Objective To formulate the 2025 edition of the Pharmacopoeia of the People's Republic of China of prefilled syringe silicone oil determination method,and to interpret the method content.Methods The prefilled syringe was added silicone solvent ethyl acetate to the roll edge of the sleeve and let it stand for extraction for 5 minutes,then put the silicon solvent in the evaporating dish dried at 105 ℃ to constant weight,then add 1mL ethyl acetate into the sleeve for rinsing and placing in the same evaporating dish,and then dry in a water bath at 105℃ to constant weight.The content of silicone oil in the sleeve of the prefilled syringe was calculated according to the quality difference.Results The reliability of the experimental method was verified by the ultimate extraction test,standard recovery test,and precision investigation.The results showed that the ultimate extraction could be achieved after 5 minutes of extraction with ethyl acetate.The recovery rate of the method was 100.0％-101.6％,and the precision was 3.5％.Conclusion The formulation of the determination method refers to the measurement method of silicone oil content in relevant standards at home and abroad,combined with the problems existing in the measurement of silicone oil content in daily tests,to further improve the operability of the detection method,the method is simple,efficient,feasible and reliable.

Objective To investigate the expression levels of peroxisome proliferator-activated receptor gamma coactivator-1β(PGC-1β),hypoxia-inducible factor-1α(HIF-1α),and resistin(RETN)in gouty arthri-tis(GA),and analyze their correlation with the degree of joint damage.Methods A total of 134 patients with GA in the hospital from January 2022 to October 2023 were selected as GA group,and 134 healthy people who underwent the physical examination in the same period were selected as control group.The serum expression levels of PGC-1β,HIF-1α and Retn were compared between the two groups.The expression levels of PGC-1β,HIF-1α and Retn in serum and synovial fluid of patients with different clinical characteristics in GA group were compared,the degree of joint destruction was graded according to the subjective pain grading method(VAS)and the patients were divided into a severe GA subgroup of 78 cases and a mild GA subgroup of 56 ca-ses.The expression levels of PGC-1β,HIF-1α,RETN,bone destruction factors[β-cross linked degradation products(β-CTX),tartrate resistant acid phosphatase-5b(TRACP5b),receptor activator of nuclear factor kappa B ligand(RANKL)]and inflammatory factors[tumor necrosis factor-α(TNF-α),interleukin-1β(IL-1β)]were compared among different degrees of joint destruction,and the correlation between serum and syno-vial fluid PGC-1β,HIF-1α,RETN and the degree of joint destruction,bone destruction factors,and inflamma-tory factors was analyzed.Results The expression level of PGC-1β in serum of GA group was lower than that of the control group,while the expression levels of HIF-1α and RETN in serum were higher than those of the control group(P＜0.05).There were statistically significant differences in serum and synovial fluid PGC-1β,HIF-1α,and RETN levels among GA patients with different clinical stages,affected joints,disease duration,and annual seizure frequency(P＜0.05).The expression levels of PGC-1β in the serum and synovial fluid of the severe GA subgroup were lower than those of the mild GA subgroup(P＜0.05),while the expression lev-els of HIF-1α and RETN were higher than those of the mild GA subgroup(P＜0.05).The expression levels ofβ-CTX and TRACP5b in the severe GA subgroup were higher than those in the mild GA subgroup(P＜0.05),while the expression level of RANKL was lower than that in the mild GA subgroup(P＜0.05).PGC-1βin serum and synovial fluid was negatively correlated with the degree of joint destruction,β-CTX,TRACP5b,TNF-α,and IL-1β,and positively correlated with RANKL.HIF-1α and RETN were positively correlated with the degree of joint destruction,β-CTX,TRACP5b,TNF-α,and IL-1β,and negatively correlated with RANKL.Conclusion PGC-1β,HIF-1α,and RETN are abnormally expressed in patients with GA,and are closely associ-ated with the degree of joint destruction,bone destruction factors,and inflammatory factors.They are expec-ted to become reliable indicators for evaluating the occurrence and progression of GA.

