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CONTENTS 2024, 21(8): 0-0.  Abstract ( 164 )   PDF (459KB) ( 144 )   Related Articles | Metrics

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Study of a microgel method for the examination of bacterial endotoxins ZHANG Chenxue, CAI Tong, CHEN Chen, LIU Tao, LI Wenlong, PEI Yusheng 2024, 21(8): 841-846.  DOI: 10.19803/j.1672-8629.20240341 Abstract ( 138 )   PDF (1379KB) ( 99 )   Objective To determine whether the microgel method can meet the requirements of Chinese Pharmacopoeia, as a supplement to the existing bacterial endotoxin test method. Methods According to the provisions of “9101 Guidelines for the validation of pharmaceutical quality analysis methods” in Part IV of the Pharmacopoeia of the People’s Republic of China(2020 edition), the microgel method (5 μL samples+50 μL limulus ambocyte lysate) was analyzed for “specificity”, “limit of detection” and “durability” in the item of “Determination of impurities”. The gel method and microgel method were used to compare 85 batches of samples for variety applicability and 384 batches of samples for consistency comparison. Results The microgel method was methodologically validated and showed that it met the requirements of the Pharmacopoeia of the People’s Republic of China for the qualitative methods, and the microgel method was equivalent to the gel method for the comparison of the applicability and consistency of the varieties. Conclusion The microgel method can be promoted as a supplementary alternative to the gel method in China. References | Related Articles | Metrics

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Current situation and reflection on limulus amebocyte lysate and recombinant reagents for testing YANG Yuxi, PEI Yusheng, LIU Tao, GAO Hua, CAI Tong 2024, 21(8): 847-851.  DOI: 10.19803/j.1672-8629.20240267 Abstract ( 66 )   PDF (1350KB) ( 80 )   Objective To provide support for the scientific and orderly development of endotoxin detection and the use of limulus amebocyte lysate by studying the current status of the use and management of limulus amebocyte lysate and recombinant reagents for testing. Methods The relevant historical evolution and domestic and international regulatory status of limulus amebocyte lysate for testing were sorted out, and the basic situation of the main alternative methods for endotoxin testing and the recombinant reagents used in the context of horseshoe crab resource shortage was analyzed, combined with daily medical product testing and management practices. Results and Conclusion Summarize and sort out the main problems that may be faced in the field of endotoxin testing for sterile medical products, such as raw material shortages and outdated regulatory methods. Propose suggestions for clarifying the management of limulus amebocyte lysate, conducting research on improving the quality standards and production quality management of limulus amebocyte lysate used in medical product testing, and strengthening the supervision of reagents related to alternative methods for limulus amebocyte lysate testing. References | Related Articles | Metrics

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Bacterial endotoxin test of (R)-lansoprazole raw material XU Meibao, PEI Yusheng, CHEN Chen, LI Wenlong, LIU Tao, CAI Tong 2024, 21(8): 852-856.  DOI: 10.19803/j.1672-8629.20240375 Abstract ( 73 )   PDF (1339KB) ( 81 )   Objective To establish a bacterial endotoxin detection method for the poorly soluble active pharmaceutical ingredient (R)-Lansoprazole. Methods Three methods were attempted to establish the bacterial endotoxin detection method.① The test sample was dissolved in acetonitrile to a concentration of 10 mg·mL-1, diluted 100-fold, and tested using the gel-clot method with a lysate sensitivity of 0.25 EU·mL-1. ② The sample was dissolved in 1.4 mg·mL-1 sodium hydroxide solution to a concentration of 10 mg·mL-1, diluted 600-fold, and tested for bacterial endotoxins using the gel-clot method with a lysate sensitivity of 0.03 EU·mL-1.③ Dissolve the test sample in chloroform, and then perform endotoxin detection using extraction method. Results For all three batches of test samples, dissolving the samples in both acetonitrile and 1.4 mg·mL-1 sodium hydroxide solution then diluted by water for bacterial endotoxin test, could eliminate the interference of the solvent and test sample on endotoxin detection. The results of the interference test meet the requirements. The endotoxin content of the test samples was found to be below the limit and in compliance with the pharmacopoeia requirements. However, the chloroform extraction method has significant interference and the results are not valid. Conclusion A bacterial endotoxin detection method for the active pharmaceutical ingredient (R)-Lansoprazole is successfully established, which solves the detection problem of this sample and provides a reference for establishing bacterial endotoxin detection methods for other insoluble samples. References | Related Articles | Metrics

