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Determination of meglumine in lansoprazole for injection by HPLC-NQAD YANG Qian, HUI Yanchun, WANG Chen, ZHANG Xianhua, XU Mingzhe 2023, 20(4): 361-364.  DOI: 10.19803/j.1672-8629.20230045 Abstract ( 166 )   PDF (1431KB) ( 187 )   Objective To establish a method for determining the content of meglumine in lansoprazole for injection based on HPLC-NQAD. Methods The HPLC-NQAD method was established on a CAPCELL PAK CR 1:4 column(2.0 mm × 150 mm, 5 μm) by using a mobile phase of 5 mmol·L-1 ammonium formate-2% acetonitrile(A) and 50 mmol·L-1 ammonium formate-50% acetonitrile(B) under gradient elution at a flow rate of 0.3 mL·min-1. The column temperature was 40℃, injection volume was 5 μL, NQAD evaporation temperature was 35℃, atomization temperature was 30℃, and nitrogen pressure was 30 psi. Results Meglumine was separated completely in the test solution. The calibration curve was linear within the range of 1.0 µg·mL-1 to 100.0 µg·mL-1 for meglumine(r = 0.999 8). The average recovery was 99.96%, and the RSD was 1.01%. Conclusion This method has proved to be simple, accurate, sensitive and reliable. It can be used for the determination of meglumine in lansoprazole for injection. References | Related Articles | Metrics

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Determination of bactericidal sodium benzoate and potassium sorbate in pediatric oral liquid preparations by HPLC ZHOU Yuanhua, WU Liangyong, ZHANG Liwen, DONG Shunling, YAO Shangchen, XU Mingzhe, ZHANG Xianhua 2023, 20(4): 365-369.  DOI: 10.19803/j.1672-8629.20230094 Abstract ( 105 )   PDF (1350KB) ( 404 )   Objective To establish an HPLC method for screening analysis of sodium benzoate and potassium sorbate in pediatric oral liquid preparations. Methods The chromatography was performed on Ecosil C18 column(250 mm×4.6 mm, 5μm) using. 0.02 mL·min-1 ammonium acetate solution-acetonitrile(95∶5, V/V) as mobile phase at a flow rate of 1.0 mL·min-1, and detected at 225 nm. Results Sodium benzoate and potassium sorbate showed a good linear relationship with the peak area in the range of 1.140~114.0 μg·mL-1（r=1.000 0）and 1.082~108.2 μg·mL-1（r=1.000 0）, respectively.The limit of quantification (LOD) were 0.220 9 ng and 0.202 1 ng, and the limit of quantification (LOQ) were 0.673 8 and 0.736 4 ng. The average recoveries were 100.4% with an RSD of 0.4% (n=9) and 100.7% with an RSD of 0.5% (n=9) .In 21 samples of 15 species, the sodium benzoate and potassium sorbate detected were within the reference limits. Conclusion The proposed HPLC method is specificity, accuracy and serviceability. It can be successfully applied in quality control of different types of pediatric oral liquid preparations. References | Related Articles | Metrics

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Determination of ethylene oxide genotoxic impurity in metoprolol succinate LIU Chunliang, LIU Xiaoqiong, ZHANG Lei, ZHU Kexu, CAO Jieyong, WANG Chen, XU Mingzhe, ZHANG Xianhua 2023, 20(4): 370-373.  DOI: 10.19803/j.1672-8629.20230071 Abstract ( 100 )   PDF (1549KB) ( 97 )   Objective To establish an HPLC method for the determination of ethylene oxide genotoxic impurity XI in metoprolol succinate. Methods The Wondasil C18-WR (4.6 mm×250 mm, 5.0 μm) column was used. The mobile phase consisted of methanol and buffer (potassium dihydrogen phosphate 2.72 g, sodium perchlorate monohydrate 6.13 g, dissolved in 1 000 mL water, with pH adjusted to 6.0 with 1. 0 mol·L-1 sodium hydroxide solution) under gradient elution. The flow rate was 1.0 mL·min-1, the injection volume was 40 μL, the column temperature was 30℃ and the detection wavelength was 226 nm. Results The linear range of impurity XI was 0.853 2 to 6.818 3 μg·mL-1(r=0.999 9). The detection limit was 0.426 1 μg·mL-1, with a quantitative limit of 0.852 3 μg·mL-1. The average recovery was 94.21%. Conclusion This method is highly specific, sensitive and user-friendly, which can be used for the determination of genotoxic impurity of ethylene oxide in metoprolol succinate. References | Related Articles | Metrics