Permanent left superior vena cava aneurysm is a rare mediastinal venous lesion，the majority of the literature is in the form of case reports. In this article，a 50-year-old female with an incidental permanent left superior vena cava aneurysm discovered on echocardiography in Nanjing Gulou Hospital，and the right heart contrast-enhanced echocardiographic played an important role in the process of clear diagnosis. The patient was observed without intervention. No complications were attributable to the permanent left superior vena cava aneurysm during follow-up.

Objective This study aims to conduct a comprehensive analysis of the domestic and international standards for prefilled syringes to advance the scientific and international alignment of China's PFS standard system.Methods A thorough review of the framework,scope,and quality control key points of the 2015 national pharmaceutical packaging material standards(abbreviated as YBB standards),the ISO 11040 international standard system and the United States Pharmacopeia standard system was conducted.Comparative analysis was employed to reveal the similarities and differences among the three,thereby uncovering the unique characteristics of each.Results The YBB standards emphasize quality control for prefilled syringes,offering clear and operational guidelines that provide companies with precise directives for production and testing.However,the scope of these standards is relatively limited.ISO standards apply to a wide range of products,featuring comprehensive coverage and a degree of flexibility.They emphasize the universality of products and compatibility with other international standards,which facilitates global production and trade.USP includes several chapters related to prefilled syringes but lacks a certain level of specificity and systematic approach.Conclusion By thoroughly studying and drawing upon the quality control philosophies,standard frameworks,and key control points of prefilled syringes from both domestic and international standards,we aim to provide valuable references for the development of a robust prefilled syringe standard system within the Chinese Pharmacopoeia.

Objective This study aims to conduct a comprehensive analysis of the domestic and international standards for prefilled syringes to advance the scientific and international alignment of China's PFS standard system.Methods A thorough review of the framework,scope,and quality control key points of the 2015 national pharmaceutical packaging material standards(abbreviated as YBB standards),the ISO 11040 international standard system and the United States Pharmacopeia standard system was conducted.Comparative analysis was employed to reveal the similarities and differences among the three,thereby uncovering the unique characteristics of each.Results The YBB standards emphasize quality control for prefilled syringes,offering clear and operational guidelines that provide companies with precise directives for production and testing.However,the scope of these standards is relatively limited.ISO standards apply to a wide range of products,featuring comprehensive coverage and a degree of flexibility.They emphasize the universality of products and compatibility with other international standards,which facilitates global production and trade.USP includes several chapters related to prefilled syringes but lacks a certain level of specificity and systematic approach.Conclusion By thoroughly studying and drawing upon the quality control philosophies,standard frameworks,and key control points of prefilled syringes from both domestic and international standards,we aim to provide valuable references for the development of a robust prefilled syringe standard system within the Chinese Pharmacopoeia.

Objective To formulate the 2025 edition of the Pharmacopoeia of the People's Republic of China of prefilled syringe silicone oil determination method,and to interpret the method content.Methods The prefilled syringe was added silicone solvent ethyl acetate to the roll edge of the sleeve and let it stand for extraction for 5 minutes,then put the silicon solvent in the evaporating dish dried at 105 ℃ to constant weight,then add 1mL ethyl acetate into the sleeve for rinsing and placing in the same evaporating dish,and then dry in a water bath at 105℃ to constant weight.The content of silicone oil in the sleeve of the prefilled syringe was calculated according to the quality difference.Results The reliability of the experimental method was verified by the ultimate extraction test,standard recovery test,and precision investigation.The results showed that the ultimate extraction could be achieved after 5 minutes of extraction with ethyl acetate.The recovery rate of the method was 100.0％-101.6％,and the precision was 3.5％.Conclusion The formulation of the determination method refers to the measurement method of silicone oil content in relevant standards at home and abroad,combined with the problems existing in the measurement of silicone oil content in daily tests,to further improve the operability of the detection method,the method is simple,efficient,feasible and reliable.

