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.Effectiveness of the integrated schistosomiasis control programme in Sichuan Province from 2015 to 2023
Chen PU ; Yu ZHANG ; Jiajia WAN ; Nannan WANG ; Jingye SHANG ; Liang XU ; Ling CHEN ; Lin CHEN ; Zisong WU ; Bo ZHONG ; Yang LIU
Chinese Journal of Schistosomiasis Control 2025;37(3):284-288
Objective To investigate the effectiveness of the integrated schistosomiasis control programme in Sichuan Province during the stage moving from transmission interruption to elimination (2015—2023), so as to provide insights into formulation of the schistosomiasis control measures during the post-elimination stage. Methods Schistosomiasis control data were retrospectively collected from departments of health, agriculture and rural affairs, forestry and grassland, water resources, and natural resources in Sichuan Province from 2015 to 2023, and a database was created to document examinations and treatments of human and livestock schistosomiasis, and snail survey and control, conversion of paddy fields to dry fields, ditch hardening, rivers and lakes management and building of forests for snail control and schistosomiasis prevention. The completion of schistosomiasis control measures was investigated, and the effectiveness was evaluated. Results A total of 20 545 155 person-times received human schistosomiasis examinations in Sichuan Province during the period from 2015 to 2023, and 232 157 person-times were seropositive, with a reduction in the seroprevalence from 2.10% (44 299/2 107 003) in 2015 to 1.12% (9 361/837 896) in 2023 (χ2 = 7.68, P < 0.001). The seroprevalence of human schistosomiasis appeared a tendency towards a decline in Sichuan Province over years from 2015 to 2023 (b = −8.375, t = −10.052, P < 0.001); however, no egg positive individuals were identified during the period from 2018 to 2023, with the prevalence of human Schistosoma japonicum infections maintained at 0. Expanded chemotherapy was administered to 2 754 515 person-times, and medical assistance of advanced schistosomiasis was given to 6 436 persontimes, with the treatment coverage increasing from 46.80% (827/1 767) in 2015 to 64.87% (868/1 338) in 2023. Parasitological tests for livestock schistosomiasis were performed in 35 113 herd-times, and expanded chemotherapy was administered to 513 043 herd-times, while the number of fenced livestock decreased from 121 631 in 2015 to 103 489 in 2023, with a reduction of 14.92%. Snail survey covered 433 621.80 hm2 in Sichuan Province from 2015 to 2023, with 204 602.81 hm2 treated by chemical control and 4 637.74 hm2 by environmental modifications. The area of snail habitats decreased from the peak of 5 029.80 hm2 in 2016 to 3 709.72 hm2 in 2023, and the actual area of snail habitats decreased from the peak of 8 585.48 hm2 in 2016 to 473.09 hm2 in 2023. The mean density of living snails remained low across the study period except in 2017 (0.62 snails/0.1 m2). Schistosomiasis control efforts by departments of agriculture and rural affairs in Sichuan Province included conversion of paddy fields to dry fields covering 153 346.93 hm2, hardening of 6 110.31 km ditches, building of 70 356 biogas digesters, replacement of cattle with 227 161 sets of machines, and captive breeding of 21 161 070 livestock from 2015 to 2023, and the control efforts by departments of water resources included rivers and lakes management measuring 5 676.92 km and renovation of 2 331 irrigation areas, while the control efforts by departments of forestry and grassland included building of forests for snail control and schistosomiasis prevention covering 23 913.33 hm2, renovation of snail control forests covering 8 720 hm2 and newly building of shelterbelts covering 764 686.67 hm2. All 63 endemic counties (cities and districts) had achieved the criterion for schistosomiasis elimination criteria in Sichuan Province by the end of 2023. Conclusion Following the integrated control efforts from 2015 to 2023, remarkable achievements have been obtained in the schistosomiasis control programme in Sichuan Province, with all endemic counties successfully attaining the schistosomiasis elimination target at the county level.
