Introduction to National Pharmaceutical Engineering Center (NPEC) for Solid Preparation in Chinese Herbal Medicine

     National Development and Reform Commission authorized the National Pharmaceutical Engineering Center (NPEC) for Solid Preparation in Chinese Herbal Medicine for establishment in August 2002. Jiangxi Herbfine Hi-tech Co., Ltd, as the corporate entity of NPEC, jointly invested by Jiangzhong Pharmaceutical Group and Jiangxi University of Traditional Chinese Medicine College, was setup at same time. In October 2005, NPEC passed the strict evaluation by an expert group representing the National Development and Reform Commission. Thus NPEC becomes one of the organic parts in Jiangxi University of Traditional Chinese Medicine in the chain of manufacture, teaching and research.
     NPEC runs as an independent institute with enterprise management, and its mission is mainly aimed to develop the solid preparations forming techniques with gathering all related high techniques, and setup the innovative technical platforms for solid preparations, including in extraction, isolation, purification, identification, formulation, on-line inspection, quality control, new dosage forming, new pathway for medication and new medicinal adjuvant manufacture in herbal medicine industry. It gives priority to the R&D in mutual techniques or exclusive techniques of solid preparation in Chinese herbal medicine and the industrialization of new herbal products, so as to improve the competition power in pharmaceuticals of China.
     NPEC has 8 research departments with well-equipped laboratories, including the departments in quality control, phytochemistry, solid preparation dosage forming, pharmacology, pharmaceutical engineering, standard substance R&D, healthy products R&D and herbal formulation. NPEC has initially formed the technical platforms in designs and evaluation of herbal new drugs, herbal dosage form and its new administration system, pharmaceutical engineering technique, quality control, R&D of herbal standard substances. Meanwhile, NPEC has owned a postdoc research workstation named by China Ministry of Human, and named as the Key laboratory of Modern TCM Preparation and Quality Control of Jiangxi Province, the Demonstration Base in science and technology of Nanchang city, and the Patent Demonstration Base of Nanchang city. In 2005, it was identified as new and high technology enterprise by Jiangxi provincial Department of Science and Technology.
     There is a GMP certificated semi-work in NPEC. Jiangxi Herbfine Pharmaceutical Co., Ltd, as the subordinate enterprise of NPEC, has 2 production lines (GMP certificated) for drugs and health care food manufacture.
     By gathering and absorbing new techniques, NPEC has utilized the techniques in the product development, and formed a batch of core technical platforms with its own intellectual property rights, such as the platforms in herbal isolation and purification, on-line inspection in tablet manufacture, two-phase capsule development, herbal effervescent tablet development, herbal dispersible tablet development, colon oriented herbal medicine development, herbal tardy and controlled release medicine, pharmacological evaluation for herbal medicine. Up to now, NPEC has purified more than 400 TCM standard substances and more than 120 medicinal materials, and could supply all the standard substances and medicinal materials recorded in China pharmacopoeia of 2005. The TCM standard substances R&D center is one of the biggest exchange centers with good quality and quantity.
     NPEC has formed a professional working team in herbal medicine research and development. There are 115 specialized technical personals, among then, 3 titled with tutors of doctor degree students, 8 with tutors of master students, 6 with PhD, 40 with masters in science. By the end of 2005, 23 national or provincial research projects on herbal medicine research have been conducted in NPEC , including 2 “863 plan” projects, 1 “863 guiding research project ”, 2 innovation medicine and the modernization of TCM projects in the tenth five year plan,2 from national enterprise technology innovation foundation, and 15 provincial research projects. Also NPEC initiated 38 new drug development projects. Among them, 13 have applied for registration of new drug, 3 for new healthy food. 4 new drug certification was issued to NPEC by State Drug and Food Administration. NPEC has applied 57 patents in pending, and 4 patents were approved.
     NPEC gives full play to the technical radiation effect, and provides the technical service for the herbal product enterprises, so as to promote the development of herbal industry of China with its technical advantages. NPEC has collaborated with many enterprises and institutions from Jiangxi, Beijing, Guangdong, Yunnan, Guizhou, Sichuan, Hubei and Hainan with 3 years, and won the broad trusts and the supports with its service and technical achievement.