To analyze the standard establishment approach and compilation rationale for metallic pharmaceutical packaging standard development in the 2025 edition of the Pharmacopeia of the People's Republic of China.This article systematically explained the background and process of establishing the guiding principles for metallic materials and containers used in pharmaceutical packaging in the Chinese Pharmacopoeia through basic information,relevant domestic and international standards,the establishment of key quality attributes of metallic pharmaceutical packaging materials,and the construction of metallic pharmaceutical packaging material standards.The newly established guidelines,the Pharmacopeia of the People's Republic of China 9625,prioritized product critical quality attributes(CQAs)and real-world applicability.This dual emphasis on rigidity and adaptability enhances drug safety,meets the regulatory requirements,and promotes the globalization and scientific advancement of China's pharmaceutical packaging industry.

Based on the practical experience of the Human Sperm Bank, Obstetrics and Gynecology Hospital, Fudan University, this paper explores the necessity, core content, process, and common challenges of genetic counseling for sperm donors, while proposing optimization strategies. Genetic counseling for sperm donors employs methods such as family history investigation, karyotype analysis, high-throughput gene sequencing, and genetic matching to effectively identify and mitigate hereditary risks in donor-conceived offspring, thereby enhancing the scientific rigor and operability of sperm bank quality control systems. Addressing challenges such as donor acceptance, technological limitations, the complexity of genetic matching, ethical issues and privacy protection, and long-term health monitoring, this paper suggests strategies including optimizing genetic screening protocols, establishing intelligent genetic matching systems, strengthening privacy protection mechanisms, and improving long-term health management. The aim of this paper is to provide a scientific and practical reference for professionals to optimize genetic counseling management in sperm banks, ensuring sperm donor quality and the safety of assisted reproduction.

BACKGROUND:Knee replacement is a successful technology for treating severe knee diseases,but there are still problems such as low surgical precision,long operation time,and long postoperative recovery period.The clinical application of intelligent orthopedic robots can solve these problems and make knee replacement technology more optimized.OBJECTIVE:To compare the efficacy of MAKO robot-assisted knee replacement with navigation knee replacement.METHODS:Twenty-five patients treated with MAKO robot-assisted knee replacement in Xuzhou Renci Hospital from January to December 2022 were selected as observation group.100 patients treated with navigation knee replacement during the same period were selected as the control group.Perioperative related indexes of the two groups were compared,including planned and actual medial proximal tibial angle,distal lateral femoral angle,hip-knee-ankle angle,visual analog scale score,joint range of motion,American Knee Society functional score,and Western Ontario and McMaster University Osteoarthritis Index score before and 3 months after surgery.RESULTS AND CONCLUSION:(1)The operation time of observation group was significantly longer than that of the control group(P＜0.05),and the intraoperative blood loss was significantly less(P＜0.05).(2)The difference of medial proximal tibial angle,distal lateral femoral angle,and hip-knee-ankle angle in observation group was significantly lower than that in the control group(P＜0.05).(3)Three months after surgery,visual analog scale score in both groups was lower than that before surgery(P＜0.05);range of motion in both groups was higher than that before surgery(P＜0.05).Visual analog scale score in observation group was significantly lower than that in the control group,and range of motion in observation group was significantly higher than that in the control group(P＜0.05).(4)Three months after surgery,the clinical and functional scores of American Knee Society in both groups were higher than those before surgery(P＜0.05),and those in observation group were significantly higher than those in the control group(P＜0.05).(5)Three months after surgery,the scores of function,stiffness and pain of Western Ontario and McMaster University Osteoarthritis Index in both groups were lower than those before surgery(P＜0.05),and the scores in observation group were significantly lower than those in the control group(P＜0.05).(6)It is indicated that compared with navigational knee replacement,MAKO robot-assisted knee replacement can decrease intraoperative blood loss,reduce lower limb force line and prosthesis position error,help to accurately place prosthesis,achieve planned force line,diminish postoperative pain,improve knee motion,and promote the recovery of knee function.

