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Interpretations of Revised Guidelines for Bacterial Endotoxin Testing in Chinese Pharmacopoeia 2025 PEI Yusheng, GAO Hua, ZHU Ran, LIU Tao, CAI Tong Chinese Journal of Pharmacovigilance    2025, 22 (10): 1127-1131.   DOI: 10.19803/j.1672-8629.20250396 Abstract （1302）      PDF（pc） （1375KB）（1661）       Knowledge map    Save Objective To interpret the revised guidelines for bacterial endotoxin testing (9251) in Chinese Pharmacopoeia 2025 in order to help make the related testing more precise and feasible. Methods The modifications in the guidelines for bacterial endotoxin testing specified in Chinese Pharmacopoeia 2025 were analyzed. The background for the revision and implications were studied in depth. Results The major revisions included① specifications of endotoxin limits for ophthalmic medications; ②refined limit-setting requirements for raw materials, excipients, and packaging materials; ③ common interferents and ways of removal; ④ detailed descriptions of pretreatment methods for poorly soluble samples and packaging materials; ⑤ descriptions of low endotoxin recovery; ⑥ the specification of the recombinant factor C method as a complementary approach. Conclusion These revisions reflect better standards for pharmaceutical quality control in China and provide more practical technical guidance for professionals, which are of vital importance for quality control of pharmaceuticals. Reference | Supplementary Material | Related Articles | Metrics | Comments（0）

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Revision of the Provisions for Adverse Drug Reactions Reporting and Monitoring TIAN Chunhua Chinese Journal of Pharmacovigilance    2025, 22 (11): 1253-1257.   DOI: 10.19803/j.1672-8629.20250657 Abstract （1057）      PDF（pc） （1267KB）（1949）       Knowledge map    Save Objective To review the evolution of the Provisions for Adverse Drug Reaction Reporting and Monitoring and analyze the significant revisions and considerations in order to provide references for revisions. Methods The background and highlights of revisions and the role played by Provisions for the Monitoring of Adverse Drug Reaction (trial) in 1999 and the two revisions in 2004 and 2011 in enhancing the monitoring of adverse drug reactions were reviewed. The priorities of the current revision were analyzed, and the considerations were outlined from a technical perspective. Results The revisions of the provisions fully reflected the current needs of regulation, aligned with the reality in monitoring and evaluation of ADR, and served as a strong force behind related monitoring. The central purpose of this revision was to meet the requirement that “the state establish a pharmacovigilance system” stipulated in the “Drug Administration Law”. Importance was attached to the compatibility between related regulations and guidelines, and efforts were made to ensure inheritance and innovation of the provisions. Revisions involved delimiting the range of reporting, optimizing the requirements for reporting, highlighting risk control, and strengthening supervision and management. Conclusion The revisions of the provisions have a long way to go, but are of great significance for pharmacovigilance in China for some time to come, and will usher China's pharmacovigilance into a new stage of development. Reference | Related Articles | Metrics | Comments（0）

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Risk Factors for Liver Injury Induced by Anaplastic Lymphoma Kinase Inhibitors DENG Qingqing, YAO Qingqing, HU Tao, YANG Jiale, BIAN Yicong, MIAO Liyan Chinese Journal of Pharmacovigilance    2026, 23 (2): 162-166.   DOI: 10.19803/j.1672-8629.20250760 Abstract （937）      PDF（pc） （1273KB）（93）       Knowledge map    Save Objective To investigate the clinical characteristics of and risk factors for liver injury induced by anaplastic lymphoma kinase (ALK) inhibitors in patients with non-small cell lung cancer (NSCLC). Methods The clinical data of NSCLC patients treated with ALK inhibitors at the First Affiliated Hospital of Soochow University between January 2019 and July 2024 was collected. Patients were divided into a liver injury group and a non-liver injury group based on the occurrence of liver injury. Demographics, disease diagnosis, baseline biochemical indicators of livers, and other clinical data were compared between the two groups. Univariate and multivariate logistic regression analyses were used to identify risk factors for liver injury. Results A total of 75 NSCLC patients treated with ALK inhibitors were included in this study, with an overall incidence of liver injury of 42.7% (32/75). There were no significant differences in clinical characteristics such as demographic information, lung cancer stage, or baseline biochemical indicators of the liver between the two groups. Logistic regression analysis revealed that pre-existing diseases [P=0.047, hypertension P=0.006, 95%CI (1.691, 21.312)] and concomitant medications [P=0.008, concomitant use of proton pump inhibitors P=0.022, 95%CI (1.274, 23.761)] might be independent risk factors for ALK inhibitor-induced liver injury. Conclusion The results of this study suggest that the risk of liver injury in NSCLC patients receiving ALK inhibitor treatment is potentially associated with comorbid underlying diseases such as hypertension, or concurrent use of drugs like proton pump inhibitors during treatment. For such patients, close monitoring of liver function is essential in clinical practice to ensure the safe and rational use of ALK inhibitors. Reference | Related Articles | Metrics | Comments（0）

