1.Distribution characteristics and health risk assessment of trihalomethanes in drinking water in Guangzhou City
Miao LIU ; Pingsheng GAN ; Guowei LI ; Zhijun BAI ; Rongfei PENG
Journal of Public Health and Preventive Medicine 2026;37(2):35-39
Objective To comprehensively investigate the levels of exposure and distribution characteristics of trihalomethanes (THMs) in drinking water in Guangzhou City, and evaluate the health risks of different groups of children, adolescents and adults, and to provide data and evidence for protecting human health and promoting risk control of drinking water. Methods According to the technical requirements of the "Standards for Drinking Water Quality Testing Methods" (GB/T 5750-2023), the concentration of THMs, including trichloromethane (TCM), bromodichloromethane (BDCM), dibromochloromethane (DBCM), and tribromomethane (TBM) in drinking water in Guangzhou City from 2023-2024 were detected. The health risk model recommended by USEPA was used for risk assessment.Results TCM, BDCM and DBCM were detected in the factory water and terminal water, with TCM contributing the most. There was a statistically significant difference (P<0.05) between the wet and dry seasons, and the concentration of TCM in the wet season was higher than that in the dry season. Among the multiple exposure factors, the amount of exposure through drinking water intake was much greater than that through skin absorption. The carcinogenic risk index of THMs for children, adolescents, and adults was 22.0×10-6, 12.2×10-6, and 11.4×10-6, respectively, while the non-carcinogenic risk was less than 1. Conclusion The exposure risks of THMs in children, adolescents, and adults is within an acceptable range, but monitoring needs to be strengthened, with a particular focus on children.
2.Intervertebral disc rehydration after posterior lumbar dynamic internal fixation
Peng WANG ; Zhijun LI ; Shaojie ZHANG ; Yimin WU
Chinese Journal of Tissue Engineering Research 2026;30(3):711-720
BACKGROUND:With the development of the concept of minimally invasive surgery,lumbar posterior dynamic internal fixation has become the mainstream operation for the treatment of diseases caused by intervertebral disc degeneration.OBJECTIVE:To review the latest progress of lumbar posterior dynamic internal fixation in the treatment of lumbar degenerative diseases and postoperative intervertebral disc rehydration.METHODS:The relevant literature published in CNKI,WanFang,and PubMed databases from 2010 to 2025 was searched with the Chinese and English search terms"lumbar spine,dynamic internal fixation,intervertebral disc degeneration,Coflex system,Dynesys system,In-space system,PercuDyn system,intervertebral disc rehydration,crushing stress."By reading the articles,we eliminated the literature with little relevance to the article topic,poor quality and outdated content,and finally 65 articles were included for summary.RESULTS AND CONCLUSION:(1)Although the main surgical method for the treatment of disc degeneration is still the traditional open surgical method of implantation,posterior lumbar dynamic internal fixation has made great progress.(2)Posterior lumbar dynamic fixation can be divided into open dynamic fixation system and percutaneous dynamic fixation system.Each system can be divided into interspinous dynamic internal fixation system and pedicle dynamic internal fixation system according to the different fixation positions.According to the design of specific instruments and the differences of operation methods in the surgery,different operation methods have been derived.At present,the focus of research at home and abroad is on open dynamic internal fixation system.(3)Under the premise that the clinical effect of posterior lumbar dynamic internal fixation is better than that of traditional interbody fusion surgery,it can cause the rehydration phenomenon of postoperative lumbar intervertebral disc,and further improve the long-term postoperative efficacy of patients.
