Development and new technology of plant extract of traditional Chinese Medicine

In the past 10 years, the export of plant extracts in China has increased from 123 million US dollars in 1997 to 477 million US dollars in 2006, an increase of 287.8% (because most of the traditional Chinese medicine is plant medicine, the two phrases of "Chinese medicine extract" and "plant extract" are generally regarded equally in the domestic industry ——Editor's note) in view of this situation, at the "Fourth International Symposium on Extraction Technology of traditional Chinese medicine" recently held by China Pharmaceutical Biotechnology Association, the participating scholars expressed their joy and pointed out that despite the growing export volume, China's plant extract market share in the world has not achieved a substantial breakthrough in the past 10 years In 1997, China's extract The market share is 4.39%, 4.51% in 2005 and about 5% in 2006 It has been hovering between 4% and 5% Wan Deguang, Professor of the school of medicine of Chengdu University of Traditional Chinese Medicine, believes that China has a long way to go to become a big country of plant extracts, which requires efforts in scientific and technological innovation, resource protection and development Problem 1: lack of scientific and technological content and low added value of products On the whole, the main products of most manufacturers in China are still in the stage of crude extraction In 1999, the export of raw materials of traditional Chinese medicine with low processing degree and low added value accounted for 64% of the total export of traditional Chinese medicine, while the export of finished products and extracts of traditional Chinese medicine with relatively high added value accounted for only 16% and 20% By 2006, this situation has been significantly improved: the high-end extract products, synthetic and reproduced glycosides and derivatives, have become the product type with the largest export volume, with the annual export volume reaching US $299 million, a year-on-year increase of 61.52%, accounting for 63% of the total export value of extracts The main products of the top 30 enterprises in the export volume of extracts from January to June 2006 were examined It was found that some manufacturers have taken high-end extracts as their main research and development and business objects However, compared with more than 1000 extract manufacturers, the number of 30 is too low Prescription 1: increase investment in research and development of wandegang believes that the product structure of the extract actually reflects the degree of technical progress of the manufacturer Most of the manufacturers mainly engaged in crude extract are labor-intensive enterprises, while those mainly engaged in high-end extract are technology intensive enterprises In general, the technical system of plant extract industry in China has developed rapidly, but it is not balanced Among many enterprises engaged in plant extract production in China, labor-intensive enterprises still account for a large proportion Therefore, China's plant extract industry should still increase investment in technology research and development to improve the technological content of products and gradually increase the market share of high-end extracts Prescription 2: accelerate industrial technological innovation "from crude extract to high-end extract is the inevitable trend of extract product development This development process must rely on technological innovation to improve the level of technology and quality standards " Wandegang pointed out that to improve the technology level, on the one hand, it is reflected in the application of new technologies and methods, such as macroporous adsorption resin technology, supercritical fluid extraction technology, high-speed countercurrent chromatography technology, aqueous two-phase extraction technology, membrane separation technology and other new technologies have been widely used; on the other hand, it is also reflected in improving the level of process equipment, product quality standards and product quality standards Analysis and detection technology At present, analytical instruments and technologies such as high performance liquid chromatography (HPLC), high performance thin layer chromatography (HPTLC), gas chromatography (GC), gas chromatography / mass spectrometry (GC / MS), high performance liquid chromatography / mass spectrometry (HPLC-MS) are widely used, and fingerprint technology will gradually become a routine inspection technology, which will help to improve the quality control level of extract products In particular, wandegang pointed out that the extract manufacturers should focus on the development of green technology in technological innovation Green consciousness plays a great role in promoting the sale of traditional Chinese medicine products to the international market In 2003 and the first five months of 2004, the average export growth rate of green traditional Chinese medicine enterprises was much higher than that of the same industry The export volume of green traditional Chinese medicine enterprises has accounted for 1 / 6 of the total export value of Chinese patent medicine and extract In addition, in the extractive industry, the environmental damage caused by a large number of wild medicinal plants and the environmental pollution caused by factory waste are still very serious; and many extractive enterprises use a large number of harmful solvents such as chloroform and acetone for a long time, its harm can not be ignored, from the long-term development of the plant extractive industry, these problems should be paid attention to and effectively solved Definitely Prescription 3: up to the level of plant medicine, Wan Deguang believes that it is possible for China's traditional Chinese medicine to go from plant extract to plant medicine Plant medicine is the long-term goal of Chinese medicine entering the international market, and plant extract can pave the way to achieve this goal India imports a large number of crude extracts from China, and then transfers to the international market after deep processing, from which it gains a lot of profits Similarly, some of China's high-end extracts are exported to the European and American markets in large quantities, which are made into preparations by pharmaceutical enterprises in these countries, and then sold to other countries including China, and also obtain a lot of profits From this point of view, only when Chinese medicine is recognized by the world in the form of "medicine", can it embody its due value So it is the long-term interests of Chinese traditional medicine industry to upgrade from plant extract to plant medicine Question 2: there are many good and bad enterprises, which are difficult to break through the technical barriers According to statistics, from January to June 2005, 1085 enterprises in China were engaged in the import and export of plant extracts, of which 736 were involved in the export In the existing extraction production and management