经典名方产品开发政策及制备工艺探析
On the Policy and Key Technology of the Product Development of Classical Prescription
-
摘要: 经典名方产品研发是目前中医药行业的一个热点,《古代经典名方目录(第一批)》和《古代经典名方中药复方制剂简化注册审批管理规定》等相关政策对经典名方产品注册影响极大,《古代经典名方中药复方制剂及其物质基准的申报资料要求(征求意见稿)》与经典名方产品研究的相关技术要求关系密切。制备工艺直接影响经典名方产品质量的均一稳定,决定经典名方物质基准及其制剂申报工作的成败。Abstract: The research and development of classical prescription products(CPP) is a hot spot in the traditional Chinese medicine industry at present. The relevant policies have a great impact on the registration of CPP. The application materials is closely related to the relevant technical requirements of the research of CPP.The processing technology directly affects the stability of its quality and decides the success of the application of the classical prescriptions' material base and its processing technology.
-
Key words:
- classical prescription /
- policy /
- processing technology
-
[1] 仝小林,吴义春,姬航宇,等.迷失的经方剂量[J].上海中医药杂志,2009,43(12):4-6. [2] 钟文,陈莎,章军,等.重点是原料,还是工艺?——以葛根芩连汤为例探讨中成药质量一致性控制方法[J].中国中药杂志,2016,41(6):1027-1032. [3] 修彦凤,张永太,王兴发.半夏的炮制历史沿革[J].时珍国医国药,2006,17(9):1774-1775. [4] 施铮,陈仁寿,李陆杰,等.经典名方研发的几个关键问题刍议[J].南京中医药大学学报,2019,35(4):366-369. [5] 王智民,刘菊妍,刘晓谦,等.谈经典名方的化学、生产和质量控制研发和监管[J].中国中药杂志,2017,42(10):1819-1824.
点击查看大图
计量
- 文章访问数: 603
- HTML全文浏览量: 14
- PDF下载量: 580
- 被引次数: 0