Introduction
The use of ethnomedicines has a long history. For the protection, inheritance, and development of ethnomedicines, it is necessary to combine modern scientific theories and technical means to elucidate the rich traditional knowledge and practice of ethnomedicine to promote its use among broader populations.
Located in the mountains of Southwest China, Yunnan Province is one of the 35 hotspot areas of global biodiversity (as confirmed by Conservation International), and it is also the province with the most abundant biodiversity and ethnic cultural diversity in China. Almost all the 25 ethnic minorities in Yunnan have their own traditional medical theories or medication-related experiences. Based on these advantages, we proposed a research mode of “close integration of basic research and applied development.” We implemented a systematic project of innovative research and applied development of ethnomedicines. We also explored a practical and feasible innovative development path, which consists of “resource study → standardized development research → industrialization of the achievements and efforts for internationalization,” for ethnomedicines [
1]. This section focuses on the technical points involved in all stages to further elucidate the use of the innovative development path as a reference.
Study on the experiences of ethnomedicine use and the investigation of medicinal resources
Research on the experiences associated with using ethnomedicines and the investigation of medicinal resources can be divided into the following three stages: preparation, field survey, and arrangement and analysis. The preparation stage includes literature preparation, technology preparation (such as the clarification of the investigation range and content, the formulation of survey plans and programs, and the performance of pilot investigation and professional training), and material preparation. The arrangement and analysis include a timely analysis, a periodic analysis, and an overall integrated analysis and evaluation. The timely and periodic analyses are comparative analyses between all the information and data acquired from the field investigation and the literature obtained in the preparation stage to amend and to improve the investigative plans and to guide the deepening and broadening of the investigation. Meanwhile, the overall integrated analysis and evaluation entail the sorting, comprehensive analysis and evaluation based on all the data and information acquired from the field investigation and collected and analyzed from the preparation stage, and producing a written report to serve as a reference for research development and the sustainable use of ethnomedicines. The field investigations on the experiences of ethnomedicine use and medicinal resource have their own focuses. However, interaction must exist among such points to achieve twice the results with half the effort; such aspect is separately described below.
Study on the experiences of ethnomedicine use
The experiences on using ethnomedicines have been repeatedly validated by practice. These experiences are elevated, have retained use, and are the major resources for the origin of innovative ethnomedicine development. However, experiences concerning ethnomedicine use have empirical, conservative, and sporadic features [
2–
6]. Therefore, it is necessary to implement in-depth excavation, collection, arrangement, and analytical studies to protect and pass down the experiences on ethnomedicine use and to provide guidance during the research and development of ethnomedicines.
The study on the experiences associated with ethnomedicine use primarily includes two aspects: the in-depth excavation of literature resources and implementation of field surveys (field investigations). The excavation of literature involves the collection and arrangement of resources from ancient and modern medicinal literature, local chronicles, and publications on ethnological investigations and the application of computerized data mining methods to discover and to extract explicit and implicit information. On the other hand, the implementation of field surveys involves conducting in-depth field investigations to acquire first-hand information through flexible methods, such as observations, questionnaire surveys, centralized surveys (forums), individual visits, key personnel interviews, participatory observations, follow-up investigations, dynamic tracking of information, and collection of artifacts and literature [
7]. Investigations are performed using integrated methods of video recording, photography, voice recording, and writing. The investigation process follows the principle of “respecting culture and custom, benefit-sharing, and data authenticity and reliability.” [
8,
9] For theories and methods, the developmental results from ethnology and anthropology should be fully referenced, integrated, absorbed, and applied. The investigation plan is shown in Fig.1.
Investigation of ethnic medicinal resources
Ethnomedicinal resources are the material bases for the research and development of ethnomedicines. Investigation and research are guided by basic theories including plant (animal) taxonomy, plant (animal) ecology, plant resources, and mineralogy. Through field investigations and studies, the types, medication conditions, reserve amounts, ecological conditions, and utilization statuses of ethnic medicinal resources in the surveyed areas can be understood, and new resources can be excavated. Based on these investigations and studies, a comprehensive analysis of the current status and degree of resource utilization is performed to evaluate the current exploitation status as well as the potential to provide policies and bases for the sustainable development, utilization, and protection management of ethnomedicinal resources.
