1.Diagnostic value of preoperative diffusion weighted imaging histogram parameters in the depth of invasion of early rectal cancer
Shengchao JI ; Xiaofeng JIN ; Daixi YE ; Zehua LU ; Lulu XUAN ; Chengjun GENG
Journal of International Oncology 2025;52(10):621-627
Objective:To explore the diagnostic value of preoperative diffusion weighted imaging (DWI) histogram parameters in the depth of invasion of early rectal cancer.Methods:A total of 180 patients with early rectal cancer admitted to 904th Hospital of Joint Logistics Support Force of Chinese People's Liberation Army from August 2020 to August 2024 were selected as the study objects. Patients were divided into intramucosal cancer group ( n=102) and submucosal cancer group ( n=78) according to the depth of tumor invasion. The general data of the two groups were compared. The intraclass correlation coefficient (ICC) was used to analyze the consistency of DWI histogram parameters extracted by the two radiologists, and the differences between the two groups were compared. Receiver operator characteristic (ROC) curve was used to analyze the predictive value of each parameter to the depth of tumor invasion. Multivariate logistic regression was used to analyze the independent influencing factors of invasion depth, and a predictive model was constructed. The ROC curve was drawn to analyze the predictive value of the model for tumor invasion depth, and the Hosmer-Lemeshow test was used to analyze the goodness of fit of the model. Results:There were statistically significant differences in age ( t=8.15, P<0.001), maximum tumor diameter ( χ2=29.29, P<0.001), endoscopic type ( χ2=20.96, P<0.001), histological type ( χ2=24.93, P<0.001) and differentiation degree ( χ2=73.35, P<0.001) between intramucosal cancer group and submucosal cancer group. The mean, variance, skewness, kurtosis, the 1 st, 10 th, 50 th, 90 th, and 99 th percentiles of the histogram parameters of DWI had good consistency (all ICC>0.75). There were statistically significant differences in the mean ( t=5.69, P<0.001), variance ( t=9.75, P<0.001), skewness ( t=10.88, P<0.001), kurtosis ( t=10.06, P<0.001), the 1 st percentile ( t=3.43, P<0.001), 10 th percentile ( t=3.59, P<0.001), 50 th percentile ( t=9.97, P<0.001), 90 th percentile ( t=4.63, P<0.001), and 99 th percentile ( t=2.44, P=0.016) of the DWI histogram parameters between the intramucosal cancer group and the submucosal cancer group. ROC curve analysis results showed that mean [area under the curve (AUC) =0.77], variance (AUC=0.88), skewness (AUC=0.88), kurtosis (AUC=0.78), 50 th percentile (AUC=0.86) and 90 th percentile (AUC=0.82) had certain diagnostic value for submucous cancer. Multivariate analysis showed that age ( OR=9.98, 95% CI: 1.10-90.70, P=0.041), maximum tumor diameter ( OR=7.36, 95% CI: 1.08-50.23, P=0.042), and differentiation degree ( OR=19.88, 95% CI: 1.21-327.92, P=0.037), variance ( OR=16.24, 95% CI: 2.26-116.68, P=0.006), skewness ( OR=21.13, 95% CI: 2.80-59.61, P=0.003), 1 st percentile ( OR=9.78, 95% CI: 1.17-81.76, P=0.035) were independent factors in predicting tumor invasion depth in patients with early rectal cancer. The predictive model based on the above indicators was logit ( P) =1.51+2.30×age+2.00×maximum tumor diameter+2.99×differentiation degree+2.79×variance+3.05×skewness+ 2.28×the 1 st percentile. ROC curve analysis showed that the predictive model had an AUC of 0.97 (95% CI: 0.95-0.99) for judging the occurrence of submucosal cancer in patients with early rectal cancer, the sensitivity was 0.95, and the specificity was 0.88. The Hosmer-Lemeshow test results showed that the goodness of fit of the model was ideal ( P=0.823) . Conclusions:Age, maximum tumor diameter, differentiation degree, variance, skewness, and the 1 st percentile are independent factors in predicting tumor invasion depth in patients with early rectal cancer. The predictive model constructed based on these factors can effectively predict the risk of submucosal cancer in patients with early rectal cancer.
