OBJECTIVE:A HPCE method for determination of paeoniflorin in Bazhen pills and Bazhen Yimu pills was developed METHODS:Measurements were carried out in a buffer solution containing 50mmol/L borax solution (pH 10 6),at detection wavelength 230nm with 20KV running voltage applied to a 50cm?50?m capillary RESULTS:The linear range of paeoniflorin was in the range of 0 0 625～1 0mg/ml(r=0 9 995),RSD within days was 1 61%,RSD between days was 3 15% The recovery of paeoniflorin was 98 19%～98 45% The results of detection for Bazhen pills and Bazhen Yimu pills were highly correlated to those obtained by HPLC CONCLUSION:The method is simple,rapid,economical and accurate

OBJECTIVE:To clarify the responsibilities of drug clinical trial institution and ethics committee in China,and to provide reference for the improvement of drug clinical trial management. METHODS:The responsibility conflicts between drug clinical trial institution and ethics committee were summarized,and its reasons were analyzed to provide suggestions. RESULTS &CONCLUSIONS:The responsibility conflicts have been found between drug clinical trial institution and ethics committee,mainly manifesting as the essential person who submits protocol is not clear;the responsibilities in multicenter ethics investigation are con-troversial;the management of their track issues are not connected enough. 3 aspects of measures can be adopted,including reach-ing an agreement of responsibility assignment learning from foreign advanced ideas,improving laws and regulations;enhancing the management,promoting the implementation of policy and agreement. So,the responsibilities of drug clinical trial institution and ethics committee can be further clarified to improve the management of drug clinical trial.

OBJECTIVE:To systematically review the effect of stroke efficacy and bleeding risk of edoxaban versus warfarin in the prevention of patients with atrial fibrillation,and provide evidence-based reference for clinical treatment. METHODS:Re-trieved from Cochrane Library,Medline,EMBase,CJFD,Wangfang Database and VIP Database,randomized controlled trials (RCT)about the stroke efficacy and bleeding risk of edoxaban versus warfarin in patients with atrial fibrillation were collected. Me-ta-analysis was performed for the incidences of stoke and excessive hemorrhage by using Rev Man 5.3 software after data extract. RESULTS:Totally 13 RCTs were included,involving 24 950 patients. Results of Meta-analysis showed,compared with warfarin group,there were no significant differences in the incidences of stoke [RR=0.97,95%CI(0.88,1.08),P=0.60] and excessive hem-orrhage [RR=0.84,95%CI(0.59,1.19),P=0.33] in edoxaban group. But the subgroup analysis showed,when daily dose of edoxa-ban was more than 30 mg,the incidence of stroke in edoxaban group was significantly lower than warfarin group [RR=0.84,95%CI(0.72,0.97),P=0.02];when it was 30 mg,the incidence of excessive bleeding in edoxaban group was significantly lower than warfarin group [RR=0.46,95%CI(0.35,0.61),P<0.001],the difference was statistically significant. CONCLUSIONS:Compared with warfarin,higher doses(>30 mg/d)of edoxaban can more effectively prevent the occurrence of stroke and low doses(30 mg/d) can reduce the risk of excessive bleeding.

AIM:To evaluate the efficacy of amoxicillin/sulbactam in the treatment of bacterial infections METHODS:Fifty-six patients were divided into two groups:amoxicillin/sulbactam group(30 patients) and ampicillin/sulbactam group(26 patients) The test and control groups received amoxicillin/sulbactam and ampicillin/sulbactam 3g,iv,q8h for (8?2)d,respectively RESULTS:The overall effective rates of amoxicillin/sulbactam and ampicillin/sulbactam were 93% and 73%,the bacterial clearance rates were 92% and 83% and the ADRs were 6% and 11%,respectively CONCLUSION:Amoxicillin/sulbactam is a safe and potent antibacterial agent in the treatment of the bacterial infections

OBJECTIVE:A HPCE method for determination of Quercetin in acanthopanax and acanthopanax injection was developed.METHODS:Measurements were carried out in a buffer solution containing 50mmol/L boric acid solution and 50mmol/L SDS(pH 8.5),at 20kV running voltage applied to a 50cm?50?m capillary.The detection wavelength was 260nm.RESULTS:The linear range of quercetin was 0.0 125～1.0mg/ml.The recovery of acanthopanax was (98.99?0.63)%.The recovery of acanthopanax injection was (98.62?0.42)%.CONCLUSION:The method is simple,rapid,accurate and suitable for determination of quercetin in acanthopanax and acanthopanax injection.

Objective To optimize the extracting process of alkaloid from Nelumbo nucifera leaves by multi-stage countercurrent extraction.Methods The spectrophotometry was used to determine the alkaloids.The extracting process of alkaloid was optimized by L16(44) to observe the effect of extraction time,extraction temperature,solid to liquid ratio,and ethanol concentration,respectively.Results The optimum extraction parameters were extraction time 25 min,extraction temperation 90 ℃,solid to liquid ratio 1∶50,and ethanol concentration 70%.Conclusion The multi-stage countercurrent extraction is used to the extracting process of alkaloid from N.nucifera leaves.

