Table of Content

Volume 25 Issue 10
26 October 2020

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Protective effect and mechanism of manganese superoxide dismutase mimic on ulcerative colitis induced by trinitrobenzene sulfonic acid in rats

WANG Yanhong, PU Junfeng, LI Hongling, FENG Tiexin

2020, 25(10):  1081-1087.  doi:10.12092/j.issn.1009-2501.2020.10.001

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AIM: To investigate the effects of manganese superoxide dismutase mimic (MnSODm) on 2, 4, 6-trinitrobenzene sulfonic acid (TNBS) induced ulcerative colitis (UC) in rats and to probe into its underlying mechanism. METHODS: Wistar rats were randomly divided into blank group, model group, sulfasalazine (SASP, 500 mg/kg) group, and different doses of MnSODm (10, 20 and 40 mg/kg) groups. Ulcerative colitis was induced in rats by rectal administration of 100 mg/kg TNBS dissolved in 50% ethanol. Rats were killed after SASP and different doses of MnSODm treatment 7 days. The disease activity index (DAI) was recorded, and then the colonic injury and inflammation were assessed by the colon weight/length ratio and microscopic damage scores. The serum and colon tissues activities myeloperoxidase (MPO) were detected by biochemistry method. The activities of glutathione peroxidase (GSH-Px), inducible nitric oxide synthase (iNOS), and the levels of glutathione (GSH) and NO in colon tissues were also detected. The levels of TNF-α, IL-4 and IL-10 in the colon tissues were measure by ELISA. Western blot was undertaken to determine the phosphorylation levels of AKT and PI3K. RESULTS: Compared with the model group, the colonic weight/length ratios, microscopic damage scores and colon tissues and serum MPO activity were significantly decreased in MnSODm groups (P<0.05 or P<0.01). INOS, NO, TNF-α, PI3K, p-AKT levels in colon tissues were also significantly decreased in MnSODm treatment groups; while the activity of GSH-Px and the concentration of GSH, IL-4 and IL-10 obviously increased (P<0.05, P<0.01). CONCLUSION: MnSODm is protective against colitis via antioxidant activity and by inhibiting inflammatory mediators and then down-regulating PI3K/AKT signaling pathways.

Regulatory effect and mechanism of ginsenoside Rg1 on oxidative stress and inflammation in preeclampsia rats

SONG Shanshan, YANG Yang, HE Jing, TANG Junfeng

2020, 25(10):  1088-1096.  doi:10.12092/j.issn.1009-2501.2020.10.002

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AIM: To investigate the effect and mechanism of ginsenoside Rg1 on L-NAME-induced preeclampsia in rats.  METHODS: All rats were divided into four groups: control group, model group, ginsenoside Rg1 low dose group (25 mg/kg) and high dose group (50 mg/kg). The rat model of preeclampsia was established by L-NAME induction. In the treatment group, the corresponding dose of ginsenoside Rg1 was given at the 5th day of pregnancy. On the 7th, 13th, 15th, 17th and 19th day, the systolic pressure, diastolic pressure and arterial pressure of the experimental rats in each group were examined, and 24-hour urine protein on the 20th day was measured. The experimental rats were killed on the 21st day and tissue samples were collected. The protein of GCM-1 was determined by immunohistochemistry, the activities of SOD and CAT, the levels of MDA, IL-1β, IL-6 and TNF-α in serum were determined by kit. Western blot was used to detect the expressions of Nrf2, HO-1, NF-κB, IκBα, Bcl-2, Bax, Caspase-3 and Cyt-c. RESULTS: The results showed that ginsenoside Rg1 could significantly improve the systolic pressure, diastolic pressure, arterial pressure and urinary protein (P<0.05), inhibit the expressions of GCM-1, Nrf2, HO-1, Bax, Caspase-3 and Cyt-c protein in placenta (P<0.05), increase the expressions of NF-κB, IκBα and Bcl-2 protein (P<0.05), and significantly promote the activities of SOD and CAT in serum and fetal tissue of model rats. The levels of MDA, IL-1β, IL-6 and TNF-α were inhibited (P<0.05). CONCLUSION: Rg1 can significantly improve the blood pressure and urinary protein level of pre-eclampsia pregnant rats, promote the expression of GCM-1 protein in placenta, inhibit oxidative stress injury and inflammatory response, and reduce apoptosis of placenta.

