1.Study on the proficiency testing program of pharmaceutical preparation analysis.
Linbo WANG ; Meicheng YANG ; Zhukang CHEN ; Ming LU ; Peijun ZHAI ; Guiliang CHEN ; Linda WANG
Acta Pharmaceutica Sinica 2012;47(6):769-72
This proficiency testing program is established to evaluate the pharmaceutical preparation analysis capacity of laboratories recommended by 18 countries and economies. It was authorized by Asia Pacific Laboratory Accreditation Cooperation (APLAC), and organized by Shanghai Institute for Food and Drug Control (SIFDC) and China National Accreditation Service for Conformity Assessment (CNAS). The 0.3sigma test is used to evaluate the homogeneity and stability of the proficiency testing sample. The results of the laboratories were assessed by Z-score. The robust average and the robust standard deviation of the participants' results were calculated as assigned value and standard deviation for performance assessment of hydrochlorothiazide and captopril using robust statistics. Thirty-three of 38 laboratories recommended by 18 countries and economies sent their results back. Twenty-four laboratories' results were observed as satisfactory. Five laboratories were identified as having reported at least one questionable result. Four laboratories were identified as having reported at least one unsatisfactory result.
2.Role of miR-188-5p in oxygen-glucose deprivation and restoration injury to mouse N2a cells: relationship with SENP3
Guiliang SUN ; Fei SHI ; Mingshan WANG ; Huailong CHEN ; Lixin SUN ; Weiwei QIN ; Gaofeng ZHANG
Chinese Journal of Anesthesiology 2021;41(2):246-250
Objective:To evaluate the role of miR-188-5p in oxygen-glucose deprivation and restoration (OGD/R) injury to mouse neuroblastoma (N2a) cells and its relationship with small ubiquitin-like modifier-specific proteases 3 (SENP3).Methods:N2a cells were cultured and divided into 5 groups ( n=23 each) using a random number table method: control group (group C), OGD/R group, group NC, transfection of mir-188-5p agonist group (group M) and transfection of mir-188-5p inhibitor group group (group I). Cells in group C were cultured routinely.Cells in group NC, group M and group I were transfected with mir-188-5p negative control miRNA, agonist and inhibitor, respectively.N2a cells were subjected to OGD for 3 h followed by restoration of oxygen-glucose supply to establish the model of OGD/R injury.At 24 h of oxygen-glucose restoration, the cell viability was recorded by the cell counting kit-8 assay, the amount of lactic dehydrogenase (LDH) released was detected, the expression of miR-188-5p and SENP3 mRNA was detected by quantitative real-time polymerase chain reaction, and SENP3 expression was determined by Western blot.The targeting relationship between miR-188-5p and SENP3 mRNA was detected using dual luciferase reporter assay. Results:Compared with group C, the cell viability was significantly decreased, amount of LDH released was increased, and expression of SENP3 and its mRNA was up-regulated in the other 4 groups, miR-188-5p expression was down-regulated in OGD/R and I groups, and miR-188-5p expression was up-regulated in group M ( P<0.05 or 0.01). Compared with group OGD/R, the cell viability was significantly decreased, amount of LDH released was increased, and expression of SENP3 and its mRNA was up-regulated, and miR-188-5p expression was down-regulated in group I, and the cell viability was increased, amount of LDH released was decreased, expression of SENP3 and its mRNA was down-regulated, and miR-188-5p expression was up-regulated in group M ( P<0.05 or 0.01). The dual luciferase reporter assay showed that miR-188-5p could act directly on SENP3. Conclusion:miR-188-5p is involved in OGD/R injury, which is associated with targeted down-regulation of SENP3 expression in N2a cells.
3.Neuronal differentiation of adipose tissue-derived stromal cells
Bin LIU ; Menghai WU ; Jing DONG ; Ning LIU ; Jianmin LI ; Jinxia ZHANG ; Shiying LI ; Ruimin WANG ; Guiliang CHEN
Chinese Journal of Tissue Engineering Research 2010;14(1):15-18
BACKGROUND: Appropriate seed cell is important for transplantation in the treatment of cerebrovascular disease and other central nervous system disease.OBJECTIVE: To investigate the capacity of human adipose tissue-derived stromal cells (ADSCs) to differentiate into neurons.METHODS: The fatty tissue was harvested from removed abdominal unnecessary fat of healthy adult with no communicable disease or endocrine disease. Human ADSCs were isolated from human liposuction tissues and cultured in neural induction medium with GM1. Invert phase-contrast microscopy was used to observe morphology changes of ADSCs. The expression of nestin, neuron specific enolase (NSE) and microtubule-associated protein 2 (MAP2) were identified by immunocytochemistry.RESULTS AND CONCLUSION: The majority of cells displayed typical appearance of neuronal-like cells following induction. Following 1 hours of induction, some cells began to express nestin, and NSE and MAP2-positive cells were observed at 5 hours. ADSCs can differentiate into neurons, and the differentiated neurons have the capacity of expressing nestin, NSE and MAP2.
