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.Associations of adipokine with diabetic retinopathy among patients with type 2 diabetes mellitus
SUN Xia ; DAN lingying ; ZHENG Peng ; CHEN Xinyi
Journal of Preventive Medicine 2025;37(3):248-252
Objective:
To examine the associations between three adipokines (omentin-1, nesfatin-1 and apelin) and diabetic retinopathy (DR) among patients with type 2 diabetes mellitus (T2DM), so as to provide the basis for the prevention and control of DR.
Methods:
The T2DM patients hospitalized in Lishui TCM Hospital from August 2021 to May 2023 were selected and divided into three groups: no diabetic retinopathy (NDR) group, non-proliferative diabetic retinopathy (NPDR) group, and proliferative diabetic retinopathy (PDR) group based on fundus fluorescein angiography. Data on gender, age, and course of T2DM were collected through questionnaires, and serum omentin-1, nesfatin-1, apelin, and related blood biochemical indicators were measured. The associations of omentin-1, nesfatin-1 and apelin with DR were analyzed using a multinomial logistic regression model.
Results:
A total of 150 T2DM patients were enrolled, including 58 cases in the NDR group, 60 cases in the NPDR group, and 32 cases in the PDR group, with males accounting for 60.34%, 45.00% and 68.75%, respectively. The mean ages were (54.79±14.40), (57.03±12.20) and (57.72±10.70) years, respectively. The median (interquartile range) courses of T2DM were 7.00 (7.75), 10.00 (8.00) and 10.00 (5.00) years, respectively. Compared with the NDR group, the NPDR group had lower levels of omentin-1 and nesfatin-1 and higher level of apelin, while the PDR group had higher level of omentin-1 and lower level of apelin (all P<0.05). Compared with the NPDR group, the PDR group had higher levels of omentin-1 and nesfatin-1 and lower level of apelin (all P<0.05). Multinomial logistic regression analysis showed that omentin-1 level was statistically associated with NPDR (OR=0.503, 95%CI: 0.291-0.871) and PDR (OR=7.862, 95%CI: 2.956-20.910); nesfatin-1 (OR=0.971, 95%CI: 0.953-0.989) and apelin (OR=3.266, 95%CI: 1.817-5.868) levels were statistically associated with NPDR.
Conclusion
Serum levels of omentin-1, nesfatin-1 and apelin were associated with different stages of DR among T2DM patients.
3.Pharmacodynamic Substances and Mechanisms of Da Chengqitang in Treating Stroke: A Review
Yizhi YAN ; Xinyi LIU ; Yang DUAN ; Miaoqing LONG ; Chaoya LI ; Qiang LI ; Yi'an CHEN ; Shasha YANG ; Yue ZHANG ; Peng ZENG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(9):297-306
Stroke is the main cause of death and disability among adults in China and is characterized by high incidence, disability, mortality, and recurrence rates. The combination of traditional Chinese and Western medicine has great potential in treating stroke and its sequelae. The classic traditional Chinese medicine prescription Da Chengqitang (DCQT) has a long history and proven efficacy in treating stroke. Clinically, DCQT is often used to treat stroke and its sequelae. However, the number and quality of clinical trials of DCQT in treating stroke need to be improved. Because of the insufficient basic research, the active ingredients and multi-target mechanism of action of DCQT remain unclear. Our research group has previously confirmed that DCQT can effectively reverse neurological damage, reduce iron deposition, and downregulate the levels of pro-inflammatory cytokines in the rat model of hemorrhagic stroke. The treatment mechanism is related to the nuclear factor erythroid 2-related factor 2 (Nrf2)-mediated signaling pathway and p38 mitogen-activated protein kinase (MAPK) signaling-mediated microglia activation. To clarify the pharmacodynamic basis and anti-stroke mechanism of DCQT, this article reviews the research progress in the treatment of stroke with DCQT in terms of clinical trials, pharmacodynamic material basis, safety evaluation, and mechanisms of absorbed components. This article summarizes 45 major phytochemical components of DCQT, 11 of which are currently confirmed absorbed components. Among them, emodin, rhein, chrysophanol, aloe-emodin, synephrine, hesperidin, naringin, magnolol, and honokiol can be used as quality markers (Q-markers) of DCQT. The mechanism of DCQT in treating stroke is complex, involving regulation of inflammatory responses, neuronal damage, oxidative stress, blood-brain barrier, brain-derived neurotrophic factor, and anti-platelet aggregation. This article helps to deeply understand the pharmacodynamic basis and mechanism of DCQT in treating stroke and provides a theoretical basis for the clinical application of DCQT in treating stroke and the development of stroke drugs.
