【Objective】 To screen the sterilizing-grade filters applicable for production of human coagulation factor Ⅷ/von Willebrand factor complex(FⅧ/VWF)and study the sterilization filtration process. 【Methods】 Four sterilizing-grade filters for FⅧ/VWF were evaluated through indicators such as filtration capacity, filtration flux, recovery rate of FⅧ activity, recovery rate of VWF activity, recovery rate of VWF antigen, recovery rate of protein and VWF molecular distribution. The sterilizing-grade filter with the best filtration performance was selected for further study. The study was designed by general full-factor design to determine the appropriate filitered protein concentration and filitered speed range through evaluating the total filtered protein amount, recovery rate of protein and filtration efficiency, and then the process operation parameters was determined. 【Results】 The filtration flux of Sartobran P, Sartopore 2 XLG, Sartopore Platinum and Sartopore 2 XLI were 1.71±0.01, 1.80±0.01, 1.34±0.01, and 1.81±0.04 L·(m²)^-1·min^-1, respectively; the recovery rates (%) of FⅧ activity were 97.09±2.82, 99.22±0.99, 96.87±1.85 and 93.76±1.21, respectively; the recovery rates (%) of VWF activity were 98.12±1.42, 99.95±1.85, 94.80±1.62 and 92.09±1.67, respectively. Between Sartopore 2 XLG and Sartobran P, the difference of filtration flux (P<0.001) was statistically significant; between Sartopore 2 XLG and Sartopore Platinum, the differences of the filtration flux (P<0.001) and VWF potency recovery rate (P<0.05) were statistically significant; between Sartopore 2 XLG and Sartopore 2 XLI, the differences of FⅧ potency recovery rate (P<0.01) and VWF potency recovery rate (P<0.01) were statistically significant. The optimal process operating space of Sartopore 2 XLG was protein concentration of 0.45-0.58 mg/mL, and filtration rate of 1.48-2.95 L·(m²)^-1·min^-1. 【Conclusion】 Sartopore 2 XLG is the most suitable filter for the production of FⅧ/VWF and the DoE test proves that it has good process operation space.

【Objective】 To investigate the trend of neutralizing antibody level in plasma donors who received the 3rd shot of inactivated novel coronavirus vaccine. 【Methods】 Three commercial ELISA kits for novel coronavirus neutralization antibody detection, manufactured by Company A, B and C, were chosen and screened by Pseudotype Neutralization Test from December 2021 to June 2022. A total of 410 plasma samples from 64 plasma donors who received the 3rd shot of inactivated novel coronavirus vaccine and there after donated plasma within six months were detected by the selected ELISA kit from July to October, 2022. The data were analyzed by Excel 2013 and SPSS 26 software. 【Results】 The high-throughput ELISA kit for SARS-CoV-2 neutralizing antibody detection, manufactured by Company A, was selected for further antibody titer detection. The mixed plasma titers were 1 337.34, 1 148.89, 852.19, 681.38, 556.44 and 457.19 U/mL from 1 to 6 months, respectively, after the 3rd shot of vaccine. The neutralizing antibody titer level began to increase around 7 days after the 3rd shot of vaccine injection and peaked (peak range: 264.07-2 208.39 U/mL, median: 569.34 U/mL) at 1 month (range: 9-43 days, median: 22 days), and then gradually decreased (P<0.05). 【Conclusion】 The neutralizing antibody titer of plasma donors who received the 3rd shot of inactivated novel coronavirus vaccine began to rise around 7 days after vaccination, which reached the peak value at around 1 month and then gradually decreased.