Research on the expression of miR-186-5p in serum of patients with colon cancer#br#

CHENG Jianping, LI Zhen, ZHAO Xiaolin, YANG Mengyuan, JI Xiwei, YU Jiufei

2020, 25(10):  1097-1104.  doi:10.12092/j.issn.1009-2501.2020.10.003

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AIM: To investigate the expression of miR-186-5p in colon cancer and the effect on colon cancer, and provide a new therapeutic target for the treatment and prognosis of colon cancer. METHODS: Serum from eligible patients were collected and divided into five groups (n=20) including the healthy group and clinical stages I, II, III and IV. The miRNAs in patients' serum were extracted by miRVana microRNA isolation kit. The differences of miR-186-5p expression in patients' serum of colon cancer at different stages were detected with real-time quantitative PCR. The full-length gene of miR-186-5p was cloned into pENTR/D-Topo vector to construct cell lines with high expression of miRNA. 5×103 cells were seeded in 96-well plates. The expression of mir-186-5p was decreased by using miR-186-5p inhibitor. The proliferation of cells was detected with cell proliferation ELISA kit after 24 hours of incubation with BrdU and absorbance was measured at 370 and 492 nm. The effect of miR-186-5p on the sensitivity of colon cancer cell lines to chemotherapeutic drugs was detected by MTT assay. RESULTS: The expression of miR-186-5p was down-regulated in the serum of patients with colon cancer compared to normal group. Expression of miR-186-5p in serum of patients with stage I, II, III and IV was significantly decreased (P<0.01) compared with the normal group. Colon cells were transfected with a plasmid integrating the miR-186-5p gene, and miR-186-5p was highly expressed in the HCT116 and SW480 cell lines (P<0.01). The expression of mir-186-5p was decreased by mir-186-5p inhibitor (hsa-miR-186-5p inhibitor) in HCT116 and SW480 cells. The proliferation rate of HCT116 and SW480 cells with high expression of miR-186-5p was lower than control group (P<0.01). After treating with mir-186-5p inhibitor, the cell proliferation rate was higher than that of the control group (P<0.01). After treatment with different concentrations cisplatin for 24 hours, the mortality of HCT116 and SW480 cells with high expression of mir-186-5p was higher than that of the control group (P<0.01). The mortality of the cells with low expression of mir-186-5p was lower than that of the control group (P<0.01). The protein level of PLK1 was decreased after transfecting with miR-186-5p plasmid and increased after stimulating with miR-186-5p inhibitor in HCT116 and SW480 cells. CONCLUSION: The expression of miR-186-5p is decreased in colon cancer patients. Overexpression of miR-186-5p can inhibit the proliferation of colon cancer cells and reduce the drug resistance of colon cancer cells; inhibition of miR-186-5p expression can increase the proliferation and drug resistance of colon cancer cells.

