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Research progress on animal models of allergic rhinitis SUN Qiyue, GUO Shanshan, ZHAO Ronghua, BAO Lei, GENG Zihan, LI Shuran, XU Yingli, ZHANG Jingsheng, CUI Xiaolan, SUN Jing 2024, 21(3): 241-245.  DOI: 10.19803/j.1672-8629.20230654 Abstract ( 191 )   PDF (1226KB) ( 207 )   Objective To summarize the research progress on animal models related to allergic rhinitis (AR), providing a reference for further understanding of AR pathogenesis and drug evaluation. Methods Based on a literature review from both domestic and international sources, the types of AR animal models, their characteristics, modeling methods, criteria for successful models, and evaluation indicators were summarized. Results Animal models for allergic rhinitis include both Western medicine pathological models and traditional Chinese medicine combination models. Commonly used animals include guinea pigs, mice, rats, and New Zealand rabbits. Conclusion This review provides insights into existing AR animal models, their methods, and evaluation criteria, offering valuable guidance for future AR research. References | Related Articles | Metrics

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Highly pathogenic coronavirus infection and immunothrombosis: research advances SUN Qiyue, GUO Shanshan, ZHAO Ronghua, BAO Lei, GENG Zihan, LI Shuran, XU Yingli, ZHANG Jingsheng, CUI Xiaolan, SUN Jing 2024, 21(3): 246-252.  DOI: 10.19803/j.1672-8629.20230464 Abstract ( 123 )   PDF (1730KB) ( 169 )   Objective To review the mechanism of immunethrombosis in highly pathogenic coronavirus（HPCoVs）infections and provide reference for clinical prevention and treatment. Methods Domestic and foreign literature was reviewed to outline the pathogenic mechanism of host immunethrombosis caused by Hcov in terms of coagulation disorders, immune/inflammatory disorders, endothelial cell injury/dysfunction, and platelet disorders. Results The uncontrolled immunethrombosis caused by Hcov infections was related to cytokine storm, formation of neutrophil extracellular traps, excessive activation of the complement system and renin-angiotensin system, oxidative stress of endothelial cells and glycocalyx damage, which were the leading causes of critical illness and death of patients. Conclusion An in-depth study of the pathogenesis of immunethrombosis due to highly pathogenic coronavirus infections and the development and evaluation of potential therapeutic interventions could not only mitigate the acute and long-term consequences of the disease, but also have significant implications for future responses to other emerging and emergent infectious diseases. References | Related Articles | Metrics

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Therapeutic effect of aerosol inhalation of BD-77 against mycoplasma pneumoniae infection in mice SUN Jing, ZHAO Ronghua, GUO Shanshan, GAO Shuangrong, BAO Lei, GENG Zihan, LI Shuran, SUN Qiyue, XU Zhou, QIN Guangyuan, PAN Yujie, TAN Qiuxia, LONG Zhongyi, HUANG Chenggang, CUI Xiaolan 2024, 21(3): 253-256.  DOI: 10.19803/j.1672-8629.20230797 Abstract ( 109 )   PDF (1636KB) ( 110 )   Objective To evaluate the therapeutic effect of aerosol inhalation of BD-77 against mycoplasma pneumoniae (MP) infection in mice. Methods Balb/c mice were randomly divided into the normal control group, model control group, azithromycin control group (42 mg·kg-1·d-1), BD-77 high dose group (75 mg·mL-1, 15 min), and BD-77 low dose group (37.5 mg·mL-1, 15 min). The mouse model of mycoplasma pneumoniae pneumonia (MPP) was induced by intranasal infection with MP. After four consecutive days of aerosol inhalation, the therapeutic effect of BD-77 was evaluated based on the lung index, lung inhibition rate, and pathological changes of lung tissues. The contents of interleukin (IL)-6, IL-1β, tumor necrosis factor α (TNF-α) in lung tissues and the level of C reactive protein (CRP) in serum were also detected using ELISA method. Results Both doses of BD-77 aerosol administration could decrease the lung index and the release of IL-6, IL-1β and TNF-α in lung tissues, ameliorate pulmonary inflammation and reduce serum CRP levels. Conclusion Aerosol inhalation of BD-77 preparation is effective for MPP in mice. This study provides data for the development of BD-77 as a drug for prevention and treatment of MPP. References | Related Articles | Metrics

