RESUMEN
Traditional Chinese medicine (TCM) decoction pieces refer to prescription drugs that can be used in clinical or preparation production after processing medicinal herbs. TCM decoction pieces industries are inherited from the culture of TCM and are important because of their independent intellectual property rights. The Chinese Pharmacopoeia (Ch. P) 2010 edition stipulated that "All drugs taken are decoction pieces", which raised the drug status to statutory law for the first time and clearly specified that TCM decoction pieces should be applied to TCM prescription deployment and production of proprietary Chinese medicines. It also pointed out that "The specifications of the decoction pieces used in the preparation should comply with the requirements of the actual process of the corresponding formulation type". For a long time, both the processing methods and the specification grades of the clinically used pieces of Chinese medicine were based on the inheritance and supported by the classical theory and method system centered on TCM processing. However, the theoretical research and specification standards of the decoction pieces used in the production of proprietary Chinese medicines based on modern industry are scarce, and this has led to a series of problems related to the industry, making the processing of decoction pieces becoming a limiting factor in the promotion of the Chinese medicine industry. Aiming at the existing problems of the TCM decoction pieces industry, this article was guided by the standardization system of TCM based on the concept of whole-process quality control, combined with the reference to the Japanese Kampo medicine industry's feeding mode and the reflection on the combination of traditional Chinese medicine processing and modern industry, as well as the study of the core law of the whole-process of TCM production, etc. Industrial decoction pieces and the idea of building a standardized system of TCM industry decoction pieces based on the whole-process quality control were discussed in this paper, which can provide insights for exploring the effective fusion between TCM processing theory and classic heritage and modern manufacturing and can provide the basis for the establishment of a standardized system for industrial decoction pieces based on whole-process quality control of TCM. It can also offer reference for the development of the advantages of geo-authentic crude drug and the establishment of high spots of industry decoction pieces.
RESUMEN
The concept of "Quality by design" indicates that good design for the whole life cycle of pharmaceutical production enables the drug to meet the expected quality requirements. Aiming at the existing problems of the traditional Chinese medicine (TCM) industry, the TCM standardization system was put forward in this paper from the national strategic level, under the guidance by the idea of quality control in international manufacturing industry and with considerations of TCM industry's own characteristics and development status. The connotation of this strategy was to establish five interrelated systems: multi-indicators system based on tri-indicators system, quality standard and specification system of TCM herbal materials and decoction pieces, quality traceability system, data monitoring system based on whole-process quality control, and whole-process quality management system of TCM, and achieve the whole process systematic and scientific study in TCM industry through "top-level design-implement in steps-system integration" workflow. This article analyzed the correlation between the quality standards of all links, established standard operating procedures of each link and whole process, and constructed a high standard overall quality management system for TCM industry chains, in order to provide a demonstration for the establishment of TCM whole-process quality control system and provide systematic reference and basis for standardization strategy in TCM industry.