Determination of Immunoglobulin Content in Humoral Immunity Evaluation of Biomedical Material Products by Cytometric Beads Array / 中国医疗器械杂志

In this study, cytometric beads array(CBA) was used to determine the immunoglobulin content in humoral immunity evaluation of biomedical materials. The bovine-derived acellular dermal matrix was selected as a test sample and implanted into Balb/C mice subcutaneously to 4 weeks according to the high, medium and low dose groups. Four weeks later, IgG1, IgG2a, IgG2b, IgG3, IgA, and IgM were measured by CBA. The data of the test group and the control group were analyzed statistically. The results showed that compared with the negative control group, there was no significant difference in the IgG3, IgA content in the positive control group, while the IgG1, IgG2a, IgG2b, and IgM contents were significantly higher than the negative control group; no significant differences were seen in the sample groups. The results show that the method is suitable for analysis of immunoglobulin content in humoral immunity evaluation of biomedical materials.

Current Progress on Biological Evaluation for Medical Devices / 中国医疗器械杂志

To broadly understand the new direction of biological evaluation for medical devices, we introduced both domestic and international progress of biological evaluation and focused on illustrating the key points on full life-cycle biological evaluation, toxicological risk evaluation, evaluation endpoints and package material evaluation concern as well as how to use the update vision of ISO 10993-1:2018 scientifically and reasonably in order to provide us better services on performing biological evaluation for medical devices.

Application of the Threshold of Toxicological Concern (TTC) to Biological Evaluation of Medical Devices / 中国医疗器械杂志

The threshold of toxicological concern (TTC), a risk estimation method based on compound structurally-related toxicity data, has been widely used by many countries and regions for the safety risk assessment of food packaging materials and additives etc. Toxicological risk estimation is of importance in the biological evaluation of medical devices. Application of the TTC approach to leachable from medical devices may reduce or replace some unnecessary biocompatibility tests, but consideration should be taken for contact duration and route differences, which could affect the applicability of TTC. We herein focused on analyzing the eligibility of TTC for its further application in biological evaluation of medical devices.

Application of clinical cases related problem-based-learning in critical care medical education / 中华医学教育探索杂志

Objective To evaluate the application of clinical cases related problem-based-learning (PBL) method in critical care medical standardized resident training program. Methods 84 residents were randomly divided into experimental group (n=42) and control group (n=42) by lottery way. The experimental group received PBL process during clinical case analysis while the control group learned completely through traditional teaching method . The residents' clinical competence were assessed by multiple scale mixed method including question bank examination (QBE), case-based discussion (CBD), direct observation of procedural skills (DOPS), simulation etc, and Likert-type scale questionnaire was used to evaluate the feedback of training residents. SPSS 17.0 was used to do line t test to the data of both groups. Results Finally 84 residents finished the study. There were no difference in the general conditions in two groups. The PBL group achieved higher examination score during QBE [(80.26 ±8.89) vs. (86.10 ±9.32)], CBD [(84.83±5.43) vs. (75.36±6.06)], DOPS [(88.81±6.68) vs. (82.70±6.98)], simulation [(79.86±10.09) vs.(72.71±9.30)]. Except two groups residents all gave high scores in enhancing cross connection in clinical knowledge [(4.786±0.470) vs. (4.571±0.859), P=0.16], and the questionnaire results showed that the resi-dents of PBL group gave higher points in exciting autonomous learning, improving clin-ical analysis ability, accelerating clinical thinking establish, developing independent thinking habits, improving the clinical communication skills and teamwork ability (P<0.05). Conclusion The clinical cases related PBL method can improve the training effects during critical care medical standardized resident training program. It can be used broadly after adapting modification in critical care medical education.

