol was significantly positively correlated with the PCL ratio.As a consequence,patchouli alcohol can be used as one of the key indicators to control the PCL ratio.The results showed that flavonoids had a significant impact on the classification of samples with different PCL ratios.Orthogonal partial least squares-discriminant analysis(OPLS-DA)results showed that flavonoids have a significant effect on the division of decoction pieces with different PCL ratios.Simultaneous determination of the content of two main flavonoids,retusin and pachypodol,were performed and their contents had exhibited a significant difference in different PCL ratios and a positive correlation with PCL ratio,indicating the two flavones could be Q-Marker for the standardized production of PH.Considering the loss of leaves during the pieces processing,with 15%PCL ratio as the standard,it is recommended that the content of patchouli alcohol should not be less than 0.24%,and the total amount of retusin and pachypodol should not be less than 0.045%.Conclusion Based on QbP,patchouli alcohol,retusin and pachypodol are developed as the Q-Marker for standardized production of PH,which provide experimental basis for PH standard improvement and guarantee for quality of decoction pieces.

关 键 词：广藿香 质量源于生产 生产规范性 质量标志物 质量风险点 GC 指纹图谱 化学计量学 百秋李醇 藿香黄酮醇 雷杜辛黄酮醇 正交偏最小二乘-判别分析 黄酮 

分 类 号：R283.6[医药卫生—中药学]