To understand the status of testing skills and quality management in drug testing laboratories. Methods:The items, pass rate and type of participating laboratories of measurement audit were analyzed during 2011-2014. Results:The number of application items was increased year by year, more than half of which focused on the content determination, and the overall pass rate was over 80%. Conclusion:The measurement audit is important for laboratories, which should be further strengthened and standard-ized.

The internal audit is important for the management system of laboratory .The article stated how to effectively implement internal audit in drug testing laboratories in terms of the planning , checklist, pattern, problem observation , CAPA of non-compliance and application of results in internal audit .

Adrenal Cortex Hormones ; blood ; Adult ; Exercise ; physiology ; Gonadal Hormones ; blood ; Humans ; Luteinizing Hormone ; blood ; Male ; Pituitary-Adrenal System ; Serum ; metabolism ; Students ; Testosterone ; blood

Background and purpose:Heparanase is an endo?-D-glucuronindise that degrades the HS sdie chains of heparin sulphate proteoglycans in ECM,expressed in the human normal placenta and immune organ.Expression of heparanase significantly increases in many kinds of cancers,it plays a central and specific role in the regulation of tumor metastasis and invasion.This article evaluates the effect of heparanase gene on the proliferation,adhesion and invasion of human ovarian cancer cell line SKOV3 cells.Methods:Human ovarian cancer cell line SKOV3 was cultured in optimum medium and transfected with pCDNA3.0-HPA by Lipofectamine~(TM2000),and cells transfected with blank vector pCDNA3.0 were used as control.The expression of HPA mRNA,and HPA protein in SKOV3,SKOV3/neo,and SKOV3/HPA were detected by RT-PCR and immunohistochemical staining;cell growth kinetics and the ability of invading was detected by MTT and transwell-ECM methode;the ability of adhesion and separation among same cells were evaluated by cell-adhering and separating method;Flow cytometry was used to test cell cycle.Results:RT-PCR and immunohistochemical staining showed that over-expression of HPA mRNA and protein in pCDNA3.0-HPA transfected cells in comparison with that in the parental SKOV3 cells and the cells transfected with blank vector(P

Vladimiriae Radix is a Tibetan medicine with national characteristics, which contains compounds such as sesquiterpene, lignin, and volatile oil. Pharmacological studies indicated that the sesquiterpenes in Vladimiriae Radix had good activity in the digestive diseases, liver and gallbladder pain, anti-inflammatory and antispasmodic. This review mainly integrated domestic and foreign researches, and summarized the advances in the chemical constituents and the pharmacological activities of Vladimiriae Radix systematically. It provides references and scientific basis for pharmacological study and utilization of Vladimiriae Radix.

Objective To study the influence of HBV replication regulator,enhancer I and Pre- S2,on the immune response of HBV DNA vaccine.Methods DNA fragments of HBsAg,PreS2 HBsAg,HBsAg-enhancer I and PreS2-HBsAg-enhancer I region of HBV were amplified by PCR using the complete genome DNA of HBV adr subtype,and inserted into VR1012 vectors,respective- ly.The recombinant plasmids were transfected into HepG2 cells,and injected into Balb/C mice.The expression of HepG2 cells and the cellular and humoral immune response of mice were tested by cell immuno-chemistry,ELISA and ELISPOT.Results The target protein were expressed by transfected HepG2 cells,enhancer I and Pre-S2 can promote the expression of HBsAg in transfected cells.The HBsAb and the HBsAg specific CTL in inoculated mice were found in the second week after injection, PreS2 but not enhancer I can promote the immune response in inoculated mice.Conclusions When inserted into HBV DNA vaccine,enhancer I and PreS2 can promote the expression of HBsAg in transfected HepG2 cells,PreS2 can promote the immune response in inoculated Balb/C mice.

With the application of monoclonal antibody technology more and more widely, its production technology is becoming more and more perfect. Small molecule monoclonal antibody technology is becoming a hot research topic for people. The application of traditional Chinese medicine small molecule monoclonal antibody technology has been more and more widely, the technology for effective Chinese medicine component knockout provide strong technical support. The preparation of monoclonal antibodies and small molecule knockout technology are reviewed in this paper. The preparation of several steps, such as: in the process of preparation of antigen, hapten carrier coupling, coupling ratio determination and identification of artificial antigen and establishment of animal immunization and hybridoma cell lines of monoclonal antibody, the large-scale preparation; small molecule monoclonal antibody on Immune in affinity chromatography column method is discussed in detail. The author believes that this technology will make the traditional Chinese medicine research on a higher level, and improve the level of internationalization of Chinese medicine research.
Animals ; Antibodies, Monoclonal ; chemistry ; genetics ; immunology ; Humans ; Hybridomas ; metabolism ; Immunologic Techniques ; methods ; trends

OBJECTIVETo observe anti-atherosclerotic effect of Xuefu Zhuyu Granule (XZU) and Danlou Tablet (DT) on blood lipids, platelet derived growth factor (PDGF), vascular smooth muscle cells (VSMCs) proliferation, extracellular signal-regulated kinase (ERK) signal pathway in atherosclerosis (AS) model rats, and to explore their potential mechanisms.

METHODSForty male Wistar rats were randomly divided into five groups, i.e., the normal control group, the model group, the Atorvastatin group, the DT group, the XZG group, 8 in each group. Rats in the normal control group were fed with basic forage for 12 weeks, while rats in the other four groups were fed with high fat forage plus intraperitoneal injection of vitamin D3 to build AS model. Then rats in the model control group, the Atorvastatin group, the DT group, the XZG group were administered with normal saline, Atorvastatin suspension (0.18 mg/mL), DT suspension (45 mg/mL), and XZG (1 g/mL) by gastrogavage for 8 successive weeks, respectively. After intervention serum levels of TC, TG, LDL-C, HDL-C, and PDGF were detected by ELISA. Pathological changes in thoracic aorta were observed by HE staining. Protein expression levels of ERK1/2 and pERK1/2 in thoracic aorta were measured by Western blot.