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Discussion and analysis of bacterial endotoxin problems in FDA warning letters LU De, XU Wenyan, LIU Jinxin, PEI Yusheng 2024, 21(8): 857-862.  DOI: 10.19803/j.1672-8629.20240421 Abstract ( 117 )   PDF (1404KB) ( 131 )   Objective Study the common problems of drug bacterial endotoxin control in FDA warning letters to provide reference for the industry. Methods The warning letters of the deficiencies in bacterial endotoxin control of FDA in recent years were sorted out, and the deficiencies in bacterial endotoxin control were classified and summarized. Results It is very critical to control bacterial endotoxin contamination in drug production. Although the relevant regulations and guidelines of FDA put forward clear requirements, there were still shortcomings in the actual implementation of active pharmaceutical ingredients/excipient /packaging materials,process control and quality control. Conclusion Bacterial endotoxin control is the key and difficult point of drug quality control. Enterprises should focus on and continuously optimize to ensure the safety and effectiveness of drugs. References | Related Articles | Metrics

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Anti-fatigue effects and mechanism of ginseng combined with caffeine in rats ZHENG Haiyun, ZHANG Wen, WANG Shaonan, ZHAO Haiyu, DU Shouying 2024, 21(8): 863-870.  DOI: 10.19803/j.1672-8629.20240244 Abstract ( 83 )   PDF (1876KB) ( 74 )   Objective To evaluate the anti-fatigue effect and mechanism of ginseng extract combined with caffeine in rats. Methods The two components combination index was used to evaluate the synergistic effect of ginseng and caffeine in combating fatigue. SD rats were randomly divided into the control group, model group, ginseng group (60 mg·kg-1), caffeine group (3 mg·kg-1), and combined group (30 mg·kg-1+1.5 mg·kg-1). A rat fatigue model was established via weight bearing swimming, and the drugs were administered once daily for 21 consecutive days. The anti-fatigue effect was evaluated by weight bearing swimming experiments. Colorimetry was used to detect the levels of urea nitrogen (BUN), lactic acid (LD), and liver/skeletal muscle glycogen in each group of rats. Enzyme linked immunosorbent assay (ELISA) was adopted to detect the levels of interleukin 6 (IL-6), interleukin 1β (IL-1β), and C-reactive protein (CRP) while network pharmacology was used to explore the possible mechanism of anti-fatigue effect of ginseng extract combined with caffeine. Results The TCCI of ginseng and caffeine was calculated to be 0.17~0.61, indicating a synergistic anti-fatigue effect. Compared with the model group, each drug administration group prolonged the weight bearing swimming time of rats to varying degrees, increased the content of glycogen in liver/skeletal muscle tissues, decreased the level of BUN in serum, and reduced the level of inflammatory cytokines. Network pharmacology analysis found that the anti-fatigue effects were exerted through such pathways as PI3K-Akt and MAPK signaling pathway. Conclusion Ginseng extract combined with caffeine could significantly decrease the accumulation of metabolic products such as lactic acid, reduce the breakdown of glycogen, and improve fatigue symptoms of model rats. References | Supplementary Material | Related Articles | Metrics

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Effects of rosastatin combined with Danggui Buxue Tang on expressions of AR and NR3C2 ZHANG Kaihua, LIU Dingwei, FU Changhai, SUN Xuelin, MIN Xianjun 2024, 21(8): 871-877.  DOI: 10.19803/j.1672-8629.20240067 Abstract ( 42 )   PDF (2163KB) ( 58 )   Objective To predict the mechanism of roxadustat combined with Danggui Buxue Tang against renal anemia (RA) based on network pharmacology, and to verify the result via animal experiments. Methods The target proteins and signaling pathways were retrieved from PharmMapper, TCMSP, STRING, GeneCards, OMIM and DAVID database. The potential targets of roxadustat combined with Danggui Buxue Tang in treating RA were explored. A “drug-target-pathway” model was established to predict possible biological pathways. Subsequently, rat experiments were conducted to validate the main targets. Results Network pharmacology research found that the combination of roxadustat and Danggui Buxue Tang mainly exerted therapeutic effects on renal anemia through four common protein targets, namely NR3C2, AR, NR1I3, and RUNX1T1, as well as through 16 common signaling pathways such as PI3K-Akt pathway. The combination of roxadustat and Danggui Buxue Tang could upregulate the expression of target protein AR but inhibit the expression of target protein NR3C2 to exert its effects. Conclusion The combination of roxadustat and Danggui Buxue Tang can improve inflammation and oxidative stress in the body by inhibiting the expression of NR3C2 and upregulating the expression of AR, thereby exerting a therapeutic effect on renal anemia. References | Related Articles | Metrics