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Preparation, characterization and stability of three forms of prulifloxacin HUANG Yinyin, ZHANG Liwen, LIU Jing, CHEN Jing, ZHOU Yuanhua, XU Mingzhe, YAO Shangchen, WANG Chen, ZHANG Xianhua 2023, 20(4): 374-378.  DOI: 10.19803/j.1672-8629.20230093 Abstract ( 71 )   PDF (1568KB) ( 75 )   Objective To study the polymorphism of prulifloxacin and provide a scientific basis for the quality control of the polymorphic impurities in the drug. Methods Three forms of prulifloxacin (formⅠ, formⅡ and form Ⅲ) were prepared. The forms were characterized by using powder X-ray diffraction, infrared spectroscopy, differential scanning calorimetry and Raman spectroscopy, and the stability relationship and crystal transformation rules of the three forms were explored by suspension experiments. Results Powder X-ray diffraction, infrared spectroscopy, thermal analysis and Raman spectroscopy were used to identify the three polymorphs of prulifloxacin effectively. The stability relationship of forms is: formⅠ> formⅡ > form Ⅲ. Conclusion This study provides references for the formulation of the standard of prulifloxacin. References | Related Articles | Metrics

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Comprehensive tests and risk assessment of exogenous harmful residues in Isatidis Radix NIE Lixing, CHEN Jia, ZHANG Ye, ZHAO Hui, DAI Zhong, MA Shuangcheng 2023, 20(4): 379-382.  DOI: 10.19803/j.1672-8629.20210658 Abstract ( 125 )   PDF (1301KB) ( 138 )   Objective To conduct a comprehensive inspection and risk assessment of exogenous harmful residues in Isatidis Radix so as to provide reference for safe use of Isatidis Radix. Methods Thirty-three forbidden pesticides were determined using gas chromatography-tandem mass spectrometry (GC-MS-MS) and high performance liquid chromatography-tandem mass spectrometry (HPLC-MS-MS) methods. Four aflatoxins were determined with the high performance liquid chromatography with fluorescence detection after immunoaffinity column clean-up (IC-HPLC-FD) method. Five heavy metals and harmful elements were determined via inductively coupled plasma mass spectrometry (ICP-MS). Sulfur dioxide was determined by means of ion-chromatography (IC). Subsequently, risk assessment was performed using the target hazard quotient (THQ) method. Results Thirty-three forbidden pesticides or aflatoxin B1, B2, G1 and G2 were not detected in 64 batches of Isatidis Radix. Contents of sulfur dioxide were all below the limit specified by the Chinese Pharmacopeia (150 mg·kg-1). THQ of sulfur dioxide, Pb, Cd, As, Hg and Cu in 64 samples and Isatidis Radix were far below one. Based on risk assessment, limits of Pb, Cd, As, Hg and Cu in Isatidis Radix were proposed as 2, 1, 2, 0.2 and 20 mg·kg-1, respectively. Conclusion The risk of exogenous harmful residues in Isatidis Radix is low. References | Related Articles | Metrics

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Determination of cis(trans)-THSG in Polygoni Multiflori Radix from different areas and Polygoni Multiflori Radix Preparata using different processing methods by UPLC WANG Xueting, YANG Jianbo, GAO Huiyu, SONG Yunfei, CHENG Xianlong, GU Donglin, WANG Ying, MA Shuang-cheng, WEI Feng 2023, 20(4): 383-387.  DOI: 10.19803/j.1672-8629.20210925 Abstract ( 59 )   PDF (1421KB) ( 66 )   Objective To provide data for quality control of Polygoni Multiflori Radix (PMR) and processing standards for Polygoni Multiflori Radix Preparata (PMRP) by observing the changes of cis(trans)-THSG (2, 3, 5, 4'- tetrahydroxystilbene-2-O-β-D-glucoside) of this plant grown in different areas and processed differently and to explore the mechanism by which processing can reduce its toxicity and increase efficacy. Methods An HPLC method was employed to determine the contents of cis(trans)-THSG. Results The content of cis(trans)-THSG in PMR and PMRP ranged from 27.23 to 358.19 μg·g -1 and from 10.30 to 52.00 mg·g -1 respectively. Conclusion This method is simple, accurate and reproducible, which can be used for References | Related Articles | Metrics

