1.Overview of the amendments and revisions to the General Technical Requirements adopted by the Volume Ⅳ of the Chinese Pharmacopoeia 2025 Edition
ZHANG Jun ; NING Baoming ; WEI Shifeng ; SHEN Haoyu ; SHANG Yue ; ZHU Ran ; XU Xinyi ; CHEN Lei ; LIU Tingting ; MA Shuangcheng
Drug Standards of China 2025;26(1):034-044
		                        		
		                        			
		                        			To introduce the general thinking, guidelines, work objectives and elaboration process of the general technical requirements adopted by volume Ⅳ of the Chinese Pharmacopoeia 2025 Edition, and to summarize and figure out the main characteristics on dosage forms, physico-chemical testing, microbial and biological testing, reference standards and guidelines The newly revised general chapters of pharmacopoeia give full play to the normative and guiding role of the Chinese Pharmacopoeia standard, track the frontier dynamics of international drug regulatory science and the elaboration of monographs, expand the application of state-of-the-art technologies, and steadily promote the harmonization and unification with the ICH guidelines; further enhance the overall capacity of TCM quality control, actively implement the 3 R principles on animal experiments, and practice the concept of environmental-friendly; replace and/or reduce the use of toxic and hazardous reagents, strengthen the requirements of drug safety control This paper aims to provide a full-view perspective for the comprehensive, correct understanding and accurate implementation of general technical requirements included in the Chinese Pharmacopoeia 2025 Edition.
		                        		
		                        		
		                        		
		                        	
2.The experience on the construction of the cluster prevention and control system for COVID-19 infection in designated hospitals during the period of "Category B infectious disease treated as Category A"
Wanjie YANG ; Xianduo LIU ; Ximo WANG ; Weiguo XU ; Lei ZHANG ; Qiang FU ; Jiming YANG ; Jing QIAN ; Fuyu ZHANG ; Li TIAN ; Wenlong ZHANG ; Yu ZHANG ; Zheng CHEN ; Shifeng SHAO ; Xiang WANG ; Li GENG ; Yi REN ; Ying WANG ; Lixia SHI ; Zhen WAN ; Yi XIE ; Yuanyuan LIU ; Weili YU ; Jing HAN ; Li LIU ; Huan ZHU ; Zijiang YU ; Hongyang LIU ; Shimei WANG
Chinese Critical Care Medicine 2024;36(2):195-201
		                        		
		                        			
		                        			The COVID-19 epidemic has spread to the whole world for three years and has had a serious impact on human life, health and economic activities. China's epidemic prevention and control has gone through the following stages: emergency unconventional stage, emergency normalization stage, and the transitional stage from the emergency normalization to the "Category B infectious disease treated as Category B" normalization, and achieved a major and decisive victory. The designated hospitals for prevention and control of COVID-19 epidemic in Tianjin has successfully completed its tasks in all stages of epidemic prevention and control, and has accumulated valuable experience. This article summarizes the experience of constructing a hospital infection prevention and control system during the "Category B infectious disease treated as Category A" period in designated hospital. The experience is summarized as the "Cluster" hospital infection prevention and control system, namely "three rings" outside, middle and inside, "three districts" of green, orange and red, "three things" before, during and after the event, "two-day pre-purification" and "two-director system", and "one zone" management. In emergency situations, we adopt a simplified version of the cluster hospital infection prevention and control system. In emergency situations, a simplified version of the "Cluster" hospital infection prevention and control system can be adopted. This system has the following characteristics: firstly, the system emphasizes the characteristics of "cluster" and the overall management of key measures to avoid any shortcomings. The second, it emphasizes the transformation of infection control concepts to maximize the safety of medical services through infection control. The third, it emphasizes the optimization of the process. The prevention and control measures should be comprehensive and focused, while also preventing excessive use. The measures emphasize the use of the least resources to achieve the best infection control effect. The fourth, it emphasizes the quality control work of infection control, pays attention to the importance of the process, and advocates the concept of "system slimming, process fattening". Fifthly, it emphasizes that the future development depends on artificial intelligence, in order to improve the quality and efficiency of prevention and control to the greatest extent. Sixth, hospitals need to strengthen continuous training and retraining. We utilize diverse training methods, including artificial intelligence, to ensure that infection control policies and procedures are simple. We have established an evaluation and feedback mechanism to ensure that medical personnel are in an emergency state at all times.
		                        		