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Chronic toxicity study of Zhinao capsules in SD rats WANG Yan, TENG Jingjing, YANG Tongjin, XIA Xin, YU Dandan, ZHAN Haibing, YANG Wenming 2024, 21(8): 878-883.  DOI: 10.19803/j.1672-8629.20230792 Abstract ( 50 )   PDF (1707KB) ( 46 )   Objective To evaluate the chronic toxicity of Zhinao capsules to SD rats and to provide reference for safe clinical medications. Methods One hundred and sixty normal rats were randomly divided into four groups: the negative control group (pure water) and three-dosage groups of Zhinao capsules (6 400, 2 100 and 710 mg·kg-1), with 40 rats in each. The rats were orally administrated with Zhinao capsules for 26 weeks. The health status, food consumption and body weight of rats were observed during the test. At 13 weeks, 26 weeks and after two weeks of recovery, 10, 20 and 10 rats in each group were dissected respectively before hematology, blood biochemistry, the organ-body ratio and histopathology were measured. Results Compared with the negative control group, the body weight of male rats in the high-dose group decreased from week 13 to week 21 (P < 0.05) but returned to normal at 26 weeks (P > 0.05). Compared with the negative control group, some hematological and blood biochemical indexes of rats in the medium and high dose groups were increased before they decreased (P < 0.05), but all were within the normal range. Compared with the negative control group, the male kidney/body ratio, the female liver/body ratio and the ovary/body ratio were increased in the high dose group after 26 weeks of administration (P < 0.05). There was no difference in the organ-body ratio between the three groups in the two weeks of recovery (P > 0.05), and no histopathological lesions of organs induced by drugs were observed either. Conclusion Long-term administration of Zhinao capsules is highly safety, and the NOAEL of Zhinao capsules is considered to be 6 400 mg·kg-1, equal to 95 times the proposed clinical adult . References | Related Articles | Metrics

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Clinical compatibility of bromhexine injectable preparations LIU Yi, LIU Xiaoqiang, YAO Xiao, LI Xuantang, GUO Xianhui, GENG Ying, PEI Yusheng 2024, 21(8): 884-887.  DOI: 10.19803/j.1672-8629.20230305 Abstract ( 70 )   PDF (1258KB) ( 83 )   Objective To investigate the causes of turbidity that occurs during infusion of bromhexine injectable preparations. Methods Representative clinical compatibility tests for verification were carried out in combination with bromhexine solubility analysis, and the relevant compatibility of non therapeutic drugs was observed. Results The solubility of bromhexine was highly correlated with the pH environment. Combined with confirmatory clinical compatibility tests of compound sodium chloride injection and multiple electrolytes injection, it was confirmed that bromhexine injectable preparations were likely to become turbid when the environmental pH value of the clinical compatibility medication was slightly alkaline. Conclusion The turbidity of bromhexine injectable preparations is chiefly due to pH rather than the infusion solvent, suggesting the need to attach importance to clinical compatibility of non-therapeutic drugs. References | Related Articles | Metrics

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Chiral separation and content determination of sotalol hydrochloride by HPLC HU Haoran, ZHANG Lei, ZHENG Lei 2024, 21(8): 888-891.  DOI: 10.19803/j.1672-8629.20240242 Abstract ( 33 )   PDF (1449KB) ( 54 )   Objective To separate and determine the content of sotalol hydrochloride by HPLC. Methods A CHIRALPAK AD-H chiral phase column (5 μm, 250 mm×4.6 mm) was used, with a mobile phase of n-hexane-ethanol (80∶20), at the flow rate of 1.0 mL·min-1. The detection wavelength was 225 nm, the column temperature 25 ℃, and the injection volume was 10 μL. Results The two enantiomers were well separated, and the resolution between the peaks of the two enantiomers exceeded 2.0. The linearity between the two enantiomers was good within the range of 1.005~100.5 μg·mL-1 (r=0.999) and 1.073~107.3 μg·mL-1 (r=0.999), respectively. The average recovery of the two enantiomers was 97.05% and 98.24% respectively, with an RSD of 2.26% and 2.80%, respectively. The detection limit of the two enantiomers was 0.1 μg·mL-1, and the quantification limit was 0.3 μg·mL-1. The precision test, repeatability test, and stability test proceeded well. Conclusion The established method is accurate and reliable, which can be used in chiral separation and content determination of sotalol hydrochloride. References | Related Articles | Metrics