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Rapid detection of sitagliptin in complex matrices by paper spray ionization mass spectrometry SONG Dongning, LIU Jing, ZHANG Caiyu, LIU Yang, HE Lan, ZHANG Qingsheng 2023, 20(4): 388-391.  DOI: 10.19803/j.1672-8629.20220163 Abstract ( 55 )   PDF (1345KB) ( 58 )   Objective To establish an analytical method based on paper spray ionization mass spectrometry (PSI-MS) for rapid screening of sitagliptin in complex matrices. Methods Such experimental parameters as the spray voltage, spray solvent, distance from the tip of the chromatographic paper to the injection port of the mass spectrometer were optimized. A semi-quantitative method for rapid characterizing sitagliptin was established by adding an internal standard. Results Sitagliptin could be detected in less than one minute. The linear relationship of this method was good and the correlation coefficient r2 was 0.999 8 within the range of 0.1 to 10 μg·mL-1. The recovery rates were between 94% and 109% with an RSD of less than 5%. Conclusion This method is simple, user-friendly, sensitive and precise, which can be used to quantitatively determine the content of sitagliptin in complex matrices. References | Related Articles | Metrics

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Determination of genotoxic impurities in clozapine by UPLC-MS/MS SHI Hui, ZHAO Zhenkun, WANG Shuling 2023, 20(4): 392-396.  DOI: 10.19803/j.1672-8629.20220426 Abstract ( 71 )   PDF (1548KB) ( 78 )   Objective To establish an analytical method based on UPLC-MS/MS for the determination of genotoxic impurities in clozapine. Methods The impurities were separated using an Inert Sil-ODS-3 (75 mm×?.? mm×? mm) with a mobile phase composed of 0.1% formic acid aqueous solution (mobile phase A) and acetonitrile (mobile phase B) by gradient elution at a flow rate of 0.7 mL·min-1. Multiple reaction monitoring (MRM) was performed on a mass spectrometer equipped with an ESI source in the negative mode. Results The linearity of anthranilic acid, cyclized and condensed compounds, and cyclized acid precipitates was desirable within ranges of 20 to 100 ng·mL-1, 0.16 to 3.2 ng·mL-1 and 0.48 to 3.2 ng·mL-1. The recoveries of spiked samples at low（80%）, medium（100%） and high（120%）concentrations ranged from 90.8% to 117.2%, and RSD was between 3.9% and 12.8%. The limit of detection ranged from 0.08 to 10 ng·mL-1 and the limits of quantification of anthranilic acid, cyclized and condensed compounds, and cyclized acid precipitates were 20 ng·mL-1, 0.16 ng·mL-1 and 0.48 ng·mL-1, separately. The detected concentration was below the limit. Conclusion The established method is simple and reliable, which is applicable to quantifications of three genotoxic impurities in clozapine. References | Related Articles | Metrics

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Preparation and quality evaluation of standard decoctions of Rosa chinensis Jacq. LI Ning, JIANG Xiaoya, ZHANG Zezhao, GAO Le, WANG Xinguo, LIU Xiaoming 2023, 20(4): 397-402.  DOI: 10.19803/j.1672-8629.20220717 Abstract ( 72 )   PDF (1429KB) ( 77 )   Objective To establish a quality evaluation method for the standard decoctions of Rosa chinensis Jacq. so as to provide reference for the use and quality control of the standard decoction of Rosa chinensis Jacq..Methods Fifteen batches of prepared slices of Rosa chinensis Jacq. were collected from different areas of production to prepare standard decoctions. Hypericin and isoquercitrin were selected as indicators of quantitative detection to calculate the transfer rate while HPLC characteristic chromatograms were established and analyzed with the Similarity Evaluation System for Chromatographic Finger-print of Traditional Chinese Medicine (2012). Results Among the standard decoctions made from 15 batches of Rosa chinensis Jacq. samples, the extraction rate of the standard decoction of samples was 16.32%-23.22%. The transfer rates of hypericin and isoquercitrin ranged from 27.57% to 45.42% and from 34.38% to 49.71% respectively. Eleven common peaks were determined with four characteristic peaks identified．Moreover, the similarity was over 0.90. Conclusion A simple, stable and feasible method for the preparation and quality evaluation of standard decoctions of the Rosa chinensis Jacq. is established, which can provide reference for related research. References | Related Articles | Metrics