Objective To evaluate the application of neutrophil CD 64 in diagnosis of sepsis in adult patients.Methods Literature retrieval from PubMed, EMBASE, ISI Web of Knowledge, Cochrane Library, CBM, CNKI, CQVIP, Wanfang Data from the establishment of database to the year 2015 was conducted to identify all studies on CD 64 in diagnosis of sepsis .The quality of the literature was evaluated with the quality assessment of diagnostic accuracy studies ( QUADAS).Meta-Disc 1.4 and STATA 12.0 were used for meta analysis . Fixed-effects or random-effects model was performed based on the heterogeneity.The sensitivity, specificity, positive likelihood ratio, negative likelihood ratio and diagnostic odds ratio were calculated .Summary receiver operating characteristic curves ( SROC ) and area under the curve (AUC) were used to evaluate the diagnostic performance of CD 64 for sepsis.Results A total of 24 studies involving 3 198 patients were included for systemic review .The sensitivity, specificity, positive likelihood ratio, negative likelihood ratio and diagnostic odds ratio of CD 64 for diagnosis of sepsis were 0.79 (95 %CI:0.77-0.81), 0.86 (95 %CI:0.84-0.88), 7.40 (95 %CI:5.02-10.91), 0.15 (95 %CI:0.10-0.22) and 60.07 (95%CI: 29.19-123.60), respectively.The area under SROC of CD64 in diagnosis of sepsis was 0.95, and the Q* value was 0.88.Conclusion CD64 can be used to diagnose sepsis in adult patients , but it needs to be further confirmed by large multicenter studies .

Objective To analyse the encoding gene of ? lactamase of the clinically isolated Klebsiela pneumoniae 99 799 and to identify its subtype. Methods The gene of ? lactamase derived from a stain of Klebsiela pneumoniae 99 799 named as was amplified by PCR. The purified PCR product was cloned into pUCm T vector and sequenced by Sanger's dideoxy chain termination composition method. Results The encoded gene of the bacterium was identified as TEM by PCR. It had the same sequence as the gene encoding TEM 1 and positioned at the 150 bp and 80 bp plasmids. Conclusion The TEM 1 ? lactamase exists in Chongqing area.

OBJECTIVE :To develop a RP-HPLC method for determination of minocycline concentration in human plasma.METHODS:Chromatographic separation has been achieved on C18 column with acetonitrile-H2O-TFA(15∶85∶0.1)as the mobile phase, and oxytetracycline as internal standard.The detection wavelength was 350nm.The minocycline was extracted from buffered plasma(pH=6.5)by ethyl- acetate, and quantified by the ratio of minocycline peak area to that of internal standard.RESULTS :The linear range of minocycline detection concentration was 0.05～8?g/ml(r=0.9 999).The minimum detection concentration was 0.02?g/ml with an average recovery of 101.89% .The inter and intra-day RSD were both less than 5%.CONCLUSION :The present method is simple, rapid and accurate for determination of minocycline in human plasma.

Objective To investigate how the clinical laboratory conducting the verification of analytical measurement range (AM R) of quantitative items detected by the biochemical analyzer according to the requirements of the international standards by verifying the serum creatinine AMR for ensuring the accuracy and reliability of detection results .Methods The enzyme method was adopted to detect the 7‐concentration levels test specimens of CAP linear range proficiency test on the Roche Cobas 501 biochemical analyzer .These 7 specimens target values covered the low ,middle and high values of creatinine AMR marked by the manufacturer′s instructions .Each specimen was detected twice and the mean value was taken ,then the bias between the mean value and target value was calculated .In addition ,referring to the requirements of CLSI guiding document EP6‐P ,the patients′fresh serum contai‐ning high value creatinine was collected ,then mixed with certain proportion and centrifuged .The mixture concentration was calcu‐lated and served as the high value specimen(H) ,and the low value specimen was obtained by the same treatment .Then the high and low value specimens were dispensed with the relations of 5L ,4L+1H ,3L+2H ,2L+3H ,1L+4H and 5H and formed the series specimens .The creatinine levels in each specimen was detected on the Roche Cobas 501 biochemical analyzer ,each specimen was de‐tected 4 times .The obtained data were performed the regression analysis .Results The bias of 7‐level CAP specimen and target val‐ue was less than the allowable error ± 7 .5% [(1/2 × TE)% ] set by the clinical laboratory of the Beijing Sanfine Hopsital .The re‐gression equation of fresh mixed serums from patients was Y =0 .988 6X+16 .614 ,b=0 .988 6 ,between 0 .97 -1 .03 ,intercept a and 0 ,ta < t0 .05 ,P>0 .05 ,which showed no significant difference between intercept and 0 ,the regression line was through 0 point in fact .Conclusion The verification of creatinine AMR marked by the manufacturer′s instructions is passed ,which can be adopted by the clinical laboratory .