3.Establishment and verification of a detection method for the cytotoxic activity of human cascade-primed immune cell injection against non-small cell lung cancer
ZHOU Qiao1 ; LI Meiling1 ; CHEN Zhigang2 ; WANG Zhuang1 ; SHANG Sunyulin1 ; XU Qiuling1 ; ZHU Yanping1 ; ZHANG Yili1
Chinese Journal of Cancer Biotherapy 2025;31(8):862-869
[摘 要] 目的:构建绿色荧光蛋白(GFP)/萤光素酶(Luc)双荧光标记的肿瘤细胞株,建立人链式激活免疫细胞制剂对非小细胞肺癌细胞杀伤活性的检测方法,并进行初步验证。方法: 通过HLA高分辨分型筛选出HLA-A、HLA-B、HLA-C基因型别为纯合子且相应等位基因的分布频率高于2.500%的非小细胞肺癌细胞系作为细胞模型,采用携带有GFP和Luc基因的重组慢病毒感染原始细胞株而获得GFP、Luc稳定表达的细胞系作为靶细胞。通过效应细胞与靶细胞共培养,并优化靶细胞前处理步骤、共培养时间、效靶比等参数,建立人链式激活免疫细胞制剂对非小细胞肺癌杀伤活性的检测方法,并进行专属性、精密度验证。结果:通过HLA高分辨分型,成功筛选出高频等位基因HLA‑A*11:01:01(20.893%)、HLA‑B*52:01:01(2.991%)、HLA‑C*12:02:02(3.139%)的非小细胞肺癌(HCC827)细胞株作为细胞模型。通过慢病毒载体成功构建GFP/Luc双荧光标记的HCC827细胞株,GFP阳性率达 96%。重组慢病毒滴度为1.83 × 10⁷ TU/mL。效靶比为5∶1、10∶1、15∶1、20∶1时,各组间杀伤活性差异显著(P < 0.05),且杀伤活性随培养时间延长显著升高(P <0.000 1)。经综合评估后确认最优参数效靶比为10∶1,共培养时间为72 h。方法学验证表明,建立的方法专属性强;重复性变异系数为0.80%~1.86%;精密度变异系数为1.00%~1.58%,方差分析显示差异无统计学意义(P > 0.05),说明方法重复性良好。结论: 成功建立了人链式激活免疫细胞制剂对非小细胞肺癌杀伤活性的检测方法并验证成功,该方法有助于人链式激活免疫细胞制剂在细胞免疫治疗有效性评价中发挥重要作用。
4.Epidemiological and clinical characteristics of respiratory syncytial virus infections in children in Jiangsu Province, 2014-2023
Wenxin GU ; Ke XU ; Shenjiao WANG ; Fei DENG ; Qigang DAI ; Xin ZOU ; Qingxiang SHANG ; Liling CHEN ; Yu XIA ; Wenjun DAI ; Jie ZHA ; Songning DING ; Min HE ; Changjun BAO
Chinese Journal of Epidemiology 2024;45(11):1537-1543
Objective:To analyze the epidemiological and clinical characteristics of respiratory syncytial virus (RSV) infection in children in Jiangsu Province from 2014 to 2023.Methods:The acute respiratory infection cases in children aged 0-14 years were selected from outpatient/emergency or inpatient departments in 2 surveillance sentinel hospitals, respectively, in Nanjing, Suzhou and Taizhou of Jiangsu from 1 July 2014 to 31 December 2023, and RSV nucleic acid test was conducted and the intensity of the RSV infection was accessed by WHO influenza epidemiological threshold method, and case information and clinical data were collected. χ2 test was used to compare the differences between groups, and the Bonferroni method was used for pairwise comparisons between groups. Results:In 4 946 cases of acute respiratory infections, the RSV positive rate was 8.21% (406/4 946), and the age M( Q1, Q3) of the cases was 1 (0, 3) years. The RSV positive rate was 10.92% (258/2 362) during 2014-2019 and 6.06% (118/1 948) during 2019-2023, the difference was significant ( χ2=31.74, P<0.001). RSV infection mainly occurred from October to March during 2014-2019, with the incidence peak in December and moderate or higher intensity. The seasonality of RSV infection was not obvious during 2019-2023, with low intensity. The RSV positive rate was highest in children in age group 0- years (17.85%, 151/846), and the positive rate declined gradually with age ( χ2=184.51, P<0.001). The RSV positive rate was higher in inpatient cases (9.84%, 244/2 480) than in outpatient/emergency cases (6.57%, 162/2 466) ( χ2=17.54, P<0.001). In the 155 RSV infection cases with complete clinical data, the clinical symptoms mainly included cough (99.35%, 154/155), fever (55.48%, 86/155), and shortness of breath (45.16%, 70/155). In the cases aged <6 months, the proportion of those with fever was low, but the proportion of those with shortness of breath, transferred to intensive care units, and receiving oxygen therapy were higher (all P<0.05). Children aged <6 months and those with underlying diseases were more likely to have severe RSV infection (all P<0.05). Conclusions:RSV infection in children in Jiangsu Province showed seasonal prevalence in winter from 2014 to 2019. Since 2020, the seasonal characteristics of the epidemic have changed, the epidemic period has been dispersed and the epidemic intensity has decreased. Infants <1 year old were at high risk for RSV infection, and those <6 months old and with underlying diseases might have severe infection.