5.Open reduction and internal fixation via two lateral approaches in treating Sanders type III intra-articular calcaneal fractures: a comparative analysis
Pengbin LI ; Wei CHEN ; Huanxia XING ; Zixin SU ; Xinhua MA ; Guiliang WANG ; Chonqiu SUN
Chinese Journal of Trauma 2020;36(8):698-703
Objective:To compare the post-operative outcomes between extended lateral approach and L-shaped lateral approach in surgical treatment of Sanders type III intra-articular calcaneal fractures.Methods:A retrospective case-control study was made on clinical data of 34 patients with fresh Sanders type III intra-articular calcaneal fractures hospitalized in Langfang Hospital of Traditional Chinese Medicine from October 2014 to October 2017. There were 33 males and 1 female, with the age of 18-56 years [(42.5±9.4)years]. All fractures were fresh. Seventeen patients were fixed by the extended lateral approach (extended approach group) and seventeen patients by L-shaped lateral approach (L-shaped approach group). Operation duration, intraoperative bleeding volume, length of hospital stay, one-stage wound healing rate and complication rate were observed. B?hler and Gissane angle were measured before operation, one week after operation and 12 months after operation. American Orthopedic Foot and Ankle Society (AOFAS) ankle-hindfoot scale was applied to evaluate function recovery.Results:There were no significant differences between groups in operative time and intraoperative bleeding volume ( P>0.05). There were significant differences between extended approach group and L-shaped approach group in length of hospital stay [(15.7±4.0)days vs.(22.4±9.6)days], one-stage wound healing rate [88%(15/17) vs. 47%(8/12)] and postoperative complication rate [12%(2/17) vs. 47%(8/17)] ( P<0.05). The B?hler and Gissane angles did not differ significantly between groups before operation and one week and 12 months after operation ( P>0.05). At postoperative 12 months, the B?hler and Gissane angles were improved from preoperative (8.2±6.0)°, (85.3±10.5)° to (23.9±6.1)° and (119.3±6.2)° respectively in extended approach group, and those from preoperative (9.4±3.9)°, (85.5±7.1)° to (25.8±3.7)° and (122.2±5.6)° respectively in L-shaped approach group (all P>0.05). At 12 months after operation, the AOFAS score was (86.9±7.5)points in extended approach group, with the excellent and good rate of 88%; and was (83.3±12.5)points in L-shaped approach group, with the excellent and good rate of 76% ( P>0.05). While the score of hindfoot joint activity in extended approach group was (5.8±0.7)points, significantly higher than (3.4±1.0)points in L-shaped approach group ( P<0.05). Conclusion:For Sanders III intraarticular calcaneal fractures, compared with L-shaped approach group, plate fixation via extended approach can promote fracture healing, shorten hospital stay, reduce incidence of complications and facilitate function recovery of subtalar joint.
6. Applications of drug interaction study in new drug development and regulartory decision-making
Bo SUN ; Guiliang CHEN ; Shujun FU ; Li LI
Chinese Journal of Clinical Pharmacology and Therapeutics 2021;26(10):1095-1102
Drug-drug interactions (DDI) change dose-response relationships, and may result in low efficacy or high toxicity, which are important considerations especially in medical practice with multiple-drug therapies. Predicting clinically significant drug interactions during new drug development is an important part of benefit and risk assessment in drug development and review. This article summarizes the purpose and significance of drug interactions in new drug development, the main content and precautions of DDI studies in vivo and in vitro. Drug interaction studies on novel drug approvals for 2020 in the National Medical Products Administration (NMPA) and US Food and Drug Administration (USFDA) are examined, respectively. It aims to provide reference for DDI studies and regulatory reviews in new drug development in our country.
7.Effect of synergistic polarization macrophage modulated by N-terminal domain of a2 vacuolar ATPase and macrophage colony stimulating factor on proliferation of gastric cancer cells.
Dandan LIAN ; Guiliang MA ; Chen SUN ; Weizheng MAO
Chinese Journal of Gastrointestinal Surgery 2016;19(2):209-215
OBJECTIVETo investigate the synergistic effect between the N-terminus domain of the a2 isoform of vacuolar ATPase (a2NTD) and macrophage colony-stimulating factor (M-CSF) on modulating macrophage polarization and the impact of polarized macrophages on proliferation of gastric cancer cells.
