National Engineering Laboratory for Quality Control of Traditional Chinese Medicine
Key Research Laboratory of the State Administration for Traditional Chinese Medicine Process Control Technology
National Administration of Traditional Chinese Medicine TCM Chemistry Level 3 Laboratory
Our center was established in 2005 and formed by merging the Traditional Chinese Medicine (TCM) Chemistry Laboratory, Analytical Chemistry Laboratory, and Instrumental Analysis Laboratory. The TCM Chemistry Laboratory was approved as a Level III TCM Research Laboratory by the National Administration of Traditional Chinese Medicine in 2003. It successfully passed its re-accreditation assessment with excellent results in 2008. In 2017, the Key Research Laboratory for TCM Process Control Technology was rated "Excellent" by the National Administration of Traditional Chinese Medicine; among all institutions nationwide (9 total), it ranked third.
Our work focuses on addressing common challenges and key technical issues in the traditional Chinese medicine (TCM) industry. Leveraging TCM chemistry and modern instrumental analysis, we conduct research on the active constituents of TCMs and their compound formulations, develop chemical reference standards, establish quality standards and evaluation methods, and support the development of new TCM drugs.
1. Academic Standing
The Center's predecessors—the Department of Chinese Medicine Chemistry and the Department of Chinese Medicine Analysis—were both established in 1955. They were among the first departments nationwide to conduct modern research on Chinese medicine. Through more than 60 years of persistent effort across multiple generations, the Institute has achieved significant breakthroughs in Chinese medicine chemistry and quality evaluation, becoming one of the nation's leading centers for these fields. Its research capabilities are now at the forefront nationally.
1, the birthplace of artemisinin
Artemisinin is China's first innovative drug recognized globally and one of the nation's top ten scientific achievements. Our laboratory first isolated artemisinin in 1972 and developed it into China's first new drug approved since the implementation of the new drug approval system [ ( 86 ) Wei Yao Zheng Zi X-01 ]. Subsequently, we also developed dihydroartemisinin. Both artemisinin and its suppositories, as well as dihydroartemisinin and its tablets, were developed by our laboratory.
The discovery of artemisinin is a monumental contribution our center has made to humanity and stands as our flagship achievement. Dr. Tu Youyou, a distinguished representative of all former directors of the Department of Medicinal Chemistry, exemplifies this legacy. Our center has achieved numerous firsts:
— First to obtain artemisinin crystals internationally (1972 11, 8)
— First to synthesize Dihydroartemisinin internationally (1973)
— China's First New Drug [ 1986, ( 86 ) Wei Yao Zheng Zi X-01 ]
Tu Youyou, China's first Nobel Prize laureate in Physiology or Medicine and a lifetime senior researcher
Tu Youyou, the first recipient of China's highest national award in traditional Chinese medicine and a Lifetime Research Fellow
2, the sole contractor of China's only national engineering laboratory for traditional Chinese medicine
After fierce nationwide competition, our center's proposal for a National Engineering Laboratory was approved by experts. In 2008, the National Development and Reform Commission authorized the establishment of the National Engineering Laboratory for Quality Control Technology in Traditional Chinese Medicine (Document No. 406 issued by the General Office of High-Tech Industries [Dev] [2009]). It is the only National Engineering Laboratory in the TCM industry.
II. Research Areas
We primarily employ modern separation and analytical techniques and instruments—including HPLC, preparative MPLC, NMR, GC, MS, IR, UV, GC-MS, LC-MS, GC-IR, and HPCE—to conduct research guided by the principles of Traditional Chinese Medicine (TCM) theory in the following areas:
1: Systematic research on chemical composition and quality evaluation of commonly used Chinese medicines, toxic medicinal materials, ethnic medicines, and Chinese medicine compound preparations; isolation, purification, structural identification, and active component tracking for targeted extraction of effective components; accumulation of Chinese medicine chemical reference standards.
2 Leverage chemical reference standards and instrumental analysis to conduct quality standard research and evaluation for Chinese herbal medicines, processed slices, formula granules, extracts, and proprietary medicines.
3 Collaborate with other disciplines to conduct research on the geographical authenticity of Chinese medicinal materials, serum pharmacology, pharmacokinetics of Chinese medicines and compound prescriptions, and novel drug delivery systems.
4 Collaborate with partner institutions to build a high-throughput screening library of TCM samples and conduct derivative synthesis research on TCM lead compounds.
In recent years, our center's experts have led or participated in numerous strategic studies on TCM technology, industry standards, international registration regulations, and industrial development and planning. We drafted the national "10th Five-Year Plan" through the "13th Five-Year Plan," shaping major scientific and industrial decisions for the TCM sector. During significant public health emergencies, we stepped up to lead nationwide research efforts—such as the study on screening TCMs for anti-SARS applications—and successfully fulfilled the critical missions entrusted by the Party and the State.
Leveraging our status as the WHO Collaborating Centre for Traditional Medicine, we not only provide training, capacity building, and hospitality for international researchers sent by WHO but also actively pursue global scientific collaborations. We have already established TCM research partnerships with countries including the United States, Austria, Canada, Japan, and others.
III. Basic Information
1 Research Team
The center currently employs 33 researchers, including 10 senior researchers, 8 associate researchers, and 17 with doctoral degrees.
Researchers: Wang Zhimin (PhD, Director), Yang Bin (PhD), Gao Huimin (PhD), Zhu Jingjing (PhD), Li Chun (PhD), Wang Hongjie (MS), Chao Zhimao (MS), Feng Weihong (MS), Yang Jian, Fu Meihong.
Associate Researcher: Yan Lihua (PhD), Li Hua (PhD), Chen Sha (PhD), Dai Yuntao (PhD), Ma Hai (PhD), Wang Weihao (PhD), Si Nan (Master's), Yang Lixin.
2: Laboratory Area
Current area 1580m2, instrument room area 730 m².
3 Research Projects and Funding
From 2015 to 2017, the organization undertook more than 80 national-level research projects with a total funding of nearly 20000 million yuan.
4 Awards and Patents
Won 1 first-prize and 2 second-prize awards in the National Science and Technology Progress Award, plus 5 first-prize, 7 second-prize, and 5 third-prize awards from provincial or ministerial levels. Received 25 patent authorizations.
IV. Research Directions
1: Key Research Directions:
① Research on the pharmacologically active substances and chemical reference standards of commonly used traditional Chinese medicines (including ethnic medicines).
② Research on new methods for quality control and evaluation of traditional Chinese medicine and their technical adaptability.
③ Research on quality standards for traditional Chinese medicine.
4. Research on reference standards for Chinese herbal medicines and their detection methods.
2 Exploratory Research Directions:
① Research on the application of advanced and appropriate technologies in modifying major Chinese proprietary medicines.
② Research on the application of Traditional Chinese Medicine fingerprint analysis and rapid TLC in industrial production.
③ Research on toxic/harmful substances and safety standards for toxic medicinal materials, processed pieces, and injectables.
Application of Biological Evaluation Methods in Quality Control of Traditional Chinese Medicine.