1.Determination of Residues of 5 Organic Solvents in Teicoplanin Raw Material and Injection by Headspace GC
Wenfei GENG ; Junying WU ; Chunxia WANG ; Lemin REN ; Aibing KE
China Pharmacy 2015;(18):2554-2556
OBJECTIVE:To establish the method for the residues determination of 5 organic solvents in teicoplanin raw materi-al and injection. METHODS:Headspace GC was performed on the column with 6% cyanopropylphenyl-94% dimethyl polysiloxane (DB-624)as the stationary phase capillary column,the carrier gas was nitrogen,using the temperature program. The temperature of inlet was 200 ℃,detector was hydrogen flame ionization detector with the flow rate of 1 ml/min,split ratio was 40 ∶ 1 and the vol-ume was 1 ml. RESULTS:Good linearity of ethanol,acetone,ethyl acetate,tetrahydrofuran and triethylamine were obtained(r were 0.999 0-0.999 3);the average recoveries were respectively 95.6%,97.0%,103.2%,94.3%and 98.2%(RSD were 2.1%-4.9%, n=9);RSDs of precision and repeatability tests ≤2.6%;and the minimum detectable concentration were respectively 2,2,2,0.7 and 0.3 μg/ml. CONCLUSIONS:The established method is rapid,sensitive and accurate,and can be used for the residues determi-nation of organic solvents in teicoplanin raw materials and injection.
2.Serial research of traceability and harmonization of thyroid-stimulating hormone detection approved by IFCC
Xiang YU ; Wenfei CHEN ; Xiaoliu YU ; Ming JIANG ; Ke LI ; Zhiguang YU
International Journal of Laboratory Medicine 2016;37(6):751-753
Objective To implement the harmonization of thyroid-stimulating hormone(TSH) of Mindray assay system by par-ticipating in harmonization research program of International Federation of Clinical Chemistry (IFCC)-Standardization of Thyroid Function Tests(C-STFT ) .Methods A total of three combinations of TSH reagents and calibrators were used to measure 20 serum samples of healthy human .Within-run precision and batch-to-batch variation were assessed .The concept of harmonization was dem-onstrated by comparing our test results with All Procedure Trimmed Mean (APTM ) provided by IFCC and recalibrating with Mater Calibrators .Results The within-run precision was 1 .96% ,batch-to-batch variation was 0 .47% - 1 .15% ,depending on the level of TSH analyte .There existed a positive bias compared to APTM values .After recalibration with Mater Calibrators and Passing &Bablok regression ,the slope of method comparison was 1 .0 ,and correlation coefficient was more than 0 .975 .Conclusion By using a panel of real human specimen and recalibration based on APTM ,the test results of Mindray assay system could be harmonized with mainstream manufacturers globally .
3.Advances of Molecular Targeted Therapy in EGFR-mutated Squamous Cell Lung Cancer
XIONG BINGWAN ; KE WENFEI ; JIANG WENYANG
Chinese Journal of Lung Cancer 2024;27(4):283-290
Non-small cell lung cancer(NSCLC)is a prevalent tumour type in our country,with lung squamous car-cinoma being a commonly observed NSCLC subtype besides lung adenocarcinoma.Epidermal growth factor receptor(EGFR)is a significant driver gene in lung cancer,and EGFR mutation frequency is considerably lower in lung squamous carcinoma in comparison to lung adenocarcinoma.Although targeted therapy against EGFR has demonstrated significant advancements in lung adenocarcinoma,while progress in lung squamous carcinoma has been relatively sluggish.This paper reviews recent stud-ies on molecular targeted therapy for EGFR-mutated lung squamous carcinoma and summarises the efficacy of EGFR-tyrosine kinase inhibitors(TKIs)in treating squamous carcinoma of the lung,in order to provide a reference for treating patients with EGFR-mutated squamous carcinoma of the lung.