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Advances in Research of Mesenchymal Stem Cell-Derived Exosomes BAI Zhijie, GAO Yue Chinese Journal of Pharmacovigilance    2026, 23 (1): 1-6.   DOI: 10.19803/j.1672-8629.20250908 Abstract （901）      PDF（pc） （1319KB）（512）       Knowledge map    Save Objective To explore the current research, core mechanisms, opportunities, and challenges related to mesenchymal stem cell-derived exosomes in disease treatment, and to provide references for their subsequent clinical translation. Methods PubMed was searched for related literature by using mesenchymal stem cell and exosome as key words. Articles published within the past ten years and those published earlier were included to summarize the research findings and applications associated with the discovery, components and functional mechanisms of mesenchymal stem cell-derived exosomes. Challenges facing the clinical translation of mesenchymal stem cell-derived exosomes were discussed. Results Exosomes were the crucial mediator of functions of mesenchymal stem cells and could be potentially used for the treatment of diseases. Exosomes enjoyed advantages over mesenchymal stem cells in quality control and safety assessment due to their simpler structure and lower immunogenicity. In addition, mesenchymal stem cell-derived exosomes were nanoscale in size, making it possible for them to cross the blood-brain barrier. These exosomes promised to be a sphere of study that was capable of easy translation. Conclusion Mesenchymal stem cell-derived exosomes are one of the hot spots for regenerative medicine and rapid progress is being made in basic research and clinical translation. There is evidence that exosomes are lower in immunogenicity, stronger in tissue penetration and higher in targeting potential compared with mesenchymal stem cell therapies, which makes mesenchymal stem cell-derived exosomes superior to traditional stem cell therapies. The cell-free therapy strategy generated herein can possibly provide a new line of thought for research into stem cell therapies. Reference | Related Articles | Metrics | Comments（0）

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Pharmacovigilance for Radioprotective Drugs LONG Huan, WANG Kaixin, YANG Yueqi, AN Minghui, LIANG Yuwei, LIU Hongran, GAO Xu, ZHANG Li, DING Jiaxin, GONG Jian Chinese Journal of Pharmacovigilance    2026, 23 (3): 355-360.   DOI: 10.19803/j.1672-8629.20250771 Abstract （832）      PDF（pc） （1321KB）（738）       Knowledge map    Save Objective To analyze the challenges facing pharmacovigilance related to radioprotective drugs and propose optimization strategies so as to promote safe and rational clinical use of drugs. Methods Through literature review, radioprotective drugs and the identified representative agents were categorized. Major problems with pharmacovigilance were summarized while corresponding countermeasures were proposed. Results Radioprotective drugs were classified into three major categories: radioprotective agents, radiation mitigators, and radiotherapeutic agents. Five major challenges were identified: inadequate regulatory frameworks, insufficient research on pharmacology and toxicology, the lack of real-world data, difficulties in detecting adverse reactions, and imperfect data collection and sharing mechanisms. Conclusion A multidimensional approach is required to enhance the pharmacovigilance system for radioprotective drugs by strengthening regulatory frameworks, broadening nonclinical and clinical research, establishing real-world data platforms, developing intelligent risk identification tools, and promoting data sharing and international collaboration to ensure medication safety and efficacy. Reference | Related Articles | Metrics | Comments（0）