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Comparative research on active post-marketing drug safety surveillance systems worldwide based on real-world data SUN Yixin, NIE Xiaolu, WANG Xiaoling, GUO Peng 2024, 21(8): 892-899.  DOI: 10.19803/j.1672-8629.20240376 Abstract ( 180 )   PDF (1301KB) ( 164 )   Objective s To compare and analyze the active post-marketing safety surveillance practices based on real-world data (RWD) worldwide, in order to provide the reference for establishing an effective and feasible nationwide active surveillance system in China. Methods The literature on active surveillance systems around the world were searched and reviewed. The framework synthesis was used to determine the analytical framework, coding and mapping the information related to organizational structure, data characteristics, and operation mechanism. The similarities and differences of the active surveillance model were summarized. Results A total of 12 systems/organizations that conduct active surveillance based on RWD were included in this study, 9 of which are located in Europe and the United States, and in Asia. There are two Chinese systems, the China Hospital Pharmacovigilance System (CHPS) and the Adverse Drug Event Active Surveillance and Assessment System-Ⅱ (ADE-ASAS-Ⅱ). After integrating the information, the active monitoring model was summarized in six dimensions: (i) The organizational model was divided into three categories, including the government (with academia and pharmaceutical companies) led consortium, the direct government management, and the academic alliance consultation; (ii) The data integration and sharing model included the common data model, the common study protocol, and the centralized database; (iii) The data collection model could be divided into two forms: automatic collection from databases, and manual collection for target populations or specialized studies; (iv) The data management model included anonymizing, structuring and standardizing processes; (v) The data storage and transmission model can be categorized into the distributed data networks and the central database storage; (vi) Correspondingly, the data analysis model was divided into two categories: distributed computing and centralized analysis. Conclusion At present, the pattern of active surveillance for drug safety based on RWD are relatively mature in developed countries. While learning from those advanced experiences, we should also explore the active surveillance in line with the actual situation of China, to protect the medication safety of patients. References | Related Articles | Metrics

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Foreign methods for benefit-risk assessment of pharmaceutical products WEI Fenfang, WU Wenyu, LI Limin, TANG Biyu, WU Jianru 2024, 21(8): 900-905.  DOI: 10.19803/j.1672-8629.20240129 Abstract ( 180 )   PDF (1419KB) ( 209 )   Objective To find out more about foreign benefit-risk assessment methods of drugs and to provide reference for related work in China via a comparison of their advantages and disadvantages. Methods Foreign literature and other publicly available information on benefit-risk assessment methods for pharmaceuticals were reviewed and analyzed. Results Seven qualitative methods and 18 quantitative methods were identified that could be used for regulatory decision-making from theories on research abroad, and related cases were collected for adaptive research, as well as, recommendations to promote benefit-risk evaluation methodology for medicines in China were made. Conclusion Some of the methods are highly applicable. It is recommended that the framework of benefit-risk assessment of drugs be specified in China, quantitative evaluation methods be established within a qualitative evaluation framework, the standard for comparison of benefits and risks be set, and a comprehensive data collection network be constructed in China. References | Related Articles | Metrics

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Brief introduction and inspiration to the WHO guidance on Ethics and Governance of Artificial Intelligence for Health WANG Tao, SONG Haibo, WANG Qing, HOU Yongfang, LIU Hongliang, ZHANG Lin 2024, 21(8): 906-909.  DOI: 10.19803/j.1672-8629.20230518 Abstract ( 93 )   PDF (1244KB) ( 109 )   Objective To systematically introduce the WHO guidance on Ethics and Governance of Artificial Intelligence for Health, as well as the status of ethics and governance of AI in medicine and health in China, other major countries and regions in the world, in order to provide a reference for formulating AI-based ethical guidelines in drug regulation in our country in the future. Methods The formulation, main contents and ethical principles of the WHO guideline were introduced. The general situation of AI ethics and governance in the medical and health field of government departments and related organization in the United States, the European Union and China through literature review and the websites of regulatory agencies was also elucidated. Results The WHO guideline elaborated 6 core ethical principles for the healthy development and use of AI in the field of medicine and health. Government departments and related organization in the United States, the European Union and China have formulated a series of policies and regulations on AI ethics and governance around the principles of fairness and justice, respect for privacy, security and control, shared responsibility, openness and transparency. Conclusion Drawing on the experience of WHO and foreign countries, it is suggested that NMPA actively formulate and implement the regulatory standards or relevant guidelines of new AI technologies in the whole life cycle of products, strengthen the transparency of artificial intelligence drugs and medical device products and other aspects to strengthen the governance of AI ethics. References | Related Articles | Metrics