Objective To investigate the clinical efficacy and safety of facilitated percutaneous coronary intervention(PCI)with half-dose recombinant staphylokinase(r-SAK)in patients with ST-segment elevation myocardial infarction(STEMI)who are expected to undergo PCI within 120 minutes.Methods From October 2021 to August 2022,a total of 200 STEMI patients in eight centers were included and randomly assigned in a 1﹕1 ratio to either r-SAK group or control group.Patients received loading doses of aspirin and ticagrelor and intravenous heparin and were randomized to receive an intravenous bolus of either 5 mg r-SAK or normal saline prior to PCI.The outcomes were set as ST-segment resolution(STR)at 60-90 minutes after PCI,the proportion and transition of pathological Q waves on the 5th day after PCI,and the proportion of high-sensitivity cardiac troponin T(hs-cTnT)peaking within 12 hours of onset.The safety outcome was major bleeding events defined as Bleeding Academic Research Consortium(BARC)≥type 3 bleeding during hospitalization.Results Compared with the control group,the r-SAK group had a higher proportion of STR≥70%within 60-90 minutes after PCI(58.3%vs.40.3%,P=0.009);a lower proportion of pathological Q waves(59.1%vs.74.1%,P=0.040);a lower rate of Q wave progression(14.8%vs.43.2%,P＜0.001);a higher rate of Q wave disappearance(12.5%vs.3.7%,P=0.027);and a higher proportion of hs-cTnT peaking within 12 hours of symptom onset[31/40(77.5%)vs.17/33(51.5%),P=0.027].Regarding the safety outcome,no significant difference in BARC≥type 3 bleeding was found between the two groups during hospitalization(P＞0.05).Conclusions For STEMI patients who were expected to undergo primary PCI within 120 minutes of symptom onset,the facilitated PCI with half-dose r-SAK significantly increased the proportion of STR≥70%at 60-90 minutes after PCI,reduced the formation of pathological Q waves,and shortened the time to peak hs-cTnT,without increasing the risk of bleeding,which should be an alternative reperfusion strategy worthy of further study.

Objective To investigate the effect and mechanism of benserazide on bleomycin-induced pulmonary fibrosis in mice.Methods Male C57BL/6 mice were randomly divided into normal control group,model control group,pirfenidone group(50 mg·kg-1),and low-dose and high-dose benserazide groups(300 and 600 mg·kg-1),with 6 mice in each group.Except for normal control group,the other groups were given bleomycin(3.5 mg·kg-1)by non-invasive tracheal instillation to establish a mouse model of pulmonary fibrosis.Seven days after modeling,pirfenidone group and low-dose and high-dose benserazide groups were intragastrically administered the corresponding doses of drugs for 14 consecutive days.After the drug administration,the mice in each group were sacrificed.The pathological morphology of the lung tissue in each group was observed by hematoxylin-eosin(HE)staining and Masson staining.The content of hydroxyproline(HYP)in the lung tissue of mice,the content of lactic acid in the lung tissue and serum,and the activity of hexokinase(HK)in the lung tissue were detected by using kits.The expression levels of Collagen I and Fibronectin in the lung tissue of mice in each group were detected by immunohistochemistry.The expression levels of α-SMA,TGF-β1,Smad2,p-Smad2,TNF-α and IL-6 proteins in the lung tissue of mice in each group were detected by Western blotting.Results Compared with normal control group,the lung tissue structure of model control group mice was damaged,with thickened alveolar septa and fibrotic changes such as collagen accumulation.The content of HYP and lactic acid and the activity of HK in the lung tissue increased significantly,and the expression levels of Collagen I,Fibronectin,α-SMA,TGF-β1,Smad2,p-Smad2,TNF-α,and IL-6 proteins were significantly increased.Compared with model control group,treatment with benserazide significantly alleviated the pathological damage of lung tissue in mice,significantly reduced the content of HYP,lactic acid and HK activity in lung tissue,and significantly decreased the expression levels of Collagen I,Fibronectin,α-SMA,TGF-β1,Smad2,p-Smad2,TNF-α and IL-6 proteins.Conclusion Benserazide ameliorates bleomycin-induced pulmonary fibrosis in mice by modulating the HK2-mediated glycolysis pathway.

To analyze the standard establishment approach and compilation rationale for metallic pharmaceutical packaging standard development in the 2025 edition of the Pharmacopeia of the People's Republic of China.This article systematically explained the background and process of establishing the guiding principles for metallic materials and containers used in pharmaceutical packaging in the Chinese Pharmacopoeia through basic information,relevant domestic and international standards,the establishment of key quality attributes of metallic pharmaceutical packaging materials,and the construction of metallic pharmaceutical packaging material standards.The newly established guidelines,the Pharmacopeia of the People's Republic of China 9625,prioritized product critical quality attributes(CQAs)and real-world applicability.This dual emphasis on rigidity and adaptability enhances drug safety,meets the regulatory requirements,and promotes the globalization and scientific advancement of China's pharmaceutical packaging industry.

Based on the practical experience of the Human Sperm Bank, Obstetrics and Gynecology Hospital, Fudan University, this paper explores the necessity, core content, process, and common challenges of genetic counseling for sperm donors, while proposing optimization strategies. Genetic counseling for sperm donors employs methods such as family history investigation, karyotype analysis, high-throughput gene sequencing, and genetic matching to effectively identify and mitigate hereditary risks in donor-conceived offspring, thereby enhancing the scientific rigor and operability of sperm bank quality control systems. Addressing challenges such as donor acceptance, technological limitations, the complexity of genetic matching, ethical issues and privacy protection, and long-term health monitoring, this paper suggests strategies including optimizing genetic screening protocols, establishing intelligent genetic matching systems, strengthening privacy protection mechanisms, and improving long-term health management. The aim of this paper is to provide a scientific and practical reference for professionals to optimize genetic counseling management in sperm banks, ensuring sperm donor quality and the safety of assisted reproduction.