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WHODrug Global: a Validated, Regularly Updated and Standardised Drug Dictionary for Medicinal Information Coding STRESE Sara, LAGERLUND Olof, SHEN Ling, AHNFELT Emelie, YUE Qunying, FLADVAD Malin Chinese Journal of Pharmacovigilance    2025, 22 (10): 1194-1200.   DOI: 10.19803/j.1672-8629.20250092 Abstract （760）      PDF（pc） （812KB）（318）       Knowledge map    Save The WHODrug Global (WHODrug in short) medicinal information dictionary aim to facilitate the coding of medications in clinical trials as well as identification of medication-related problems in post-marketing surveillance, and thereby supporting the development and usage of effective and safe medications. WHODrug is a product provided by the Swedish foundation Uppsala Monitoring Centre (UMC). WHODrug contains individual product names, active ingredients and additional information such as marketing authorisation holder, country of sale, pharmaceutical form and strength, available in an English and a Chinese version. All related medications are linked using a structured WHODrug alphanumeric code, connecting product names and variations of the ingredient with the active moiety of the active ingredient s, including the International Nonproprietary Name (INN). Medications in WHODrug are classified using the ATC system and clustered into Standardised Drug Groupings, to allow for grouping of medications with one or more properties in common. The different information levels in WHODrug are used to explore the relationship between a medication or a class of medications and an adverse event. Using WHODrug in clinical trials and post-marketing safety work enables the use of accurate standardised medication nomenclature and other information that supports easier global information exchange. The ISO standards for Identification of Medicinal Products (IDMP) global Pharmaceutical Product Identifier (PhPID) is currently being added to WHODrug Global. To meet the demands of WHODrug users from the pharmaceutical industry, academia and regulatory authorities, it is essential to keep the dictionary comprehensive, validated and constantly updated on a global scale. This article introduces the application of WHODrugin practice, its data structure and applications of the structure, as well as uses of other products within the product portfolio, with the aim of supporting the effective and safe development and use of drugs. Reference | Related Articles | Metrics | Comments（0）

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Periplocin-Induced Hepatotoxicity in Zebrafish via Inhibition of the HNF4α-CYP Axis:a Combination of CYP Inhibitors and Transcriptomics LIU Yuxin, SHENG Yuhan, YU Weijie, CHENG Yunzhe, LI Jiaqi, SUN Yan, ZHAO Chongjun Chinese Journal of Pharmacovigilance    2026, 23 (4): 398-404.   DOI: 10.19803/j.1672-8629.20260018 Abstract （754）      PDF（pc） （2914KB）（157）       Knowledge map    Save Objective To elucidate the underlying mechanisms of periplocin-induced hepatotoxicity using a zebrafish model, combined with cytochrome P450 (CYP) inhibitor interventions and transcriptomics. Methods Zebrafish larvae at 4 days post-fertilization (4 dpf) were used as the experimental model. Hepatotoxicity was evaluated by analyzing liver phenotypes in transgenic zebrafish and performing hematoxylin-eosin (H&E) staining following combined exposure to periplocin and CYP inhibitors. Subsequently, transcriptome sequencing and real-time quantitative PCR (RT-qPCR) were employed to uncover and validate the molecular mechanisms. Results Periplocin exposure caused a dose-dependent decrease in liver fluorescence intensity and induced pathological damage, including hepatocyte vacuolization and disordered arrangement. Notably, co-treatment with CYP inhibitors exacerbated these toxic effects, suggesting that the hepatotoxicity of periplocin was closely associated with its metabolic clearance. Transcriptomic analysis revealed significant alterations in the hepatic gene transcription profile, characterized primarily by the suppression of pathways related to CYP-mediated xenobiotic metabolism, lipid metabolism, and bile acid synthesis. RT-qPCR confirmed the significant downregulation of the key transcription factor hnf4a and its downstream phaseⅠmetabolic enzymes (cyp3a65, cyp2p6), phaseⅡmetabolic enzyme (gstp1), as well as the lipid metabolism regulator pparab and the bile acid regulator cyp8b1 (P<0.05). Conclusion Periplocin can induce severe liver injury by suppressing the expression of the upstream core transcription factor-hepatocyte nuclear factor 4α (HNF4α). This suppression triggers a transcriptional inhibition cascade affecting downstream CYP detoxification systems and the PPARα lipid metabolism pathway, leading to disrupted hepatic homeostasis, diminished detoxification capacity, and metabolic disorders. Reference | Related Articles | Metrics | Comments（0）

