1.Quality Evaluation on Huatan Pingchuan Tablets Based on National Drug Sampling and Testing
Dan LI ; Xianling YANG ; Hongyu ZHAI ; Yuhua SHEN ; Qiaosen REN ; Jing HAN ; Zhenbin FENG ; Jialiang ZHU
Herald of Medicine 2025;44(1):39-46
Objective Based on the sampling test of national drugs,the quality of Huatan Pingchuan tablets was systematically evaluated,and the quality problems were analyzed to provide references and suggestions for the quality control of this variety and to improve its quality standard.Methods A total of 157 batches of samples were tested according to the statutory standard,and based on the testing results and prescription characteristics,microscopic identification and comprehensive analysis of its quality using thin-layer chromatography,high-performance liquid chromatography,and other methods were subsequently established or improved for the exploratory research.Results The established thin-layer chromatography identification for Radix Scutellariae,as well as the content determination methods for Radix Scutellariae,Syringae Cortex,and promethazine hydrochloride,are easy to operate and have good durability and specificity and can be applied to the quality control and evaluation of Huatan Pingchuan tablets.Conclusions The overall quality of the tablets is average;some enterprises should strengthen the quality control of raw medicinal materials(decoction pieces);individual enterprises have significant differences in the quality of samples from different batches,so they need to pay attention to the quality of raw materials and the stability of production processes;the inspection items of the current standards cannot fully reflect the key quality attributes of drugs,and standards improvement work needs to be carried out.
2.Quality Evaluation on Huatan Pingchuan Tablets Based on National Drug Sampling and Testing
Dan LI ; Xianling YANG ; Hongyu ZHAI ; Yuhua SHEN ; Qiaosen REN ; Jing HAN ; Zhenbin FENG ; Jialiang ZHU
Herald of Medicine 2025;44(1):39-46
Objective Based on the sampling test of national drugs,the quality of Huatan Pingchuan tablets was systematically evaluated,and the quality problems were analyzed to provide references and suggestions for the quality control of this variety and to improve its quality standard.Methods A total of 157 batches of samples were tested according to the statutory standard,and based on the testing results and prescription characteristics,microscopic identification and comprehensive analysis of its quality using thin-layer chromatography,high-performance liquid chromatography,and other methods were subsequently established or improved for the exploratory research.Results The established thin-layer chromatography identification for Radix Scutellariae,as well as the content determination methods for Radix Scutellariae,Syringae Cortex,and promethazine hydrochloride,are easy to operate and have good durability and specificity and can be applied to the quality control and evaluation of Huatan Pingchuan tablets.Conclusions The overall quality of the tablets is average;some enterprises should strengthen the quality control of raw medicinal materials(decoction pieces);individual enterprises have significant differences in the quality of samples from different batches,so they need to pay attention to the quality of raw materials and the stability of production processes;the inspection items of the current standards cannot fully reflect the key quality attributes of drugs,and standards improvement work needs to be carried out.
3.Establishment of a direct detection method for serum M-proteins without antibody enrichment based on MALDI-TOF MS technology
Ruifang CUI ; Shunli ZHANG ; Dehui SUN ; Mo WANG ; Yuhua ZHAI ; Yuhong YUE ; Xiaoguang ZHOU ; Qingtao WANG ; Rui ZHANG
Chinese Journal of Laboratory Medicine 2022;45(10):1087-1092
Objective:To establish a matrix-assisted laser desorption ionization time-of-flight mass spectrometry (MALDI-TOF MS) method for the direct detection of serum M protein without antibody enrichment, and to assess its detection performance.Methods:Method establishment. A total of 712 waste serum samples were collected from patients who applied for the M protein identification test in Beijing Chaoyang Hospital affiliated to Capital Medical University. The immunoglobulin light chain was obtained by reduction of IgG and IgA by TCEP, and the detection method was preliminarily determined. The waste serum samples from 20 healthy people were collected to determine the range of mass-to-charge ratios of κ and λ light chain ions. 8 parallel tubes and 8 batches were set up for intra-and inter-batch reproducibility evaluation. 10-fold, 100-fold and 200-fold diluted M protein from 23 positive samples were detected by established MALDI-TOF MS method, and its sensitivity was evaluated. 3 methods of IFE, SPE and MALDI-TOF MS were used to detect M protein simultaneously, and the coincidence rate between MALDI-TOF MS and IFE and SPE was calculated.Results:The repeatability within and between batches was 100%, respectively. The original, 10-, 100-and 200-fold dilutions of 23 M protein-positive samples were determined, and the detection limit of MALDI-TOF MS for M protein was 0.06-0.18 g/L. IFE as the gold standard, the overall coincidence rates of SPE and MALDI-TOF MS were 85.9% and 92.3%, respectively, and the positive coincidence rates of SPE and MALDI-TOF MS were 72.8% and 99.7%, respectively, of the 712 samples. Among the different types of M-proteins, MALDI-TOF-MS agreed 100% with IFE M-protein results for IgA, IgD, IgM, free light chain type and biclonal group, while the agreements of SPE for IgM, IgA and free light chain samples were only 66.7%, 58% and 19.5%, respectively. One positive sample in the IgG group was not detected by MALDI-TOF MS. 23 M-proteins positive samples were diluted by original, 10, 100 and 200 times to access the sensitivity of MALDI-TOF MS method. The coincidence rate of MALDI-TOF MS was 100% and IFE was 96% at 10-fold dilution. The coincidence rate of IFE was 28% and 23% of MALDI-TOF MS at 100-fold and 200-fold dilution, respectively.Conclusions:A MALDI-TOF MS method for the detection of serum M-proteins was successfully established. This method has the advantages of high detection throughput, fast speed, good sensitivity, specificity and coincidence rate.