5.Deep neural networks analysis of 18F-FDG PET imaging in postoperative patients with temporal lobe epilepsy
Huanhua WU ; Shaobo CHEN ; Jingjie SHANG ; Hailing ZHOU ; Biao WU ; Jian GONG ; Xueying LING ; Qiang GUO ; Hao XU
Chinese Journal of Nuclear Medicine and Molecular Imaging 2024;44(4):220-224
Objective:To predict the short-term postoperative recurrence status of patients with refractory temporal lobe epilepsy (TLE) by analyzing preoperative 18F-FDG PET images and patients′ clinical characteristics based on deep residual neural network (ResNet). Methods:Retrospective analysis was conducted on preoperative 18F-FDG PET images and clinical data of 220 patients with refractory TLE (132 males and 88 females, age 23.0(20.0, 30.2) years)) in the First Affiliated Hospital of Jinan University between January 2014 and June 2020. ResNet was used to perform high-throughput feature extraction on preprocessed PET images and clinical features, and to perform a postoperative recurrence prediction task for differentiating patients with TLE. The predictive performance of ResNet model was evaluated by ROC curve analysis, and the AUC was compared with that of classical Cox proportional risk model using Delong test. Results:Based on PET images combined with clinical feature training, AUCs of the ResNet in predicting 12-, 24-, and 36-month postoperative recurrence were 0.895±0.073, 0.861±0.058 and 0.754±0.111, respectively, which were 0.717±0.093, 0.697±0.081 and 0.645±0.087 for Cox proportional hazards model respectively ( z values: -3.00, -2.98, -1.09, P values: 0.011, 0.018, 0.310). The ResNet showed best predictive effect for recurrence events within 12 months after surgery. Conclusion:The ResNet model is expected to be used in clinical practice for postoperative follow-up of patients with TLE, helping for risk stratification and individualized management of postoperative patients.
6.Differential component analysis between Fructus Tritici Levis and Triticum aestivum based on qualitative and quantitative methods
Xuejiao LI ; Yu HU ; Yun CHEN ; Juan SHANG ; Zhenyang LI ; Yunhua FENG ; Jiandong ZOU ; Weifeng YAO ; Su LU ; Meijuan XU
China Pharmacy 2024;35(11):1296-1302
OBJECTIVE To analyze the compositional differences between Fructus Tritici Levis and Triticum aestivum, and to provide reference for identification and quality control of both. METHODS Twenty batches of Fructus Tritici Levis and three batches of T. aestivum were collected, and their fingerprints were acquired by high-performance liquid chromatography and the similarities were evaluated by the Evaluation System of Similarity of Chromatographic Fingerprints of Traditional Chinese Medicine (2012 version). Cluster analysis (CA), principal component analysis (PCA) and orthogonal partial least squares-discriminant analysis (OPLS-DA) were performed to analyze the difference of Fructus Tritici Levis and T. aestivum from different regions, and the differential components were screened. The contents of the six identified components in Fructus Tritici Levis and T. aestivum were determined. RESULTS The similarities of the fingerprints of Fructus Tritici Levis ranged from 0.928 to 0.996, and the relative similarities of T. aestivum with Fructus Tritici Levis ranged from 0.761 to 0.773. A total of 19 common peaks were calibrated, and six components including linolenic acid, linoleic acid, 5-heptadecylresorcinol, 5-nonadodecylresorcinol, 5- heneicosylresorcinol, and 5-tricosylresorcinol were identified. The results of CA and PCA showed that Fructus Tritici Levis and T. aestivum could be clearly distinguished; the distribution of Fructus Tritici Levis from Anhui province was relatively concentrated. The results of OPLS-DA showed that linolenic acid, linoleic acid, and other six unknown compounds were the differential components between Fructus Tritici Levis and T. aestivum. The average contents of the six identified components in Fructus Tritici Levis were 0.100 9, 1.094 0, 0.005 1, 0.030 9, 0.098 2,and 0.024 8 mg/g, respectively; the contents of linolenic acid and linoleic acid in Fructus Tritici Levis were significantly higher than those in T. aestivum (P<0.05).CONCLUSIONS The established qualitative and quantitative methods are simple and reliable, and can be used for the identification and quality evaluation of Fructus Tritici Levis and T. aestivum. The identified differential components, such as linolenic acid and linoleic acid, can also provide clues for the differentiation and pharmacological study of Fructus Tritici Levis and T. aestivum.
