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11 result(s) for "安全性评价"
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三种林蛙油内重金属的含量测定及食用安全性评价
为初步了解林蛙油重金属的污染现状,采集东北林蛙、黑龙江林蛙和中国林蛙的林蛙油,以湿法消化法消化,利用荧光比色法测定锡含量、原子吸收法分别检测镉、铬、铜和铅的含量,并采用单因子污染指数及每周可耐受摄入量分别评价5种重金属在3种林蛙油中的污染程度并对其食用安全进行评价。结果表明,该批次样品中东北林蛙蛙油重金属含量分别为锡10~20、镉50~90、铬670~720、铜100~250和铅60~90 μg/kg; 黑龙江林蛙蛙油重金属含量分别为锡12~22、镉80~110、铬700~820、铜150~250和铅80~100 μg/kg; 中国林蛙蛙油重金属含量分别为锡2~10、镉30~60、铬590~700、铜800~130和铅30~60 μg/kg,5种金属分别在3种林蛙油内的含量差异显著。单因子污染指数结果显示3种林蛙油中锡、铅的含量均未超过轻度污染指数; 铬、镉的含量,除中国林蛙蛙油中铬为轻度污染,其余皆为中度污染,根据样本数据可知仅黑龙江林蛙油镉超标40%,其余皆在食品污染物限量国家标准范围之内。根据每周可耐受摄入量评定,其结果显示3种林蛙油的食用风险依次是铬>镉>铜>铅>锡。因此本批次所检测的林蛙油可食性良好,但仍有必要监测林蛙油中镉、铬的含量。
Substrate-dependent modulation of the catalytic activity of CYP3A by erlotinib
Aim: To ascertain the effects of erlotinib on CYP3A, to investigate the amplitude and kinetics of erlotinib-mediated inhibition of seven major CYP isoforms in human liver microsomes (HLMs) for evaluating the magnitude of erlotinib in drug-drug interaction in vivo. Methods: The activities of 7 major CYP isoforms (CYPIA2, CYP2A6, CYP3A, CYP2Cg, CYP2D6, CYP2C8, and CYP2E1) were assessed in HLMs using HPLC or UFLC analysis. A two-step incubation method was used to examine the time-dependent inhibition of erlotinib on CYP3A. Results: The activity of CYP2C8 was inhibited with an IC50 value of 6.17±2.0 pmol/L. Erlotinib stimulated the midazolam l'-hydroxy reaction, but inhibited the formation of 6β-hydroxytestosterone and oxidized nifedipine. Inhibition of CYP3A by erlotinib was substratedependent: the IC50 values for inhibiting testosterone 6β-hydroxylation and nifedipine metabolism were 31.3±8.0 and 20.5±5.3 μmol/L, respectively. Erlotinib also exhibited the time-dependent inhibition on CYP3A, regardless of the probe substrate used: the value of K+ and kinact were 6.3 pmol/L and 0.035 min-1 for midazolam; 9.0 pmol/L and 0.045 min-1 for testosterone; and 10.1 μmol/L and 0.058 min^-1 for nifedipine, Conclusion: The inhibition of CYP3A by erlotinib was substrate-dependent, while its time-dependent inhibition on CYP3A was substrate- independent. The time-dependent inhibition of CYP3A may be a possible cause of drug-drug interaction, suggesting that attention should be paid to the evaluation of erlotinib's safety, especially in the context of combination therapy.
Pharmacokinetics and pharmacodynamics of SCT800, a new recombinant FVIII, in hemophilia A mice
Aim: SCT800 is a new third-generation recombinant FVill agent that is undergoing promising preclinical study. This study aimed to investigate the pharmacokinetic and pharmacodynamic profiles of SCT800 in hemophilia A mice. Methods: After hemophilia A mice were intravenously injected with single dose of SCT800 (80, 180, and 280 IU/kg) or the commercially available product Xyntha (280 IU/kg), pharmacokinetics profiles were evaluated based on measuring plasma FVIIh C. For pharmacodynamics study, dose-response curves of SCT800 and Xyntha (1-200 IU/kg) were constructed using a tail bleeding model monitoring both bleeding time and blood loss. Results: Pharmacokinetics profile analysis showed a dose independency of SCT800 ranging from 80 to 280 IU/kg and comparable pharmacokinetic profiles between SCT800 and Xyntha at the doses tested. Pharmacodynamics study revealed comparable ED50 values of SCT800 and Xyntha in the tail bleeding model: 14.78 and 15.81 IU/kg for bleeding time, respectively; 13.50 and 13.58 IU/kg for blood loss, respectively. Moreover, at the doses tested, the accompanying dose-related safety evaluation in the tail bleeding model showed lower hypercoagulable tendency and wider dosage range potential for SCT800 than Xyntha. Conclusion: In hemophilia A mice, SCT800 shows comparable pharmacokinetics and pharmacodynamics to Xyntha at the doses tested, and possibly with better safety properties.
