摘要
结合《中药新药用饮片炮制研究技术指导原则》起草过程中的相关思考,就饮片炮制研究的基本思路及与《中药、天然药物原料的前处理研究技术指导原则》(2005)不同的技术要求进行探讨,提出以下建议:(1)加强直接粉碎入药饮片的清洗工艺研究,降低微生物污染水平;(2)在保证药材质量的前提下,进行药材趁鲜切制等研究,减少有效成分的损失;(3)研究采用机器视觉等新技术对饮片炮制程度进行客观量化评价,加强饮片炮制过程的质量控制;(4)进行新型干燥技术的研究,节能降耗,保证饮片质量;(5)加强炮制用辅料的原料质控、制备工艺及质量标准研究;(6)根据饮片特点和常见问题研究完善饮片质量标准,反映饮片的关键质量属性。必要时可参考国家补充检验方法增加针对性检测项目,根据质量控制及风险管理情况对饮片标准中的特定项目进行定期检验。
This article combines the relevant thoughts in the drafting process of the"Guideline on the Processing of Chinese Herbal Pieces for New Drugs of Chinese Mdeicine",and discusses the basic ideas for the processing of Chinese herbal pieces and the technical requirements that are different from the"Guideline on the Research on Pretreatment of Chinese Medicine and Natural Medicine Raw Materials"(2005).Recommendations are presented as following:(1)Strengthen the research on the cleaning technology of directly crushed pieces of medicine to reduce the level of microbial contamination;(2)Under the premise of ensuring the quality of Chinese medicinal materials,enterprises can study fresh cutting technology of Chinese herbs to reduce the loss of active ingredients;(3)The enterprises can adopt new technologies such as machine vision to objectively and quantitatively evaluate the processing degree of Chinese herbal pieces,and strengthen the quality control of processing process of the Chinese herbal pieces;(4)The research of new drying technology can save energy and reduce consumption,and ensure the quality of Chinese herbal pieces;(5)Strengthen the research of raw material quality control,preparation process and quality standard of processing auxiliary materials;(6)Research and improve the quality standards according to the characteristics and common problems of Chinese herbal pieces,reflecting the key quality attributes of Chinese herbal pieces.When necessary,refer to the national supplementary inspection methods to increase targeted testing items,and conduct regular inspections on specific items in the standard for Chinese herbal pieces based on quality control and risk management.
作者
王玲玲
周跃华
李计萍
林丹
顾杰
吴静义
唐溱
WANG Ling-ling;ZHOU Yue-hua;LI Ji-ping;LIN Dan;GU Jie;WU Jing-yi;TANG Zhen(Center for Drug Evaluation,National Medical Products Administration,Beijing 100022,China)
出处
《中草药》
CAS
CSCD
北大核心
2021年第1期9-13,共5页
Chinese Traditional and Herbal Drugs
关键词
趁鲜切制
新型干燥技术
饮片炮制
炮制用辅料
饮片质量标准
定期检验
fresh-cut
new drying technology
processed Chinese herbal pieces
processing auxiliary materials
standard of Chinese herbal pieces
regular inspection
