Method for the Evaluation of Uncertainty in Biological Sample Analysis Laboratory and Its Applications in Laboratory Quality Control / 中国药房

OBJECTIVE:To provide a way to evaluate test capability for biological sample analysis laboratory,so as to im-prove this test quality. METHODS:By analyzing the use of measurement uncertainty in China and detailing the steps of biological sample analysis laboratory measurement uncertainty,the effects of measurement uncertainty on biological sample analysis laborato-ry are illustrated from two aspects of inner and outer quality control. RESULTS & CONCLUSIONS:National laboratories mainly examine the source of uncertainty through establishing mathematical model,and then uncertainty is evaluated. Uncertainty evalua-tion is a continuous process. Uncertainty assessment and assurance is the overall situation in a biological sample analysis laboratory quality control. Thus,biological sample analysis laboratory can find a method of self-testing capabilities by uncertainty evaluation, find the maximum uncertainty and eliminate or reduce it gradually,ultimately improve laboratory testing quality.

Analysis of 128 Cases of ADRs Induced by Quinolones in our Hospital / 药物流行病学杂志

Objective:To analyze the occurrence information and clinical manifestations of adverse reactions caused by quinolones antimicrobial drugs in Beijing Hospital and to provide the basis for clinical use.Method:In a retrospective study,128 cases of adverse reactions caused by quinolones antimicrobial drugs from 2003 to 2007 in Beijing Hospital were statistically analyzed in respect of drug categories,genders,ages,routes of administration,organs or systems, clinical manifestations,etc.Result:The drugs causing adverse drug reactions included seven categories.Levofloxacin showed the highest propotion,and intravenous drip was the main route of administration,and damages of skin were the most common manifestation.Conclusion:Adverse reactions monitoring of anti-infective agents should be strengthened to ensure the rational and safe patient medication.

Effect of Thalidomide on Pharmacokinetics of Irinotecan and SN-38 in Rats / 中国药房

OBJECTIVE: To study pharmacokinetics of irinotecan and its metabolite SN-38 in rats after administration of irinotecan and thalidomide.METHODS: Healthy male SD rats were randomized to given 10 mg?kg-1 irinotecan and 20 mg?kg-1 irinotecan (control group) or irinotecan combined with 20 mg?kg-1 thalidomide (trial group).Blood samples were collected at 0.083 h,0.5 h,1.0 h,2.0 h,4.0 h,6.0 h,8.0 h,10 h and 12 h after medication.The plasma concentrations of irinotecan and SN-38 were determined and pharmacokinetic parameters were calculated using DASver2.0 software.RESULTS: As compared with control group,AUC0～t and Cmax of irinotecan in 10 mg?kg-1 irinotecan trial group were increased significantly (P

Bioequivalence of Domestic Meloxicam Tablets in Healthy Volunteers / 中国药房

OBJECTIVE:The bioequivalence and pharmacokinetics of two kinds of domestic meloxicam tablets were studied in 20 healthy male volunteers METHODS:A dose of 15mg of domestic or imported meloxicam(test and reference preparation)was given according to arandomized 2-way cross-over design,blood samples were withdrawn up to 96 hours post administration,and plasma concentration of meloxicam was determined by high performance liquid chromatography(HPLC)method RESULTS:The peak plasma levels(Cmax)of meloxicam test drug and reference drug were (2 736 2?312 0)and(2 665 6?333 8)?g/L,respectively,the peak time(Tmax)were(4 25?1 16)h and(4 00?1 30)h,respectively,T1/2ke were(21 67?3 81)h and(21 05?3 30)h,respectively,and AUC0～t were(96 454 6?25 526 6)and(95 692 5?24 532 6)?g/(h?L),respectively There were no significant differences in AUC0～t,Tmax,Cmax and T1/2ke between two kinds of tablet CONCLUSION:The relative bioavailability data obtained in the study furnished definite proof of bioequivalence of both domestic meloxicam tablets and imported meloxicam tablets The relative bioavailablility of the test drug was(101 3?11 9)%

Determination of Bioequivalence of Cefixime by Three-way Crossover Design / 中国药房

OBJECTIVE:To study the bioequivalence of suspension formulation of cefixime(A),capsule formulation of ce-fixime(B) and reference preparation(C: Cefixime Capsules or Cefspan) in human body.METHODS: The study was conducted as a 3- way crossover design in 18 healthy volunteers whose plasma concentrations of cefixime were determined by HPLC after receiving a single oral dose of 200 mg trial preparations or reference preparation.RESULTS:The main pharmacokinetics of the three preparations(A、B、C) were as follows after undergoing BIO3 program fitting:AUC0-1 were(18.54?6.31)mg?h-1?L-1, (16.10?5.51)mg?h-1?L-1 and (17.16?5.96)mg?h-1?L-1, Cmax were(2.63?0.76) mg?L-1, (2.43?0.78)mg?L-1 and (2.57?0.90)mg?L-1;tmax were(4.11?0.58)h,(4.56?0.51)h and (4.56?0.70)h,respectively .The relative bioavailability of cefixime suspensions(A) and cefixime capsules(B) were (108.8?12.3)% and (95.7?15.9)% ,respectively as against reference preparation(C) .CONCLUSION:The test formulations(A and B) were found bioequivalent to the reference formulation(C).