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Safety Risks of Ranitidine Hydrochloride Injection Preparations WANG Chunting, ZHANG Ruifang, CHEN Yafei Chinese Journal of Pharmacovigilance    2026, 23 (2): 181-184.   DOI: 10.19803/j.1672-8629.20250814 Abstract （595）      PDF（pc） （1502KB）（208）       Knowledge map    Save Objective To analyze the safety risks of ranitidine hydrochloride injection preparations and provide a reference for safe medication. Methods Related data from the National Adverse Drug Reaction Monitoring Database (collected in 2004-2023), foreign databases (collected from inception to October 2025), domestic and foreign literature (published from inception to October 2025), and from drug inserts was compared while precautions against risks taken by drug regulators were analyzed. Results The number of reports about adverse reactions related to ranitidine hydrochloride injection preparations had trended upward since 2021. Patients ages 45 to 64 were a high-risk group. The dosage had to be adjusted for patients with renal insufficiency and patients with liver dysfunction had to use it with caution. Reports of serious reactions accounted for 12.63% of the total, with systemic diseases and reactions at the site of administration dominating. Reports about anaphylactic shock accounted for 10.86% of the total of reports on serious reactions. Rapid administration could induce serious adverse reactions like arrhythmia. Meanwhile, there were differences in information about safety between domestic and foreign drug inserts. Conclusion Marketing authorization holders of drugs should devote more effort to the monitoring of adverse reactions of the drug while offering guidance. Clinicians ought to take into consideration the patient’s age and liver and kidney function when giving prescriptions. The concentration and speed of administration should be under rigorous control to prevent serious adverse reactions such as anaphylactic shock. Reference | Related Articles | Metrics | Comments（0）

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One Case of Agranulocytosis Caused by Zoledronic Acid Injection FANG Wei, WANG Huanping, ZHU Hongxia Chinese Journal of Pharmacovigilance    2026, 23 (4): 467-469.   DOI: 10.19803/j.1672-8629.20241010 Abstract （570）      PDF（pc） （1193KB）（141）       Knowledge map    Save Objective To investigate a rare adverse reaction caused by zoledronic acid injection and provide a reference for safe and rational drug use in clinical practice. Methods The process of diagnosing and treating one case of agranulocytosis induced by zoledronic acid injection was analyzed. The clinical manifestations, risk factors, and prevention strategies related to this adverse reaction were summarized based on both domestic and foreign literature. Results After the administration of zoledronic acid injection, the patient developed persistent fever accompanied by sore throat. Three days later, a blood routine examination pointed to agranulocytosis. Following treatment with granulocyte colony-stimulating factors, the granulocyte count returned to normal while the associated symptoms, including fever and sore throat, were mitigated. Conclusion When zoledronic acid injection is used clinically, clinicians should be vigilant to the occurrence of agranulocytosis and ensure quick identification and treatment. Reference | Related Articles | Metrics | Comments（0）

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148 Case of Drug-Induced Liver Adverse Reactions TUO Kangxiu, YANG Chengli, LI Ming, JIANG Man Chinese Journal of Pharmacovigilance    2025, 22 (10): 1154-1158.   DOI: 10.19803/j.1672-8629.20250482 Abstract （565）      PDF（pc） （713KB）（1037）       Knowledge map    Save Objective To investigate the characteristics of drug-induced liver injury and provide references for related medications and prevention. Methods The case reports of drug-induced liver adverse reactions submitted to the National Adverse Drug Reaction Monitoring System by the Affiliated Hospital of Guizhou Medical University in 2021-2024 were collected and analyzed. Results A total of 148 cases of drug-induced liver adverse reactions were collected. Using the RUCAM scale, 109 cases were scored 6 to 8, and 39 cases 3 to 5. Among the 59 cases of liver injury whose detection indicators met the classification criteria, hepatocyte injury was the dominating type (44 cases), followed by the cholestatic type (10 cases) and the mixed type (5 cases). There were 55 grade Ⅰ cases and 4 grade Ⅱ cases. The top three drug categories responsible for live injury were antineoplastic drugs (41.58%), anti-infective drugs (36.63%) and drugs for the cardiovascular system (13.86%). The time from drug administration to the first detection of abnormal liver biochemical indicators was 2 to 15 days. Clinically, hepatoprotective drugs were used by 137 patients (92.57%) with drug-induced liver adverse reactions, 129 of whom provided detailed reports on their usage of hepatoprotective drugs. The types of hepatoprotective agents used ranged from 1 to 3 types: 73 cases (56.59%) took one type of hepatoprotective agent, 43 cases (33.33%) received two types of hepatoprotective agents, and 13 cases (10.08%) were given three types of hepatoprotective agents. Conclusion A wide range of drugs can cause drug-induced liver adverse reactions, with those causing hepatocellular injury as the dominating type. In clinical practice, high-risk drugs for liver injury should be monitored more rigorously. When formulating liver-protecting treatment plans, clinicians are advised to weigh the advantages and disadvantages of combined medications. Reference | Related Articles | Metrics | Comments（0）