Pharmacokinetics and tissue distribution characteristics of sunitinib#br#

CHEN Aiying, CHENG Min, MIAO Yunping, YE Xiaodi, TIAN Xuejun, ZHENG Gaoli

2020, 25(10):  1105-1110.  doi:10.12092/j.issn.1009-2501.2020.10.004

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AIM: To establish a HPLC-UV method to determine sunitinib in rat plasma and mouse tissues, and to study its pharmacokinetics in rats and tissue distribution characteristics in mice.  METHODS: The biotic samples were prepared by protein precipitation followed by a stereoselective analysis of sunitinib was achieved on Waters XBridgeTM C18 (4.6 mm×250 mm, 5 μm) with a mobile phase composing of methanol-0.02 mol/L sodium dihydrogen phosphate (70∶30) at a flow rate of 1.0 mL/min. The detection wavelength was 310 nm, and the column temperature was 25 ℃. RESULTS: The calibration curve for rat plasma sunitinib was linear in the range of 0.019 2-15.34 μg/mL. The linear ranges in mice brain and kidney were 0.038 3-11.50 and 0.038 3-69.00 μg/mL, respectively. After intragastric administration of sunitinib at a dose of 20 mg/kg to rats, the pharmacokinetic characteristics were Tmax=9.0 h, Cmax=0.194 mg/L, t1/2=18.4 h, AUC(0-∞)=6.8 mg·L-1·h. And the absolute bioavailablity was 47.1%. It was indicated that sunitinib could permeate the blood brain barrier, but the concentration was lower in brain and higher in kidney. CONCLUSION: A HPLC-UV method for the determination of sunitinib in rat plasma and mouse tissues was established. The method is simple, rapid, reliable, and provides a reference for the clinical application of sunitinib.

Protective effect of salvianolic acid on skeletal muscle ischemia-reperfusion injury in rats

SHEN Yun, ZHANG Zhanfeng, WANG Hongling, ZHAO Ji'an

2020, 25(10):  1111-1118.  doi:10.12092/j.issn.1009-2501.2020.10.005

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AIM: To analyze the effects of salvianolic acid on autophagy and apoptosis of skeletal muscle ischemia-reperfusion injury mice through AKT/mTOR/p70S6K signaling pathway.  METHODS: A total of 45 SPF male rats were randomly divided into sham operation group, model group, salvianolic acid group. Model group and salvianolic acid group were prepared for skeletal muscle ischemia-reperfusion injury model. At 72 h, 48 h, 24 h and 15 min before reperfusion, 1 mL of salvianolic acid solution was administered intraperitoneally at a dose of 30 mg/kg. Rats in the sham operation group and the model group were intraperitoneally injected with 1 mL of normal saline. The pathological morphology of the gastrocnemius muscle, the contents of serum CK and LDH, the expression of Akt, p-Akt, p70S6K, p-p70S6K, mTOR and p-mTOR in the gastrocnemius muscle and the expression of Bcl-2 and Bax in the gastrocnemius muscle were observed. RESULTS: At the 0 h, 4 h and 24 h within reperfusion, the W/D ratio of gastrocnemius muscle in the model group were higher than those in the sham operation group. The W/D ratio of the gastrocnemius muscle in the salvianolic acid group was lower than that in the model group (P<0.05). The levels of serum LDH and CK in the model group were higher than those in the sham operation group at 0 h, 4 h and 24 h after reperfusion. The serum levels of LDH and CK in the salvianolic acid group were lower than those in the model group (P<0.05). The expression of Akt protein in the gastrocnemius of the model group was lower than that in the sham operation group, and the expression of p-Akt protein was higher than that in the sham operation group. The protein expressions of Akt, p-Akt, p70S6K, p-p70S6K, mTOR and p-mTOR in the salvianolic acid group were significantly higher than those of the model group (P<0.05). The IOD value quantified the expression of Bax and Bcl-2 protein in the gastrocnemius muscle cells. The Bcl-2 IOD value and Bcl-2/Bax ratio in the model group were lower than those in the sham operation, whlie the Bax IOD value in the model group was higher than that in the sham operation group. The Bcl-2 IOD value and Bcl-2/Bax ratio in the salvianolic acid group were higher than those in the model group, and the Bax IOD value was lower than that in the model group, the difference was statistically significant (P<0.05). CONCLUSION: Salvianolic acid can maintain the homeostasis of Bax and Bcl-2 in bone cells of rats with skeletal muscle ischemia-reperfusion injury and inhibit cell apoptosis. The mechanism may be related to the activation of AKT/mTOR/p70S6K signaling pathway.