Safety evaluation for railway vehicles using an improved indirect measurement method of wheel-rail forces
The wheel-rail force measurement is of great importance to the condition monitoring and safety evaluation of railway vehicles. In this paper, an improved indirect method for wheel-rail force measurement is proposed to evaluate the running safety of railway vehicles. In this method, the equilibrium equations of a suspended wheelset are derived and the wheel-rail forces are then be obtained from measured suspension and inertia forces. This indirect method avoids structural modifications to the wheelset and is applicable to the long-term operation of railway vehicles. As the wheel-rail lateral forces at two sides of the wheelset are difficult to separate, a new derailment criterion by combined use of wheelset derailment coefficient and wheel unloading ratio is proposed. To illustrate its effectiveness, the indirect method is applied to safety evaluation of railway vehicles in different scenarios, such as the cross wind safety of a high-speed train and the safety of a metro vehicle with hunting motions. Then, the feasibility of using this method to identify wheel-rail forces for low-floor light rail vehicles with resilient wheels is discussed. The values identified by this method is compared with that by Simpack simulation for the same low-floor vehicle, which shows a good coincidence between them in the time domain of the wheelset lateral force and the wheel-rail vertical force. In addition, use of the method to determine the high-frequency wheel-rail interaction forces reveals that it is possible to identify the high-frequency wheel-rail forces through the accelerations on the axle box.
Synthesis and Characterization of a Hydroxyethyl Derivative of Chitosan and Evaluation of Its Biosafety
Hydroxyethyl chitosan (HE-chitosan) is a water-soluble derivative of chitosan with many apparent biological properties. For example, it is non-toxic and rapidly biodegradable. Moreover, HE-chitosan has advantages in water-solubility, moisture retention and gelling property due to its hydroxyethyl group. However, the biocompatibility and biodegradability of this multifimctional de- rivative have rarely been documented although they are critical for its application in biomedical and clinical treatments. The purpose of this work was to evaluate the biosafety of HE-chitosan, and draw important clues for its diverse applications. HE-chitosan was synthesized and characterized its chemical structure with FTIR. Its molecular weight (Mw) was determined by gel permeation chro- matography (GPC), and its deacetylation degree (DD) was investigated through potentiometric analysis. The cytotoxicity of HE-chitosan on mouse fibroblast cell L929 was tested. The biocompatibility and biodegradability of HE-chitosan in rat and rabbit were evaluated. The FTIR results indicated that the hydroxyethyl groups were linked to C6 of chitosan. The GPC analysis confirmed that its Mw was about 90.01 kDa. It was also demonstrated that HE-chitosan had excellent biocompatibility and biodegradability in vivo and had no cytotoxicity on L929. These findings indicated that HE-chitosan can potentially be applied as a biomaterial in tissue engineering, drug delivery, and other biomedical fields.
Consecutive combined response spectrum
Appropriate estimates of earthquake response spectrum are essential for design of new structures, or seismic safety evaluation of existing structures. This paper presents an alternative procedure to construct design spectrum from a combined normalized response spectrum (NRSc) which is obtained from pseudo-velocity spectrum with the ordinate scaled by different peak ground amplitudes (PGA, PGV, PGD) in different period regions. And a consecutive function./(/) used to normalize the ordinates is defined. Based on a comprehensive study of 220 strong ground motions recorded during recent eleven large worldwide earthquakes, the features of the NRSc are discussed and compared with the traditional normalized acceleration, velocity and displacement response spectra (NRSA, NRSv, NRSD). And the relationships between ground amplitudes are evaluated by using a weighted mean method instead of the arithmetic mean. Then the NRSc is used to define the design spectrum with given peak ground amplitudes. At last, the smooth spectrum is compared with those derived by the former approaches, and the accuracy of the proposed spectrum is tested through an analysis of the dispersion of ground motion response spectra.