3.Intervertebral disc rehydration after posterior lumbar dynamic internal fixation
Peng WANG ; Zhijun LI ; Shaojie ZHANG ; Yimin WU
Chinese Journal of Tissue Engineering Research 2026;30(3):711-720
BACKGROUND:With the development of the concept of minimally invasive surgery,lumbar posterior dynamic internal fixation has become the mainstream operation for the treatment of diseases caused by intervertebral disc degeneration.OBJECTIVE:To review the latest progress of lumbar posterior dynamic internal fixation in the treatment of lumbar degenerative diseases and postoperative intervertebral disc rehydration.METHODS:The relevant literature published in CNKI,WanFang,and PubMed databases from 2010 to 2025 was searched with the Chinese and English search terms"lumbar spine,dynamic internal fixation,intervertebral disc degeneration,Coflex system,Dynesys system,In-space system,PercuDyn system,intervertebral disc rehydration,crushing stress."By reading the articles,we eliminated the literature with little relevance to the article topic,poor quality and outdated content,and finally 65 articles were included for summary.RESULTS AND CONCLUSION:(1)Although the main surgical method for the treatment of disc degeneration is still the traditional open surgical method of implantation,posterior lumbar dynamic internal fixation has made great progress.(2)Posterior lumbar dynamic fixation can be divided into open dynamic fixation system and percutaneous dynamic fixation system.Each system can be divided into interspinous dynamic internal fixation system and pedicle dynamic internal fixation system according to the different fixation positions.According to the design of specific instruments and the differences of operation methods in the surgery,different operation methods have been derived.At present,the focus of research at home and abroad is on open dynamic internal fixation system.(3)Under the premise that the clinical effect of posterior lumbar dynamic internal fixation is better than that of traditional interbody fusion surgery,it can cause the rehydration phenomenon of postoperative lumbar intervertebral disc,and further improve the long-term postoperative efficacy of patients.
4.Characteristic volatile organic compounds in exhaled breath of coal workers' pneumoconiosis patients by thermal desorption gas chromatography-mass spectrometry
Yazhen HE ; Chunguang DING ; Junyun WANG ; Yuzhen FENG ; Fangda PENG ; Gaisheng LIU ; Fan YANG ; Chunmin ZHANG ; Rui GAO ; Qingyu MENG ; Zhijun WU ; Jingguang FAN
Journal of Environmental and Occupational Medicine 2025;42(5):571-577
Background Coal workers' pneumoconiosis is a serious occupational disease in China. Exhaled volatile organic compounds (VOCs) can serve as the "breath fingerprint" of internal pathological processes, which provides a theoretical basis for exhaled VOCs to be used as potential non-invasive biomarkers for early diagnosis of coal workers' pneumoconiosis. Objective To screen out the characteristic VOCs and important characteristic VOCs of exhaled air in patients with coal workers' pneumoconiosis, and to explore the potential of these VOCs as biomarkers for early non-invasive diagnosis of the disease. Methods In this study, 27 VOCs in the exhaled breath of 22 patients with stage I coal workers' pneumoconiosis, 77 workers exposed to dust, and 92 healthy controls were quantitatively detected by thermal desorption gas chromatography-mass spectrometry (TD-GC-MS). Substances with P<0.05 in univariate analysis and variable importance projection (VIP) >1 in supervised orthogonal partial least squares discriminant analysis (OPLS-DA) model were selected as the characteristic VOCs for early diagnosis of coal workers' pneumoconiosis. Age was included in the LASSO regression model as a covariate to screen out important characteristic VOCs, and the diagnostic performance was evaluated by receiver operating characteristic (ROC) curve. Spearman correlation was further used to explore the correlation between important characteristic VOCs and clinical lung function indicators. Results Through univariate analysis and OPLS-DA modeling, 8 VOCs were selected, including 2-methylpentane, 3-methylpentane, n-hexane, methylcyclopentane, n-heptane, methylcyclohexane, 4-methyl-2-pentanone, and 2-hexanone, in exhaled breath of patients with coal workers' pneumoconiosis. The concentrations of 4 VOCs, including 3-methylpentane, n-hexane, 4-methyl-2-pentanone, and 2-hexanone, showed a decreasing trend with the increase of dust exposure years. By LASSO regression, the important characteristic VOCs of the coal workers' pneumoconiosis group and the dust exposure group were n-hexane, methylcyclohexane and 4-methyl-2-pentanone, and the important characteristic VOCs of the coal workers' pneumoconiosis group and the healthy group were 2-methyl-pentane and 4-methyl-2-pentanone. The ROC analysis showed that the area under the curve (AUC) of n-hexane, methylcyclohexane, and 4-methyl-2-pentanone were 0.969, 0.909, and 0.956, respectively, and the AUC of combined diagnosis was 0.988 and its Youden index was 0.961, suggesting that these results can serve as a valuable reference for further research on early diagnosis. The Correlation analysis found that there was a positive correlation between n-hexane and lung function indicators in the important characteristic VOCs, indicating that it could indirectly reflect the obstruction of lung function ventilation, further proving that important characteristic VOCs have the potential to monitor lung function decline. Conclusion Three important characteristic VOCs selected in this study have the potential to be used as non-invasive biomarkers for early diagnosis and disease monitoring of coal workers' pneumoconiosis, and are worthy of further study and verification.
