1.Overview of Chemical Imaging Guidelines in the Chinese,United States and European Pharmacopoeias
Shifeng WEI ; Xinru QIAO ; Linghui QIAN ; Xinyi XU
Drug Standards of China 2025;26(4):345-348
In recent years,chemical imaging technology has found increasingly broad applications in pharmaceuti-cal analysis,encompassing component distribution analysis,assessment of mixing uniformity,content uniformity e-valuation,polymorphism identification,and studies of drug delivery mechanisms.Chemical imaging has been pro-gressively recognized as an efficient tool for real-time quality control and online analysis.This article provides an o-verview of the chemical imaging guidelines in the Chinese,United States,European pharmacopoeias.The discus-sion aims to promote the application of multi-information fusion technologies in pharmaceutical analysis,enhance regulatory efficiency,and further advance the high-quality development of the pharmaceutical industry in China.
2.Overview of Chemical Imaging Guidelines in the Chinese,United States and European Pharmacopoeias
Shifeng WEI ; Xinru QIAO ; Linghui QIAN ; Xinyi XU
Drug Standards of China 2025;26(4):345-348
In recent years,chemical imaging technology has found increasingly broad applications in pharmaceuti-cal analysis,encompassing component distribution analysis,assessment of mixing uniformity,content uniformity e-valuation,polymorphism identification,and studies of drug delivery mechanisms.Chemical imaging has been pro-gressively recognized as an efficient tool for real-time quality control and online analysis.This article provides an o-verview of the chemical imaging guidelines in the Chinese,United States,European pharmacopoeias.The discus-sion aims to promote the application of multi-information fusion technologies in pharmaceutical analysis,enhance regulatory efficiency,and further advance the high-quality development of the pharmaceutical industry in China.
3.Liangxue Jiedu Huayu Formula improves liver function of mice with acute-on-chronic liver failure by inhibiting excessive activation of the cGAS-STING signaling pathway.
Qiao TANG ; Chao ZHOU ; Zhaofang BAI ; Qing YAO ; Simin CHEN ; Xinru WEN ; Zhaoyun HE ; Jin ZHANG ; Ruisheng LI ; Man GONG
Journal of Southern Medical University 2024;44(12):2291-2299
OBJECTIVES:
To explore the role of the cGAS-STING signaling pathway in the therapeutic mechanism of Liangxue Jiedu Huayu Formula (LXJDHYF) for acute-on-chronic liver failure (ACLF) in mice.
METHODS:
Thirty C57BL/6 mice were randomly divided into blank control group, model group, low- and high-dose LXJDHYF groups, and H151 (a specific cGAS-STING pathway inhibitor) group (n=6). In all but the control group, the mice were treated with CCl4 to induce liver cirrhosis followed by intraperitoneal injections of lipopolysaccharide and D-amino galactose to establish mouse models of ACLF. After the treatments, the mouse livers were collected for HE and TUNEL staining, and serum levels of ALT, AST and TBil were determined. In bone marrow-derived macrophages (BMDMs) and liver tissues of ACLF mice, the expressions of cGAS-STING signaling pathway-related mRNAs including IFN‑β, ISG15, IL-6 and TNF-α were determined with RT-qPCR, and the phosphorylation levels of IRF3 and STING proteins were investigated using Western blotting.
RESULTS:
Compared with the mice in the model group, the LXJDHYF-treated mice exhibited milder hepatocyte necrosis and inflammatory cell infiltration in the liver with significantly reduced hepatocyte apoptosis. LXJDHYF treatment also significantly lowered serum levels of ALT, AST, TBil, IL-6 and TNF-α in ACLF mice and effectively suppressed the expressions of cGAS-STING signaling pathway-related mRNA in both the BMDMs and the liver tissues and the phosphorylation of IRF3 and STING proteins in the BMDMs.
CONCLUSIONS
LXJDHYF can significantly improve liver function and attenuate inflammation in ACLF mice possibly by inhibiting excessive activation of the cGAS-STING signaling pathway.