Bioequivalence of capecitabine tablets in cancer patients

XU Guofang, GAO Pan, LIU Ping, ZHANG Xiaolei, JING Cui, ZHANG Cuicui, JING Huixia, LI Xiaosu, QI Qi

2020, 25(10):  1119-1124.  doi:10.12092/j.issn.1009-2501.2020.10.006

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AIM: To evaluate the pharmacokinetics, bioequivalence, and safety of capecitabine tablet in cancer patients following single oral administration.  METHODS: Based on an open-randomized two-period crossover designation, subjects were orally given capecitabine tablet (test or reference products, 0.6 g single dosage). Blood samples were then collected and the plasma concentrations of capecitabine and its active metabolite, 5-fluorouracil (5-FU) were examined by HPLC-MS/MS. The bioequivalence between the test and reference formulations were evaluated with the pharmacokinetic parameters determined by the Phoenix WinNonlin 7.0 software. RESULTS: The numbers of the major pharmacokinetic parameters in patients treated with test and reference products were similar. To analyze the numbers of Cmax, tmax, AUC0-t, AUC0-∞, the 90% confidence interval (CI) for Cmax, AUC0-t and AUC0-∞ were 84.48-106.70, 93.03-96.54 and 96.34-102.84, respectively. For the 5-FU, the 90%CI of the for Cmax, AUC0-t and AUC0-∞ were 84.32-99.67, 90.55-98.76 and 96.99-103.48, respectively. Both sets of numbers fell within the bioequivalent limit ranges of 80.00%-125.00%. No serious adverse event was observed. CONCLUSION: The current data indicate that the test and reference formulations of capecitabine tablets were bioequivalent in cancer patients.

Analysis of the current status of clinical drug trial institutions in Chongqing and reflections on the establishment of regional institutions

GUO Wei, XIE Linli, CAO Liya, XIE Jiangchuan, XIA Peiyuan, CHEN Yongchuan

2020, 25(10):  1125-1130.  doi:10.12092/j.issn.1009-2501.2020.10.007

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AIM: Given the fact that Chongqing is a place rich in medical resource and the government is marking every effort in promoting the reform of drug clinical trial evaluation and the development of medical and health industry, the present study was designed to evaluating the current status of drug clinical research institute in Chongqing by investigating its administrative staff to further find ways for innovative development. METHODS: This study conducted a questionnaire survey on 54 managers from 20 clinical drug trial institutions in our city and systematically analyzed the level of institutions construction in our city by comparing the corresponding public data.RESULTS: Analyze of questionnaire survey revealed that the projected preformed in Chongqing were mainly from domestic pharmaceutical companies (90.00%) while 65%of the institutes took less than 40 projects in the past 3 years. The working seniority of administrative staff were mainly less than 6 years (79.59%) while some of the administrative staff still didn't get systemic training on clinical research. Additionally, public data analyze has revealed that 81 projects were registered as "ongoing" on ClinicalTrails.gov in the past 3 years in 22 drug clinical research institutes in Chongqing, which is much less than that in Beijing (61 institutes, 433 projects) and Shanghai (53 institutes, 326 projects). CONCLUSION: It is of great urgency to promote the development of drug clinical research institutes in Chongqing. The acceleration of innovative development of medical and health industry could be achieved by integrating the city's medical resources and constructing regional drug clinical research institute system.

Effects of DRD2 and 5-HTR2A gene polymorphisms and their interaction on olanzapine in the treatment of schizophrenia

YAN Pan, SHI Jianfei, LI Jing, WANG Shengdong, WANG Shuqi, WANG Chengpeng, SONG Mingfen