4.Hemolytic disease of the fetus and newborn caused by Rh system anti-c antibodies: a case report and literature review
Luyan CHEN ; Dong XIANG ; Dingfeng LYU ; Zhenyun LIU ; Xinyi ZHU ; Shuan TAO ; Qiming YING ; Wei LIANG
Chinese Journal of Blood Transfusion 2025;38(6):843-848
Objective: To summarize the laboratory findings of a case of hemolytic disease of the fetus and newborn (HDFN) caused by Rh system anti-c antibodies and to review the literature, so as to explore the characteristics of anti-c HDFN. Methods: The ABO blood type, Rh blood type, direct antiglobulin test (DAT) results, and the presence of unexpected antibodies and their titers were determined by serological methods. The cases of anti-c HDFN in our laboratory in China and abroad were statistically analyzed, and the incidence of severe HDFN caused by anti-c, anti-D and anti-E was compared. Results: The blood type of the child was B (Rh CcDee) with a positive DAT. Anti-c antibody was detected in both serum and eluate, with a serum antibody titer of 4. The mother’s blood type was AB (Rh CCDee) with a negative DAT, and anti-c antibody was detected in the serum with a titer of 128. Among 20 cases of anti-c HDFN, 17 were DAT positive, and 9 (45%, 9/20) underwent blood transfusion or exchange transfusion. The incidence of severe HDFN was 47.60% (10/21) for anti-c, 47.60% (10/21) for anti-D and 31.30% (5/16) for anti-E. Conclusion: Maternal pregnancy and/or blood transfusion are the main reasons for the production of Rh alloantibodies such as anti-c. The prevention and management of anti-c should be similar to that of anti-D. Rh antigen-matched (five antigens of Rh blood group) transfusion is necessary for women of childbearing age to avoid antibody production, and Rh typing and antibody screening during prenatal examination is recommended to ensure early detection, intervention and treatment.
5.Analysis of notifiable infectious diseases in Zhejiang Province in 2024
DING Zheyuan ; YANG Yan ; FU Tianying ; LU Qinbao ; WANG Xinyi ; WU Haocheng ; LIU Kui ; LIN Junfen ; WU Chen
Journal of Preventive Medicine 2025;37(5):433-438,442
Objective:
To investigate the epidemic situation of notifiable infectious diseases in Zhejiang Province in 2024, so as to summarize the epidemic characteristics.
Methods:
Data of notifiable infectious diseases cases in Zhejiang Province from January 1 to December 31, 2024 were collected from the Infectious Disease Surveillance System of Chinese Disease Prevention and Control Information System. The epidemiological characteristics were analyzed according to the classification and transmission routes using the descriptive epidemiological method.
Results:
A total of 32 types of notifiable infectious diseases with 1 858 695 cases and 392 deaths were reported in Zhejiang Province in 2024, with a reported incidence of 2 804.73/105 and a reported mortality of 0.591 5/100 000. A total of 238 infectious disease public health emergencies were reported, of which 218 (91.60%) occurred in schools and kindergartens. There were 22 types of class A and B notifiable infectious diseases reported, with incidence of 470.62/100 000 and mortality of 0.591 5/100 000. Totally 10 types of class C notifiable infectious diseases, with a reported incidence of 2 334.11/105, and no deaths were reported. Classified by transmission route, respiratory infectious diseases had the highest reported incidence of 2 423.87/100 000, among which influenza exhibited the highest reported incidence of 2 024.22/100 000. The reported incidence of intestinal infectious diseases was 312.94/105, among which the incidence of other infectious diarrhea and hand-foot-mouth disease (HFMD) were high, with reported incidences of 169.52/100 000 and 136.18/100 000, respectively. Blood-borne and sexually transmitted infectious diseases accounted for the largest number of reported deaths, among which AIDS had the highest mortality of 0.424 0/100 000. Natural and insect-borne infectious diseases exhibited a low reported incidence of 1.37/105. The reported incidence of dengue fever was 0.40/100 000, and 95.08% of the cases were imported.