5.Effect of Q Chromatography on the Recovery of Human Plasminogen in Affinity Chromatography
Shenglan YUE ; Taojing LI ; Juan LI ; Yan PENG ; Lianzhen LIN ; Yanxiang ZHOU ; Feifei WANG ; Chen ZHU ; Shang WANG ; Deming JI ; Shuangying ZENG ; Yong HU ; Zhijun ZHOU
Chinese Journal of Blood Transfusion 2025;38(10):1382-1388
Objective: To compare quality control (relative purity and specific activity) and process control [plasminogen (Pg) antigen recovery and potency recovery] indexes of samples before and after adding the Q chromatography step to the full chromatography process of human Pg, thereby determining whether the addition of this step could improve Pg recovery by affinity chromatography. Methods: A Q chromatography step was added before the Pg affinity chromatography in the original Pg chromatography process. The loading solution, flow through solution and eluate of Q chromatography and Pg affinity chromatography were collected. The potency of coagulation factor Ⅱ (FⅡ), Ⅶ (FⅦ), Ⅷ (FⅧ), Ⅸ (FⅨ), and Ⅹ(FⅩ) were detected by the coagulation method, the total protein content was detected by the BCA method, and the Pg potency was detected by the chromogenic substrate method. The content of specific plasma proteins was detected by immunoturbidimetry, the potency recovery of coagulation factors was calculated, and the flow direction of coagulation factors was analyzed. The recovery of different plasma protein antigens were calculated, and the distribution of impurity proteins was analyzed. The relative purity and specific activity of Pg, antigen content, and potency recovery in the target fractions were calculated and compared with the original process indicators, so as to determine the effect of adding Q chromatography on the original process. Furthermore, the reproducibility after process modification was assessed. Results: 100% of FⅡ, FⅩ, and FⅨ, 87.81% of FⅧ, and 40.44% of FⅦ in filtered plasma were removed by Q chromatography. The residual FⅦ (53.26%) and FⅧ (13.30%) in Q flow-through fraction were completely removed by Pg affinity chromatography. In both the original process (without Q-chromatography) and the modified process (with Q-chromatography), non-target plasma proteins mainly existed in the flow-through fraction of Pg affinity chromatography. The antigen recovery of IgM, ceruloplasmin (CER), and fibronectin (FNC) in Q-chromatography flow-through fraction were reduced. In contrast, antigen recovery of other plasma proteins [IgG, IgA, Pg, albumin (AlB), alpha-1-antitrypsin (AAT), and fibrinogen (Fg)] were all >90%, which were consistent with the protein composition and proportion in the original affinity chromatography loading solution. Compared with the recovery rate of Pg antigen in the original process (74.4%), the total recovery of Pg antigen in the modified process was significantly increased (89.97%). Compared with the recovery of IgG (97.48%) and Fg (95.32%) in the Pg affinity flows-through fraction of the original process, the modified process resulted in a slight reduction in the recovery of IgG (94.60%), while the recovery of Fg was not affected (95.05%). The potency recovery rate, specific activity, and relative purity of Pg after Q chromatography were 99.3%, 0.016 U/mg, and 0.15%. These values were the same as those of Pg affinity chromatography loading solution by the original process, indicating that introduction of Q chromatography did not affect subsequent Pg affinity chromatography. Compared with the recovery of Pg antigen in three batches of the original process (66.49±1.02)%, the recovery of Pg antigen in the affinity chromatography eluent of the modified process [five batches; (77.43±4.43)%] was significantly improved. Furthermore, the potency recovery was (86.80±4.28)%, the relative purity was (81.99±1.25)%, the specific activity was (8.679±1.073)U/mg, and the process was reproducible. Conclusion: The addition of Q chromatography could improve the recovery of Pg affinity chromatography in the full chromatography process.
