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Uncertainty evaluation for the determination of 6-MP in Beagle dog plasma by UPLC-MS/MS WANG Jiaqing, WANG Qi, SHI Weizhong, ZHANG Dongjie, NING Xiao 2023, 20(12): 1321-1325.  DOI: 10.19803/j.1672-8629.20230593 Abstract ( 103 )   PDF (1592KB) ( 91 )   Objective To evaluate the uncertainty for the determination of 6-mercaptopurine (6-MP) in beagle dog plasma by UPLC-MS/MS. Methods The whole process during the 6-MP determination was analyzed and the uncertainty from various sources were calculated. The combined and expanded uncertainty were also evaluated. Results The expanded uncertainty of 6-MP at low (15 ng·mL-1 ) and high (375 ng·mL-1) levels were 1.04 ng·mL-1and 30.14 ng·mL-1, respectively (P = 95%, k = 2). Conclusion The uncertainty for the determination of 6-MP in beagle dog plasma by UPLC-MS/MS at low concentration is mainly caused by calibration curve fitting, recovery and matrix effect, while at high concentration the uncertainty is mainly caused by recovery, calibration curve fitting and sample preparation. References | Related Articles | Metrics

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Study on the mass spectrometric cleavage pattern of diphenhydramine constituents based on UPLC-Q-TOF-MS technology MA Chunyan, NING Xiao, DUAN Qiong, HU Weijie, LI Jingyun, ZHANG Jing 2023, 20(12): 1326-1331.  DOI: 10.19803/j.1672-8629.20230587 Abstract ( 73 )   PDF (1016KB) ( 70 )   Objective To explore the fragmentation pathway of dipyridamole compounds under the electrospray ionization mass spectrometry (ESI-MS), so as to provide a reference for the identification and structural analysis of these compounds. Methods A Shim-packXR-ODS (100 mm×2.0 mm, 2.2 μm) column was used for secondary mass spectrometry (MS/MS) analysis of dipyridamole (nisoldipine, nifedipine, nimodipine, nitrendipine, nicardipine, felodipine, amlodipine) in positive ion mode with a gradient elution of 0.1% formic acid solution (A) - 0.1% formic acid acetonitrile (B) as the mobile phases, ultra performance liquid chromatography-quadrupole time-of-flight mass spectrometry (UPLC-Q-TOF-MS) and the fragmentation behaviors of dipyridamole were summarized. Results The constituents of dipyridamole were easy to be protonated in the positive ion detection mode, forming quasi-molecular ions of [M+H]+. The dipyridamole compounds had similar cleavage pathways, and the fracture process in the positive ion mode mainly focuses on the ester groups near the parent nucleus of the dihydropyridine or the substituents on the benzene ring, forming specific ionic fragments (m/z 315.097 7, m/z 195.090 8, and m/z 165.080 2). That is, the mother ion removes one molecule of the esterification group - OR, and then loses the neutral fragment to replace the phenyl. On this basis, another molecule of the esterification group - OR is lost, forming a mother nucleus derived form of 1,4-dihydropyridine. These ion fragments can intuitively represent the substituent groups on the parent nucleus, thereby further reflecting the molecular structure of dipine drugs. Conclusion The electrospray mass spectrometry cleavage pattern proposed in this paper can help to analyze and deduce the structure of diphenhydramine compounds, which can provide a reference basis for the identification and structural analysis of these components. References | Related Articles | Metrics

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Analysis of impurity spectra and quality control of betahistine hydrochloride injection based on HPLC-QE-MS technology WANG Guoying, ZHOU Gang, WANG Qin, JI Ziwei, NING Xiao, CUI Li 2023, 20(12): 1332-1338.  DOI: 10.19803/j.1672-8629.20230588 Abstract ( 79 )   PDF (1791KB) ( 137 )   Objective To analyze the impurity spectra of betahistine hydrochloride injection to provide a basis for quality control of this variety. Methods HPLC-QE-MS technology were applied to identify and analyze the structure of an unknown impurity of betahistine hydrochloride injection. According to forced degradation test, the source of impurities and impurity spectra were determined. ADMET Predictor software was used to predict the toxicity of impurities. Results The method established for related substances was simple with high accuracy and good reproducibility, total of four unknown impurities were detected, Impurities 1, 2, and 3 were all process impurities, impurities A, impurities B, and impurities 4 were all degradation impurities, and impurity C was both process and degradation impurity. The toxicity prediction results showed that impurity 1, 2, and 3 had potential acute toxicity in rats; Impurities A, B, 1, and 4 had potential liver toxicity. Correlation analysis of impurity mass spectrometry and sterilization process showed that betahistine hydrochloride was thermally unstable, and the sterilization process currently used by various enterprises would increase the quantity and content of related substances. Conclusion By studying the impurity mass spectrometry of betahistine hydrochloride inject References | Related Articles | Metrics