Animals
;
Signal Transduction/drug effects*
;
Mice
;
Nucleotidyltransferases/metabolism*
;
Mice, Inbred C57BL
;
Acute-On-Chronic Liver Failure/etiology*
;
Membrane Proteins/metabolism*
;
Drugs, Chinese Herbal/therapeutic use*
;
Liver/metabolism*
;
Disease Models, Animal
;
Interferon Regulatory Factor-3/metabolism*
;
Interleukin-6/metabolism*
;
Male
4.Evidence-based clinical guideline for the diagnosis and treatment of surgical site infection in spinal trauma (version 2024)
Zhu GUO ; Chao WANG ; Hongfei XIANG ; Zhongqiang CHEN ; Liang CHEN ; Tongwei CHU ; Shucai DENG ; Jian DONG ; Xinru DU ; Shiqing FENG ; Baorong HE ; Xijing HE ; Jianzhong HU ; Yong HAI ; Qingquan KONG ; Guiqing LIANG ; Qi LIAO ; Zhongjun LIU ; Shaoyu LIU ; Baoge LIU ; Xiaoguang LIU ; Weishi LI ; Li LI ; Fang LI ; Bin LIN ; Shibao LU ; Tao NIU ; Zhenli QIAO ; Dike RUAN ; Yueming SONG ; Haipeng SI ; Jun SHU ; Zhongyi SUN ; Qing WANG ; Zili WANG ; Huan WANG ; Hongli WANG ; Yan WANG ; Xiaolin WU ; Zhanyong WU ; Jinglong YAN ; Tengbo YU ; Qiang ZHANG ; Guoqing ZHANG ; Xuesong ZHANG ; Fengdong ZHAO ; Jie ZHAO ; Zhaomin ZHENG ; Qingsan ZHU ; Dingjun HAO ; Bohua CHEN
Chinese Journal of Trauma 2024;40(12):1057-1070
Spinal surgical site infection (SSI), especially deep SSI after internal fixation is difficult in treatment, with long course of disease and poor prognosis. At present, there are many controversies in the diagnosis and treatment of spinal SSI, with unsatisfactory overall efficacy of its diagnosis and treatment. Besides, no diagnosis and treatment guideline based on evidence-based medicine has been in existence. To this end, the Spinal Infection Group of the Orthopedic Branch of the Chinese Medical Doctor Association and the Spinal Infection Group of the Spinal Surgery Branch of the Chinese Rehabilitation Medicine Association jointly organized relevant experts to formulate Evidence-based clinical guideline for the diagnosis and treatment of surgical site infection in spinal trauma ( version 2024) based on an evidence-based approach. A total of 10 recommendations were proposed on the diagnosis and treatment of spinal SSI, so as to provide a clinical reference for the diagnosis and treatment of spinal SSI.
5.Liangxue Jiedu Huayu Formula improves liver function of mice with acute-on-chronic liver failure by inhibiting excessive activation of the cGAS-STING signaling pathway
Qiao TANG ; Chao ZHOU ; Zhaofang BAI ; Qing YAO ; Simin CHEN ; Xinru WEN ; Zhaoyun HE ; Jin ZHANG ; Ruisheng LI ; Man GONG
Journal of Southern Medical University 2024;44(12):2291-2299
Objective To explore the role of the cGAS-STING signaling pathway in the therapeutic mechanism of Liangxue Jiedu Huayu Formula(LXJDHYF)for acute-on-chronic liver failure(ACLF)in mice.Methods Thirty C57BL/6 mice were randomly divided into blank control group,model group,low-and high-dose LXJDHYF groups,and H151(a specific cGAS-STING pathway inhibitor)group(n=6).In all but the control group,the mice were treated with CC14 to induce liver cirrhosis followed by intraperitoneal injections of lipopolysaccharide and D-amino galactose to establish mouse models of ACLF.After the treatments,the mouse livers were collected for HE and TUNEL staining,and serum levels of ALT,AST and TBil were determined.In bone marrow-derived macrophages(BMDMs)and liver tissues of ACLF mice,the expressions of cGAS-STING signaling pathway-related mRNAs including IFN-β,ISG15,IL-6 and TNF-α were determined with RT-qPCR,and the phosphorylation levels of IRF3 and STING proteins were investigated using Western blotting.Results Compared with the mice in the model group,the LXJDHYF-treated mice exhibited milder hepatocyte necrosis and inflammatory cell infiltration in the liver with significantly reduced hepatocyte apoptosis.LXJDHYF treatment also significantly lowered serum levels of ALT,AST,TBil,IL-6 and TNF-α in ACLF mice and effectively suppressed the expressions of cGAS-STING signaling pathway-related mRNA in both the BMDMs and the liver tissues and the phosphorylation of IRF3 and STING proteins in the BMDMs.Conclusion LXJDHYF can significantly improve liver function and attenuate inflammation in ACLF mice possibly by inhibiting excessive activation of the cGAS-STING signaling pathway.