For example, Qi Ye Lian is the dried stem and leaf of
Schefflera elliptica (Blume) Harms, which belongs under the genus
Schefflera of the Araliaceae family. Field investigations in Yunnan have shown that Qi Ye Lian is the raw material for the Tongshu capsules and Zhongtong aerosols in the Gold series of Yi ethnomedicines. Approximately 1100 species of
Schefflera plants are found worldwide, and the plants are distributed extensively throughout the tropical and subtropical areas of both hemispheres. A total of 35 species in China are distributed over the southwestern and southeastern areas [
10]. The primary production area is Yunnan (with more than 30 species) [
11]. In Yunnan, the dried stems and leaves of whole
Schefflera plants, including
S. elliptica,
S. delavayi,
S. pauciflora,
S. parvifoliolata, and
S. heptaphylla, are all used as Qi Ye Lian. Field investigations showed that one type of medicinal material, Qi Ye Lian, is used extensively by the Yi population in Yunnan. Qi Ye Lian has wind-expelling and pain-alleviating functions. The plant can also reduce swelling and promote blood circulation. As a prescription medicine, Qi Ye Lian is used for treating diseases and other conditions, such as injuries from falls, fractures, contusions, strains, and rheumatoid arthritis. Before developing the prescription, to screen and confirm the original plant that should be used as “Qi Ye Lian” in the prescription, we tracked and investigated the specific original plant and medications conventionally used by different ethnic groups in Yunnan. Original plant specimens and corresponding medicinal materials were collected. After classification and identification, results showed that the original Qi Ye Lian plant used in Yi folk medicine in Yunnan is
S. elliptica, which is called “Wo Mi Pa” and “Gui Shou” by the Yi people in Yunnan; “Mei Jia Duo”, “Ya Que Mu”, and “Mai Ji Tun” by the Zhuang people; “Song Wen Yang”, “Ke Qi Duo”, and “Ke Bei Jie” by the Yao people; “Mu Ke Mai” by the Dai people, “Kao Ga Ga” by the Wa people, “La Ga” by the Lahu people, and “A Niu Niu Xiu” by the Hani people [
12]. The original plant is confirmed to ensure that the raw materials of related preparations and products at the developmental stage and subsequent stages can be provided in a consistent and stable form. Thus, performing in-depth studies on the specific distribution condition, ecological conditions, and reserves of the resources to provide bases for studies on the quality of medicinal materials, reasonable harvest and utilization, suitability analysis of medicinal material production, and screening of the optimal production areas is then possible.
Investigation of medicinal plant resources
Investigative methods include interview investigations, field investigations (spot investigations and detailed investigations), route investigations, and sampling investigations. During practical operations, the selection and application of the investigative method is flexibly handled based on actual conditions to comprehensively integrate all types of data to acquire all possible objective and comprehensive information [
13–
15]. Among the various methods, the interview investigations are conducted during the entire period of the investigative work. In addition, investigation forums and individual interviews about the investigation of medication experiences can be performed in an immersive fashion. Per the interview investigations and references in the relevant graphic data, spot investigations can be performed initially to understand the general regularity of the data, including the type and distribution of the medicinal plant resources in the investigation area. Based on spot investigations, detailed investigations on the type and reserve of sources are implemented in the investigation and sample areas. Per the results of the interviews and spot investigations, combined with the relevant information, an investigation route penetrating all types of terrain and vegetation in a perpendicular direction should be selected to perform route investigations. The actual conditions of the spot investigations and detailed investigations are fully analyzed and referenced. Furthermore, the principle of using similar habitats, communities, and species is used to establish sample plots on the investigation route to perform sampling investigations.