6.Mechanism of Huangqi Gegen Decoction in Treatment of Type 2 Diabetes Mellitus via Intestinal Mucosal Barrier
Lili PENG ; Miao HAO ; Zhijun YANG ; Yajie LIU ; Hongxia YUAN
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(15):1-9
ObjectiveTo investigate the mechanism of Huangqi Gegentang (HGT) in the treatment of type 2 diabetes mellitus (T2DM) through the application of proteomic techniques. MethodsThe rat model of T2DM was established by streptozotocin combined with a high-fat, high-sugar diet. Thirty-two male SD rats were randomized into four groups: blank, model, HGT (8.10 g·kg-1·d-1), and positive control (metformin hydrochloride, 76.5 mg·kg-1·d-1). After 6 weeks of drug intervention, the fasting blood glucose level was measured, and an oral glucose tolerance test (OGTT) was performed. The area under the curve (AUC) was calculated. Enzyme-linked immunosorbent assay was performed to assess the level of glycated hemoglobin (GHbA1c) in the serum. The limulus amebocyte lysate assay was employed to measure the serum level of lipopolysaccharide (LPS). Pathological changes in the colon were observed by hematoxylin-eosin staining. The mRNA levels of pro-inflammatory cytokines including tumor necrosis factor (TNF)-α, interleukin (IL)-6, and IL-1β in the colon tissue were quantified via Real-time fluorescence quantitative polymerase chain reaction (Real-time PCR). Additionally, the protein and mRNA levels of zonula occludens-1 (ZO-1), Occludin, and Claudin-1 in the colon tissue were assessed by Western blot and Real-time PCR, respectively. Label-free quantitative proteomics was employed to identify the differentially expressed proteins between the colon tissue samples from the blank, model, and HGT groups. Key proteins identified were subsequently validated by Western blot and Real-time PCR. Finally, bioinformatics analysis was conducted on the differentially expressed proteins. ResultsCompared with the blank group, the model group exhibited increased fasting blood glucose, AUC, and GHbA1c levels (P<0.01), damaged colonic mucosal epithelial structure and inflammatory cell infiltration, up-regulated mRNA levels of TNF-α, IL-6, and IL-1β in the colon and an increase in serum LPS content (P<0.05, P<0.01), and down-regulated protein and mRNA levels of ZO-1, Occludin, and Claudin-1 in the colon (P<0.01). Compared with the model group, the HGT group showed reductions in fasting blood glucose, AUC, and GHbA1c (P<0.01), alleviated damage to the colonic mucosal epithelium, down-regulated mRNA levels of TNF-α, IL-6, and IL-1β in the colon, a reduction in serum LPS content (P<0.05, P<0.01), and up-regulated protein and mRNA levels of ZO-1, Occludin, and Claudin-1 in the colon (P<0.05, P<0.01). Proteomics analysis identified 70 differentially expressed proteins that exhibited a downward trend in the model group relative to the blank group and an upward trend in the HGT group relative to the model group. These findings were corroborated by Western blot and Real-time PCR, which confirmed that the protein and mRNA levels of mucin 2 (Muc2) and transforming growth factor (TGF)-beta receptor 1 (Tgfbr1) in the colon tissue were consistent with the proteomic data. Bioinformatics analysis showed that these 70 differentially expressed proteins identified were significantly enriched in multiple signaling pathways, among which the TGF-β and advanced glycation endproduct (AGE)/receptor for advanced glycation endproduct (RAGE) signaling pathways were closely associated with damage to the intestinal mucosal barrier. This suggests that HGT may ameliorate intestinal mucosal barrier damage by regulating these pathways. ConclusionHGT potentially exerts anti-T2DM effects by influencing AGE/RAGE and TGF-β signaling pathways, thereby contributing to the restoration of the intestinal mucosal barrier.