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Bleeding Risk and Interactions of Warfarin Combined with Traditional Chinese Medicine ZHAO Ziyi, LU Chengjin, ZHANG Xiaomeng, HUANG Huaijuan, ZHANG Bing Chinese Journal of Pharmacovigilance    2025, 22 (11): 1217-1222.   DOI: 10.19803/j.1672-8629.20250658 Abstract （532）      PDF（pc） （1895KB）（213）       Knowledge map    Save Objective To investigate the bleeding risk associated with the concomitant use of warfarin and traditional Chinese medicine (TCM), and the underlying mechanisms for interactions in order to provide evidence for rational clinical co-administration. Methods Such databases as CNKI, Wanfang and Sinomed were searched for literature published between January 1, 2000 and June 30, 2025 to perform data mining on risk factors for warfarin-induced bleeding and the characteristics of TCM used in combination. Network pharmacology and molecular docking were employed to explore potential pharmacological interactions between warfarin and commonly co-administered TCM. Results Seventy-nine cases of warfarin-related bleeding were retrieved in the analysis. The concurrent use of TCM did not significantly increase the risk of bleeding during the initial phase of warfarin therapy (P>0.05). Data mining revealed frequent co-prescription patterns, particularly the herb pair SALVIA MILTIORRHIZA RADIX (Danshen) and OPHIOPOGONIS RADIX (Maidong), which were traditionally used to nourish yin and promote blood circulation. Pathway enrichment analysis indicated that these herbs and warfarin might work together to modulate key signaling pathways such as the PI3K-Akt pathway, lipid metabolism, and atherosclerosis. Molecular docking results demonstrated strong binding affinities between the active components of these herbs and critical targets including STAT3 and ESR1. Conclusion The study has offered evidence about clinical risks, patterns of medications, and interaction mechanisms that suggests warfarin can be used in combination with TCM under some conditions. However, enhanced pharmaceutical surveillance and more research on risk stratification are warranted to ensure patients' safety. Reference | Supplementary Material | Related Articles | Metrics | Comments（0）

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Safety of Long-Term Oral Nucleos(t)ide Analogues Therapy for Chronic Hepatitis B ZHU Haomin, LI Yue, ZHANG Mengdie, GAO Lihong, WANG Jia, LI Xin, TAO Tiantian Chinese Journal of Pharmacovigilance    2025, 22 (11): 1315-1320.   DOI: 10.19803/j.1672-8629.20250189 Abstract （529）      PDF（pc） （1270KB）（1017）       Knowledge map    Save Objective To explore the safety of long-term oral nucleos(t)ide analogues (NAs) in treating chronic hepatitis B (CHB) and to provide references for clinical practice. Methods By analyzing drug inserts, results of clinical trials, data on post-marketing surveillance and real-world cohort data, the risks of nephrotoxicity, bone toxicity, and dyslipidemia were compared between entecavir (ETV), tenofovir disoproxil fumarate (TDF), tenofovir alafenamide fumarate (TAF) and tenofovir amibufenamide (TMF). Results NAs were generally safe, but chronic use might lead to decreased renal function, hypophosphatemia and dyslipidemia. TAF and TMF caused significantly lower nephrotoxicity and bone toxicity than TDF, but were associated with a higher risk of hyperlipidemia. Conclusion NAs should be selected based on differences between individual patients. TAF/TMF is the first option for patients with renal insufficiency or at high risk of bone metabolism. For patients with cardiovascular risks or dyslipidemia, TAF/TMF should be used with caution. Reference | Related Articles | Metrics | Comments（0）