2.Network toxicology and its application in studying exogenous chemical toxicity
Yanli LIN ; Zehua TAO ; Zhao XIAO ; Chenxu HU ; Bobo YANG ; Ya WANG ; Rongzhu LU
Journal of Environmental and Occupational Medicine 2025;42(2):238-244
With the continuous development of society, a large number of new chemicals are continuously emerging, which presents a challenge to current risk assessment and safety management of chemicals. Traditional toxicology research methods have certain limitations in quickly, efficiently, and accurately assessing the toxicity of many chemicals, and cannot meet the actual needs. In response to this challenge, computational toxicology that use mathematical and computer models to achieve the prediction of chemical toxicity has emerged. In the meantime, as researchers increasingly pay attention to understanding the interaction mechanisms between exogenous chemical substances and the body from the system level, and multiomics technologies develop rapidly such as genomics, transcriptomics, proteomics, and metabolomics, huge amounts of data have been generated, providing rich information resources for studying the interactions between chemical substances and biological molecules. System toxicology and network toxicology have also developed accordingly. Of these, network toxicology can integrate these multiomics data to construct biomolecular networks, and then quickly predict the key toxicological targets and pathways of chemicals at the molecular level. This paper outlined the concept and development of network toxicology, summarized the main methods and supporting tools of network toxicology research, expounded the application status of network toxicology in studying potential toxicity of exogenous chemicals such as agricultural chemicals, environmental pollutants, industrial chemicals, and foodborne chemicals, and analyzed the development prospects and limitations of network toxicology research. This paper aimed to provide a reference for the application of network toxicology in other fields.
3.Application of blood conservation measures with different red blood cell transfusion volumes in obstetrics and their impact on postpartum outcomes
Huimin DENG ; Fengcheng XU ; Meiting LI ; Lan HU ; Xiao WANG ; Shiyu WANG ; Xiaofei YUAN ; Jun ZHENG ; Zehua DONG ; Yuanshan LU ; Shaoheng CHEN
Chinese Journal of Blood Transfusion 2025;38(5):691-698
Objective: To evaluate the application of blood conservation measures in obstetric patients with different red blood cell transfusion volumes and to assess the impact of different transfusion volumes on postpartum outcomes. Methods: A retrospective investigation was conducted on 448 obstetric patients who received blood transfusions at the Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine from January 2016 to December 2022. Patients were divided into four groups (1-2 units group, 3-4 units group, 5-6 units group, and >6 units group) based on the volumes of red blood cells (RBCs) transfused during and within 7 days after delivery. The maternal physiological indicators, pre- and postpartum laboratory test indicators, obstetric complications, application of blood conservation measures, use of blood products, and postpartum outcomes were reviewed. The clinical characteristics, application of blood conservation measures, and their impact on postpartum outcomes were compared among different transfusion groups. Results: There were statistically significant differences in the multivariate logistic analysis of history of previous cesarean section (OR=1.781), eclampsia/pre-eclampsia/(OR=1.972) and postpartum blood loss>1 000 mL(OR=1.699)(P<0.05) among different transfusion groups. In terms of blood conservation measures, the more RBCs transfused, the higher the rate of mothers receiving blood conservation measures such as balloon occlusion, arterial ligation, autologous blood transfusion with a cell saver, and hysterectomy. With the increase in the volume of RBCs transfusion, the demand for fresh frozen plasma(FFP), cryoprecipitate, and platelet transfusions also increased. The hospitalization days for the four groups of parturients were 6.0 (4.0-9.0), 7.5 (5.0-14.8), 7.0 (4.5-13.0) and 11.0 (9.0-20.5), respectively (P<0.05) and the rates of ICU transfer were 2.0% (5/250), 9.4% (12/128),18.2% (6/33) and 51.4% (19/37), respectively (P<0.05). Both increased significantly with the increase in the volume of RBCs transfusion, and the differences between groups were statistically significant. Conclusion: Parturients who received higher volume of RBCs had multiple risks factors for bleeding before childbirth, had higher postpartum blood loss, and had a higher rate of application of various blood conservation measures. In addition, an increase in the volume of RBCs transfusion may have adverse effects on postpartum recovery.