2020, 25(10):  1131-1138.  doi:10.12092/j.issn.1009-2501.2020.10.008

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AIM: To investigate the association of dopamine D2 receptor (DRD2) and 5-hydroxytryptamine 2A receptor (5-HTR2A) gene polymorphisms and their interactions with efficacy of olanzapine in treatment of schizophrenic patients.  METHODS: A total of 147 schizophrenic patients who treated with olanzapine alone were recruited. The positive and negative symptom scale (PANSS) was used to evaluate the efficacy of drugs. According to PANSS reduction rate ≥50% and <50%, patients were divided into the effective group and the ineffective group. The gene polymorphisms of DRD2 (rs1799978, rs1800497) and 5-HTR2A (rs6311, rs6313) were detected by improved multiple ligase detection reaction (iMLDR). Multivariate Logistic regression analysis was used to analyze the correlation between genotypes and olanzapine efficacy, and multifactor dimensionality reduction (MDR) was used to analyze gene-gene interactions. RESULTS: There were significant differences in genotype and allele frequencies of rs1799978 and rs6313 between the effective group and the ineffective group (P<0.05), while there was no difference in genotype and allele frequencies of rs1800497 and rs6311 (P<0.05). Patients with GA and GG of rs1799978 locus were more effective than those with wild type AA when treated with olanzapine, and the ORs (95%CI) were 5.101 (1.118-23.267) and 6.051 (2.454-14.925), respectively. Patients with CT and CC of rs6313 locus were more effective than those with wild type TT when treated with olanzapine, and the ORs (95%CI) were 2.623 (1.054-6.528) and 3.412 (1.180-9.869), respectively. There was a interaction between the gene polymorphisms of rs1799978, rs1800497 and rs6313. The interaction model was the optimal gene-gene interaction model (P<0.05) with the verify sample accuracy rate of 0.727 3 and a cross-validation consistency of 10/10. CONCLUSION: The gene polymorphisms of DRD2 (rs1799978) and 5-HTR2A (rs6313) may be associated with efficacy of olanzapine in treatment of schizophrenic patients, and there is a interaction between DRD2 (rs1799978, rs1800497) and 5-HTR2A (rs6313) on the efficacy of olanzapine.

Effects of tight control of metabolic acidosis with 5% sodium bicarbonate on early renal function after living donor renal transplantation

YAN Wenlong, SHU shuhua, LI Juan

2020, 25(10):  1139-1144.  doi:10.12092/j.issn.1009-2501.2020.10.009

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AIM: To observe whether tight control of metabolic acidosis by infusion of 5% sodium bicarbonate can improve early post-operative renal function in living renal transplant recipients.  METHODS: A total of 120 patients who underwent living donor renal transplant surgery in the First Affiliated Hospital of University of Science and Technology of China from March 2019 to March 2020, ASA Ⅲ-Ⅳ, were randomly divided into observation group and control group using random digits table. In observation group, 5% sodium bicarbonate was infused intra-operatively according to Base Excess (BE) measurements to achieve the normal values of BE (－3 to +3 mmol/L). In control group, infusion of 5% sodium bicarbonate was allowed only in case of severe metabolic acidosis (BE≤－10 mmol/L or pH≤7.25). Minute ventilation was adjusted to keep PaCO2 within the normal range. Hemodynamic parameters of two groups were recorded before anesthesia (T0), 10 minutes after induction of anesthesia (T1), before opening of renal artery (T2), 5 minutes after opening renal artery (T3) and the end of surgery (T4). The amount of bleeding, infusion fluid and operative time were recorded. Creatinine,urea nitrogen, urine outputs were recorded on days 1, 2, 3, 7 ,30 after surgery. RESULTS: Compared with the control group, the amount of 5% sodium bicarbonate was significantly increased, the phenylephrine was decreased in the observation group (P<0.05), there was no indication of 5% sodium bicarbonate infusion in control group; the pH and BE in observation group were significantly higher than that in control group at the end of surgery (P<0.05). The MAP and CVP of both groups at T3 were lower than before anesthesia (P<0.05).The creatinine and urea nitrogen of observation group was lower than control group on days 1, 2, 3, 7 after surgery (P<0.05). The urine volume of observation group was higher than control group on days 1, 2, 3 after surgery(P<0.05). CONCLUSION: Intraoperative tight control of metabolic acidosis by infusion of 5% sodium bicarbonate in living renal transplant recipients may improve early post-operative renal function.

