Objective To compare the purification process of two types of ceramic hydroxyapatite(CHT I and CHT II)to remove the aggregates from two monoclonal antibodies(mAb 1 and mAb 2).Methods All the chromatography runs were performed on AKTA AVANT 150 with Tricon 10/50 column.The dynamic binding capacity( DBC) of two types of CHT was studied firstly, and then purification research was carried out selecting the suitable DBC.The column was equilibrated with 5 mmol/L sodium dihydrogen phosphate pH 6.5, and then was eluted with gradient buffers which were 10 mmol/L sodium dihydrogen phosphate pH 6.5 and 2 mol/L sodium chloride pH 6.5.Aggregate content in loading and elution pool was evaluated by size exclusion chromatography.Scale-up process was carried on 20 cm height chromatography column XK16/40.Results DBC of CHT I for mAb 1 was 40 mg/mL and mAb 2 was 45 mg/mL.After purity, monomer content of mAb 1 reached 98.6% and yield was 92.5% and monomer content of mAb 2 reached 98.8%and yield was 91.5%.DBC of CHT II for mAb1 was 16 mg/mL and mAb 2 was 20 mg/mL.After purity, monomer content of mAb 1 reached 99.8% and yield was 91.8% and monomer content of mAb 2 reached 99.9% and yield was 92.2%.Conclusion Two types of CHT both can remove aggregates effectively from monoclonal antibodies when aggregate content reaches more than 10%, and results conform to the regulations.CHT I has higher dynamic binding capacity than CHT II, and CHT II is superior to CHT I in removing aggregate efficiency.The purification process is simple and can be easily scaled up in pilot and manufacture.Therefore, it meets the requirement pilot and scale production.

OBJECTIVE Toillustratethepharmacokineticsandpharmacodynamicsofdifferentdos-agesofsustained-releaseimplantofgoserelininrats.METHODS Theratsreceivedasingledoseof sustaineed-release i mplant of goserelin 0.3,0.6 and 1 .2 mg per rat by subcutaneous injection,respec-tively.Concentrations of goserelin and testosterone in plas ma were determined by HPLC-MS/MS.The pharmacokineticparameterswerecalculatedbyWinNonlin6.3.RESULTS Themainpharmacokinetic parameters of the 0.3,0.6 and 1 .2 mg per rat were as fowllows:the area under the concentration-time curve(AUC0-t)was 770 ±96,1534 ±299 and (3233 ±777)μg·L-1·h,and the maximum plasma con-centration(cmax)was 3.7 ±0.3,6.8 ±2.2 and (1 7.6 ±5.4)μg·L-1 ,respectively.Regression analysis was applied to analyze the relationship between AUC0-t and cmax at different doses and those relative coefficients were 0.942 and 0.923 respectively.AUC0-t and cmax increased with the dose in the range of 0.3-1 .2 mg per rat.As for other main pharmacokinetic parameters (peak time,half life,mean resi-dence time,clearance and apparent volume of distribution),there was no significant difference between the three groups.Testosterone plasma concentration reached the highest level following administration and then kept decreasing to low concentrations.Between 28 d and 35 d,testosterone plas ma concentra-tionslowlyincreasedtothenormallevel.CONCLUSION Pharmacokineticcharacteristicsofsustained-release implant of goserelin in rats show a linear relationship,within the dose range of 0.3-1 .2 mg per rat.The results from pharmacodynamic data show that testosterone does not change in a dose-depend-ent manner at a dose ranging from 0.3 to 1 .2 mg per rat.Testosterone plasma concentration decreases to theoretical castrate level (0.5 μg·L-1 )after 4 d following a dose of 0.6-1 .2 mg per rat.

A stable HMG-CoA reductase (HMGR) reaction in vitro was developed by a sensitive, selective and precise liquid chromatography–tandem mass spectrometry (LC–MS/MS) method. The optimized enzyme reac-tion condition contained 1.5μg of HMGR, 20 nM of NADPH with 50 min of reaction time. The method was validated by several intra-and inter-day assays. The production transitions of m/z 147.0/59.1 and m/z 154.0/59.1 were used to detect and quantify mevalonolactone (MVAL) and MVAL-D7, respectively. The accuracy and precision of the method were evaluated over the concentration range of 0.005–1.000μg/mL for MVAL and 0.010–0.500μg/mL for lovastatin acid in three validation batch runs. The lower limit of quantitation was found to be 0.005μg/mL for MVAL and 0.010μg/mL for lovastatin acid. Intra-day and inter-day precision ranged from 0.95%to 2.39%and 2.26%to 3.38%for MVAL, 1.46%to 3.89%and 0.57% to 5.10% for lovastatin acid, respectively. The results showed that the active ingredients in Xuezhikang capsules were 12.2 and 14.5 mg/g, respectively. This assay method could be successfully applied to the quality control study of Xuezhikang capsule for the first time.

