我国炮制用辅料标准现状探究及工作建议.docVIP

我国炮制用辅料标准现状探究及工作建议 　　[摘要] 该文对《中国药典》2015年版、《全国中药炮制规范》及29个省、自治区、直辖市的地方炮制规范中炮制用辅料相关内容的现状进行了梳理，整理出了药典、全国炮制规范、地方炮制规范这三级标准中对炮制用辅料的通用性要求、个性化技术要求、质量标准等的收载情况，根据炮制用辅料存在的“药辅同源”、“食辅同源”的特点，对标准现状进行了分析；对炮制用辅料全国性标准研究情况进行了介绍；对炮制用辅料标准目前存在的问题进行了深入的分析和探讨，针对标准体系不完善、缺乏总体性要求、标准水平低、标准引用混乱、标准研究工作不足等问题提出了相关的工作建议，为下一步炮制用辅料国家药品标准体系的建设提供建议和参考 [关键词] 炮制用辅料； 标准； 炮制规范； 中药炮制 Status and suggestions for adjuvant standard for Chinese materia medica processing in China YANG Chunyu1， CAO Hui2， WANG Xiaotao1， TU Jiasheng3， QIAN Zhongzhi4， YU Zhiling5， SHANG Yue4， ZHANG Baoxian1* （1. Institute of Chinese Materia Medica， China Academy of Chinese Medical Sciences， Beijing 100700， China； 2.School of Pharmacy， Jinan University， Guangzhou 510632， China； 3. School of Pharmacy， China Pharmaceutical University， Nanjing 210009， China； 4. Chinese Pharmacopoeia Commission， Beijing 100061， China； 5. School of Chinese Medicine， Hong Kong Baptist University， Hong Kong 999077， China） [Abstract] In this paper， the status of adjuvant standard for Chinese materia medica processing in the Chinese Pharmacopoeia 2015 edition， the National Specification of Chinese Materia Medica Processing， and the 29 provincial specification of Chinese materia medica was summarized， and the the status including general requirements， specific requirements， and quality standard in the three grade official specifications was collected and analyzed according to the “medicineadjuvant homology” and “foodadjuvant homology” features of adjuvants. This paper also introduced the research situation of adjuvant standard for Chinese materia medica processing in China； In addition， analyzed and discussed the problems existing in the standard system of adjuvant for Chinese materia medica processing， such as lack of general requirements， low level of standard， inconsistent standard references， and lack of research on the standard， and provided suggestions for the further establishment of the national standards system of adjuvan