Changes in serum thyroid hormone levels in psychiatric patients after risperidone monotherapy or polytherapy treatment

ZHANG Jiaxuan, DENG Shunshun, QIU Mali, YANG Shuangshuang

2020, 25(10):  1145-1150.  doi:10.12092/j.issn.1009-2501.2020.10.010

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AIM: To investigate changes in serum thyroid hormone levels in psychiatric patients after risperidone monotherapy or polytherapy treatment.  METHODS: Twenty-nine in-patients who received risperidone monotherapy treatment and 25 in-patients who received polytherapy treatment of risperidone and other second-generation antipsychotics were included. Changes in thyroid hormone levels after treatment were retrospectively analyzed. RESULTS: After risperidone monotherapy treatment, serum levels of free thyroxine (FT4) and total thyroxine (TT4) significantly decreased, and serum TSH levels significantly increased (changes from baseline: FT4: median －2.52 pmol/L, P<0.001; TT4: －21.17 nmol/L, P=0.012; TSH: median 0.49 mIU/L, P=0.001). After risperidone polytherapy treatment, serum levels of free triiodothyronine (FT3), total triiodothyronine (TT3) and FT4 significantly decreased, and serum TSH levels significantly increased (changes from baseline: FT3: median －0.37 pmol/L, P=0.001; TT3: median－0.17 nmol/L, P=0.008; FT4: median －2.25 pmol/L, P<0.001; TSH: median 0.97 mIU/L, P=0.029). After risperidone monotherapy treatment, moderately positive relation was found between changes in serum TT4 levels and average daily dose of risperidone. No statistical difference was found on the incidence of subclinical thyroid dysfunction between the two therapeutic regimen (6.9% vs. 12.0%, P=0.862). CONCLUSION: To avoid other disease caused by abnormal thyroid hormone levels, changes in serum thyroid hormone levels should be noticed after risperidone treatment.

Advances in the evaluation of intra-tumoral delivery of antitumor drugs

LIU Yan, LIU Jiali, JIA Yuanwei, ZHOU Fang, WANG Guangji, ZHANG Jingwei

2020, 25(10):  1151-1159.  doi:10.12092/j.issn.1009-2501.2020.10.011

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Tumor tissue is highly heterogeneous and complex in structure. Numerous barriers make it difficult for anti-tumor drugs to reach the center of the tumor tissue, which affects the efficacy. Currently, various strategies to improve intra-tumoral drug delivery are emerging in an endless stream, but the clinical conversion efficiency is low. Hence, it is essential to improve the early evaluation system of intra-tumoral drug delivery. Reasonable evaluation of intra-tumoral drug delivery can rely on three-dimensional cell models, in-vivo imaging technology and appropriate mathematical model to comprehensively reveal the drug delivery process in tumor tissues, predict and screen various influencing factors, and feedback to guide the optimization of intra-tumoral delivery of drugs. This article reviews the evaluation methods of intra-tumoral delivery of anti-tumor drugs, aiming to evaluate the transport of anti-tumor drugs in tumor tissues more accurately and reasonably, and to provide reference and ideas for the synthesis, preparation design, drug combination and optimization of clinical drug regimen of anti-tumor drugs.

Research progress of endoplasmic reticulum stress and its role in lung cancer#br#

MAO Xike, YU Chenxi, HUANG Tao, Mao Tongjun, WU Zhihao

2020, 25(10):  1160-1170.  doi:10.12092/j.issn.1009-2501.2020.10.012

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The endoplasmic reticulum (ER) is a place where secreted proteins and membrane proteins are synthesized and folded. The homeostatic environment of the endoplasmic reticulum is necessary to keep ER protein synthesis proceed smoothly. When unfolded proteins and misfolded proteins aggregate in the ER abnormally, it often leads to protein synthesis disorder and triggers endoplasmic reticulum stress (ERS). The endoplasmic reticulum can maintain the endoplasmic reticulum homeostasis and restore cellular function by inducing an unfolded protein response (UPR). However, as the ERS increasingly intensify, the continuous UPR reaction will trigger programmed cell death. There is close relationship between the tumorigenesis of lung cancer and ERS in cells. This article will introduce ERS, UPR and related pathways, and summarize their main causes and their roles in lung cancer, aiming to providing new ideas and potential therapeutic targets for basic research and clinical treatment of lung cancer. 