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Efficacy and safety of salvianolic acid preparations for adjuvant therapy on related diseases of coronary heart disease, angina and cerebral infarction: a systematic review ZHANG Jing, ZHANG Kai, YI Zhanmiao 2024, 21(8): 910-915.  DOI: 10.19803/j.1672-8629.20230583 Abstract ( 88 )   PDF (1517KB) ( 149 )   Objective To evaluate the efficacy and safety of salvianolic acid salts for injection and salvianolic acid for injection (referred to as “salvianolic acid preparations”) for adjuvant therapy on related diseases of coronary heart disease, angina and cerebral infarction. Methods Randomized controlled trials of adverse cardiovascular events of salvianolic acid preparations for adjuvant treatment on related diseases of coronary heart disease, angina and cerebral infarction were collected by searching PubMed, Embase, Cochrane Library, CNKI, WanFang Data and VIP, et al. from the inception to February 1, 2023. The quality and Meta-analysis of the included studies were evaluated. Results A total of 16 RCTs involving 2 018 patients were included. The results of the Meta-analysis showed that salvianolic acid preparations for adjuvant therapy on related diseases of coronary heart disease and angina could significantly reduce the risk of the composite outcomes of MACEs [RR=0.46, 95%CI(0.31, 0.67), P<0.001], [NNT=12.19, 95%CI（11.71,12.68）] and angina [RR=0.49, 95%CI(0.33, 0.73),P<0.001], [NNT=14.44, 95%CI (13.88, 14.99)] in the 180 d follow-up subgroup, and there were no significant differences in the risk of cardiovascular death, myocardial infarction, stroke, revascularization between the intervention group and the control group. There was no statistical difference in the risk of adverse drug reactions between the intervention group and the control group (P=0.10). Major adverse drug reactions were elevated ALT/AST, abdominal distension, nausea, dizziness/headache, fatigue and so on. There was no statistical difference in the risk of various adverse drug reactions (P=0.25). Conclusion In the 180 d follow-up subgroup, salvianolic acid preparations for the adjuvant therapy on related diseases of coronary heart disease and angina could reduce the risk of angina, and were safe. But the above conclusions still need further confirmation. References | Supplementary Material | Related Articles | Metrics

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Lanqin oral liquid combined with antibacterial drugs for the treatment of acute tonsillitis: a systematic review and Meta-analysis LIU Qian, LI Bo, SHU Xinyang 2024, 21(8): 916-920.  DOI: 10.19803/j.1672-8629.20230685 Abstract ( 77 )   PDF (1366KB) ( 80 )   Objective To systematically evaluate the efficacy and safety of Lanqin oral liquid combined with antibiotics in the treatment of acute tonsillitis. Methods Literature about randomized controlled trials (RCTs) of Lanqin oral liquid in the treatment of acute tonsillitis that was published between the inception and January 1, 2023 was retrieved from Cochrane Library, EMbase, PubMed, SinoMed, CNKI, Wanfang and Weipu. Two researchers independently conducted literature screening and data retrieval according to the classification criteria. The Cochrane manual was used for quality evaluation while RevMan 5.3 software was used for data analysis. Results 5 RCTs were included involving a total of 640 patients. The results of meta-analysis showed that the treatment of acute tonsillitis with oral liquid combined with antibiotics was far more effective than antimicrobials alone in terms of shortened time of sore throat relief (MD = -20.21, 95%CI[-25.18, -15.24], P<0.001) (MD = -22.62, 95%CI[-30.48, -14.75], P<0.001) and response rate (RR = 3.07, 95%CI[1.92, 4.89], P<0.001). Conclusion However, due to the low quality of clinical trials, the above findings need to be confirmed by more high-quality clinical trials, and related adverse reactions deserve attention. References | Related Articles | Metrics