Conclusions
The reported incidence of respiratory and intestinal infectious diseases and the reported mortality of AIDS were high in Zhejiang Province in 2024. It is recommended to strengthen the prevention and control of infectious diseases such as influenza, other infectious diarrhea, and HMFD in schools and kindergartens.
6.Methodology for the Development of Clinical Practice Guidelines for Chinese Patent Medicine (Part 8): Quality Evaluation with AGREE Ⅱ and RIGHT
Fuqiang ZHANG ; Ziteng HU ; Yujing ZHANG ; Lijiao YAN ; Juyi WANG ; Cehan ZHANG ; Jiaqi CHEN ; Mengyi WANG ; Shuoming LIU ; Xinyi XIE ; Ning LIANG ; Nannan SHI ; Yanping WANG
Journal of Traditional Chinese Medicine 2024;65(2):185-191
ObjectiveTo evaluate the methodological and reporting quality of clinical practice guidelines for Chinese patent medicine (CPM) with internationally recognized tools the appraisal of guidelines for research and evaluation (AGEREE) Ⅱ and reporting items for practice guidelines in healthcare (RIGHT), thereby providing refe-rence for the clinical application and future development of CPM guidelines. MethodsDatabases including CNKI, VIP, Wanfang and Sinomed were searched for CPM guidelines, as well as medlive.cn, websites of China Association of Chinese Medicine and Chinese Medical Association, and reference lists of the included papers. The quality of the guidelines was evaluated using the AGREE Ⅱand RIGHT tools, and consistency tests were performed using Interclass Correlation Coefficient, and descriptive analysis and chi-square test were used to analyze the reporting rate for each domain and the average score for each item. ResultsFinally, 140 CPM guidelines were included, of which 51 were disease-oriented and 89 were drug-oriented, all of which were issued by China. For 51 disease-oriented CPM guidelines, the highest average score of all six AGREE Ⅱ domains was 73.32% for clarity, and the lowest was 26.80% for application; for 89 drug-oriented CPM guidelines, the highest average score was 55.62% for scope and purpose, and the lowest was 31.32% for rigour of development. In terms of the seven domains of the RIGHT checklist, the highest reporting rate was 68.26% for background, and lowest was 27.45% for other areas regarding the disease-oriented CPM guidelines; the highest reporting rate was 61.31% for background, and the lowest was 4.49% for other areas regarding drug-oriented CPM guidelines. The average reporting rate was higher for disease-oriented than drug-oriented CPM guidelines in three domains of AGREE Ⅱ (rigour of development, clarity of presentation, editorial independence), as well as four domains of RIGHT checklist (basic information, evidence, funding and declaration and management of interests, and other areas). ConclusionThe overall methodology and reporting quality of the current CPM guidelines still need to be improved. It is recommended that future guideline development teams should strictly refer to the AGREE Ⅱ and RIGHT checklist, and take into account of the characteristics of CPM guidelines and relevant methodo-logical suggestions in the development and reporting of CPM guidelines, thereby guiding the clinical use of CPM in a better way.
7.Electrospun nanofiber scaffolds for soft and hard tissue regeneration
Xinyi WANG ; Xianrui XIE ; Yujie CHEN ; Xiaoyu WANG ; Xiaoqing XU ; Yihong SHEN ; Xiumei MO
Chinese Journal of Tissue Engineering Research 2024;28(3):426-432
BACKGROUND:Currently,electrospun nanofibers,which are biomimetic materials of natural extracellular matrix and contain a three-dimensional network of interconnected pores,have been successfully used as scaffolds for various tissue regeneration,but are still faced with the challenge of extending the biomaterials into three-dimensional structures to reproduce the physiological,chemical as well as mechanical properties of the tissue microenvironment. OBJECTIVE:To summarize the process and principles of electrostatic spinning and to explore the applications of the resulting electrospun nanofibers in tissue regeneration of skin,blood vessels,nerves,bone,cartilage and tendons/ligaments. METHODS:With"electrospinning,electrospun nanofibers,electrospun nanofiber scaffolds,tissue regeneration"as the Chinese and English search terms,Google Academic Database,PubMed,and CNKI were searched,and finally 88 articles were included for review. RESULTS AND CONCLUSION:(1)The electrospun nanofibers are a natural fibrous extracellular matrix mimetic material and contain a three-dimensional network of interconnected pores that have been successfully used as scaffolds for a variety of tissue regeneration applications.(2)Several papers have described the great potential of electrospun nanofiber scaffolds applied to the regeneration of skin,blood vessels,nerves,bones,cartilage and tendons/ligaments,providing a solid theoretical basis for its final application in clinical disease treatment,or for its transformation into practical products to enter the market.(3)However,the current research results are mostly based on cell experimental research results in vitro,and whether it can be finally applied to human body still needs clinical verification.(4)At present,many kinds of electrospun products for various clinical needs have been commercialized in and outside China,indicating that the research field of electrospun nanofiber scaffolds for soft and hard tissue regeneration has great research value and application potential.