7.Association between overweight and lymph node metastasis in patients with papillary thyroid carcinoma and its sex-based heterogeneity
Lu CHEN ; Yan SUN ; Zhijun ZHAN ; Hailong TAN ; Ning LI ; Junda YIN ; Neng TANG ; Shi CHANG ; Peng HUANG
Chinese Journal of General Surgery 2025;34(5):892-902
Background and Aims:Papillary thyroid carcinoma(PTC)is the most common endocrine malignancy in China,with cervical lymph node metastasis being a frequent and critical clinical feature that directly affects patient prognosis and recurrence risk.In recent years,with the rapid increase in the prevalence of overweight and obesity in China,the role of body mass index(BMI)in various tumors has attracted growing attention.This study aimed to investigate the association between overweight and cervical LNM in PTC,analyze sex-specific differences and influencing factors,and provide evidence for precise clinical management.Methods:A retrospective analysis was conducted on the clinicopathologic data of 1 445 patients with classical PTC treated at Xiangya Hospital of Central South University between August 2021 and June 2022.Patients were divided into groups based on the presence or absence of lymph node metastasis.Restricted cubic spline analysis explored the nonlinear relationship between BMI and lymph node metastasis risk.Univariate and multivariate Logistic regression analyses were applied to identify independent risk factors.Furthermore,sex-stratified analysis was performed among overweight patients(BMI≥24 kg/m2)to determine sex-specific risk factors for lymph node metastasis.Results:Among all patients,716(49.6%)had lymph node metastasis.Univariate analysis showed that BMI,sex,age,tumor diameter,multifocality,and extrathyroidal extension were significantly associated with cervical lymph node metastasis in PTC patients(all P<0.05).A nonlinear positive correlation was observed between BMI and lymph node metastasis risk,which was more pronounced in male patients.Additionally,BMI was positively correlated with triglyceride levels and negatively correlated with high-density lipoprotein cholesterol.Sex-stratified analysis revealed that in overweight male patients,younger age(OR=0.954),larger tumor diameter(OR=1.085),and multifocality(OR=2.776)were independent risk factors for LNM;in overweight female patients,younger age(OR=0.943)and larger tumor diameter(OR=1.074)were the main influencing factors.Conclusion:Overweight is closely associated with cervical lymph node metastasis in PTC,and the high-risk factors for LNM differ between male and female overweight patients.Young age,larger tumor size,and multifocality in overweight males,and young age and larger tumors in overweight females indicate a higher risk of metastasis.It is recommended that high-risk populations receive enhanced preoperative evaluation and individualized lymph node dissection strategies to achieve precise treatment and improved risk control.
