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
Objective To investigate the effect of procyanidin on permeability of rodamin 123(R123)and fluorescein sodium (FS)via different intestinal mucosa in rat. Methods The cumulative permeability and the apparent permeability cofficient(Papp)of R123 and FS via rat intestinal membranes at the procyanidin concentration of 20 mg/L was evaluated by the method of Ussing Cham?ber. The concentrations of R123 and FS in the receptor samples were determined by fluorospectrophotometry. Results The absorptive directed permeability of R123 across all membranes was increased by co-administration of procyanidins,whereas that of the secretive direct was decreased. Compared with control group,the secretive directed permeability of R123 was significantly decreased in colon (P<0.01). Conclusion Procyanidin could inhibit the secretion of R123 on different intestinal mucosa which might be related to the inhibition of P-gp function.
ABSTRACT
Objective To investigate the effect of expression of microRNA-27a(miR-27a) and microRNA-451(miR-451) in A2780/T cells and its relativity to multidrug resistance (MDR)1 mRNA inhibition by procyanidin. Methods Stem-loop PCR method was performed to evaluate the expression of miR-27a and miR-451 in use of procyanidin (0-40μmol/L) in 0-48 h in A2780/T cells. Additionally, over-expressing or interfecting microRNAs by using mimics or inhibitor of miR-27a and miR-451, the expression of MDR1 mRNA was assessed by RT-PCR in cells exposing to procyanidin. Results The expression of miR-27a and miR-451 was significant inhibited by procyanidin in both time- and concentration-dependency. Over-expressed MDR1 mRNA associated with miR-27a or miR-451 mimics was blocked by procyanidin, whereas there was no effect on down-expressed MDR1 mRNA associated with miR-27a or miR-451 inhibitor by procyanidin. Conclusion Procyanidin inhibits MDR1 mRNA expression by inhibiting miR-27a and miR-451 expression in A2780/T cells.