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560 cases of adverse drug reaction/event caused by Mailu Shutong pills WANG Yuxi, ZHANG Zonglin, WANG Yingli, CHEN Yafei, LI Junsheng, HUO Yanfei, XIE Yanjun, LIU Wenqi 2024, 21(8): 921-924.  DOI: 10.19803/j.1672-8629.20230795 Abstract ( 108 )   PDF (1340KB) ( 104 )   Objective To analyse the characteristics of adverse drug reaction/event(ADR/ADE) induced by Mailuo Shutong pills, so as to provide reference for clinical safe medication. Methods Five hundred and sixty cases of ADR/ADE reports involving Mailuo Shutong pills in Shandong Province Adverse Drug Reaction Monitoring System between 2004 and 2023 were analyzed in terms of the types of reports, categories of reporting institutions, annual changes, gender, age, systems-organs ADR/ADE involved, clinical manifestations, reasons for medication, combined medications and clinical outcomes. Results There were a total of 560 cases of ADR/ADE caused by Mailuo Shutong pills, 540 (96.43%) of which were normal ones, and 20 (3.57%) were severe ones. The main systems-organs involved in ADR/ADE were the gastrointestinal system, skin and its accessories, systemic reactions, and the central and peripheral nervous system. The clinical manifestations of ADR/ADE were mostly nausea, vomiting, diarrhea, itching and rash. In 471 of these cases (84.11%), ADR/ADE had no significant effect on the preexisting diseases, but 19 s (3.39%) refused to improve, and 70 (12.50%) lost contact. Conclusion The post-marketing safety of Mailuo Shutong pills is good, but there are occasionally serious adverse reactions. Clinicians need to be alert to potential risks to drug quality or medications. References | Related Articles | Metrics

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Adverse reaction/event reports of esmolol ZHAO Jun, DONG li, WANG Yang, LIANG Yu, YANG Xue, LI Enze 2024, 21(8): 925-930.  DOI: 10.19803/j.1672-8629.20240020 Abstract ( 113 )   PDF (1345KB) ( 127 )   Objective To analyze the characteristics of esmolol-related adverse reactions/events so as to provide reference for safe drug use. Methods Case reports of esmolol-induced adverse reactions/events that were published between the inception and October 31, 2023 were retrieved from Web of Science, Pubmed, Springer Link, CNKI, Wanfang and VIP database. The consistency was verified by FAERS database between 2004 and 2023. Results A total of fourteen pieces of literature were included, involving fourteen patients who reported esmolol-related adverse reactions/events. These patients ranged in age from 15 to 94, with an average age of 59.79 years. The onset could take a few minutes or 9 days. The adverse reactions/events included seizures, delirium, hyponatremia, cardiac arrest, severe ventricular arrhythmia, and coronary artery spasm. A total of 208 patients with esmolol adverse events were detected in the FAERS database, with a total of 559 adverse events, involving 21 systematic organ classifications (SOCs). The signal was the strongest in case of junctional ectopic tachycardia, followed by decreased stroke volume, pulseless electrical activity, extravasation, heat attack, ventricular dysfunction, ventricular fibrillation, infusion site exudation, cardiogenic shock and coronary artery spasm, which was highly consistent with the case reports collected in literature. Conclusion Esmolol has been widely used in clinic, and most of the adverse reactions/events have been mild and transient. However, there are adverse reactions/events that are serious and left unmentioned in specifications. It is recommended that esmolol be used with caution, requiring early judgement of adverse effects, prompt discontinuation of the drug, and early administration of relevant symptomatic treatments. References | Related Articles | Metrics

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Detection and analysis of signals of adverse events induced by deferasirox based on FAERS ZHONG Hong, CHEN Hong, ZHANG Xuanyi, DENG Huiyuan, LUO Xianglin, WAN Jie, KONG Wenqiang 2024, 21(8): 931-935.  DOI: 10.19803/j.1672-8629.20240031 Abstract ( 85 )   PDF (1221KB) ( 110 )   Objective To provide reference for clinical safe medication by exploring adverse event reports of deferasirox. Methods The adverse event (AE) reports of deferasirox collected between November 2005 and September 2023 were retrieved from FAERS database, and classified according to the system organ class (SOC) and preferred term (PT). Suspicious risk signals were mined and analyzed using the reporting odds ratio (ROR) and information component (IC) method. Results A total of 19 657 AEs related to deferasirox as the primary suspect were reported. The male-to-female ratio was 1.04 : 1 and the age mainly ranged from 18 to 85 years old (7 948 cases, 40.43%). A total of 870 AE signals were detected, involving 20 SOC. Among the top 20 PTs of reports, 4 positive signals were not mentioned in drug instructions, including infections, infestations (2 signals), general disorders and administration site conditions (2 signals). Conclusion In clinical use of deferasirox, clinicians should be alert not only to adverse reactions, but to the risk of infection, cerebrovascular accidents, constipation and hypersensitivity myocarditis so as to ensure the safety of medication for patients. References | Related Articles | Metrics