4.Evaluation of prognosis of patients with acute anterior circulation large vessel occlusive stroke treated with mechanical thrombectomy by early CT score of Alberta stroke program with plain CT
Zehua LU ; Yujie JIN ; Xiaofeng JIN ; Chengjun GENG
Chinese Journal of Radiology 2025;59(5):505-510
Objective:To explore the value of Alberta stroke program early CT Score (ASPECTS) regional net water intake (NWU) based on plain CT in evaluating the neurological outcome of patients with acute large vessel occlusive stroke (ALVOS) after mechanical thrombectomy.Methods:The study was a prospective cross-sectional study. The clinical and imaging data of patients with ALVOS who underwent mechanical thrombectomy in the 904 Hospital of the PLA Joint Service Support Force from June 2022 to June 2024 were prospectively collected. Clinical data analysis included age, gender distribution, National Institutes of Health Stroke Scale (NIHSS) score and Glasgow Coma Scale (GCS) score at admission. All patients underwent plain CT and CT angiography (CTA). Automated processing software quantified ischemic brain edema by calculating ASPECTS and measuring the ASPECTS regional NWU rate (CT-ASPECTS-NWU) based on plain CT. Cerebral collateral circulation was assessed using CTA images. According to the modified Rankin Scale score of patients with mechanical thrombectomy 90 days after the telephone follow-up, 0-2 points were defined as good neurological outcome, and 3-6 points were defined as poor neurological outcome. Independent samples t test, Mann-Whitney U test and χ2 test were used to analyze the differences of clinical and imaging indicators between patients with good and poor neurological outcome, indicators with statistically significant differences were included in multivariate logistic regression analysis to screen out the independent influencing factors that predicted the neurological outcome of patients with ALVOS after mechanical thrombectomys. The efficacy of related indicators to predict neurological outcomes after mechanical thrombectomy in patients with ALVOS was evaluated using receiver operating characteristic (ROC) curve analysis, with the area under the curve (AUC) calculated. Results:A total of 122 patients with ALVOS were included, including 101 patients with good neurological outcome and 21 patients with poor neurological outcome after mechanical thrombectomy. There were statistically significant differences in preoperative GCS score, collateral circulation status, NIHSS score at admission, preoperative ASPECTS and CT-ASPECTS-NWU between patients with good neurological outcome and patients with poor neurological outcome ( P<0.05). Multivariate logistic regression analysis showed that the status of collateral circulation ( OR=3.450, 95% CI 1.158-10.277, P=0.026), preoperative ASPECTS ( OR=0.510, 95% CI 0.274-0.952, P=0.034) and CT-ASPECTS-NWU ( OR=2.131, 95% CI 1.301-3.493, P=0.003) were independent predictors of neurological outcome in patients with ALVOS after mechanical thrombectomy. ROC curve analysis showed that CT-ASPECTS-NWU had the highest predictive value, with an AUC of 0.881, a sensitivity of 85.7%, a specificity of 85.1%, and an optimal cutoff value of 7.55. Conclusion:CT-ASPECTS-NWU demonstrates high diagnostic value in evaluating the neurological outcome of patients with ALVOS after mechanical thrombectomy, and can provide an objective imaging biomarker to guide clinical decision-making.
5.Evidence-based clinical practice guideline for bone cement-augmented pedicle screw technique (version 2025)
Sihao HE ; Junchao XING ; Tongwei CHU ; Zhengqi CHANG ; Xigao CHENG ; Fei DAI ; Xiaobing JIANG ; Jie HAO ; Jiang HU ; Jinghui HUANG ; Tianyong HOU ; Fei LUO ; Bo LIAO ; Changqing LI ; Lei LIU ; Guodong LIU ; Peng LIU ; Sheng LU ; Weishi LI ; Yang LIU ; Zhen LIU ; Wei MEI ; Peifu TANG ; Bing WANG ; Bing WANG ; Ce WANG ; Hongli WANG ; Liang WANG ; Shengru WANG ; Xiaobin WANG ; Yang WANG ; Yingfeng WANG ; Zheng WANG ; Jianzhong XU ; Guoyong YIN ; Haiyang YU ; Qiang YANG ; Zhaoming YE ; Bin ZHANG ; Chengmin ZHANG ; Jun ZOU ; Qiang ZHOU ; Min ZHAO ; Rui ZHOU ; Xiaojun ZHANG ; Yongfei ZHAO ; Zhongrong ZHANG ; Zehua ZHANG ; Yingze ZHANG
Chinese Journal of Trauma 2025;41(11):1035-1047
For middle-aged and elderly patients with conditions such as spinal fractures and degenerative spinal diseases, spinal internal fixation is a core surgical procedure for reconstructing spinal stability, heavily relying on the biomechanical stability provided by pedicle screw systems. Whereas, these patients are often complicated by osteoporosis that can significantly compromise the stability of the bone-pedicle screw interface, leading to a marked increase in pedicle screw loosening and surgical failure rates. The bone cement-augmented pedicle screw technique, which involves injecting bone cement into the vertebral body or screw trajectory to optimize the mechanical properties of the bone-pedicle screw composite, has been proven to significantly enhance fixation strength and effectively prevent screw-related failures, thereby reducing the incidence of internal fixation failure in high-risk populations undergoing spinal fusion. However, the widespread clinical application of this technique has faced challenges such as inaccurate clinical decision-making (indication and contraindication selection), non-standardized operative practices, and insufficient awareness of complication prevention, resulting in considerable variability in clinical outcomes and even severe complications. To address this, Prof. Luo Fei from First Affiliated Hospital of Army Medical University initiated the project and the Chinese Association Orthopaedic Surgeons organized relevant experts to develop the Evidence-based clinical practice guideline for bone cement-augmented pedicle screw technique ( version 2025), based on current evidence. The guidelines put forward 8 recommendations regarding the clinical value, scope of application, and operational standards of the technique, aiming to provide evidence-based medical support and technical standardization for clinical decision-making.