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Effect of Lutongning granulethe to trigeminal neuralgia induced by chronic constriction injury of the infraorbital nerve in rats LI Shuran, GUO Shanshan, GAO Suangrong, BAO Lei, GENG Zihan, ZHAO Ronghua, ZHANG Jingsheng, PANG Bo, ZHANG Yu, WANG Yaxin, XU Yingli, CAO Shan, HAN Bing, CUI Xiaolan, SUN Jing 2024, 21(3): 257-262.  DOI: 10.19803/j.1672-8629.20230591 Abstract ( 56 )   PDF (1832KB) ( 117 )   Objective To investigate the therapeutic effect of Lutongning granules to rat with Trigeminal neuralgia, and provide reference materials for the clinical applications. Methods Trigeminal neuralgia was made by chronic constriction injury of infraorbital nerve in rats. Rats were randomly divided into normal group, sham group, model group, carbamazepine group, Lutongning high dose group (2.70 g crude drug·kg-1·d-1) and Lutongning low dose group (1.35 g crude drug·kg-1·d-1). Von Frey Brush brush was used to detect the mechanical pain threshold of rat whisker pad, biochemical method was used to detect the coagulation and hemostream function, HE staining was used to observe the microcirculation change of the infraorbital nerve after perfusion, western blot was used to detect the p38 and p-p38 expression in the trigeminal nerve. Results Lutongning granulethe increased the pain threshold in model rats (P<0.05, P<0.01), reduced the plasma viscosity (P<0.05, P<0.01) and the whole blood reduction viscosity in model rats (P<0.05, P<0.01), improved the flow ability in model rats, increased PT, APTT and TT levels in model rats (P<0.05, P<0.01), reduced FIB levels (P<0.01), improved the microcirculation on the infraorbital nerve in the model rats, reduced the p-p38 expression in the trigeminal nerve of model rats (P<0.01). Conclusion Lutongning granules have the effect of improving trigeminal neuralgia, which may be related to the function of promoting blood circulation and removing blood stasis. References | Related Articles | Metrics

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Effect of Tutengcao granules on MSU-induced acute gouty arthritis in rabbits YAO Rongmei, MAO Xin, XU Yingli, ZHANG Zhibin, GAO Yingjie, BAO Lei, BAO Yanyan, MENG Fengxian, CUI Xiaolan 2024, 21(3): 263-268.  DOI: 10.19803/j.1672-8629.20230619 Abstract ( 46 )   PDF (1157KB) ( 84 )   Objective To observe the pharmacodynamic effect of Tutengcao granules (TTC) on monosodium urate-induced acute gouty arthritis model in rabbits. Methods Male Japanese big-eared white rabbits were randomly divided into normal control group, model control group, colchicine group (0.18 mg·kg-1), high (600 mg·kg-1), medium (300 mg·kg-1) and (150 mg·kg-1) low-dose groups. An acute gouty arthritis model was established by injecting monosodium urate (MSU) into the knee joint cavity of the left hind limb of rabbits. Five days after injection, synovial fluid was collected. The number of white blood cells in joint effusion was detected, and the contents of inflammatory cytokines interleukin-6 (IL-6), interleukin-8 (IL-8), tumor necrosis factor-α (TNF-α), interleukin-1β (IL-1β), and prostaglandin E2 (PGE2) in joint fluid were measured. Blood was collected to detect the blood uric acid value, and the serum urea, cholesterolesterol (CHO), serum creatinine (Cre), glucose (GLU) and triglyceride contents (TG) before and after administration. Results The number of white blood cells in the joint cavity of the TTC high, medium and low dose groups all decreased after 5 days of administration, and there was a significant difference between the medium dose group and the model control group (P<0.01). TTC high- and medium-dose groups tended to reduce blood uric acid. TTC had no effect on the contents of UREA, CHO, Cre, GLU and TG in rabbit serum. Compared with the model control group, the contents of IL-6, IL-8, TNF-α and PGE2 in the high, medium and low dose groups of TTC were significantly reduced. Among them, the contents of IL-6 and TNF-α in the high, medium and low dose groups were significantly reduced. There was a significant difference between the IL-8 content in the high-dose group and the medium-dose group and the PGE2 content in the middle-dose group (P<0.01). TTC high, medium and low dose groups can reduce the IL-1β content in synovial fluid to a certain extent. Conclusion TTC has a significant therapeutic effect on the MSU-induced acute arthritis rabbit model. It can reduce the number of white blood cells in the animal’s joint cavity, inhibit the expression of inflammatory cytokines, and reduce the uric acid content in the serum. References | Related Articles | Metrics

