Objective:To compare the test methods for aluminum content determination in vaccines by inductively coupled plasma-mass spectrometry(ICP-MS),inductively coupled plasma optical emission spectrometry(ICP-OES)and titration of the Chinese Pharmacopoeia 2020.Methods:The pre-treatment procedures,linearity,repeatability,accuracy,quantification limit,detection limit and sample determination results of the three methods were compared and analyzed by methodological verification and sample testing.Results:There was a good linear relationship of ICP-OES in the concentration range of 1-20μg·mL-1 aluminum content,r=0.9999.Aluminum content in 6 types of vaccines was in the range of 99％-104.6％,and RSDs were lower than 3％(n=9).There was a good linear relationship of ICP-MS in the concentration range of 2.5-80ng·mL-1(r=0.999).Aluminum content in 6 types of vaccines were in the range of 99.4％-108.9％,and RSDs were lower than 8％(n=9).There was no significant difference between the three methods in the determination of aluminum content in vaccines,and RSDs were lower than 10％.Conclusion:Both ICP-MS and ICP-OES methods can be used for the determination of alu-minum content in aluminum adjuvant vaccine.Both detection methods are simple,fast and accurate.ICP-OES has lower instrument costs and is easier to promote in the laboratory.

OBJECTIVE：To establish a method for the determination of related substances in dibasol hydrochloride raw materials and tablets ， and to predict the maximum unknown impurity ’s structure. METHODS ： The related substances （o-phenylenediamine，phenylacetic acid ）in dibasol hydrochloride raw materials and tablets were determined by HPLC. The determination was performed on Kromasil C 18 column with mobile phase consisted of mobile phase-methanol-glacial acetic acid-triethylamine（45 ∶ 55 ∶ 0.5 ∶ 0.5，V/V/V/V）at the flow rate of 1.0 mL/min. The detection wavelength was set at 220 nm，and column temperature was 30 ℃. Sample size was 10 μL. UPLC-TOF-MS，1H-NMR and 13C-NMR were used for structure prediction. The determination was performed on Waters Acquity UPLC BEH C 18 column with mobile phase consisted of water-methanol （45∶55， V/V）at the flow rate of 0.2 mL/min. The column temperature was 30 ℃，and sample size was 1 μL. The ion source was electrospray ion source . The scanning mode was negative ion scanning mode. The first-order mass spectrum scanning range was m/z 100-800，the capillary voltage was 3 000 V，the source temperature was 100 ℃，the desolvent gas was nitrogen ，and the solvent free gas flow rate was 600 L/h. The flow rate of the conical orifice was 50 L/h. RESULTS： The linear range of o-phenylenediamine，phenylacetic acid and dibasol hydrochlo- ride were 0.427-4.27 μg/mL（r＝0.998 9），0.403-4.03 μg/mL（r＝ 0.998 9）and 0.82-8.20 μg/mL（r＝0.999 9），respec-tively. The limits of quantitation were 0.042 7，0.134 3，0.088 7 μg/mL. The limits of detection were 0.021 4，0.067 1，0.044 3 μ g/mL. RSDs of precision ，stability，reproducibility and durability tests were all less than 2％. The average recoveries were 98.31％- 99.78％-102.23％ for phenylacetic acid （RSD＝0.70％，n＝9）. No o-phenylenediamine was detected in 6 batches of dibazol hydrochloride raw materials ；the contents of phenylacetic acid · were 0-0.04％ ；the contents of maximum unknown impurity were 0.05％ -0.25％ ；total contents of unknown impurity were 0.05％-0.31％. In 77 batches of Dibasol hydrochloride tablets ，the contents of o-phenylenediamine were 0-0.11％，the contents of phenylacetic acid were 0-0.03％；the contents of maximum unknown impurity were 0.06％-0.51％；total contents of unknown impurity were 0.10％-0.62％. It was speculated that maximum unknown impurity was 2-（hydroxyphenylmethyl）benzimidazole （hydrobenzde）. CONCLUSIONS ：Established method is rapid ，accurate and specific ，and can be used for the determination of related substances in dibasol hydrochloride raw materials and tablets. The maximum unknown impurity may be benzimidazoles.