Investigation of medicinal animal resources
The investigation of medicinal animal resources primarily includes the distribution, species, and population quantity of the medicinal animal. A distribution investigation is primarily performed using interview investigations and data analysis. For the investigations of species and quantities, different species and different investigation periods and seasons should be combined with the local phenology and living habits of animal to confirm the optimum investigative periods and seasons. The statistical methods of investigation generally include the tramp count, dunghill count, quadrat count, and mark-recapture method [
15,
16].
Investigation of medicinal mineral resources
An estimation of the reserve is performed through literature studies, interview investigations, and field investigations, combined with the medicinal features of mineral medicines, the relevant information compiled by regional mineral bureaus [
17], and all ethnic medicine conditions.
Using the ethnic medicinal plant and animal resources as examples, the types, methods, purposes, and contents of the investigations are shown in Fig. 2.
In addition, ethnic minorities in China live in vast territories with complex conditions. Therefore, the resource investigation task is very difficult. To meet the demands of the investigation and management, modern information technology can be actively explored and combined with studies based on traditional investigative methods. For example, the 3S technologies, which use a geographic information system, global positioning system, and remote sensing as the core, have more extensive applications [
18], providing improved technical support for investigations on ethnomedicine resources.
Study on the identification of ethnomedicines
Identification of the origin of ethnic medicinal plants (animals)
Ethnic medicine primarily uses local raw materials. Given that ethnic groups live in vast territories, their production and living environments are not exactly the same. Moreover, various types of medicines and many different local terms and usage habits are available. Therefore, some ethnomedicines may have numerous translation terms. In addition, similar products and substitutes are constantly emerging, and the appearances of medicinal materials are similar. Thus, the homonym and synonym phenomena are universal. For homonyms, a medical material called “Sun Di” includes the dried whole plant or flowers of the Saxifragaceae plant
Saxifraga tangutica Engler and dried whole plants or flowers of the
Swertia of Gentianaceae, including
Swertia mussotii Franchet,
S. punicea,
S. franchetiana,
S. tetraptera,
S. wolfgangiana, and
S. bifolia [
19–
21]. For synonyms, Entada is the dried mature seed of
Entada phaseoloides (Linnaeus) Merrill in the
Entada genus of order Fabales. The other names of the plant include “La He” by the Achang people, “Ma Ke Ba” by the Blang people, “Ma Wa” and “He Ma Ba” by the Dai (West Dai) people, “Jian Lin Liang” by the Dai (Der Dai) people, “Hei Lin Niang” by the Deang people, “A Bei Ma” and “Ha Ba Ku Zha” by the Hani people, “Sha Mian” and “Ge Chang” by the Jingpo people, “Po Nen Pa Mao” by the Jino people, “Ka Na Pei” by the Lahu people, “A Ji Dai” by the Lisu people, “E Li Gen Shao Sha” by the Mongol people, “Qing Ba Xiao Xia” by the Tibetan people, “Da La He” by the Wa people; “Niu Gu Feng” “Lian Dao Feng”, “Niu Pei Mei”, and “Mo Bi Dong” by the Yao people, “Xin Nuo Jian Ma” by the Yi people, and “Kou Mie” and “Kou Lin” by the Zhuang people [
22–
24]. The different translation terms for some ethnomedicines result in the increased number of synonyms. For example, the conventional drug
Cynanchum otophyllum C. K. Schneider (Asclepiadaceae), which is used by the Bai people, has been translated into various Chinese terms, such as “Dou Bang You”, “Gai Zi Gai Mu Ba”, “Ge Xu Mian Zou”, “Xi Hu Sheng”, and “Yang Ba Mi” [
12,
25].
Ethnomedicines with different origins have different chemical compositions, biological activities, and toxicities that affect the scientificity of chemical and efficacy studies, the accuracy of the production of preparations, clinical efficacy, and drug safety [
19,
26]. Therefore, the principles and methods of plant and animal taxonomy [
27,
28] are used to perform scientific classification, identification, and nomenclature to improve the accuracy of the medicinal origin and to ensure drug efficacy and safety.
