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  • Xin XU
    Laboratory Testing. 2024, 2(12): 117-120.

    Objective To establish a chemiluminescence immunoassay (CLIA) for the detection of serum thyroid function. Methods The clinical data of 121 patients with hyperthyroidism, 101 patients with hypothyroidism and 67 patients with normal thyroid function admitted to Tianjin Medical University General Hospital were retrospectively analyzed from February 2023 to May 2024. The levels of serum thyroid stimulating hormone (TSH), free thyroxine (FT4) and free triiodothyronine (FT3) were examined by CLIA, and then the linear range, precision and accuracy of TSH, FT4 and FT3 monitored by CLIA system were counted. Results The linear correlation coefficient(r)values of TSH, FT4 and FT3 were$\geq {0.990}$, and slope(b)was within 0.95-1.00. The intra-batch and inter-batch precision values of TSH, FT4 and FT3 were less than 1/4TEa (CLIA’88) and 1/3TEa (CLIA’88) respectively. The bias of TSH, FT4 and FT3 were less than 1/2TEa (CLIA’88). The levels of TSH, FT4 and FT3 in patients with hyperthyroidism, hypothyroidism and normal thyroid function detected by CLIA were higher than those detected by RAI (P<0.05). Conclusion CLIA has good accuracy and precision in the detection of three items of serum thyroid function, and provides an important basis for clinical detection of three indexes of serum thyroid function.

  • Shao-Hua ZHOU, Jie LUAN, Ping XUE
    Laboratory Testing. 2024, 2(11): 99-101.

    In recent years, with the increasing concern of the public regarding drug safety, the detection capabilities of drug inspection systems have been continuously improving. There has been an explosive growth in the number of drug inspection equipment, which poses new challenges for equipment quality management. Currently, there are some issues in the equipment quality management of drug inspection units. This article analyzes the problems existing in the equipment quality management of drug inspection units and proposes corresponding improvement suggestions and measures. The aim is to provide scientific and effective management approaches for the equipment quality management of drug inspection departments, and to collectively strive for improved efficiency in drug inspection equipment quality management.

  • Lan-Bo DUAN, Chun-Yan LIANG, Li-Li HUANG
    Laboratory Testing. 2024, 2(12): 1-5.

    Objective To establish a gas-mass spectrometry method for determination of epichlorohydrin in Metoprolol succinate tablets. Methods The chromatographic column is HP-1MS. Injection temperature is${220}^{\circ }\mathrm{C}$; The injection method is split injection, and the split ratio is${10}: 1$. The heating procedure is to keep the initial temperature at${50}^{\circ }\mathrm{C}$for$3\mathrm{\;{min}}$, then raise the temperature to${80}^{\circ }\mathrm{C}$at a rate of${20}^{\circ }\mathrm{C}/\mathrm{{min}}$for$5\mathrm{\;{min}}$, and to${280}^{\circ }\mathrm{C}$at a rate of${40}^{\circ }\mathrm{C}/\mathrm{{min}}$for$8\mathrm{\;{min}}$. The sample intake capacity is${1\mu }\mathrm{L}$. The ion source is electron bombardment source (EI), ion source temperature is${230}^{\circ }\mathrm{C}$. Mass spectrometry interface temperature is${260}^{\circ }\mathrm{C}$; the monitoring mode of mass spectrometry is SIM. The mass to charge ratios (m/z) are 49, 57 and 62. Results The linear range of epichlorohydrin concentration is${30}\sim {120}\mathrm{{ng}}/\mathrm{{mL}}\left({r >{0.99}}\right)$. The detection limit is${32.37}\mathrm{{ng}}/\mathrm{{mL}}$. The limit of quantitation is${107.89}\mathrm{{ng}}/\mathrm{{mL}}$. RSD of precision is${1.8}\%\left({n = 6}\right)$. The average recovery is${103.8}\%$with RSD of${2.5}\%\left({n = 6}\right)$. Epichlorohydrin was not detected in 3 batches of Metoprolol succinate tablets. Conclusion The established gas-mass coupling method is simple, practical, accurate and reliable, and can be used for the determination of epichlorohydrin in Metoprolol succinate tablets.

  • Mei YANG, Hou-Ji GUO, Hui-Jiao NONG, Yuan GUAN, Cai-Ying JIANG, Qiu-Juan LIANG
    Laboratory Testing. 2024, 2(11): 109-111.

