1.Protective Effect of Xuebijing on Lung Injury in Rats with Severe Acute Pancreatitis by Blocking FPRs/NLRP3 Inflammatory Pathway
Guixian ZHANG ; Dawei LIU ; Xia LI ; Xijing LI ; Pengcheng SHI ; Zhiqiao FENG ; Jun CAI ; Wenhui ZONG ; Xiumei ZHAO ; Hongbin LIU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(1):113-120
ObjectiveTo explore the therapeutic effect of Xuebijing injection (XBJ) on severe acute pancreatitis induced acute lung injury (SAP-ALI) by regulating formyl peptide receptors (FPRs)/nucleotide-binding oligomerization domain-like receptor 3 (NLRP3) inflammatory pathway. MethodsSixty rats were randomly divided into a sham group, a SAP-ALI model group, low-, medium-, and high-dose XBJ groups (4, 8, and 12 mL·kg-1), and a positive drug (BOC2, 0.2 mg·kg-1) group. For the sham group, the pancreas of rats was only gently flipped after laparotomy, and then the abdomen was closed, while for the remaining five groups, SAP-ALI rat models were established by retrograde injection of 5% sodium taurocholate (Na-Tc) via the biliopancreatic duct. XBJ and BOC2 were administered via intraperitoneal injection once daily for 3 d prior to modeling and 0.5 h after modeling. Blood was collected from the abdominal aorta 6 h after the completion of modeling, and the expression of interleukin (IL)-1β, IL-6, and tumor necrosis factor-α (TNF-α) in plasma was measured by enzyme-linked immunosorbent assay (ELISA). The amount of ascites was measured, and the dry-wet weight ratios of pancreatic and lung tissue were determined. Pancreatic and lung tissue was taken for hematoxylin-eosin (HE) staining to observe pathological changes and then scored. The protein expression levels of FPR1, FPR2, and NLRP3 in lung tissue were detected by the immunohistochemical method. Western blot was used to detect the expression of FPR1, FPR2, and NLRP3 in lung tissue. Real-time fluorescence quantitative polymerase chain reaction (Real-time PCR) was used to detect the mRNA expression of FPR1, FPR2, and NLRP3 in lung tissue. ResultsCompared with the sham group, the SAP-ALI model group showed significantly decreased dry-wet weight ratio of lung tissue (P<0.01), serious pathological changes of lung tissue, a significantly increased pathological score (P<0.01), and significantly increased protein and mRNA expression levels of FPR1, FPR2, and NLRP3 in lung tissue (P<0.01). After BOC2 intervention, the above detection indicators were significantly reversed (P<0.01). After treatment with XBJ, the groups of different XBJ doses achieved results consistent with BOC2 intervention. ConclusionXBJ can effectively improve the inflammatory response of the lungs in SAP-ALI rats and reduce damage. The mechanism may be related to inhibiting the expression of FPRs and NLRP3 in lung tissue, which thereby reduces IL-1β and simultaneously antagonize the release of inflammatory factors IL-6 and TNF-α.
2.Current Situation, Problems and Countermeasures of Experimental Research on Traditional Chinese Medicine Regulating PI3K/Akt Signaling Pathway in Rats with Polycystic Ovary Syndrome
Pengxuan YAN ; Yiqing LIU ; Nanxing XIAN ; Linjing PENG ; Kun LI ; Jingchun ZHANG ; Yukun ZHAO
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(1):259-266
Polycystic ovary syndrome(PCOS) and its resulting infertility is one of the common diseases of gynecology and reproductive endocrinology. The phosphatidylinositol 3-kinase/protein kinase B(PI3K/Akt) signaling pathway is relatively well-studied in the development of intervention in PCOS, and the experiments on PCOS in rats conducted by traditional Chinese medicine through this signaling pathway is also the main direction of mechanistic research. In this paper, 20 articles published in academic journals in the past 5 years were selected through the corresponding criteria, and the objective situation and existing problems of the selected research projects were analyzed from five aspects, namely, baseline data, modeling and treatment, grouping, evaluative indexes, and pharmacodynamic indexes. It is found that there were different degrees of problems in each research project, such as the observation indicators of modeling, criteria for judging the success of the model, the treatment period, the calculation of dosage of prescription/active ingredients and specific dosage were not clearly defined, which could easily lead the bias of the results or reduce the validity of experimental data. Based on this, the list of PCOS rat experimental research operations was formed, involving five categories of experimental rats, model construction, study implementation, outcome measures and analysis and report with a total of 21 operation lists, with a view to provide a reference for the subsequent PCOS experiments related to scientific research and helping to form high-quality results.