Identification of crude drugs from ethnic medicinal plants (animals)
The identification of crude drugs is performed per the technical regulations in
the Pharmacopoeia of the People’s Republic of China,
the drug standard of the Ministry of Public Health of the People’s Republic of China, and the drug standards of provinces, autonomous regions, and municipalities, referencing the relevant information or monographs to examine the authenticity, purity, and excellent quality of crude drugs. The primary content is aimed at studying the origins, traits, microscopic characteristics, and physical and chemical properties to provide basis for ensuring the sources of crude drugs, evaluating their quality, and establishing quality standards [
26].
Identification of mineral medicine
The identification of mineral medicine uses relevant knowledge from mineralogy and crystallography and relies on routine testing methods (e.g., observation, touch, tasting, smelling, burning, squeezing, stretching, and carving) and modern instrumental analytical methods (e.g., microscopy, thermoanalysis, X-ray diffraction analysis, infrared spectroscopic analysis, and atomic absorption spectrommetry) in examining and identifying physical and chemical properties [
29–
31]. This identification is performed according to
the Pharmacopoeia of the People’s Republic of China,
the drug standard of the Ministry of Public Health of the People’s Republic of China, the drug standards of provinces, autonomous regions, and municipalities, and the relevant information or monographs. The identification typically begins with appearance characteristics (the crystal properties, color, striation, transparency, odor, hardness, etc.), and then the appropriate instruments and methods are used to examine and to identify a mineral per the detection limit requirement and precision of the relevant examination. Ethnomedicine identification studies are shown in Fig.3.
Standardized studies of ethnomedicines
Selection of topics and the establishment of new drug study projects
The new drug study of ethnomedicines is a systemic project involving a long period for completion, a high level of difficulty and costs as well as multiple subjects and fields. Thus, a successful research relies on the correct topics and projects, which are then used as the starting points of the studies on new drugs.
From the perspectives of clinical demands, markets, and resources, the selection of topics about new ethnomedicinal drugs should primarily include the selection of a prescription and the confirmation of diseases or indicators. Thorough investigation and research are the keys to selecting topics for studying ethnomedicines and for implementing a research project. Fig. 4 shows that according to the differences in the involved investigative and research methods, two types are primarily involved in the selection of topics in studying ethnomedicines. One type uses literature research as basis. The method starts with clinical demands, which are combined with the dominant diseases treated by ethnomedicines, to clarify the targeted diseases or indicators. Furthermore, this type of thinking is used to perform targeted literature research, such as consulting ancient books on ethnomedicines or relevant modern medical literature, to choose candidate prescriptions. Meanwhile, the other type uses field investigations and research as bases for discovering prescriptions with excellent efficacy. Prescriptions with clinical demands and market space are used as candidate prescriptions after a comprehensive evaluation.
After the topics are selected, a preliminary screening of the medicine and a comprehensive evaluation are performed on candidate prescriptions through studies on resources, manufacturing technology, pharmacodynamics, pharmacokinetics, toxicology, and quality control. Notably, the type of thinking underlying the studies on a single drug and a compound drug should be distinguished from that underlying the selection of candidate prescriptions for preliminary studies. Generally, after a single drug enters the tracking and screening phase to target a disease or symptom, a compound screening is then performed after the active parts or ingredients are obtained. The compound can directly enter the preliminary phase of studies. After a preliminary compound screening, the basic principles of “safety, effectiveness, and quality controllability” are followed to perform a comprehensive evaluation and to obtain the candidate medicines. In addition, in combination with various factors, such as policy, laws and regulations, and economics, the feasibility and reasonability of projects are comprehensively evaluated to confirm whether a development phase can be initiated.