    The comprehensive scientific research experimental platform of university affiliated hospitals integrates medical treatment, scientific research and teaching, which is the pioneer field of medical research and the core element of scientific and technological innovation system. This paper aims to analyze the current situation and dilemma of safety management of scientific research experimental platform, combined with national policies, take the affiliated hospital of Youjiang Medical University for Nationalities as an example, and introduce the practical experience of safety management of comprehensive scientific research platform in affiliated hospitals of universities. It includes comprehensively strengthening the safety awareness of scientific research personnel, comprehensively improving the safety management system and process, rationally planning the construction layout of scientific research platform, and enabling scientific research platform safety management, etc., providing a referable safety management mode of scientific research platform for affiliated hospitals of universities.

  • Hai-E XU, Ji-Qiao XU, Xue-Lu DAI, Yun-Ming LIU
    Laboratory Testing. 2024, 2(11): 29-32.

    Objective To develop a gas chromatography-mass spectrometry solid-phase extractionfor detectingphthalic acid esters (PAEs) in the serum of patients with thyroid cancer. Four PAEs, namely, dimethyl phthalate (DMP), diethyl phthalate (DEP), dibutyl phthalate (DBP), and di (2-ethyl) hexyl phthalate (DEHP), were used in experiments. Methods Samples of PAEs were extracted and enhanced using a solid-phase extraction glass column. The column temperature parameters were as follows: the initial temperature was${60}^{\circ}\mathrm{C}$. The temperature was maintained at${60}^{\circ}\mathrm{C}$for 1 min and then increased by${20}^{\circ}\mathrm{C}/\mathrm{{min}}$to${220}^{\circ}\mathrm{C}$. The temperature was then increased by${5}^{\circ}\mathrm{C}/\mathrm{{min}}$to${290}^{\circ}\mathrm{C}$and maintained at${290}^{\circ}\mathrm{C}$for 2 min. The mass spectrometry conditions were as follows: the ionization mode was electron impact, the source energy was${70}\mathrm{{eV}}$, the ion source temperature was${240}^{\circ}\mathrm{C}$, the quadrupole temperature was${150}^{\circ}\mathrm{C}$, and the scanning mode was selective ion monitoring (SIM). These parameters were qualitatively based on the target compound’s retention time and the mass-to-charge ratio (m/z). Quantitative analysis was conductedusing the standard internal method. Results The standard curve regression equations of DMP, DEP, DBP, and DEHP all had excellent linear relationships with correlation coefficients greater than 0.997. The precision of DMP, DEP, DBP, and DEHP was 2.60%, 4.73%, 5.50% and 5.70%, respectively. The average recoveries were in the average range of${94.5}\%$. The detection rate of DBP, DMP, DEP and DEHP were 100%,31.6%,73.46%, and${100}\%$, respectively. Conclusion The method is suitable for simultaneous detection of PAEs in human serum, with low organic dose, short extraction time, good recovery and reproducibility, and low detection limit.

  • He-Ping MAO
    Laboratory Testing. 2024, 2(11): 45-47.

    In this study, a detection method based on infrared thermal imaging technology is developed for the defect detection problem of agricultural distribution network lines. This method combines advanced laser technology and infrared thermal imaging analysis to effectively improve the accuracy and efficiency of detection. The laser device is used to thermal motivate the rural distribution network line from multiple angles, and then the thermal image data is collected through an infrared thermal imager. The in-depth analysis of the thermal images accurately identifies the tiny cracks and other potential defects in the line. Experimental data show that this method can significantly improve the SNR of defect identification and reduce the missed detection rate, and it is an efficient detection technology adapted to meet the needs of modern agricultural power grid. This technology not only optimizes the detection process, but also greatly shortens the detection time, and improves the operation safety and reliability of the rural distribution network.

  • Yi-Rong XU, Dong-Ling LI, Kun YANG, Yu LIANG, Chun-Cui TAN, Wen-Jing WU, Fu QIN
    Laboratory Testing. 2024, 2(11): 7-11.

    Objective To establish a rapid method for the determination of benzo [a] pyrene in vegetable oil by liquid-liquid extraction-high performance liquid chromatography. Methods The sample was extracted by acetonitrile oscillation, and after centrifugation, the supernatant was taken and passed through${0.22\mu }\mathrm{m}$filter membrane, and injected into high-performance liquid chromatograph for measurement. Results were quantified using matrix external standard method. Results Benzo [a] pyrene had a good correlation in the linear range of${0.5}- {20.0}\mathrm{{\mu g}}/\mathrm{{kg}}$, and the correlation coefficient${r}^{2}$was$\geq {0.9990}$. The recoveries at 0.5,2.0 and${10.0}\mathrm{{\mu g}}/\mathrm{{kg}}$were${87.0}\%\sim {111.2}\%$, and the relative standard deviations were${2.2}\%\sim {14.2}\%$. The limits of detection and quantitation were${0.2\mu }\mathrm{g}/\mathrm{{kg}}$and${0.5\mu }\mathrm{g}/\mathrm{{kg}}$, respectively. Conclusion The method is simple, rapid and accurate, and is suitable for the determination of benzo [a] pyrene in vegetable oil.

