Objective:To establish a headspace GC method for the determination of 7 kinds of residual solvents in bicalutamide, including dichloromethane, n-hexane, tetrahydrofuran, ethanol, ether, acetone and ethyl acetate. Methods: The residual solvents in the substance were determined by GC equipped with an FID detector and linked with an Agilent DB-624 capillary column (30. 0 m × 0. 25 mm × 1. 4 m). The inlet temperature was 200℃ and the FID detector temperature was 250℃. The column temperature was raised by program:the initial temperature was 35℃, maintained for 13 min, raised to 180℃ with a rate of 100℃/min, and maintained for 5 min. The carrier gas was nitrogen and the flow rate was 1. 2 ml·min-1. The heated temperature of the headspace oven was 90℃, the heated time lasted 30 min, and the injection volume was 1. 0 ml. The solution medium was dimethyl sulphoxide (DMSO). Results:Each solvent could be completely separated, and the calibration curve of each solvent showed good linear relationship with good accuracy. Conclusion:The method can be applied for the determination of residual solvents in bicalutamide.

This study was aimed to investigate potential biomarkers in different traditional Chinese medicine (TCM) syndromes of angina pectoris of coronary heart disease (CHD) by using metabolomic technology,and to explore the objective law of different TCM syndromes of CHD.Endogenous metabolites in serum and urine from the healthy group,and patients with DHD angina pectoris patients of the syndrome of Qi deficiency and blood stasis,as well as the syndrome of Qi deficiency,blood stasis and phlegm turbidity were detected by the liquid chromatography-mass spectrometry (LC-MS).Metabolic profiles were analyzed by the principal component analysis (PCA) and the orthogonal partial least squares discriminant analysis (OPLS-DA).The results showed that in PCA,the healthy group,Qi deficiency and blood stasis group,as well as the Qi deficiency,blood stasis and phlegm turbidity group can be obviously distinguished.Potential biomarkers in the Qi deficiency and blood stasis syndrome contained aspartyl methionine and cysteine sulfinic acid.Potential biomarkers in the Qi deficiency,blood stasis and phlegm turbidity syndrome contained hippuric acid,amino glucose,fructosamine and triglyceride.The objective performance of Qi deficiency syndrome was the absence of biotin,lysyl tyrosine,phosphatidylglycerol and glycocholic acid.It was concluded that through the new metabolomic technology,different endogenous metabolites in the syndrome of Qi deficiency and blood stasis,as well as the syndrome of Qi deficiency,blood stasis and phlegm turbidity of patients with DHD angina pectoris were detected.It provided ideas for the clinical practice of prevention,diagnosis and treatment of different TCM syndromes.

A rapid resolution liquid chromatography quadruple time-of-flight mass spectrometric ( RRLC-Q-TOF/MS) method combined with multivariate statistical analysis was applied to investigate the changes of endogenous metabolites in murine urine before and after ultraviolet B ( UVB ) irradiation for the purpose of discussing the physiological mechanism of acute injury caused by UVB radiation. A narrow-band UVB ( NB-UVB) (TL-01, peak value 312nm) was used to establish the acute light damage model. The urine samples were centrifuged before four times dilution treatment, subsequently the diluted urine samples were separated on a Supelco Ascentis Express C18 column using water (0. 1% formic acid) and acetonitrile as mobile phase by gradient elution. The differences metabolites with major contribution for grouping were found out based on the metabolic profiling analysis of principal component analysis ( PCA) and cluster analysis ( CA) , which could illustrate their possible mechanism of actions by means of relevant pathways. A prediction model was built to investigate the forecasting ability of the acute photo damage induced by UVB irradiation through the partial least square discriminant analysis ( PLS-DA ) . The results of multivariate statistical analysis showed that the blank control group was separated from UVB model group quite well, 11 endogenous metabolites were identified as the potential biomarkers through comparison with the database, tandem mass spectrum data and standard substance, which indicated the UVB radiation may affect the sphingolipid metabolism, nucleic acid metabolism, linoleic acid metabolism and amino acid metabolism pathways. These different metabolites could be helpful for diagnosing the light damage induced by UVB radiation