6.Evidence-based clinical practice guideline for bone cement-augmented pedicle screw technique (version 2025)
Sihao HE ; Junchao XING ; Tongwei CHU ; Zhengqi CHANG ; Xigao CHENG ; Fei DAI ; Xiaobing JIANG ; Jie HAO ; Jiang HU ; Jinghui HUANG ; Tianyong HOU ; Fei LUO ; Bo LIAO ; Changqing LI ; Lei LIU ; Guodong LIU ; Peng LIU ; Sheng LU ; Weishi LI ; Yang LIU ; Zhen LIU ; Wei MEI ; Peifu TANG ; Bing WANG ; Bing WANG ; Ce WANG ; Hongli WANG ; Liang WANG ; Shengru WANG ; Xiaobin WANG ; Yang WANG ; Yingfeng WANG ; Zheng WANG ; Jianzhong XU ; Guoyong YIN ; Haiyang YU ; Qiang YANG ; Zhaoming YE ; Bin ZHANG ; Chengmin ZHANG ; Jun ZOU ; Qiang ZHOU ; Min ZHAO ; Rui ZHOU ; Xiaojun ZHANG ; Yongfei ZHAO ; Zhongrong ZHANG ; Zehua ZHANG ; Yingze ZHANG
Chinese Journal of Trauma 2025;41(11):1035-1047
For middle-aged and elderly patients with conditions such as spinal fractures and degenerative spinal diseases, spinal internal fixation is a core surgical procedure for reconstructing spinal stability, heavily relying on the biomechanical stability provided by pedicle screw systems. Whereas, these patients are often complicated by osteoporosis that can significantly compromise the stability of the bone-pedicle screw interface, leading to a marked increase in pedicle screw loosening and surgical failure rates. The bone cement-augmented pedicle screw technique, which involves injecting bone cement into the vertebral body or screw trajectory to optimize the mechanical properties of the bone-pedicle screw composite, has been proven to significantly enhance fixation strength and effectively prevent screw-related failures, thereby reducing the incidence of internal fixation failure in high-risk populations undergoing spinal fusion. However, the widespread clinical application of this technique has faced challenges such as inaccurate clinical decision-making (indication and contraindication selection), non-standardized operative practices, and insufficient awareness of complication prevention, resulting in considerable variability in clinical outcomes and even severe complications. To address this, Prof. Luo Fei from First Affiliated Hospital of Army Medical University initiated the project and the Chinese Association Orthopaedic Surgeons organized relevant experts to develop the Evidence-based clinical practice guideline for bone cement-augmented pedicle screw technique ( version 2025), based on current evidence. The guidelines put forward 8 recommendations regarding the clinical value, scope of application, and operational standards of the technique, aiming to provide evidence-based medical support and technical standardization for clinical decision-making.