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Adverse Drug Reactions and Medications among 213 Pediatric Inpatients ZHAO Jie, XU Juan, LI Xinghua Chinese Journal of Pharmacovigilance    2025, 22 (11): 1282-1286.   DOI: 10.19803/j.1672-8629.20250288 Abstract （528）      PDF（pc） （1417KB）（316）       Knowledge map    Save Objective To analyze the adverse drug reactions (ADR) among and medications for hospitalized pediatric patients so as to provide references for rational drug use. Methods A retrospective analysis was conducted of ADR reports involving inpatients treated at a tertiary children's hospital between April 1, 2024 and March 31, 2025. The association between medications and ADR was studied, and the severity of ADR was graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Results Among the 213 patients involved, 110 were male and 103 were female. There were 10 cases (4.70%) aged 1 or younger, 36 cases (16.90%) ages 1 to 3, 68 cases (31.92%) ages 4 to 6, 91 cases (42.72%) ages 7 to 12 and 8 cases (3.76%) aged 12 to 17. The most common type of drug involved was anti-infective drugs, the dominating route of administration was intravenous injection (79.73%), and the most vulnerable organ was the skin and its accessories (59.73%), with rash as the primary clinical manifestation. Severe adverse reactions occurred in 45 cases (21.13%), and the top three drugs involved were cefotaxime sodium for injection (5 cases), erythromycin lactobionate for injection (4 cases), and chloral hydrate enema solution (3 cases). One case of new drug adverse reactions was reported. Conclusion ADR among pediatric patients are mostly adverse reactions that are caused by anti-infective drugs and manifest as skin damage. Severe allergic reactions caused by non-anti-infective drugs (such as chloral hydrate and turmeric oil) in children deserve more attention. Self-medication by parents is an important risk factor for ADR in children. Clinicians should try to ensure safe medications among children under 12. Reference | Related Articles | Metrics | Comments（0）

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Research Advancements in Applications of Single-Cell Transcriptome Sequencing Technology in Mechanism Elucidation of Pharmacodynamics and Toxicity of Traditional Chinese Medicine NI Haoyu, ZHOU Lei, WANG Ningning, YANG Xingxin, ZHOU Wei, SHEN Pan, GAO Yue Chinese Journal of Pharmacovigilance    2025, 22 (9): 975-982.   DOI: 10.19803/j.1672-8629.20250374 Abstract （514）      PDF（pc） （1746KB）（1916）       Knowledge map    Save Objective To explore the applicability of single-cell RNA sequencing (scRNA-seq) technology in TCM research given the current challenges to precise characterization of the therapeutic efficacy and toxicological profiles of Traditional Chinese Medicine (TCM). Methods Recent research advances in utilizing scRNA-seq to investigate the efficacy and toxicity mechanisms of TCM were reviewed in general and related disease treatments and toxicity in particular. The functional positioning and key findings of scRNA-seq in various studies were also analyzed. Results A standardized research paradigm known as "component analysis-cellular localization-target screening-mechanism validation" was established to explore the efficacy and toxicity of TCM using scRNA-seq that could overcome the limitations of traditional organ-level observations and reveal the microscopic essence of TCM’s pharmacological and toxicological actions by enabling precise identification of cellular subpopulation-specific responses and dynamic gene expression changes. Based on these insights, we proposed a single-cell network pharmacological or toxicological strategy for systematic elucidation of mechanisms. Conclusion scRNA-seq has emerged as a pivotal methodology for deciphering what is underlying the pharmacology and toxicology of TCM. Research strategies in TCM using this technology can provide novel perspectives and references for advancing the modernization of TCM. Reference | Related Articles | Metrics | Comments（0）