New drug study of ethnomedicines
Provisions for Drug Registration (which are referred to as Provisions hereafter), which can clearly categorize ethnomedicines under the scope of managing traditional China medicine and natural medicine, are implemented by the Chinese Food and Drug Administration. The applications for new ethnomedicines are conducted per the regulation required by Attachment 1: requirement for traditional Chinese medicine and natural medicine registration classification and reporting information in the Provisions. For comprehensive evaluation of the safety, efficacy, and quality controllability of drugs, candidate drugs entering the development phase should be included in in-depth, well-regulated pharmaceutical, pharmacological, toxicological, and clinical studies according to the relevant regulations in Attachment 1 of the Provisions. Among these studies, the toxicological studies should follow Good Laboratory Practice (GLP), whereas clinical studies should follow Good Clinical Practice. The specific development process for new drugs should be conducted in strict accordance with the relevant technical guidelines to ensure the scientific, normative, and systematic features of the new drug studies. The general procedure for the new drug studies is shown in Fig.5. The specific experimental design and evaluation should also include specific analyses of related issues.
To display the features of ethnomedicines and to support their development, the Supplementary Regulations on TraditionalChinese Medicine Registration and Management also specifically regulate the registration and management of ethnomedicines, such as Tibetan medicine, Uygur medicine, and Mongolian medicine, to ensure that the development of ethnomedicines will meet the requirements of the ethnomedicinal theory. Therefore, new ethnomedicine studies should pay attention to experimental studies and should not ignore the theory of ethnomedicines and specific experiences. New studies should also explore certain better animal models, experimental methods, clinical study means, and evaluation indicators that meet the requirements associated with the theory of ethnomedicines and the features of drug use. Based on respecting the use of ethnomedicines, new ethnomedicine studies should be combined with new theories and methods to perform scientific analyses and to provide a reasonable inheritance. Hence, the resulting products have rich ethnomedicine characteristics and can undergo innovation and improvement.
Secondary development of ethnomedicines
“Secondary development of ethnomedicines” refers to the process of using modern theory and technology in performing in-depth research and discussing how to target problems or influence factors affecting drug quality and clinical application of ethnomedicine-derived drugs on the market. The development of ethnomedicines is lagging, and the investment in basic research and the concept of using new technologies and means is inadequate. Therefore, although some of the products on the market have excellent clinical efficacy and application bases, some issues, including indefinite clinical localization, unidentified effective components, vague action mechanisms, low levels of quality control, and unstable product quality, still remain. Thus, increasing ethnomedicine safety, effectiveness, and quality controllability to adapt to the needs related to providing timely development is urgently needed. The application of modern technological theory and methods in engaging in the secondary development of ethnomedicines not only increases the quality of products on the market but also provides the necessary means for protecting the intellectual property of ethnomedicines. Maintaining the features of ethnomedicines and promoting further innovation of ethnomedicines is also important. The “compound Danshen dripping pills” entered the market successfully after secondary development based on the traditional Chinese medicine, “compound Danshen tablet.” This introduction provided a reference and an example of secondary ethnomedicine development.
The secondary development of ethnomedicines, as shown in Fig. 6, should adhere to ethnomedicinal theories or ethnomedicine use experiences as guidelines. Such development should also focus on clinical demands to select types of ethnomedicines that have been clinically validated and have clear efficacy and extensive market basis and market prospect as the object of development. Upon clearly defining clinical application goals and targeting bottleneck issues restricting ethnomedicinal product development, modern technical theories and methods should be applied to further research on the sustainable development of resources. In addition, research on the therapeutic material basis and safety evaluation should be performed to elucidate the efficacy and safety of drugs, to increase the quality of the pharmaceutical manufacturing process for ethnomedicines and the technical levels of quality control during the pharmaceutical process, and to ensure the stability and controllability of ethnomedicine quality.
The secondary development of ethnomedicines should use the “supplementation of the deficiency, enhancement of the advantage, and making up of the shortage” as its guiding principle [
32,
33] to implement personalized research and to successfully engage in the industrial transformation of secondary development production for ethnomedicine types.