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Therapeutic effect of Foshao granules in mice with functional abdominal pain LI Shuran, GUO Shanshan, BAO Lei, SUN Jing, ZHAO Ronghua, BAO Yanyan, GENG Zihan, ZHANG Yu, CAO Shan, LYU Yaozhong, WANG Zhenzhong, CUI Xiaolan, WANG Hongmei 2024, 21(3): 269-272.  DOI: 10.19803/j.1672-8629.20230285 Abstract ( 57 )   PDF (1608KB) ( 124 )   Objective To clarify the therapeutic effect of Foshao granules in mice with spastic abdominal pain, and provide basic research data support for clinical application. Methods Experimental mice were randomly divided into seven groups according to their body weight: the normal control group, model control group, Domperidone control group (12 mg·kg-1), Sini Powdered control group (3 g·kg-1), Foshao granules high dosage group (48 g crude drug·kg-1), Foshao granules middle dosage group (24 g crude drug·kg-1), Foshao granules low dosage group (12 g crude drug·kg-1), with 10 mice in each group. A cold stagnation functional abdominal painmedical syndrome combination model made by cold stimulation combined with an intraperitoneal injection of formalin. The therapeutic effect of mice with spastic abdominal pain induced by neostigmine was evaluated with the pain latency, the pain incidence, duration of pain, the pathological changes in the colon of the mice. Results The Foshao granules can significantly reduce the incidence of pain, prolong the pain incubation (P<0.05, P<0.01), shorten the pain length, and reduce the mucosal hyperplasia, and the enlargement and increase of goblet cells in the interstitial inflammation machine in the colon. Conclusion The Foshao granules significantly improved cold stimulation combined with formalin-induced functional abdominal pain in mice, providing a reference for the clinical application of Foshao granules. References | Related Articles | Metrics

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Research progress in bacterial endotoxin test methods for insoluble raw materials, excipients and preparations ZHANG Chenxue, PEI Yusheng, CAI Tong 2024, 21(3): 273-279.  DOI: 10.19803/j.1672-8629.20230423 Abstract ( 127 )   PDF (1344KB) ( 173 )   Objective To summarize the ideas behind test methods established for insoluble samples in the Chinese Pharmacopoeia and related literature in China over the past 10 years, and to provide reference for endotoxin detection of insoluble APIs, excipients and preparations. Methods The determination of endotoxin limits, inspection methods, dissolution methods, and strategies for excluding interferences in domestic literature on insoluble samples were analyzed by focusing on the selection of organic solvents. Results and conclusion The difficulty in establishing a method for the detection of bacterial endotoxin in insoluble samples lies in the search for suitable solvents and the elimination of interferences. Dissolution methods involve organic solvents, non-organic solvents and physical methods, while the elimination of interferences involves the adjustment of pH, the supplementation of divalent cations, and the use of antiproliferative fluids and dispersants. This study is expected to inspire ideas for subsequent research. References | Related Articles | Metrics

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Research routes of hygroscopicity of chemical reference substances LIU Yi, GENG Ying, QIN Ling, GUO Xianhui, CHEN Hua, PEI Yusheng 2024, 21(3): 280-282.  DOI: 10.19803/j.1672-8629.20230331 Abstract ( 66 )   PDF (1335KB) ( 112 )   Objective To investigate the research routes of hygroscopicity of chemical reference substances. Methods Dynamic vapor absorption analysis (DVS) was mainly used to study related hygroscopicity. During the analysis with DVS, the temperature was 25℃, the gas flow rate of N2 was 200 mL·min-1, and the relative humidity changes and time were program-controlled. Results Based on a case study of pyridostigmine bromide, the three-step research routes of hygroscopicity of chemical reference substances were analyzed in depth. Conclusion Studies on related research routes can contribute to research on hygroscopicity of chemical reference substances based on water adsorption. References | Related Articles | Metrics

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Applications of TGA and DSC in pharmaceutical analysis LIU Yi, QIN Ling, GUO Xianhui, CHEN Hua, PEI Yusheng 2024, 21(3): 283-289.  DOI: 10.19803/j.1672-8629.20230286 Abstract ( 182 )   PDF (1364KB) ( 218 )   Objective To explore the application of thermogravimetric analysis (TGA) and Differential scanning calorimetry (DSC) in drug analysis to lay the foundation for pharmaceutical quality control. Methods a short overview of the applicative research on the water content, thermal stability, melting-point, purity, polymorphism and others in recent years, had been reported. The future development prospect was also discussed. Results and Conclusion TGA and DSC played an important role in the analysis of moisture, melting point, purity, crystallinity and stability of drugs to meet the higher analytical demands of pharmaceutical inspection and testing. It was looking forward to providing methods and ideas for the further research on drug quality and safety. References | Related Articles | Metrics

