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 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 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.

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 explore the effects of visual feedback training based on the mirror neuron theory in upper limb function reconstruction in stroke patients.Methods:From June 2017 to June 2018, totally 61 stroke patients hospitalized in the Rehabilitation Medical Center of the Second Hospital of Jiaxing were selected by convenient sampling and divided into the observation group ( n=31) and the control group ( n=30) according to the random number table. Patients in both groups received routine rehabilitation therapy, while patients in the observation group underwent visual feedback training on this basis. They were evaluated using Barthel Index , Fugl-Meyer Assessment (FMA) (upper limb) , and the latency and amplitude of N9 and N20 were detected using somatosensory evoked potentials (SEP) before and 8 weeks after rehabilitation intervention. Results:After the intervention, the FMA score of the upper limbs in the observation group was (47.91±6.92) , higher than (40.31±7.87) in the control group, the Barthel Index of the observation group was (77.33±11.82) , higher than (66.79±12.31) in the control group, and the differences between the two groups were statistically significant ( P<0.01) . The SEP values of the upper limbs of the hemiplegia side in the observation group were better than those in the control group, and the differences between the two groups were statistically significant ( P<0.05) . Conclusions:The visual feedback training based on the mirror neuron theory can improve the upper limb motor function in stroke patients with early hemiplegia, improve their daily living activities, increase the N9 and N20 amplitudes of SEP, shorten their latency, and enhance the excitement of the upper limb movement related brain area in the mirror neuron system.

Objective To explore the impacts of leukoaraiosls (LA) on the short-term outcome of acute cerebral infarction. Methods 204 patients after acute cerebral infarction were reviewed from January 2012 to August 2014. They were divided into 4 groups according to the brain magnetic resonance imaging: cerebral infarction without LA (LA-0), and with LA (LA-1, LA-2 and LA-3). The Logistic regression analysis was applied with the short-term outcome of cerebral infarction as the dependent variable, and 16 possible factor as independent variables. Results There were 4 independent factors risk to the worse outcome of acute cerebral infarction, including LA, age, hypertension and cerebral infarction size (OR>1, P<0.05). Conclusion LA is an independent risk factors to the worse short-term outcome of acute cerebral infarction.

[Objective] To explore the anti-inflammatory effects of emodin and its therapeutic effect on acute lung injury. [Methods] By means of analyzing the relevant literatures in PUBMED,CNKI,CBM,Wanfang and Vip Da-tabase from 1998 to 2012,summarized the anti-inflammatory effects and mecha-nisms of emodin, as wel as its therapeutic effect on acute lung injury. [Results] A variety of studies have confirmed the anti-inflammatory effects of emodin, whose mechanism is related to emodin inhibiting the activation of NF-kappa B,modulaing various inflammatory factors, etc. In addition, the effect of emodin in the treatment of acute lung injury has been confirmed on celland animal levels. [Conclusion] Emodin has good prospect of clinical application.

OBJECTIVETo identify endophytic fungi bn12 from Cinnamomum camphora chvar, borneol and analysis its volatile metabolites.

METHODThe endophytic fungi bn12 was identified by morphological observation. volatile metabolites of endophytic fungi bn12 was analyzed by gas chromatography/mass spectrography (GC-MS).

RESULTVolatile metabolites of endophytic fungi bn12 contain borneol and much indoles. The ITS sequence of endophytic fungi bnl2 is most similar to the ITS sequence of pleosporaceae fungus, particularly C. nisikadoi.

CONCLUSIONEndophytic fungi bn12 is belong to pleosporaceae fungus. It has the ability of producing broneol.

Bornanes ; analysis ; Cinnamomum camphora ; microbiology ; DNA, Ribosomal Spacer ; genetics ; Endophytes ; genetics ; metabolism ; Fungi ; classification ; genetics ; metabolism ; Gas Chromatography-Mass Spectrometry ; Phylogeny ; Volatile Organic Compounds ; analysis