8.Epidural fibrous scar formation in rabbits following autologous ligamentum flavum intervention
Debao ZHANG ; Peng WANG ; Kun LI ; Shaojie ZHANG ; Zhijun LI ; Shuwen LI ; Yimin WU
Chinese Journal of Tissue Engineering Research 2025;29(6):1168-1175
BACKGROUND:It has been proved clinically that adhesion of fibrous scar with the dura mater or nerve root after lumbar operation is an important factor for postoperative symptoms,such as postoperative pain and numbness. OBJECTIVE:To verify the inhibitory effect of autologous ligamentum flavum on the formation of epidural fibrous scar after lumbar surgery and explore the possible molecular biological mechanism. METHODS:Forty-eight Japanese white rabbits(6-8 months old)were randomly divided into three groups:a ligamentum flavum preservation group,a ligamentum flavum non-preservation group,and an autologous fat reposition group.A lumbar laminectomy model was established in all the three groups of rabbits,and rabbit epidural tissues were collected at 3 and 6 weeks after modeling.Hematoxylin-eosin staining was used to observe histological changes and the number and density of fibroblasts,VG staining was used to observe the percentage of collagen fiber area,and immunohistochemistry was used to observe the expression of transforming growth factor β1 and Smad3 proteins. RESULTS AND CONCLUSION:Hematoxylin-eosin staining results revealed that fibroblasts in the ligamentum flavum preservation group were few and loosely arranged,while the cells in the ligamentum flavum non-preservation and autologous fat reposition groups were more numerous and closely arranged.The number density of fibroblasts in the ligamentum flavum preservation group was lower than that in the ligamentum flavum non-preservation and autologous fat reposition groups at 3 and 6 weeks after surgery(P<0.05);however,there was no significant difference between the latter two groups.VG staining results showed that the collagen fibers in the ligamentum flavum preservation group were sparse and distributed unevenly,while a lot of red collagen fibers were gathered in the ligamentum flavum non-preservation and autologous fat reposition groups.The area percentage of collagen fibers in the ligamentum flavum preservation group was lower than that in the ligamentum flavum non-preservation and autologous fat reposition groups at 3 and 6 weeks after surgery(P<0.05),but there was no significant difference between the latter two groups.The results of immunohistochemistry showed that the degree of positive staining of retained histone the ligamentum flavum preservation group was significantly lower than that of the other two groups.The absorbance value of transforming growth factor β1 and Smad3 in the ligamentum flavum preservation group was significantly lower than that in the other two groups at 3 and 6 weeks after surgery(P<0.05),but there was no significant difference between the latter two groups.To conclude,there are different degrees of epidural fibrous scar formation after lumbar surgery.If the ligamentum flavum is preserved,it can help to reduce the number of epidural fibroblasts as well as the formation of collagen fibers,thus reducing the adhesion of the fibrous scar tissue to the dural sac and nerve root.The mechanism is not only a purely mechanical blockade,but also to reduce the formation of epidural fibrous scar by interfering with the transforming growth factor β1/Smad3 signaling pathway.
9.Association between overweight and lymph node metastasis in patients with papillary thyroid carcinoma and its sex-based heterogeneity
Lu CHEN ; Yan SUN ; Zhijun ZHAN ; Hailong TAN ; Ning LI ; Junda YIN ; Neng TANG ; Shi CHANG ; Peng HUANG
Chinese Journal of General Surgery 2025;34(5):892-902
Background and Aims:Papillary thyroid carcinoma(PTC)is the most common endocrine malignancy in China,with cervical lymph node metastasis being a frequent and critical clinical feature that directly affects patient prognosis and recurrence risk.In recent years,with the rapid increase in the prevalence of overweight and obesity in China,the role of body mass index(BMI)in various tumors has attracted growing attention.This study aimed to investigate the association between overweight and cervical LNM in PTC,analyze sex-specific differences and influencing factors,and provide evidence for precise clinical management.Methods:A retrospective analysis was conducted on the clinicopathologic data of 1 445 patients with classical PTC treated at Xiangya Hospital of Central South University between August 2021 and June 2022.Patients were divided into groups based on the presence or absence of lymph node metastasis.Restricted cubic spline analysis explored the nonlinear relationship between BMI and lymph node metastasis risk.Univariate and multivariate Logistic regression analyses were applied to identify independent risk factors.Furthermore,sex-stratified analysis was performed among overweight patients(BMI≥24 kg/m2)to determine sex-specific risk factors for lymph node metastasis.Results:Among all patients,716(49.6%)had lymph node metastasis.Univariate analysis showed that BMI,sex,age,tumor diameter,multifocality,and extrathyroidal extension were significantly associated with cervical lymph node metastasis in PTC patients(all P<0.05).A nonlinear positive correlation was observed between BMI and lymph node metastasis risk,which was more pronounced in male patients.Additionally,BMI was positively correlated with triglyceride levels and negatively correlated with high-density lipoprotein cholesterol.Sex-stratified analysis revealed that in overweight male patients,younger age(OR=0.954),larger tumor diameter(OR=1.085),and multifocality(OR=2.776)were independent risk factors for LNM;in overweight female patients,younger age(OR=0.943)and larger tumor diameter(OR=1.074)were the main influencing factors.Conclusion:Overweight is closely associated with cervical lymph node metastasis in PTC,and the high-risk factors for LNM differ between male and female overweight patients.Young age,larger tumor size,and multifocality in overweight males,and young age and larger tumors in overweight females indicate a higher risk of metastasis.It is recommended that high-risk populations receive enhanced preoperative evaluation and individualized lymph node dissection strategies to achieve precise treatment and improved risk control.