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Reversal of multidrug resistance in human oral epithelial cancer cells KBV200 by a natural product HUANG Wei, WU Ruiqing, SUN Hua, SHI Jiangong, LIU Qian 2023, 20(4): 403-408.  DOI: 10.19803/j.1672-8629.20220534 Abstract ( 48 )   PDF (1450KB) ( 58 )   Objective To investigate the ability of a natural product EM-E-11-4 at non-cytotoxic concentrations to reverse P-gp-mediated multidrug resistance (MDR) in human oral epithelial cancer cells KBV200 and to reveal the mechanism of action. Methods The effect of EM-E-11-4 on the growth of KB cells and the corresponding resistant cells KBv200 was determined by MTT assay. Using VRP as positive control, the ability of non-cytotoxic concentrations of EM-E-11-4 (2.5, 5, 10 µmol·L-1) with/without such chemotherapeutic agents as paclitaxel vincristine and adriamycin to reverse MDR was evaluated, while the reversal folds (RF) of EM-E-11-4 and VRP were calculated and compared. The effect of EM-E-11-4 and VRP on the accumulation and efflux function of P-gp was studied. Furthermore, the effect of EM-E-11-4 on the ATPase activity of P-gp was measured by Pgp-GloTM kit. Results 10 µmol·L-1 of EM-E-11-4 effectively reversed the MDR-phenotype of KBv200 cells to paclitaxel, vincristine and adriamycin. The RF was 33.8、36.4 and 20.1, respectively. In addition, the P-gp functional study suggested that EM-E-11-4 elevated the intracellular accumulation of adriamycin in a dose-dependent manner. EM-E-11-4 suppressed VRP-stimulated ATPase activity of P-gp in a dose-dependent manner. Conclusion EM-E-11-4 can be a potential agent that can overcome P-gp-mediated MDR by suppressing the transport function of P-gp. References | Related Articles | Metrics

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Mechanism of activation of NLRP3 inflammasome by α-synuclein performed fibrils MA Yidan, YAN Jiaqing, CHU Shifeng, ZHANG Zhao, LIU Yangbo, CHEN Naihong, PENG Can 2023, 20(4): 409-415.  DOI: 10.19803/j.1672-8629.20220710 Abstract ( 57 )   PDF (1804KB) ( 112 )   Objective To investigate the mechanism by which fibrillar α-synuclein aggregates induce neuroinflammation by activating NLRP3 inflammasomes. Methods α-synuclein performed fibrils (PFF) was established and added to BV-2 cells. Levels of such inflammatory factors as IL-1β, IL-18, IL-6 and TNF-α as well as protein and mRNA levels of NLRP3, caspase-1 and ASC were detected. LDH release assay was used to investigate pyroptosis. For mechanism research, activation of TLR2 and TLR4 was measured. C29 and TAK-242, inhibitors for TLR2 and TLR4, were used to detect the influence on NLRP3 inflammasome activation mediated by PFF. Results PFF was established as revealed by Western blot and Thioflavin T (ThT) staining. After PFF treatment, NLRP3 inflammasomes were activated in BV-2 cells as evidenced by the release of IL-1β, increased protein levels of NLRP3 and caspase-1 as well as significantly higher mRNA levels of NLRP3, caspase-1 and ASC in the PFF group compared with the control group. However, pyroptosis was not detected in either the PFF group or in the control group. TLR2, but not TLR4, was activated by PFF treatment. Inhibition of TLR2 rather than TLR4 could block PFF induced activation of NLRP3 inflammasomes. Conclusion Fibrillaraα-synuclein aggregates can activate NLRP3 inflammasomes, and the mechanism may be related to the activation of TLR2. References | Related Articles | Metrics