3.Optimization Strategy and Practice of Traditional Chinese Medicine Compound and Its Component Compatibility
Zhihao WANG ; Wenjing ZHOU ; Chenghao FEI ; Yunlu LIU ; Yijing ZHANG ; Yue ZHAO ; Lan WANG ; Liang FENG ; Zhiyong LI
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(1):299-310
Prescription optimization is a crucial aspect in the study of traditional Chinese medicine (TCM) compounds. In recent years, the introduction of mathematical methods, data mining techniques, and artificial neural networks has provided new tools for elucidating the compatibility rules of TCM compounds. The study of TCM compounds involves numerous variables, including the proportions of different herbs, the specific extraction parts of each ingredient, and the interactions among multiple components. These factors together create a complex nonlinear dose-effect relationship. In this context, it is essential to identify methods that suit the characteristics of TCM compounds and can leverage their advantages for effective application in new drug development. This paper provided a comprehensive review of the cutting-edge optimization experimental design methods applied in recent studies of TCM compound compatibilities. The key technical issues, such as the optimization of source material selection, dosage optimization of compatible herbs, and multi-objective optimization indicators, were discussed. Furthermore, the evaluation methods for component effects were summarized during the optimization process, so as to provide scientific and practical foundations for innovative research in TCM and the development of new drugs based on TCM compounds.
4.Clinical Efficacy of Modified Huangqi Chifengtang in Treatment of IgA Nephropathy Patients and Exploration of Dose-effect Relationship of Astragali Radix
Xiujie SHI ; Meiying CHANG ; Yue SHI ; Ziyan ZHANG ; Yifan ZHANG ; Qi ZHANG ; Hangyu DUAN ; Jing LIU ; Mingming ZHAO ; Yuan SI ; Yu ZHANG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(2):9-16
ObjectiveTo explore the dose-effect relationship and safety of high, medium, and low doses of raw Astragali Radix in the modified Huangqi Chifengtang (MHCD) for treating proteinuria in immunoglobulin A (IgA) nephropathy, and to provide scientific evidence for the clinical use of high-dose Astragali Radix in the treatment of proteinuria in IgA nephropathy. MethodsA total of 120 patients with IgA nephropathy, diagnosed with Qi deficiency and blood stasis combined with wind pathogen and heat toxicity, were randomly divided into a control group and three treatment groups. The control group received telmisartan combined with a Chinese medicine placebo, while the treatment groups were given telmisartan combined with MHCD containing different doses of raw Astragali Radix (60, 30, 15 g). Each group contained 30 patients, and the treatment period was 12 weeks. Changes in 24-hour urinary protein (24 hUTP), traditional Chinese medicine (TCM) syndrome scores, effective rate, and renal function were observed before and after treatment. Safety was assessed by monitoring liver function and blood routine. ResultsAfter 12 weeks of treatment, 24 hUTP significantly decreased in the high, medium, and low-dose groups, as well as the control group (P<0.05, P<0.01). The TCM syndrome scores in the high, medium, and low-dose groups also significantly decreased (P<0.01). Comparisons between groups showed that the 24 hUTP in the high-dose group was significantly lower than in the medium, low-dose, and control groups (P<0.05, P<0.01), and the 24 hUTP in the medium-dose group was significantly lower than in the control group (P<0.05). The TCM syndrome scores in the high and medium-dose groups were significantly lower than in the low-dose and control groups (P<0.05, P<0.01). The total effective rates for proteinuria in the high, medium, low-dose, and control groups were 92.59% (25/27), 85.19% (23/27), 60.71% (17/28), and 57.14% (16/28), respectively. The effective rates in the high and medium-dose groups were significantly higher than in the low-dose and control groups (χ2=13.185, P<0.05, P<0.01). The effective rates for TCM syndrome scores in the high, medium, low-dose, and control groups were 88.89% (24/27), 81.48% (22/27), 71.43% (20/28), and 46.43% (13/28), respectively. The efficacy of TCM syndrome scores in the high and medium-dose groups was significantly higher than in the control group (χ2=14.053, P<0.01). Compared with pre-treatment values, there was no statistically significant difference in eGFR and serum creatinine in the high and medium-dose groups. However, eGFR significantly decreased in the low-dose and control groups after treatment (P<0.05), and serum creatinine levels increased significantly in the control group (P<0.05). No statistically significant differences were observed in urea nitrogen, uric acid, albumin, total cholesterol, triglycerides, liver function, and blood routine before and after treatment in any group. ConclusionThere is a dose-effect relationship in the treatment of IgA nephropathy with high, medium, and low doses of raw Astragali Radix in MHCD. The high-dose group exhibited the best therapeutic effect and good safety profile.