Objective To learn the economic operation and the existing problems of county TCM hospitals in Chongqing from 2012 to 2014.Methods 2012-2014 data of annual health financial report were used to conduct descriptive statistics and analysis of the current operation benefit, operating efficiency, debt paying ability, development ability, and cost management ability.Results From 2012 to 2014, the annual incomes of TCM county hospitals in Chongqing were 2.802, 3.412, and 4.385 billion RMB; the annual expenses were 2.813, 3.343, and 4.347 billion RMB; the ratios of income and expense about medical treatment were 0.86, 0.90, and 0.92; the ratios of income and expense of medicine were 1.16, 1.15, and 1.11; the outpatient amounts were 5.45, 5.87, and 6.99 million; the hospital discharge amounts were 330.4, 405.2, and 469.3 thousand; the charges per patient were 153.40, 177.12, and 188.71 RMB; the charges pre bed were 465.83, 533.14, and 571.02 RMB; medical expenses per patient were 4923.26, 5416.77, and 5576.01 RMB; the current ratios were 1.00, 1.06, and 1.09; the asset-liability ratios were 62.25%, 63.79%, and 61.37%; the annual growth rates of total assets were 14.06 % and 24.54%, and the annual growth rates of net assets were 19.44% and 21.70% during 2013 to 2014; 100-yuan hygienic materials and medicine consumption were 51.23, 51.10, and 50.07 RMB during 2012 to 2014; the management fee rates were 18.55%,15.44%, and 14.82%.Conclusion The general economic running of county TCM hospitals in Chongqing is stable and financial balance moves towards rationality; social benefit, expand capacity and cost management ability are enhanced gradually. However, the problems about insufficient government finance input, small medical income elasticity, poor debt paying ability, and diseconomies of scale still exist.

OBJECTIVETo investigate the isoflavones from the vines of Pueraria lobata.

METHODThe compounds were isolated by column chromatography over silica gel and RP-C18, and purified by Sephadex LH-20 column chromatography and preparative TLC. The structures were elucidated on the basis of physico-chemical properties and spectral data.

RESULTTwelve compounds were isolated and identified as: 3'-methoxydaidzein (1), formononetin (2), genistein (3), daidzein (4), daidzin (5), genistin (6), ononin (7), 5-hydroxyl ononin (8), calycosin (9), 6"-O-acetyl genistein (10), 6"-O-acetyl daidzin (11), puerarin (12).

CONCLUSIONFor the first time, compounds 9-11 were isolated from the genus Pueraria plant, and compounds 1, 3, 6-8 were obtained from the vines of this plant.

Genistein ; chemistry ; Glucosides ; chemistry ; Isoflavones ; chemistry ; Magnetic Resonance Spectroscopy ; Plant Stems ; chemistry ; Pueraria ; chemistry

A sero-epidemiological survey on 1 833 healthy residents was carried out in 6 villages of a leprosy high-endemic area in Wenshan and Guangnan counties, Yunnan Province. The part of the residents with initially antibody-positive as well as the part of residents with initially antibody-negative have been followed up for 3 consecutive years by serology and clinical examination for studying kinetic changes of antibody to M.leprae and its relation with clinical disease. The results showed that the rates of subclinical infection of leprosy in a high-endemic area are different from village to village, and the risk of developing clinical disease does not associate with subclinical infection rate. It correlates with the number of cured accumulative leprosy cases and active cases within the village. The authors consider that in leprosy high-endemic villages, especially those cropped up new multi-bacillary leprosy cases frequently in recent years, it may be helpful to use serology to detect early leprosy cases.

