The adverse reactions caused by traditional Chinese medicine have occurred frequently, but there is a lack of scientific,objective and standardized methods for safety evaluation of traditional Chinese medicine.In the process of preclinical evaluation of traditional Chinese medicine, it is imperative to form a set of scientific, standardized and feasible evaluation system of modem Chinese herbal drug.We established the preclinical safety evaluation system of modem Chinese herbal drug including the quality control system of samples for the preclinical safety evaluation, the toxicity evaluation system of modem Chinese herbal drug and its preparation and the evaluation management system, and standardized each research link of preclinical evaluation of traditional Chinese medicine.Whether from protecting patients' health and increasing the safety of clinical medication, or from enriching and improving traditional Chinese medicine science, developing traditional Chinese medicine and promoting mutual connection of traditional Chinese medicine and international medicine, it has important instructional significance and application value.

Objective To investigate the correlation of miR-181a and miR-181b with fucosyltransferase FUT1, the functional mechanism was elucidated in a colorectal cancer ( CRC).Methods It collected 32 pairs of tissue samples , 18 males and 14 females in the first affiliated hospital of Dalian Medicinal University, from March 2014 to January 2016.The expression of miR-181a and miR-181b was detected by RT-PCR in CRC tissues , adjacent tissues , serum of colorectal cancer patients and healthy people, and CRC cell lines SW620 and SW480 with differently metastatic ability.The relationship of FUT1 and miR-181a, miR-181b expression were verificated by Pearson's correlation curve.FUT1 was identified the target of miR-181a and miR-181b by Network prediction softwares ( TargetScan Human 7.1, microRNA.org and Starbase v2.0) and luciferase assay.The effects of miR-181a and miR-181b expression on the proliferation, migration, invasion and angiogenesis of SW 480 and SW620 cells were further detected by CCK8, wound healing, transwell and tube foramtion assays.T-test was used for comparison between two independent samples , and one-way anova was used for comparison between multiple samples . Pearson correlation coefficient was used for correlation analysis .Results The levels of miR-181a and 181b in CRC tissues were much lower than in tumor-adjacent tissues (3.12 ±1.88 vs 6.44 ±2.32, t=11.74;3.16 ± 1.77 vs 5.52 ±2.45, t=3.24 ;P<0.05).The levels of miR-181a and 181b in serum of colorectal cancer patients were much lower than in healthy people (1.32 ±0.25,2.57 ±0.48,t=10.26;0.91 ±0.14,1.63 ± 0.29,t=5.19;P<0.05 ) .The levels of miR-181a and miR-181b in SW620, SW480 CRC cells were detected to be much lower than in normal colorectal epithelial cells [(0.65 ±0.10, 0.50 ±0.09) vs 1.0;(0.60 ±0.12,0.42 ±0.03)vs 1.0;t=3.08, P<0.05].FUT1 was highly expressed in CRC tissues and SW620 (t=5.23, P<0.05).Based on the network prediction softwares and luciferase assays , FUT1 was the common target of miR-181a and miR-181b.Over expression of miR-181a or miR-181b inhibited FUT1 level and attenuated the capacity of cell migration , invasion and proliferation in SW 620.Down-regulation of miRNAs in SW480 increased FUT1 expression and promoted the capability of cell migration , invasion and proliferation.Downregulation of the two miRNAs attenuated the capability of cell invasion in SW 480, which was blocked by the reductive FUT1.Conclusion MiR-181a and miR-181b mediated the progression of CRC cells by targeting FUT1.

Under the background of scientific and technological innovation in the new era, ethical review of traditional Chinese medicine (TCM) is facing new opportunities and challenges. Focusing on how to maintain integrity and innovation in the ethical review work of TCM clinical research in TCM medical institutions, starting from the characteristics of innovation and inheritance of TCM clinical research, this paper discussed the construction of the ethical review system of TCM clinical research, key elements of attention, shortcomings and deficiencies, training and communication, etc. It is also proposed that the joint construction of a Chinese characteristic scientific and technological ethics governance system should consider the unique requirements of modern technological means for the ethical review of scientific and technological projects such as dialectical treatment, re-evaluation of prescription projects, and expansion of indications in clinical research of TCM; innovate the form of review and strengthen the process management of ethical review; scientifically, objectively and impartially evaluate the scientific nature and social value of clinical research projects in TCM; pay attention to the toxic side effects of TCM, especially compound preparations. So as to further improve the procedural norms and quality of ethical review of clinical research of TCM, protect the legitimate rights and interests and safety of subjects, and promote the development of medicine in China.