Objective:This study aims to study the mental health status of people with different identities during the fight against COVID-19. Further, we propose psychological intervention strategies for people with different identities.Methods:857 participants from Guangdong province (215 identified as first-level population referring to the impact severity of the outbreak, 91 as second-level population, 120 as third-level population, and 431 as fourth level population) were cross-sectionally surveyed online from January 30 to February 28, 2020. The Generalized Anxiety Disorder Scale (GAD-7), the Patient Health Questionnaire-9 (PHQ-9), and the Perceived Stress Scale (PSS-10) were used to evaluate the mental health status of different populations. The Kruskal-Wallis H test was used to test the differences of the total scores of these three scales across populations at different levels, and the groups were compared pairwise with the Bonferroni method. Finally, the Wilcoxon rank sum test was used to further analyze the dimensions between the scales. Results:In all 857 subjects, the total scores of GAD-7, PHQ-9, and PSS-10 were 4(1,8), 4(1,9), and 16(11,19), respectively. There were statistically significant differences in the scores of GAD-7 ( H=15.235, P<0.01), PHQ-9 ( H=9.265, P=0.026), and PSS-10 ( H=8.435, P=0.049) among different levels of the population. For the score of GAD-7, the anxiety severity of the first-level crowd was higher than that of the second-level crowd and the fourth-level crowd. The pairwise comparisons were statistically significant ( Z=-2.932, -4.012, -2.949, P<0.005); there were significant between-group differences in domains of "becoming easily annoyed or irritable" and "seemingly terrible things will happen". For the score of PHQ-9, the depression severity of the first-level crowd and the second-level crowd was higher than that of the fourth-level crowd, and the pairwise comparisons were statistically significant ( Z=-3.387, -2.682, P<0.005). There were significant between-group differences in domains of "difficult to fall asleep or not awake", "feeling depressed" and other related domains. For the score of PSS-10, the stress severity of the third-level crowd was higher than that of the first-level crowd and the fourth-level crowd ( Z=-2.702, -3.693, -2.735, P<0.005). There were significant between-group differences in domains of "feel confident", "life is as expected", "the ability to control anger", "the things are all under control", and other related domains. Conclusion:The impact of the COVID-19 on mental health in people with different identities is different, and appropriate psychological interventions should be provided for different populations according to their mental health status.

Objective:This study aims to study the mental health status of people with different identities during the fight against COVID-19. Further, we propose psychological intervention strategies for people with different identities.Methods:857 participants from Guangdong province (215 identified as first-level population referring to the impact severity of the outbreak, 91 as second-level population, 120 as third-level population, and 431 as fourth level population) were cross-sectionally surveyed online from January 30 to February 28, 2020. The Generalized Anxiety Disorder Scale (GAD-7), the Patient Health Questionnaire-9 (PHQ-9), and the Perceived Stress Scale (PSS-10) were used to evaluate the mental health status of different populations. The Kruskal-Wallis H test was used to test the differences of the total scores of these three scales across populations at different levels, and the groups were compared pairwise with the Bonferroni method. Finally, the Wilcoxon rank sum test was used to further analyze the dimensions between the scales. Results:In all 857 subjects, the total scores of GAD-7, PHQ-9, and PSS-10 were 4(1,8), 4(1,9), and 16(11,19), respectively. There were statistically significant differences in the scores of GAD-7 ( H=15.235, P<0.01), PHQ-9 ( H=9.265, P=0.026), and PSS-10 ( H=8.435, P=0.049) among different levels of the population. For the score of GAD-7, the anxiety severity of the first-level crowd was higher than that of the second-level crowd and the fourth-level crowd. The pairwise comparisons were statistically significant ( Z=-2.932, -4.012, -2.949, P<0.005); there were significant between-group differences in domains of "becoming easily annoyed or irritable" and "seemingly terrible things will happen". For the score of PHQ-9, the depression severity of the first-level crowd and the second-level crowd was higher than that of the fourth-level crowd, and the pairwise comparisons were statistically significant ( Z=-3.387, -2.682, P<0.005). There were significant between-group differences in domains of "difficult to fall asleep or not awake", "feeling depressed" and other related domains. For the score of PSS-10, the stress severity of the third-level crowd was higher than that of the first-level crowd and the fourth-level crowd ( Z=-2.702, -3.693, -2.735, P<0.005). There were significant between-group differences in domains of "feel confident", "life is as expected", "the ability to control anger", "the things are all under control", and other related domains. Conclusion:The impact of the COVID-19 on mental health in people with different identities is different, and appropriate psychological interventions should be provided for different populations according to their mental health status.