10.Feasibility of preparing human plasminogen by full chromatography from precipitation of Fraction Ⅲ in low temperature ethanol method
Jin ZHANG ; Shenglan YUE ; Chen ZHU ; Yan PENG ; Yanxiang ZHOU ; Lianzhen LIN ; Kejin CHEN ; Lu FENG ; Yong HU ; Zhijun ZHOU
Chinese Journal of Blood Transfusion 2024;37(11):1293-1300
[Objective] To determine the feasibility of preparing plasminogen (Pg) with Fraction Ⅲ precipitation (hereinafter referred to as FⅢ-P) from low-temperature ethanol process by full chromatography (hereinafter referred to as FⅢ-P process). [Methods] The FⅢ-P was diluted with dissolution buffer at different dilution times and stirring time. The potency and antigen concentration of Pg in dissolution sample were detected and the dissolution and clarification conditions were determined. Pre-treatment of loading sample and pre-experiment of affinity chromatography were carried out on the FⅢ-P dissolution sample to judge whether the loading sample had an impact on the chromatography by observing the performance of the affinity chromatography column and to evaluate whether the affinity chromatography could achieve the purpose of purifying Pg by detecting the plasma protein antigen concentration and Pg potency of the samples in the process. Two batches of FⅢ-P process were studied step by step, and the specific activity, steps and total recovery, and the output of Pg per ton of plasma were calculated. The feasibility of preparing Pg by FⅢ-P process was evaluated by comparing with the data of full chromatography process using plasma as raw material (hereinafter referred to as plasma process). [Results] The FⅢ-P was dissolved with 10 times of dissolution buffer, stirred for 1 hour, centrifuged at room temperature of 10 000×g for 15 minutes. The supernatant was first filtered with a screen, then clarified with an 8/0.8 μm filter, and finally filtered with a 0.45/0.2 μm filter and loaded. Pre-test showed that from clarification and filtration to Pg affinity chromatography, the step recovery of activity and antigen was 39.51% and 108.64%, respectively, the antigen concentration of Pg increased by 31.16 times and the activity increased by 11.39 times after affinity chromatography, which reaching the effect of affinity chromatography purification of Pg. The results of 2 batches of step-by-step scale-up FⅢ-P process showed that the total recoveries of antigen and activity from plasma to SP chromatography of FⅢ-P process were (45.76±1.10)% and (24.15±0.59)%, respectively, which had a total loss of about 1/3 of antigen and about 2/3 of activity compared to the plasma process. The Pg specific activity of SP chromatography eluent was (4.68±0.25) U/mg, which was about half of that of plasma process, but meeted the internal standard of > 4 U/mg. The output of Pg antigen per ton of plasma in the FⅢ-P process was 68.73% of that in the plasma process, and the output of Pg activity per ton of plasma in the plasma process was 29.82% of that in the plasma process, which basically achieved the purpose of waste utilization of FⅢ-P. [Conclusion] The technical route of preparing Pg from FⅢ-P by full chromatography is feasible.


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