Strategy on improving quality of study of triazavirin for 2019 novel coronary pneumonia (COVID-19) with features of "core data targeted"

GAO Jingshu, WANG Yu, QIN Huichao, ZHU Mengyi, WU Xiaoke

2020, 25(10):  1171-1177.  doi:10.12092/j.issn.1009-2501.2020.10.013

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With the spread of the new coronavirus pneumonia in China, medical researchers at home and abroad have carried out clinical studies in order to find the best way to combat the epidemic. The quality control measures are the key to ensure the scientificity of results. An overview of a multi-center randomized controlled double-blind clinical study was presented which was on the efficacy and safety of terazavirin in the treatment of COVID-19. It has pointed out that the difficulty of quality control in this study lies in obtaining the first-line data for the research assistant due to the isolation, and the delay of quality control only through the verification of EDC data. And these problems could be solved by using "core data targeting" quality control form. The features of this form include the concise content directly aiming at the main chart data in the research report for quality control, focusing on the implementation of the core elements of the programme and function of reminding and helping research assistants understand the capabilities of the project. 

Research progress on model of Alzheimer's disease in vitro#br#

LI Hongxing, ZHANG Xinyue, WU Ningzi, GU Lili, LU Jiaqi, ZHANG Lingxi, LI Qin

2020, 25(10):  1178-1187.  doi:10.12092/j.issn.1009-2501.2020.10.014

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Alzheimer's disease (AD) is a neurodegenerative disease that seriously affects the quality of life of patients. Hitherto, the specific pathogenesis of AD has not been clarified and the only 5 anti-AD drugs approved for marketing also have some problems such as obvious side effects and limited efficacy. The ideal disease model is an important tool to explore the etiology and develop new drugs. This paper focuses on the traditional "induced" AD model in vitro. The modeling agents, basic principle, main characteristics and application examples are described, and the research progress of new AD models in vitro in recent years are summarized, in order to provide reference and guidance for researchers to study AD. 

Pharmacological activities and clinical application of yuanhuacine

WANG Yujue, SHANG Xinyue, YAO Guodong

2020, 25(10):  1188-1194.  doi:10.12092/j.issn.1009-2501.2020.10.015

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Yuanhuacine is a daphne-type diterpene isolated from Daphne genkwa. It is also isolated from the plant of Daphne and Euphorbia. With the further research on yuanhuacine, it has been found that yuanhuacine has strong anti-tumor activity, and it also exhibits significant anti-virus, anti-inflammatory, neuroprotective and anti-fertility activities. Yuanhuacine can enter various tissues with the blood, and pass through the blood-brain barrier. The bioavailability of yuanhuacine is good, which has potential therapeutic significance for the lesions of all tissues. However, the researches on yuanhuacine mainly focus on the preclinical research and yuanhuacine is only used to induce labor clinically. The purpose of this study is to systematically summarize and analyze the pharmacological activity, drug metabolism in vivo, and clinical application of yuanhuacine, so as to provide a theoretical basis for its development and application.

Risk based quality management in clinical trials

WANG Yongfang, SONG Meining, LI Boyang

2020, 25(10):  1195-1200.  doi:10.12092/j.issn.1009-2501.2020.10.016

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Based on the relevant provisions of the Standard for Good Clinical Practice, combining with the published at home and abroad about the quality of the quality risk management, risk-based quality management, risk management, and other related regulations, this paper summarizes the whole process of clinical trial risk-based quality management as well as the relevant regulations and suggestions for each process from the perspective of the sponsor. The aim is to provide theoretical basis for the next step of conducting risk-based quality management.