4.Simultaneous Determination of 4 Kinds of Effective Components in Volatile Oil of Forsythia suspensa by QAMS
Ting WU ; Liyuan TAN ; Xuwen WANG ; Kangxin ZHAI ; Jin CHEN ; Xiangping PEI ; Yonggang ZHOU ; Yuhua ZHANG ; Shan WEI ; Shurong ZHANG
China Pharmacy 2019;30(14):1981-1984
OBJECTIVE: To establish a method for simultaneous determination of α-pinene, β-pinene, limonene and α-terpineol in volatile oil of Forsythia suspensa. METHODS: GC method was adopted. The determination was performed on HP-5 capillary column through temperature-programmed route. The inlet temperature was 230 ℃, and detector temperature was 250 ℃; split sampling was applied (split ratio of 8 ∶ 1); the air flow rate was 300 mL/min, the hydrogen flow rate was 30 mL/min, the tail gas flow rate was 30 mL/min, and the injection volume was 1 μL. Using limonene as internal reference, relative correction factors of α-pinene, β-pinene and α-terpineol were established, and the reproducibility of relative correction factors were investigated by using different chromatographs and columns, and chromatographic peak location of components was measured. The contents of above components were calculated with QAMS, and then compared with the results of external standard method. RESULTS: The linear range of α-pinene, β-pinene, limonene and α-terpineol were 16.5-990.0, 38.1-2 287.5, 8.2-491.2, 2.4-142.5 μg/mL, respectively (r≥0.999 1). RSDs of precision, reproducibility and stability tests were all lower than 3% (n=6). Average recoveries were 99.7%-105.5%(RSD<4%,n=9). Compared with limonene (1.00),the average relative correction factors of α-pinene, β-pinene and α-terpineol were 0.91,0.86 and 1.11(n=3); relative retention time were 0.69-0.74, 0.81-0.86, 1.25-1.35(RSD<3%,n=3). By using different chromatographs and columns, RSDs of relative correction factors were 0.21%-4.65%(n=6). Compared with external standard method, determination results of above 4 components were consistent (the absolute value of relative error were all less than 7%). CONCLUSIONS: QAMS can be used for simultaneous determination of 4 kinds of effective components in volatile oil from F. suspensa.
5.Application of subjective visual otolith function test on the medical evaluation of pilots
Lihong ZHAI ; Jinye LUO ; Xianrong XU ; Yuhua LIU
Chinese Journal of Aerospace Medicine 2019;30(1):25-29
Objective To provide the references on otolith function evaluation by investigating subj ective visual vertical (SVV)and subj ective visual horizontal (SVH),as well as the tilt range of SVV and SVH when pilot,s head tilted 45°to the left or right side for the selection and the medical evaluation of pilots . Methods XZ-2008 Otolith function test instrument was chosen for the tests.①One hundred active fighter pilots were chosen as the subj ects and the angle range of their head upright SVV was recorded.②Twenty-four active fighter pilots were chosen as the subjects.The angle range of their head upright SVV and the angle ranges of head 45°right or left tilt SVH and SVV were recorded.Normal value range was caculated according to Mean±1 .96 SD Results ①The angle range of head upright SVV of 100 pilots was -1 .61°-1 .73°.②The angle range of head upright SVH of 24 pilots was -2.34°-3.18°,the angle range of head 45°left tilt SVV was -7.12°-6.12°,and the range of -6.76°-4.84°for their head 45°right tilt.The angle range of 45°left tilt and 45°right tilt SVH was respectively -9 .84°-6.74°,and -6 .70°-6 .20°. Conclusions The study has established the test method and the normal angle range of SVV and SVH in military pilots,which is crucial for the assessment of the otolith function in medical selection and medical evaluation of military pilots.When head tilts to left or right by 45°the angles of SVV and SVH will change.We will further study its clinical signification and provide more evidence for the vestibular function medical evaluation of military flying personnel.