OBJECTIVE:To establish a method for the determination of ethanol,acetonitrile,dichloromethane,ethyl acetate, pyridine in vidarabine monophosphate. METHODS:Headspace GC was performed on the column of Agilent DB-624,programmed temperature,inlet temperature was 200 ℃,the detector was flame ionization detector,detecting temperature was 250 ℃,nitrogen was carrier gas,flow rate was 3 ml/min,split ratio was 1∶1,the top bottles equilibrium temperature was 100 ℃,and equilibrium time was 45 min,injection volume was 1 ml. external standard was used for quantitative analysis. RESULTS:The peaks of five re-sidual solvents could be completely separated from the other peaks respectively,The linear rang was 24.7-296.3 μg/ml for ethanol (r=0.999 6)、1.9-23.2 μg/ml for acetonitrile(r=0.999 0),2.8-33.6 μg/ml for dichloromethane(r=0.998 0),24.7-295.9 μg/ml for ethyl acetate(r=0.999 5),1.0-11.9 μg/ml for pyridine(r=0.998 6);RSDs of precision and reproducibility tests were lower than 4.35%;recoveries were 102.4%(RSD=2.0%,n=9)、102.1%(RSD=3.4%,n=9)、105.5%(RSD=4.8%,n=9)、100.3%(RSD=4.8%, n=9)、98.3%(RSD=4.0%,n=9). The minimum quantifation limit was 0.304 4-0.988 0 μg/ml and the minimum detection limit was 0.101 5-0.329 3 μg/ml. CONCLUSIONS:The method is simple,accurate and reproducible,and can be used for the determination of residual solvents in vidarabine monophosphate.

Objective To establish a method for determining the molecular weight (Mw) and molecular weight distribution of Iron Maltose Syrup. Methods HPGPC was used; PSS HEMA was used as column.Detector was differential refraction detector.Mobile phase was phosphate buffer solution (pH6.8) at 0.5 mL/min, column temperature was 45℃.Results The Mw of 3 batches of Iron Maltose Syrup were 45000-47000 Da with good linearity, precision and reproducibility.Conclusion The method is simple, reliable and accepted by the specification for controlling the molecular weight and weight distribution of Iron Maltose Syrup.

Objective To establish a method for HPLC to determine content of acetyl tyrosine in pediatric compound amino acid injection (19AA-Ⅰ).Methods The chromatographic separation was achieved on a Agilent Hypersil ODS column (250 mm ×4.0 mm,5 μm) with Agilent 1200 liquid chromatography system.The mobile phases consisted of 20 mmol/L sodium dihydrogen phosphate solution ( adjusting pH to 2.5 with phosphoric acid)-acetonitrile (90:10) at a flow rate of 1.0 mL/min, the detection wavelength was 210 nm, the column temperature was 25℃.Results Acetyl tyrosine was completely separated from other amino acids.The calibration curves for acetyl tyrosine revealed good linearity in the range of 12.062-120.62μg/mL (r=0.9999).The average recoveries (n=9) of acetyl tyrosine was 100.0%, RSD% (n=9) was 0.9.The limits of quantification (S/N=10) was 0.15μg/mL.Conclusion The methodological validation results indicate that the established method can be applied to quality control of acetyl tyrosine in pediatric compound amino acid injection (19AA-Ⅰ).

