Quality standards lag behind, active ingredients and mechanism is not clear, poor controllability problems hampering the traditional Chinese medicine (TCM) and the international community --

Quality control standard system power internationalization of traditional Chinese medicine (TCM)

Time: 2016-02-22

Source: China's traditional Chinese medicine

Author: Zhou Manyi

In the face of traditional Chinese medicine is hard to find a place in the world pharmaceutical market situation, ZhongYaoJie people in growing Numbers are beginning to realize that Chinese traditional medicine to the world, must adapt to the discourse system of modern medicine. Recently, by the Chinese academy of sciences, Shanghai institute of medicine, Chinese medicine, director of the center for fruit nickelodeon led to complete the "building and application of Chinese medicine overall quality control standard system" won the 2015 annual "kang yuan cup" won the first prize in the science and technology prize of China association of Chinese medicine, also provides beneficial reference for the bottleneck problem of traditional Chinese medicine internationalization.

The effect is remarkable, evaluation of quality innovative strategy

In reality, most of the traditional Chinese medicine in China because the concept of quality standards lag, indicator composition method is simple, and update the slow, difficult and comprehensive quality control effectively. In order to solve this problem, the research team innovation in overall quality control strategy is put forward, and its application to the domestic and international mainstream pharmacopoeia of traditional Chinese medicine (medicine) in the process of building quality standards, both qualitative analysis and quantitative analysis, uphold the principle of the a, let more can represent the active ingredients of traditional Chinese medicine composition index or to identify medicinal material authenticity and quality evaluation.

Renal injection and salvia miltiorrhiza injection is the project focused on the two core of Chinese traditional medicine products. Research team, said the standard system as a whole to better control the product homogeneity, effectively guarantee the safety of products, improve the product quality control, improve the relevant product market share, has brought considerable economic benefits for the enterprise, through the economic benefits of the project research involves the related products to nearly 4.3 billion yuan, at the same time to ensure the clinical medication safety. In addition of the standards set for enterprises to promote the protection of intellectual property rights of the product.

TCM injections because its clinical study of the quality control standards of safety and adverse reactions and more important, Chinese medicine injection is often a longer because of the change of some parameters in the process of production caused the change of the ingredients, which affects the final product quality control. To solve this problem, the project to introduce fingerprint combined with chemometrics analysis method, the study of traditional Chinese medicine (TCM) renal injection quality standards, from medicine to intermediates (semi-finished products), and finished all the production process of quality control research.

It is understood that the project team also cooperate with enterprises to complete the injection with salvia miltiorrhiza polyphenols acid salt green valley pharmaceutical co., LTD. (Shanghai) and salvia miltiorrhiza injection (compared to pharmaceutical group co., LTD.), danshen injection drops (anhui tianyang pharmaceutical quality standard study project, by adopting the combination of multi-target ingredients and fingerprint method, improve the quality of the corresponding product standards.

Based on the international, Chinese medicine to enter the United States pharmacopoeia standard template

Traditional Chinese medicine quality control standard is a part of traditional Chinese medicine (TCM) standard, its quality is good or bad, directly affect the accuracy of test results. Fruit nickelodeon introduces, at present this project has been successfully for the United States pharmacopoeia ganoderma lucidum, notoginseng, fructus schisandrae, red ginseng, semen coicis and uncaria European pharmacopoeia standards more than a test review content determination method is established. Determination of content of ganoderma lucidum standard item in ganoderma lucidum acid A determination of ten triterpenoid acid and triterpene acid content, its technical data has been the United States pharmacopoeia commission identified as Chinese medicine to enter the United States pharmacopoeia standard template.

Research team said the project is based on TCM chemistry, TCM analysis and study of traditional Chinese medicine standard practice for many years, in the building in conformity with the characteristics of Chinese traditional medicine complex system overall exploration and research of quality standard system, established a series of traditional Chinese medicines adopted by national pharmacopoeia and the international mainstream pharmacopoeia overall quality standard, for the more traditional Chinese medicine (TCM) standard in Europe and the United States pharmacopoeia played an exemplary role, and apply standard system to the quality standards of TCM products ascension, effectively promote the traditional Chinese medicine scientific and international standards.

At the same time, the team also editor in chief of the commonly used traditional Chinese medicine (TCM) ultra high performance liquid chromatography (HPLC) analysis, the traditional Chinese medicine overall quality control standard system to build the four core elements of successful application in the United States pharmacopoeia quality standards.

It is reported, by the research team members to write "Chinese medicine overall quality control method" are also published in the journal science.