		                        		
		                        		
		                        	
3.Molecular traceability analysis of Plasmodium vivax from a cluster outbreak
LIU Yaobao ; XU Sui ; ZHU Guoding ; HU Xiangke ; ZHUANG Shifeng ; GAO Qi
China Tropical Medicine 2024;24(4):377-
		                        		
		                        			
		                        			Abstract:  Objective   To conduct genotyping and molecular tracing analysis on Plasmodium vivax samples from a cluster of P. vivax malaria outbreak in order to provide a reference for case geographical origin determination. Methods    Blood samples from 4 patients in a vivax malaria cluster in Longhui County, Hunan Province from June to July 2018 were collected for species identification by qPCR, and 9 microsatellite molecular markers were used to genotype the parasite strains from four samples. The population genetic STRUCTURE analysis was performed based on the VivaxGEN-MS microsatellite genotype database of P. vivax in the Asia Pacific Malaria Elimination Network, to determine the genetic subgroups and geographical origin of the strains. Results    By qPCR, all 4 cases were identified as Plasmodium vivax infection, and 9 microsatellite loci of the 4 cases were successfully typed, and the four samples had different genetic haplotypes, among which case 1, case 3, and case 4 were infected by a single clonal strain, and case 2 was infected by a polyclonal strain. When all P. vivax samples were divided into 2 subpopulations (K=2) by STURCTURE analysis, 4 Hunan samples were classified into tropical genetic subpopulations (comprising strains from Ethiopia, Iran, Bhutan, Malaysia, Indonesia, and southern China). When the samples were divided into 4 subgroups by STURCTURE analysis (K=4), the 4 Hunan samples were classified as South Asian/Southeast Asian genetic subgroups (originating from Bhutan, Malaysia, Indonesia, and southern China). Conclusions    The results of molecular tracing do not support that the 4 P. vivax strains in this outbreak originated from the population of central China. The technology of molecular tracing of P. vivax can provide objective evidence for determining the source of infection in malaria cases during the stage of malaria elimination and post-elimination.
		                        		
		                        		
		                        		
		                        	
4.Efficacy analysis of jejunal side anastomosis combined with jejunal nutrition tube in gastric cancer surgery
Shifeng JIA ; Jianquan ZHU ; Bin ZHENG ; Feng YAN
Clinical Medicine of China 2022;38(1):5-11
		                        		
		                        			
		                        			Objective:To investigate the adverse reactions and postoperative inflammatory reactions of Bill-Roth Ⅱ (BⅡ) gastroenterostomy with jejunal anastomosis and jejunal nutrient tube placement using linear cutting and closing device in gastric cancer surgery.Methods:A retrospective case-control study was conducted on 93 patients undergoing gastric cancer surgery in The Affiliated Hospital of North China University of Science and Technology from February 2017 to April 2020. According to 2016 (American Joint Committee on Cancer/Universal Integrated Circuit Card) AJCC/UICC, (Tumor, Node, stage; Tumor lymph node metastasis; Distant metastasis) TNM, there were 11 cases in stage ⅠA, 14 cases in stage ⅠB, 13 cases in stage ⅡA, 15 cases in stage ⅡB, 11 cases in stage ⅢA, 13 cases in stage ⅢB, and 16 cases in stage ⅢC. There were 51 cases of gastric antrum carcinoma, 26 cases of gastric body carcinoma and 16 cases of gastric pylorus carcinoma. There were 27 cases of papillary adenocarcinoma, 26 cases of tubular adenocarcinoma, 22 cases of mucinous adenocarcinoma, 9 cases of signet-ring cell carcinoma, 7 cases of adenosquamous carcinoma, and 2 cases of squamous carcinoma. The patients were divided into experimental group (48 cases) and control group (45 cases) according to whether or not the linear cutting and closing device was added and jejunal anastomosis was performed and jejunal nutrition tube was placed. The gender composition, age, lesion site, pathological type, pathological stage, postoperative hospital stay and postoperative complications were compared between the two groups, and the white blood cell count WBC, C-reactive protein CRP on the 7th day after surgery, erythrocyte Sedimentation rate (ESR), tumor necrosis factor-α (TNF-α), interleukin-6 (IL-6) inflammation indicators were compared between the two groups.Results:There was no significant difference in gender composition, age, lesion location, pathological type and pathological stage between the two groups (all P>0.05). The incidence of abdominal pain, abdominal distension, nausea, vomiting and pleural effusion in 93 patients were 18.3%(17/93), 21.5%(20/93), 23.7%(22/93), 17.2%(16/93) and 18.3%(17/93), respectively. The complication rates of the above indexes in the two groups were 10.4% (5/48) Compared with 26.7% (12/45), 12.5% (6/48) and 31.1% (14/45), 15.6%(7/48) and 33.3% (15/45), 8.3%(4/48) and 26.7% (12/45), 8.3% (4/48) and 28.9% (13/45) (χ 2 values were 4.11, 4.77, 4.52, 4.27 and 5.27, respectively; P values were 0.043, 0.029, 0.033, 0.039 and 0.022, respectively). There was no significant difference in lower extremity venous thrombosis, anastomotic bleeding, accumulated pneumonia and incision dehiscence between the two groups ( P>0.05). WBC on the 7th day after operation in the experimental group and the control group (7.02±1.83)×10 9/L and (8.39±2.27)×10 9/L ( t=3.22, P=0.002), TNF-α (2.44±0.70) μg/L and (3.56±1.14) μg/L ( t=5.71, P<0.001), IL-6 (235.31±41.72) μg/L and (365.91±73.16) μg/L ( t=10.66, P<0.001) there was significant difference between the two groups. There was no significant difference in CRP and ESR between the two groups on the 7th day after operation ( P>0.05). The postoperative hospital stay between the experimental group and the control group was (13.88±2.81) d and (22.78±2.51) d, the difference was statistically significant ( t=16.07, P<0.001). Conclusion:The application of side-to-side jejunostomy combined with jejunal nutrition tube for enteral nutrition in gastric cancer surgery can reduce the occurrence of adverse reactions such as postoperative abdominal pain, abdominal distension, accumulated pneumonia, nausea, vomiting and pleural effusion, reduce the postoperative hospital stay and reduce the postoperative inflammatory reaction to a certain extent.
		                        		