Preparation and characterization of polyhydroxyalkanoate bioplastics with antibacterial activity / 生物工程学报

Polyhydroxyalkanoates (PHAs), as a novel class of biopolymer, are attracting more attention due to their diverse material properties and environment-independent biodegradability. Here we report the preparation of PHA exhibiting efficient antibacterial activity by embedding Nisin, a food additive generally recognized as safe, into poly(3-hydroxybutyrate-co-3-hydroxyhexanoate) (PHBHHx), a type of PHA with high biocompatibility. We first prepared Nisin-containing PHBHHx films using solvent casting method. Confocal laser scanning microscopy analysis showed that a well-mixed integrated structure of the films with an even distribution of the Nisin particles in the PHBHHx matrices. Then the antimicrobial activity of PHBHHx/Nisin films against Micrococcus luteus was quantified on agar plate by measuring the size of inhibition zone. Cultivation in liquid media further confirmed the releasing of Nisin from the films and the long-time antibacterial activity. Results showed that the threshold of Nisin concentration for long-time and effective inhibition against bacteria growth is 25 μg/g. These results altogether establish a technological foundation for the application of PHA in biomedicine and food industry.

Changes of serum levels of myeloperoxidase and lipoxin A 4 in patients with coronary heart disease and its significance / 心血管康复医学杂志

Objective:To observe changes of serum levels of myeloperoxidase (MPO) and lipoxin A4 (LXA4) in pa‐tients with coronary heart disease (CHD) and explore its clinical significance .Methods :A total of 120 CHD patients treated in our hospital from Jun 2013 to Sep 2014 were selected as CHD group ,another 40 healthy subjects were re‐garded as normal control group .According to CHD type ,patients were divided into stable angina pectoris (SAP) group (n=36) ,unstable angina pectoris (UAP) group (n=46) and myocardial infarction (MI) group (n=38) .Ac‐cording to plaque nature assessed by CT value ,patients were divided into calcified plaque group (n= 27) ,mixed plaque group (n=31) and non-calcified plaque group (n=62) .Levels of MPO and LXA4 and ratio of MPO/LXA4 were compared among all groups .Results:Compared with normal control group ,there were significant rise in MPO level [ (167.2 ± 20.4) U/L vs .(218.3 ± 32.5) U/L] and MPO/LXA4 [ (0.78 ± 0.08) vs .(1.34 ± 0.27)] ,and sig‐nificant reduction in LXA4 level [ (214.6 ± 31.3) nmol/L vs .(162.4 ± 22.4) nmol/L] in CHD group ,P<0.05 or<0.01 .Compared with SAP group ,there were significant rise in MPO level [ (180.4 ± 21.6) U/L vs .(230.3 ± 32.5) U/L vs .(238.6 ± 44.7) U/L] and MPO/LXA4 [ (0.97 ± 0.11) vs .(1.37 ± 0.23) vs .(1.62 ± 0.25)] ,and significant reduction in LXA4 level [ (184.7 ± 23.7) nmol/L vs .(156.3 ± 21.2) nmol/L vs .(148.4 ± 19.6) nmol/L] in UAP group and MI group ,and MPO/LXA4 of MI group was significantly higher than that of UAP group , P<0.05 or < 0.01 . Compared with calcified plaque group and mixed plaque group , there were significant rise in MPO level [(196.3 ± 27.2) U/L vs .(211.2 ± 24.6) U/L vs .(231.6 ± 26.5) U/L] and MPO/LXA4 [(1.13 ± 0.14) vs .(1.26 ± 0.16) vs .(1.51 ± 0.21)] ,and significant reduction in LXA4 level [ (174.3 ± 23.4) nmol/L vs .(167.4 ± 21.2) nmol/L vs .(154.6 ± 19.2) nmol/L] in calcified plaque group ,and MPO/LXA4 of mixed plaque group was significantly higher than that of calcified plaque group , P<0.05 or <0.01 .Conclusion:There exist significant ab‐normal levels of MPO and LXA4 in CHD patients ,ratio of MPO/LXA4 is more helpful for determining disease se‐verity and stability of atherosclerotic plaque .

Study of collagen sponge extracts on mouse splenic lymphocyte transformation in vitro / 中国医疗器械杂志

Immunogenicity for medical devices of animal origin is the key and difficult point during immune safety evaluation for these devices. This paper firstly investigated the effect of collagen sponge of animal origin on mouse splenic lymphocyte transformation and proliferation, and then analyzed the influence factors on the MTT method and CFSE method. The results showed that collagen sponge extract cannot significantly induce transformation and proliferation of mouse splenic lymphocyte in vitro.

