Two basic factors for the interpretation of traditional Chinese medicine injection, culturing "safe, effective and quality control of modern traditional Chinese medicine

Dan red injection innovative Chinese medicine safety evaluation

Time: 2016-03-24

Source: China's traditional Chinese medicine

Author: Zhou Manyi

Report from our correspondent (reporter Zhou Manyi) in recent years, safety evaluation of traditional Chinese medicine injection caused extensive concern of drug evaluation institutions, pharmaceutical companies, recently completed by step group Zhao Buchang etc, led by the "varieties of traditional Chinese medicine (TCM) big Dan red injection efficacy material base, action mechanism, quality control and industrialization" won "kang yuan cup" 2015 year won the first prize in the science and technology prize of China association of Chinese medicine, and innovation in the traditional Chinese medicine safety evaluation mechanism, improve the whole competitiveness of the Chinese traditional medicine.

Create TCM injections post-market safety evaluation method of system and technical specification is the premise and key for the implementation of safety evaluation. Research team, said the study was the first to use evidence-based medicine and hospital focused on monitoring the research method of evaluation methodology of TCM injections listed security after research, the research method of the innovation of the "real world" and pharmacists as the main body of the post-marketing safety study pattern, illustrates the two basic factors of traditional Chinese medicine injection, "chemical basic clear mechanism, basic understood", cultivating "safe, effective and quality control" of modern Chinese medicine, for traditional Chinese medicine injection of secondary development research provides the ideas and methods.

Based on the traditional concept of secondary development, shandong red pharmaceutical co., LTD., to strengthen the top-level design, overall layout, and tianjin university of Chinese medicine, the first affiliated hospital of henan institute of traditional Chinese medicine and the Chinese people's liberation army general hospital, nankai university and other units to carry out collaborative research. For Dan red injection "safe, effective and controllable quality" the key scientific issues, using modern pharmaceutical technology and quality control system, Dan red injection for the research and evaluation system, for Dan red injection safety and effectiveness in the clinical treatment of disease of heart head blood-vessel, quality control, provides the technology support, formed the prescription screening and optimizing the source of innovation.

Market survey, shandong red pharmaceutical co., LTD. Dan Dan red injection, in key cities of heart head blood-vessel proprietary Chinese medicine hospital in the market, the market share of 4.24% in 2013, ranked third; In key cities of cardiovascular proprietary Chinese medicine injection in the hospital market, market share of 5.59% in 2013, ranked third, Dan red injection since listed by city drug inspection departments across the country to sample, inspection situation shows that the listed product inspection percent of pass is 100%.

The varieties of traditional Chinese medicine (TCM) big Dan red injection since 2002 after the state food and drug administration approved registration, as of December 2014 sales profit of 4.95 billion yuan, tax 4.95 billion yuan, create a good social benefit and economic value, its core technology "a combination of drugs to treat disease of heart head blood-vessel content and its preparation method" won the national invention patent.