【Objective】 To study the effect of different concentrations of heparin, ATⅢ or a mixture of heparin and antithrombin Ⅲ (ATⅢ) (1∶1)on the activity of human coagulation factor Ⅸ (FⅨ). 【Methods】 The heparin or heparin/ATⅢ with different concentrations were added into human coagulation Ⅸ products or human prothrombin complex (PCC) to prepare heparin or heparin/ATⅢ samples, containing 0, 0.1, 0.3, 0.5, 0.8, 1, 2 and 4 IU per unit. ATⅢ with different concentrations were added into FⅨ or PCC to prepare ATⅢ samples containing ATⅢ 0, 0.1, 0.5 and 1 IU per unit. The FⅨ activity of the samples prepared was tested by one-stage coagulation method. Then corresponding amount of protamine sulfate were added to neutralize heparin or heparin/ATⅢ to detect the FⅨ activity again. Their influence of heparin, ATⅢ and heparin/ATⅢ with different concentrations on the activity of FⅨ were analyzed. 【Results】 When the content of heparin or heparin/ATⅢ was 0, 0.1, 0.3 and 0.5 IU per unit of FⅨ, the detection results of FⅨ titer in samples were consistent. When the content of heparin or heparin/ATⅢ per unit of FⅨ was 0.8, 1, 2 and 4 IU, the detection results of FⅨ titer were all lower than those of samples without heparin. When the ATⅢ content was 0, 0.1, 0.5 and 1 IU, the FⅨ titer of the samples was consistent. 【Conclution】 When the content of heparin or heparin/ATⅢ in the product is less than or equal to 0.5 IU per IU of FⅨ, the step of protamine sulfate adding could be omitted as it has little effect on FⅨ activity. When >0.5 IU per IU of FⅨ, however, protamine sulfate adding, to neutralize heparin, is necessary before FⅨ activity testing.

【Objective】 To establish a method for detecting human immunoglobulin Fc function based on surface plasmon resonance technology. 【Methods】 Based on the characteristic that FcγRI can be binded to the Fc segment of IgG, the affinity constant of the sample was detected by surface plasmon resonance, and its Fc function was the KD ratio of the sample to the standard. The method was validated for specificity/specificity, precision and robustness. The method and the pharmacopoeia method were used to detect the Fc function of 30 human immunoglobulins, and the correlation and consistency of the detection results were analyzed. 【Results】 The method validation results showed that this method has strong specificity/specificity (t values were 0.15, 0.22, both P>0.05), good precision (CV value 5.37%~10.69%) and good robustness (CV value 10.06%). The detection results of this method and the pharmacopoeia method have high correlation (r=0.96, P<0.05) and high consistency (Bias-2.060, 95% Limits of Agreement-5.628~1.508). 【Conclusion】 A method for detecting human immunoglobulin Fc function based on surface plasmon resonance has been successfully established.

Plasma protein products, essential drugs for various clinical diseases, are therapeutic biological products extracted from healthy human plasma. The research and development of new plasma protein products, led by United States and European, has been widely deepened and enhanced. Therefore, accelerating the development of new plasma protein products in China is of great significance. This review summarizes the research and development of plasma protein products that have been marketed abroad but have not produced in China, as well as analyzes the difficulties and prospects of the development of plasma protein products in China.

Objective To explore the sleep characteristics of submariners during a long-term voyage, so as to provide scientific evidence for ensuring submariners with good sleep during long-term voyages. Methods The sleep status of submariners who participated in a long-term voyage was tested by Self-Rating Scale of Sleep (SRSS) before the voyage, and before and after each voyage section during the voyage. The sleep status variation of submariners who performed different types of tasks, from the beginning to the end of each voyage section and of each resting-on-the-sea section was analyzed respectively. Comparison of sleep scores was performed between submariners and surface ship crew in the second voyage section. Numbers of submariners with sleep problem were compared in each voyage section. Results Generally speaking, submariners' sleep status at the end of voyage section was significantly worse than that at the beginning of voyage section and that before the whole voyage (P<0.001, P<0.01), and the sleep status at the beginning of the third voyage section was significantly worse than that before the whole voyage (P<0.05). Submariners had a steady sleep status when taking a resting-on-the-sea before starting their first voyage section, which was no significant difference from that before the whole voyage (P>0.05). After finishing a voyage section and taking a resting-on-the-sea, submariners' sleep status returned to the level of pre-voyage (P>0.05), and was significantly better than that before the resting-on-the-sea (P<0.05, P<0.01). After finishing two voyage sections and then taking a resting-on-the-sea, the submariners' sleep status showed no obvious variation (P>0.05). Compared with that of surface ship crew who accomplished the same voyage section, submariners had an obviously better sleep status after taking a resting-on-the-sea (P<0.05). Meanwhile, submariners who finished a voyage section showed a significantly worse sleep status than those resting on the sea (P<0.01) and surface ship crew who finished a same voyage section (P<0.05). In each voyage section, submariners with sleep problems who finished resting-on-the-sea were significantly less than those who finished navigation (P<0.001, P<0.05). There was no significant difference in the number of submariners with sleep problems between those who taking non-resting and taking resting-at-dock after finishing the first voyage section (P>0.05), but the latter was significantly more than the former when the second voyage section was finished (P<0.05). During the resting-on-the-sea period, the numbers of submariners with sleep problems in both the second and the third voyage section were significantly more than those in the first voyage section (P<0.05, P<0.01). The numbers of submariners with sleep problems who implemented the third voyage section were significantly more than those who implemented the first and the second voyage section (P<0.01). Conclusions Generally, the sleep quality of submariners is significantly worse after accomplished a voyage section task, and the degree of sleep problems may be accumulated to worse and worse along with the increase of long-term voyage time. Whereas, submariners may have a significantly better sleep status after taking a resting-on-the-sea, implying that resting-on-the-sea is an effective way to ensure submariners a good sleep during a long-term voyage.

