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1.中国中医科学院 中药研究所,北京 100700;
2.中国中药协会 中药饮片质量保障专业委员会,北京 100700
张村,研究员,博士生导师,从事中药化学、炮制及中药质量标准研究,Tel:010-64032658,E-mail:zhc95@163.com
肖永庆,研究员,博士生导师,从事中药化学、炮制及中药质量评价研究,E-mail:x.heqi@163.com
收稿日期:2019-04-15,
网络出版日期:2019-04-23,
纸质出版日期:2019-10-05
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张村, 刘颖, 肖永庆. 中药炮制规范修订、执行及监管的相关问题探讨[J]. 中国实验方剂学杂志, 2019,25(19):195-197.
Cun ZHANG, Ying LIU, Yong-qing XIAO. Discussion on Revision, Implementation and Supervision of Regulations on Processing of Decoction Pieces of Chinese Crude Drugs[J]. Chinese journal of experimental traditional medical formulae, 2019, 25(19): 195-197.
张村, 刘颖, 肖永庆. 中药炮制规范修订、执行及监管的相关问题探讨[J]. 中国实验方剂学杂志, 2019,25(19):195-197. DOI: 10.13422/j.cnki.syfjx.20191553.
Cun ZHANG, Ying LIU, Yong-qing XIAO. Discussion on Revision, Implementation and Supervision of Regulations on Processing of Decoction Pieces of Chinese Crude Drugs[J]. Chinese journal of experimental traditional medical formulae, 2019, 25(19): 195-197. DOI: 10.13422/j.cnki.syfjx.20191553.
近几年来,为进一步提高中药饮片的质量,相关专家围绕中药饮片炮制开展了大量基础研究工作,并对《全国中药饮片炮制规范》的修订工作提出了许多意见和建议。为了进一步做好《全国中药饮片炮制规范》编制,加强对地方炮制规范修订的指导工作,明确饮片流通、使用以及监管工作相关问题,国家药品监督管理局药品注册管理司及国家药典委员会多次组织专家进行讨论。笔者仅就相关问题提出一点建议,以达到“抛砖引玉”之目的。①中药饮片规范化研究应在“继承”基本工艺路线的基础上对具体工艺过程进行“规范”。②《全国中药饮片炮制规范》的修订应在已有研究成果的基础上进行相应的完善,炮制过程规范不宜过度“参数化”;《全国中药饮片炮制规范》的修订应与《中国药典》的修订同步进行。③《中国药典》与《全国中药饮片炮制规范》内容应各有侧重,前者应侧重于标准,而后者则应侧重于工艺过程。④地方(省级)炮制规范的修订只收集真正具有地方特色而又具有临床特色应用的饮片。⑤各省市生产的饮片只能在生产地(省)应用,备案通过后允许在其他省、直辖市、自治区生产及流通。⑥对用量较大的地方炮制规范收载的中药饮片,建议尽快收载于《全国中药饮片炮制规范》中,其质量标准应收入《中国药典》。
In recent years
in order to further improve the quality of decoction pieces of Chinese crude drugs
many related basic research work around the processing of decoction pieces of Chinese crude drugs have been carried out by relevant experts. Many opinions and suggestions on the revision of the
National Regulations on the Processing of Decoction Pieces of Chinese Crude Drugs
were put forward. In order to further improve the preparation of the
National Regulations on the Processing of Decoction Pieces of Chinese Crude Drugs
strengthen the guidance on the revision of local processing standards
and clarify issues related to the circulation
use and supervision of decoction pieces
the Department of Drug Registration Management of the National Medical Products Administration and the Chinese Pharmacopoeia Commission have organized experts to discuss these problems. The author only puts forward some suggestions on related issues in order to achieve the purpose of " throwing a brick to attract jade" . ①The study of the national regulations on the processing of decoction pieces of Chinese crude drugs should be standardized on the basis of the inheritance for the specific process. ②The revision of the
National Regulations on the Processing of Decoction Pieces of Chinese Crude Drugs
should be improved on the basis of the existing research results. The regulation of the processing process should not be excessively parameterized
the revision of the
National Regulations on the Processing of Decoction Pieces of Chinese Crude Drugs
also should be synchronization to the revision of the
Chinese Pharmacopoeia
. ③The contents of the
Chinese Pharmacopoeia
and the
National Regulations on the Processing of Decoction Pieces of Chinese Crude Drugs
should have different emphasis. The former should focus on the standard
while the latter should focus on the processing process. ④The revision of local (provincial) processing specifications only collects the pieces that truly have local features and clinical characteristics. ⑤Decoction pieces of local Chinese crude drugs can only be applied at the place of production (province). They are allowed to be produced and distributed in other provinces
municipalities and autonomous regions after through filing. ⑥For the decoction pieces of Chinese crude drugs with large-scale use contained in local processing specifications
they should be included in the
National Regulations on the Processing of Decoction Pieces of Chinese Crude Drugs
as soon as possible
and their quality standards should be included in the
Chinese Pharmacopoeia
.
肖永庆 , 张村 , 李丽 . 中药科研中几个值得探讨的问题 [J]. 中华中医药杂志 , 2010 , 25 ( 4 ): 487 - 490 .
肖永庆 , 张村 , 刘颖 , 等 . 中药炮制学科和饮片产业传承与创新过程中几个值得探讨的问题 [J]. 中国实验方剂学杂志 , 2019 , 25 ( 1 ): 224 - 227 .
肖永庆 , 李丽 , 刘颖 , 等 . 制定中药饮片行业标准,促进中药饮片产业发展 [J]. 中国实验方剂学杂志 , 2016 , 22 ( 6 ): 216 - 218 .
肖永庆 , 张村 , 李丽 , 等 . 构建饮片质量保障体系,确保中药临床疗效 [J]. 中国中药杂志 , 2012 , 37 ( 14 ): 2178 - 2180 .
质量技术监督行业职业技能鉴定指导中心 . 质量技术监督基础 [M]. 2 版. 北京 : 中国质检出版社 , 2014 .
中华人民共和国国家质量监督检验检疫总局 . GB/T 20000.1-2014标准化工作指南 [S]. 北京 : 中国标准出版社 , 2014 .
于江泳 , 余伯阳 , 钱忠直 , 等 . 加快编制《全国中药饮片炮制规范》,规范统一饮片炮制国家标准 [J]. 中国中药杂志 , 2011 , 36 ( 19 ): 2751 - 2754
肖永庆 , 李丽 , 刘颖 . 构建中药饮片质量保障体系的关键问题 [J]. 世界科学技术—中医药现代化 , 2015 , 17 ( 1 ): 167 - 172 .
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