ABSTRACT
The development and application of processing technology is closely related to the quality of Chinese medicine. Currently， Chinese medicine processing is still in the mechanization stage with limited processing equipment， low levels of automation and intelligence. As a result， the imprecise control of parameters during processing leads to unstable quality of Chinese herbal pieces. However， with the arrival of the big data era and the continuous development of "Internet+"， Chinese medicine processing technology and equipment have been continuously improved and updated， and gradually shifted to the development direction of automation and intelligence. The linkage production technology of Chinese herbal pieces optimizes the separate processing equipment coupling into the production line for continuous manufacture of Chinese herbal pieces， intending to improve production efficiency. The large-scale industrialized production of Chinese herbal pieces tends towards digital technology of processing experience and online inspection technology based on machine vision， electronic nose， and electronic tongue. These technologies are crucial prerequisites for standardizing the parameters of Chinese medicine processing. And further by docking the processing process and equipment with the internet， realizing the intelligent control of the production process is an important process for the transformation and upgrading of Chinese herbal piece industry in the future. In this paper， we summarized the development characteristics of different stages of Chinese medicine processing technology， combed application and development of processing theory， the evolution of processing equipment， and problems in the current industrial development stage of Chinese medicine processing， in order to provide ideas and methods for achieving digital and intelligent innovation of processing technology as well as high-efficient and high-quality production of Chinese herbal pieces.
ABSTRACT
Against the backdrop of "Internet+" and Made in China 2025, Chinese medicinal processing equipment embraces various opportunities and develops to an unprecedented level. In the 20 years of the new century, the processing equipment has gradually developed in the direction of high efficiency, energy saving, environmental protection, integration, and automation, and this field has tended to highlight the establishment and application of the linkage production line for the processing of Chinese medicinal decoction pieces. Integrating automation control technology, online detection technique, and the internet of things technology, the online detection system of Chinese medicinal processing equipment and the computer information management system of Chinese medicinal proces-sing are the mainstream development trends of Chinese medicinal processing equipment. Standard Chinese medicine processing equipment is the prerequisite for the standardization of processing parameters. A standard system for processing equipment and processing parameters is the key to the modernization of Chinese medicinal decoction pieces. This paper summarized the research and application of Chinese medicinal processing equipment in the 20 years of the 21 st century and predicted the development trend, which is expected to serve as a reference for the technological innovation and development of the processing equipment.
Subject(s)
Automation , Drugs, Chinese Herbal , Medicine, Chinese Traditional , Quality Control , Reference StandardsABSTRACT
OBJECTIVE: The manufacturing site of drugs is a combination of a series of production factors to meet the requirements of drugs production, which is not only the material basis of drugs production, but also the evaluation basis for the review when applying for registration. The purpose of this paper is to preliminarily discuss the definition and extension of production lines for chemical drugs in China, and provide some references for standardizing new drug application. METHODS: The historical requirements for manufacturing site information in application materials of chemical drugs in China were briefly introduced, with daily pharmaceutical evaluation works and specific cases study. RESULTS: AND CONCLUSION: It should make clear the definition and extension of production lines in the application materials, strengthen the effective communication between different regulatory authorities, update the relevant information in time, and should pay continuing attention to the revision progress of the laws and regulations requirements on the production line in China.
ABSTRACT
This paper illustrates the company's cleaning validation of many varieties of Chinese materia medica (CMM) preparation manufatured in the same production line by real case from four aspects such as selection of target product, confirmation of marker, validation of acceptance criteria, and analytical methods. It is a scientific, rational, and economic validation strategy to use CMM preparation extract or the whole extract powder as marker components for validation and determination of the marker components using UV-full wavelength scan method.