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Research on the related substances of adenosine cobalt amine for injection based on HPLC-QE-MS technology HAO Gang, HAN Feng, ZHOU Gang, YAN Hao, WU Xing, LI Xuyang, HOU Hailing, NING Xiao, WANG Qi, CUI Li 2023, 20(12): 1339-1345.  DOI: 10.19803/j.1672-8629.20230592 Abstract ( 75 )   PDF (1778KB) ( 58 )   Objective High performance liquid chromatography was used to study the related substances of adenosine cobalt amine for injection, and mass spectrometry analysis and toxicity prediction were performed on the related impurities. Methods Determination by high-performance liquid chromatography, the chromatographic conditions were using octadecylsilane bonded silica gel as the filling agent in the chromatographic column, with a detection wavelength of 260 nm, a column temperature of 35℃, and an injection volume of 10 μL. 0.01 mol·L-1 ammonium acetate solution (adjusted to pH 4.0 with glacial acetic acid) was used as mobile phase A, and methanol was used as mobile phase B for gradient elution. The established method was used to evaluate the related substances in 105 batches of adenosine cobalt amine for injection. Unknown impurities with a content of ≥0.1% were scanned by high-resolution mass spectrometry and genotoxicity prediction was performed on the unknown impurities. Results The impurity peaks of the established method were effectively separated from the main peak, with a detection limit of 1.497×10-4 mg·mL-1. The methodological validation of the detection method was conducted, and the results met the requirements of the pharmacopoeia. Conclusion The established method has strong specificity, high accuracy, good repeatability, and can effectively obtain comprehensive impurity information. It is suitable for impurity detection and control of adenosine cobalt amine for injection. References | Related Articles | Metrics

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Uncertainty evaluation on the determination of norvancomycin in human cerebrospinal fluid by UPLC-MS/MS WANG Jiaqing, WANG Qi, ZHANG Dongjie, MEI Shenghui, NING Xiao 2023, 20(12): 1346-1350.  DOI: 10.19803/j.1672-8629.20230541 Abstract ( 59 )   PDF (1695KB) ( 56 )   Objective To evaluate the uncertainty in norvancomycin (NVCM) determination in human cerebrospinal by UPLC-MS/MS. Methods The whole process during the NVCM determination was analyzed and the uncertainty sources were established, then the combined and expanded uncertainty were also evaluated. Results The expanded uncertainty with low (3 mg·L-1) and high (300 mg·L-1) levels of NVCM (P=95%, k=2) were 1.18 mg·L-1 and 70.97 mg·L-1, respectively. Conclusion The uncertainty in NVCM determination in human cerebrospinal by UPLC-MS/MS was mainly caused by curve fitting, repeatability and recovery for low concentrations and repeatability, matrix effect and recovery for high concentrations. The method for determining the content of NVCM in cerebrospinal fluid established by our research institute provides an effective regulatory means for the safety and effectiveness of the drug’s use. References | Related Articles | Metrics

