At present, drug safety has gradually become the focus of world attention, and the study and control of related sub-stances is one of the key elements for drug safety. The national drug standards are also gradually increased the control requirements for related substances. Therefore, the detection and control of related substances are extremely important in the safety of drugs. By summa-rizing the analysis methods for related substances in drugsand their application , the paper alms to provide references for quality control of drugs.

Because of its unique advantages , zebrafish has been more and more widely used in drug screening and safety assessment , environmental protection , developmental biology and other fields . But the standardization of environments, feed, and water environment of zebrafish are prominent problems and weakness which hindered their application .This paper probes into the standardization of environment and feed of zebrafish in Zhejiang , in order to promote its standardization construction .

Recently,thesituationofchemicalsubstancesillegallyaddedinTCMandhealthproductsismoreandmorecomplex and subtle, which not only results in latent danger and harm to customers, but also induce supervision difficulty and challenge for su-pervision departments. The variety and composition of chemical substances added illegally, analytical methods and relative state laws and regulations were illustrated in detail in the paper, which can provide the basis for the rational and safe use of TCM and health prod-ucts, and provide the reference and technology support for the supervision departments.

Objectives To explore the value of Silenz MRA in the follow-up assessment of intracranial aneurysms embolization. Methods Fifteen patients underwent coiled embolization were prospectively collected. Silenz and time of flight MRA (TOF MRA) were performed on the same day as DSA examination. Two neuro-radiologists scored the structures of peripheral vascular with a 4-score grading system and evaluate embolism status (two-grade montreal scale). The scores of vascular structures were compared using Wilcoxon signed rank tests. Weighted Kappa statistics was used to assess the inter-observer agreement on each MRA scoring, the inter-modality agreement between MRA and DSA, the inter-modality agreement between the MRA methods. Results There were 11 cases with complete occlusion, 4 cases with residual aneurysm revealed by DSA. For depiction, Silenz MRA was significantly better than TOF MRA [(3.50 ± 0.62) vs. (3.00 ± 0.63), Z=-3.12, P=0.002]. Inter-modality agreement of Silenz MRA and DSA was excellent (Kappa=0.82), while the agreement of TOF MRA and DSA was moderate(Kappa=0.60). Inter-modality agreement between Silenz MRA and TOF MRA was good (Kappa=0.76). Conclusions Silenz MRA is superior to TOF MRA for depiction of vascular structures and evaluation of embolism status, which is highly related with DSA. It has the value in the postoperative follow-up evaluation.

The clinical data,endoscopic and CT findings of 39 patients with Crohn's disease(CD) and 24 patients with intestinal tuberculosis (ITB) were retrospectively reviewed.Diarrhea,hematochezia,perianal disease,intestinal obstruction,occurred more frequently in CD than in ITB (P ＜0.05 or ＜0.01).Night sweating,febrility,pulmonary tuberculosis and ascites were more common in ITB than in CD (P ＜0.01).The endoscopic findings showed that longitudinal ulcer,cobblestone sign,intestinal stricture were detected more often in CD than in ITB (P ＜ 0.05 or ＜ 0.01),but transverse ulcer and rodent ulcer were more frequently found in ITB than in CD (P ＜0.05 or ＜0.01).On the CT imaging mural gas,fat,enteric cavity stenosis and layering thickening were more common in CD than in ITB (P ＜ 0.05 or ＜ 0.01),but mural single layer thickening and hollow lymph nodes were discovered more frequently in ITB than in CD (P ＜ 0.01).The degree of intestinal wall thickening,enhancement and lymph nodes enlargement of ITB were more severe than that of CD (P ＜ 0.01).The clinical manifestations combined with endoscopic and CT finding may improve the differential diagnosis between Crohn's disease and intestinal tuberculosis.