6.Comparative study on the reference value of vestibular autorotation test between military pilots and ordinary personnel
Zhanguo JIN ; Xianrong XU ; Yuhua LIU ; Lihong ZHAI ; Yuanjun LI
Chinese Journal of Aerospace Medicine 2019;30(1):12-16
Objective To compare the various parameters of vestibular autorotation test (VAT) between the Chinese military pilots and ordinary personnel. Methods Thirty-four pilots who had passed the physical examination,including the caloric test and video-head impulse test of vestibular functions,were selected as subj ects.They received vestibular autorotation test by VAT98-3 detector that manufactured by the WSR Company of United States.The frequencies,horizontal and vertical gains and phase shift of the vestibular ocular reflex (VOR)in VAT were analyzed and compared with the corresponding parameters of 100 ordinary personnel stored in the detector. Results By comparing the measured values of 34 military pilots with 100 ordinary personnel the significant differences were found on the horizontal gain at 2.0,2.3,4.7,5.1,5.5,5.9 Hz,the horizontal phase shift at 2.0,3.9,4.7,5.1 Hz,the vertical gain at 5.5,5.9 Hz and the vertical phase shift at 2.0,3.9, 5.1 Hz (t=2.106-18.647,P<0.05).The vertical phase shifts on the frequencies of 2.3,2.7,3.1, 3.5,4.3 Hz and the asymmetry showed insignificant difference as compared with the reference values of ordinary personnel. Conclusions The military pilots show higher gains on the 2.0 and 2 .3 Hz VAT than the ordinary personnel and the gain is close to 1 ,but on 4.7 ,5 .1 ,5 .5 ,and 5 .9 Hz.The differences should be considered in the evaluation of vestibular functions for military pilots.The aeromedical assessment should take the norm of military pilot as the reference.
7.Application of subjective visual otolith function test on the medical evaluation of pilots
Lihong ZHAI ; Jinye LUO ; Xianrong XU ; Yuhua LIU
Chinese Journal of Aerospace Medicine 2019;30(1):25-29
Objective To provide the references on otolith function evaluation by investigating subj ective visual vertical (SVV)and subj ective visual horizontal (SVH),as well as the tilt range of SVV and SVH when pilot,s head tilted 45°to the left or right side for the selection and the medical evaluation of pilots . Methods XZ-2008 Otolith function test instrument was chosen for the tests.①One hundred active fighter pilots were chosen as the subj ects and the angle range of their head upright SVV was recorded.②Twenty-four active fighter pilots were chosen as the subjects.The angle range of their head upright SVV and the angle ranges of head 45°right or left tilt SVH and SVV were recorded.Normal value range was caculated according to Mean±1 .96 SD Results ①The angle range of head upright SVV of 100 pilots was -1 .61°-1 .73°.②The angle range of head upright SVH of 24 pilots was -2.34°-3.18°,the angle range of head 45°left tilt SVV was -7.12°-6.12°,and the range of -6.76°-4.84°for their head 45°right tilt.The angle range of 45°left tilt and 45°right tilt SVH was respectively -9 .84°-6.74°,and -6 .70°-6 .20°. Conclusions The study has established the test method and the normal angle range of SVV and SVH in military pilots,which is crucial for the assessment of the otolith function in medical selection and medical evaluation of military pilots.When head tilts to left or right by 45°the angles of SVV and SVH will change.We will further study its clinical signification and provide more evidence for the vestibular function medical evaluation of military flying personnel.
