OBJECTIVE: To establish a RP-HPLC method for the determination of 5-fluorouracil(5-Fu)in magnetic micropheres (MMS), and to evaluate the target ability of 5-Fu magnetic microspheres in mice. METHODS: 5-Fu-MMS was digested with 0.5% pepsin, and then free 5-Fu was extracted from tissue with ethyl acetate, and detected by a validated RP-HPLC method. RESULTS: The calibration curve was linear over the range of 0.1～25mg?L-1 and the limit of quantization was 0.1mg?L-1. The tissue distribution of 5-Fu-MMS in the liver was significantly increased as compared to control(P

To determine the pharmacokinetics and bioequivalence of epinastine (EPN) hydrochloride, a promising histamine H1 receptor antagonist, in healthy Chinese volunteers under fasting conditions. METHODS: EPN hydrochloride test and reference tablets were administered as a single dose on two treatment days separated by a 1-week washout period. After dosing, serial blood samples were collected for a period of 36 h, and plasma EPN hydrochloride concentrations were determined by a validated reversed-phase HPLC method and pharmacokinetic parameters were calculated with DAS software. RESULTS: Plasma concentration-time profiles were adequately described by a two-compartment open model. The compound was rapidly absorbed and cleared slowly from plasma with a half-life of approximately 10 h. The main pharmacokinetic parameters of EPN hydrochloride test and reference tablets were as follow: tmax were (2.2±0.5) and (2.0±0.4)h, Cmax were (66±16)and (68±13)μg/L, t1/2 were(10.1±1.3) and (10.4±2.4)h, AUC0-36 were (592±88) and (601±94)μg·h·L-1, respectively. The relative bioavailability of test tablets was (99±13)%. CONCLUSION: The results indicate that the two formulations of EPN hydrochloride tablets are bioequivalent in the rate and extent of absorption.

AIM: To compare the bioavailability of the test and reference formulation of secnidazole (2 g) tablets under fasting conditions. METHODS: This bioequivalence study was carried out in 20 healthy male Chinese volunteers according to a single dose, two-sequence, crossover randomized design. Fifteen blood samples per period were collected over 96 h, and plasma secnidazole concentrations were determined by locally validated high performance liquid chromatography (HPLC) assay and pharmacokinetic parameters were analyzed by the non-compartmental and compartmental methods. RESULTS: Plasma concentration-time profiles were adequately described by a one-compartment open model with first-order absorption. The main pharmacokinetic parameters of secnidazole test and reference tablets were as follows: tmax were (2.30±1.06) and (2.28±1.10) h, Cmax were (49.63±6.35) and (46.17±4.24) mg/L, t1/2 were (28.84±3.41) and (29.05±4.01) h, AUC0-96 were (1832.06±180.15) and (1847.14±204.14) mg·h-1·L-1, respectively. The relative bioavailability of test tablets was (99.99±11.92)%. CONCLUSION: The results indicate that the two formulations of secnidazole tablets are bioequivalent in the rate and extent of absorption.

AIM: To study pharmacokinetics and relative bioavailability of pantoprazole sodium enteric-coated test and reference tablets in healthy volunteers. METHODS: A single oral dose of 40 mg pantoprazole sodium enteric-coated test and reference tablets were given to 20 male healthy volunteers in a randomized two-way crossover design. Plasma concentrations of pantoprazole were determined by HPLC method. Pharmacokinetic parameters and relative bioavailability were calculated with DAS program to evaluate the bioequivalence of the two preparations. RESULTS: Plasma concentration-time profiles were adequately described by a two-compartment open model. The main pharmacokinetic parameters of pantoprazole sodium test and reference tablets were as follow: The values of Tmax were (3.18±0.54) and (3.30±0.47) h, Cmax were (2.98±0.83) and (2.91±0.87) mg·L-1, T1/2β were (1.86±0.41) and (1.72±0.48) h, AUC0-t were (9.51±3.71) and (9.77±4.55) mg·h·L-1, respectively. The relative bioavailability of test tablets was (102.3±19.6)%. CONCLUSION: The two preparations of pantoprazole sodium are bioequivalent.

Objective To analyze pathogenic bacteria distribution and antimicrobial susceptibility in children with acute otitis media(AOM ) .Methods Otorrhea samples from 146 episodes of AOM were cultured .The antimi‐crobial susceptibility of the main pathogenic bacteria was determined .The results were analyzed by SPSS19 .0 .Re‐sults 1) The strains of bacteria were isolated from 109 children with the positive rate of 74 .66% .Streptococcus pneumoniae (SP ) was the major bacteria(64 episodes ,58 .72% ) ,followed by staphlococcus aureus(SA) (19 epi‐sodes ,17 .43% ) .2) Sp was all sensitive to vancomycin ,levofloxacin ,moderate to penicillin ,amoxicillin ,cefo‐taxime ,and highly resistent to erythromycin and clindamycin .Staphlococcus aureus were all sensitive to vancomy‐cin ,tetracycline ,and Amy card ,and moderate to amoxicillin clavulanic acid potassium ,cefoxitin ,and oxacillin ,all resistent to penicillin and ampicillin .3) The strains of SP in age≤1year ,>1 -3years ,and >3 years respectively were 31(50 .82% ) ,25(56 .82% ) ,8 (19 .51% ) .There were significant differences between them(χ2 =14 .073 ,P=0 .001) .4)The strains of SP in 2012 ,2013 ,2014 respectively were 16(30 .19% ) ,22(48 .89% ) ,26(54 .17% ) ,There were significant differences between them(χ2 =6 .557 ,P=0 .038) .The antimicrobial susceptibility of SP had no sig‐nificant differences among 2012 ,2013 ,2014 ,but a yearly resistance decreasing trend was seen .Conclusion SP was the main bacterial contributor for AOM in Wuhan children .SP detection rate increases every year ,mainly in chil‐dren less than 3 years old .T he antimicrobial susceptibility is stable .