5.Effect of Rhei Radix et Rhizoma Before and After Steaming with Wine on Intestinal Flora and Immune Environment in Constipation Model Mice
Yaya BAI ; Rui TIAN ; Yajun SHI ; Chongbo ZHAO ; Jing SUN ; Li ZHANG ; Yonggang YAN ; Yuping TANG ; Qiao ZHANG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(2):192-199
ObjectiveTo study on the different therapeutic effects and potential mechanisms of Rhei Radix et Rhizoma(RH) before and after steaming with wine on constipation model mice. MethodsFifty-four male ICR mice were randomly divided into control group, model group, lactulose group(1.5 mg·kg-1), high, medium and low dose groups of RH and RH steaming with wine(PRH)(8, 4, 1 g·kg-1). Except for the control group, the constipation model was replicated by gavage of loperamide hydrochloride(6 mg·kg-1) in the other groups. After 2 weeks of modeling, each administration group was gavaged with the corresponding dose of drug solution, and the control and model groups were given an equal volume of normal saline, 1 time/d for 2 consecutive weeks. After administration, the feces were collected for 16S rRNA sequencing, the levels of gastrin(GAS), motilin(MTL), interleukin-6(IL-6), γ-interferon(IFN-γ) in the colonic tissue were detected by enzyme-linked immunosorbent assay(ELISA), the histopathological changes of colon were observed by hematoxylin-eosin(HE) staining, flow cytometry was used to detect the proportion changes of CD4+, CD8+ and regulatory T cell(Treg) in peripheral blood. ResultsCompared with the control group, the model group showed significantly decrease in fecal number in 24 h, fecal quality and fecal water rate(P<0.01), the colon was seen to have necrotic shedding of mucosal epithelium, localized intestinal glands in the lamina propria were degenerated, necrotic and atrophied, a few lymphocytes were seen to infiltrate in the necrotic area in a scattered manner, the contents of GAS and MTL, the proportions of CD4+, CD8+ and Treg were significantly reduced(P<0.01), the contents of IL-6 and IFN-γ were significantly elevated(P<0.05, P<0.01). Compared with the model group, the fecal number in 24 h, fecal quality and fecal water rate of high-dose groups of RH and PRH were significantly increased(P<0.05, P<0.01), the pathological damage of the colon was alleviated to varying degrees, the contents of GAS, MTL, IL-6 and IFN-γ were significantly regressed(P<0.05, P<0.01), and the proportions of CD4+ and CD8+ were significantly increased(P<0.01), although the proportion of Treg showed an upward trend, there was no significant difference. In addition, the results of intestinal flora showed that the number of amplicon sequence variant(ASV) and Alpha diversity were decreased in the model group compared with the control group, and there was a significant difference in Beta diversity, with a decrease in the relative abundance of Lactobacillus and an increase in the relative abundances of Bacillus and Helicobacter. Compared with the model group, the ASV number and Alpha diversity were increased in the high-dose groups of RH and PRH, and there was a trend of regression of Beta diversity to the control group, the relative abundance of Lactobacillus increased, and the relative abundances of Bacillus and Helicobacter decreased. ConclusionRH and PRH can improve dysbacteriosis, promote immune system activation, inhibit the release of inflammatory factors for enhancing the gastrointestinal function, which may be one of the potential mechanisms of their therapeutic effect on constipation.