RESULTSCompared with the normal group, serum TC, TG, LDL-C, PDGF levels, and expression levels of ERK1/2 and pERK1/2 significantly increased (P <0. 05) in the model control group. HE staining showed irregular intimal thickness, accumulated endothelial foam cells, lipids deposited, disarranged media VSMCs, forming typical AS plaque. Compared with the model group, TC and PDGF levels decreased in all medicated groups (P < 0.05, P < 0.01). Serum levels of TG and LDL-C significantly decreased in the Atorvastatin group and the DT group (P < 0.01, P < 0.05). Expressions of ERK1/2 and pERK1/2 significantly decreased in the Atorvastatin group, the DT group, and the XZG group (P < 0.01). HE staining also showed typical AS plaque in three medicated groups, but with reduced pathological degree of endometrial hyperplasia and plaque area.

CONCLUSIONSXZG and DT could reduce the plaque area and attenuate pathological degree of AS in model rats, thereby postponing the progress of AS. Its mechanism might be achieved through reducing serum lipids and release of PDGF, inhibiting ERK signal pathway activation and VSMC proliferation.

Animals ; Aorta, Thoracic ; Atherosclerosis ; drug therapy ; Drugs, Chinese Herbal ; administration & dosage ; pharmacology ; therapeutic use ; Extracellular Signal-Regulated MAP Kinases ; Lipids ; Male ; Plaque, Atherosclerotic ; Rats ; Rats, Wistar ; Tablets

Objective To explore the personality change in patients with epilepsy during the interictal period and the correlation between clinical features and personality change. Methods One hundred and fifteen patients with idiopathic or cryptogenic epilepsy were chosen as the epileptic group and 42 age- and sex-matched healthy subjects served as controls. All participants were evaluated by Mini Mental Status Examination and Brief Psychiatric Rating Scale to ensure the normality of cognition and mental state.Personality was evaluated by adult version of Eysenck Personality Questionnaire (EPQ)in interictal epilepsy patients and healthy controls.Scores of psychoticism (P),extraversion (E),neuroticism (N) and lie (L)were obtained using computer software. Pearson correlation analysis and logistic regression were used to investigate the scores of EPQ and influential factors.Results P and N scores were significantly elevated in epilepsy patients compared with controls ( P scores:50.48 ± 9.55 vs 46.59 ± 7.28,N scores:51.13 ±12.89 vs 46.83 ± 9.40 ; t =2.374,2.266,both P ＜ 0.05 ),while E scores were significantly decreased (51.74 ± 10.74 vs 60.37 ± 9.84;t =- 4.511,P ＜ 0.01 ).There were no significant differences in L scores.Multivariate analysis showed that disease duration was independently correlated to P scores (β =0.043,P＜0.05),while education was correlated to E scores (β =0.109,P ＜ 0.05 ).There were no significant correlations between personality scores,patient age,gender,age of onset,frequency,seizure type,National Hospital Seizure Severity Scale scores,family history,history of status epilepticus and antiepileptic drugs usage.Conclusions High psychoticism and neuroticism and low cxtraversion scores are correlated to patients with epilepsy during the interictal period.Disease duration is an independent risk factor for psychoticism personality,and education level is an independent risk factor for extraversion personality in epilepsy patients.

Objective:To compare the difference of epileptiform discharges detection in patients with epilepsy between the 25 electrodes electroencephalogram (EEG) system proposed by the International Federation of Clinical Neurophysiology in 2017 and the previous 19 electrodes EEG system.Methods:Patients suspected of epilepsy or with confirmed epilepsy who need a follow-up EEG were collected in Zhongshan Hospital, Fudan University from March 2018 to November 2019, and conventional video-EEG recording was performed on all patients for two hours with the standard 25 electrodes EEG system. Two neurophysiologists reviewed the recordings blindly using the 19 electrodes system and the 25 electrodes system, marking the epileptiform discharges and their amplitudes. Finally, the data were statistically analyzed.Results:A total of 403 patients were included in the study, in which 263 cases were diagnosed as epilepsy, including 129 cases of generalized epilepsy, 115 cases of temporal lobe epilepsy, 13 cases of frontal lobe epilepsy, two cases of parietal lobe epilepsy and four cases of occipital lobe epilepsy. In 115 temporal lobe epilepsy patients, 76 (66.09%) and 100 (86.96%) records were detected epileptiform discharges by the 19 or 25 electrodes EEG system respectively, and the difference was statistically significant (χ2=13.939, P<0.001). While in patients with non-temporal lobe epilepsy, there was not statistically significant difference between the two systems. In 76 patients whose temporal epileptiform discharges were detected by the two systems, the amplitudes of epileptiform discharges in the newly-added inferior temporal electrodes (F9/F10, T9/T10, P9/P10) and the original temporal electrodes (F7/F8, T7/T8, P7/P8) were (61.53±22.64) μV and (48.25±20.90) μV, respectively, with statistically significant difference between the two groups ( t=5.486, P<0.001). In patients with abnormal [79.59% (39/49) vs 61.22% (30/49), χ2=3.967, P=0.046] and normal [95.45% (42/44) vs 70.45% (31/44), χ2=9.724, P=0.003] imaging, the ability of the 25 electrodes EEG system to detect epileptiform discharges was higher than that of the 19 electrodes EEG system. Conclusion:The 25 electrodes EEG system can significantly improve the detection ability of temporal epileptiform discharges in patients with epilepsy, which is recommended for regular use to increase the detection ability of temporal area abnormal wave and assist the diagnosis and treatment of epilepsy.