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Pharmaceutical care of hyperprolactinemia in a patient induced by risperidone ZHANG Qian, YUN Yuan, HE Lian 2024, 21(8): 936-938.  DOI: 10.19803/j.1672-8629.20230760 Abstract ( 89 )   PDF (1281KB) ( 92 )   Objective To analyze a case of hyperprolactinemia caused by the use of risperidone, so as to provide reference for clinical safety and rational medication. Methods In a case of hyperprolactinemia caused on by risperidone use, individualized treatment plan adjustment, pharmacological monitoring, and medication education were carried out, and relevant literature was combined to summarize the clinical manifestations, mechanisms, adverse outcomes, treatment plans, and key points of pharmaceutical monitoring of hyperprolactinemia. Results This case is a patient with severe depressive episodes accompanied by psychotic symptoms. The patient suffered lactation, menstrual problems, and elevated serum prolactin levels on the 17th day of therapy with risperidone for mental illness; however, with the combination of aripiprazole treatment, the patient’s serum prolactin level gradually decreases and the nipple discharge disappears. Conclusion The adverse reaction of hyperprolactinemia caused by antipsychotic drugs have a sense of shame and concealment. During medication, patient monitoring and medication education should be strengthened, and serum prolactin levels should be regularly checked to achieve early identification and adjustment of treatment plans. References | Related Articles | Metrics

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One case of severe systemic rash caused by atorvastatin calcium tablets LI Fang, LONG Xiuying, BAI Na, WEI Jingxia 2024, 21(8): 939-942.  DOI: 10.19803/j.1672-8629.20240094 Abstract ( 125 )   PDF (1234KB) ( 129 )   Objective To analyze the clinical characteristics and potential allergenic mechanisms of atorvastatin induced severe generalized rash in patients with chronic diseases, providing a warning for future polypharmacy and reference for early clinical management. Methods A retrospective study was conducted on a patient with cerebral infarction who developed a generalized rash after polypharmacy (amlodipine, aspirin, atorvastatin, urinary kallidinogenase and edaravone dexborneol) was conducted. The rash worsened even after discontinuing urinary kallidinogenase and edaravone dexborneol and switching aspirin to clopidogrel. The rash subsided only after discontinuing all medications except for antiallergic drugs. When clopidogrel and amlodipine were reintroduced, the rash did not recur. The Naranjo score and literature review were used to analyze the potential allergenic drug. Results Based on the clinical presentation of the rash and its relationship with the timing of medication, combined with the Naranjo score of 5 for atorvastatin, it is very likely that atorvastatin is the drug causing the patient’s rash. Conclusions Clinicians should be aware that atorvastatin can cause severe generalized rash in chronic diseases patients a few days after administration during polypharmacy. References | Related Articles | Metrics

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One case of ureterolith combined with gallstone caused by Ceftriaxone sodium for injection in children CHAO Ying, ZHANG Xuemei, ZHANG Chengjian, WANG Bei 2024, 21(8): 943-945.  DOI: 10.19803/j.1672-8629.20240158 Abstract ( 91 )   PDF (1140KB) ( 89 )   Objective To explore the mechanism of ceftriaxone injection causing ureterolith and gallstone in children, and provide reference for the safe and reasonable use of ceftriaxone injection in clinical practice. Methods The diagnosis and treatment process of ureterolith and gallstone in the children after receiving treatment with ceftriaxone was analyzed. And Related literature were searched to analyze the mechanism of adverse drug reactions and clinical countermeasures. Results After 5 days of using ceftriaxone, this child developed ureterolith and gallstones. After discontinuing the use of ceftriaxone, ureterolith naturally improved. Based on the analysis of relevant literature, children may develop ureterolith and gallstone after using ceftriaxone, but most of them disappear automatically after discontinuation. Conclusion Ceftriaxone is likely to cause ureterolith and gallstone in children, which deserves more attention in clinic. References | Related Articles | Metrics