METHODSPeripheral blood mononuclear cells were derived from healthy donor and induced into macrophages. Then macrophages were randomly divided into four groups: the control group (RPMI 1640), the experimental group I (M-CSF 100 μg/L), the experimental group II (a2NTD 500 μg/L) and the experimental group III (a2NTD 500 μg/L plus M-CSF 100 μg/L). After stimulation for 48 hours, double color immunofluorescence cytochemistry was adopted to detect the expression of cell membrane molecules on macrophages; ELISA was used to measure the secretion of cytokines IL-10 and IL-12; CCK-8 assay was used to evaluate the impact of macrophages on proliferation ability of gastric cancer cell strain SGC-7901.
RESULTSThe expression of CD68, also known as macrophage surface antigen, was detected on macrophage membrane in all four groups (+). The mean absorbance (A) was 0.092 ± 0.005 in control group, 0.095 ± 0.006 in group I, 0.094 ± 0.005 in group II, 0.094 ± 0.005 in group III, and no significant differences were observed among 4 groups (all P>0.05). Meanwhile, the expression of CD206, which mainly exists on M2 macrophage membrane, was hard to detect in control group (-) with A 0.025 ± 0.004; it was normal in groupI and group II (+) with A 0.191 ± 0.012 in group I and 0.197 ± 0.136 in group II (P=0.212), and it was up-regulated significantly in group III (+++) with A 0.285 ± 0.011. There were significant differences between either two groups except group I and group II (all P<0.01). Secretion of IL-10 in group I and group II [(85.65 ± 13.64) ng/L and (87.77 ± 14.25) ng/L] was significantly higher compared with control group [(71.67 ± 7.56) ng/L, P<0.01]. Secretion of IL-12 in group I and group II [(9.91 ± 1.50) ng/L and (10.15 ± 1.80) ng/L] was significantly lower compared with control group [(16.87 ± 1.10) ng/L, P<0.01]. Secretion of IL-10 in group III [(116.98 ± 14.27) ng/L] was the highest, and secretion of IL-12 [(5.31 ± 0.88) ng/L] was the lowest (all P<0.01). There was a synergistic effect between a2NTD and M-CSF on the secretion of both IL-10 and IL-12. Elevated proliferation of gastric cancer cell strain SGC-7901 was detected in all four groups, in which group III showed the greatest impact compared with other 3 groups (P<0.01).
CONCLUSIONSa2NTD and M-CSF show a synergistic effect in modulating macrophage phenotype and the secretion of IL-10 and IL-12. The polarized macrophage can significantly enhance proliferation of gastric cancer cell strain SGC-7901.
Cell Proliferation ; Humans ; Interleukin-10 ; metabolism ; Interleukin-12 ; metabolism ; Macrophage Colony-Stimulating Factor ; pharmacology ; Macrophages ; cytology ; Phenotype ; Stomach Neoplasms ; pathology ; Tumor Cells, Cultured ; Vacuolar Proton-Translocating ATPases ; pharmacology
8.Exploration of establishing the evaluation index system of professional and specialized drug inspectors in China
Di HU ; Yuemin DAI ; Ruoyin DING ; Xin ZHU ; Yuanyuan GE ; Guiliang CHEN ; Yuwen CHEN
China Pharmacy 2023;34(8):911-916
OBJECTIVE To provide scientific basis for establishing the evaluation index system of professional and specialized drug inspectors in China. METHODS Through the method of literature research, group discussions and behavioral event interview, combined with the practice situation of drug inspection at home and abroad, in accordance with the requirements of Chinese laws and regulations and department rules, the evaluation indexes for drug inspectors were extracted and screened. In addition, the Delphi method was used to conduct correspondence with experts in relevant fields so as to determine the evaluation index system of drug inspectors. RESULTS & CONCLUSIONS Finally, 62 experts completed two rounds of anonymous online questionnaires, including 29 experts in the first round and 33 experts in the second round. The questionnaire recovery rates were 96.67% and 94.29% respectively, and the expert authority coefficients were 0.81 and 0.79, indicating a high level of authority among experts. After expert consultation, evaluation index system for professional and specialized drug inspectors had been constructed, including five first-level indexes (personal characteristics, professional knowledge, professional skills, professional behavior and professional ethics) and their corresponding 27 second-level indexes. The average score of the importance of second-level indexes was 4.224- 4.879, the full score ratio was 81.8%-100%, the coefficient of variation was 0.067-0.177, and Kendall’s W was 0.643 (P<0.001). It indicates that this evaluation index system is relatively reliable and is expected to become a management tool for promoting the construction of professional and specialized drug inspector team and ensuring the quality of drug inspection.