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General toxicology of Yiya Jianpi jel among juvenile animals LIU Huan, YUAN Hui, YIN Jingjing, LIU Mengya, QIN Xiujun, LI Jianguo 2023, 20(4): 416-422.  DOI: 10.19803/j.1672-8629.20220081 Abstract ( 47 )   PDF (1552KB) ( 62 )   Objective To evaluate the safety of Yiya Jianpi jel and its effects on the growth of juvenile SD rats via acute toxicity and long-term toxicity tests. Methods The acute toxicity test was conducted using the maximum tolerable dose (MTD) method. The maximum dose was 5.2 g·kg-1, twice a day, and the total dose was 10.4 g·kg-1. After administration, the toxic reactions of rats were closely observed. The 200 juvenile SD rats used in the long-term toxicity test were divided into the high (3.9 g·kg-1), medium (2.6 g·kg-1), low (1.3 g·kg-1) dose groups and control group, with 50 rats in each. The drug was administered for ninety consecutive days before the rats were allowed to recover for twenty-eight days. The main indexes for examination were body mass, food intake, hematology, blood biochemistry, physiological development, endocrine, neuroethology and pathology. Results The MTD of Yiya Jianpi jel exceeded 10.4 g·kg-1 in juvenile SD rats, and no obvious side effects were observed. In the high dose group, transient changes were observed in some of the indexes during the long-term toxicity test, but no drug-related toxic pathological changes were observed (3.9 g·kg-1). Conclusion Under the conditions used in this experiment, Yiya Jianpi jel causes no obvious toxic reactions to the tested animals and clinical use in children is supported. References | Related Articles | Metrics

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Applicability of patient registry research to regulation of medical devices ZHAO Yan, LIU Wenbo, ZHAO Yifei, LI Dong, ZHENG Lijia, SONG Yana, ZHAO Yujuan, DONG Fang 2023, 20(4): 423-427.  DOI: 10.19803/j.1672-8629.20220654 Abstract ( 117 )   PDF (1265KB) ( 136 )   Objective To explore the feasibility and significance of active monitoring of patient registries in the light of actual supervision of medical devices in China, and to propose the incorporation of patient registries into regulatory science as a new method of monitoring. Methods Based on literature review, cases of patient registry research that had been carried out at home and abroad were analyzed and the application of patient registries as a proactive monitoring method in regulatory decision-making for high-risk implantable medical devices was elaborated. Results As an important real-world data source, patient registries have become a useful means and method to gather “real-world” evidence on high-risk implantable medical devices and provide critical evidence for national regulatory decisions. Conclusion In order to become aligned with the characteristics of the medical device industry and trends of globalization, it is recommended that patient registries be incorporated into the science of medical device supervision in China as a new tool for proactive monitoring. References | Related Articles | Metrics

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Pharmacovigilance in retail pharmacies for special or major diseases HUO Peiqiong, ZHENG Peng, SU Zhenhao 2023, 20(4): 428-432.  DOI: 10.19803/j.1672-8629.20220591 Abstract ( 172 )   PDF (1244KB) ( 174 )   Objective To explore how to exercise pharmacovigilance in retail pharmacies for special or major diseases (DTP pharmacies) so as to contribute to the construction of pharmacovigilance systems. Methods By means of field research and literature review, the characteristics, problems and solutions regarding pharmacovigilance in DTP pharmacies were described. Results Pharmacovigilance in DTP pharmacies is necessary, unique, representative and user-friendly, but is hindered by incompetence of practitioners, low trust from patients, imperfect pharmacovigilance mechanisms and a lack of targeted laws, regulations and guidelines. Conclusion It is recommended that pharmacovigilance professionals in DTP pharmacies should be better-trained, patients'trust enhanced through professional services and branding, and the pharmacovigilance mechanisms, related laws, regulations and guidelines revised. References | Related Articles | Metrics

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Efficacy and safety of Toutongning capsules in the treatment of chronic headache: a Meta-analysis SU Xinxin, LYU Jian, XIE Yanming 2023, 20(4): 433-440.  DOI: 10.19803/j.1672-8629.20211045 Abstract ( 110 )   PDF (1502KB) ( 102 )   Objective To evaluate the efficacy and safety of Toutongning capsules in the treatment of chronic headache. Methods Literature related to randomized controlled trials of Toutongning capsules for chronic headache that was published between inception and April 30, 2021 was screened out by searching CNKI, Wanfang, VIP, SinoMed, Cochrane Library, PubMed, Embase and Web of Science. The evaluation criteria of Cochrane Handbook 5.1.0 and RevMan 5.3 software were used for Meta-analysis of the enrolled studies. Results A total of 9 studies were included in the meta-analysis, with a total sample size of 886 cases including 450 cases in the experimental group and 436 cases in the control group. The results of Meta-analysis showed that after the literature with poor heterogeneity was excluded, the headache severity score of Toutongning capsules combined with conventional treatments was better than that of conventional treatments alone (MD=-0.91, 95%CI[-1.19, -0.63], P＜0.000 01), so were the duration of therapeutic effect (MD=-2.32, 95%CI[-3.86, -0.79］, P=0.003) and efficacy(RR=2.55, 95%CI[1.96, 3.30］against chronic headache (P＜0.000 01). In terms of safety, the adverse reactions caused by Toutongning capsules included chest tightness, dizziness, gastrointestinal reaction, stomach discomfort, dizziness and dry mouth, but there was no significant difference in the incidence of adverse reactions between the experimental group and the control group. Conclusion Toutongning capsules alone or combined with conventional treatments are more effective than conventional treatments alone. No serious adverse reactions have been found, which can provide evidence-based data for clinical practice and clinical drug use. References | Related Articles | Metrics