7.Differential component analysis between Fructus Tritici Levis and Triticum aestivum based on qualitative and quantitative methods
Xuejiao LI ; Yu HU ; Yun CHEN ; Juan SHANG ; Zhenyang LI ; Yunhua FENG ; Jiandong ZOU ; Weifeng YAO ; Su LU ; Meijuan XU
China Pharmacy 2024;35(11):1296-1302
OBJECTIVE To analyze the compositional differences between Fructus Tritici Levis and Triticum aestivum, and to provide reference for identification and quality control of both. METHODS Twenty batches of Fructus Tritici Levis and three batches of T. aestivum were collected, and their fingerprints were acquired by high-performance liquid chromatography and the similarities were evaluated by the Evaluation System of Similarity of Chromatographic Fingerprints of Traditional Chinese Medicine (2012 version). Cluster analysis (CA), principal component analysis (PCA) and orthogonal partial least squares-discriminant analysis (OPLS-DA) were performed to analyze the difference of Fructus Tritici Levis and T. aestivum from different regions, and the differential components were screened. The contents of the six identified components in Fructus Tritici Levis and T. aestivum were determined. RESULTS The similarities of the fingerprints of Fructus Tritici Levis ranged from 0.928 to 0.996, and the relative similarities of T. aestivum with Fructus Tritici Levis ranged from 0.761 to 0.773. A total of 19 common peaks were calibrated, and six components including linolenic acid, linoleic acid, 5-heptadecylresorcinol, 5-nonadodecylresorcinol, 5- heneicosylresorcinol, and 5-tricosylresorcinol were identified. The results of CA and PCA showed that Fructus Tritici Levis and T. aestivum could be clearly distinguished; the distribution of Fructus Tritici Levis from Anhui province was relatively concentrated. The results of OPLS-DA showed that linolenic acid, linoleic acid, and other six unknown compounds were the differential components between Fructus Tritici Levis and T. aestivum. The average contents of the six identified components in Fructus Tritici Levis were 0.100 9, 1.094 0, 0.005 1, 0.030 9, 0.098 2,and 0.024 8 mg/g, respectively; the contents of linolenic acid and linoleic acid in Fructus Tritici Levis were significantly higher than those in T. aestivum (P<0.05).CONCLUSIONS The established qualitative and quantitative methods are simple and reliable, and can be used for the identification and quality evaluation of Fructus Tritici Levis and T. aestivum. The identified differential components, such as linolenic acid and linoleic acid, can also provide clues for the differentiation and pharmacological study of Fructus Tritici Levis and T. aestivum.
