莲子心药材含量测定标准修订建议  

Suggestions on the revision of the assay standard of Nelumbinis Plumula

作　　者：王协和 陈盛君[2,3,4] 陈可冀 覃美景 杜俊潮 李松 徐以亮 WANG Xie-he;CHEN Sheng-jun;CHEN Ke-ji;QIN Mei-jing;DU Jun-chao;LI Song;XU Yi-liang(Key Laboratory of Preparation and Quality Control of TCM Formula Granules in Jiangsu Province,Wuxi 214000,China;Jiangyin Tianjiang Pharmaceutical Corporation,Wuxi 214000,China;Institute of Integrative Medicine,Fujian University of Traditional Chinese Medicine,Fuzhou 350000,China)

机构地区：[1]江苏省中药配方颗粒制备与质量控制关键技术重点实验室,无锡214000 [2]江阴天江药业有限公司,无锡214000 [3]福建中医药大学中西医结合研究院,福州350000 [4]江阴天江药业有限公司研究院,无锡214000

出　　处：《中华中医药杂志》2021年第9期5464-5468,共5页China Journal of Traditional Chinese Medicine and Pharmacy

基　　金：国家科技部国家科技重大专项项目(No.2018ZX09201011-004-004)。

摘　　要：目的:改进并优化莲子心中有效成分莲心碱、异莲心碱和甲基莲心碱的含量测定方法,为《中华人民共和国药典》中莲子心含量测定标准修改提供参考。方法:建立莲心碱、异莲心碱、甲基莲心碱一测多评测定方法。在全国道地产区和主产区取样38批样品,对其进行含量测定,确定莲子心中莲心碱含量范围和莲心碱、异莲心碱、甲基莲心碱总含量范围。结果:莲心碱含量均值为0.156%,范围为0.019%~0.763%,仅31.579%符合《中华人民共和国药典》标准。莲心碱、异莲心碱、甲基莲心碱总量均值为1.586%,范围为0.659%~2.059%。结论:建议莲子心药材质量标准中含量测定指标由莲心碱修改为莲心碱、异莲心碱、甲基莲心碱总量,含量限度建议定为不得低于1.10%。Objective: To improve and optimize the content assay methods of the active components of Nelumbinis Plumula, including liensinine, isoliensinine, methyllianthine, and to provide reference for the modification of the content determination standard of lotus seed heart in Pharmacopoeia of the People’s Republic of China. Methods: A one-test and multievaluation method was established for the assay of lianthine, isolianthine and methyllianthine, and 38 batches of samples were sampled from national real estate and main production areas, and their contents were assaied to determine the content range of lianthine and the total content range of lianthine, isolianthine and methyllianthine in the heart of lotus seed. Results: The mean content of lotus heart base was 0.156%, ranging from 0.019% to 0.763%, and only 31.579% of the batches met the Pharmacopoeia of the People’s Republic of China. The average total content of lianxine, isolianxine and methyllianxine was 1.586%, ranging from 0.659% to 2.059%. Conclusion: It is suggested that the content assay index in the quality standard of Nelumbinis Plumula should be modified from lotus heart base to the total amount of liensinine, isoliensinine, methyllianthine, and the content limit should not be less than 1.10%.

关 键 词：莲子心 莲心碱 异莲心碱 甲基莲心碱 含量测定 

分 类 号：R284.1[医药卫生—中药学]