Objective To evaluate the correlation and difference of reversed phase high performance liquid chromatography (RP-HPLC) and fluorescence polarization immunoassay (FPIA) on determining serum concentration of carbamazepine.Methods Fifty serum samples were collected,both RP-HPLC and FPIA methods were employed to determine the concentration of carbamazepine.The results were analyzed by paired t test,Bland-Altman and Deming regression methods,respectively.Results The results of measuring 50 samples by the two methods showed that FPIA datas were significantly higher than RP-HPLC datas,and there was statistically significant difference(P<0.05) and poorer consistency between two methods;There was good correlation between carbamazepine concentrations determined by the two methods.Deming regression equation was CFPIA=1.195 3 CRP-HPLC-0.144 0,and Pearson correlation coefficient was 0.968 5.Conclusion Clinicians should pay more attention to the difference of carbamazepine concentration determination by different methods when carbamazepine individualized dosage regimen was adjusted according to therapeutic drug monitoring.

Objective:To study the stability of compound Kushen mixed liquid to provide reliable evidence for safe clinical drug application.Methods:Compound Kushen injection was mixed respectively with 0.9% sodium chloride injection and 5% glucose injection,and then placed under the different conditions for 0,1,2,4,8,12,24 and 48 h.HPLC was conducted to determine the content changes of four components in compound Kushen mixed liquid,and the appearance,pH and insoluble particles were observed as well.Results:The mixed liquid of compound Kushen with 0.9% sodium chloride injection was stable in 48 h without the influence of light and temperature.However,the mixed liquid of compound Kushen with 5% glucose injection had poorer stability with storage time shorter than 12 h at room temperature and 2 h at high temperature.Conclusion:The stability of the mixed liquid of compound Kushen is closely related to the pH value of solvent.0.9% Sodium chloride injection is recommended as the solvent,and the mixed liquid should be used up in 48 h.

Objective To develop a rapid ultra high performance liquid chromatography-tandem mass spectrometry (UPLC-MS/ MS) for determination of 11 sedative-hypnotics in human plasma. Methods The plasma samples were extracted with dichloromethane:n-hexane:acetoacetate (5∶4∶1). The separation was performed on a Waters ACQUITY UPLC HSS T3 column (2.1 mm×100 mm,1.8 μm) using the mobile phase composed of acetonitrile-0.1% ammonium solution at a flow rate of 0.2 mL?min-1 in gradient elution mode. The detection was performed on a triple quadrupole tandem mass spectrometer by multiple reaction monitoring (MRM) via electrospray ionization (ESI) source in positive mode. Results Good linear relation was obtained over the investigated concentration range, with all correlation coefficients higher than 0.99. The limit of detection was 200 pg?mL-1 for dexzopiclone,and 10- 20 pg?mL-1 for other sedative-hypnotics. The intra- and inter-day RSD of 11 sedative-hypnotics were no more than 15.0%. The recoveries were in the range of 72.3%-108.0%, and the matrix effects were approximately 0.86- 1. 12. Conclusion The method is rapid, sensitive and reliable, and suitable for the simultaneous determination of 11 sedative-hypnotics in human plasma.

OBJECTIVE:To improve the hospital workflow and efficiency in temporary drug purchase approval process. METHODS:The approval function for temporary drug purchase was introduced into office automation(OA)system in our hospi-tal,and the effects were evaluated. RESULTS:According to ensuring the administrative approval process,system function permis-sion assignment and approval process design in temporary drug purchase in our hospital,functions for approving temporary drug purchase were established in OA system. It achieved convenient,efficient,timely,networking and paperless approval work,as well as standardized record,checking out at any time and automatic statistics for drug purchase. CONCLUSIONS:Introducing tem-porary drug purchase approval function into hospital OA system can simplify workflow,provide better service for clinic,and pro-mote development of hospital pharmacy management.

OBJECTIVE:To develop a method for the simultaneous determination of 5 components in Shuganning injections. METHODS:HPLC method was adopted. The determination was performed on Symmetry? C18 column with mobile phase consisted of methanol-0.4% phosphoric acid(gradient elution)at the flow rate of 1.0 mL/min. The detection wavlengths were set at 238 nm (geniposide,baicalin) and 327 nm (chlorogenic acid,baicalein,scutellarin). The column temperature was 30 ℃ and the sample size was 10 μL. RESULTS:The linear ranges were 0.4062-26.0 μg/mL for chlorogenic acid(r=0.9999),2.5000-160.0 μg/mL for geniposide (r=0.9999),6.5620-420.0 μg/mL for baicalin (r=0.9999),0.3125-20.0 μg/mL for baicalein (r=0.9996), 0.5859-37.5 μg/mL for scutellarin (r=0.9998). The limits of quantify were no higher than 31.20 ng,limits of detection were no higher than 15.60 ng. RSDs of precision, stability and reproducibility tests were lower than 2.0% ;the recoveries were 97.72%-101.10%(RSD=1.21%,n=6),97.67%-102.40%(RSD=1.87%,n=6),97.64%-101.10%(RSD=1.31%,n=6), 96.45%-100.10%(RSD=1.47%,n=6),96.16%-101.10%(RSD=1.69%,n=6),respectively. CONCLUSIONS:The method is simple,precise,stable and reproducible,and can be used for simultaneous determination of 5 components in Shuganning injection.

