Quality process control system of Chinese medicine preparation based on "holistic view" / 中国中药杂志
China Journal of Chinese Materia Medica
;
(24): 197-203, 2018.
Artigo
em Chinês
| WPRIM
| ID: wpr-776403
ABSTRACT
"High quality, safety and effectiveness" are the primary principles for the pharmaceutical research and development process in China. The quality of products relies not only on the inspection method, but also on the design and development, process control and standardized management. The quality depends on the process control level. In this paper, the history and current development of quality control of traditional Chinese medicine (TCM) preparations are reviewed systematically. Based on the development model of international drug quality control and the misunderstanding of quality control of TCM preparations, the reasons for impacting the homogeneity of TCM preparations are analyzed and summarized. According to TCM characteristics, efforts were made to control the diversity of TCM, make "unstable" TCM into "stable" Chinese patent medicines, put forward the concepts of "holistic view" and "QbD (quality by design)", so as to create the "holistic, modular, data, standardized" model as the core of TCM preparation quality process control model. Scientific studies shall conform to the actual production of TCM preparations, and be conducive to supporting advanced equipment and technology upgrade, thoroughly applying the scientific research achievements in Chinese patent medicines, and promoting the cluster application and transformation application of TCM pharmaceutical technology, so as to improve the quality and effectiveness of the TCM industry and realize the green development.
Texto completo:
DisponíveL
Índice:
WPRIM (Pacífico Ocidental)
Assunto principal:
Controle de Qualidade
/
Padrões de Referência
/
Medicamentos de Ervas Chinesas
/
China
/
Tecnologia Farmacêutica
/
Medicina Tradicional Chinesa
Tipo de estudo:
Estudo diagnóstico
/
Estudo prognóstico
País/Região como assunto:
Ásia
Idioma:
Chinês
Revista:
China Journal of Chinese Materia Medica
Ano de publicação:
2018
Tipo de documento:
Artigo
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