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Methodological study of adenosylcobalamin bacterial endotoxin examination for injection HAO Gang, HAN Feng, ZHOU Gang, WU Xing, YAN Hao, LI Xuyang, HOU Hailing, NING Xiao, CUI Li 2023, 20(12): 1351-1356.  DOI: 10.19803/j.1672-8629.20230589 Abstract ( 78 )   PDF (1294KB) ( 58 )   Objective To establish a quality standard for the bacterial endotoxin test method of adenosine cobalt amine for injection, so as to provide reference for the formulation and revision of the national standard for this drug. Methods According to the 1143 bacterial endotoxin test method in the 2020 edition (Part 4) of the Chinese Pharmacopoeia, bacterial endotoxin test methodology was studied on 24 batches of adenosine cobalt amine injection from 8 production enterprises using different manufacturers of horseshoe crab reagents. Results A bacterial endotoxin limit of 40 EU·mg-1 for adenosine cobalt amine injection was established, which was suitable for the examination of 1143 bacterial endotoxin detection methods in the four general principles of the Chinese Pharmacopoeia in 2020. Conclusion Adenosylcobalamin for injection can be controlled by bacterial endotoxin examination, and the limit of bacterial endotoxin can be set as follows, the content of endotoxin per mg of adenosylcobalamin shall not exceed 40 EU. References | Related Articles | Metrics

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Evaluation of anaphylactoid reactions induced by human immunoglobulin for intravenous injection(pH 4.0) based on mouse auricular blue staining experiments KE Bingbing, LI Yan, WANG Pinghui, XU Xiaoling, SHEN Jiate, LYU Xiaojun 2023, 20(12): 1357-1361.  DOI: 10.19803/j.1672-8629.20230514 Abstract ( 57 )   PDF (1643KB) ( 78 )   Objective To evaluate the anaphylactoid reactions induced by human immunoglobulin for intravenous injection(pH4.0) via the mouse auricular blue staining experiments, and to investigate the anaphylactoid reactions induced by products with different proportions of polymers. Methods Three batches of products with different proportions of polymers, A(1.3%), B(0.1%) and C(0.5%), were selected respectively, and products with increased proportions of polymers were prepared by heating as the control (product C was heated in the water bath at 50℃ for 10 min and 20 min respectively). The symptoms of these mice after administration, the auricular blue staining rate, blue staining score, and Evans blue exudation were used as indicators for evaluation of anaphylactoid reactions. Results There were considerable differences in the symptoms of anaphylactoid reactions caused by products with different proportions of polymers, and there were statistically significant differences in the auricular blue staining rate, blue staining score, and Evans blue exudation. After the products were heated, the symptoms of anaphylactoid reactions deteriorated with the increase of proportions of polymers. Conclusion The mouse auricle blue staining experiment can be used to preliminarily evaluate the anaphylactoid reactions of products with different proportions of polymers, which can provide reference for quality control and safety evaluation of human immunoglobulin for intravenous injection(pH4.0). References | Related Articles | Metrics

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Preliminary study on extraction technology of tea extract used for Xinnaojian preparation WANG Zhao, LIU Yue, ZAN Ke, LI Hailiang, JIN Hongyu, MA Shuangcheng 2023, 20(12): 1362-1367.  DOI: 10.19803/j.1672-8629.20230614 Abstract ( 45 )   PDF (1643KB) ( 72 )   Objective To study the extraction technology of tea extract under Xinnaojian Tablet in ChP2020, and compare the related preparations. In order to undertake an initial investigation of the product at current situation. And provide reference for the drug quality control and safe usage. Methods According to the requirements of ChP2020, 8 batches of tea from different sources were extracted by means of decocting them with water, filter, combine the filtrate and add alkali, adjust the extract to be alkaline, and allow to stand. And then add acid to the precipitate and adjust to be acidic, filter, extract the filtrate with ethyl acetate by shaking, and finally, recover the solvent in vacuum. And then the extraction rate was calculated. Tea raw materials, tea extracts prepared in our laboratory, 7 batches of tea extracts collected from the market, tea extracts provided by enterprises and corresponding batches of Xinnaojian capsules were analyzed by visualized analysis with the fingerprint method which including 9 omponents of gallate, epigallocatechin, catechins, caffeine, epicatechin, epigallocatechin-3-gallate, gallocatechin gallate, epicatechin-3-gallate, epicatechin-3-gallate. And the differences were compared. Results The extraction rate of tea extract prepared in the laboratory according to the ChP2020 method is about 0.3-0.5%, and the extraction rate of tea extract produced by a company that we investigated is about 5%, while it is said that the extraction rate of tea extract purchased on the market can be as high as 20~30%. The fingerprint results showed that the fingerprint of tea extracts from different sources varied greatly, especially for the extracts purchased on the market. Conclusion In this study, the extraction technology of tea extract was preliminarily discussed, and the possible problems of existing methods and products were pointed out, which provided scientific basis for improving the extraction technology of tea extract and ensuring the quality and safety of products. References | Related Articles | Metrics