OBJECTIVE:To investigate drug combination in outpatient prescriptions of hypertension patients in our hospital, provide reference for rational drug use in clinic. METHODS:The outpatient prescriptions of patients diagnosed as hypertension dur-ing Jan. 1st to Feb. 1st in 2015 were collected from the hospital. The prescriptions of two or more than two drugs were screened, and the prescriptions of drug combination containing CYP enzyme substrate,inhibitor or inducer were recorded. Guided by metabol-ic enzymology theory,the potential metabolic drug interactions in prescriptions were evaluated on the basis of relevant literature and data reports. RESULTS:Totally 1042 prescriptions were consulted. The prescriptions of the combined medication were 551, and the potential metabolic drug-drug interactions were detected at 249 prescriptions,accounting for 45.2％. Main CYP enzyme sub-types were CYP3A4,CYP2C9,CYP2C19 and CYP2D6. Totally 214 prescriptions were correlated with CYP3A4,accounting for 85.9％ of drug interaction prescriptions;CYP3A4 substrate combined with substrate in 199 prescriptions,with inhibitor in 27 pre-scriptions,and with inducer in 11 prescriptions. Totally 27 prescriptions were correlated with CYP2C9,accounting for 10.8％ of drug interaction prescriptions;CYP2C9 substrate combined with substrate in 8 prescriptions,and with inhibitor in 20 prescriptions. Totally 27 prescriptions were correlated with CYP2D6,accounting for 10.8％ of drug interaction prescriptions;CYP2D6 substrate combined with substrate in 15 prescriptions,and with inhibitor in 12 prescriptions. Totally 4 prescriptions were correlated with CYP2C19,accounting for 1.6％ of drug interaction prescriptions;CYP2C9 substrate combined with inhibitor in 2 prescriptions, and with inducer in 2 prescriptions. CONCLUSIONS:Many metabolic drug-drug interactions are detected in the outpatient prescrip-tions of hypertension patients in our hospital. In order to improve the rationality and safety of the prescription,clinicians and phar-macists should pay attention to the drug combinations with drug-drug interactions which have been reported in the existing litera-ture,and choose similar drugs without or with little interactions.

Objective:To determine and investigate the stability of ginkgo biloba extract injection from three different manufactur-ers respectively in 0.9% NaCl infusion and 5% glucose infusion under different conditions (room temperature, high temperature and light). Methods:Ginkgo biloba extract injection was mixed with the two kinds of infusions,and then divided into the normal tempera-ture group,the high temperature group and the light group. The appearance,insoluble particles,pH and content of flavonoids after the relevant treatment were investigated. The appearance and insoluble particles were tested according to the characteristics of the inspec-tion method described in Chinese Pharmacopoeia(2015 edition,volume IV,the general rule),and the content of flavonoids was detec-ted by HPLC-UV. Results:All the mixed solutions were yellow. No significant changes were found in the appearance,pH value,in-soluble particles and contents of quercetin and isorhamnetin in all the mixed solutions in 24 h. The pH value of the mixed solution with 5% glucose infusion was lower than that with 0.9% NaCl infusion,and all the pH values met the standard in Chinese Pharmacopeias. The kaemphenol content in the injection from Shenwei pharmaceutical company was higher than that from the other manufacturers, while the content of kaemphenol in all the injections was within the standard range. Conclusion:The quality of Ginkgo biloba extract injection from the three different manufacturers is stable under different conditions.

OBJECTIVE： To establish a method for determination of fluconazole concentration in human plasma. METHODS： UPLC-MS/MS method was adopted to determine plasma after precipitated with acetonitrile. Using isotope fluconazole-d4 as internal standard， the determination was performed on ACQUITY UPLC BEH C18 column with mobile phase consisted of 0.1％ formic acid-acetonitrile （gradient elution） at the flow rate of 0.3 mL/min. The column temperature was 40 ℃， and the sample size was 3 μL. ESI was used for positive ion scanning by multiple reaction monitoring mode. The ion pairs for quantitative analysis were m/z 307.1→220.0 （fluconazole） and m/z 311.1→223.0 （internal standard）. RESULTS： The linear range of fluconazole was 10-5 000 ng/mL （r＝0.998 1）. The limits of quantitation was 10 ng/mL. RSDs of intra-day and inter-day were less than 8％； accuracy ranged 95.8％-106.7％. The extraction recovery ranged 97.3％-107.3％ （RSD＜5.0％， n＝6）， and matrix effect， dilution effect and residual effect didn’t influence quantitative analysis of the substance to be measured. CONCLUSIONS： The method is simple， rapid， specific and accurate， which can be used for therapeutic drug monitoring and pharmacokinetic study of fluconazole.

Objective To standardize the management of clinical trials in our hospital,reduce the incidence of protocol deviations,and provide a reference for improving the quality of clinical trials.Methods The healthcare failure mode and effect analysis(HFMEA)method was used to determine the potential failure modes of the current protocol deviation.The frequency,severity and detectability of failure modes were quantified and evaluated.The risk priority number(RPN)was calculated and the corresponding improvement measures were proposed.The RPN values before and after the implementation of HFMEA were statistically analyzed to evaluate the improvement effect.Results After the implementation of HFMEA activities,the RPN values of 14 potential failure modes decreased significantly(P<0.05);The risk level of 12 potential failure modes decreased.The HFMEA team members'ability in finding and solving problems,communication and cooperation were significantly improved.Conclusions The implementation of HFMEA activities contributes to the management of protocol deviation in clinical trials,can effectively reduce the occurrence of protocol deviation,and provides experience for improving the quality of drug clinical trials.