7.Comparison of the actions of different anesthetics in the post-stroke dysphagia model of mouse
Tong RAO ; Zehua RAO ; Cong TIAN ; Meng LU ; Ankun CHEN ; Xin LIU ; Zhimiao MURONG ; Zenghui YUE
Chinese Journal of Neuroanatomy 2025;41(1):59-66
Objective:To explore the effects three of anesthetics(tribromoethanol,isoflurane,and pentobarbital so-dium)on the outcome of mice with post-stroke dysphagia(PSD)induced by photothrombosis(PT)method,and to e-valuate which anesthetic is more suitable for the preparation of this model.Methods:Sixty-six male C57BL/6J mice were divided into Tribromoethanol group,Isoflurane group,Pentobarbital sodium group and Sham group.The post-stroke dysphagia model was established by PT.Before and 5 min after modeling,a laser speckle imager was used to measure the regional cerebral blood flow(rCBF)decrease rate of mice and record the wake-up time of mice.Forty-eight hours after modeling,the mortality rate of PSD mice in three groups was recorded and the rCBF decrease rate was meas-ured again.The neurological function of mice was evaluated using the neurological deficit score,the water intake of mice was recorded using the 4-min drinking test,the infarct volume ratio was measured using the TTC staining method,and the swallowing counts induced by water administration was recorded using the multichannel physiological recorder MP160 and the myoelectric area of the swallowing muscle was calculated.Results:There was no statistical difference in the percentage of decrease in rCBF,infarct volume ratio,neurological deficit score,water intake,swallowing counts,and myoelectric area of swallowing muscle among the three groups of PSD mice 48 h after modeling(P>0.05).Com-pared with the Tribromoethanol group and the Pentobarbital sodium group,the rCBF of the mice in the Isoflurane group decreased rapidly within 5 min(P<0.05),and the mortality rate of the mice was lower and the awakening time was shorter.(P<0.05).Conclusion:The use of different anesthesia will affect the mortality rate,wake-up time and the downward trend of rCBF within 48 h after modeling of PSD mice.Among the three anesthetics,isoflurane is more suit-able as an anesthetic for the PSD mouse model.
8.Comparison of the actions of different anesthetics in the post-stroke dysphagia model of mouse
Tong RAO ; Zehua RAO ; Cong TIAN ; Meng LU ; Ankun CHEN ; Xin LIU ; Zhimiao MURONG ; Zenghui YUE
Chinese Journal of Neuroanatomy 2025;41(1):59-66
Objective:To explore the effects three of anesthetics(tribromoethanol,isoflurane,and pentobarbital so-dium)on the outcome of mice with post-stroke dysphagia(PSD)induced by photothrombosis(PT)method,and to e-valuate which anesthetic is more suitable for the preparation of this model.Methods:Sixty-six male C57BL/6J mice were divided into Tribromoethanol group,Isoflurane group,Pentobarbital sodium group and Sham group.The post-stroke dysphagia model was established by PT.Before and 5 min after modeling,a laser speckle imager was used to measure the regional cerebral blood flow(rCBF)decrease rate of mice and record the wake-up time of mice.Forty-eight hours after modeling,the mortality rate of PSD mice in three groups was recorded and the rCBF decrease rate was meas-ured again.The neurological function of mice was evaluated using the neurological deficit score,the water intake of mice was recorded using the 4-min drinking test,the infarct volume ratio was measured using the TTC staining method,and the swallowing counts induced by water administration was recorded using the multichannel physiological recorder MP160 and the myoelectric area of the swallowing muscle was calculated.Results:There was no statistical difference in the percentage of decrease in rCBF,infarct volume ratio,neurological deficit score,water intake,swallowing counts,and myoelectric area of swallowing muscle among the three groups of PSD mice 48 h after modeling(P>0.05).Com-pared with the Tribromoethanol group and the Pentobarbital sodium group,the rCBF of the mice in the Isoflurane group decreased rapidly within 5 min(P<0.05),and the mortality rate of the mice was lower and the awakening time was shorter.(P<0.05).Conclusion:The use of different anesthesia will affect the mortality rate,wake-up time and the downward trend of rCBF within 48 h after modeling of PSD mice.Among the three anesthetics,isoflurane is more suit-able as an anesthetic for the PSD mouse model.