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Comparative study of fresh and dried houttuynia based on the electronic nose and GC-MS technique and correlations between “ fishy odor ” components DONG Caihong, HU Shaowei, TIAN Guanghuan, KONG Xixian, WU Hongwei, LI Hui 2023, 20(12): 1368-1374.  DOI: 10.19803/j.1672-8629.20230056 Abstract ( 59 )   PDF (2137KB) ( 60 )   Objective To conduct a comparative study of the odor and chemical composition of fresh and dried houttuynia samples. Methods The “fishy odor” and volatile components of fresh and dried houttuynia samples were analyzed using the electronic nose technique and gas chromatography-mass spectrometry (GC-MS). The correlation between the expressions of chemical components and the “fishy odor” indexes was analyzed based on a comparison of fresh and dried houttuynia samples. Results The radar map of 10 sensors of the electronic nose visually depicted the differences in the “fishy odor” between fresh and dried houttuynia. The differences in odor between fresh and dried houttuynia groups were characterized by modeling analysis (PCA, OPLS-DA). Four main differential sensor indicators-W1W, W2W, W3C, W5C-were screened. GC-MS analysis identified and characterized a total of 90 volatile components from fresh and dried houttuynia, while modeling analysis (PCA, OPLS-DA) characterized the differences in chemical composition between fresh and dried houttuynia groups before 35 major components were screened. The results of correlation analysis showed that nine substances, including d-pinene, (±)-2-pinene, beta-pinene, stigmasterol, (-)-spathulenol, n-nonenal, (Z)-beta-farnesene, lauricene and o-isopropylbenzene, played an important role in the “ fishy odor “ of houttuynia. Conclusion The above findings reveal the characteristics of and differences in the “fishy odor” of fresh and dried houttuynia, and provide reference for the establishment of a quality evaluation system based on sensory evaluation techniques and quality control of fresh and dried houttuynia. References | Related Articles | Metrics

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Quality analysis of donepezil hydrochloride tablet GUAN Haoyue, LIU Nian, QI Mengjie, SUN Baihao, LIU Xuejing, HU Yang, NIU Jianzhao 2023, 20(12): 1375-1381.  DOI: 10.19803/j.1672-8629.20230390 Abstract ( 97 )   PDF (1979KB) ( 103 )   Objective To evaluate the quality status of donepezil hydrochloride for providing reference for its production, quality control and supervision. Methods According to the general requirements of inspection program, the statutory methods combined with the exploratory studies were used to evaluate the quality condition of 140 batches of donepezil hydrochloride produced by 7 manufactures. Results All samples were inspected according to the executive standards, and the qualified rate was 100%. But there were some quality differences in related substances and assay among generic drugs, RLD (reference listed drug), and products passing the consistency evaluation. The legal standards were various with different test items and the methods and limits of standards were not uniformed. Conclusion The overall quality of donepezil hydrochloride was good, but there was still a gap between the quality level of the generic drug and the RLD. The current standard is basically feasible,but it still needs to be perfected to control the production process and improve the quality of preparations. References | Related Articles | Metrics

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Implementation of periodic benefit risk evaluation reports in China TIAN Chunhua, WU Guizhi 2023, 20(12): 1382-1384.  DOI: 10.19803/j.1672-8629.20230579 Abstract ( 460 )   PDF (1254KB) ( 598 )   Objective To elaborate on the revision of PSUR in the Adverse Drug Reaction Reporting and Monitoring Management(Order 81) in combination with the current regulation of drugs in China. Methods The revision and implementation of the ICH E2C guideline system and related requirements in China were introduced. The status quo, problems and challenges related to the transformation and implementation of ICH E2C were outlined before recommendations were offered. Results Compared with PSUR, PBRER was more comprehensive and detailed, which could better reflect the overall situation of product benefits and risks. However, the adoption of PBRER also faced many challenges, such as a lack of knowledge of PBRER on the part of drug marketing authorization holders, the need for more professional participation in PBRER writing, and the difficulty in obtaining complete data for mature products. Conclusion The full adoption of PBRER can promote the accountability of holders and help the national and provincial adverse drug reaction monitoring agencies to supervise holders. It is recommended that PBRER be fully adopted following the revision of Order 81. References | Related Articles | Metrics

