1.Method for the Evaluation of Uncertainty in Biological Sample Analysis Laboratory and Its Applications in Laboratory Quality Control
China Pharmacy 2016;27(10):1426-1429
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.
2.Analysis of 128 Cases of ADRs Induced by Quinolones in our Hospital
Ying HAN ; Aixin SHI ; Dexing FU
Chinese Journal of Pharmacoepidemiology 2006;0(04):-
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.
3.Treating the spinal marrow and brain injury by the theory of “substantial yin and functional yang”
Ting ZHANG ; Aixin LI ; Qi SHI
International Journal of Traditional Chinese Medicine 2016;38(3):200-203
Combined with the five Zang Yin-Yang theory, to discuss the spinal marrow and cerebral Yin Yang state. As the internal organs, we believe that the spinal marrow and cerebral are substantial Yin and functional Yang. Further we can diagnose and treat the cerebral and spinal marrow injury related diseases. In the clinical therapy of acute and chronic cerebral and spinal marrow diseases, we should maintain the substantial Yin by avoiding injury, preventing spinal degeneration and maintaining the blood supply; and we should adjusting the functional Yang by nourishing the blood and promoting blood circulation, calming the liver to stop the wind, keep Yin and Weiqi in balance, tonifying the spleen and kidney etc. From the author's experience ,the patient with acute cerebral and spinal marrow injury diseases should be treated by regulating lung, liver, spleen and kidney to remove the wet water and purge the fire;the patient with chronic cerebral and spinal marrow injury diseases should be treated by regulating heart, liver, spleen and kidney to enhance Yang and nourish Yin.
4.Effect of Thalidomide on Pharmacokinetics of Irinotecan and SN-38 in Rats
Aixin SHI ; Yanling HU ; Xin HU
China Pharmacy 2005;0(21):-
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
5.Bioequivalence of Domestic Meloxicam Tablets in Healthy Volunteers
Jie HAN ; Aixin SHI ; Guangwei HE ; Lei LIU ; Qi YIN ; Chunhua SUN ; Youhua SONG
China Pharmacy 2001;0(12):-
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)%
6.Determination of Bioequivalence of Cefixime by Three-way Crossover Design
Aixin SHI ; Yufei FENG ; Kexin LI ; Lei LIU ; Qi YIN ; Chunhua SUN
China Pharmacy 1991;0(02):-
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).
7.Surveillance of antimicrobial resistance in the Streptococcus pneumoniae strains isolated from respiratory tract of children
Xiaohua YANG ; Yanhui CHEN ; Dongmei SHI ; Nan TAN ; Guilan WANG ; Aixin LIN ; Chunlei YUAN ; Jianming PENG ; Fengjuan CAI
Chinese Journal of Infection and Chemotherapy 2018;18(3):292-296
Objective To investigate the antimicrobial resistance profile of the Streptococcus pneumoniae strains isolated from respiratory tract of children in Zhongshan Boai Hospital, Guangdong Province for better management of such infections. Methods The sputum samples were collected from respiratory tract of children in pediatric outpatient and inpatient from May 2013 to August 2017. S. pneumoniae strains were isolated and identified and their susceptibility to antimicrobial agentswas determined. Results The prevalence of S. pneumoniae was 10.6% (2 963/28 006) in the sputum samples. S. pneumoniae was mainly isolated from children under 6 years old, and relatively higher in winter and spring. About 43.0% of the S. pneumoniae isolates was associated with mixed infection, especially Moraxella catarrhalis and Haemophilus influenzae. About 6.0% of the S. pneumoniae isolates were non-susceptible to penicillin, 59.3% non-susceptible to ceftriaxone, and more than 95% non-susceptible to erythromycin, clindamycin or tetracycline. However, more than 95% of the isolates were susceptible to chloramphenicol or ofloxacin. No S. pneumoniae isolate was found resistant to rifampin, linezolid or vancomycin. Conclusions The respiratory tract infection caused by S. pneumoniae of children is increasing year by year, which is associated with age, season, and higher rate of mixed infection. These data showed that penicillin non-susceptible S. pneumoniae is highly prevalent in Zhongshan. More than 95% of the S. pneumoniae isolates from children are resistant to erythromycin, clindamycin or tetracycline. S. pneumoniae isolates should be closely monitored for the emergence of multidrug resistant strains. Appropriate control measures must be taken according to the results of susceptibility testing.