Objective:To evaluate the effect of deep brain stimulation(DBS)of the lateral cerebellar nucleus(LCN)on synaptic plasticity in a traumatic brain injury(TBI)rat model of the medial prefrontal cortex(mPFC).Methods:A controllable mPFC injury rat model was prepared using a hydraulic impact method.Two weeks after inju-ry,stimulation electrodes were implanted into the left LCN.Electrical stimulation was initiated at the 4th week after injury and continued for 30 days.The learning and memory function of the rats was evaluated using the Morris water maze.RT-qPCR and Western blot were used to detect the mRNA and protein expressions of brain-derived neurotrophic factor(BDNF),postsynaptic density protein 95(PSD95),and growth-associated protein 43(GAP43)in the mPFC region.Results:The learning and memory function of the mPFC-injured rats significantly decreased.The expressions of BDNF,PSD95,and GAP43 in mPFC decreased.DBS treatment significantly enhanced the learning and memory ability of mPFC-injured rats,and simultaneously upregulated the expressions of BDNF,PSD95,and GAP43 in mPFC.Conclusion:LCN DBS is an effective method for treating cognitive impairment caused by TBI,and it may achieve this through activating the neural plasticity mechanism of the mPFC.

BACKGROUND:Knee replacement is a successful technology for treating severe knee diseases,but there are still problems such as low surgical precision,long operation time,and long postoperative recovery period.The clinical application of intelligent orthopedic robots can solve these problems and make knee replacement technology more optimized.OBJECTIVE:To compare the efficacy of MAKO robot-assisted knee replacement with navigation knee replacement.METHODS:Twenty-five patients treated with MAKO robot-assisted knee replacement in Xuzhou Renci Hospital from January to December 2022 were selected as observation group.100 patients treated with navigation knee replacement during the same period were selected as the control group.Perioperative related indexes of the two groups were compared,including planned and actual medial proximal tibial angle,distal lateral femoral angle,hip-knee-ankle angle,visual analog scale score,joint range of motion,American Knee Society functional score,and Western Ontario and McMaster University Osteoarthritis Index score before and 3 months after surgery.RESULTS AND CONCLUSION:(1)The operation time of observation group was significantly longer than that of the control group(P＜0.05),and the intraoperative blood loss was significantly less(P＜0.05).(2)The difference of medial proximal tibial angle,distal lateral femoral angle,and hip-knee-ankle angle in observation group was significantly lower than that in the control group(P＜0.05).(3)Three months after surgery,visual analog scale score in both groups was lower than that before surgery(P＜0.05);range of motion in both groups was higher than that before surgery(P＜0.05).Visual analog scale score in observation group was significantly lower than that in the control group,and range of motion in observation group was significantly higher than that in the control group(P＜0.05).(4)Three months after surgery,the clinical and functional scores of American Knee Society in both groups were higher than those before surgery(P＜0.05),and those in observation group were significantly higher than those in the control group(P＜0.05).(5)Three months after surgery,the scores of function,stiffness and pain of Western Ontario and McMaster University Osteoarthritis Index in both groups were lower than those before surgery(P＜0.05),and the scores in observation group were significantly lower than those in the control group(P＜0.05).(6)It is indicated that compared with navigational knee replacement,MAKO robot-assisted knee replacement can decrease intraoperative blood loss,reduce lower limb force line and prosthesis position error,help to accurately place prosthesis,achieve planned force line,diminish postoperative pain,improve knee motion,and promote the recovery of knee function.

Objective:To evaluate the effect of deep brain stimulation(DBS)of the lateral cerebellar nucleus(LCN)on synaptic plasticity in a traumatic brain injury(TBI)rat model of the medial prefrontal cortex(mPFC).Methods:A controllable mPFC injury rat model was prepared using a hydraulic impact method.Two weeks after inju-ry,stimulation electrodes were implanted into the left LCN.Electrical stimulation was initiated at the 4th week after injury and continued for 30 days.The learning and memory function of the rats was evaluated using the Morris water maze.RT-qPCR and Western blot were used to detect the mRNA and protein expressions of brain-derived neurotrophic factor(BDNF),postsynaptic density protein 95(PSD95),and growth-associated protein 43(GAP43)in the mPFC region.Results:The learning and memory function of the mPFC-injured rats significantly decreased.The expressions of BDNF,PSD95,and GAP43 in mPFC decreased.DBS treatment significantly enhanced the learning and memory ability of mPFC-injured rats,and simultaneously upregulated the expressions of BDNF,PSD95,and GAP43 in mPFC.Conclusion:LCN DBS is an effective method for treating cognitive impairment caused by TBI,and it may achieve this through activating the neural plasticity mechanism of the mPFC.