		                        		
		                        		
		                        	
5.Acute pancreatitis and epigenetic regulation mechanisms
Xianlin ZHAO ; Shifeng ZHU ; Hongxin KANG
Journal of Clinical Hepatology 2020;36(1):227-230
		                        		
		                        			
		                        			 Acute pancreatitis is a local pancreatic and systemic inflammatory disease due to various living and environmental factors, such as alcohol, gallstones, high lipids, and smoking, and its pathogenesis remains unclear. Studies have shown that epigenetic regulation mechanisms, such as DNA methylation, histone modification, and non-coding RNA, play an important role in the development and progression of acute pancreatitis. This article introduces the association between the common causes of acute pancreatitis (including alcohol, gallstones, high lipids, and smoking) and epigenetic regulation mechanisms, as well as the association between inflammatory response and epigenetic regulation mechanisms. The preliminary exploration of epigenetic regulation mechanisms in acute pancreatitis provides new thoughts for further understanding the development, progression, and treatment of acute pancreatitis. 
		                        		
		                        		
		                        		
		                        	
6.Effect of KN93 on delayed afterdepolarization and calcium ion in ventricular myocytes of rabbits with heart failure
Jun KE ; Yang LI ; Feng CHEN ; Chao ZHU ; Xiaoping WANG ; Bendun CHEN ; Shifeng LI ; Zheng GONG
Chinese Journal of Emergency Medicine 2018;27(10):1089-1094
		                        		
		                        			
		                        			Objective To observe the effect of KN93, a CaMK Ⅱ inhibitor, on delayed afterdepolarization (DAD) and calcium ion in ventricular myocytes of rabbits with heart failure, and to investigate the effect of CaMK Ⅱ signaling pathway on trigged arrhythmia after heart failure. Methods Thirty male New Zealand White rabbits were randomized(random number) into the sham operated group (sham group), heart failure group (HF group) and heart failure with KN93 group (HF+KN93 group) (n=10 each group). The rabbit heart failure model was established by abdominal aortic constriction combined with aortic valve regurgitation. The ventricular myocytes were isolated by double enzyme digestion. The action potential and the transient inward current (Iti) were recorded by the whole-cell patch-clamp. The intracellular calcium transient was measured by the ion concentration measurement system. The main calcium transporter protein was detected by Western blotting. Data were analyzed by pCLAMP10.2. Statistical analysis was performed using SPSS 17.0. Comparisons among groups were conducted using ANOVA, and SNK-q multiple comparison procedure was utilized for post-hoc analysis.Results (1) After induction of heart failure, DAD and increment of trigger activity (TA) were observedin rabbit ventricular myocytes. Treatment of KN93 with 1.0 μmol/L reduced the events of DAD and TA.(2) After induction of heart failure, Iti densities were increased from -0.12±0.02 pA/pF to -0.95±0.06pA/pF at the polarization potential of -50 mV (n=10, P<0.01). The current densities were reduced to -0.44±0.04 pA/pF after application of 1.0 μmol/L of KN93 (n=10, P<0.01). (3) KN93 led to decrementof intracellular calcium ion concentration and calcium transient amplitude, and acceleration of the decayprocess of calcium transient. (4) KN93 upregulated the expression of pPLN and SERCA2a, increased the uptake of intracellular calcium ion, downregulated the expression of NCX, decreased the Iti, and reduced the occurrence of DAD and TA. Conclusions KN93 can reduce the intracellular calcium ion concentration of the heart failure animal model, and the occurrence of the DAD and TA. CaMK Ⅱ may be a new therapeutic target for arrhythmias in the heart failure.
		                        		