Industrialization of ethnomedicines
The core goal of the industrialization of ethnomedicines is to construct an integrated industrial chain from the implementation of ethnomedicines to the production of ethnomedicine products and the distribution of the products to consumers [
34,
35]. Furthermore, the construction of such chain includes four primary links: the ethnomedicine agriculture, the ethnomedicine industry, the ethnomedicine distribution industry, and the intellectual economic ethnomedicine industry (Fig. 7).
Ethnomedicine agriculture is the basis and upstream link to the ethnomedicine industrial chain. The core objective of ethnomedicine agriculture is to perform quality control on the entire selection process related to the base location, the breeding of excellent species, cultivation management, collection and processing, packaging, and storage and transportation. The entire process needs to meet the strict requirements of Good Agricultural Practice for constructing modern planting standards for ethnomedicinal herbs. This link aims to provide raw medicine materials, which are safe and effective and have a controllable quality and sufficient resources for industrial production, for engaging in the sustainable utilization of ethnomedicinal herbs [
36]. Ethnomedicine industry is the core and midstream link of the ethnomedicine industrial chain. This industry is responsible for the quality control of the entire process including the equipment, factory buildings and facilities, pharmaceutical water, worker’s personnel hygiene, and drug production are in strict accordance with the Good Manufacturing Practice (GMP) requirement and relevant national laws and regulations. In addition, ethnomedicine industry focuses on the application of new technologies and manufacturing processes [
37], which are involved in the overall increase in the levels of manufacturing equipment, production capacity, and quality control of the enterprise. Ethnomedicine distribution industry is the intermediate link that mediates production and consumption. This specific industry includes purchase and acceptance checking, storage and maintenance, outputting, sales, transportation and distribution, and after-sales service. This industry should perform comprehensive quality control on circulation enterprises while strictly following the Good Supplying Practice guidelines. With the further development of electronic pharmaceutical commerce, logistics distribution, and other modern marketing methods, ethnomedicine circulation can become highly efficient at low cost and with high benefits [
38]. Thus, ethnomedicine enterprises should greatly increase the awareness of intellectual property protection. From the perspectives of scientific research, business, and development strategy, these enterprises should combine and use protection methods, such as geographical markers, new plant species, patents, and trademarks, on their ethnomedicines to improve the intellectual property protection of ethnomedicines and to strengthen the core competitive strength of the ethnomedicine enterprises [
39].
All the links in the ethnomedicine industrial chain can communicate with and influence one another, with the former sequentially providing material bases for the downstream links and the latter providing the necessary services and guidance for the upstream links. Therefore, the interlinkages among all the links in the industrial ethnomedicine chain should be systematically strengthened to maximize the function of all industrial divisions to increase the comprehensive benefits of the ethnomedicine industry.
Discussion of the internationalization of ethnomedicines
Ethnomedicines have very practical characteristics, and their safety and effectiveness have been repeatedly validated through “clinical trials in the human body.” However, to achieve internationalization, pre-clinical and clinical trials should be systemically implemented per the laws, regulations, and guidelines of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, the Food and Drug Administration (FDA), and the European Medicines Agency (EMA) to confirm the safety, to clarify efficacy, and to maintain the consistency of chemical components among batches. Thus, ethnomedicines can eventually be sold as a drug on the market of the applying country, especially in the form of a prescription drug.
