《中华人民共和国药典》2020版一部收载矿物药及含矿物药中成药的质量标准分析与探讨

Analysis and Discussion on Quality Standards of Mineral Drugs and Chinese Patent Medicines Containing Mineral Drugs in 2020 Edition of Chinese Pharmacopoeia

对《中华人民共和国药典》2020版一部“药材及饮片”部分和“中成药”部分收载的矿物药、含矿物药中成药的品种、性状、鉴别、检查、含量测定等方面的内容进行了总结与分析。根据矿物药中含有的阳离子种类(汞、钙、镁、钠、铁、砷、铝及其他8类)将含矿物药的中成药进行分类统计,包括对矿物药的入药方式、鉴别检查、含量测定以及毒性矿物药用法用量、注意事项等方面,分析了含矿物药的中成药的质量标准控制的现状和不足,整理了“药材及饮片”部分中未收载但中成药处方中含有的矿物药品种(9种),希望能够为进一步丰富《中华人民共和国药典》中收载的矿物药品种提供参考。通过以上内容的分析,希望能够全面地了解《中华人民共和国药典》2020版一部中矿物药、含矿物类中成药的质量控制现状,为矿物药的全面质量控制提供借鉴,为更加科学、完整地评价矿物药、含矿物药中成药提供参考。

This paper summarized and analyzed the varieties,properties,identification,inspection and content determination of mineral drugs and Chinese patent drugs containing mineral drugs contained in“medicinal materials and decoction pieces”and“Chinese patent drugs”in Volume I of Chinese Pharmacopoeia 2020.According to the types of cations(mercury,calcium,magnesium,sodium,iron,arsenic,aluminum and other 8 categories)contained in mineral drugs,the Chinese patent medicines containing mineral drugs are classified and counted,including the way of drug administration,identification and inspection,content determination,usage and dosage of toxic mineral drugs,precautions,etc.The current situation and deficiencies of quality standard control of Chinese patent medicines containing mineral drugs were analyzed.It sorted out the mineral drug varieties(9 kinds)not included in the“medicinal materials and decoction pieces”but contained in the prescription of Chinese patent medicine,hoping to provide reference for further enriching the mineral drug varieties included in the Chinese Pharmacopoeia.Through the analysis of the above contents,we hope to have a comprehensive understanding of the quality control status of mineral drugs and mineral containing Chinese patent medicines in Volume I of Chinese Pharmacopoeia 2020,so as to provide reference for the overall quality control of mineral drugs and provide reference for a more scientific and complete evaluation of mineral drugs and mineral containing Chinese patent medicines.