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Methodological Validation of RQ-TRAP for Telomerase Activity Detection and Its Applications in Human Mesenchymal Stem Cells ZHANG Zhen, YU Xie'an, XU Chunqi, CHEN Ning, QIN Meirong, WANG Ping Chinese Journal of Pharmacovigilance    2026, 23 (2): 121-126.   DOI: 10.19803/j.1672-8629.20250916 Abstract （510）      PDF（pc） （1403KB）（167）       Knowledge map    Save Objective To validate the methodological performance of the real-time quantitative telomeric repeat amplification protocol (RQ-TRAP), including the specificity, accuracy, precision, linearity, amplification efficiency, and lower limit of quantification, and detect telomerase activity in human mesenchymal stem cells (hMSCs) using this method in order to assess the proliferative potential, senescence process, and potential tumorigenic risk of hMSCs. Methods Telomerase activity in hMSCs was detected using the RQ-TRAP method. hMSCs derived from human umbilical cords were cultured in MEM-α medium. Samples were prepared via cell lysis and extraction, and absolute quantification was performed on a real-time polymerase chain reaction system using TRAP reaction buffer. Methodological validation was conducted using TSR8 control templates to evaluate the specificity, accuracy (recovery rate), intermediate precision (RSD), linearity (R2 and amplification efficiency), and LLOQ (confidence interval of recovery). For hMSCs assessment, telomerase activity was calculated based on standard curve fitting and Ct values. Results Methodological validation results indicated a good specificity with no interference from heat-inactivated cell matrices. The 95% confidence interval (CI) for accuracy recovery ranged from 91.37% to 111.0% (meeting the standard of 75%-125%). The intermediate precision (RSD) was less than 25% for all samples. Linearity assessment showed an R2>0.99 with an amplification efficiency of 104.1% (within the 90%-110% range). The LLOQ was determined to be 0.2 TPG Units (recovery CI: 70%-130%). The telomerase activity in hMSCs was measured at 1.432 TPG per 10 000 cells and the amplification efficiency of the standard curve in this assay was 102.6%. Conclusion The RQ-TRAP method has proved to be reliable and sensitive, which can be used for quantitative detection of telomerase activity in hMSCs and for effective assessment of cell senescence and tumorigenic risks. This method fills the gap in standardized testing for hMSCs and supports safe applications of regenerative medicine. Reference | Related Articles | Metrics | Comments（0）

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Comparison and Evaluation of Hepatotoxicity of Different Processed Samples of Paris polyphylla Based on a Zebrafish Model YU Weijie, LIU Yuxin, LIN Ruichao, LI Xiangri, ZHAO Chongjun Chinese Journal of Pharmacovigilance    2026, 23 (4): 390-397.   DOI: 10.19803/j.1672-8629.20250828 Abstract （489）      PDF（pc） （2256KB）（133）       Knowledge map    Save Objective To investigate the differences in hepatotoxicity between diverse prepared samples of Paris polyphylla in a zebrafish system and confirm the role of PolyphyllinⅠ(PPⅠ) in the overall hepatotoxicity of the herb so as to provide data for elucidating the toxic material basis of PPⅠ and its safe applications. Methods Methanol was used to extract Paris polyphylla medicinal materials while crude total saponins were obtained via n-Butanol extraction. More separation by column chromatography yielded the Paris extract without PolyphyllinⅠ(PE-PPⅠ). On this basis, a zebrafish model was used to evaluate the toxicity of different samples, involving the determination of lethal concentration 10% (LC10), observation of histopathological sections of livers, Nile Red staining, acridine orange staining, and fluorescence morphological analysis of livers. Meanwhile, the serum levels of triglycerides (TG), total cholesterol (TC), high-density lipoprotein (HDL), and low-density lipoprotein (LDL) were detected. Real-time quantitative PCR (RT-qPCR) was used to measure the mRNA expression levels of such genes as apoa2, cyp7a1, cyp27a1, hmgcs1, fabp4 and cd36. Results At specific mass concentrations, the methanol extract (ME), n-Butanol extract (NBE), and PE-PPⅠ of Paris polyphylla all induced liver injury in zebrafish, but there were significant differences in toxicity and pathology. In the high- and low-dose NBE groups, toxicity was relatively strong, characterized by extensive liver tissue damage that was accompanied by obvious hepatocyte apoptosis, compensatory enlargement of the liver size, and significant lipid metabolism disorders. In the ME group, focal hepatocyte damage with moderate lipid accumulation was observed. In the PE-PPⅠ group, only mild liver lesions occurred. RT-qPCR results indicated that the expression levels of core genes related to lipoprotein metabolism were significantly upregulated, the rate-limiting enzyme genes for bile acid synthesis were inhibited, the regulatory genes for cholesterol synthesis were upregulated, and that the key factors for fat transport trended upward. Conclusion PolyphyllinⅠ is one of the key active components responsible for the hepatotoxicity of Paris polyphylla, which may interfere with lipid metabolism pathways, leading to liver lipid accumulation, hepatocyte apoptosis, and structural damage to liver tissues. Reference | Related Articles | Metrics | Comments（0）

