1.Monitoring nucleic acid contamination and assessing biosecurity risk in temporary 2019-nCoV nucleic acid testing laboratory from designated infectious disease care facilities
Junfei SHEN ; Zhimin MENG ; Qingfen SHI ; Chong WANG ; Baishen PAN ; Beili WANG ; Wei GUO
Chinese Journal of Laboratory Medicine 2023;46(9):943-949
Objective:To monitor nucleic acid contamination and evaluate the biosecurity risk in a temporary 2019-nCoV nucleic acid testing laboratory situated within designated infectious disease care facilities.Methods:Quantitative real-time PCR technology was used to detect nucleic acid contamination in samples collected from high-risk experimental activity areas and the surface of the laboratory staff′s personal protective equipment. Sampling was conducted every Monday from March 14 to May 16, 2022, both during and after disinfection procedures.Results:A total of 760 samples were collected from 40 sampling sites. A total of 27 out of 100 samples (27%) collected from 8 sampling sites in the sample processing area were positive. Among them, the contaminated area of biological safety cabinet, the outer surface of the sample transport box, and the sample rack were found to have the highest positive detection rates, with rates of 5/10, 4/10, and 6/10, respectively. Ten out of 140 samples (7.1%) obtained from 7 sampling sites in the nucleic acid detection area showed positive results. The inner wall of sample transfer window and the door handle of the nucleic acid detection area had the highest positive detection rates, both at 4/20. The Ct values for the target genes from the positive samples in the sample processing area were significantly higher than those from the nucleic acid detection area. The detection rate for nucleic acid contamination on the surface of the personal protective equipment of the laboratory staff was 20% (16/80), and the positive detection rate of the outer gloves from operator during the experiment reached 9/10. After disinfection, the nucleic acid residues on the surfaces of the various areas of the 2019-nCoV nucleic acid laboratory and the surfaces of the personal protective equipment of the laboratory staff were observed to be effectively removed.Conclusions:During experimental operation, the positive detection rate and nucleic acid contamination intensity of 2019-nCoV are higher in the sample processing area compared to those in the nucleic acid detection area. The laboratory staff are exposed to high biosecurity risk during the experiment. Implementing a scientific disinfection process can significantly reduce the risk of 2019-nCoV residues from the laboratory environment and the surface of the personal protective equipment of the laboratory staff, ensuring the accuracy of inspections and the safety of the laboratory staff.
2.Simultaneous determination of seven components in Piqin oral liquid by dual-wavelength HPLC
Qingfen WANG ; Xiaoling LIU ; Yuru YANG ; Jie LI
Journal of Pharmaceutical Practice 2022;40(2):161-164
Objective To establish a high performance liquid chromatography(HPLC) method for simultaneous determination of the contents of 7 components of chlorogenic acid, caffeic acid, paeoniflorin, ammonium glycyrrhizinate, baicalin, baicalein, and wogonin in Piqin oral liquid. Methods A double-wavelength HPLC method was performed. The column was Agilent Zorbax SB-C18 (250 mm × 4.6 mm, 5 μm). The mobile phase was 0.02% phosphoric acid aqueous solution (A)-acetonitrile (B) gradient elution; Flow rate: 1.0 ml/min; Column temperature: 35℃; Injection volume: 20 μl; Detection wavelength: 0-18.0 min, 325 nm (detect chlorogenic acid, caffeic acid); 18.0-65.0 min, 280 nm (detect paeoniflorin, baicalin, baicalein, ammonium glycyrrhizinate, wogonin). Results The chlorogenic acid, caffeic acid, paeoniflorin, ammonium glycyrrhizinate, baicalin, baicalein and wogonin were completely separated. Seven components have a good linear relationship between the peak area and concentration, with the recoveries between 96.41% and 99.70%. Conclusion This method is simple, accurate and reproducible, and can be used for the quality control of Piqin oral liquid.
3.Analysis on 59 cases of preparation deviation in our hospital from 2017 to 2019
Jie LI ; Yuru YANG ; Bashi YANG ; Qingfen WANG ; Jinshan CHEN
Journal of Pharmaceutical Practice 2022;40(1):93-96
Objective To provide direction for the improvement of quality control of hospital preparations and ensure the safety for clinical use by analyzing the hospital preparation deviations in recent three years. Methods A retrospective analysis on 59 minor hospital preparation deviations from 2017 to 2019 was conducted. Brainstorming, fishbone drawing and, Minitab software were used to analyze the root causes of deviations from five aspects: personnel, machine, materials, methods and environment. The preventive and corrective measures were implemented. The results were evaluated. Results 1 significant deviation (1.7%), 24 major deviation (40.7%), and 34 minor deviation (57.6%) were identified among the 59 casses of preparation deviation. With the implementation of preventive and corrective measures, the total number of deviations in 2018 was significantly reduced compared to that in 2017. The total number of deviations in 2019 was about the same as that in 2018. The human factors need to be focused. Conclusion The pharmaceutical preparation deviations in our hospital have been reduced. The further quality improvements for pharmaceutical preparations will be carried out by following the regulations of pharmaceutical production quality management standards and pharmaceutical production supervision and administration measures.