Objective To investigate the effect of spectral CT monochromatic images for improving imaging quality in hepatic venography.Methods Thirty patients underwent spectral CT examination on a GE Discovery CT 750 HD scanner.During portal phase,1.25 mm slice thickness polychromatic images and optimal monochromatic images were obtained,and volume rendering and maximum intensity projection were created to show the hepatic veins respectively.The overall imaging quality was evaluated on a five-point scale by two radiologists.Inter-observer agreement in subjective image quality grading was assessed by Kappa statistics.Paired-sample t test were used to compare hepatic vein attenuation,hepatic parenchyma attenuation,CT value difference between the hepatic vein and the liver parenchyma,image noise,vein-to-liver contrast-to-noise ratio (CNR),the image quality score of hepatic venography between the two image data sets.Results The monochromatic images at 50 keV were found to demonstrate the best CNR for hepatic vein.The hepatic vein attenuation[(329 ± 47) HU],hepatic parenchyma attenuation [(178 ± 33) HU],CT value difference between the hepatic vein and the liver parenchyma [(151 ± 33) HU],image noise (17.33 ±4.18),CNR(9.13 ±2.65),the image quality score(4.2 ±0.6) of optimal monochromatic images were significantly higher than those of polychromatic images[(149 ± 18) HU],[(107 ± 14) HU],[(43 ±11) HU],12.55 ± 3.02,3.53 ± 1.03,3.1 ± 0.8 (t values were 24.79,13.95,18.85,9.07,13.25 and 12.04,respectively,P ＜ 0.01).In the comparison of image quality,Kappa value was 0.81 with optimal monochromatic images and 0.69 with polychromatic images.Conclusion Monochromatic images of spectral CT could improve CNR for displaying hepatic vein and improve the image quality compared to the conventional polychromatic images.

Objective To develop an ultrasmall superparamagnetic iron oxide(USPIO)based MR probe targeting CD40 mutant and investigate its biological and chemical properties and its targeting effect on ovarian cancer cells in vitro.Methods To prepare immunologically competent probe,the monoclonal antibody was conjugated with USPIO particles modified by DMSA based on chemical crosslinking method.The USPIO labeled anti-human CD40 mutant monoclonal antibody 5H6(5H6-USPIO)was the experimental probe,and the USPIO labeled anti-human CD40 monoclonal antibody 5C11(5C11-USPIO)and USPIO served as control agents.The flow cytometry,confocal microscopy and Prussian blue staining were employed to assess the magnetic performance and analyze its bioactivity of the probe.The probe's cell MR imaging in vitro was carried out using ovarian caner cells(HO8910)with high CD40 mutant expression.The analysis of signal data of different groups was conducted by using one-way ANOVA andLSD test.The probe's effect on ovarian caner cells' growth was measured by CCK-8 kit.Results The stable molecular probe carrying nanoparticles and CD40 mutant antibody was built and purified successfully.The probe had similar magnetic property compared with original USPIO.Immunofluorescence and Prussian blue staining confirmed that the molecular probe could recognize CD40 mutant on ovarian cancer cells(HO8910)with high specificity.The probe had no effect on the growth of HO8910 cells.MR cell imaging in vitro showed that the value of T2 and T2 * decreased significantly after the probe binding with HO8910 cells and T2WI became darker than control groups.The T2 and T2* relaxation time of 5H6-USPIO group was(40.05 ± 1.62)ms and(3.08 ± 0.11)ms,respectively.The T2 and T2 * relaxation time of 5H6-USPIO group was shorter than 5C11-USPIO [(85.38 ± 4.74)and(11.82 ± 1.00)ms,respectively]and USPIO[(91.62 ± 3.35)and(13.60 ± 1.92)ms,respectively]groups with statistical significance(F =196.29,60.73,P ＜0.01).The difference of T2 and T2* relaxation time between 5C11-USPIO and USPIO groups showed no statistical significance (P ＞0.05).Conclusions CD40 mutant antibody can conjugate with ultrasmall superparamagnetic iron oxide particles to form MR molecular probe using chemical crosslinking method.The probe has good magnetic characters and high bioactivity.The probe can specifically bind with HO8910 cells.

Objective To evaluate the clinical results of indirect reduction and fixation with the self-manufactured external fixator as a viable alternative in the surgical treatment of intraarticular calcaneal fractures.Methods From May 2006 to May 2009,a total of 30 patients undergone surgical treatment of intraarticular calcaneal fractures were analyzed,including 20 males and 10 females with an average age of 36 years (range,15-53).According to Sanders classification based on the computed tomography scan of intraarticular calcaneal fractures,16 patients were classified as type-Ⅲ,and 14 type-Ⅳ in this series.All fractures were treated first with the external fixator as indirect reduction and fixation device on the whole,which can enlarge the interspace of the subtalar joint significantly.Then,posterior articular facet of calcaneus was exposed and reduced through a small lateral incision.The calcaneal's length,breadth,thalamus height,maximum vertical displacement of the post-articular surface,and B(o)hler angle were measured preoperatively,3 days and 6 months after operation in X-ray film.Reduction results were evaluated by CT scan according to the standard of Buckley.Results The average follow-up time of all patients was 29 months (range,4-45).Lateral and axial roentgenograms showed satisfactory restoration of the calcaneal's anatomical structure.There were significant differences between preoperative values and those 3 days or 6 months postoperatively.There were no significant differences between values 3 days postoperatively and those 6 months postoperatively.The reduction results of posterior articular facet were evaluated by CT scan.Twenty-seven patients obtained anatomical reduction,3 patients obtained uneven articular facet within 2 mm.Conclusion This selfmanufactured external fixator is a vialbe alternative in the treatment of intraarticular calcaneal fractures,which has advantages of minimal invasion,practicality and less complications.