OBJECTIVE:To establish a HPLC method for the determination of mycophenolic acid (MPA) in human plasma and to study its pharmacokinetics in human body.METHODS:After sedimentation by methanol,plasma sample of MPA was determined directly on Symmetry Shield C18 column with column temperature at 30℃,detective wavelength at 218mn and sample size at 20?L.The mobile phase consisted of acetonitrile-water-triethylamine(40∶60∶0.3) with a flow rate of 1.0mL?min-1.RESULTS:The calibration curve was linear over the range of 0.2～50mg?L-1(r=0.999 6)and the limit of quantitation was 0.2mg?L-1.The mean methodological recovery was 101.94% and the mean extraction recovery was 87.06%.The RSD of both the intra-day and the inter-day were less than 6%.The pharmacokinetic study showed that MPA had enterohepatic circulation in human body,which resulted in the occurrence of double peaks,and the concentration-time curves of MPA were fitted to one-compartment open model.CONCLUSION:This method is sensitive,rapid,specific,accurate and precise,and can be used for the study of pharmacokinetics of MPA.

Objective To study suitability of a series of lyophilized serum with definitive HBV DNA value in fluorescence quantitative COBAS Amplicor HBM kit and a sample with 106 copies/ml HBV DNA was prepared, and sent to various manufactures which would be asked to detect the samples using their own kits. Then a calibration curves from CT values of the series to the corresponding concentrations was compared with that obtained from the external standard-calibration curve with the manufactures series. Results The standard-calibration curve with the series of lyophilized serum showed an excellent correlation (

Objective To establish a statistics internal quality control method for false-positive in clinical qualitative immunoassays.Methods When the positive rates are normal distribution, the half-Levey-Jennings chart can be used. Based on the positive rates of more than 20 runs routine tests, mean value and standard deviation (SD) were calculated and quality control chart was plotted.The control rules are 1_ +2S for out-of-control.For non-normal distribution data, elementary probability calculation could be used.ResultsThe half-Levey-Jennings chart and elementary probability calculation are suitable for statistics internal quality control method for false-positive in clinical qualitative immunoassays.Conclusion The proposed internal quality control statistics method for false-positive monitoring in clinical qualitative immunoassays is practical and useful.

Objective To investigate the value of laparoscopy in the treatment of liver cancer.Methods The clinical data of 128 liver cancer patients who received laparoscopic surgery at Southwest Hospital from March 2007 to October 2009 were retrospectively analyzed.Of all patients,116 were with primary liver cancer,and 12 with metastatic liver cancer.There were 107 patients who received laparoscopie bepatectomy,15 received laparoscopic radiofrequency ablation(RFA)and 6 received laparoscopic ligation of the right branch of portal vein.Results Of the 107 patients who received laparoscopic bepatectomy,7 were converted to open surgery,and 5 were converted to hand-assisted laparoscopic hepatectomy.Anatomical hepatectomy was performed on 88 patients,including left lateral lobectomy on 21,left hemihepatectomy on 15,extended left hemihepatectomy on 2,medial lobectomy on 1,right hemihepatectomy on 11,right posterior lobeetomy on 9 and hepatic segmentectomy on 29.Combined hepatic resection was performed on 4 patients,and nonanatomical hepatectomy on 15.The mean oporatire time and blood loss were(228±92)minutes and(393±213)ml,with no operative mortality.The mean postoperative hospital stay was(8±4)days,and the incidence of complications was 15%(16/107).A total of 126 patients were followed up for 1-42 months,12 patients with laparoscopic hepatectomy died within 16 months,with the mean survival time of(118±7)weeks and the mean tumor free survival time of(105±7)weeks;2 patients with laparoscopic RFA died within 11 months:2 patients with laparoseopie ligation of the right branch of portal vein received two-stage radical resection.Conclusion Laparoscopic surgery is safe and feasible with the advantages of minimal operative trauma and quick recovery of patients when it is applied to the treatment of liver cancer.

Objective To study the efficacy and safety of entacapone as an adjunct to levodopa treatment in pakinsonian patients with wearing-off motor fluctuations. Methods A total 209 pakinsonian patients with end-of-dose deterioration participated in a multi-center,12-weeks randomized,placebo-controlled,double blind,parallel-group trial.The efficacy of entacapone was assessed using the patient’s diary card,the Unified Parkinson’s Disease Rating Scale (UODRS) score,the daily levodopa dosage,and the global assessment of changes.Results 96.2% of the entacapone and 92.4% of the placebo-treated patients completed the study.In 209 cases of the ITT population,in comparison to the placebo-treated patients,entacapone had increased the mean “on” time (h/d) from 7.4?1.8 in base-line to 9.1?2.5 in week 12,decreased the “fof” time (from 6.8?2.2 in base-line to 5.2?2.8 in week 12),improved the motor scores (from 36.7?11.3 in base-line to 30.0?14.4 in week 12),and reduced the levodopa dose (from 589.2?264.3 in base-line to 561.5?248.1 in week 4). The improvement was also evident on impression of successful treatment for 69.9% of neurologists through global change assessment.There was no significant difference in the frequency of dopaminergic adverse events and serious laboratory abnormalities between entacapone and placebo groups.Conclusion The results of this study demonstrate that entacapone,the COMT inhibitor is a safe and effective extender of levodopa treatment for Parkinson’s disease patients with motor flucturations.