Objective:To analyze the genetic sequence characteristics of amomum viosum and establish a rapid identification meth-od for amomum viosum by fluorescent quantitative PCR based on DNA analysis. Methods:Amomum viosum and the other samples be-longing to the same genera were collected and identified by experts in the domain. DNA was isolated using commercial kits. The prim-ers and probe were designed according to the conserved region of ITS in amomum viosum. The reaction conditions were optimized to es-tablish the fluorescent quantitative PCR method for the rapid detection of amomum viosum. Results:The fluorescent quantitative PCR method for the rapid detection of amomum viosum was set up. The method could identify amomum viosum successfully, while those samples in the same genera were without amplification curves. Conclusion: Amomum viosum can be identified rapidly by fluorescent quantitative PCR besides the traditional identification by experts.

Objective:To establish an HPLC method for the determination of the related substances in vidarabine monophosphate for injection. Methods:The known impurities vidarabine and adenine in vidarabine monophosphate for injection were analyzed by an external standard method on a Kromasil 100-5 C18 column(250 mm × 4. 6 mm,5μm)with the mobile phase consisting of water(contai-ning 10 mmol·L-1 tetrabutyl ammonium hydroxide and 10 mmol·L-1 potassium dihydrogen phosphate)-methanol(80:20)at a flow rate of 1. 0 ml·min-1,the detection wavelength was set at 258nm,the column temperature was at 30℃,and the sample size was 20μl. Meanwhile,the unknown impurities were examined by a self-control method. Results:Good linear relationships of vidarabine and adenine were obtained within the range of 0.0765 ~1.530 7μg·ml-1(r =0.999 9)and 0.078 0 ~1.560 0 μg·ml-1(r =0. 999 9). The corresponding average recovery was 99. 8% with RSD of 0. 2%(n=9)for vidarabine and 97. 0% with RSD of 1. 2%(n=9)for adenine. Conclusion:The method can be used to determine the related substances in vidarabine monophosphate for injec-tion.

OBJECTIVE: To investigate the standard value of foot tapping test (FTT) in healthy population and FTT for lower extremity motor function in patients with cervical compressive myelopathy. METHODS: Totally 124 patients [68 males, (58.49±14.60) years old; 56 females, (57.55±18.27) years old] diagnosed of cervical myelopathy and 160 healthy volunteers [80 males, (45.43±17.98) years old; 80 females, (45.2±17.47) years old] participated in our study. The patients who underwent surgery were evaluated both before and 1 year after the surgery. We performed FTT and Grip and Release Test and evaluated with the modified Japanese Orthopaedic Association (JOA) score for cervical myelopathy. RESULTS: The value of FTT was (22.23±2.53) in myelopathic patients, significantly lower than (33.23 ±3.17) in the healthy group (decreasing with age) (P<0.05). The value of FTT was positively correlated with the lower extremity motor function of modified JOA score and the value of Grip and Release Test. In the patients who underwent surgery, the value of FTT was (22.23±2.53) preoperatively and was improved to (28.48±1.99) at one year postoperatively (P<0.05). CONCLUSION The FTT score has been improved by surgery. The FTT is an easy and useful quantitative assessment for lower extremity motor function in patients with cervical myelopathy, especially those who cannot walk.
Adult ; Aged ; Cervical Vertebrae ; Female ; Foot ; Humans ; Lower Extremity ; physiopathology ; Male ; Middle Aged ; Movement ; Orthopedics ; methods ; Postoperative Period ; Spinal Cord Compression ; diagnosis ; physiopathology ; Treatment Outcome