Objective To evaluate the feasibility of process scale-up for the production of human prothrombin complex concentrate(PCC) by comparing the quality parameters of PCC samples obtained at different stages of process scale-up.Methods The PCC production process was scaled up sequentially through bench scale, pilot scale and production scale.Samples were collected at critical process control points across the three scales for comparative quality analysis. The final PCC products from each scale were tested in accordance with the Chinese Pharmacopoeia(VolumeⅢ, 2020 edition) to assess process stability and regulatory compliance during scale-up.Results After the first ultrafiltration step, no statistically significant differences were observed in the potency of human coagulation factor Ⅸ(FⅨ) or protein content among samples from the three scales(F = 1. 066 and 0. 590, respectively, each P > 0. 05). The FⅨ recovery rates were(69. 3 ± 10. 3)%,(73. 9 ±11. 1)%, and(69. 8 ± 7. 3)%, respectively, with no significant difference( F = 0. 330, P > 0. 05). Following solvent/detergent(S/D) treatment, the pH remained stable, and no significant differences were observed in FⅨ potency or protein content(F =1. 414 and 0. 542, respectively, each P > 0. 05). After the secondary ion-exchange chromatography step, no significant differences were found in FⅨ potency or specific activity(F = 0. 437 and 0. 201, respectively, each P > 0. 05), with FⅨ recovery rates of(90. 6 ± 6. 7)%,(82. 6 ± 4. 6)% and(87. 2 ± 6. 1)%, respectively, with no significant difference(F = 2. 513, P > 0. 05).At the bulk solution stage, no significant differences were observed in FⅨ potency or specific activity(F = 0. 187 and 0. 135,respectively, each P > 0. 05) with stable pH, and FⅨ recovery rates were(90. 6 ± 7. 5)%,(97. 2 ± 8. 3)%, and(92. 2 ± 6. 4)%,respectively, with no significant difference(F = 1. 016, P > 0. 05). After dry-heat virus inactivation, no significant differences were noted in the potency of factorsⅡ, Ⅶ, Ⅸ, and Ⅹ(F = 0. 11, 0. 473, 0. 818, and 0. 244, respectively, each P > 0. 05).The critical quality attributes of final PCC products from all three scales were consistent and complied with the requirements of Chinese Pharmacopoeia(Volume Ⅲ, 2020 edition).Conclusion The established PCC production process is stable, reliable, and reproducible, demonstrating the feasibility of process scale-up.

Objective To compare the quality and centrifugal efficiency of human plasma cryoprecipitates extracted by GQ142 high-speed tube centrifuge and BKB45 continuous flow centrifuge and the differences in the production process of human coagulation factor Ⅷ(FⅧ).Methods The main functions, parameters and work efficiency of GQ142 high-speed tube centrifuge and BKB45 continuous flow centrifuge were compared. Cryoprecipitates were extracted for FⅧ production,sampling and testing, comparing the quality, yield, and virus safety of cryoprecipitates, as well as the quality and virus safety of FⅧ production process and finished products.Results Compared with GQ142 high-speed tube centrifuge, BKB45 continuous flow centrifuge had more perfect functions and higher working efficiency. The appearance of the cryoprecipitates extracted by both centrifuges was normal, the virus safety was in accordance with the internal quality control standard, and there was no statistically significant difference in cryoprecipitates yield(t = 1. 507, P > 0. 05). The recovery rates of FⅧactivity were(48. 7 ± 4. 2)% and(49. 2 ± 5. 4)%, respectively, with no statistically significant difference(t =-0. 250, P >0. 05). There was no statistically significant difference in FⅧ potency, protein content and FⅧ specific activity among cryoprecipitate solution, post chromatographic products and ultrafiltration products(t =-1. 466,-2. 084,-0. 998,-1. 701,-1. 973, 0. 472,-0. 975, 1. 116, and-1. 215, respectively, each P > 0. 05). The recovery rates of FⅧ activity of post chromatographic products were(38. 0 ± 4. 4)% and(38. 7 ± 5. 6)%, respectively, with no statistically significant difference(t =-0. 275, P > 0. 05). The pH of ultrafiltration products was stable. The appearance of the finished products was normal, and the virus safety indicators, FⅧ potency, moisture, pH, protein content and FⅧ specific activity were all in accordance with the quality standards of Chinese Pharmacopoeia(Vol Ⅲ, 2020 edition).Conclusion Compared with GQ142 high-speed tube centrifuge, BKB45 continuous flow centrifuge can significantly improve production efficiency while ensuring the quality of cryoprecipitates and FⅧ, making it suitable for large-scale production.