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One case of persistent hiccup caused by Wenxin Keli GUO Haiyan, HE Bo, YAN Hongli, YANG Xueting 2024, 21(8): 946-948.  DOI: 10.19803/j.1672-8629.20240066 Abstract ( 62 )   PDF (1254KB) ( 76 )   Objective To analyze the new adverse reaction of Wenxin Keli causing persistent hiccups. Methods A case of persistent hiccups in a 29-year-old woman taking Wenxin Keli was analyzed. The relevance of persistent hiccups to the suspected drug was evaluated, and the causes and mechanisms of persistent hiccups in the patient caused by Wenxin Keli were analyzed through a literature review. Results By correlation evaluation, this case of hiccup is most likely due to Wenxin Keli. Discontinuation measures were used, and the patient did not experience further symptoms of persistent hiccups. Conclusion Medical personnel should be vigilant and strengthen the monitoring of the adverse reaction of Wenxin Keli causing persistent hiccups. References | Related Articles | Metrics

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Research progress of sustained and controlled release preparations of Chinese medicine SUN Li, XIE Bin, XU Yanqin 2024, 21(8): 949-954.  DOI: 10.19803/j.1672-8629.20240249 Abstract ( 67 )   PDF (1293KB) ( 68 )   Objective To summarize the research progress on the slow and controlled release preparations of traditional Chinese medicine, and provide a basis for understanding the preparation process, prescription and quality evaluation of slow and controlled release preparations of traditional Chinese medicine. Methods Through literature search,the advantages and disadvantages, preparation process, and quality evaluation system was summarized from different new types of sustained and controlled release formulations. Results The new types of sustained and controlled release formulations involve solid lipid nanoparticles sustained and controlled release formulations, oral osmotic pump sustained and controlled release formulations, gastric retention delivery sustained and controlled release formulations, bioadhesive microspheres, and solid dispersions, and the preparation process uses multiple screening methods to arrive at the optimal process, and the quality evaluation methods for the sustained and controlled release formulations of traditional Chinese medicines include in vitro release studies, in vivo release, and in vitro and in vivo correlation studies. Conclusion The research on slow and controlled release preparations of traditional Chinese medicine mainly focuses on the single component of traditional Chinese medicine, traditional Chinese medicine extracts or active parts, and combination of several single components of traditional Chinese medicine, and the quality evaluation system mainly includes in vivo release, in vitro release and in vitro and in vivo correlation studies, which can provide reference basis for the future development of slow and controlled release preparations of traditional Chinese medicine. References | Related Articles | Metrics

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Methods of preparation of Bupleuri Radix based on the idea of ‘Tong Quan Da Bian’ ZHENG Changhui, MA Lina, HE Ting, ZHAO Wei, GU Yuanyuan, HU Xiaozhen, NIU Yuanfei, GUO Yueshan, CAO Junling 2024, 21(8): 955-960.  DOI: 10.19803/j.1672-8629.20240192 Abstract ( 44 )   PDF (1380KB) ( 63 )   Objective To analyze the ancient and modern experience concerning medications with Bupleuri Radix and recent research progress in processed products of this drug based on the idea of “Tong Quan Da Bian” so as to provide reference for the study of the processing mechanism and processing technology of Bupleuri Radix. Methods The evolution of processing methods of Bupleuri Radix and the way in which Bupleuri Radix decoction pieces were used clinically were retrieved from such databases as Chinese Medical Classics and Duxiu. Based on literature review, the current research progress in a range of processed products of Bupleurum chinense was analyzed. Results According to the records of medical classics, the processed products of Bupleuri Radix were diverse, and there were considerable differences in the efficacy of different processed products: the effect of soothing the liver and relieving depression by vinegar Bupleuri Radix was enhanced while the property of elevating and dispersing qi was weakened; the effect of nourishing yin and reducing fever by Bupleuri Radix processed with trionyx blood was enhanced, and the property of floating yang was weakened; the effect of relieving rigidity of muscle, activating collaterals and pain relief was enhanced. Modern research has interpreted the connotations of different processed products of Bupleuri Radix to different extents, but there are still some problems, such as variations in processing technology and inconsistent quality standards. Conclusion Bupleuri Radix has been long used as a medicinal herb, with wide clinical applications and varieties of processed of products. It is urgent to conduct systematic research on the pharmacodynamic material basis and processing mechanism of different processed products, advance our understanding of the connotations of different processed products of Bupleuri Radix, standardize the processing technology and formulate better quality standards, provide processed products of Bupleuri Radix that are stable and controllable in quality and of different varieties for clinical use, and give full play to the clinical superiorities of Bupleuri Radix. References | Supplementary Material | Related Articles | Metrics