Objective To analyze the clinical symptoms,pathological features and K-ras mutation alterations of intraductal tubulopapillary neoplasm (ITPN),and to better understand ITPN.Methods We collected the clinical data of 3 cases of ITPNs of Changhai Hospital and 16 cases in literature,and analyzed the morphology,K-ras mutation,immunophenotype of tumor cells by routine H&E staining,immonohistochemistry,and fluorescence PCR.Then it was compared with 81 cases of intraductal papillary mucinous tumor (IPMT).Results All the 3 patients of ITPN were male,with a median age of 43 years.Two lesions were located in pancreatic head and 1 case in pancreatic body and tail.ITPNs presented as intraductal solid masses,and consisted of cells with uniformly median-to-high grade nuclear atypia,and tumor cells were arranged as glandular and cribriform.One case was accompanied with invasive ductal adenocarcinoma and peripancreatic lymph node metastasis.All tumor cells of epithelial marker cytokeratin was positively expressed,and p53 was positively expressed in some tumor cells.However,CHR,NSE,MUC2 and MUC5AC were negatively expressed,and K-ras mutation was not detected.The tumor cells of IPMT were presented as papillary pattern and cribriform structure was observed.The majority of cells were mucous epithelium,or goblet cells (intestinal type),a few were eosinophilic epithelium (eosinophilic cells type) and cuboidal epithelium (pancreatic,biliary duct type),MUC2 and MUC5AC was positively expressed,and K-ras mutation rate was 50％.Conclusions As a new tumor entity of pancreas,ITPNs show distinctive features with IPMTs.

【Objective】 To study the quality control of human albumin intermediates content in production process using High Performance Liquid chromatography (HPLC) method. 【Methods】 In accordance with the general principles of The Chinese Pharmacopoeia (2015 edition), 3121 human albumin polymer was used to determine the component V precipitation solution, human albumin stock solution, human albumin semi-finished products and human albumin products in the production process of human albumin. The chromatographic retention time and the chromatographic peak area percentage corresponding to the retention time were analyzed. 【Results】 The polymer content of component V precipitation solution, human albumin stock solution, human albumin semi-finished products, and human albumin products were was 0.2% vs 0.0% vs 1.9% vs 1.7%, 0.2% vs 0.0% vs1.8% vs1.5% and 0.1% vs 0.0% vs 1.6% vs 1.5%, respectively. 【Conclusion】 HPLC can be used as a monitoring method for human albumin production.

【Objective】 To establish gas chromatography for the determination of tributyl phosphate(TBP) residues in human prothrombin complex and then verify it. 【Methods】 Acid modified polyethylene glycol(PEG)(20M) capillary column was used with n-hexane as solvent. The chromatographic parameters were as follows: gasification chamber temperature at 220 ℃, column temperature at 155 ℃, detector temperature at 220 ℃, column flow rate at 2.0 mL/min, carrier gas as N2, detector as FID, and collection time for 10min. The accuracy, repeatability, linearity, specificity, intermediate precision, detection limit, quantitative limit, range and durability were verified. 【Results】 The verification results showed that the method had good specificity. The linear regression correlation coefficient of standard curve was 0.999 90. The recovery rate were 98.4%, 97.5% and 95.7% when the concentration at 50%, 100%(30μg/mL) and 150%, respectively, with an average recovery of 97.2% and a relative deviation of 2.15%. When the concentration was 100%, the repeatability was 2.08%, and the relative deviation of intermediate precision was 1.63%. The detection limit was 0.255 μg/mL, and the quantitative limit was 0.511 μg/mL. After changing capillary chromatographic columns with different batch numbers but the same types and manufacturer, the applicability test of the system met the requirements, and the method had good durability. 【Conclusion】 This method can be used for the determination of TBP residues of human prothrombin complex in laboratory.