1.Formulation and Interpretation of the Measuring Method of Silicone Oil in Prefilled Syringe
Changshuai ZHAO ; Xueting LIU ; Aijuan LIU ; Xiaoyi MENG ; Yong SHEN ; Lei CHEN
Herald of Medicine 2025;44(7):1070-1073
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.
2.Interpretation of the Standard for Plastic Bottle Systems and Components for Eye Drops in the 2025 Edition of the Pharmacopoeia of the People's Republic of China
Yong SHEN ; Xiaowen BO ; Xueting LIU ; Changshuai ZHAO ; Xin WANG ; Lei CHEN
Herald of Medicine 2025;44(7):1040-1044
To provide an in-depth interpretation of the background and rationale behind the development of the standard for plastic bottle systems and components for eye drops as outlined in the 2025 edition of the Pharmacopoeia of the People's Republic of China(referred as the Chinese Pharmacopoeia),to facilitate stakeholders thorough understanding of the standard content,and to offer a strong support for its subsequent smooth implementation.Starting from the background of standard construction,an in-depth exploration was conducted into the quality control requirements for plastic bottle systems and components used for eye drops,and a detailed analysis was provided of the logic and rationale behind the establishment of quality control items.Related parties should develop product quality standards based on the general requirements of the guidelines for plastic materials and containers used in pharmaceutical packaging,taking into account the specific characteristics and practical application scenarios of plastic bottle systems and components for eye drops.The standard for plastic bottle systems and components for eye drops in the 2025 edition of the Chinese Pharmacopoeia are more scientific and flexible,which will help improve the quality of eye drop products in our country while also promoting innovation and development in the eye drop packaging industry.
3.Formulation and Interpretation of the Measuring Method of Silicone Oil in Prefilled Syringe
Changshuai ZHAO ; Xueting LIU ; Aijuan LIU ; Xiaoyi MENG ; Yong SHEN ; Lei CHEN
Herald of Medicine 2025;44(7):1070-1073
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.
4.Interpretation of the Standard for Plastic Bottle Systems and Components for Eye Drops in the 2025 Edition of the Pharmacopoeia of the People's Republic of China
Yong SHEN ; Xiaowen BO ; Xueting LIU ; Changshuai ZHAO ; Xin WANG ; Lei CHEN
Herald of Medicine 2025;44(7):1040-1044
To provide an in-depth interpretation of the background and rationale behind the development of the standard for plastic bottle systems and components for eye drops as outlined in the 2025 edition of the Pharmacopoeia of the People's Republic of China(referred as the Chinese Pharmacopoeia),to facilitate stakeholders thorough understanding of the standard content,and to offer a strong support for its subsequent smooth implementation.Starting from the background of standard construction,an in-depth exploration was conducted into the quality control requirements for plastic bottle systems and components used for eye drops,and a detailed analysis was provided of the logic and rationale behind the establishment of quality control items.Related parties should develop product quality standards based on the general requirements of the guidelines for plastic materials and containers used in pharmaceutical packaging,taking into account the specific characteristics and practical application scenarios of plastic bottle systems and components for eye drops.The standard for plastic bottle systems and components for eye drops in the 2025 edition of the Chinese Pharmacopoeia are more scientific and flexible,which will help improve the quality of eye drop products in our country while also promoting innovation and development in the eye drop packaging industry.
5.Effects of exercise therapy on cancer prevention and related molecular mechanisms
Yu JIANG ; Tiecheng JI ; Changshuai WANG ; Bing LIANG ; Shun YANG ; Lijing ZHAO
Chinese Journal of Immunology 2024;40(1):208-212,219
Approximately 25%of cancers worldwide are related to obesity and sedentary lifestyle.Changing behavior(exer-cise)may be a cost-effective means of prevention and treatment.Studies have found that exercise plays an important role in reducing cancer risk,inhibiting tumor growth,improving cancer-related quality of life,and improving the effectiveness of treatment.However,this protection mechanism is largely unclear.Clarifying the mechanism of action is essential to fully exploit the potential of exercise therapy,this article reviews the possible mechanisms for exercise to reduce the risk of cancer.
6.Preliminary study on quantification of rabbit central nervous system by DTI sequence
Chuanyu CUI ; Tianwei WANG ; Jie LEI ; Jingbo WU ; Yanhua CHENG ; Yuchong WANG ; Ming YAO ; Changshuai GENG ; Rui ZHAO
Journal of Practical Radiology 2018;34(3):456-458,469
Objective To explore the feasibility and application in quantifying the rabbit central nervous system by using magnetic resonance diffusion tensor imaging(DTI)sequences.Methods 12 normal New Zealand rabbits were used to scan the brain and spinal cord of rabbits by DTI sequence of 1.5T MR machine,and the normal apparent diffusion coefficient(ADC)and fractional anisotropy (FA)values were obtained in the different regions of the brain and every spinal segment of rabbits,to analyse the characteristics and regularity of numerical changes.Results The average ADC value in the brain of rabbits was (0.87±0.08)×10-3mm2/s,the average FA value was 0.23±0.09;the average ADC value in cervical spinal cord was (1.05±0.14)×10-3mm2/s,the average FA value was 0.55±0.08.The average ADC value in thoracic spinal cord was (1.14±0.12)×10-3mm2/s,and the average FA value was 0.57±0.06;the average ADC value in lumber spinal cord was (1.20±0.12)×10-3mm2/s,and the average FA value was 0.61±0.06.Conclusion FA average value in the brain is lower than that in spinal cord (P<0.001),the difference is related to the distribution of nerve fibers and physiological curvature of spine.ADC average value in the brain is lower than that in spinal cord(P<0.001),this is related to the volume of spinal canal and the peripheral structure of spinal cord.The difference of FA value in the brain and spinal cord is higher than ADC value.
7.Gender differences of brain metabolic networks: a 18F-FDG PET study
Lei FANG ; Jianping AN ; Junfeng MAO ; Xuejiao CHEN ; Yuanwei XIE ; Hui ZHAO ; Wansheng LIANG ; Changshuai YAO
Chinese Journal of Nuclear Medicine and Molecular Imaging 2017;37(9):544-549
Objective To investigate the gender differences of glucose metabolic network in brains of healthy adults at resting state by 18F-FDG PET.Methods A total of 204 dextromanual,healthy individuals (104 males,average age:(53.45±11.51) years;100 females,average age:(54.11±12.09) years) were enrolled from June 2011 to June 2016 to construct brain metabolic networks.The nodal and global parameters,including clustering coefficient (Cp),characteristic path length (Lp) and betweenness centrality (Cb),were analyzed by graph theory.Permutation test with 1 000 repetitions was used.Results The brain metabolic networks derived from 18F-FDG PET data were with small-world properties in both male group and female group.Compared with Cb in females,Cb in males was significantly reduced in left postcentral gyrus,right angular gyrus and left temporal pole/middle temporal gyrus (permutation test,all P<0.05);and it was increased in left amygdala,left precuneus,right temporal pole/middle temporal gyrus and left inferior temporal gyrus (permutation test,all P<0.05).Comparing with the females,the male group had higher Cp and longer absolute Lp but without significant difference (permutation test,all P>0.05).Conclusions There are gender-related differences of topological structure in whole-brain metabolic networks.Gender should be considered as a covariate while designing experiments,accounting for cerebral metabolic data from normal control and experimental patients as well as making clinical decisions.

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