BACKGROUND:Conditioned medium from mesenchymal stem cels (MSC-CM) may represent a promising alternative to MSCs transplantation. Previous studies have shown that inflammatory activation can strengthen the multiple biological potencies of MSCs; however, normal MSCs with insufficiency of immunocompetence and migration ability are not effective for tissue damage repair. OBJECTIVE:To investigate differential effects of MSC-CM with and without inflammatory activation on radiation-induced intestinal injury.METHODS:MSCs from the bone marrow of SD rats were separated, cultured and identified, and then co-cultured with non-irradiated IEC-6 or irradiated IEC-6 in a transwel system for 24 hours. Then, MSCs with inflammatory activation were cultured alone for another 48 hours. After that, the supernatant was colected as non-activated MSC-CM (MSC-CMNOR) and MSC-CM under radiation-induced inflammatory condition (MSC-CMIR). Rats were exposed to 14 Gy whole abdominal irradiation and randomly divided into four groups: control group, radiation injury group (DMEM/F12), MSC-CMNOR group and MSC-CMIR group. Continuous administration was givenvia tail vein and intraperitoneal implantation of Alzet microosmotic pumps. Intestinal samples were colected at 1, 3, 7 days after radiation for analysis of short circuit variation, at 3 days after radiation for analysis of intestinal epithelium ultrastructure, and at 1, 3, 5, 7, 14 days after radiation for histological observation of the intestinal epithelium using hematoxylin-eosin staining. Blood samples were colected at 1, 3, 7 days after radiation for analysis of serum xylose levels. In addition, the survival state and survival time of rats were observed and recorded. RESULTS AND CONCLUSION: The short circuit variation responding to electrical field stimulation was significantly reduced at al frequencies, but it was significantly improved in the MSC-CMIR group. Similarly, the intestinal absorption (serum xylose levels) was also significantly impaired by irradiation, but improved by delivery of MSC-CMIR (P < 0.05). At 3 days after MSC-CMIR infusion, the intestinal epithelium exhibited an increase in crypt size and vilous length (P < 0.05). Under the electron microscope, a reduction in intestinal microvili and open tight junctions in irradiated intestinal epithelium was found, and the intestine from rats treated with MSC-CMIR had more obvious tight junctions. In addition, treatment with MSC-CMIR dramaticaly improved the survival rate and mean survival time of irradiated rats as compared to those treated with DMEM/F12 or MSC-CMNOR (P < 0.05). Taken together, the present study demonstrated that MSC-CMIR , but not non-activated MSC-CM, improves the structural and functional restoration of the smal intestine after radiation-induced intestinal injury.

BACKGROUND:The establishment of a standardized clinical liver transplantation specimen bank is the primary condition for scientific research in this field, which can help to provide a qualified sample resource platform for research. OBJECTIVE:To primarily establish biological specimen bank of hepatocelular carcinoma for liver transplantation, to explore the standardized procedures of specimen colection, processing and preservation of hepatocelular carcinoma for liver transplantation, and to establish the sound and comprehensive information management system of clinical information of colected specimens. METHODS: In accordance with standardized procedures to establish biological specimen banks, the operational processes and quality control system were formulated. Liver tissue and blood samples of hepatocelular carcinoma recipients undergoing liver transplantation were regularly colected, managed and stored. Simultaneously, liver tissue and blood samples of benign liver disease in liver transplant recipients and of healthy donor were colected as controls. A systematic management was conducted in colected specimens and corresponding clinical information. RESULTS AND CONCLUSION:From August 2009, tissue and blood samples of 501 cases of receipts and donors undergoing liver transplantation with complete clinical information were colected from the specimen bank, including 203 hepatocelular carcinoma specimens, 214 benign liver disease specimens and 84 healthy donor specimens. These specimens included tumor tissue, adjacent tissues and distal non-cancerous tissue specimens, totaly 1 773. A total of 45 specimens were randomly selected for quality monitoring. The colected specimens had a high quality. Specimen information data computer management system was developed. This study initialy established a standardized research-based clinical transplantation specimen bank, which is helpful to elevate sample quality and has a good manipuility.

Human cytomegalovirus (HCMV) is a DNA virus and serious opportunistic pathogen for both newborn and immunocompromised individuals.To research technique for gene silence and antiviral agents, ribozyme M1GS-T6 was constructed from external guide sequences(EGSs)that consist of a sequence complementary to HCMV UL54 gene RNA and M1 RNA, the catalytic RNA subunit of RNase P from Escherichia coli. The results showed that M1GS can efficiently cleave the mRNA sequence encoding UL54 protein in vitro.

