中药鼻用制剂的现代研究进展  

Modern Research of Nasal Preparations of Traditional Chinese Medicine:A Review

作　　者：余方坤 陈姣[1] 李岭慧 张倩[1] 朱宗萍 李锐[1] 侯曙光 廖婉[1] YU Fangkun;CHEN Jiao;LI Linghui;ZHANG Qian;ZHU Zongping;LI Rui;HOU Shuguang;LIAO Wan(National Key Laboratory of Specific Chinese Drug Resources in Southwest China,School of Pharmacy,Chengdu University of Traditional Chinese Medicine,Chengdu 611137,China;Sichuan Purity Pharmaceutical Co.Ltd.,Chengdu 610041,China)

机构地区：[1]成都中医药大学西南特色中药资源国家重点实验室,药学院,成都611137 [2]四川普锐特药业有限公司,成都610041

出　　处：《中国实验方剂学杂志》2022年第16期245-253,共9页Chinese Journal of Experimental Traditional Medical Formulae

基　　金：国家自然科学基金面上项目(82073994);四川省杰出青年科技人才基金项目(2020JDJQ0049);成都市科技局国际科技合作项目(2017-GH02-00054-HZ);成都大学农业部杂粮加工重点实验室开放课题(2019CC02);成都中医药大学杏林学者学科人才科研提升计划项目(XSGG2019005、QNXZ2018026、CXTD2018003);四川省首批中医药学科建设重点项目(川中医药函[2020]84号);教育部春晖计划项目(20191083-127)。

摘　　要：鼻用制剂具有独特的给药优势,在局部和全身性疾病的临床治疗中应用广泛。我国中医药鼻腔给药治疗历史悠久,近年来,中药鼻用制剂受到广泛关注。基于国家药品监督管理局(NMPA)数据库、药智网及中国知网近30年收载的中药鼻用制剂相关信息,笔者对现代中药鼻用制剂的剂型、上市产品、常用中药、辅料、临床应用及安全性研究方面进行了梳理,围绕中药鼻用制剂发展中面临的部分产品剂量不准确、辅料质量标准体系不齐全、安全性评价建设不完善、鼻腔给药装置研发较为缺乏等诸多问题,从中药提取分离工艺的优化、辅料的质量控制与使用、新剂型的开发、中药鼻腔给药的安全性评价、鼻腔给药装置的设计研发等方面提出了可能的解决对策和展望,以期为中药鼻用制剂的开发提供思路,并为其可持续发展提供科学依据。Nasal preparations have unique advantages in drug delivery and are widely used in the treatment of local and systemic diseases.Nasal administration of traditional Chinese medicine(TCM)has a long history in China.In recent years,nasal preparations of TCM have attracted wide attention.Based on the information about nasal preparations of TCM from the database of National Medical Products Administration(NMPA),Yaozh.com and China National Knowledge Internet(CNKI)in the recent 30 years,the formulation,the listed products,commonly used TCM,pharmaceutical excipients,clinical application and safety research of modern nasal preparations of TCM were summarized and expounded.Focusing on many problems in the development of modern nasal preparations of TCM,such as inaccurate dosage of some products,incomplete quality standard system of pharmaceutical excipients,imperfect safety evaluation,lack of research and development of nasal drug delivery devices and so on,the possible solutions and prospects were put forward from the aspects of optimizing the extraction and separation process of TCM,the quality control and application method of pharmaceutical excipients,the development of new dosage forms,the safety evaluation of nasal administration of TCM,and the design and development of nasal administration devices.The aim is to provide ideas for the development of nasal preparations of TCM and provide scientific basis for its sustainable utilization.

关 键 词：鼻用制剂 鼻腔给药 药用辅料 临床试验 新剂型 中医药(TCM) 安全性评价 

分 类 号：R987[医药卫生—药品] R28[医药卫生—药学] G353.11[文化科学—情报学] R943