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Post-marketing active monitoring of medical devices under vigilance ZHAO Yan, LI Yao, SONG Ya’na, ZHENG Lijia, LI Dong, ZHAO Yifei, BIAN Rongrong, DONG Fang 2023, 20(12): 1385-1390.  DOI: 10.19803/j.1672-8629.20230529 Abstract ( 177 )   PDF (1357KB) ( 178 )   Objective To study the feasibility and importance of post-marketing active monitoring of medical devices in China based on the pilot vigilance of medical devices and to offer recommendations for active monitoring using new methods for medical device vigilance. Methods Based on the current methods for adverse event monitoring of medical devices, cases of research on active monitoring conducted at home and in the United States were analyzed while the applications of active monitoring in medical device vigilance were elaborated. Results As a new mean of medical device vigilance, active monitoring will play an important role in the field of post-marketing safety supervision of medical devices. Conclusion In order to adapt to new requirements for risk control over medical devices and draw on the experience of the United States in terms of regulation of medical devices, it is recommended that new methods for active monitoring of medical device vigilance be explored in China in order to continue to improve the effectiveness of risk monitoring of medical devices and ensure the safety of medical devices. References | Related Articles | Metrics

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Diagnosis and treatment of mycoplasma pneumoniae pneumonia in children and rational administration of related drugs JIA Zhaoguang, XU Wenshuai, JI Li’na, WANG Linlin, ZHAO Li’na, ZHAO Jingquan, MU Xiangdong 2023, 20(12): 1391-1395.  DOI: 10.19803/j.1672-8629.20230739 Abstract ( 257 )   PDF (1401KB) ( 320 )   Objective To study the clinical diagnosis and treatment of Mycoplasma pneumoniae pneumonia (MPP) in children and the safe and reasonable use of related drugs. Methods Review from the perspectives of epidemiology, clinical and imaging manifestations, treatment methods, and side effects. Results Since the autumn of 2023, there has been a significant increase in MPP in children in China, with clinical manifestations such as fever and cough, which are generally mild and have a good prognosis; A few may develop into severe illness. For children with MPP, macrolides should be the preferred drug, but drug resistance is relatively common in China; Tetracyclines can be substituted and resistance is rare, but they are required for children more than 8 years; Quinolone drugs under the age of 18 belong to the category of over-the-counter medication and are not necessary; Severe MPP can also receive short-term symptomatic anti-inflammatory treatment with glucocorticoids. For children with complications such as extensive lung consolidation, atelectasis, and plastic bronchitis, early bronchoalveolar lavage treatment is recommended, and it is recommended to implement it under general anesthesia, which can significantly improve the outcome and prognosis. Conclusion For mild MPP, the application of anti-mycoplasma drugs and symptomatic treatment generally achieves good therapeutic effects; For severe MPP, on the basis of effective anti-infection, short-term treatment with glucocorticoids can be added, and if necessary, bronchoscopic alveolar lavage can significantly improve the outcome and prognosis. References | Related Articles | Metrics

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Revision of safety information in instructions of traditional Chinese patent medicines and simple preparations LEI Chao, QIAO Meng, CHEN Zijia, ZHANG Qiang, XIE Yanming, WANG Zhifei 2023, 20(12): 1396-1400.  DOI: 10.19803/j.1672-8629.20230315 Abstract ( 275 )   PDF (1361KB) ( 359 )   Objective To study how to revise the safety information items in instructions for traditional Chinese patent medicines and simple preparations. Methods With reference to the Technical Guidelines for the Revision of Safety Information Items in the Instructions of Listed Traditional Chinese Medicine (Trial) (No. 1 in 2022), this paper analyzed the contents of such warnings as “taboos”, “adverse reactions”, “precautions” and “medications for special groups” in the instructions for traditional Chinese patent medicines and simple preparations, and offered recommendations in combination with the practical experience associated with the revision of safety information items in these instructions. Results and Conclusion Marketing authorization holders can improve the safety information items in the instructions by supplementing the missing items, standardizing related terminology, and correctly labeling safety information. During the process of revision, marketing authorization holders are to conduct exhaustive search of safety information by different means, and sort out and analyze the retrieved information as items of evidence that underlie any revision. The safety information items in the instructions for traditional Chinese patent medicines and simple preparations should be revised on this basis so as to provide more accurate guidance for clinical use of traditional Chinese patent medicines and simple preparations. References | Related Articles | Metrics