  • Xue-Qin WANG
    Laboratory Testing. 2024, 2(11): 131-134.

    Objective This study aims to improve the accuracy and reliability of the determination of active ingredient content in Enteritis Ning Granules by optimizing high-performance liquid chromatography (HPLC) technology, and comprehensively evaluate the uncertainty of the determination results. Methods In this study, the Agilent 1260 HPLC system was used to determine the content of gallic acid active ingredient in Enteritis Ning Granules by optimizing chromatographic conditions such as mobile phase ratio, detection wavelength, column temperature, and solvent. At the same time, establish mathematical models toquantify multiple sources of uncertainty such as instrument errors, operational errors, and sample preparation errors. Results The optimized chromatographic technique significantly improved the sensitivity and accuracy of detecting active ingredients in Enteritis Ning Granules. The content of gallic acid is${27.5}\mathrm{{mg}}$, the chromatographic peak shape is symmetrical, and the separation degree and theoretical plate number have reached the ideallevel. The uncertainty analysis shows that the total uncertainty is small$\left({{U}_{\text{total }}={5.40}\%}\right)$, indicating that the optimized chromatographic technique has high reliability. Conclusion This study successfully optimized the HPLC method for determining the content of Enteritis Ning Granules, and demonstrated the accuracy and reliability of the method through a comprehensive evaluation of uncertainty. This provides a more accurate and reliable analytical method for the quality control of Enteritis Ning Granules, and also offers a new methodology for the modernization analysis of traditional Chinese medicine preparations.

  • Shu-Yin CHEN, Guo-Cheng LIANG, Xin QIN, Jun-Ting MO, Wen-Yong FENG, Zhen LONG
    Laboratory Testing. 2024, 2(11): 115-118.

    Objective To establish a specific, reliable and accurate quality control method to improve the quality standard of Anwei Granules. Methods The chromatography system, temperature and humidity of different reagents were investigated by silica gel thin layer chromatography (TLC) to optimize the thin layer identification of Coptidis rhizoma, Radix salviae miltiorrhizae and Linderae Radix. The content of total alkaloids in the preparation was determined by UV-Vis. Results The development system of Coptidis rhizoma was determined to be n-butanol-acetic acid-water (7 : 2.5 : 2), the development system of Radix salviae miltiorrhizae was toluene-trichloromethane-ethyl acetate-methanol-formic acid$\left({2 : 3 : 4 :{0.5}: 2}\right)$, and the development system of Linderae Radix was trichloromethane-ethyl acetate-formic acid$\left({4 : 3 :{0.2}}\right)$. The negative results of the three drugs were not interfered. The total alkaloid content was${4.8328}\mathrm{{mg}}/\mathrm{g}$and RSD% was 1.83% by UV-Vis assay. Conclusion In this study, an effective method for improving the quality standard of Anwei Granules was established, which has the characteristics of good repeatability and strong specificity.

  • Chun-Rui LIAO
    Laboratory Testing. 2024, 2(11): 123-126.

    Objective The relationship between fitness and single nucleotide gene polymorphism of Yersinia pestis was investigated. Methods In this paper, the mechanism of GTG in competition between different strains was revealed through continuous in vitro co-incubation competition and in vitro static competition. Results With the increase of passage times, GTG strain quickly became the absolute dominant strain and showed competitive adaptability. Under different stresses (Asp deficiency, weak acid and high salt), GTG and TTG strains showed more remarkable adaptability. In the competitive survival test of macrophages, the ratio of GTG strains to TTG strains did not change significantly. In the intracellular competitive amplification product experiment, mice with GTG: TTG=10: 1, the average dose exceeded the theoretical value during the administration process, resulting in early death of the mice. Conclusion GTG has competitive adaptability among different strains. There was no significant difference between the fitness of GTG and TTG strains in the intracellular competition of macrophages and the competition in mice, but TTG strains showed a fitness advantage in E. coli competition.