6.Characteristics Evaluation and Application Analysis on Animal Models of Recurrent Spontaneous Abortion
Tiansong DING ; Jinghong XIE ; Bin YANG ; Heqiao LI ; Yizhuo QIAO ; Xinru CHEN ; Wenfan TIAN ; Jiapei LI ; Wanyi ZHANG ; Fanxuan LI
Laboratory Animal and Comparative Medicine 2024;44(4):393-404
Objective To summarize and evaluate the characteristics of current recurrent spontaneous abortion(RSA)animal models at home and abroad,and to provide reference and guidance for the standardized preparation of RSA models.Methods"Recurrent spontaneous abortion"and"animal model"were used as co-keywords in CNKI,Wanfang,VIP,PubMed and Web of Science databases to search the RSA animal experimental literature,covering the period up to January 20,2024,and a total of 1 411 articles were collected.The analysis focused on construction methods and essential elements of RSA animal models,the modeling process and result evaluation,as well as the application of these models in pharmacological and pharmacodynamic research.An Excel table was established for systematic analysis and discussion.Results A total of 138 experimental studies were obtained after screening.In constructing RSA animal models,immunological models were the most widely used in Western medicine(96.92%),with the Clark model being the main one(92.31%).In traditional Chinese medicine(TCM)models,70.00%were kidney deficiency-luteal inhibition-syndrome combination models,20.00%were kidney deficiency and blood stasis models,and 10.00%were deficiency-heat syndrome models.Most animals were selected at 6-8 weeks(33.86%)and 8 weeks(32.28%)of age.The majority of animals were paired for mating at 18:00 on the day of cage pairing.In 81.03%of literatures,vaginal plugs were checked once the following morning,with 8:00 being the most common time(17.02%).The most commonly used drug administration cycle was 14 days of continuous gavage after pregnancy.Among the tested drugs,Western drugs were mainly protein-based(29.17%),while TCM drugs were mainly TCM decoction(81.11%).The most frequently used methods for detecting indicators included visual observation of embryos(22.54%),western blot(15.96%),PCR(13.58%),ELISA(12.91%),HE staining(10.80%)and immunohistochemistry(9.39%).Conclusion The etiology of RSA is complex,and corresponding animal models should be established based on different etiologies.Clark model is commonly used in the construction of Western medicine model,while the kidney deficiency-luteal inhibition-syndrome combination model is predominant in TCM.RSA animal model is widely used in related research,but systematic evaluation needs to be strengthened.
7.Differentiation and Treatment of Polycystic Ovary Syndrome from Perspective “Deficiency Cause,Cold Accumulation, and Qi Stagnation” in Essentials from the Golden Cabinet (《金匮要略》)
Yizhuo QIAO ; Yi LI ; Yini SUN ; Yajun LI ; Yating QI ; Heqiao LI ; Xinru CHEN ; Jinghong XIE
Journal of Traditional Chinese Medicine 2024;65(7):745-749
“Deficiency cause, cold accumulation, and qi stagnation” originates from Essentials from the Golden Cabinet (《金匮要略》), which is a guiding principle for the pathogenesis of women's diseases, pioneering the differentiation and treatment of women's diseases based on patterns, and having a profound influence on future generations. Following the classical principles and simplifying the complexities, this paper explored the pathogenesis and mechanism of polycystic ovary syndrome (PCOS) from the perspective of “deficiency cause, cold accumulation, and qi stagnation”, and believed that depletion of essence and blood, long-term accumulation of internal cold, and qi constraint and blood stasis are the causes of PCOS, with depletion of essence and blood, and lack of nourishment of zang-fu (脏腑) organs as the root, and cold pathogen invasion, qi constraint and blood stasis as the branch. The main treatment principle is “treating deficiency with supplementation”, and dispelling pathogen while reinforcing healthy qi, along with “treatment of cold by warming” and “treatment of stagnation by dispersing”. This is of great significance for the treatment of polycystic ovary syndrome. Clinically, these methods can be used flexibly to guide treatment and formula selection for PCOS, with the goal of harmonizing qi and blood and regulating menstruation.