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Analysis and thinking on the status quo of safety item information in the instructions of traditional Chinese patent medicines containing Asari Radix et Rhizoma and its extracts QIAO Meng, LEI Chao, CHEN Zijia, ZHANG Qiang, WANG Zhifei 2023, 20(12): 1401-1406.  DOI: 10.19803/j.1672-8629.20230303 Abstract ( 133 )   PDF (1321KB) ( 178 )   Objective To analyze the current situation of safety problems in the instructions of Chinese patent medicine containing Asari Radix et Rhizoma and its extracts, and to provide suggestions for the revision of instructions. Methods The Chinese pharmacopoeia 2020, Guidelines for clinical application of national essential drug 2012, Formulary of national essential drug were searched for Chinese patent medicines containing Asari Radix et Rhizoma and its extracts, and the composition and dosage, indications, usage and dosage of the Chinese patent medicine, and the safety information in the drug instructions were collected. Besides, the basic characteristics, dosage of Asari Radix et Rhizoma and safety items of Chinese patent medicine instructions were summarized and statistically analyzed in Excel 2019. Results 40 Chinese patent medicines containing Asari Radix et Rhizoma and its extracts were included after removing duplicates. The dosage of Asari Radix et Rhizoma from most of these Chinese patent medicines meets the regulations of Chinese pharmacopoeia, but there is a lack of the information on usage and dosage for special populations, “eighteen anti” and “nineteen fear”. There were still problems of the safety information of the drug instructions of the marketing authorization holders collected in this study including missing safety information and the nonstandard terminology. Conclusion We suggest the marketing authorization holders to revise the safety information of instructions based on related laws and regulations such as Technical Guiding Principles for Revision of Safety Information in Marketed Chinese Patent Medicine Instructions (Trial) and the guidance of the syndrome differentiation system of traditional Chinese medicine and the clinical medication experience to provide foundation for safe use of clinical drugs. The safety information in the instructions includes adverse events, contraindications, precautions, warnings, application for specific populations, and usage and dosage for specific populations. References | Related Articles | Metrics

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Clinical applicability and safety risks of puerarin in tumor adjuvant therapy based on CiteSpace and bioinformatics technology LIU Yadi, WANG Xue, YIN Xiaoyang, LIU Zeyu, ZHANG Xiaomeng, ZHANG Bing, LIN Zhijian 2023, 20(12): 1407-1414.  DOI: 10.19803/j.1672-8629.20230192 Abstract ( 69 )   PDF (2146KB) ( 80 )   Objective To study the clinical applicability and hotspots of research of puerarin and to identify the potential risks to safety. Methods Based on exhaustive analysis of data on the anti-cancer properties of puerarin and using CiteSpace software, visual analysis was conducted by searching databases for the data on the prevention of tumors and cancer by puerarin that was published between January 1, 1990 and October 31, 2022. At the same time, the GSE85871 gene chip in GEO database was detected and studied using biotechnology while the GO function annotation and KEGG pathway of differentially expressed genes in human breast cancer cell MCF7 were explored. Results Visual analysis suggested that the role of puerarin in treating liver cancer, lung cancer, cervical cancer, bladder cancer, ovarian cancer, breast cancer and other diseases had been extensively studied. However, the results of bioinformatics research also showed that when puerarin was used in adjuvant treatment of breast cancer, puerarin tended to act on the cGMP signaling pathway and the nerve ligand receptor interaction signaling pathway, thus affecting oxytocin secretion and osteoclast differentiation. There might be potential safety risks to the cardiovascular system, nervous system and bone metabolism. Conclusion Despite the utility of puerarin in the adjuvant treatment of cancers, the related adverse reactions have to be taken into consideration, and rational use of traditional Chinese medicines containing puerarin should be recommended to ensure safe and effective use. References | Related Articles | Metrics