8.Comparative study on the reference value of vestibular autorotation test between military pilots and ordinary personnel
Zhanguo JIN ; Xianrong XU ; Yuhua LIU ; Lihong ZHAI ; Yuanjun LI
Chinese Journal of Aerospace Medicine 2019;30(1):12-16
Objective To compare the various parameters of vestibular autorotation test (VAT) between the Chinese military pilots and ordinary personnel. Methods Thirty-four pilots who had passed the physical examination,including the caloric test and video-head impulse test of vestibular functions,were selected as subj ects.They received vestibular autorotation test by VAT98-3 detector that manufactured by the WSR Company of United States.The frequencies,horizontal and vertical gains and phase shift of the vestibular ocular reflex (VOR)in VAT were analyzed and compared with the corresponding parameters of 100 ordinary personnel stored in the detector. Results By comparing the measured values of 34 military pilots with 100 ordinary personnel the significant differences were found on the horizontal gain at 2.0,2.3,4.7,5.1,5.5,5.9 Hz,the horizontal phase shift at 2.0,3.9,4.7,5.1 Hz,the vertical gain at 5.5,5.9 Hz and the vertical phase shift at 2.0,3.9, 5.1 Hz (t=2.106-18.647,P<0.05).The vertical phase shifts on the frequencies of 2.3,2.7,3.1, 3.5,4.3 Hz and the asymmetry showed insignificant difference as compared with the reference values of ordinary personnel. Conclusions The military pilots show higher gains on the 2.0 and 2 .3 Hz VAT than the ordinary personnel and the gain is close to 1 ,but on 4.7 ,5 .1 ,5 .5 ,and 5 .9 Hz.The differences should be considered in the evaluation of vestibular functions for military pilots.The aeromedical assessment should take the norm of military pilot as the reference.
9.Survey on aerodontalgia in fighter pilots and relevant factors analysis
Zhanguo JIN ; Lihong ZHAI ; Yuhua LIU ; Jianliang PANG ; Jun ZHENG ; Xianrong XU
Chinese Journal of Aerospace Medicine 2018;29(1):49-52
Objective To investigate the incidence rate of aerodontalgia in fighter pilots and analyze the related factors . Methods The cross-section study was used . The invasion of aerodontalgia was obtained upon a questionnaire survey from 192 fighter pilots , including the occurrence time ,degree ,and location and the incidence rate was calculated .The flying hours and the dental disease were compared between the pilots with and without aerodontalgia . Results The incidence rate of aerodontalgia in fighter pilots was 4 .17% (8/192) .In 8 aerodontalgia cases 7 pilots had dental disease .But in 184 pilots who felt free of aerodontalgia ,53 pilots (28 .80% ) were diagnosed as dental disease .There were significant difference between the incidence rates (χ2= 109 .634 , P<0 .01) .In 8 pilots with aerodontalgia ,5 cases had toothache during taking-off and 3 landing .The flying altitude was 500-1 000 m .Two of 8 aerodontalgia cases appeared the toothache on maxillary teeth and jaw ,5 on lower jaw and 1 on maxillary teeth .There was no significant difference among them (P>0 .05) .The average flying hours of 8 pilots with aerodontalgia were (2 425 .00 ± 1 445 .93) h while the average flying hours of 184 pilots without aerodontalgia was (1 703 .56 ± 1 331 .08) h .There was no significant difference between them (P>0 .05) . Conclusions The incidence rate of aerodontalgia was higher in the fighter pilots with dental disease .But the incidence rate has no correlation to the location of toothache and flying hours .It is suggested that pilots should conduct oral examinations every 6-12 months in order to detect and treat dental diseases in time .
10.Survey on aerodontalgia in fighter pilots and relevant factors analysis
Zhanguo JIN ; Lihong ZHAI ; Yuhua LIU ; Jianliang PANG ; Jun ZHENG ; Xianrong XU
Chinese Journal of Aerospace Medicine 2018;29(1):49-52
Objective To investigate the incidence rate of aerodontalgia in fighter pilots and analyze the related factors . Methods The cross-section study was used . The invasion of aerodontalgia was obtained upon a questionnaire survey from 192 fighter pilots , including the occurrence time ,degree ,and location and the incidence rate was calculated .The flying hours and the dental disease were compared between the pilots with and without aerodontalgia . Results The incidence rate of aerodontalgia in fighter pilots was 4 .17% (8/192) .In 8 aerodontalgia cases 7 pilots had dental disease .But in 184 pilots who felt free of aerodontalgia ,53 pilots (28 .80% ) were diagnosed as dental disease .There were significant difference between the incidence rates (χ2= 109 .634 , P<0 .01) .In 8 pilots with aerodontalgia ,5 cases had toothache during taking-off and 3 landing .The flying altitude was 500-1 000 m .Two of 8 aerodontalgia cases appeared the toothache on maxillary teeth and jaw ,5 on lower jaw and 1 on maxillary teeth .There was no significant difference among them (P>0 .05) .The average flying hours of 8 pilots with aerodontalgia were (2 425 .00 ± 1 445 .93) h while the average flying hours of 184 pilots without aerodontalgia was (1 703 .56 ± 1 331 .08) h .There was no significant difference between them (P>0 .05) . Conclusions The incidence rate of aerodontalgia was higher in the fighter pilots with dental disease .But the incidence rate has no correlation to the location of toothache and flying hours .It is suggested that pilots should conduct oral examinations every 6-12 months in order to detect and treat dental diseases in time .

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