6.Clinical Evidence Profile of Eleven Expensive Chinese Patent Medicines: A Scoping Analysis
Yajing LI ; Miaomiao LI ; Le ZHANG ; Wenya WANG ; Hui ZHAO ; Xing LIAO
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(2):227-238
ObjectiveThis study employed the scoping review method to systematically retrieve and analyze the basic information and clinical research evidence of expensive Chinese patent medicines (CPMs), aiming to provide a basis for future related research and clinical applications. MethodsEight Chinese and English databases were systematically searched for the clinical research evidence on expensive CPMs. ResultsEleven expensive CPMs (Angong Niuhuang Wan, Jufang Zhibao Wan, Suhexiang Wan, Pien Tze Huang, Niuhuang Qingxin Wan, Qinggong Shoutao Wan, Compound Realgar Natural Indigo Tablets, Xihuang Wan, Dingkun Wan, Babao Wan, and Guilingji Capsules) were selected. A total of 365 related studies were included in this review, comprising 331 clinical studies (of which 291 were randomized controlled trials), 30 systematic reviews and Meta-analyses, 3 expert consensus, and 1 rapid health technology assessment. Among the 11 CPMs, 2(Angong Niuhuang Wan and Jufang Zhibao Wan) had a daily price over 500 yuan. The famous and precious Chinese medicinal materials involved included Moschus (frequency of 7), Bovisc Alculus (7), and Borneol (5). The dosage forms included pills, capsules, oral liquid, tablets, and lozenges. The diseases treated by these CPMs mainly included malignant tumors, cerebrovascular diseases, gynecological diseases, and hepatobiliary system diseases. The sample sizes of the clinical studies were mainly concentrated within the range of 51-100 cases, and the main control form was CPM + basic Western medicine treatment vs. basic Western medicine treatment. The 331 clinical studies reported a total of 44 adverse events occurred, of which 36 were determined to be adverse reactions. ConclusionThe scarcity of raw materials leads to the high prices of expensive CPMs. The difficulty of conducting clinical research and the critical and severe cases treated lead to a lack of clinical research evidence with large sample sizes. The uneven distribution of existing studies, incomplete information on medicine package, and non-standard clinical research designs remain to be addressed in the future.
7.Yishen Huashi Granules Protect Kidneys of db/db Mice via p38 MAPK Signaling Pathway
Kaidong ZHOU ; Sitong WANG ; Ge JIN ; Yanmo CAI ; Xin ZHOU ; Yunhua LIU ; Xinxue ZHANG ; Min ZHANG ; Zongjiang ZHAO
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(3):58-68
ObjectiveTo explore the mechanism of Yishen Huashi granules in alleviating renal tubular epithelial cell injury and relieving diabetic kidney disease by regulating the mitogen-activated protein kinase (MAPK) signaling pathway. MethodsThe db/db mice of 12 weeks old were randomly assigned into model , dapagliflozin (1.6 mg·kg-1), and Yishen Huashi granules (4.7 g·kg-1), and db/m mice were used as the control group. The general conditions of mice were observed, and fasting blood glucose and 24-h urinary protein and albumin-to-creatinine ratio (ACR) were measured at weeks 0 and 12 of administration. After 12 weeks of treatment, the levels of serum creatinine (SCr), blood urea (UREA), triglycerides (TG), total cholesterol (TC), and low density lipoprotein (LDL) were measured. The pathological changes in the renal tissue were observed by hematoxylin-eosin (HE) staining, Periodic acid-Schiff (PAS) staining, Mallory staining, and transmission electron microscopy. Real-time PCR was employed to determine the mRNA levels of monocyte chemotactic protein-1 (MCP-1) and CC chemokine receptor-2 (CCR2) in the renal tissue of mice. The immunohistochemical assay was employed to examine the expression of p38, phospho-p38 (p-p38), MCP-1, and CCR2 in the renal tissue of mice. Western blotting was employed to measure the protein levels of p-p38, p38, MCP-1, and CCR2 in the renal tissue of mice.HK-2 cells cultured in vitro were grouped as follows: negative control, high glucose(30 mmol·L-1), Yishen Huashi granule-containing serum, and SB203580. After 48 h of cell culture in each group, RNA were extracted and the levels of MCP-1, and CCR2 mRNA were determined by Real-time PCR,proteins were extracted and the levels of p38, p-p38, MCP-1, and CCR2 were determined by Western blot. ResultsThe in vivo experiments showed that before treatment, other groups had higher body weight, blood glucose level, 24 h urinary protein, and ACR than the control group (P<0.05,P<0.01). After 