Abstract:
Large variety of traditional Chinese medicine (TCM) refers to the traditional Chinese medicines that have achieved large-scale production and undergone long-term clinical trials, proving to have ideal clinical value and market prospects. However, these medicines are limited by the technological capabilities at the time registration, always leading to the possible problems such as insufficient research into raw materials, unclear clinical mechanisms, backward manufacturing techniques and relatively low quality standards. Consequently, a more extensive and systematic research effort is needed, as well as a comprehensive improvement of the raw materials, manufacturing processes, and quality standards, in order to raise the quality of products and provide better service to the public. The research mentioned above is known as the secondary development of large variety of TCM, which specifically includes the following four parts of contents.
The initial research that should be conducted is the material basis research on the TCM, and subsequently identifying its Q-markers based on the findings. Specifically, the material basis of raw materials, extract intermediates, and final preparations are explored based on a combination of plant chemistry and modern analytical techniques to fully clarify their composition, and combining pharmacology, toxicology, pharmacokinetics, and other methods to determine Q-markers. Meanwhile, researches on safety indicators such as heavy metals, pesticide residues, and fungal toxins in medicines are carried out to lay the foundation for the studies of the raw materials, production processes and products quality.
The second part of content is focused on the mechanism of clinical action of the TCM, which can provide a more scientific evaluation of its clinical therapeutic prospects. Through modern pharmacological research, the active ingredients and their related mechanisms of action are identified, and suitable animal models are constructed to conduct pharmacological studies. Subsequently, conducting evidence-based medicine research to obtain richer clinical data, and integrating traditional Chinese medicine theory with modern medical concepts from the chemical and biological levels in an organic manner, in order to achieve individualized treatment based on syndrome differentiation.
The third part of the research is to establish a comprehensive quality control system that involves the raw materials, preparation processes and final products. This system is designed to comprehensively improve the quality standards and level of quality control in the large varieties of TCM. Traditionally, the quality control of TCM often involves post-production testing of the final product, as known as quality by test (QbT), which ignores the fundamental reasons for the formation of TCM quality. Under the modern pharmaceutical manufacturing concepts, such as “quality formed in production” and “quality by design (QbD)”, it is crucial to establish a comprehensive quality control system that can be applied to the large varieties of TCM. This system should include an online monitoring system to visualize the entire production process of the medicine, thereby improving its controllability and quality.
The last part of content involves the continuous optimization of the existing pharmaceutical processes, pharmaceutical machines, dosage forms, and clinical administration routes. However, due to the limited technological capabilities during the research and registration of the large varieties of TCM, there is still considerable room for improvement in these areas. With the continuous advancement of science and technology, various efficient separation and purification technologies have emerged, represented by column chromatography, membrane separation, and supercritical fluid extraction. Similarly, modern pharmaceutical production technologies, including hot melt extrusion, fluidized bed, 3D printing, continuous manufacturing, and intelligent production, have also emerged. Moreover, novel high-end formulations, such as those with controlled release and targeting, and new administration routes, such as transdermal, inhalation, and microneedles, have provided ample technological options for the secondary development of large varieties of TCM. In summary, it is important to be bold in exploring and daring to try to apply these emerging techniques to the production process of TCM varieties.
Since the founding of the People's Republic of China, the government has prioritized the advancement of TCM by improving the quality and quantity of traditional Chinese patent medicines. During this process, a series of large varieties of TCM with significant therapeutic effects for specific diseases have been developed. Conducting research on the secondary development of large varieties of TCM in this background can expedite the standardization, modernization, and internationalization process of TCM, and better benefit the health of all mankind.