OBJECTIVETo analyze the efficacy and safety of laparoscopic adjustable gastric placation (LAGBP), a new procedure for surgical treatment of obesity.

METHODSClinical and 1-year follow-up data of 10 patients who underwent LAGBP in our department between September and November 2011 were analyzed retrospectively.

RESULTSThe mean operative time was (93.0±13.4) min, while the mean intraoperative blood loss was (15.5±4.7) ml. The mean excessive body weight loss rate(%EWL) at 3, 6, 9 and 12 months after the operation was 25.1%, 40.6%, 45.3% and 50.8% respectively. There were no severe post operative complications.

CONCLUSIONSLAGBP is associated with high safety and good short-term efficacy.

Objective To analyze the efficacy and safety of laparoscopic adjustable gastric placation (LAGBP), a new procedure for surgical treatment of obesity. Methods Clinical and 1-year follow-up data of 10 patients who underwent LAGBP in our department between September and November 2011 were analyzed retrospectively. Results The mean operative time was (93.0±13.4) min, while the mean intraoperative blood loss was (15.5±4.7) ml. The mean excessive body weight loss rate (%EWL) at 3, 6, 9 and 12 months after the operation was 25.1%, 40.6%, 45.3% and 50.8%respectively. There were no severe post operative complications. Conclusions LAGBP is associated with high safety and good short-term efficacy.

Objective To analyze the efficacy and safety of laparoscopic adjustable gastric placation (LAGBP), a new procedure for surgical treatment of obesity. Methods Clinical and 1-year follow-up data of 10 patients who underwent LAGBP in our department between September and November 2011 were analyzed retrospectively. Results The mean operative time was (93.0±13.4) min, while the mean intraoperative blood loss was (15.5±4.7) ml. The mean excessive body weight loss rate (%EWL) at 3, 6, 9 and 12 months after the operation was 25.1%, 40.6%, 45.3% and 50.8%respectively. There were no severe post operative complications. Conclusions LAGBP is associated with high safety and good short-term efficacy.

ObjectiveTo test and verify whether Ba-alginate-Poly-L-Ornithine-Alginate microcapsules(B-PLO-A) can improve the physical properties and biocompatibility of the traditional BPA microcapsules.MethodsThe B-PLO-A and Ba-alginate-Poly-L-lysine-alginate（B-PLL-A） microcapsules were made by the static generator. The physical property of the microcapsules was evaluated by observing the morphological changes of the microcapsules in the hypotonic environment, changes in diameter of microcapsules in vitro culture and calculating broken microcapsules ratio by shaking method. The biocompatibility was observed by transplanting into peritoneal cavity of rat.ResultsB-PLO-A microcapsules are stronger and more stable in a hypotonic environment than B-PLL-A microcapsules. After 96 h mechanism shaking, the unbroken microcapsules ratio of B-PLO-A and B-PLL-A microcapsules were (99.3±1.0)% and (96.2±1.5)% respectively. The microcapsules were retrieved from peritoneal cavity of rat at 2, 4 and 8 weeks after transplantation, most of the microcapsules were of integrity, rotundity, and surface smooth without obviously bundled by connective tissue. 8 weeks after transplantation the intact microcapsules ratio of B-PLO-A and B-PLL-A microcapsules were (97.3±2.1)% and (95.4±2.4)% respectively.ConclusionB-PLO-A microcapsules as a whole have bettermechanical strength compared with B-PLL-A microcapsules, while maintaining a good biocompatibility.