Permanent left superior vena cava aneurysm is a rare mediastinal venous lesion，the majority of the literature is in the form of case reports. In this article，a 50-year-old female with an incidental permanent left superior vena cava aneurysm discovered on echocardiography in Nanjing Gulou Hospital，and the right heart contrast-enhanced echocardiographic played an important role in the process of clear diagnosis. The patient was observed without intervention. No complications were attributable to the permanent left superior vena cava aneurysm during follow-up.

Life science and medical research involving human beings cannot be separated from the support of research participants.The safety,health,and rights and interests of research participants are the primary considerations in clinical research,and their rights and interests include the right of compensation,privacy protection,health and so on.Protecting the compensation rights of research participants is a necessary responsibility of the research-related departments and personnel.Based on laws and regulations and literature review,and combined with practical experience,this paper made an in-depth discussion on compensation rights.It puts forward the types of compensation(conventional compensation,research-related damage compensation),compensation principles(necessity,timeliness,appropriateness,fairness),compensation elements(method,amount,plan,consent,notification,and reference of compensation),compensation under special circumstances(compensation for participants without or with limited informed consent ability and withdraw from the study midway),protection measures of compensation right(sponsor/contract research organizations,research institutions,research management departments,(main)researchers and research teams,ethics(review)committee).The compensation rights should be implemented to protect research participants.

The seventh article of Measures for the Ethical Review of Biomedical Research Involving Humans (2016) stipulated that medical and health institutions without an ethics committee shall not carry out biomedical research involving Humans. The Opinions on Strengthening the Governance of Ethics in Science and Technology, issued in March 2022, clearly stated that the institutions that do not meet the conditions for establishing a scientific and technological ethics (review) committee should entrust other institutions to conduct the review. The fourteenth article of Measures for Ethical Review of Life Science and Medical Research Involving Humans (2023) proposes that if an institution, which carries out life science and medical research involving humans, has not established an ethics committee or its ethics committee is not competent for ethics review, it can entrust a competent ethics committee or regional ethics committee in writing to carry out ethical review. Most medical institutions at or above the second level in China have set up ethics committees. While most universities and colleges, scientific research institutions, enterprises and grass-roots medical and health institutions have not set up ethics committees, which lack a working system to protect the safety and interests of the participants, and is difficult to conduct life sciences and medical research involving humans. At present, there is a need for some research institutions that do not have the conditions to establish ethics committees to entrust their projects of life science and medical research involving humans to other institutions for ethical review. The entrusted review is still in the exploratory stage, and there is no relevant specification. The hasty implementation of entrusted review may not achieve the goal of effectively protecting the safety and interests of the participants, and even cause legal disputes. Based on the thematic discussion, with reference to the relevant laws and regulations, departmental rules, ethical standards, and the experience of the ethics committees of some domestic institutions in implementing the entrusted review, the guideline was formulated for the reference of the current entrusted review to ensure the safety and interests of the participants.

The passing of ethical review is a necessary conditions and prerequisite for the development of life science and medical research involving humans. At present, some medical and health institutions have no or insufficient ethical review capabilities. The lack of ethical review ability has become a bottleneck restricting the development of life science and medical research involving humans. According to documents such as Opinions on Deepening the Reform of the Review and Approval System and Encouraging the Innovation of Pharmaceutical and Medical Devices, Opinions on Strengthening the Ethical Governance of Science and Technology, institutions can entrust competent institutional ethics review committees or regional ethics review committees in writing to conduct ethical review. Entrustment ethical review provides a viable solution for institutions that need to carry out life science and medical research involving humans but do not have an ethics (review) committee or the ethics (review) committee is not competent to review. To conduct the entrustment ethical review, the entrustment between the principal and the trustee is required. According to The Measures for Ethical Review of Life Sciences and Medical Research Involving Humans, if medical and health institutions and their ethical review committees do not accept the formal entrustment to provide the ethical review opinions for other institutions, the local health authorities at or above the county level will impose administrative penalties and sanctions on the relevant institutions and personnel in accordance with the law. Signing the entrustment ethical review contract, implementing legal compliance entrusted ethical review to protect the rights and interests of the trustee and the principal, and protect the research participants.