		                        		
		                        		
		                        	
7.Identification, sequence analysis, and infectivity of H9N2 avian influenza viruses isolated from geese
Rui ZHU ; Xueqin YANG ; Jianjun ZHANG ; Danwen XU ; Jiawen FAN ; Huoying SHI ; Shifeng WANG ; Xiufan LIU
Journal of Veterinary Science 2018;19(3):406-415
		                        		
		                        			
		                        			The subtype H9N2 avian influenza virus greatly threatens the Chinese poultry industry, even with annual vaccination. Waterfowl can be asymptomatically infected with the H9N2 virus. In this study, three H9N2 virus strains, designated A/Goose/Jiangsu/YZ527/2011 (H9N2, Gs/JS/YZ527/11), A/Goose/Jiangsu/SQ119/2012 (H9N2, Gs/JS/SQ119/12), and A/Goose/Jiangsu/JD564/2012 (H9N2, Gs/JS/JD564/12), were isolated from domestic geese. Molecular characterization of the three isolates showed that the Gs/JS/YZ527/11 virus is a double-reassortant virus, combining genes of A/Quail/Hong Kong/G1/97 (H9N2, G1/97)-like and A/Chicken/Shanghai/F/98 (H9N2, F/98)-like; the Gs/JS/SQ119/12 virus is a triple-reassortant virus combining genes of G1/97-like, F/98-like, and A/Duck/Shantou/163/2004 (H9N2, ST/163/04)-like. The sequences of Gs/JS/JD564/12 share high homology with those of the F/98 virus, except for the neuraminidase gene, whereas the internal genes of Gs/JS/YZ527/11 and Gs/JS/SQ119/12 are closely related to those of the H7N9 viruses. An infectivity analysis of the three isolates showed that Gs/JS/SQ119/12 and Gs/JS/YZ527/11 replicated well, with seroconversion, in geese and chickens, the Gs/JS/JD564/12 did not infect well in geese or chickens, and the F/98 virus only infected chickens, with seroconversion. Emergence of these new reassortant H9N2 avian influenza viruses indicates that these viruses can infect both chicken and goose and can produce different types of lesions in each species.
		                        		
		                        		
		                        		
		                        			Animals
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		                        			Asian Continental Ancestry Group
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		                        			Chickens
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		                        			Geese
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		                        			Humans
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		                        			Influenza A Virus, H7N9 Subtype
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		                        			Influenza A Virus, H9N2 Subtype
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		                        			Influenza in Birds
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		                        			Neuraminidase
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		                        			Population Characteristics
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		                        			Poultry
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		                        			Sequence Analysis
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		                        			Seroconversion
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		                        			Vaccination
		                        			
		                        		
		                        	
8.The effect of allicin on the ventricular myocytes of rabbit with heart failure
Jun KE ; Yang LI ; Feng CHEN ; Chao ZHU ; Xiaoping WANG ; Bendun CHEN ; Shifeng LI ; Zheng GONG
Chinese Journal of Emergency Medicine 2018;27(7):729-734
		                        		