Objective To assess the effectiveness of extra-anatomic prosthesis bypass in the retroperitoneum as a treatment for infected abdominal aortic aneurysms (iAAAs).Methods We retrospectively reviewed the records of 10 consecutive patients diagnosed with iAAAs and treated by an extraanatomic prosthesis bypass in the retroperitoneum over the past 7 years.All 10 patients were regularly followed up by outpatient observation after their discharge.Results Ten patients with iAAAs underwent an extra-anatomic prosthesis bypass in the retroperitoneum and debridement of the infected aneurysm.An emergency operation was performed for one patient who underwent concomitant gastrointestinal procedures for aortoduodenal fistula,the other 9 cases underwent an elective operation after an intravenous antibiotic therapy for 2-4 weeks.All 10 patients were definitely diagnosed by one or more sequential CT scans combining with other methods.All patients had at least a positive preoperative blood culture or intraoperative tissue culture during the perioperative period,including Salmonella in 5 cases,Burkholderia pseudomallei in 3 cases,Escherichia coli in 1 case,Klebsiella pneumoniae in 1 case.All patients were discharged in 4-6 weeks after their operations.Except 1 case who died 16 months after surgery,all other patients were alive and were free from graft infection during the follow-up period.Conclusions The extra-anatomic prosthesis bypass in the retroperitoneum for treating iAAAs are safe and effective.

Objective To provide theoretical and experimental proof for selecting and implying Tourette's syndrome(TS) animal models, validities of four TS models induced by chemical factors were compared. Methods Four TS models,namely AMP model,APO model,DO1 model and IDPN model were built up by using different chemical modeling agents. Through detecting spontaneous movement, climbing time and monoamine transmitters levels in striatum, four TS animal models were compared and evaluated from three levels of validities-face, prediction,construct. Results Compared with control group, spontaneous movement times raised ( t = 4. 746, P =0. 000) and level of DOPAC ( (0.99 ± 0. 177 ) ng/mg) in striatum increased (P = 0.029 ), and level of NE in striatum decreased in AMP model group( (0.11 ± 0.033 )ng/mg, P = 0.012). Compared with control group, climbing time prolonged (P = 0. 004) and levels of DA ( ( 10. 19 ± 1.23 ) ng/mg), 5-HT ( ( 0. 54 ± 0.08 ) ng/mg) in striatum raised(P=0. 019, P=0. 002),at the same time ,levels of DOPAC( (0.63 ±0.11 )ng/mg),HVA ((0.45 ±0.04 ) ng/mg) in striatum reduced (P ＜ 0.01 ) in APO model group; Compared with control group, levels of DA ( ( 13.66 ± 1.55 ) ng/mg), DOPAC( (0.80 ±0. 11 ) ng/mg), HVA( ( 1.04 ± 0.14) ng/mg) grew downwards in striatum of DOI model mice(P=0.029,P=0.001, P= 0.004). Compared with control group, level of 5-HT in striatum increased in IDPN300 group ( (0.77 ± 0.09) ng/mg, P = 0.031 ). ConclusionFace validity of AMP model is temporal and that of IDPN model is steady and persistent. AMP model,APO model and DOI model possess predictive validity. AMP model,APO model,DOI model and IDPN model have potentiality of becoming construct validity model.

Data quality management system is essential to ensure accurate, complete, consistent, and reliable data collection in clinical research. This paper is devoted to various choices of data quality metrics. They are categorized by study status, e.g. study start up, conduct, and close-out. In each category, metrics for different purposes are listed according to ALCOA+ principles such us completeness, accuracy, timeliness, traceability, etc. Some general quality metrics frequently used are also introduced. This paper contains detail information as much as possible to each metric by providing definition, purpose, evaluation, referenced benchmark, and recommended targets in favor of real practice. It is important that sponsors and data management service providers establish a robust integrated clinical trial data quality management system to ensure sustainable high quality of clinical trial deliverables. It will also support enterprise level of data evaluation and bench marking the quality of data across projects, sponsors, data management service providers by using objective metrics from the real clinical trials. We hope this will be a significant input to accelerate the improvement of clinical trial data quality in the industry.

Objective To assess the relationship of methylation status of CpG islands in the promoter region of insulin-like growth factor binding protein 7 (IGFBP7) gene with the expression of IGFBP7 gene in human melanoma cell lines and primary melanocytes.Methods Primary melanocytes from human forcskin tissue as well as 4 human melanoma cell lines,including A375,M14,SK-MEL-1 and MV3,were used in this study.Bisulfite sequencing PCR (BSP) was applied to detect the methylation status of 54 CpG sites in the 5'-flanking promoter region of IGFBP7 gene in all of the melanoma cell lines and primary melanocytes.Results As hierarchical cluster analysis showed,IGFBP7-positive cells (including A375,M14 and SK-MEL-1 ) differed significantly from IGFBP7-negative cells (including MV3 cells and primary melanocytes) in the methylation pattern of IGFBP7 gene promoter region.Conclusion The methylation status of CpG island in the promoter region of IGFBP7 gene may be associated with its expression in melanoma cell lines.