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Active monitoring of adverse reactions of capecitabine-induced hand-foot syndrome based on the hospital information system ZHENG Yujing, ZHAO Zinan, JIN Pengfei, ZHAO Fei, HU Xin, ZHANG Yatong 2023, 20(4): 441-443.  DOI: 10.19803/j.1672-8629.20220007 Abstract ( 140 )   PDF (1147KB) ( 98 )   Objective To explore active monitoring methods of capecitabine-induced hand-foot syndrome. Methods Retrospective risk signal mining was performed on patients who had been hospitalized in Beijing Hospital and taken capecitabine between October 1, 2020 and September 30, 2021 using the PASS ADR. Manual causality evaluation and screening were performed on suspected cases of capecitabine-induced hand-foot syndrome, and the clinical characteristics, therapeutic drugs, treatments and outcomes of the positive cases of capecitabine-induced hand-foot syndrome were analyzed. Results A total of 257 inpatients were treated with capecitabine in the course of monitoring, 35 of whom had risk signals of hand-foot syndrome detected through PASS ADR. Through manual screening and causality evaluation, 14 patients with capecitabine-related drug-induced hand-foot syndrome were finally obtained. The incidence of capecitabine-induced hand-foot syndrome was 5.45%, and the correct rate of identification by the active monitoring system was 40.0%. Conclusion Active monitoring can effectively improve the sensitivity of ADR monitoring and early detection of mild adverse reactions. References | Related Articles | Metrics

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289 cases of adverse drug reactions associated with monoclonal antibody antitumor drugs LUO Shishu, QU Jie, ZHOU Nan, XU Cuixiang, LIU Yi, ZHANG Lijie, WANG Jianhua 2023, 20(4): 444-448.  DOI: 10.19803/j.1672-8629.20210679 Abstract ( 196 )   PDF (1272KB) ( 162 )   Objective To analyze the patterns and characteristics of adverse drug reactions（ADR）caused by monoclonal antibody anticancer drugs in order to facilitate clinical treatment. Methods A total of 289 cases of ADR induced by monoclonal antibody anticancer drugs between 2016 and 2020 were collected from Shaanxi Province Adverse Drug Reaction Center before being analyzed statistically．Results In these 289 ADR reports, five types of antineoplastic drugs were involved．The majority of the patients with ADR were over 40 years old and female patients outnumbered male ones. Gamage to blood systems was the dominating ADR, followed by damage to the digestive system, systemic reactions, and damage to the skin and accessories. The ADR were similar in that a large proportion of them were induced by bone marrow suppressors. However, many of the symptoms of the digestive tract were caused by bevacizumab and trastuzumab. The skin toxicity of cetuximab and pertuzumab was obvious. Rituximab was likely to cause shivering and high fever. These five types of drugs were mainly given by intravenous drip, but there were still eleven cases of intravenous injection or intrapleural administration. Rituximab caused the large number of severe ADR (34 cases) such as myelosuppression and high fever, followed by bevacizumab (27 cases), the main ADR of which was myelosuppression. 86.51% of the ADR were cured and improved. However, one elderly female patient with colon cancer developed colonic perforation 20 days after bevacizumab treatment and died one month later. Conclusion The incidence of ADR caused by monoclonal antibody anticancer drugs is closely related to the patient's age, route of administration and types of drugs. Some drugs that require special usage and considerations deserve attention. In order to use monoclonal antibody antitumor drugs properly, clinicians should take into account the patient's conditions and the characteristics of drugs in order to prevent ADR. References | Related Articles | Metrics