		                        			
		                        			Objective To observe the effect of allicin on the action potential duration (APD) and L-type calcium current (ICa,L) in the ventricular myocytes of rabbits with heart failure in order to explore the mechanisms of therapeutic effect of allicin on cardiac arrhythmias complicated with heart failure.Methods Forty-five New Zealand White male rabbits were randomly (random number) assigned to 3 groups (n=15 in each group):sham operated group (sham group),heart failure group (HF group),and heart failure treated with allicin group (HF+All group).The rabbit heart failure model was established by abdominal aortic constriction coupled with aortic regurgitation,the ventricular myocytes were obtained by enzyme double digestion,and the whole cell clamp was used to record action potential and calcium current.The action potential duration (APD),Ica,L and gating mechanism were observed during heart failure and allicin administered.Data were processed with pCLAMP version 10.2.Statistical analysis was performed using SPSS 17.0.Comparisons among groups were carried out using ANOVA,and SNK-q was used for multiple comparison as post-hoe.Results (1) Prolonged APD was found during heart failure,APD50 was prolonged from (93.4±4.7) ms in sham group to (115.5±6.2) ms in HF group(P<0.01).After administration of allicin 30 μmol/L,APD50 was shortened to (105.2±5.5) ms (P<0.05).(2) The density of ICa.L increased during heart failure,peak current density increased increased from (-8.4±0.6) pA/pF in sham group to (-15.1± 1.1) pA/pF while 0 mV attained at depolarizations (P<0.01).After administration of allicin 30 μmol/L,the current density reduced to (-10.1+0.8) pA/pF (P<0.01).The effect of allicin presented in both voltage dependent and consentration dependent manner.(3) According to the gating mechanism study,the main mechanism of lowering the density of ICa,L by allicin after heart failure was the acceleration of the steady inactivation of the channel,and the de-escalation of the recovery kinetic after the inactivation of the channel.Conclusions Allcin can be used to reduce the calcium current of ventricular myocytes in animal heart failure model,it has the potential of clinical use in treating cardiac arrhythmias during heart failure.
		                        		
		                        		
		                        		
		                        	
9.Establishment and evaluation of the VX2 orthotopic lung cancer rabbit model: a ultra-minimal invasive percutaneous puncture inoculation method.
Lijuan WANG ; Keke CHE ; Zhonghong LIU ; Xianlong HUANG ; Shifeng XIANG ; Fei ZHU ; Yu YU
The Korean Journal of Physiology and Pharmacology 2018;22(3):291-300
		                        		
		                        			
		                        			The purpose of the present work is to establish an ultra-minimal invasive percutaneous puncture inoculation method for a VX2 orthotopic lung cancer rabbit model with fewer technical difficulties, lower mortality of rabbits, a higher success rate and a shorter operation time, to evaluate the growth, metastasis and apoptosis of tumor by CT scans, necropsy, histological examination, flow cytometry and immunohistochemistry. The average inoculation time was 10–15 min per rabbit. The tumor-bearing rate was 100%. More than 90% of the tumor-bearing rabbits showed local solitary tumor with 2–10 mm diameters after two weeks post-inoculation, and the rate of chest seeding was only 8.3% (2/24). The tumors diameters increased to 4–16 mm, and irregularly short thorns were observed 3 weeks after inoculation. Five weeks post-inoculation, the liquefaction necrosis and a cavity developed, and the size of tumor grew further. Before natural death, the CT images showed that the tumors spread to the chest. The flow cytometry and immunohistochemistry indicated that there was less apoptosis in VX2 orthotopic lung cancer rabbit model compared to chemotherapy drug treatment group. Minimal invasive percutaneous puncture inoculation is an easy, fast and accurate method to establish the VX2 orthotopic lung cancer rabbit model, an ideal in situ tumor model similar to human malignant tumor growth.
		                        		
		                        		
		                        		
		                        			Apoptosis
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		                        			Drug Therapy
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		                        			Flow Cytometry
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		                        			Humans
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		                        			Immunohistochemistry
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		                        			Lung Neoplasms*
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		                        			Lung*
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		                        			Methods*
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		                        			Mortality
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		                        			Necrosis
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		                        			Neoplasm Metastasis
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		                        			Punctures*
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		                        			Rabbits
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		                        			Thorax
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		                        			Tomography, X-Ray Computed
		                        			
		                        		
		                        	
10.Progress on chemokines participating in Alzheimer′s disease
Piao LUO ; Shifeng CHU ; Tianbi ZHU ; Naihong CHEN
Chinese Pharmacological Bulletin 2017;33(8):1051-1055
		                        		
		                        			
		                        			Chemokines play pleiotropic roles in the pathology of Alzheimer′s disease(AD),a chronic inflammatory disease of central nervous system.The neuropathological features of AD include neurofibrillary tangles,amyloid plaques,neuroinflammation,and neuronal synaptic loss.Chemokines are involved in the pathogenesis of AD by activating or regulating inflammatory cells or glial cells,playing dual key roles of the pro-and anti-inflammatory properties in AD.The levels of chemokines in serum,cerebrospinal fluid and brain tissue of AD patients are changed accordingly.This review summarizes the role of chemokines and their receptors in AD in the biological activities and unveils the changing rules,aiming to provide new strategies for clinical treatment of AD.
		                        		
		                        		
		                        		
		                        	
            
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