The primary route for internationalizing ethnomedicines is by registering them as herbal/traditional medicines in the United States of America (USA), European Union (EU), or Southeast Asia. In the USA, the FDA has established the Botanical Review Team, which is responsible for coordinating the review and approval of the herbal medicine. FDA has also issued the
Botanical Drug Product Guidance (2004) to guide product applications. To date, the FDA has approved two herbal medicines, namely, Veregen
® (2006), which is used for treating external genital and perianal warts, and Fulyzaq
® (2012), which is specific for treating HIV-associated diarrhea. In the EU, the EMA has established the Committee on Herbal Medicinal Products to assist each country in reviewing and approving herbal medicinal products. The committee has issued the
Traditional Herbal Medicinal Products Directive (2004/24/EC) to allow herbal medicines on the market through registration and enrollment methods. Typical representatives of herbal medicine on the market in this region are
Ginkgo biloba leaf extract EGb761 and its preparations as well as Sinupret from the extracts of five plants [gentian (
Gentiana lutea, Gentianaceae) root, primrose (
Primula veris, Primulaceae) flowers with calyx, elder (
Sambucus nigra, Caprifoliaceae) flowers, common sorrel (
Rumex acetosa, Polygonaceae) herb, and European vervain (
Verbena officinalis, Verbenaceae) herb] that are used for treating acute/chronic sinusitis. In Southeast Asia, the drug administration agency in Vietnam has the highest recognition of Chinese-marketed drugs. In addition, given that both countries have similar traditional medicine environments, Vietnam can be used as a trial for the internationalization of ethnomedicines. Currently, the representatives of Chinese medicinal products are attempting internationalization include compound Danshen dripping pills (which are available in Canada and in phase III clinical trials in the USA), Di’ao Xin Xue Kang (on the market in the Netherlands), Xuezhikang capsules (available in the Netherlands and in phase II clinical trials in the USA), Guizhi fuling capsules (in phase II clinical trials in the USA), Fuzheng-Huayu tablets (in phase II clinical trials in the USA), and Kanglaite injections (in phase III clinical trials in the USA). Moreover, some products, such as Shensong Yangxin capsule [
40] and Tongshu capsule, are also aiming for internationalization. The thinking involved in their development can serve as a reference for the internationalization of other ethnomedicines.
The major tasks necessary for the internationalization of ethnomedicines include the selection of topics for investigation and research; Chemistry, Manufacturing and Control (CMC) research; non-clinical, clinical, and post-marketing studies, and the registration and application work that covers the entire process. Using the application for FDA approval as an example, the technical process is shown in Fig.8. Among these tasks, the selection of indicators should consider whether competing products on the market of relevant countries are present, and whether implementing clinical trials and efficacy evaluation is conducive. In addition, the selection of ethnomedicines with a simple prescription and manufacturing process for internationalization can significantly reduce the difficulty of the CMC study.
Establishment of a research platform and the cultivation of ethnomedicine talent teams
The research platform provides the basis for studying and developing ethnomedicines. The establishment of a research platform for ethnomedicines aims to develop technical, scientific, standardized, and systematic procedures to form a research and development chain, which is fit for ethnomedicines, and to construct a research and development platform supported by scientific connotation and modern technology to ensure the more stable development of ethnomedicines. The platforms of ethnomedicines include resource, planting, chemistry, preparation, pharmacology, drug safety evaluation, clinical research platforms, registration management platforms, and an intellectual property management platform. Together, these platforms compose the whole process of new drug research and development. Remarkably, during the implementation process of the new drug research and development project, a special department named as the “department of project management” should be involved to coordinate the efforts from each platform. The construction of each type of research platform includes the laboratory set-up, the installation of related instruments and equipment, and the study and formulation of standard operating procedures, and so on, as covered in all the aspects of the sites, equipment, and technology. The construction of the platform should focus on investments in hardware and the reasonable allocation of resources. The operational process of the platform should focus on the standardized management and the production of results, encourage public services, and emphasize the summarization of experiences and key technologies. Improvement in the construction of platforms should be continuously promoted to provide modern and diversified services for the development of ethnomedicine research.
Human resources are the core of scientific innovation. Therefore, team development is also an important condition for the development of ethnomedicine research. The cultivation of talent teams for ethnomedicines should be performed with the following three objectives: building an excellent environment, which is open, autonomous, and competitive for attracting talents; focusing on talent discovery, talent cultivation, and talent agglomeration during practice; and fully increasing the motivation of sci-tech personnel and the scientific and reasonable use of personnel to promote the innovative development of ethnomedicines. The construction of the research platform and the cultivation of teams are shown in Fig.9.
Higher Education Press and Springer-Verlag Berlin Heidelberg
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