中药散剂在口腔黏膜部位临床使用与制备的关键问题探讨  

Discussion of Key Problems in the Clinical Use and Preparation of Traditional Chinese Medicine Pulvis in Oral Mucosal Areas

作　　者：刘梓琛 郭宁 吴飞[2] 郎卿 徐剑 林晓[1,2] 赵立杰[2] LIU Zi-chen;GUO Ning;WU Fei;LANG Qing;XU Jian;LIN Xiao;ZHAO Li-jie(College of Chinese Materia Medica,Shanghai University of Traditional Chinese Medicine,Shanghai 201203,China;Engineering Research Center of Modern Preparation Technology of TCM,Ministry of Education,Shanghai University of Traditional Chinese Medicine,Shanghai 201203,China;Traditional Chinese Medicine Department,Beicai Community Health Service Center of Pudong New District,Shanghai 201204,China;Jing Brand Co.,Ltd.,Daye 435100,China)

机构地区：[1]上海中医药大学中药学院,上海201203 [2]上海中医药大学中药现代制剂技术教育部工程研究中心,上海201203 [3]上海市浦东新区北蔡社区卫生服务中心中医科,上海201204 [4]劲牌有限公司,湖北大冶435100

出　　处：《南京中医药大学学报》2023年第1期84-92,共9页Journal of Nanjing University of Traditional Chinese Medicine

基　　金：上海市浦东新区中医药科技创新项目(PDZY-2021-0813);上海市卫健委科研基金(201940296,202140347)。

摘　　要：中药散剂使用历史悠久,以其剂型特色、制法简单、疗效确切成为中药的代表性剂型之一。中药外用散剂在口腔黏膜部位的临床应用历来较为广泛。由于剂型的特殊,临床用量长期以来没有明确的共识,而外用散剂处方中多含矿物类生药,因此会带来一定的安全性隐患;随着制剂工艺的不断发展更新,一些新的粉碎工艺也不断应用于散剂制剂工艺中,但同时带来的相关问题也值得讨论。对上述中药外用散剂的剂量、安全性、工艺合理性等方面的关键问题进行梳理和探讨,为其规范临床应用、确保用药安全、进一步新药开发等提供启发。Traditional Chinese medicine pulvis has a long history of application and has become one of the representative dosage forms of Chinese medicine with its distinctive dosage form,simple preparation and precise efficacy.Topical Chinese medicine bulking agents have been more widely used in the clinical application of oral mucosal areas.Due to the special dosage form,there is no clear consensus on the clinical dosage for a long time,and the prescription of topical dispersant mostly contains mineral raw drugs,so it will bring certain safety risks;with the continuous development and update of preparation process,some new crushing processes have been applied to the preparation process of dispersant,but at the same time,the related problems brought about are also worth discussing.This paper sorts out and discusses the key problems of dosage,safety and process rationality of the above-mentioned topical Chinese medicine dispensers to provide inspiration for their standardized clinical application,ensure medication safety and further new drug development.

关 键 词：中药散剂 口腔黏膜 剂量 安全性 超微粉碎 混合 

分 类 号：R283[医药卫生—中药学]