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Adverse drug reaction/ event caused by oral antidiabetic drugs WEI Anhua, QI Jianjun, WANG Lu, ZENG Lu, GONG Xuepeng, JIANG Ying 2023, 20(12): 1415-1420.  DOI: 10.19803/j.1672-8629.20230077 Abstract ( 266 )   PDF (1230KB) ( 297 )   Objective To study the characteristics and regularity of adverse drug reaction / adverse drug event (ADR/ADE) caused by oral antidiabetic drugs, and to provide reference for rational use of these drugs in clinic. Methods A retrospective study was conducted to retrieve all ADR/ADE reports involving 10 types of oral antidiabetic drugs from the database of Wuhan ADR/ADE spontaneous reporting system that were submitted between 2012 and 2022. The demography of the users, usage of drugs, organs and systems involved in ADR/ADE and clinical manifestations were analyzed using the descriptive statistical methods. Results A total of 953 ADR/ADE reports and 1 405 cases related to oral antidiabetic drugs were included in this study. The number of reports trended up. Mild cases and serious ones accounted for 88.67% and 11.33% respectively. The most common ADR/ADE were gastrointestinal, skin, and metabolic disorders while drugs involved most frequently were α-glycosidase inhibitors, thiazolidinediones (TZD) and biguanide combined with TZD. Meanwhile, the ADR/ADE caused by different types of oral antidiabetic drugs varied in terms of system -organ distribution and clinical manifestations. Sodium-glucose cotransporter-2 inhibitors (SGLT2i) were most likely to induce urinary tract damage and genital pruritus, dipeptidyl peptidase-IV inhibitors (DPP4i) tended to lead to skin or skin accessory disorders, glinides were mainly associated with hypoglycemia, and other drugs were mainly linked to gastrointestinal damage. Conclusion The ADR/ADE due to oral antidiabetic drugs involve a wide range of systems and keep increasing each year. The ADR/ADE caused by new oral antidiabetic drugs deserve more attention. In order to ensure the safety of oral antidiabetic drugs in clinical use, potential risks need to be prevented, users need to improve their self-control, and related ADR/ADE have to be detected and handled quickly. References | Related Articles | Metrics

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Drug use evaluation of bevacizumab injection based on weighted TOPSIS method YIN Jinjun, WANG Shuwei, SHAO Jiangchao, WANG Bing 2023, 20(12): 1421-1426.  DOI: 10.19803/j.1672-8629.20230480 Abstract ( 82 )   PDF (1346KB) ( 80 )   Objective To establish the drug utilization evaluation criteria for bevacizumab and promote the rational use of bevacizumab through appropriate pharmaceutical interventions. Methods The archived medical records of 100 inpatients using bevacizumab injection in the first half of 2022 and the second half of 2022 were retrospectively analyzed. According to the instructions of bevacizumab and relevant clinical guidelines, the evaluation criteria of bevacizumab drug utilization were formulated, and the weighted advantage and inferiority solution method (TOPSIS) was used to objectively evaluate the use of bevacizumab. According to the evaluation results, the possible reasons were analyzed, and then the corresponding pharmaceutical intervention measures were formulated and continuous intervention was given. Finally, the weighted TOPSIS method was used to evaluate the use of bevacizumab after intervention. Results Before pharmaceutical intervention, there were 17 reasonable prescriptions (17.00%), 0 basic reasonable prescriptions and 83 unreasonable prescriptions (83.00%). After the intervention, there were 55 reasonable prescriptions (55.00%), 24 basically reasonable prescriptions (24.00%) and 21 unreasonable prescriptions (21.00%), which was improved compared with that before the intervention. After pharmaceutical intervention, the previous chemotherapy regimen, medication sequence, indications and combination drugs were improved, and the differences were statistically significant (P<0.05). Conclusion The weighted TOPSIS method can objectively and comprehensively evaluate the use of bevacizumab, which is convenient to find problems and intervene in time and promote the reasonable use of drugs. References | Related Articles | Metrics