Objective:To explore the predictive value of helper T cell(Th)immune response indicators for asthma control in children with cough variant asthma(CVA)and its relationship with the risk of recurrence.Methods:A total of 112 children with CVA in Hengshui City People's Hospital from August 2020 to August 2021 were selected,all received conventional western medicine treat-ment,and were divided into well-controlled group(n=85)and poorly-controlled group(n=27)according to their asthma control status after 4 weeks of treatment.compare the general data,pulmonary function indexes before treatment[forced expiratory volume in 1 se-cond(FEV1),FEV1/forced vital capacity(FVC)],Th immune response indexes(Th1/Th2,IL-2,IFN-γ,IL-4,IL-10)levels,ana-lyze the correlation between Th immune response indicators and pulmonary function indicators,and predict the value of asthma control in children with CVA.After 6 months of follow-up,the recurrence situation in the well-controlled group was counted,the Th immune response indexes before treatment were compared between the children with recurrence and those without recurrence,and the relation-ship between Th immune response indexes and recurrence were analyzed.Results:Before treatment,the levels of FEV1,FEV1/FVC,Th1/Th2,IL-2 and IFN-γ in the poor control group were lower than those in the well-controlled group,and the levels of IL-4 and IL-10 were higher than those in the well-controlled group(P<0.05).Th1/Th2,IL-2,IFN-γ levels were positively correlated with FEV1,FEV1/FVC before treatment in children with CVA,and IL-4,IL-10 levels were negatively correlated with FEV1,FEV1/FVC(P<0.05);the areas under the curve(AUC)of Th1/Th2,IL-2,IFN-γ,IL-4 and IL-10 levels before treatment for predicting poor asthma control in children with CVA were all>0.7,and the combined predicted AUC(0.933)was the largest;before treatment,the levels of Th1/Th2,IL-2 and IFN-γ in the relapsed children in the group were lower than those of the non-relapsed children,and the levels of IL-4 and IL-10 were higher than those of the non-relapsed children(P<0.05);The levels of Th1/Th2,IL-2,and IFN-γ before treat-ment were negatively correlated with CVA recurrence,while IL-4 and IL-10 levels were positively correlated with CVA recurrence(P<0.05).Conclusion:Th immune response index has a certain value in predicting asthma control in children with CVA,and is closely related to the recurrence of CVA.

Objective To verify the performance of LIAISON chemiluminescence immunoassay analyzer in the prenatal screening for TORCH .Methods Reference to the US Institute of Clinical and Laboratory Stand-ards(NCCLS) series of documents and literature and combining with actual work ,we designed the verification program ,and tested and evaluated the LIAISON chemiluminescent immunoassay systems for the measurement precision ,accuracy ,linearity analysis ,clinical reportable range and biological reference intervals of Tox IgG , Tox IgM ,Rub IgG ,Rub IgM ,CMV IgG ,CMV IgM ,HSV IgG ,HSV IgM .We also compared the results with analysis performance provided by manufacturers (Italy LIAISON ) or recognized quality indicators .Results Intra-assay imprecision CV values were between 3 .58％ -7 .03％ ,which were less than the predetermined range;inter-assay imprecision CV values were between 3 .13％ -10 .73％ .Linear range validation regression coefficients a values were between 0 .97 -1 .03 and r2 >0 .95 .The linear relationship met the requirements . Both biological reference interval and reportable range meet the requirements .Conclusion The performance of LIAISON chemiluminescence immunoassay detection system satisfied the clinical requirements ,and the meas-urement results had advantages of high sensitivity ,specificity ,stability ,wide detection range ,good accuracy and repeatability ,which was suitable for clinical application .

Objective:To synthesize the real experiences of medical staff's organizational silence behavior.Methods:A systematic search was conducted in databases including PubMed, Web of Science, Embase, Cochrane Library, CINAHL, EBSCO, ProQuest, China National Knowledge Infrastructure, Wanfang Data, VIP, and China Biology Medicine disc, collecting qualitative studies on medical staff's experiences related to organizational silence behavior. The search period covered the establishment of the databases until June 2024. The quality of the included studies was assessed using the Joanna Briggs Institute's qualitative research quality evaluation standards, and results were integrated using an aggregative synthesis approach.Results:A total of 10 studies were included, with 65 findings summarized into 11 new categories, which were further synthesized into four overarching conclusions: organizational silence is complex, with respect and concern coexisting, many factors contribute to organizational silence, medical staff experience negative emotions as a result of organizational silence, there is a desire for recognition and support.Conclusions:The experience of organizational silence behavior among medical staff is complex. Managers should focus on this issue, encourage individuals to voice their concerns, provide diverse support mechanisms, and enhance positive experiences to reduce the prevalence of organizational silence.

The reuse of high-cost single-use medical devices (SUD) is permitted in many countries, such as the United States, Germany and the United Kingdom, but strict regulatory requirements must be met. In addition to regulatory policies and regulations, such as market access mode and special requirements on Good Manufacture Practice (GMP), there are strict technical requirements on the potential risk control and quality assurance system. Therefore, effective risk assessment and risk control technology are the keys to ensure effective quality control and safe use of SUDs. In this article, based on analyzing the technological requirements of the national regulatory on SUDs in the United States, Germany and Britain, and combined with the review from latest relevant literature, to discuss the strategies of how to carry out scientific risk assessment. Some risk control technologies on the reuse of SUDs are introduced, which will provide support for the further study on risk control strategies and regulatory decisions for the reuse of SUDs in China.