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The key issues and development strategy of Chinese Classical Formulas pharmaceutical preparations
Hua Luo1; Hongguo Chen1; Chang Liu1; Siyuan Zhang1; Chi Teng Vong1; Dechao Tan1; Yuntao Dai2; Yitao Wang1; Shilin Chen2
2021-12-01
Source PublicationChinese Medicine
ISSN1749-8546
Volume16Issue:1Pages:70
Abstract

It is well-known that Prof. Tu Youyou won the Nobel Prize in Physiology or Medicine in 2015 due to the research on artemisinin treating malaria, and this can be regarded as the milestone of modernization of Traditional medicine. This first Nobel Prize in Traditional Chinese medicine (TCM) has aroused profound impetus in the investigation of TCM and attracted global attention to the ancient books of TCM. Three new medicines for the treatment of COVID-19 derived from Chinese Classical Formula (经典名方, CCF) have been approved in 2021 due to their effectiveness for the treatment of COVID-19. This article introduced the research background of CCF pharmaceutical preparation (CCFPP), explained the ideas for the modernization of CCF and analyzed related issues involved in the development process of CCFPP, including the origin of medicinal materials, processing methods, dosages and the preparation process of CCF Material Reference. The strategy for industrialization was proposed in terms of the evaluation of the pharmaceutical properties, industrialization considerations, and clinical positioning of CCFPP. The key contents and requirements for the development CCFPP were also summarized according to the recently published registration guidance by the Center for Drug Evaluation in China. In addition, the safety issues of CCFPP were described, including the discussion on the non-clinical safety evaluation and analyzation on the international registration of Traditional herbal medicines. This article is aimed to provide references for enterprises, researchers, and relevant personnel of government departments that are engaged in the development of CCF to speed up the developing process of CCFPP.

KeywordChinese Classical Formulas Material Reference Origin Of The Medicinal Materials Processing Methods Dosage Verifcation Quality Control Development Strategies Safety Evaluation
DOI10.1186/s13020-021-00483-6
URLView the original
Indexed BySCIE
Language英語English
WOS Research AreaIntegrative & Complementary Medicine ; Pharmacology & Pharmacy
WOS SubjectIntegrative & Complementary Medicine ; Pharmacology & Pharmacy
WOS IDWOS:000683454700001
PublisherBMC, CAMPUS, 4 CRINAN ST, LONDON N1 9XW, ENGLAND
Scopus ID2-s2.0-85111992792
Fulltext Access
Citation statistics
Document TypeJournal article
CollectionInstitute of Chinese Medical Sciences
Corresponding AuthorYuntao Dai; Yitao Wang
Affiliation1.Macau Centre for Research and Development in Chinese Medicine, Institute of Chinese Medical Sciences, University of Macau, Macao, China
2.Key Laboratory of Beijing for Identifcation and Safety Evaluation of Chinese Medicine, Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences, Beijing, China
First Author AffilicationInstitute of Chinese Medical Sciences
Corresponding Author AffilicationInstitute of Chinese Medical Sciences
Recommended Citation
GB/T 7714
Hua Luo,Hongguo Chen,Chang Liu,et al. The key issues and development strategy of Chinese Classical Formulas pharmaceutical preparations[J]. Chinese Medicine, 2021, 16(1), 70.
APA Hua Luo., Hongguo Chen., Chang Liu., Siyuan Zhang., Chi Teng Vong., Dechao Tan., Yuntao Dai., Yitao Wang., & Shilin Chen (2021). The key issues and development strategy of Chinese Classical Formulas pharmaceutical preparations. Chinese Medicine, 16(1), 70.
MLA Hua Luo,et al."The key issues and development strategy of Chinese Classical Formulas pharmaceutical preparations".Chinese Medicine 16.1(2021):70.
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