8.Effect of Portable Oto-endoscopy System in Clinical Teaching of Otorhinolaryngology
Bin WANG ; Wei LYU ; Zhiqiang GAO ; Hua YANG ; Keli CAO ; Guodong FENG ; Haiyan WU ; Yingying SHANG ; Xingming CHEN ; Jian WANG ; Xu TIAN ; Weiqing WANG
Medical Journal of Peking Union Medical College Hospital 2024;15(6):1475-1479
To explore the value of portable oto-endoscopy system in clinical teaching of otolaryngology residents. The postgraduate students serving as resident doctors in the Department of Otolaryngology of Peking Union Medical College Hospital from February to March 2022 and from February to March 2023 were selected as the research objects. Random number table method was used to divide them into experimental group and control group. The control group was first taught by theoretical explanation + electrooto-endoscopy system, and the experimental group was first taught by theoretical explanation + portable oto-endoscopy system. After one month, the two groups interchanged their teaching methodologies. The results of theoretical assessment, self-evaluation at the end of the first month of clinical learning and satisfaction with teaching effectiveness at the end of two months of clinical learning were compared between the two groups. A total of 36 residents were included in this study, with 18 in each group. After one month of clinical study, the theoretical test scores of the experimental group were significantly higher than those of the control group[(93.17±4.16) points The portable oto-endoscopy system can display the anatomy and diseases of otolaryngology more vividly and intuitively in the clinical teaching of otolaryngology, facilitate the management of clinical data, increase the learning interest of residents, fully mobilize the image thinking of medical students, and improve the post competence of residents more efficiently.
9.Digital and Intelligent Generalized Inspection in Traditional Chinese Medicine and Related Equipment Development from Evidence-based Perspective
Xiaowei ZHANG ; Xiaoyu ZHANG ; Chen ZHAO ; Mengqi PENG ; Xue XU ; Hongyuan LIN ; Wenhui WANG ; Hongcai SHANG
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(22):94-101
As the foremost among the four examinations in traditional Chinese medicine (TCM), inspection and related equipment research face challenges in landing and transformation due to variations in evidence quality, lack of standardization, insufficient algorithm transparency, and poor reliability and stability of decision-making. Against the backdrop of rapid development of emerging technologies such as big data, the internet of things, and artificial intelligence, coupled with macro policy support from the government, digital and intelligent generalized inspection in TCM has emerged, with the aim of utilizing digital technologies to overcome the limitations of naked-eye inspection and comprehensively perceive and analyze facial and bodily expressions. The research in this field intelligently correlates Zang-fu organ functions with health conditions and disease progression and establishes a technical system for digital and intelligent inspection, multi-dimensional and multimodal perception, fusion analysis, and decision-making. This system aims to enhance the accuracy of disease risk warning and diagnosis, bridging the gap between inspection equipment and assistance in clinical decision-making. From an evidence-based perspective, this paper systematically examines the research ideas of digital and intelligent inspection and the development of related equipment, deeply explores how to propose clinical practice-oriented key scientific issues, comprehensively acquire and co-apply multi-dimensional data, establish precise inspection models driven by digital intelligence, optimize standards to enhance equipment interoperability and reliability, construct post-effect evaluation mechanisms to promote improvement, and actively address potential risks such as the black box nature and information security in the application of intelligent technology. This paper not only demonstrates the tremendous potential of digital technologies in improving the accuracy and clinical application efficiency of inspection but also provides new perspectives and ideas for the modernization of inspection in TCM, paving the way for the application of inspection in the global medical and health field.
10.Design and implementation of medical alliance nursing collaborative management system based on block chain
Mei-Gui CHEN ; Xu XU ; Xiao-Ping ZHU ; Xiong CHEN ; Qiao-Mei SHANG
Chinese Medical Equipment Journal 2024;45(3):47-55
Objective To design a medical alliance nursing collaborative management system based on block chain to provide technical support for nursing collaborative management.Methods A medical alliance system was designed based on the five-layer technical architecture of consortium blockchain,which used Linux system for establishing a Fabric development environment and network configuration,smart contract and Java language software development kit for realizing user interface operation,Bootstrap and Jquery technologies for constructing the front-end Web interface,Spring Boot for constructing the back-end interface.There were five functional modules for consortium blockchain member management,business management,data storage and sharing,patient medical record management and platform supervision involved in the system,which were developed with the technologies of encryption algorithm,hash operation,smart contract,consensus mechanism and etc.Results The system developed contributed to improving the mechanism for quality nursing resource sinking and continuous nursing care,reconfiguring the point incentive mechanism,promoting the collaborative development of nursing symbiotic network and enabling multi-node interactions to form a synergistic synergy.Conclusion The system developed conforms to the development trend of integrated care service of medical alliance,enhances the core competitiveness of nursing care and provides references for formulating blockchain solutions applicable to medical alliance scenarios.[Chinese Medical Equipment Journal,2024,45(3):47-55]

Result Analysis
Print
Save
E-mail