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Characteristics of Psoralea corylifolia induced liver injury CHEN Chao, ZHU Lan, LIU Lihong, HAN Jiayin, ZHU Yan 2023, 20(4): 449-453.  DOI: 10.19803/j.1672-8629.20220167 Abstract ( 119 )   PDF (1394KB) ( 123 )   Objective To analyze the characteristics, risk factors and prognosis of liver injury caused by Psoralea corylifolia so as to provide data for rational drug use. Methods The literature about liver injury caused by Psoralea corylifolia or its related preparations that was published between 1962 and 2021 was searched for. The literature was screened before the related data was statistically analyzed. Results A total of 47 articles were retrieved from the databases, involving 55 cases. The incidence of the disease was higher among females, and most of the patients raged from 21 to 60 in age, mainly due to unprocessed Psoralea corylifolia. Clinical medications lasted more than 30 days. Patients who had a previous history of liver disease or used drugs that caused liver injury were more vulnerable to severe and fatal liver injury. Liver injury caused by Psoraleae corylifolia was dominated by liver cell injury, accounting for nearly 90%, and most of the cases were acute liver injury. Symptoms were likely to improve via active treatment after drug withdrawal, and the prognosis was good. Conclusion Women, elders and patients with liver disease history and previous liver injury induced by Psoraleae corylifolia should not take any Psoraleae corylifolia or its preparations in order to prevent fatal reactivation. Liver function should be monitored during clinical use of Psoralea corylifolia. Drugs should be withdrawn in case of abnormality. References | Related Articles | Metrics

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Effects of Panax notoginseng on gene expressions in rats with cerebral ischemia-reperfusion injury based on bioinformatics LIU Jie, LIU Shengwei, REN Zhongyang, DING Ling, CHEN Chang, HU Yi 2023, 20(4): 454-459.  DOI: 10.19803/j.1672-8629.20220269 Abstract ( 71 )   PDF (1683KB) ( 69 )   Objective To predict the possible targets and signaling pathways involved in anti-cerebral ischemia/reperfusion injury by Panax Notoginseng (PN) based on bioinformatics. Methods Gene expressions in the cerebral cortex of the middle cerebral artery occlusion (MCAO) model group and the Panax notoginseng (PN) drug delivery group of rats were obtained from the GEO database. The key differentially expressed genes (DEGs) were screened before GO enrichment and KEGG pathway analyses were performed to explore the possible molecular mechanisms by which Panax notoginseng combated cerebral ischemia/reperfusion injury. Results Four hundred and forty-four differential mRNAs were screened, and the key DEGs were Fn1, Gsk3b and Snap25. Twenty significant pathways were obtained after KEGG enrichment pathway analysis. Based on the mechanism for cerebral ischemia/ reperfusion injury and related literature, the key pathways were found to be to Rap1 signaling pathway, cAMP signal pathway, autophagy signal pathway, and AMPK signal pathway. There have been few studies related to Panax notoginseng and autophagy pathways on the MCAO rat model. No studies have been found on Panax notoginseng related targets of Gsk3b and Snap25. Conclusion Panax notoginseng may protect against cerebral ischemia / reperfusion injury by combating inflammation, oxidation, apoptosis or via autophagy. References | Related Articles | Metrics

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Analysis of reports of allergic shock in Chongqing between 2015 and 2020 CHEN Cheng, DENG Li, LIU Songqing, DU Qian, XI Xin 2023, 20(4): 460-464.  DOI: 10.19803/j.1672-8629.20220570 Abstract ( 214 )   PDF (1270KB) ( 198 )   Objective To study the patterns and characteristics of drug-induced allergic shock, and to provide reference for clinical prevention of severe drug allergic reactions. Methods A retrospective analysis method was used to process the reports of allergic shock collected by Chongqing Adverse Reaction Monitoring Center between 2015 and 2020. The basic information about patients, the time allergic shock occurred, drugs involved, routes of administration, outcomes and cases of death was statistically analyzed. Results The incidence of drug-induced allergic shock was higher in the elderly (≥ 60 years old). More than 75% of the cases experienced allergic shock within 30 min of administration. The proportion of allergic shock caused by intravenous drugs was the highest (85.56%). The top five categories of drugs that caused anaphylactic shock were anti-infective drugs (48.80%), traditional Chinese medicine injections (9.62%), nervous system drugs (8.37%), digestive system drugs (5.49%), vitamins, electrolytes, acid-base balance and nutritional drugs (4.43%). The top five drugs causing allergic shock were ceftriaxone, levofloxacin, penicillin, piperacillin/tazobactam and cefoperazone/sulbactam, all of which were antibacterial drugs. Conclusion A range of drugs can cause allergic shock that often occurs quickly. Clinical monitoring and management of intravenous medications should be improved, especially among the elderly. Antibiotics and traditional Chinese medicine injections should be used more rationally while adverse drug reactions have to be observed closely in order to detect allergic shock in time and take immediate measures to reduce the incidence of severe consequences of allergic shock. References | Related Articles | Metrics