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Detection of single-chain precursor residues in insulin glargine by ELISA ZHANG Xiaoming, LYU Ping, HU Xinyue, DING Xiaoli, LI Jing, LIANG Chenggang 2024, 21(3): 290-294.  DOI: 10.19803/j.1672-8629.20230404 Abstract ( 54 )   PDF (1470KB) ( 85 )   Objective To establish an enzyme-linked immunoassay for the detection of single-chain precursor residues in insulin glargine so as to recommend a new method for quality control and safety evaluation of insulin glargine. Methods An enzyme-linked immunoassay based on double antibody sandwich was established by using proinsulin glargine as the standard. The repeatability, accuracy, scope and precision of the method were verified, and nine batches of insulin glargine drug substances were tested using this method. Results Four-parameter curve fitting was performed using the proinsulin glargine standard at concentrations ranging from 0.156 to 10.00 ng·mL-1, and the correlation coefficient of the curve exceeded 0.99. This method was highly accurate and repeatable. Three batches of insulin glargine drug substances were repeatedly detected. The average recovery ranged from 104% to 113%, and the RSD% was less than 10%, suggesting the good precision of this method. The single-chain precursor residues in all the nine batches were less than 1 ng·mg-1. Conclusion The enzyme-linked immunoassay established in this study can be used for quality control and safety evaluation of single-chain precursor residues in insulin glargine and other recombinant human insulin analogues. References | Related Articles | Metrics

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Determination of residual solvents in extract of Coleus amboinicus by headspace-gas chromatography WANG Dandan, WANG Ying, YAO Lingwen, LIU Yuanxi, JIN Hongyu, MA Shuangcheng 2024, 21(3): 295-299.  DOI: 10.19803/j.1672-8629.20230521 Abstract ( 52 )   PDF (1395KB) ( 87 )   Objective To establish a headspace-gas chromatography method for the determination of residues of benzene, acrylonitrile, methyl methacrylate, toluene, 1, 2-dichloroethane, p-xylene, m-xylene, o-xylene, chlorobenzene, styrene and divinylbenzene in Coleus amboinicus extracts, which is a traditional Chinese medicine (TCM). Methods The samples were balanced by a headspace injector at 85℃ for 45 min, and the split ratio was 10:1 (V : V). The DB-WAX capillary column (30 m long, 0.32 mm wide, and 0.5 μm thick), which was fixed using polyethylene glycol, was used to separate samples, while a flame ionization detector (FID) was used for analysis. Results The eleven volatile organic compounds were well-separated. Experimental results showed that the linearity of these volatile organic compounds ranged from 0.22 μg·mL-1 to 23.86 μg·mL-1 with correction coefficients above 0. 99. The limit of quantification was between 0.008 4 μg·mL-1 and 0.543 2 μg·mL-1. The average recovery of the target compounds ranged from 84% to 103% at three spike levels, with relative standard deviations less than 10.0% (n=6), which met the requirements of trace determination. Toluene, m-xylene, o-xylene and divinylbenzene were detected in three batches of samples, but below the limit of quantitation and the standard. Conclusion This method is simple, reliable, and applicable to the detection of residual solvents in the extract of Coleus amboinicus, which can facilitate the analysis of residual solvents in other TCM extracts and medication safety. References | Related Articles | Metrics

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Comformity study of formulation and manufacture process for bromohexine hydrochloride parenteral preparations using Near-infrared and Raman spectroscopy GENG Ying, LIU Yi, WANG Xuelei, ZHU Rongdie, JIN Ying, CHEN Hua, ZHENG Li'e 2024, 21(3): 300-306.  DOI: 10.19803/j.1672-8629.20230435 Abstract ( 51 )   PDF (1770KB) ( 90 )   Objective To establish qualitative models of Near-infrared spectroscopy for the conformity investigation of bromohexine hydrochloride powder for injection in terms of formulation and manufacture process, develop quantitatvie models of Near-infrared spectroscopy for the determination of bromohexine of bromohexine hydrochloride powder for injection. To develop Raman spectroscopy qualitative models to investigate the conformity of formulation and manufacture process for bromohexine hydrochloride injections and infusions. Methods The Near-infrared and Raman spectra of bromohexine hydrochloride parenteral preparations (powder for injection, injections and infusions) selected for evaluative sampling were investigated: Near-infrared spectroscopic qualitative and quantitative models were established for bromohexine hydrochloride powder for injection. Raman spectroscopy-principal component analysis was used to study bromohexazine hydrochloride injections and infusion. Results Near-infrared and Raman conformity models for bromohexine hydrochloride powder for injection of two manufacturers was established, and the prediction success rate was 100%. The principal component analysis method was used to study the conformity of powder for injection, injections and infusions. The results corresponded to the conformity models reflected the similarity of the formulation and manufacture process. The Near-infrared quantitative models showed to be robust and accurate for the determination of the content of bromohexine hydrochloride. Conclusion Near-infrared spectroscopy and Raman spectroscopy can be used to identify Bromohexine Hydrochloride Parenteral preparations (powder for injection, injections and infusions) with stable quality process. Near-infrared spectroscopy quantitative model can be used to predict the content of bromohexine for bromohexine hydrochloride powder for injection and enables rapid detection, screening as well as process control and release. References | Related Articles | Metrics