9.Evaluation of prognosis of patients with acute anterior circulation large vessel occlusive stroke treated with mechanical thrombectomy by early CT score of Alberta stroke program with plain CT
Zehua LU ; Yujie JIN ; Xiaofeng JIN ; Chengjun GENG
Chinese Journal of Radiology 2025;59(5):505-510
Objective:To explore the value of Alberta stroke program early CT Score (ASPECTS) regional net water intake (NWU) based on plain CT in evaluating the neurological outcome of patients with acute large vessel occlusive stroke (ALVOS) after mechanical thrombectomy.Methods:The study was a prospective cross-sectional study. The clinical and imaging data of patients with ALVOS who underwent mechanical thrombectomy in the 904 Hospital of the PLA Joint Service Support Force from June 2022 to June 2024 were prospectively collected. Clinical data analysis included age, gender distribution, National Institutes of Health Stroke Scale (NIHSS) score and Glasgow Coma Scale (GCS) score at admission. All patients underwent plain CT and CT angiography (CTA). Automated processing software quantified ischemic brain edema by calculating ASPECTS and measuring the ASPECTS regional NWU rate (CT-ASPECTS-NWU) based on plain CT. Cerebral collateral circulation was assessed using CTA images. According to the modified Rankin Scale score of patients with mechanical thrombectomy 90 days after the telephone follow-up, 0-2 points were defined as good neurological outcome, and 3-6 points were defined as poor neurological outcome. Independent samples t test, Mann-Whitney U test and χ2 test were used to analyze the differences of clinical and imaging indicators between patients with good and poor neurological outcome, indicators with statistically significant differences were included in multivariate logistic regression analysis to screen out the independent influencing factors that predicted the neurological outcome of patients with ALVOS after mechanical thrombectomys. The efficacy of related indicators to predict neurological outcomes after mechanical thrombectomy in patients with ALVOS was evaluated using receiver operating characteristic (ROC) curve analysis, with the area under the curve (AUC) calculated. Results:A total of 122 patients with ALVOS were included, including 101 patients with good neurological outcome and 21 patients with poor neurological outcome after mechanical thrombectomy. There were statistically significant differences in preoperative GCS score, collateral circulation status, NIHSS score at admission, preoperative ASPECTS and CT-ASPECTS-NWU between patients with good neurological outcome and patients with poor neurological outcome ( P<0.05). Multivariate logistic regression analysis showed that the status of collateral circulation ( OR=3.450, 95% CI 1.158-10.277, P=0.026), preoperative ASPECTS ( OR=0.510, 95% CI 0.274-0.952, P=0.034) and CT-ASPECTS-NWU ( OR=2.131, 95% CI 1.301-3.493, P=0.003) were independent predictors of neurological outcome in patients with ALVOS after mechanical thrombectomy. ROC curve analysis showed that CT-ASPECTS-NWU had the highest predictive value, with an AUC of 0.881, a sensitivity of 85.7%, a specificity of 85.1%, and an optimal cutoff value of 7.55. Conclusion:CT-ASPECTS-NWU demonstrates high diagnostic value in evaluating the neurological outcome of patients with ALVOS after mechanical thrombectomy, and can provide an objective imaging biomarker to guide clinical decision-making.
10.Determination of Antioxidants and Their Degradation Products in Recombinant Exendin-4-FC Fusion Protein Injection by HPLC
Zehua LU ; Sulong JI ; Shuaihu LIU ; Li WANG ; Yan GAO ; Zhiqiang SHEN ; Jingyan LI ; Bin WANG
Chinese Journal of Modern Applied Pharmacy 2024;41(1):112-118
OBJECTIVE
To establish a method for determining the content of 11 antioxidants and their degradation products in recombinant Exendin-4-FC fusion protein injection by HPLC.
METHODS
The protein was precipitated with saturated ammonium sulfate. After centrifugation, the supernatant was transferred to a C18 solid phase extraction cartridge activated by methanol. Then the cartridge was eluted with 4 mL of methanol and 5 mL of ethyl acetate respectively, and the eluent was diluted with methanol-ethyl acetate(2∶3) mixed solvent and passed through a 0.22 µm PTFE hydrophobic filter. It was analyzed by HPLC and quantified by external standard method. Chromatographic conditions: Kinetex® XB-C18 100Å (100 mm×4.6 mm, 2.6 µm)column, the detection wavelength was 230 nm, the column oven was 30 ℃, the injection volume was 5 µL and the flow rate was 0.4 mL·min–1, mobile phase was 0.1% formic acid-methanol(A)-0.1% formic acid aqueous solution(B), the running time was 45 min.
RESULTS
The 11 target substances showed a good linear relationship in the range of 2.5−35 μg·mL–1 with R2 ≥0.99. At three different concentration(25, 10, 5 μg·mL–1) of spiked samples, the average recovery rates of 11 antioxidants ranged from 88.1% to 106.5%, with RSDs in the range of 0.10%–9.05%. The RSDs of 6 repeatable samples was 2.01%–4.77%, which of 12 intermediate precision samples was 2.58%–9.75%. The positive/inverted samples of three batches of recombinant Exendin-4-FC fusion protein injection were detected at 0 month, 3 months and 6 months(25 ℃), and the results showed that there was no antioxidant and its degradation leaching in all batches of samples at different detection points.
CONCLUSION
The method has good specificity, high accuracy and precision, good solution stability, high durability and can be used for the content detection of antioxidants in drugs.


Result Analysis
Print
Save
E-mail