enterprises in our country, there are not enough large-scale enterprises Many Chinese patent medicine factories and fine chemical enterprises are also producing this kind of extraction, and there are many enterprises in similar workshop production Wandegang believes that the rapid increase in the number of extract manufacturers, on the one hand, can promote and stimulate the research and production of extract products in China, but there are at least two negative effects First, it leads to the confusion of quality standards of many products and the lack of industry standards in line with international standards At present, Europe, the United States, Japan and other countries and regions have formulated strict and detailed specifications for plant extracts The lack of standards will inevitably lead to the lack of competitiveness of Chinese extract products and the inability to break through the technical barriers of foreign countries Second, it leads to non benign market competition Some kinds of products can be produced by everyone In order to win the market, many enterprises are competing to reduce the price or replace the inferior products with the best ones to obtain the low price and sales volume For example, in 1995, the export price of Ginkgo biloba extract was $500 / kg, but due to domestic vicious competition, its export price has now dropped to about $25 / kg Prescription 1: strengthen the industry planning In order to solve the above problems, the extract industry in China needs to further strengthen the industry planning and adjust the product structure Relevant industry associations should actively guide the industry and play a role in the industrial structure layout, industry resource integration, etc For example, in order to avoid the vicious competition of a, B, C and D enterprises in galanthamine hydrobromide project, class A enterprises can be guided to cultivate Lycoris aurea, class B enterprises to produce alcohol extract, class C enterprises to produce crude extract and class D enterprises to produce refined products (according to the operation and management of the enterprise, customs declaration and compliance with customs laws and regulations, the Customs has set up four management categories of a, B, C and D for the enterprise - editor's note) this can not only ensure the sufficient supply of raw materials, but also avoid the loss of interests generated in the process from rough extraction to refining abroad, thus forming a fixed and stable industrial chain Prescription 2: the implementation of market access system Wan Deguang believes that the implementation of market access system in extract industry is likely to become a trend of industry reform Market access system may be limited from two levels First, enterprise access restrictions, first, product access restrictions Enterprise access restriction is to restrict the enterprises with poor hardware facilities, backward technology and low management level to enter the market Product access restrictions mainly from the perspective of product quality, prohibit products that cannot meet the pharmacopoeia or industry standards from entering the market If the enterprise access restriction is implemented, it should be a step-by-step process without affecting the overall development of the industry Product access restrictions should be based on industry standards This will not only restrain the vicious competition in the industry for a long time, but also promote the technological progress of enterprises and improve the quality of products Moreover, from the perspective of international market, the export of extract must meet the requirements of foreign pharmacopoeia or standards and pass relevant certification, so it is an inevitable choice for the extract industry to implement enterprise access restrictions and product access restrictions Prescription 3: the implementation of GMP and GEP "is better than the active improvement of extract enterprises' own level rather than passively adjusting the industrial structure according to the problems in the market" Wandegang believes that the implementation of GMP, GEP and other production specifications is one of the solutions to the above problems GMP has been introduced into China's pharmaceutical industry for a long time, and has accumulated more experience, which is easy to be implemented in the extract industry The implementation of GMP will help to form industry awareness based on product quality and enhance the international image of China's extract enterprises GEP means a good extraction specification Unlike GMP, which comprehensively monitors all aspects of product production, GEP focuses on the management of extraction process, such as the standardization of extraction, concentration, chromatography, crystallization, filtration, drying and other unit operations The implementation of GEP is very useful to improve the quality and stability of extract products Prescription 4: to speed up the establishment of industry standards at present, the vast majority of extract products in China do not have industry standards It is necessary to establish and improve the industry standards in line with the international standards for our extract to break through various technical barriers At present, China's extractive industry is developing rapidly, and the call to speed up the establishment of industry standards is getting higher and higher According to Wan Deguang, the extract branch of China Chamber of Commerce for import and export of medical and health products has done some work on this, and authorized Hunan Jinnong biological resources Co., Ltd., Hunan Jiuhui modern Chinese Medicine Co., Ltd., Xi'an Tiancheng pharmaceutical Bioengineering Co., Ltd., Shandong LVYE Pharmaceutical Co., Ltd and other enterprises as "standard setting units of single plant extract" At present, China's export of extracts is expanding day by day It can be predicted that in the next 3-5 years, it is possible to draft a large number of industrial standards for plant extracts Problem 3: the increase of resource consumption and unsustainable development due to the low average export price, the increase of export volume of Chinese herbal extracts should be attributed to the increase of export volume to a large extent, which means the increase of consumption of plant resources and the decrease of some medicinal plant resources, which may lead to unsustainable situation For example, the price of huperzine A is very high (about 3 million yuan / kg), so many enterprises have made great efforts to develop it, but few enterprises attach importance to its tower, which is mainly wild, and it is difficult to cultivate After several years of intensive mining, the amount available for mining is significantly reduced The price of its medicinal materials has increased from 13-15 yuan / kg in 2002 to 60-80 yuan / kg today, and has continued to rise The upward trend Prescription: to build a sustainable industrial chain, wandegang pointed out that if the current utilization speed is not controlled, it will not take a few years