8.RAS-selective lethal small molecule 3 inhibits the fibrosis of pathological scar fibroblasts
Jiangyong SHEN ; Xi HE ; Yuting TANG ; Jianjun WANG ; Jinyi LIU ; Yuanyuan CHEN ; Xinyi WANG ; Tong LIU ; Haoyuan SUN
Chinese Journal of Tissue Engineering Research 2024;28(8):1168-1173
BACKGROUND:Abnormal extracellular matrix accumulation and excessive proliferation of fibroblasts are the main manifestations of pathological scars.Excessive proliferation of fibroblasts leads to the production of large amounts of collagen-based extracellular matrix.Therefore,to investigate the role of fibroblast fibrosis in the formation of pathological scar will provide a new idea for revealing the mechanism of pathological scar and biological therapy. OBJECTIVE:To investigate the effect of RAS-selective lethal small molecule 3(RSL3)on the fibrosis of human pathological scar fibroblasts. METHODS:Then cases of pathological scar tissue and normal skin tissue samples from the same individuals,provided by the Department of Burn Plastic Surgery,General Hospital of Ningxia Medical University,were collected.Fibroblasts of human pathological scar and human normal skin were extracted and used in the following experiments.The general condition of the pathological scar tissue and the normal skin tissue was detected by hematoxylin-eosin staining.The appearance of fibroblasts from pathological scar and normal skin were observed by inverted microscope.The fibroblasts were verified by immunofluorescence assay.The cells were treated with different concentrations of RSL3(1,3,5,7,9,11,13 μmol/L).The inhibitory concentration of RSL3 on fibroblasts was detected by cell counting kit-8.Control group(without treatment)and RSL3 intervention group(treated with 7 μmol/L RSL3 for 24 hours)were set up.The mRNA and protein expressions of glutathione peroxidase 4,type Ⅰ collagen,type Ⅲ collagen and α-smooth muscle actin were detected by Qrt-PCR and western blot,respectively.Level of malondialdehyde in cells was detected.The residual scratch area was measured by cell scratch test after 24 hours to calculate the percentage of residual scratch area. RESULTS AND CONCLUSION:The expression of glutathione peroxidase 4 in the pathological scar group was higher than that in the normal skin group(Mrna:t=3.252,P<0.01;protein:t=5.075,P<0.01).The expression of glutathione peroxidase 4 in the pathological scar fibroblast group was higher than that in the normal skin fibroblast group(Mrna:t=10.32,P<0.01;protein:t=26.22,P<0.01).Compared with the control group,the expression of glutathione peroxidase 4 was decreased(Mrna:t=2.798,P<0.05;protein:t=4.643,P<0.01),the content of malondialdehyde was increased(t=2.917,P<0.05),the expression of type Ⅰ collagen(Mrna:t=15.84,P<0.01;protein:t=4.610,P<0.01),type Ⅲ collagen(Mrna:t=28.86,P<0.01;protein:t=7.713,P<0.01)and α-smooth muscle actin(Mrna:t=2.671,P<0.05;protein:t=7.417,P<0.01)were decreased in the RSL3 intervention group.Compared with the control group,the migration ability was weakened in the RSL3 intervention group(t=14.06,P<0.01).To conclude,RSL3 can inhibit the expression of glutathione peroxidase 4 and then inhibit the ability of fibrosis and migration of pathological scar fibroblasts.