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Mutagenicity risk of N-nitrosobumetanil in SD rats WEN Hairuo, HUANG Qin, HAN Suqin, JIANG Hua, QIN Chao, SHI Haokun, ZHAO Tingting, GENG Xingchao, WANG Qi 2024, 21(3): 307-312.  DOI: 10.19803/j.1672-8629.20230684 Abstract ( 48 )   PDF (1932KB) ( 91 )   Objective To evaluate the mutagenicity risk and hepatocyte DNA damage risk of bumetanide impurity-N-nitrosobumetanil in vivo. Methods SD rats were randomly divided into six groups: control group (0.5% CMC-Na), 100 mg·kg-1 dose group, 300 mg·kg-1 dose group, 1 000 mg·kg-1 dose group, positive control group 1 (N-ethyln-nitrosourea, ENU, 40 mg·kg-1) and positive control group 2 (ethyl mesylate, EMS, 200 mg·kg-1). Both positive control groups consisted of six animals and the other groups had twelve animals in each. Rats were administered with N-nitrosobumetanil by oral intragastric administration for fourteen days. Peripheral blood was collected at about 14 days and 28 days after the initial administration for the detection of Pig-a gene mutation rates. Liver cells were collected about 3 hours after the last administration for comet test. Results During the study, N-nitrosobumetanil did not result in abnormal clinical symptoms and there was no change in animal body mass or food intake. The averaged tail% DNA values (mean/median) of animal hepatocytes in 100 mg·kg-1, 300 mg·kg-1 and 1 000 mg·kg-1 dosage groups were 2.90±0.38/2.34±0.46, 3.58±0.27/2.87±0.51 and 3.45±0.59/2.21±1.44, respectively, which showed no difference compared with the solvent control group, and no significant dose-effect correlation was observed. Fourteen days after the initial administration, the mean incidence of RBCCD59- and RETCD59- per million cells (RBCCD59-/RETCD59-) in 100 mg·kg-1 dose group, 300 mg·kg-1dose group and 1 000 mg·kg-1 dose group were 2.9±1.6/1.2±0.8, 2.8±2.4/1.3±1.5 and 2.4±1.0/1.3±1, respectively. Twenty-eight days after the initial administration, the mean incidence of RBCCD59- and RETCD59- per million cell (RBCCD59-/RETCD59-) in the 100 mg·kg-1 dose group, 300 mg·kg-1 dose group and 1 000 mg·kg-1 dose group was 5.1±1.5/2.2±0.6, 4.3±1.5/3.5±3.6, and 4.8±2.4/2.5±2.7, respectively. The above values were not different from those of the solvent control group at the same time point, and no correlation of dose effect was observed by statistical analysis. Conclusion After fourteen days of oral administration of N-nitrosobumetanilis, the maximum tolerance of SD rats exceeds 1 000 mg·kg-1, and the risk of peripheral blood gene mutation and hepatocyte DNA damage is not detected. The data can be used to back up the regulation of genotoxic impurities in drugs and the safe use of drugs containing N-nitroso impurities. References | Related Articles | Metrics

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Comparative study on pharmacodynamics of extracts from Pith-nodecayed and Pith-decayed products of Scutellariae Radix on rats with damp-heat ulcerative colitis HUANG Wei, LUO Yaqin, YU Xinyang, DONG Hongjing, WANG Xiao 2024, 21(3): 313-318.  DOI: 10.19803/j.1672-8629.20230551 Abstract ( 41 )   PDF (2059KB) ( 80 )   Objective To observe and compare the pharmacodynamics of extracts from Pith-decayed and Pith-nodecayed products of Scutellariae Radix on rats with damp-heat ulcerative colitis (UC). Methods Fifty healthy SD rats were randomly divided into 5 groups: normal group, model group, Pith-decayed products of Scutellariae Radix group, Pith-nodecayed products of Scutellariae Radix group and mesalazine group, with 10 rats in each group. The damp-heat UC rat model was established by the combination of high-fat and high-sugar diet+high-liquor administration+5% dextran sodium sulfate (DSS). Each group was given intragastric administration on the first day of modeling, respectively. The dosage of Pith-decayed products group and Pith-nodecayed products group was 5.25 g·kg-1·d-1, and that of mesalazine group was 0.266 g·kg-1·d-1. Normal group and model group were given equal volume of normal saline. The drug was administered continuously for 28 days. The general condition of rats was observed. The change of body mass and the score of disease activity index (DAI) were evaluated. The colonic mass of rats was measured, the colonic length was measured, and the colonic mass per unit length was calculated. HE staining and PAS staining were performed to observe the histopathological changes of rat colon. Serum levels of interleukin-6 (IL-6), tumor necrosis factor-α(TNF-α), interleukin- 1β (IL-1β) and transforming growth factor-β1(TGF-β1) were detected by Elisa. Results Compared with normal group, body mass and colon length of rats in model group were significantly decreased, DAI score, colon mass, colon mass per unit length and serum levels of IL-6, TNF-α and IL-1β were significantly increased, and TGF-β1 level was significantly decreased(P<0.01). The upper layer of colon tissue was exfoliated, the margins were scattered, the crypts were unclear, the mucosal layer was edema, inflammatory cells infiltrated and invaded the submucosa, and the intestinal glands were disturbed. Compared with model group, the above indexes and related symptoms were significantly improved in Pith-decayed products of Scutellariae Radix group, Pith-nodecayed products of Scutellariae Radix group and mesalazine group(P<0.05, P<0.01). Compared with Pith-decayed products of Scutellariae Radix group, Pith-nodecayed products of Scutellariae Radix group and mesalazine group were superior to Pith-decayed products of Scutellariae Radix group in increasing colon mass per unit length, decreasing DAI score and improving inflammatory factor levels (P<0.05 or P<0.01). Conclusion The extract of Pith-decayed products of Scutellariae Radix and Pith-nodecayed products of Scutellariae Radix have better therapeutic effect on damp-heat UC rats, and Pith-nodecayed products of Scutellariae Radix is superior to Pith-decayed products of Scutellariae Radix. References | Related Articles | Metrics