Objective To compare the quality and centrifugal efficiency of human plasma cryoprecipitates extracted by GQ142 high-speed tube centrifuge and BKB45 continuous flow centrifuge and the differences in the production process of human coagulation factor Ⅷ(FⅧ).Methods The main functions, parameters and work efficiency of GQ142 high-speed tube centrifuge and BKB45 continuous flow centrifuge were compared. Cryoprecipitates were extracted for FⅧ production,sampling and testing, comparing the quality, yield, and virus safety of cryoprecipitates, as well as the quality and virus safety of FⅧ production process and finished products.Results Compared with GQ142 high-speed tube centrifuge, BKB45 continuous flow centrifuge had more perfect functions and higher working efficiency. The appearance of the cryoprecipitates extracted by both centrifuges was normal, the virus safety was in accordance with the internal quality control standard, and there was no statistically significant difference in cryoprecipitates yield(t = 1. 507, P > 0. 05). The recovery rates of FⅧactivity were(48. 7 ± 4. 2)% and(49. 2 ± 5. 4)%, respectively, with no statistically significant difference(t =-0. 250, P >0. 05). There was no statistically significant difference in FⅧ potency, protein content and FⅧ specific activity among cryoprecipitate solution, post chromatographic products and ultrafiltration products(t =-1. 466,-2. 084,-0. 998,-1. 701,-1. 973, 0. 472,-0. 975, 1. 116, and-1. 215, respectively, each P > 0. 05). The recovery rates of FⅧ activity of post chromatographic products were(38. 0 ± 4. 4)% and(38. 7 ± 5. 6)%, respectively, with no statistically significant difference(t =-0. 275, P > 0. 05). The pH of ultrafiltration products was stable. The appearance of the finished products was normal, and the virus safety indicators, FⅧ potency, moisture, pH, protein content and FⅧ specific activity were all in accordance with the quality standards of Chinese Pharmacopoeia(Vol Ⅲ, 2020 edition).Conclusion Compared with GQ142 high-speed tube centrifuge, BKB45 continuous flow centrifuge can significantly improve production efficiency while ensuring the quality of cryoprecipitates and FⅧ, making it suitable for large-scale production

Immune response is one of the main reasons causing neurological deficits in the patients with cere -brovascular diseases , which activates microglia , induces inflammatory reaction and finally results in serious neuronal and endothelial injury .MicroRNAs take part in the regulation of immunoreaction , and simultaneously regulates many target genes and induces faster post-transcriptional regulation to its target genes compared with the traditional transcriptional regu -lation.For providing a basis for the clinical use of microRNAs and applying new therapy , this review mainly focuses on the function and mechanism of microRNAs in the regulation of the immunoreaction caused by cerebrovascular diseases .

地震造成大规模人群的复杂创伤,病情进一步发展,常导致多脏器功能障碍(MODS)。本文总结了地震伤后MODS的发病机制、预防、早期诊断以及治疗措施。

ObjectiveTo summarize the application of pressure support ventilation (PSV) on cervical spinal cord injured patients with respiratory dysfunction.MethodSixteen patients were studied.Respiratory rate (RR),tidal volume (VT), minute ventilation (VE),peak inspiration pressure (PIP), dynamic lung conpliance (Cdyn), blood pH value, PaO2 and PaCO2 were measured under the different pressure levels of PSV. ResultAll parameters correlated with the level of PSV. Conclusion Appropriate PSV levels can make the respiratory parameters close to the reasonable level and respiratory functional status for the cervical cord injured patients with respiratory dysfunction.

ObjectiveTo observe the difference between pressure support ventilation(PSV) and synchronized intermittent mandatory ventilation(SIMV) in cervical spinal cord injury patients with respiratory failure.MethodsThe blood gas analysis,respiratory rate,heart rate,blood pressure and subjective feelings were observed in the same patient under different ventilation(PSV or SIMV).ResultsThere was no significant difference in blood pressure when patients underwent PSV and SIMV.Otherwise,There was significant difference in respiratory rate,heart rate,pH,PaO2,PaCO2 and subjective feelings when patients underwent PSV and SIMV,which showed that of PSV were better.ConclusionThe effect of PSV was better than that of SIMV on respiratory failure after cervical spinal cord injury.

ObjectiveTo identify the status of quality of life in breast cancer patients and explore the impact of environmental factors on quality of life in breast cancer patients receiving chemotherapy. MethodsTotally 201 primary breast cancer patients undergoing chemotherapy after surgery were investigated.Self-developed demographic and clinical character investigation questionnaire,WHO Disability Assessment Schedule Ⅱ(WHODAS Ⅱ),and environmental factors in International Classification of Functioning Disability and Health(ICF)core sets for breast cancer patients were adopted to collect relevant data. ResultsBreast cancer patients had different levels of difficulties on each domain of WHODAS Ⅱ.Multiple stepwise regression analysis demonstrated that“material and emotional support and interrelationship with friends”, “social security service,system and policies” and“social norms,practices and ideologies” were factors influencing quality of life of breast cancer patients. ConclusionsIn addition to the strengthen of rehabilitation exercise training,nurses should advocate more services from society through policy making,prompt public awareness and scientific cognition,as well as construct effective nursing interventions to help enlarge social support resources and improve social support level.

Alcohol is closely related to the occurrence and prognosis of cerebral ischemia.Researches on the relationship between alcohol and cerebral ischemia using different animal models draw different conclusions.This paper summarizes the common alcohol intervention methods in making animal models of cerebral ischemia, and evaluates the advantages and disadvantages of these models to provide reference for the future research.

Pancreatic encephalopathy (PE)is one of the severe complications of severe acute pancreatitis (SAP).Early diagnosis mostly depends on the history of disease as well as clinical symptoms and signs.PE progresses rapidly and is often complicated by multiple organ dysfunction,and it may finally develop into multiple organ failure with a high fatality rate if not treated in time.It is currently known that de-myelination is one of the important pathological features of this disease,with fat -soluble demyelination of cerebral gray matter and white matter,as well as inflammatory changes such as hemorrhage and edema.The target antigen of demyelinating lesions,however,is myelin basic protein (MBP).This paper reviews the changes in MBP levels in the demyelinating lesions of the central nervous system among PE pa-tients,with the purpose of providing clues for the early diagnosis and prognostic study of demyelinating lesions in PE.