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Chinese Journal of Pharmacovigilance    2025, 22 (10): 0-0.   Abstract （482）      PDF（pc） （504KB）（327）       Knowledge map    Save Related Articles | Metrics | Comments（0）

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Interpretations of Amendments to Guidelines for Applications of Safety Tests for Injections in Chinese Pharmacopoeia 2025 Edition XU Lin, WU Yanlin, PEI Yusheng, CAI Tong, HUA Xiaodong Chinese Journal of Pharmacovigilance    2025, 22 (11): 1258-1262.   DOI: 10.19803/j.1672-8629.20250648 Abstract （481）      PDF（pc） （1303KB）（1523）       Knowledge map    Save Objective To interpret the revised guidelines for applications of safety tests for injections in the Chinese Pharmacopoeia 2025 edition (Volume IV) in order to provide a reference for related applications. Methods The revisions in guidelines 9301 between the 2020 and 2025 editions of the Chinese Pharmacopoeia were compared and contrasted before the amendments were interpreted based on relevant literature at home and abroad. Results This revision focused on alignment with international practices. The principles about safety tests were specified, items for safety testing such as pyrogen testing and abnormal toxicity testing were revised, and details on experiments were elaborated. Raw materials, excipients, and packaging materials that came into direct contact with drugs were described together. Conclusion The revised guidelines have been made compatible with the formation of standards for medical products administration in other countries, and can contribute to standardization and guidance, which is of vital importance for quality control of injections. Reference | Related Articles | Metrics | Comments（0）

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Monitoring of Adverse Drug Reactions Caused by Hospital Preparations and Evaluation Systems JIANG Xiaofeng, YANG Shuting, BAI Liqin, QI Jun, HE Jianxiong, CHEN Wenge, LIANG Zuhong, LI Yu, YU Xiaoxia Chinese Journal of Pharmacovigilance    2025, 22 (9): 1008-1011.   DOI: 10.19803/j.1672-8629.20250218 Abstract （462）      PDF（pc） （1226KB）（234）       Knowledge map    Save Objective To construct an intelligent adverse drug reaction (ADR) monitoring system for hospital-made preparations in order to prevent underreporting, data fragmentation, and delayed risk signals. Methods Based on Java 2 Platform and Enterprise Edition (J2EE), a multi-layer and distributed architecture system was designed to integrate the Hospital Information System (HIS) with the China Hospital Pharmacovigilance System (CHPS), making possible real-time synchronization and intelligent analysis of multi-source heterogeneous data. Its performance was evaluated through empirical studies conducted at two healthcare institutions in Yunnan and Guangdong. Results Among the 3,680 cases who had used blood-activating and stasis-resolving preparations, the identified incidence rate of ADR was 0.54 per thousand. In the 7,950 cases administered with heat-clearing and detoxifying preparations, one case of ADR was identified via active monitoring. Conclusion This system can quickly identify ADR risk signals associated with hospital preparations, but its performance needs to be verified by large-scale empirical studies. Reference | Related Articles | Metrics | Comments（0）

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Global Trends and China’s Practices Related to Medical Device Vigilance Systems SONG Yana, ZHAO Yan, LI Dong, ZHAO Yifei, ZHENG Lijia, ZHI Rui, DENG Gang Chinese Journal of Pharmacovigilance    2026, 23 (3): 290-295.   DOI: 10.19803/j.1672-8629.20250930 Abstract （456）      PDF（pc） （1237KB）（848）       Knowledge map    Save Objective To analyze the developments of the medical device vigilance system so as to provide a reference and guidance for the establishment of such a system in China. Methods The developments of the medical device industry, post-market supervision of medical devices in developed countries, and the evolution of pharmacovigilance in China were traced. On this basis, the need to establish a vigilance system of medical devices in China was elaborated in combination with the progress in our pilot programs concerning adverse event monitoring and vigilance in medical device. Results and Conclusion Medical device vigilance is critical to risk management throughout the lifecycle of medical devices. Amid such vigilance, efforts should be made to accelerate the transition from oversight of adverse events to medical device vigilance, establish a new framework for related vigilance, and enforce proactive risk monitoring, precise analysis, and effective management of medical device products, which will boost product innovation and industrial upgrading. Reference | Related Articles | Metrics | Comments（0）