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Tianlongjie stage intervention on TGF-β1 level and pathological changes in lung tissue of pulmonary fibrosis rats CHEN Bing, YUAN Dezheng, FU Yi 2024, 21(3): 319-323.  DOI: 10.19803/j.1672-8629.20230507 Abstract ( 38 )   PDF (2546KB) ( 80 )   Objective To observe the effects of Tianlongjie on the expression of TGF-β1 and histopathological changes in lung tissue of pulmonary fibrosis(PF) rats and to explore the possible mechanism of Tianlongjie in treating PF. Methods Rat pulmonary fibrosis models were prepared by intratracheal bleomycin infusion. Ninety male Wista rats were randomized divided into 9 groups: control group(C), model early group(ME) and model late group(ML), Tianlongjie early intervention group with middle dose(TEM), Tianlongjie late intervention group with low dose group(TLL), TIANLONGJIE late intervention group with middle dose group(TLM), Tianlongjie late intervention group with high dose group(TLH)(1.26、2.52、5.04 g·kg-1·d-1). Pirfenidone early intervention group(PFDE) and Pirfenidone late intervention group(PFDL). Rats of early intervention group were given drug from 7th day after PF model was established, and late intervention group was given drug from 14th day. Observe the survival state of rats and select materials on the 28th day. The protein and mRNA expression of TGF-β1 in lung tissue were detected by SABC and Real Time PCR. HE staining and Masson triple staining of lung tissue were used to analyze the pathological morphology. Results Expression of TGF-β1, Compared with the model group, early and late intervention with Tianlongjie inhibit the expression of TGF-β1 mRNA and protein in lung tissue of PF rats (P<0.05, P<0.01), and there was a significant difference between TEM and TLM (P<0.05). Compared with TLL, the TLM and TLH were more effective (P<0.05). Early and late intervention with Pirfenidone inhibit the expression of TGF-β1 mRNA and protein in lung tissue of PF rats (P<0.05). There was no statistical difference between TEM and PFDE(P>0.05), and the same was true in TLM and PFDL. Pathological morphology: The pathological results showed that intervention with Tianlongjie and Pirfenidone reduce the degree of alveolitis, the deposition of collagen and interstitial cell proliferation in lung tissue. The effect of early intervention is more obvious. Based on pathomorphology quantitative analysis, there was no statistical difference between TEM and PFDE (P>0.05). Conclusion Tianlongjie can effectively reduce bleomycin-induced alveolitis and fibrosis, early intervention has more significance. The mechanism may related to the inhibition of the expression of TGF-β1 in lung tissue, which is an important factor affects the occurrence and development of PF. References | Related Articles | Metrics