Objective To explore the value of single source dual energy CT for quantitative measurement of liver fat fraction in the rabbit model of nonalcoholic fatty liver disease(NAFLD).Methods Thirty male New Zealand rabbits were randomly divided into five groups.Six rabbits were fed with standard chow as a control group for 3 weeks.TwentyGfour rabbits were divided into four groups and fed with highGfat, highGcholesterol diet to reach different stage of NAFLD model for 1 ,3 ,4 and 8 weeks respectively before dualGenergy CT scanning.1 40 keV polychromatic CT values (QC),70 keV monochromatic CT values (Mono 70 keV),slope,effective atomic number (EffectiveGZ)and fat concentration based on dualGenergy CT fat decomposition (Fat/Water)were measured.Liver samples were obtained to measure the fat fraction and staged according to Burnt staging system.Correlations between different CT indexes and fat fraction were analyzed.ROC was used to evaluate the diagnosis efficacy of different parameters.Results Correlation between fat concentration based on dualGenergy CT fat decomposition and fat fraction (r＝0.936)was better than that between 140 keV polychromatic CT values (r＝－0.838)and 70 keV monochromatic CT values (r＝－0.906),as well as effective atomic number (r＝－0.858)and slope (r＝0.863).In terms of diagnostic performance of material decomposition fat imaging,the values of area under the curve were 0.944 (stage 0 vs.stage 1 or more severe),0.995 (stage 1 or less severe vs.stage 2 or more severe)and 1 (stage 2 or less severe vs.stage 3)with optimal cutoff values of 59.310,99.5 17 and 22 3.02 3 mg/cm3 ,respectively.Conclusion The dualGenergy CT can quantitatively measure liver fat concentration as a noninvasive surrogate bioGmarker in the rabbit model of nonalcoholic fatty liver disease.DualGenergy CT derived material decomposition fat images can provide more diagnostic information at the early stage of NAFLD.

Objective:To evaluate image quality and diagnostic performance of silent MR angiography (MRA) and discuss the feasibility of silent MRA in diagnosing intracranial aneurysms.Methods:Twenty seven patients suspected with cerebrovascular disorders and 30 intracranial aneurysms in Northern Jiangsu People's Hospital, were enrolled prospectively in this study from December 2015 to December 2018. Silent and time of flight (TOF) MRA were performed on the same day prior to CTA examination. The corresponding MRA images were independently and blindly evaluated by two experienced neuroradiologists in the aspects of signal homogeneity, lesion conspicuity, venous signal/artifact and diagnostic confidence (4-point scale). The aneurysms were divided into tiny (≤ 3 mm) and non-tinyaneurysm groups(> 3 mm) according to the measured diameters of aneurysms. The differences in image quality ratings between silent MRA and TOF MRA were analyzed using Wilcoxon signed rank tests. Intra-class correlation coefficients (ICC) were used to test the consistency of measurements between MRAs (silent MRA, TOF MRA) and CTA.Results:CTA revealed 32 intracranial aneurysms. For silent MRA and TOF MRA, the scores of signal homogeneity were 3.38±0.49 and 3.00±0.62, andthe scores of venous signal/artifact were 3.77±0.42 and 2.65±0.48.Significant differences were found between the two MRAs in these aspects ( Z=-2.21, P=0.02; Z=-5.69, P=0.01). The scores of lesion conspicuity were 3.19±0.56 and 3.15±0.46, and the scores of diagnostic confidence were 3.27±0.44 and 3.12±0.51.There were no significant differences found in these aspects ( P>0.05).The ICC coefficient was excellentfor silent MRA (0.94, 95%CI 0.82- 0.98)and was good for TOF MRA (0.72, 95%CI 0.30-0.91) in tiny aneurysm group. The ICC coefficient was excellent (silent MRA, 0.98, 95%CI 0.95-0.99; TOF MRA, 0.95, 95%CI 0.87-0.98) for both MRA in non-tiny aneurysm group. Conclusions:Compared with TOF MRA, silent MRA could achieve higher image quality and higher diagnostic confidence, and higher consistency with CTA. Silent MRA can be a promising non-contrast-enhanced alternative MRA technique in clinical setting.