| Natural product extracts which plays a unique role in maintenance of human health and environment have received much more attention. Especially, with the development of modern technology and the improvement of awareness on environment and the level of life and health, the application and development of natural product extracts were put forward higher requirements. While strict quality control is the key factor to protect the natural product extracts and their products useage in safe, stable and effective way. Therefore, according to the characteristics of industry chain of natural product extracts, how to comprehensively and effectively enhance the level of quality control in the whole industry has become the core and primary task that need to address urgently for promoting core competitiveness of our natural product extracts industry, and stepping to modernization, industrialization and internationalization.Based on the basic laws of industrial technology development and the theory of industry chain optimization and control, the significant influence of various aspects of industrial chain on the quality of natural product extracts was analysised. Focus on the effect of the quality control of each aspect of the industrial chain and their effective associations and integrations on the quality control level of the whole industry chain, the innovative industrial technology roadmap of quality control was introduced to improve the quality of the natural product extracts. It is very important and significance that this research and its results can improve the quality of natural product extracts, enhance the industry's core competitiveness and lead the sustainable development of industry.By reference to the information and data of the large number of literatures, which include the authority of sci-tech journals, development information and databases of industry, and related industrial development planning, policy documents over the past decade, and combining with the survey and investigation on the representation of domestic enterprises and universities and scientific research institutes, SWOT analysis for the status of our country's natural product extracts industry and the problems of quality control were carried out. Furthermore, on the basis of accurately grasping development status of quality control in our country's natural product extracts, after analyzed and discussed, the quality control of effective fractions of the natural product extracts was the core of the industrial chain of quality control. Then, according to principles of integrity, non-cross and relevance, and characters of effective fractions of the natural product extracts, two scopes of industry, processing and equipment and detection technology and evaluasion system were defined. Finally, in the order of importance for quality control, six key processes of quality control in industry chain, which include separate, extract, prepare, dry, concentrate, raw materials and excipients were concluded in turn.Along with the route of"market demandsâ†'industry goalsâ†'technology barriersâ†'R & D demands"as well as their relationships with each other, the short-term, mid-term and long-term technology roadmap were drawn respectively. According to the key process of industry chain in effective fractions of natural products impact on the quality control, a large number of literatures which include the authority of sci-tech journals, development information of industry, databases of patent and related industrial development planning, policy documents over the past decade were analyzed and research on the development of domestic representative enterprises, R & D status of scientific research academy, and development trends of technology in future were also investigated. Based on these research and analysis, survey questionnaires were designed and sent, extensive research in the industry was carried out, series of expert seminars were held and market demand factors, industry target factors, technical barriers factors, and R & D demand factors were analyzed respectively by using the Delphi method, brainstorming, patent analysis, correlation analysis and other scientific methods.Firstly, market demamds were analyzed. According to the industry background, technical status, development trends and driving forces of natural products extracts in domestic and foreign, and via questionnaire survey and brainstorming sessions, the requirements of natural product extracts industry for future market, and market position of industrial development at short term, medium term and long-term were screened out.Secondly, industry targets were analyzed. The targets of quality control of effective fractions of natural product at short-term, medium-term and long-term were concluded by agglomerating experts'judgment on development goals which should meet market demand in future, and analyzing the relevence between market demand factors and industry target factors.Thirdly, technical barriers were analyzed. According to the targets of quality control in natural product extracts industry at short-term, mid-term and long-term, the domestic and foreign patents were analyzed based on the priority development of market demand factors that were condensed in market demand analysis. The obstacles of proventing the development of industrial technology and the key and common technical problems which were existed in the industrial chain were investigated through the deep analysis of the production processes, technologies, equipments, related analytical techniques and the evaluation system of quality criteria. As analyzing the relevance between technical barriers factors and industry target factors, and perfecting, replenishing, analyzing and summarizing each industry target factors, technical barriers factors and their priority order were determined, which would restricted the technologies of quality control upgrading and hindered industry targets to achieve at different time node.At last, R & D (research and development) demands were analyzed and the technology roadmap was designed. On the basis of summarizing the results of market demands, industry targets and technical barriers, via questionnaire survey and brainstorming sessions, R & D demand factors at different stage were condensed. Moreover, the priority, main body and pattern of R & D demand essential factors have also been analyzed. And the technology roadmap of quality control for natural products extract industry at different development stage were designed by combining the market demands, industry targets, technical barriers, R & D demands, the main and model of R & D which involve in each process of industry chain. The technical problems that need to solve, the solutions, and the targets that expected to achieve in natural product extracts industry at different development stage were indicated respectively.All in all, for the urgency of quality control problem in our country's natural product extracts industry and the particularity and complexity of natural product extracts industry, the quality control of the effective fractions of natural product was chosen as the core of the quality control of the natural product industry. Based on deeply analyzing the industry status of natural product extracts and its industry chain of quality control, the ideas of industry technology roadmap was introduced into the system of solving the problem of quality control in the whole process of industry. By drawing the technology roadmap of quality control for natural product extracts industry, each chain which associated with quality control in the whole production process was effectively integrated, the obstacles were analyzed, the development process of techniques and standards of quality control in natural product extracts industry were identified, and the development goals and directions of quality control were indicated. All the results provide the foundation and basic data for enhancing the overall level of quality control of the natural product extracts of our country and improving the healthy and sustainable development of whole industry. At the same time, it also show the direction for the strategy of technological innovation for quality control, the organization form of technological innovation and management of the R & D projects. |
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