Research progress of continuous manufacturing and process knowledge system of traditional Chinese medicine / 中国中药杂志
China Journal of Chinese Materia Medica
;
(24): 2045-2050, 2021.
Artículo
en Chino
| WPRIM
| ID: wpr-879128
ABSTRACT
In the past few years, continuous manufacturing(CM) has been put forward by the FDA. Pharmaceutical enterprises are encouraged to promote the implementation of CM, which has become a hot research direction of pharmaceutical technology. In February 2019, the FDA issued a draft guideline for the implementation of CM, which greatly promoted the development of CM and provided reference for continuous manufacturing of traditional Chinese medicine(TCM). The production process of TCM is a complex system. With the innovation of production equipment and the promotion of automation and informatization of TCM production, the exis-ting policies, regulations and traditional production control capacity are difficult to meet the market demand for high-quality TCM pro-ducts. In this paper, we reviewed the new technologies and methods of quality control in accordance with the characteristics of TCM production by referring to modern manufacturing technology, information technology and quality control technology. Based on the "QbD" theory and "PAT" technology, process knowledge system(PKS), an advanced control strategy, was proposed to provide a reference for the implementation of CM in TCM production.
Texto completo:
Disponible
Índice:
WPRIM (Pacífico Occidental)
Asunto principal:
Control de Calidad
/
Medicamentos Herbarios Chinos
/
Tecnología Farmacéutica
/
Comercio
/
Medicina Tradicional China
Tipo de estudio:
Estudio diagnóstico
Idioma:
Chino
Revista:
China Journal of Chinese Materia Medica
Año:
2021
Tipo del documento:
Artículo
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