Sphingosine 1-phosphate prolongs action potential duration and inhibits voltage-dependent potassium current in guinea-pig ventricular myocytes / 基础医学与临床

Objective To investigate the effect and mechanism of sphingosine 1-phosphate(S1P)on action potential(AP)and voltage-dependent potassium current(KV)in isolated guinea pig ventricular myocytes.Methods The ventricular myocytes were isolated by using Langendorff perfusion method.The AP and KV were recorded by whole cell patch-clamp recording technique.Results S1P prolonged the 50% and 90% action potential duration(APD50 and APD90)and decreased KV which were blocked by pertussis toxin(PTX)or Calphostin C.Conclusion S1P decreased KV in a PKC pathway and prolonged action potential duration in guinea-pig ventricular myocytes.

Effect of chronic variable stress on forced swimming test of rats and parallel changes of hippocampus structure / 吉林大学学报(医学版)

Objective To observe the effect of chronic variable stress on the forced swimming test of rats,and investigate its preliminary mechanism.Methods First a mark was given to each Wistar rat by forced swimming test.12 Wistar rats which had similar scores were selected and divided into control group and model group averagely.The behavior changes of rats were induced in the forced swimming test by chronic stress and the plasma cortisol level was analyzed through radioimmunoassay(RIA) methods.The changes of hippocampus CA3 structure were observed with microscope.Results Compared with control group,chronic variable stress increased immobility time,reduced climbing time evidently and enhanced the weight of adrenal gland and the level of plasma cortisol(P

Analysis of Medicine-related Issues in New "Patent Law" / 中国药房

OBJECTIVE:To facilitate Chinese pharmaceutical industry's understanding and application of the new "Patent Law".METHODS:The amendment of the "Patent Law" related to 3 aspects of medicine,i.e.specifying regulations on the information disclosure in the utilization of genetic resources,adding the clause of forced permission for the patent drugs for the purpose of public health,and introducing the Bolar exception clause was analyzed using law hermeneutic.RESULTS & CONCLUSIONS:The medicine-related amendment of the new "Patent Law" generally reflects an international tendency of restricting pharmaceutical patents so as to maintain public interests,which is in line with the status quo of low technological level of pharmaceutical industry in China.

Property analysis of voltage-dependent potassium channel in human peripheral blood lymphocytes and its subset / 吉林大学学报(医学版)

Objective:To analyse the property of voltage-dependent potassium 〔K(v)〕 channel in healthy people′s peripheral lymphocyte so as to contribute the control for property alteration under some pathological condition,and to try to find the new subset of this channel.Methods:Patch-clamp whole cell recording technique was used.Results:In the recorded 39 cells,activated voltage of the channels was -40.3±2.5 Mv.No inactivation phenomenon appeared under repeated stimulation.The closing time of the channels was 116.3+8.2 ms under the repolarization,and the current could be inhibited by 10 mmol/L TEA.Conclusion:There might be only one type of K(v) channel in human peripheral blood lymphocytes,and its properties quite resumble the type of n K(v) channel in mice.

Simultaneous determination and correlation study on the active constituents in Salvia miltiorrhiza Bge / 中成药

AIM:To establish a simple and accurate HPLC method for quality evaluation and determination of 8 active constituents, i.e. Danshensu, Protocatechualdehyde,rosmarinic acid,Salvianolic acid B, Dihydrotanshinone, Cryptotanshinone, Tanshinone Ⅰand Tanshinone ⅡA in Radix Salviae Miltiorrhizae, at the same time, in order to study the correlations of the contents of the 8 constituents. METHODS: Detected at 286 nm, analytes were separated on a ODS C_ 18 column(150 mm?4.6 mm, 10 ?m) eluted gradually with methanol and 1% tetrafuran in 1% formic acid water solution(3∶97)on the increasement of methanol from 3% to 70% in the whole analysis. After determination, SPSS 13.0 software was used to calculate the correlation between the 8 constituents. RESULTS: Under the above conditions, HPLC method was constructed to quantify 8 constituents,and their correlation coefficients were calculated. CONCLUSION: The result shows that the contents of the 8 constituents in Salvia miltiorrhiza Bge. vary greatly from different origins; and there are significant correlations between the contents of hydrophilic constituents such as Salvianolic acid B,Danshensu,rosmarinic acid, so do hydrophobic constituents like Cryptotanshinone,Tanshinone Ⅰ,Tanshinone ⅡA,but there is no correlation between the hydrophilic constituents and hydrophobic constituents.