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Adverse drug reaction induced by antineoplastic drugs in a cancer hospital: an analysis of 613 cases HUANG Huanjun, MAI Jiaheng, ZHANG Yunhui, GUO Chenchen, LIANG Weiting 2024, 21(3): 324-328.  DOI: 10.19803/j.1672-8629.20230467 Abstract ( 293 )   PDF (1321KB) ( 397 )   Objective To analyze the characteristics and patterns of adverse drug reactions (ADR) induced by antineoplastic medications, and to provide reference for ensuring the safety of ambulatory chemotherapy. Methods A total of 613 reports about ADR caused by antineoplastic drugs between 2021 and 2022 in our hospital were collected and analyzed. Results Among the 613 cases of ADR, 60.03% occurred inside the hospital. Male patients outnumbered female ones and most of the patients ranged from 51 to 70 in age (51.23%). ADR were caused by intravenous infusion in 72.49% of these cases, 14.68% were severe ones, and 4.24% failed to improve after medication withdrawal or treatment. Cytotoxic anti-tumor medicines were responsible for 81.23% of these ADR, with oxaliplatin accounting for 18.65%. The blood or hematopoietic system was responsible for the largest number of ADR (17.68%). Conclusion ADR induced by cytotoxic anticancer drugs should be monitored, with particular attention to special populations and key drugs. When anticancer drugs are used in an ambulatory chemotherapy center, the risk of ADR should be assessed and corresponding treatment plans should be made to ensure the safety of patients. References | Related Articles | Metrics

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Analysis of the rationality and safety of clinical application of anrotinib in a hospital LIU Qi, ZHANG Yufeng, LUO Hao, LI Xin 2024, 21(3): 329-334.  DOI: 10.19803/j.1672-8629.20230635 Abstract ( 147 )   PDF (1329KB) ( 196 )   Objective To investigate the clinical application of anlotinib in a hospital and evaluate the rationality and safety of related medications, in order to standardize the clinical application of anlotinib. Methods To collect information on 106 patients with clinical application of amilorotinib in a county-level general hospital from January 1, 2022 to June 30, 2023, who received a total of 306 doses of amilorotinib-containing regimens, and to conduct a retrospective analysis of the reasonableness and safety of the clinical application of anlotinib. Results Among the 306 treatments, 89 cases (29.08%) of medication were irrational, and the types of irrationality were 47 cases (15.36%) of irrationality in combination of medication, 21 cases (6.86%) of over-indications, 19 cases (6.21%) of irrationality in dosage, and 2 cases (0.65%) of prohibited use of medication. There were 358 cases of adverse drug reactions (ADR) found in these medical records. The top five organ-system injury were diseases of the digestive system (30.73%), Metabolic and Nutritional Diseases (16.48%), diseases of the blood and lymphatic system (13.41%),diseases of the cardiovascular system (9.22%) and bleeding (5.31%). Conclusion Some irrationality in the clinical use of anrotinib in the hospital, the hospital and relevant quality control department should prescribe and rationally use anlotinib standardize the instructions of anlotinib, the latest domestic and international guidelines and consensus, strengthen the monitoring of medication, evaluate the adverse reactions, and improving the safety of anrotinib. References | Related Articles | Metrics

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Data-mining and analysis of adverse events signals for infliximab based on FAERS database YOU Xiaoyan, ZHENG Yingying, WANG Xianying 2024, 21(3): 335-340.  DOI: 10.19803/j.1672-8629.20230523 Abstract ( 144 )   PDF (918KB) ( 229 )   Objective To provide a reference for the safety in clinical use by exploring the risk signals of infliximab-related adverse drug events (ADE). Methods ADE data related to infliximab from FDA Adverse Event Reporting System (FAERS) were collected from the 1st quarter of 2004 to the 1st quarter of 2023. Data mining was performed using the reporting odds ratio (ROR) method and the Bayesian confidence propagation neural network (BCPNN) method. Results The number of ADE reports met the threshold criteria was 175 930 with 963 signals obtained, involving 26 system organ classes(SOC). The main ADE of infliximab were observed in gastrointestinal diseases, infectious and invasive diseases, systemic diseases and various reactions at the site of administration, benign, malignant and tumors of unknown nature, and various musculoskeletal and connective tissue diseases, which are consistent with the drug’s instructions. In addition, the risk of cardiovascular diseases, renal injury and skin and subcutaneous tissue-like disorders that may result from infliximab was identified in this study. Conclusion When applying infliximab, in addition to the ADE documented in the drug package insert, close attention should also be paid to ADE not mentioned in the instruction to improve the safety of patients medication. References | Related Articles | Metrics

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Risk assessment of colchicine-associated neurological adverse events based on FAERS database WU Tingxi, ZHAO Zhigang, SHI Yanfeng, ZHANG Yang, ZHANG Yinan, ZHU Bin 2024, 21(3): 341-345.  DOI: 10.19803/j.1672-8629.20230531 Abstract ( 109 )   PDF (1460KB) ( 190 )   Objective To evaluate the neurological adverse events (nAEs) caused by colchicine and provide evidence for safe use of colchicine in stroke. Methods The nAEs related to colchicine that occurred between 2004 and 2022 were retrieved from the FDA Adverse Event Reporting System (FAERS) database to mine the signals via disproportionality analysis and Bayesian analysis. Results A total of 906 cases of colchicine-associated nAEs were collected, and the top three nAEs were headache (ROR025=1.09, IC025=0.30), and hypoaesthesia (ROR025=1.79, IC025=1.09), and loss of consciousness(ROR025=1.62, IC025=0.99). Overall, no signal was detected in the ischaemic and haemorrhagic disorders of the central nervous system. The median onset-time of colchicine-associated nAEs was 30d while the fatality rate was 7.42%. Conclusion Although no association is found between colchicine and ischaemic and haemorrhagic disorders of the central nervous system, more attention should be paid to some other rare neurological AEs during clinical practice. References | Related Articles | Metrics

