1.Revision and Application of the General Rule for Particle Size Analysis by Light Scattering in the 2025 Edition of the Pharmacopoeia of the People's Republic of China
Hui WU ; Baoxi ZHANG ; Ping ZHENG ; Yongjian YANG ; Qiaoru XUE ; Yihong LU ; Xuefan CHEN ; Langui XIE ; Xia ZHAO
Herald of Medicine 2025;44(11):1773-1778
This article focused on the revision and application of General Rule 0982 Determination of Particle Size and Size Distribution by Light Scattering Method in the Chinese Pharmacopoeia(2025 edition).By referencing domestic and international technical requirements and considering practical applications,the structure and content of this general rule were analyzed,and specific revisions were proposed.Key recommendations included adding sections on method validation and results reporting to the current general rule,incorporating the appendix content into the main text,and revising/supplementing the method name,introduction,instrument requirements,and determination procedures.The revised light scattering method would strengthen China's capacity for pharmaceutical quality control.
2.Determination of the Particle Size of Medium and Long Chain Fat Emulsion Injection(C8~24Ve)by Laser Diffraction Method
Qiaoru XUE ; Hua CHEN ; Aiping OU ; Hui WU ; Langui XIE ; Feng DENG
Herald of Medicine 2025;44(11):1778-1783
Objective To establish a laser diffraction method for determining globule size distribution in medium and long chain fat emulsion injection(C8~24Ve).Methods The Mastersizer 3000 laser particle size analyzer and Hydro EV wet sampling device were used,with water as the dispersion medium.Critical parameters,including refractive index,absorption coefficient,obscuration,measurement duration,stirring speed,and sonication parameters,were systematically optimized.Comparative evaluations were conducted across different computational models(Mie vs.Fraunhofer theories)and instrument platforms.Results The optimized optical parameters for particle size distribution analysis of medium and long chain fat emulsion injection(C8~24Ve)were determined as follows:absorption rate 0.001,refractive index 1.52,measurement duration 10 s,stirring speed 1 200 r·min-1,with no sonication applied.Under these conditions,the method demonstrated satisfactory precision,repeatability,and robustness.Conclusions This method demonstrates operational simplicity,high accuracy,and excellent reproducibility,making it suitable for particle size distribution analysis of medium and long chain fat emulsion injection(C8~24Ve).The established protocol provides a valuable reference for the development of particle size determination methods for emulsion formulations.
3.Revision and Application of the General Rule for Particle Size Analysis by Light Scattering in the 2025 Edition of the Pharmacopoeia of the People's Republic of China
Hui WU ; Baoxi ZHANG ; Ping ZHENG ; Yongjian YANG ; Qiaoru XUE ; Yihong LU ; Xuefan CHEN ; Langui XIE ; Xia ZHAO
Herald of Medicine 2025;44(11):1773-1778
This article focused on the revision and application of General Rule 0982 Determination of Particle Size and Size Distribution by Light Scattering Method in the Chinese Pharmacopoeia(2025 edition).By referencing domestic and international technical requirements and considering practical applications,the structure and content of this general rule were analyzed,and specific revisions were proposed.Key recommendations included adding sections on method validation and results reporting to the current general rule,incorporating the appendix content into the main text,and revising/supplementing the method name,introduction,instrument requirements,and determination procedures.The revised light scattering method would strengthen China's capacity for pharmaceutical quality control.
4.Determination of the Particle Size of Medium and Long Chain Fat Emulsion Injection(C8~24Ve)by Laser Diffraction Method
Qiaoru XUE ; Hua CHEN ; Aiping OU ; Hui WU ; Langui XIE ; Feng DENG
Herald of Medicine 2025;44(11):1778-1783
Objective To establish a laser diffraction method for determining globule size distribution in medium and long chain fat emulsion injection(C8~24Ve).Methods The Mastersizer 3000 laser particle size analyzer and Hydro EV wet sampling device were used,with water as the dispersion medium.Critical parameters,including refractive index,absorption coefficient,obscuration,measurement duration,stirring speed,and sonication parameters,were systematically optimized.Comparative evaluations were conducted across different computational models(Mie vs.Fraunhofer theories)and instrument platforms.Results The optimized optical parameters for particle size distribution analysis of medium and long chain fat emulsion injection(C8~24Ve)were determined as follows:absorption rate 0.001,refractive index 1.52,measurement duration 10 s,stirring speed 1 200 r·min-1,with no sonication applied.Under these conditions,the method demonstrated satisfactory precision,repeatability,and robustness.Conclusions This method demonstrates operational simplicity,high accuracy,and excellent reproducibility,making it suitable for particle size distribution analysis of medium and long chain fat emulsion injection(C8~24Ve).The established protocol provides a valuable reference for the development of particle size determination methods for emulsion formulations.
5. Foodborne parasitic diseases in China: A scoping review on current situation, epidemiological trends, prevention and control
Langui SONG ; Qingxing XIE ; Zhiyue LV ; Qingxing XIE ; Zhiyue LV ; Qingxing XIE ; Zhiyue LV
Asian Pacific Journal of Tropical Medicine 2021;14(9):385-400
Objective: Foodborne parasitic diseases, although with a declining overall incidence rate, are still endangering local public safety. This review aims to describe the current situation and epidemiological trends of foodborne parasitic diseases in China in order to explore possible reasons contributors to its high prevalence in some areas, and propose strategies for prevention and control accordingly. Methods: A scoping review was conducted by searching PubMed, CNKI, Wanfang, CQVIP, Embase, and the Cochrane Library using search formula “foodborne parasitic diseases (or foodborne parasites)” AND “China”. Studies on foodborne parasitic diseases in China were considered, but only articles in English or Chinese published between January 1980 and June 2020 were retrieved. Included studies were screened according to the eligibility criteria: 1) diseases consistent with the WHO definition of foodborne parasitic diseases; 2) the food carriers were included in the WHO food classification; 3) data related to epidemiology, pathogenicity, and prevention and control; 4) Foodborne parasitic diseases cases or outbreaks in China. Results: A total of 111 out of 665 records were included and summarized. The prevalence of clonorchiasis, angiostrongyliasis, echinococcosis, trichinellosis and cysticercosis was still increasing although the infection rate of soil-transmitted nematodes has substantially decreased in recent years. Diverse eating habits, close contact with animals, and urbanization were contributing factors to the increase. Conclusions: Foodborne parasitic diseases remain an important public health issue in China with the progress of economic globalization and food diversification. We should manage to raise public awareness about the prevention and control of foodborne parasitic diseases, improve health and safety inspections, as well as public health practice.
6.Study of Simulation Application of Simulink Pharmacokinetic Compartment Model
Wei CHEN ; Yu WANG ; Xiaofei FEI ; Langui XIE ; Guohui LI
China Pharmacist 2015;(5):736-740
Objective:To dynamically describe the drug concentration change in different time in vivo to understand the in vivo be-havior patterns and rules of drugs, provide reference for performing individual treatment and avoiding adverse drug reactions and lay foundation for dynamic description of physiological pharmacokinetic model. Methods:A two-compartment model was established using Simulink dynamic simulation and used in curve fitting and parameter estimation. The results from the model were compared with those from 3P97 software. Results:There was no significant difference between the results from the dynamic model and those from 3P97 soft-ware. Conclusion:The dynamic model can be used to dynamically simulate two-compartment model for oral administration. The re-sults from the dynamic simulation are more direct, and can correct the fitting error in 3P97 software.

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