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One case of tacrolimus-caused reversible posterior leukoencephalopathy syndrome after renal transplantation in children ZHANG Zhiqi, GUO Mingxing, XU Ye, ZHANG Jian, LIN Jun, CUI Xiangli 2023, 20(4): 465-468.  DOI: 10.19803/j.1672-8629.20220643 Abstract ( 89 )   PDF (1147KB) ( 139 )   Objective To find out more about the reversible posterior leukoencephalopathy syndrome (RPLS) after solid organ transplantation (SOT) in children and to explore the methods of treatment. Methods The clinical data of a child with RPLS caused by tacrolimus after renal transplantation was analyzed. The clinical characteristics, treatment plans and outcomes of RPLS were reviewed by consulting related case reports. Results RPLS was related to high concentrations of tacrolimus, mainly manifested as nervous system symptoms with or without hypertension. Anti-hypertension and antiepileptic therapies and adjustment of immunosuppressants were popularly used. Most of the children could recover within a few weeks, but a small number of children would subsequently suffer neurological disorders or even die. Conclusion Blood concentrations of immunosuppressants in children after SOT have to be closely monitored while nervous system symptoms and blood pressure deserve attention. Early identification of RPLS and prompt treatment can improve the prognosis. References | Related Articles | Metrics

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Suicidal tendency and paresthesia induced by voriconazole: a case report HU Biyuan, WANG Jing, ZHENG Weiqi, HU Hongping, CHEN Yongwu 2023, 20(4): 469-472.  DOI: 10.19803/j.1672-8629.20220533 Abstract ( 141 )   PDF (1226KB) ( 135 )   Objective To analyze the causes of suicidal tendency and paresthesia induced by voriconazole and review the related literature so as to provide reference for safe use of this drug. Methods The clinical data on one patient with both pulmonary infection and suicidal tendency accompanied by nociception and abnormal taste who was treated with voriconazole for injection was analyzed. By reviewing relevant literature at home and abroad, and based on the trough concentration of voriconazole, CYP2C19 genotype and related indicators, the causes of adverse reactions were analyzed. Results CYP2C19 genotype was of the fast metabolic type, and the trough concentration of voriconazole was 5.12 mg·L-1.The causes of suicidal tendency and paresthesia induced by voriconazole were related to liver function, inflammatory indicators and albumin status. Conclusion Serum concentrations and metabolic enzyme gene types should be detected as soon as possible in elderly patients using voriconazole. Liver function, inflammatory indicators and nutritional status should be closely monitored. Individualized administration regimens should be formulated immediately to prevent psycho-nervous system adverse reactions caused by voriconazole. References | Related Articles | Metrics

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Research progress in toxicity prediction of traditional Chinese medicines SHEN Pan, SUN Dezhi, ZHOU Wei, GAO Yue 2023, 20(4): 473-479.  DOI: 10.19803/j.1672-8629.20220255 Abstract ( 198 )   PDF (1333KB) ( 214 )   Objective To keep track of current research on toxicity prediction of traditional Chinese medicines (TCM) so as to help gain keen insights into the toxicity of TCM. Methods Based on literature, this paper categorized and summarized the concepts and methods of TCM toxicity prediction in recent years. Results According to concepts of prediction, the methods for toxicity prediction TCM could be roughly divided into three categories: those based on quantitative structure-activity relationships, network toxicology, and on theories of properties of TCM. Future developments of toxicity prediction of TCM and its guidance in clinical medications were presented. The concept of “compound toxic effect network of ingredient-omics based on multiple levels” was proposed for TCM toxicity prediction in hopes of implementing integrated TCM toxicity prediction. Conclusion The TCM toxicity prediction methods currently available can not only provide evidence for the formulation of non-toxic drug regimens for “toxic” TCM, but also facilitate clinical compatibility and attenuation of TCM. References | Related Articles | Metrics