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

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 .

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.

Some single-use medical devices are reprocessed and reused in some countries in the world, but the regulatory approach is different, and in some countries it isn't regulated yet. In this article, the regulatory status quo of single-use medical devices is reviewed. The regulatory development, important regulatory documents and regulatory approaches of single-use medical device reprocessing in the United States, Germany and the UK are introduced. And how to perform scientific risk assessment and effective risk control is discussed. The information is useful to establish China-specific regulations, and to develop relevant standards, guidelines or specifications and the risk control strategies.
China ; Equipment Reuse ; Equipment Safety ; Equipment and Supplies ; Risk Assessment ; United States

AIM: To establish an LC-MS/MS method to determine the concentration of ambrisentan in human plasma and apply it to the study of human pharmacokinetics. METHODS: After extracting ambrisentan and internal standard from human plasma by liquid-liquid extraction, chromatographic separation was performed on a Waters Symmetry C

OBJECTIVE To establish the HPLC fingerprint of Xintongshu spray， determine the contents of identified components， and investigate the transferring patterns of the index components of decoction pieces， intermediates and spray， so as to provide scientific reference for technology management and quality control of Xintongshu spray. METHODS HPLC fingerprints of 13 batches of Xintongshu spray were established by the Similarity Evaluation System for Chromatographic Fingerprints of TCM （2012 edition）， and common peaks were identified； the contents of identified components were determined by HPLC. The paeonol in Moutan Cortex and ferulic acid in Chuanxiong Rhizoma were used as index components to investigate the transferring patterns of them in decoction pieces， intermediates and spray. RESULTS There were a total of 33 common peaks in the fingerprints of 13 batches of Xintongshu spray， and the similarities were more than 0.994. Eight components were identified， i.e. gallic acid （peak 5）， oxypaeoniflorin （peak 9）， chlorogenic acid（peak 10）， caffeic acid （peak 14）， paeoniflorin （peak 17）， ferulic acid （peak 21）， senkyunolide Ⅰ （peak 27） and paeonol （peak 31）. The contents of 8 components ranged from 0.590 3- 0.719 7， 0.565 7-0.851 3， 0.279 4-0.368 1， 0.080 6-0.106 1， 1.922 5-3.033 5， 0.151 3-0.191 6， 0.250 6-0.336 0， 3.056 7-4.161 0 mg/mL， respectively. The average transfer rates of paeonol and ferulic acid from decoction pieces to sprays were 63.76% and 38.06%， respectively. It was also found that the process in which the loss of paeonol was more than 30% was the extraction by percolation and negative pressure concentration of Moutan Cortex. The process in which the loss of ferulic acid was more than 50% was the steam distillation extraction process of Chuanxiong Rhizoma. CONCLUSIONS The established HPLC fingerprint and content determination method of Xintongshu spray are reproducible and specific. The key processes that cause a decrease in the average transfer rates of the index components are the extraction by percolation and negative pressure concentration of Moutan Cortex and steam distillation extraction of Chuanxiong Rhizoma.