9.The hemostatic effect and its mechanism of modified Sijunzi Decoction on the zebrafish intestinal bleeding model through 5-hydroxytryptamine and its receptors
Jun WANG ; Haiyan LANG ; Jiali ZHOU ; Xueying ZHANG ; Yanhong KANG ; Yun ZHANG ; Xinyi CHEN ; Wei MA
Journal of Beijing University of Traditional Chinese Medicine 2024;47(4):516-522
Objective We aimed to investigate the hemostatic effect and mechanism of modified Sijunzi Decoction(MSJZT),consisting of tangshen,India bread,largehead atractylodes rhizome,liquorice root,milkvetch root,ass hide glue,and India madder root,on the zebrafish intestinal bleeding model through 5-hydroxytryptamine(5-HT)and its receptors(5-HT2aR,5-HT2bR).Methods Zebrafish at 4 days post fertilization were used as the research object.An intestinal bleeding model was established by induction with 6 μmol/L simvastatin for 24 hours.The zebrafish were divided into normal group,model group,MSJZT low-,mid-and high-concentration groups(55.6,167,500 mg/L),and after modeling,the corresponding concentration of MSJZT was administered.The samples were collected after 24 hours.Platelet count(PLT)and bleeding status were observed.The content of 5-HT and Caspase 3/7 activity were detected by colorimetry.The gene expressions of 5-HT2aR,5-HT2bR and serotonin transporter(SERT)were detected by real-time PCR.The protein expressions of protein kinase B(AKT),phosphorylated AKT(p-AKT),extracellular signal-regulated protein kinase(ERK),and phosphorylated ERK(p-ERK)were detected by Western blotting.Results The intestinal bleeding rate in the model group was 70.0%,and that in the MSJZT low-,mid-and high-concentration groups was 36.7%,40.0%,and 80.0%,respectively;the intestinal hemostatic effect was 54%,52%,and 7%,respectively.Compared with the model group,the PLT in the MSJZT low-and mid-concentration groups decreased;the content of 5-HT in all MSJZT groups increased,and the gene expressions of 5-HT2aR and 5-HT2bR were up-regulated.The gene expression of SERT was up-regulated in the low-and mid-concentration groups;the Caspase 3/7 activity in the mid-and high-concentration groups was reduced;the expressions of p-AKT and p-ERK proteins were up-regulated in the low-and mid-concentration groups(all P<0.05).Conclusion MSJZT can reduce the incidence and severity of intestinal bleeding in zebrafish intestinal bleeding models.The mechanism may be achieved by activating AKT and ERK signaling pathways through 5-HT and its receptors.
10.Clinical discussion on the application of invigorating spleen and benefiting qi and controlling blood method for the treatment of cancer therapy-related thrombopenia
Xiang YAN ; Mei LUO ; Jiahui YU ; Yayue ZHANG ; Shaodan TIAN ; Xinyi CHEN ; Menghao LAN
Journal of Beijing University of Traditional Chinese Medicine 2024;47(6):808-812
Cancer therapy-related thrombopenia,which is called"medicinal poison purpura"in tradi-tional Chinese medicine,is a common hematologic adverse reaction during oncology treatment that is dif-ficult to treat due to the differences in oncology treatments and the complexity of the pathogenesis,resul-ting in various degrees of thrombocytopenia.Based on the theory that"spleen controlling blood",this pa-per believes that"medicinal poison purpura"is mainly caused by direct damage to the blood and qi by medicinal poison,leading to qi and blood deficiency;it also attacks the spleen and stomach,resulting in the deficiency of spleen qi and no source of qi and blood production.Due to the spleen deficiency,there is no essence to nourish kidney and bone marrow;their function of generating blood decreases,eventually it becomes"medicinal poison purpura".The theory of"regulating balance and flat regulation"is an im-portant academic idea of our team in the treatment of malignant hematological tumors.In this paper,we have systematically elaborated on the etiology,pathogenesis,and therapeutic principles of the treatment of cancer therapy-related thrombopenia with spleen deficiency pattern through the collation of relevant lit-erature.We believe that the prescription formulated according to the method of invigorating spleen and benefiting qi and controlling blood for the treatment of cancer therapy-associated thrombocytopenia with spleen deficiency pattern is in line with the principle of correspondence between prescription and syn-drome,and correspondence between drugs and syndrome in traditional Chinese medicine,which is theo-retically feasible and has a high clinical application value.


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