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Mining and analysis of ixazomib citrate capsules safety signals based on FAERS database HAO Xiaohui, ZHANG Ping, WU Lulu, WANG Lihua 2023, 20(12): 1427-1431.  DOI: 10.19803/j.1672-8629.20230408 Abstract ( 131 )   PDF (1228KB) ( 217 )   Objective To mine and analyse the potential adverse event (AE) risk signals of ixazomib citrate capsules post-marketing to provide a reference for its rational clinical application. Methods Extract the FAERS database of AE reported for Ixazomib citrate capsules from marketing (November 2015) to March 31,2023, data cleaning and de-duplication and standardization. Signal mining was performed using the Reported Ratio (ROR) and Bayesian Confidence Progressive Neural Network (BCPNN) methods. Results A total of 14 156 AE were reported in the database with Ixazomib citrate capsules as the primary suspect. Mining by ROR and BCPNN methods resulted in 204 potential positive PTs, involving 17 SOC. Among them, there are 156 PT signals that are not specified in drug instruction, including the new and relatively serious AE such as death, cardiovascular system and renal-urinary system, which require high clinical attention. Conclusion Mining the real-world adverse events of ixazomib citrate capsules suggests that the clinical caution in evaluating its AE risk factors and strengthening the medication monitoring to ensure the safety of the medication for the patients. References | Related Articles | Metrics

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One case of central nervous system toxicity induced by loratinib tablets JIANG Kun, TANFeilong, WANG Zhongjuan, TAN Hongcheng, YOU Li’na 2023, 20(12): 1432-1434.  DOI: 10.19803/j.1672-8629.20230330 Abstract ( 142 )   PDF (1087KB) ( 154 )   Objective To explore the clinical characteristics and disposal of central nervous system toxicity caused by loratinib tablets. Methods One case of central nervous system toxicity caused by loratinib tablets in a stage IV lung adenocarcinoma patient with anaplastic lymphoma kinase (ALK) positivity was analyzed. By retrieving related literature, the clinical manifestations and appropriate treatments of such central nervous system toxicity were summarized. Results The main clinical manifestations were off-the-point answers, poor sleep, emotional excitement, irritability and inability to recognize others. This medication was discontinued immediately and symptomatic treatment with olanzapine was provided. The symptoms disappeared after three days, and the patient resumed the treatment with loratinib tablets after a week at a smaller dose. Conclusion Clinicians should be alert to the central nervous system toxicity associated with loratinib tablets, which can impact the quality of life of patients. References | Related Articles | Metrics

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Study on the material basis and mechanism on glycyrrhiza co-administered with sargassum pallidum, euphorbia pekinensis, euphorbia kansui and daphne genkwa incompatibility AN Zhuojia, ZHANG Keyi, ZHOU Mijia, HUANG Lijie, XIU Linlin 2023, 20(12): 1435-1440.  DOI: 10.19803/j.1672-8629.20230324 Abstract ( 120 )   PDF (1610KB) ( 122 )   Objective By study on the the material basis and mechanism on glycyrrhiza co-administered with sargassum pallidum, euphorbia pekinensis, euphorbia kansui and daphne genkwa, so as to provide a basis for improving the theory of incompatibility of TCM and guide the use of incompatible combinations. Methods In this paper, we analyzed the changes of the material basis before and after the combination and the effects on the toxicity of incompatible combinations in the Glycyrrhiza group of “zao ji sui yuan ju zhan cao” from the perspective of material basis by searching the domestic and foreign literature in recent years. Results The compatibility of Haizao (Sargassum), Jingdaji (Euphorbiae Pekinensis Radix), Gansui (Kansui Radix), Yuanhua (Genkwa Flos) and Gancao (Glycyrrhizae Radix Et Rhizoma) had an effect on the dissolution of toxic and effective components of incompatible combinations. After the compatibility, it may play a “toxic” or “effective” effect by promoting the release of toxic components, inhibiting the metabolism of toxic components, inhibiting the dissolution of effective components, producing new substances, and destroying the structure of substances, etc. Conclusion The opposing herbal remedies combination of the Glycyrrhiza group is not an absolute incompatibility, and it is necessary to continue to study based on the material base, combined with relevant drug toxicogenomics and metabolomics and other methods, as well as efficient technologies. References | Related Articles | Metrics