ABSTRACT
OBJECTIVE To compare and study the supporting policies for the filing man agement system of traditional Chinese medicine preparation prepared by traditional technology （hereinafter referred to as “TCM preparation ”）in medical institutions issued by the state and various provinces ，and their development ，so as to provide reference for the improvement of the follow-up supervision and management of the filing works. METHODS According to Announcement on the Filing Management of TCM Preparations Prepared by Medical Institutions Using Traditional Processes issued by former National Food and Drug Administration （hereinafter referred to as the Announcement）as well as notices and specific implementation rules issued by provincial bureaus ，the filing work data of 10 provinces in recent 3 years were selected for comparison ，sorting，statistics，classification and induction. The policy characteristics and progress of filing work were studied. RESULTS & CONCLUSIONS According to the local actual situation，some provinces had refined or expanded the contents of several parts of the Announcement，such as the scope of TCM preparations，the situation not allowed to record ，the filing process and working time requirements ，the disclosure ，change and cancellation of filing information ，and the implementation of supervision and management. The statistical results of filing data in 10 provinces showed that compared with 2019，the number of TCM preparation declared for filing and medical institutions declared for filing had increased with growth rate of 91.0％ and 48.8％ respectively in 2020. There is still room for improvement in the supporting policies for the filing of TCM preparations ，which can be optimized by referring to the features of some provinces ’ implementation policies ，refining the construction of norms and standards ，and strengthening the construction of regulatory system platform. It is necessary to optimize policy and strengthen the capacity building of reporting institutions in advance ；carry out daily supervision and control risk based on risk during the filing management ；emphasize follow-up supervision ，strengthen the construction of ADR monitoring system in medical institutions ，and carry out life cycle supervision and management constructively afterwards，in order to promote the further development of TCM preparations in medical institutions.
ABSTRACT
In our country, the technology of extraction and separation of traditional Chinese medicine is backward relatively. The production process is extensive and the equipment level is low relatively. The manufacturing process is mainly based on unit operation and manual operation. The automatic control of the whole process has not been realized, which has seriously restricted the modernization of traditional Chinese medicine industry. If automatic control technology applied to traditional Chinese medicine in the extraction process, the process parameters of operation will be in the effective and strict monitoring and control, so as to improve the product quality and production efficiency, reduce costs, to achieve the green production. In this paper, the current situation and the application of new automation technology in the process of extraction traditional Chinese medicine in recent years were summarized, in order to provide a reference for Chinese medicine green and intelligent production.
ABSTRACT
Objective: To optimize a technology of integration on field processing and processing crude drugs of Polygoni Multiflori Radix (PMR) and to provide the scientific evidence for the integration of PMR. Methods: Orthogonal test was used to optimize the integration technology on primary processing and reprocessing with two major characteristic components (stilbene glucoside and combined anthraquinone). To compare the differences between the integration technology and traditional technology on pharmacological activity by models of constipation and swelling of ear in mice with Various index (small intestinal propulsion rate, first defecation time, fecal water content, swelling degree of ear, and inflammatory factors). Results: The results showed that the integration technology of 50℃, 16 h was better, and there was significant difference in chemical composition and Laxative effect between the integration technology and traditional technology. The anti-inflammatory effect of the integrated process was better than that of the traditional technology. Conclusion: The technology of integration of field processing and processing crude drugs is feasible and the operation is good.