4.Ultrasonic examination and management of adult atrial septal aneurysm
Xuejun KONG ; Xingxing WANG ; Ning MA ; Junping JIN ; Qingfen CHAI
Chinese Journal of Health Management 2021;15(5):469-473
Objective:To explore the ultrasonography and classification management strategy for adult atrial septal aneurysm (ASA).Methods:Of 138 patients diagnosed with ASA by the transthoracic echocardiography (TTE), in No.83 Army Hospital and No.988 Hospital of Joint Logistic Support Force from January 2015 to October 2019, 103 underwent the transesophageal echocardiography (TEE), and all were examined by the right heart contrast transthoracic echocardiography (cTTE). According to the semi-quantitative method, the shunt was graded, classified, and managed through follow-up or surgical treatment.Results:In the resting state, among 138 patients, 26 cases were detected by TTE as ASA with patent foramen ovale (PFO), showing left-to-right shunt. Among 112 patients with no shunt detected by TTE, 103 cases underwent TEE, of whom 44 cases had PFO and left-to-right shunt. The detection rate of PFO shunt by TEE was significantly higher than that of TTE (42.72% vs 18.84%, P<0.001). Out of the 138 patients who underwent cTTE, 96 cases had different degrees of right-to-left shunt. According to the semi-quantitative standard, there were 15 cases of grade Ⅰ, 28 cases of grade Ⅱ, and 53 cases of grade Ⅲ. The detection rate of cTTE was significantly higher than that of TTE and TEE (69.56% vs 18.84% and 42.72%, both P<0.001). Among these 96 patients with right-to-left shunt detected by cTTE, 52 cases (54.17%) were clinically diagnosed as cryptogenic stroke, with right-to-left shunt in 6 cases of grade Ⅰ, 12 cases of grade Ⅱ, and 34 cases of grade Ⅲ. The number of new infarcts in patients with grade Ⅱ or Ⅲ shunts who received PFO closure via catheter was significantly lower than that of patients who did not receive closure therapy (0 vs 27.27%, P=0.011). Conclusion:ASA combined with PFO and right-to-left shunts were detected more frequently by ultrasonography combined with cTTE in adults, this helps to formulate a reasonable management strategy.
5.Content determination of total flavones and polysaccharides in Fangshu Qingre mixture by UV-Vis spectrophotometry
Jie LI ; Yuru YANG ; Qingfen WANG ; Shaozhong ZHENG ; Jinshan CHEN
Journal of Pharmaceutical Practice 2020;38(1):63-66
Objective To establish a method for content determination of total flavones and polysaccharides in Fangshu Qingre mixture by UV-Vis Spectrophotometry. Methods The contents of total flavones and polysaccharides in Fangshu Qingre mixture were determined by UV-Vis spectroscopy with rutin and anhydrous glucose as reference substance, and the wavelength was set at 508 nm and 487 nm. Results The contents were from 0.00 to 59.20 μg/ml for total flavones and from 10.92 to 109.20 μg/ml for total polysaccharides in Fangshu Qingre mixture. The recoveries of total flavones and total polysaccharides were 104.4% and 104.8% respectively. Conclusion The method of using ultraviolet spectroscopy was simple, reproducible, accurate and reliable, which could be preferably used as the method for content determination of total flavones and polysaccharides in Fangshu Qingre mixture.
6.Simultaneous determination of five active components in Fangshu Qingre mixture by RP-HPLC
Jie LI ; Yuru YANG ; Qingfen WANG ; Jinshan CHEN
Journal of Pharmaceutical Practice 2020;38(5):462-465
Objective To establish a method for simultaneous determination of chlorogenic acid, luteolin-7-O-β-D-glucoside,3,5-dicaffeoylquinic acid, linarin and pogostone in Fangshu Qingre mixture by RP-HPLC. Methods ZORBAX-SB-C18 column(4.6 mm×250 mm, 5 μm) was used as the chromatographic column.The mobile phase was 0.2% formic acid water solution(A) and acetonitrile solution (B)with a gradient elution mode. The flow rate was 1.0 ml/min.The detective wavelength was 327 nm. The column temperature was 30 ℃. Results There were good linear relationships in the determination of chlorogenic acid, luteolin-7-O-β-D-glucoside, 3,5-dicaffeoylquinic acid, linarin and pogostone (r≥0.999 6), with the average recovery rate of 102.03%(1.63%), 102.38%(1.51%), 102.39%(1.23%), 103.14%(1.87%) and 104.01%(2.33%). Conclusion The method was simple and stable with a good reproducibility, which could be used as a quality control method for active compotents in Fangshu Qingre mixture.