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Pharmaceutical care for immune-related adverse events induced by toripalimab JI Qiuxia, JIN Jian, ZHANG Bin 2024, 21(3): 346-348.  DOI: 10.19803/j.1672-8629.20230428 Abstract ( 133 )   PDF (1266KB) ( 221 )   Objective To explore the pharmaceutical care approach of clinical pharmacists in immune-related adverse events caused by toripalimab. Methods A clinical pharmacist conducted a pharmacy checkup on a case in which renal injury, hypothyroidism and skeletal muscle toxicity were detected in a patient treated with toripalimab, and determined that the patient was most likely to have adverse reactions caused by toripalimab through the evaluation of the correlation of the adverse reactions and the analysis of the mechanism. Results A clinical pharmacist assisted the physician in formulating the treatment plan, and conducted full-scale pharmacological monitoring of the patient, achieving good results. Conclusion Clinical pharmacists play an important role in the identification and management of immune-related adverse events, effectively ensure the safety of medication. References | Related Articles | Metrics

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One case of allergic shock caused by tocilizumab injection CHEN Jie, ZHANG Bin, ZHAO Jun, ZHANG Chuanzhou 2024, 21(3): 349-351.  DOI: 10.19803/j.1672-8629.20230594 Abstract ( 140 )   PDF (1180KB) ( 302 )   Objective To analyze the characteristics of anaphylactic shock induced by tocilizumab injection in order to provide reference for clinical safe and rational drug use. Methods One case of anaphylactic shock caused by tocilizumab was analyzed. The related literature was reviewed while the causes, prevention and treatment of such adverse drug reactions were analyzed. Results According to the clinical manifestations of the patient and the correlation between the drug and the time of administration, this case of anaphylactic shock was considered to have been caused by tocilizumab. The symptoms of anaphylactic shock were relieved after effective anti-allergic treatment. Conclusion Clinicians should be wary of anaphylactic shock and other allergic conditions related to the use of tocilizumab, which should not be used in allergic patients. References | Related Articles | Metrics

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One case of acute transient depression caused by clarithromycin YANG Xueting, HE Bo, YAN Hongli, LI Dongmei 2024, 21(3): 352-354.  DOI: 10.19803/j.1672-8629.20230698 Abstract ( 262 )   PDF (1253KB) ( 465 )   Objective To analyze the adverse reactions-acute transient depression-caused by a quadruple anti-Helicobacter pylori regimen, and to provide reference for early detection and prompt clinical interventions in such cases. Methods Analysis was made of the clinical data on a 29-year-old female patient who underwent a quadruple regimen (amoxicillin, clarithromycin, pantoprazole, and bismuth potassium citrate) because of acute transient depression caused by Helicobacter pylori infection. Results The transient acute depression was considered to have been triggered by the combined use of four anti-Helicobacter pylori drugs. Evidence-based medicine suggested that clarithromycin was the drug most likely to induce acute transient depression. Conclusion Healthcare providers should vigilantly observe patients for emotional fluctuations during the administration of pharmaceutical interventions for the complete eradication of H. pylori infection. In the event of acute transient depression, it is imperative to promptly discontinue the medication to forestall the worsening of symptoms. References | Related Articles | Metrics

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Effect of sulfur fumigation on quality of Angelica dahurica and alternative processing methods in producing areas WANG Changshun, WANG Xiaolei, DUAN Jiping, YUAN Hao, LIU Yongli, ZHAO Ding 2024, 21(3): 355-360.  DOI: 10.19803/j.1672-8629.20220687 Abstract ( 114 )   PDF (1590KB) ( 195 )   Sulfur fumigation, as a processing and preservation method of traditional Chinese medicine in producing areas, is capable of insect control, mildew prevention, maintenance of bright color and acceleration of drying of traditional Chinese medicine. However, sulfur fumigation can also reduce the content of active ingredients in Chinese medicinal materials and transform them into new compounds while increasing the content of sulfur dioxide residue, heavy metals and harmful elements, which may reduce the efficacy but increase safety risks. Based on the literature available, this paper summarizes the impact of sulfur fumigation on the quality of Angelica dahurica and studies the processing methods in producing areas in order to provide reference for quality control of Angelica dahurica. References | Related Articles | Metrics