A Novel Linear Relationship for Calculating Dynamic Shear Modulus of Geomaterials
The dynamic shear modulus G of soil was determined using a dynamic triaxial test system(DTTS) together with a fitting method.First,a novel linear relationship between G and damping ratio λ was proposed,which was used to select the appropriate G.Then,a hyperbolic model was constructed using the optimized parameters a and b representing the intercept and slope,respectively,from the linear regression of 1/G and dynamic shear strain γd.Finally,the differences between the tested and predicted results for G were analyzed for different soil types.The experimental results show that this linear relationship can overcome the shortcomings of the nonlinear relationship found in the large deformation stage and can predict λ in the hysteresis loop that is not closed case.In addition to Baoji loess,G was slightly larger(10%) than the experimental curve in the elasto-plastic stage;however,the experimental results show that the attenuation curve of G for Baoji loess is greater than the calculated value in the elasto-plastic stage.The test and analysis results will improve the knowledge of the dynamic properties of soils and also provide reliable values of G for further evaluation of seismic safety at engineering sites.
Dynamic interaction numerical models in the time domain based on the high performance scaled boundary finite element method
Consideration of structure-foundation-soil dynamic interaction is a basic requirement in the evaluation of the seismic safety of nuclear power facilities. An efficient and accurate dynamic interaction numerical model in the time domain has become an important topic of current research. In this study, the scaled boundary finite element method (SBFEM) is improved for use as an effective numerical approach with good application prospects. This method has several advantages, including dimensionality reduction, accuracy of the radial analytical solution, and unlike other boundary element methods, it does not require a fundamental solution. This study focuses on establishing a high performance scaled boundary finite element interaction analysis model in the time domain based on the acceleration unit-impulse response matrix, in which several new solution techniques, such as a dimensionless method to solve the interaction force, are applied to improve the numerical stability of the actual soil parameters and reduce the amount of calculation. Finally, the feasibility of the time domain methods are illustrated by the response of the nuclear power structure and the accuracy of the algorithms are dynamically verified by comparison with the refinement of a large-scale viscoelastic soil model.
Kunming Institute of Zoology, Chinese Academy of Sciences, acquires GLP certification from the CFDA
The Center for Drug Safety Evaluation from the Kunming Institute of Zoology (KIZ) acquired Good Laboratory Practice (GLP) Certification from the China Food and Drug Administration (CFDA) on June 30, 2015. This is the second pre-clinical safety evaluation organization to have obtained GLP Certification in the Yunnan Province and within the Chinese Academy of Sciences, and is also the first GLP center to have qualification for toxicokinetics testing in Yunnan.
A Novel Approach for Evaluation of Food Functions and Safety Applied in RR GM Soybeans
[Objective] This study aimed to evaluate tbe healthy risk of genetically modified ( GM ) soybeans by using a novel approach for functions and safety of food. [ Me~od] Different from traditional evaluation of substantial equivalence, three great innovations were performed in this study, involving in basic diet, evalu- ation approaches and principle, as well as the clarification of connotation differences between absolute and relative mass of organs. Hence a novel BDI-GS (Bendib Damage Index and General Score) evaluation approach was established and applied in comparative evaluation between RR GM and natural soybeans. Healthy male ICR mice during linear growth were selected; experimental mice were fed with 15% RR GM soybeans and 15% natural soybeans blending maize meal diets, and control mice were fed with single maize meal diet for 13 d; the mice were dissected after collecting blood samples and perfectly obtained nine organs or tissues to re- cord their masses and conduct statistical analyses. [Result] Plenty of matching information was obtained through simple design. The growth performance of treated mice was markedly of individual differences, some mice were thwarted due to regular intake of RR soybeans. Meanwhile, the functions and safety of RR soybeans were markedly lowered in overall nutritional and healthy effects than those of natural soybeans expressed in GS values, and presents some declines in nutrition and health of thymus, pancreas and spermary; especially, it can make thymus immune (P 〈0.05) in markedly lower level than that of natural soybeans. [ Conclusion] Therefore, major troubles and risks of RR soybeans intake are of personal risks in different degrees, in addition, it may increase sub-health and related chronic epi- demics risks, and herein it will presents certain safety issues. The creation of this novel evaluation system provides a simple and available evaluation approach for functions and potential risks revelation of food effects, and will yield far-reaching influences to safety evaluation and healthy development of GM foods, as well as public health.