7.Determination of Ethylparaben in Potassium Chloride Solution
Yuru YANG ; Qiulian SHEN ; Qingfen WANG
China Pharmacist 2017;20(5):953-955
Objective: To investigate the content of ethylparaben in potassium chloride solution.Methods: According to the guidance for antibacterial effect test stated in Chinese Pharmacopoeia(the 4th volume of 2015 edition), 5 standard bacterial strains including Staphylococcus aureus,Escherichia coli,Pseudomonas aeruginosa,Candida albicans and Aspergillus niger were used as the challenging strains.Using the logarithm decrease of bacteria number as the index, the antimicrobial effectiveness of ethylparaben at different concentrations was studied to screen out the optimal concentration in the solution.Results: The growth of the 5 standard bacterial strains was inhibited effectively by potassium chloride solution containing 0.05% ethylparaben, which was also the minimum effective concentration.Conclusion: 0.05% Ethylparaben is suitable as the bacteriostatic agent for potassium chloride solution.
8.Optimization of Dry Granulation Technology for Yinqiao Baidu Tablet by Orthogonal Test
Yongling LIU ; Jie SHAO ; Yongxiang WANG ; Qingfen ZHANG ; Zhenzhong WANG
China Pharmacy 2017;28(25):3553-3556
OBJECTIVE:To optimize the dry granulation technology conditions for Yinqiao baidu tablet. METHODS:Using granulating difficulty degree and disintegration time as investigation indexes,ratio and amount of accessories microcrystalline cellu-lose and compressible starch in Yinqiao baidu tablet,moisture content of the sprayed powder were screened. Using yield of particle and angle of repose as indexes,L9(34)orthogonal test was used to optimize the wheel pressure,rotating speed and feeding speed in dry granulation technology,and verification test was conducted. RESULTS:The ratio of microcrystalline cellulose and compress-ible starch was 7:3,and mixing ratio of the two with spray powder+inclusion compound was 1:5. The moisture content of spray powder was controlled in 1%-2%. The optimal technology was as follow as wheel pressure of 3.5 MPa,roller speed of 4 r/min and feeding speed of 10 r/min. In verification test,average yield of particle was 69.2% and angle of repose was 31.5 °. Transfer rate of chlorogenic acid had reached over 92%,and RSD of each index was below 2.53%(n=3). CONCLUSIONS:Each index of parti-cle prepared by optimized accessories formulation and technology shows good reproducibility and feasibility,and the technology is stable and suitable for production.
9.Research on the determination of total flavonoids in compound Yinchen mixture
Xiaoling LIU ; Xiaohui CAI ; Xiaoxia NI ; Qingfen WANG
Journal of Pharmaceutical Practice 2017;35(6):547-550
Objective To establish a method for the determination of the total flavonoids content in compound Yinchen mixture by UV spectrophotometry .Methods Using rutin as comparison ,three coloration methods were studied to find the op-timal assay method .Results The sample was detected at 508 nm wavelength by NaNO2-Al(NO3 )3-NaOH reaction with rutin as reference .The rutin content had a liner relationship in the range of 0 .0125-0 .0626 g/L (n=9 ,r=0 .9999) ,and the aver-age recovery rate was 99 .49% with RSD of 0 .84% .Conclusion The NaNO2-Al(NO3 )3-NaOH coloration method is proved to be simple ,quick ,stable and reliable for the determination of total flavonoids in compound Yinchen mixture .
10.Application of nursing evaluation site in the objective structured clinical examination of new nurses
Zheng LI ; Qingfen WANG ; Hong ZHENG
Chinese Journal of Modern Nursing 2017;23(5):613-616
Objective To test nursing assessment ability of new nurses,evaluate the training effects and find defects in the training of new nurses through nursing assessment using objective structured clinical examination,so as to guide the implementation of standardized training and explore new method that is suitable for the evaluation of effects of standardized training.Methods New nurses recruited in January 2015 in Baoding No.1 Hospital were selected as the research object. Standardized training manual was established and appraisal framework of objective structured clinical examination was designed. Objective structured clinical examination was carried out every two months during one year's standardized training. Standard cases and evaluation criteria were authorized. New nurses were evaluated according to the standard after test. The main problems exposed in examination and appraisal were used as the observational indexes. Scores up to 60 were set as fail and scores above 80 were defined as excellent nurses.Results A total of 41 new nurses took part in the assessment. The scores distributed in four ranges:above 80 (2 nurses),between 70 and 80 (12 nurses),between 60 and 70 (9 nurses) and below 60 (18 nurses). Problems during the nursing assessment contained inadequate understanding of content inquisition interview,ignoring assessment of patients' main symptoms and unreasonable evaluation score caused by incomprehensive assessing content,even though they had the awareness of risk assessment.Conclusions Through the objective structured clinical examination,we found that new nurses' ability of nursing assessment is low. The assessment reflects the main problems during standardized training and guides the improvement of clinical teaching and nursing. The appraisal procedure could be used as a new assessment method of new nurses' standardized training in hospital.

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