8.Evidence-based clinical guideline for the diagnosis and treatment of surgical site infection in spinal trauma (version 2024)
Zhu GUO ; Chao WANG ; Hongfei XIANG ; Zhongqiang CHEN ; Liang CHEN ; Tongwei CHU ; Shucai DENG ; Jian DONG ; Xinru DU ; Shiqing FENG ; Baorong HE ; Xijing HE ; Jianzhong HU ; Yong HAI ; Qingquan KONG ; Guiqing LIANG ; Qi LIAO ; Zhongjun LIU ; Shaoyu LIU ; Baoge LIU ; Xiaoguang LIU ; Weishi LI ; Li LI ; Fang LI ; Bin LIN ; Shibao LU ; Tao NIU ; Zhenli QIAO ; Dike RUAN ; Yueming SONG ; Haipeng SI ; Jun SHU ; Zhongyi SUN ; Qing WANG ; Zili WANG ; Huan WANG ; Hongli WANG ; Yan WANG ; Xiaolin WU ; Zhanyong WU ; Jinglong YAN ; Tengbo YU ; Qiang ZHANG ; Guoqing ZHANG ; Xuesong ZHANG ; Fengdong ZHAO ; Jie ZHAO ; Zhaomin ZHENG ; Qingsan ZHU ; Dingjun HAO ; Bohua CHEN
Chinese Journal of Trauma 2024;40(12):1057-1070
Spinal surgical site infection (SSI), especially deep SSI after internal fixation is difficult in treatment, with long course of disease and poor prognosis. At present, there are many controversies in the diagnosis and treatment of spinal SSI, with unsatisfactory overall efficacy of its diagnosis and treatment. Besides, no diagnosis and treatment guideline based on evidence-based medicine has been in existence. To this end, the Spinal Infection Group of the Orthopedic Branch of the Chinese Medical Doctor Association and the Spinal Infection Group of the Spinal Surgery Branch of the Chinese Rehabilitation Medicine Association jointly organized relevant experts to formulate Evidence-based clinical guideline for the diagnosis and treatment of surgical site infection in spinal trauma ( version 2024) based on an evidence-based approach. A total of 10 recommendations were proposed on the diagnosis and treatment of spinal SSI, so as to provide a clinical reference for the diagnosis and treatment of spinal SSI.
9.Re-evaluation of the immunogenicity of meningococcal serogroups A and C polysaccharide vaccine among a healthy population aged 5 to 59
Zhiqiang ZHAO ; Ruijie QIAO ; Xinru WANG ; Hao WANG ; Jin YANG ; Yi QUAN ; Xiaoling SHI ; Jia LIU ; Jisheng LIN ; Guilin XIE
Chinese Journal of Microbiology and Immunology 2014;(3):228-234
Objective To re-evaluate the immunogenicity of meningococcal serogroups A and C polysaccharide vaccine among a healthy population of age 5 to 59.Methods Pre and post-vaccination ser-um samples were collected from the subjects involved in a randomized , controlled clinical trial conducted in 2005 at Hechi, Guangxi, China.Enzyme-linked immunosorbent assay (ELISA) was performed for the quan-titative detection of specific anti-capsule IgG antibody against meningococcal serogroups A and C in serum samples.Serum bactericidal assay ( SBA) was used to measure the bactericidal antibody activity against se-rougroups A and C bacterial strains .Results Geometric mean concentrations (GMCs) of specific anti-cap-sule IgG antibody were 23.66 μg/ml and 78.83 μg/ml for serogroup A (P<0.05), and 1.23 μg/ml and 51.25 μg/ml for serogroup C (P<0.05) in serum samples of pre and post-vaccination, respectively.Be-fore immunization , 99% of serum samples ( 97/98 ) showed serogroup A-specific IgG concentration ≥2μg/ml, which reached up to 100%(98/98) after vaccination (P>0.05).The percentage of serum sam-ples with serogroup C-specific IgG concentration ≥2 μg/ml rose from 20%to 99% after vaccination ( P<0.05).The ratio of positive serum samples with at least four times of increases in concentration of specific IgG against serogroup A and serogroup C after vaccine immunization were 34% and 100%, respectively . The rSBA geometric mean titers ( GMTs) for serogroups A and C in serum sample of post-vaccination were respectively elevated from 1164 to 5530 (P<0.05), and from 4 to 6225 (P<0.05).The percentage of se-rum samples with rSBA GMTs≥128 increased from 91% to 99% for serogroup A (P>0.05), and from 14%to 96%for serogroup C (P<0.05) after vaccination.The rSBA GMTs with at least four times of in-creases after vaccination were detected respectively in 53% and 100% of serogroups A and C vaccinated subjects.Pearson correlation coefficient between IgG concentration and rSBA GMTs was r=0.15 (pre) and r=0.23 (post) for serogroup A, and r=-0.14 (pre) and r=0.58 (post) for serogroup C (P<0.05). Conclusion This study has demonstrated an efficient and sustained immunogenicity with meningococcal sero -groups A and C polysaccharide vaccine as evidenced by the data from standardized assays of ELISA and SBA .
10.Preparation of a human meningococcal reference serum and standardization of IgG concentrations to capsular polysaccharides and bactericidal activities against serogroup A, C, Y and W135 strains
Zhiqiang ZHAO ; Xinru WANG ; Yanan LI ; Hao WANG ; Fanglei LIU ; Fei YUAN ; Ruijie QIAO ; Jingming JIANG ; Yanlin HE ; Jisheng LIN ; Qiang YE ; Guilin XIE
Chinese Journal of Microbiology and Immunology 2014;(6):459-464
Objective To prepare a human meningococcal reference serum and standardize IgG concentrations to capsular polysaccharides and in vitro bactericidal activities of the reference serum against serogroup A, C, Y and W135 strains.Methods Twenty healthy adults were recruited and given one dose of immunization with tetravalent (serogroups A, C, Y and W135) meningococcal polysaccharide vaccine . Plasma samples were collected and gone through a series of process treatments including defibrination , filtra-tion, and lyophilization to prepare the meningococcal reference serum Men 10.The IgG concentrations of Men10 to capsular polysaccharides of serogroups A , C, Y and W135 were calibrated by using an internation-al reference serum CDC1992 as the standard in enzyme-linked immunosorbent assay (ELISA).Provisional IgG concentrations of Men10 were intensively validated by testing a panel of 12 calibration serum samples from Centers for Disease Control and Prevention , USA ( US CDC) and a panel of 56 serum samples immu-nized with A, C, Y and W135 meningococcal polysaccharide vaccine from Lanzhou Institute of Biological Products Co., Ltd.(LIBP) with the assays using Men10 and CDC1992 as the standard and/or test sam-ples, respectively.The bactericidal titers against serogroup A , C, Y and W135 strains were measured by se-rum bactericidal assay (SBA).Results Four thousand vials (0.5 ml/vial)of lyophilized human meningo-coccal reference serum Men10 were successfully prepared with 2.5%of residual moisture .Reference serum Men10 was sterile and free from contamination by hepatitis B virus , hepatitis C virus , human immunodefi-ciency virus and syphilis .Provisional IgG concentration of Men 10 to capsular polysaccharide of serogroups A, C, Y and W135 was calibrated by using CDC1992 as the standard.Furthermore, IgG concentrations of both panels of 12 CDC calibration serum samples and 56 LIBP serum samples calibrated by using Men 10 as the standard correlated well with those by using CDC1992 as the standard (r=0.99,P<0.05).The IgG concentrations of CDC1992 as calibrated by using Men10 as the standard showed significant correlation with its previously determined values with variation <10%.SBA titers for serotype A , C, Y and W135 strains were established as well .Conclusion A panel of new human meningococcal reference serum Men 10 with accurately calibrated IgG concentration against capsular polysaccharide of serogroups A , C, Y and W135 as well as SBA titers was successfully established .

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