《中国药典》2020版陈皮质量标准修订的研究  

Study on the quality standards of Citri Reticulatae Pericarpium in Chinese Pharmacopoeia(2020 edition)

作　　者：梁奕尧 陈柏忠 杨玉华 巢颖欣 刘梦诗 王康慧 植美明 郑国栋[1] LIANG Yi-yao;CHEN Bai-zhong;YANG Yu-hua;CHAO Ying-xin;LIU Meng-shi;WANG Kang-hui;ZHI Mei-ming;ZHENG Guo-dong(Guangzhou Medical University,Guangdong Guangzhou 511436,China;Guangdong Xinbaotang Biological Technology Co.,Ltd,Guangdong Jiangmen 529000,China;Tianda Pharmaceutical(Zhuhai)Co.,Ltd.,Guangdong Zhuhai 519070,China)

机构地区：[1]广州医科大学,广东广州511436 [2]广东新宝堂生物科技有限公司,广东江门529000 [3]天大药业珠海有限公司,广东珠海519070

出　　处：《中国医院药学杂志》2022年第2期142-146,共5页Chinese Journal of Hospital Pharmacy

基　　金：2017年国家重点研发计划(2017YFC1701103);2020年珠海市社会发展领域科技计划项目(ZH22036207200009PWC);广州医科大学2017年高水平大学学术骨干培育计划(广医大发[2017]210号);广州医科大学2021—2022年度大学生科技创新项目(2020A079);2021年度广州医科大学十四五高峰学科建设药学拔尖人才培养项目(06-410-2107235)。

摘　　要：目的:针对《中国药典》2020版陈皮质量标准的修订提出两点建议,以突出"陈皮"与"广陈皮"的共性特征与个性差异,完善陈皮质量标准。方法:采用TLC三步展开法,以橙皮苷、川陈皮素和2-甲氨基-苯甲酸甲酯为对照,鉴别并区分"陈皮"与"广陈皮";同时采用HPLC法对橙皮苷、川陈皮素、橘皮素等5种黄酮成分进行含量测定,并对川陈皮素与橘皮素进行相关性分析。结果:TLC鉴别结果表明橙皮苷与川陈皮素是"陈皮"与"广陈皮"的共有成分,而2-甲氨基-苯甲酸甲酯仅在"广陈皮"中发现,可作为区分二者的特征成分;HPLC测定结果显示橙皮苷,川陈皮素和橘皮素是二者的主要活性成分,同时川陈皮素与橘皮素含量具有良好的正相关性,且以川陈皮素为高,故可考虑以橙皮苷与川陈皮素作为测定指标。结论:结合本研究结果,对《中国药典》2020版陈皮质量标准的修订提出两点建议:一是在TLC鉴别项下以橙皮苷、川陈皮素和2-甲氨基-苯甲酸甲酯为"陈皮"与"广陈皮"的鉴别对照,二是在含量测定项下以橙皮苷与川陈皮素为二者的测定指标。该实验方法具有很好的耐用性和专属性,可有效体现二者的共性特征与个性差异,为陈皮质量的有效控制提供合理参考。OBJECTIVE To highlight the common characteristics and individual differences between“Chenpi”(CP,the dried and mature pericarps of Citrus reticulata Blanco or other cultivated varieties)and“Guangchenpi”(GCP,the dried and mature pericarps of the Citrus reticulata‘Chachi’),and improve the quality standards of Citri Reticulatae Pericarpium(CRP),this paper putforward two recommendations for the revision of quality standards of CRP in Ch.P(2020 edition).METHODS CP and GCP was distinguished by TLC method with three-step development solutions with hesperidin,nobiletin and methyl 2-(methylamino)benzoate as controls..The content of five bioactive flavonoids including hesperidin,nobiletin and tangeretin were simultaneously determined by HPLC method.Moreover,the correlation analysis between nobiletin and tangeretin was carried out.RESULTS The results of TLC identification showed that hesperidin and nobiletin were the common components of CP and GCP,while methyl 2-(methylamino)benzoate was only found in GCP,which could be used as the characteristic component to distinguish them.The results of HPLC determination showed that hesperidin,nobiletin and tangeretin were the main bioactive ingredients.Meanwhile,there was a good positive correlation between nobiletin and tangeretin,and the content of nobiletin was higher,so that nobiletin and tangeretin could be considered as index for content determination.CONCLUSION Based on the results,the following two recommendations are proposed in this study for the revision of quality standards of CRP in Ch.P(2020 edition).First,hesperidin,nobiletin and methyl 2-(methylamino)benzoate are adopted as the identification control of CP and GCP within the TLC identification item.Second,in the content determination item,hesperidin and nobiletin were used as the content determination references for both.The method is practical with good durability and strong specificity,in which both the common characteristics and individual differences of CP and GCP can be effectively reflected,and conduc

关 键 词：陈皮 广陈皮 橙皮苷 川陈皮素 橘皮素 2-甲氨基-苯甲酸甲酯 

分 类 号：R932[医药卫生—生药学]