12 weeks of treatment, compared with the model group, the Yishen Huashi granules group showed improved general conditions, a decreasing trend in body weight, lowered levels of blood glucose, 24-h urinary protein, and ACR (P<0.01), reduced SCr and UREA (P<0.01), and declined levels of TC, TG, and LDL (P<0.05,P<0.01). Compared with the model group, the Yishen Huashi granules group showed alleviated damage and interstitial fibrosis in the renal tissue as well as reductions in glomerular foot process fusion and basement membrane thickening. Moreover, the Yishen Huashi granules group showed down-regulated mRNA levels of MCP-1 and CCR2 (P<0.01), reduced positive expression of p-p38, MCP-1, and CCR2 (P<0.01), and down-regulated protein levels of p-p38/p38, MCP-1, and CCR2 (P<0.05) in the renal tissue. The cell experiment showed that compared with the high glucose group, the Yishen Huashi granule-containing serum group showcased down-regulated mRNA levels of MCP-1 and CCR2 (P<0.01) and down-regulated protein levels of p-p38/p38, MCP-1, and CCR2(P<0.05,P<0.01). ConclusionYishen Huashi granules can regulate glucose-lipid metabolism, reduce 24 h urinary protein and ACR, improve the renal function, alleviate the renal tubule injury caused by high glucose, and protect renal tubule epithelial cells in db/db mice by reducing MCP-1/CCR2 activation via the p38 MAPK signaling pathway.
8.Textual Research on Key Information and Modern Clinical Application of Classical Famous Formula Liumotang
Xinyu ZHANG ; Chong LI ; Yixuan HU ; Luming LIANG ; Ye ZHAO ; Xiaoting LU ; Yu WANG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(3):201-212
Liumotang comes from the Yuan dynasty's Effective Prescription Handed Down for Generations of Physicians. It is composed of six medicinal materials: Arecae Semen, Aquilariae Lignum Resinatum, Aucklandiae Radix, Linderae Radix, Rhei Radix et Rhizoma, and Aurantii Fructus. It is a classical formula for treating abdominal pain due to Qi stagnation and constipation accompanied by heat. This study systematically collated the records of Liumotang in ancient medical books and modern clinical literature and conducted in-depth analysis and textual research on its formula source, main diseases, composition, dosage, medical books, container capacity, processing, preparation method, usage, drug basis, formula meaning, and other key information, so as to provide a powerful reference for the development and clinical application of compound preparations of the classical formula Liumotang. The results show that Liumotang was first seen in Effective Prescription Handed Down for Generations of Physicians, and many medical books of the past dynasties have imitated this. In terms of drug basis, the dried and mature seeds of the palm plant Areca catechu, resin-containing wood of the Daphneaceae plant Aquilaria sinensis, the dried roots of the Asteraceae plant woody Aucklandia lappa, the dried tuber root of the Lauraceae plant Lindera aggregata, the dried roots and rhizomes of the knotweed plant, R. palmatum, R.tangutikum, and R. officinale, and the dried and unripe fruits of the citrus genus C. aurantium and its cultivated varieties from the family Rutaceae were selected. In terms of dosage, through the textual research on bowls in the Ming and Qing dynasties, combined with the conversion of medicines and bowl capacity in the Qing dynasty, it was estimated that the dosage of each drug in the Yuan dynasty was 10.86 g. In the Ming and Qing dynasties, the dosage of drugs was mostly equal, but the dosage of drugs was somewhat different. In terms of processing, preparation method, and usage, in the medical books of the past dynasties, the processing of drugs has slightly changed, but raw drugs are used in all preparations. The preparation method and usage did not change much during the Yuan, Ming, and Qing dynasties, except for certain differences in dosage. In terms of syndrome, Liumotang was first used to treat abdominal pain due to Qi stagnation and constipation accompanied by heat. Medical books of the past dynasties often omit the symptoms of heat. In modern clinical practice, Liumotang is mainly used in the digestive system and urinary system diseases and is mostly used to treat constipation-predominant irritable bowel syndrome, biliary reflux gastritis, functional constipation, slow transit constipation, and other diseases, with no adverse reactions found yet. The above results provide a reliable scientific basis for the development and clinical treatment of Liumotang compound preparations.
