As aging and chronic diseases gradually increase, attention is being focused on the safety of medicines according to prevention and regular dose, that is, Botanic drugs with low side effects.
In South Korea, research and standardization studies are being conducted on the new efficacy of medicinal plants widely distributed in nationwide due to climate change in the four seasons and mountainous areas.
Medicinal plants have been taken for a long time as traditional herbal medicine domestically and internationally, so there is a great advantage of low concerns about safety.
Until now, Botanic drugs have not achieved much results due to the limitations of medicinal plants which become Active Pharmaceutical Ingredient (API).
The limitations is that it is difficult to secure the homogeneity and stability of active ingredients that can produce the efficacy of medicinal plants.
In short, Quality Assurance (QA) was difficult with API.
The reason is that metabolites produced in the body according to changes in the external environment due to the nature of plants, that is, the type and amount of active ingredients, continue to change due to the natural environment that changes every year.
In order to produce medicinal plants with homogeneity and stability that should be possessed as API for botanic drugs, the cultivated environment must be managed in the same way continuously.
It is only possible to grow plants in the same cultivation environment every year in confined smart farm (plant factory) that can precisely control all cultivation environments.
The fundamental characteristics of an confined smart farm that can manage all the cultivation environmental factors necessary for plant cultivation can achieve the homogeneity and stability of medicinal plants that should be used as API for botanic drugs.
In addition to pharmacokinetics, safety evaluation technology, formulation and production technology which necesseaily used in drug development process till now, Modern botanic drugs additionally require API cultivation technology, production technology, and drug evaluation technology for multiple components.
What's important here is API cultivation technology.
Other technologies are those that have been used by pharmaceutical companies to develop medicines, but API cultivation technology is a technology that grows medicinal plants with homogeneity and stability in the characteristics and functional ingredients of the target botanic drugs. The smart farm's characteristic of precise environmental control is most suitable for making, applying, and growing this API technology.
Only confined smart farms can be possible for research that maximizes the medicinal ingredients necessary for the development of botanic drugs and studies that can produce maximized ingredients uniformly and repeatedly.
The purpose of this study is confirming that API can be produced in a closed smart farm by growing ginseng, satis indigotica fort, and kale using a confined smart farm and verifying the characteristics of botanic drugs as API, and developing API cultivation technology necessary for the botanic drug development process.
It also aims to maximise the medicinal ingredients required for the development of botanic drugs by applying metabolic agriultural technology and to confirm the possibility of uniformly repeated production of the maximized medicinal ingredients.
As a result of checking the characteristics of the API of ginsenoside by growing ginseng in an confined smart farm, homogeneity and stability could be confirmed through repeated production.
As a result of checking the change of Ginsenoside API characteristics through PH and growth temperature environment control using metabolic agricultural technology, it was found that the PPD/PPT ratio of Ginsenoside was higher in alkali according to PH than growth temperature in comparison between roots, and it was found that the ratio is affected by PH rather than temperature.
As a result of confirming the characteristics of isatis indigotica fort Indirubin API by growing isatis indigotica fort in an confined smart farm, homogeneity and stability could be confirmed through repeated production.
Through hydroponic cultivation with moisture control by using metabolic agricultural technology, it was found that the indirubin content was more than four times higher than that of isatis indigotica fort grown on the field, and the indirubin content was more than 1.5 times higher than that of isatis indigotica fort grown through freshwater.
As a result of checking the characteristics of the API of kale sulforaphane by growing kale in a confined smart farm, homogeneity and stability were confirmed through repeated production.
By eliminating MeJA, Geraniol or treating moisture stress through metabolic agricultural technology, the content of sulforaphane, a medicinal ingredient of kale, was increased.
In particular, it was confirmed that the effect of increasing more than four times by eliminating Geraniol and treating moisture stress.
As a result of verifying the API characteristics of botanical drugs by growing ginseng, isatis indigotica fort, and kale using confined smart farms, it was confirmed that API which can guarantee homogeneity and stability can be produced in confined smart farms.
In addition, by using data of confined smart farm, it was possible to develop API cultivation technology that can be a consistent validation platform with API quality assurance.
Furthermore, by applying metabolic agricultural technology, it was possible to develop a technology that can maximize the active ingredients required for the development of botanical drugs and can uniformly produce these maximized active ingredients.
The present study adopted an Aerobic method among confined smart farms.
In this study, in order to develop a plant-based API required for Botanic drugs, it is required that a efficacy evaluation technology for multiple ingredients contained in plants, but only contents in single component was evaluated for each plant.
There is a limitation in that efficacy evaluation is not performed because other plants except isatidis folium are not included in the API development procedure of Botanic drugs.
Before clinical trial of Botanic drugs, there is a need for additional verification studies on mass production for industrialization of plant-based API and whether stable production is possible in different regions.