9.Expert consensus on dispensing management of intravenous infusion drugs for clinical trials in PIVAS
Xingchen YANG ; Wenhuan FU ; Donghui LAO ; Jing ZHAO ; Jianzhong ZHANG ; Group PHARMACY ; Committee HOSPITAL ; Association Pharmaceutical SHANGHAI
China Pharmacy 2025;36(1):1-6
OBJECTIVE To further standardize the dispensing management standard of intravenous infusion drugs for clinical trials in pharmacy intravenous admixture services (PIVAS), and provide reference for medical institutions to provide high-quality pharmaceutical services. METHODS Initiated by PIVAS Group, Hospital Pharmacy Professional Committee, Shanghai Pharmaceutical Association, jointly led by Longhua Hospital, Shanghai University of Traditional Chinese Medicine and Shanghai Geriatric Medical Center, a writing group was established by PIVAS experts from multiple medical institutions to discuss the basic requirements and dispensing process of intravenous infusion drugs for clinical trials in PIVAS. The experts from the leading unit sorted out, summarized, analyzed, fed back and revised the opinions, and finally reached Expert Consensus on Dispensing Management of Intravenous Infusion Drugs for Clinical Trials in PIVAS. RESULTS & CONCLUSIONS The main contents of this consensus include information management, operation process, fund management and document management of intravenous infusion drugs for clinical trials in PIVAS. This consensus establishes a more standardized model for dispensing management of intravenous infusion drugs for clinical trials in PIVAS, by standardizing clinical trail drug management operational procedures, accurately recording and preserving drug-related information, with the aim of achieving standardized and meticulous management of PIVAS’s receipt of clinical trial drugs.
10.Survey on the perception and current status of drug risk management in medical institutions
Xuelin SUN ; Mingqing XING ; Zixuan ZHANG ; Wenjing ZHAO ; Dongfang QIAN ; Yan LIANG ; Li XU ; Pengfei JIN ; Yatong ZHANG
China Pharmacy 2025;36(1):7-12
OBJECTIVE To know about the perception and current status of drug risk management among pharmacists in Chinese medical institutions, providing insights and recommendations for enhancing the drug risk management system in medical institutions. METHODS A questionnaire survey was conducted across 28 provinces, cities, and autonomous regions; stratified radom sampling was employed to study the population of medical workers and pharmaceutical professionals in medical institutions nationwide. The survey included information on the survey population, the current status of drug risk management implementation in medical institutions, the cognition, definition and process of drug risk management related concepts, and the content and mode of drug risk management work in medical institutions. Finally, suggestions were collected from various medical institutions on the system construction of drug risk management. Descriptive statistical analysis was adopted to summarize the obtained data. RESULTS A total of 446 questionnaires were collected in this survey, including 420 valid questionnaires and 26 invalid questionnaires. The questionnaire collection rate was 100%,and the effective rate was 94.17%. 51.19% of the respondents No.2020YFC2009001)。 based their understanding of drug risk management on Management Measures for Adverse Drug Reaction Reports and Monitoring, while 87.38% recognized the need for drug risk management throughout the drug use process. 63.33% of the participants stated that their medical institutions had dedicated positions related to drug risk management, with the highest proportion (72.17%) was in third-grade class A medical institutions. 66.43% reported implementing risk management across all drug use stages. Suggestions for the development of drug risk management systems in medical institutions by the research participants focused on enhancing guiding documents, clarifying concepts, establishing information-sharing mechanisms. CONCLUSIONS The overall awareness of drug risk management in China’s medical institutions is high, with practices in place across various stages in multiple forms. However, there remains a need to strengthen institutional documents, management regulations, system development, and information-sharing mechanisms to improve collaborative governance, improve drug management levels, and ensure patient safety.

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