1.Comparison of Immune Checkpoint Inhibitor-related Hepatotoxicity Management Among CSCO,NCCN and ASCO Guidelines
Hai ZOU ; Yunsong YANG ; Zhenyao CHEN ; Xinyan LI ; Yongfa ZHENG ; Biao ZHU
Herald of Medicine 2025;44(6):841-846
Immune checkpoint inhibitors(ICIs)represent the most widely used immunotherapeutic approach for antitumor treatment,yet the understanding of their associated hepatotoxicity remains incomplete.This article delves into and analyzes the similarities and differences among the management guidelines on ICI-related hepatotoxicity issued by the Chinese Society of Clinical Oncology(CSCO),the National Comprehensive Cancer Network(NCCN)of the United States,and the American Society of Clinical Oncology(ASCO),aiming to provide a more comprehensive management strategy for clinical practice.By reviewing and analyzing the latest guidelines,this study compares the differences and similarities in the diagnosis,assessment,grading criteria,and treatment strategies for ICI-related liver toxicity among these guidelines.The definitions and diagnostic criteria for ICI-related liver toxicity are generally consistent across different guidelines,primarily relying on the elevated levels of alanine aminotransferase(ALT),aspartate aminotransferase(AST),bilirubin,and alkaline phosphatase(ALP)for grading.Notably,the ASCO guidelines place a stronger emphasis on the assessment of symptoms of hepatic dysfunction.In terms of treatment strategies,all guidelines recommend using corticosteroids or immunosuppressants based on the toxicity grade.However,there are discrepancies in management strategies among the guidelines.Clinicians should tailor management strategies by considering the specific conditions of patients and integrating the recommendations from various guidelines.Additionally,given the current inadequate understanding of ICI-induced hepatotoxicity primarily manifested as cirrhosis in the existing guidelines,it is imperative to continuously update and refine these management guidelines as research progresses and clinical experience accumulates.
2.Comparison of Immune Checkpoint Inhibitor-related Hepatotoxicity Management Among CSCO,NCCN and ASCO Guidelines
Hai ZOU ; Yunsong YANG ; Zhenyao CHEN ; Xinyan LI ; Yongfa ZHENG ; Biao ZHU
Herald of Medicine 2025;44(6):841-846
Immune checkpoint inhibitors(ICIs)represent the most widely used immunotherapeutic approach for antitumor treatment,yet the understanding of their associated hepatotoxicity remains incomplete.This article delves into and analyzes the similarities and differences among the management guidelines on ICI-related hepatotoxicity issued by the Chinese Society of Clinical Oncology(CSCO),the National Comprehensive Cancer Network(NCCN)of the United States,and the American Society of Clinical Oncology(ASCO),aiming to provide a more comprehensive management strategy for clinical practice.By reviewing and analyzing the latest guidelines,this study compares the differences and similarities in the diagnosis,assessment,grading criteria,and treatment strategies for ICI-related liver toxicity among these guidelines.The definitions and diagnostic criteria for ICI-related liver toxicity are generally consistent across different guidelines,primarily relying on the elevated levels of alanine aminotransferase(ALT),aspartate aminotransferase(AST),bilirubin,and alkaline phosphatase(ALP)for grading.Notably,the ASCO guidelines place a stronger emphasis on the assessment of symptoms of hepatic dysfunction.In terms of treatment strategies,all guidelines recommend using corticosteroids or immunosuppressants based on the toxicity grade.However,there are discrepancies in management strategies among the guidelines.Clinicians should tailor management strategies by considering the specific conditions of patients and integrating the recommendations from various guidelines.Additionally,given the current inadequate understanding of ICI-induced hepatotoxicity primarily manifested as cirrhosis in the existing guidelines,it is imperative to continuously update and refine these management guidelines as research progresses and clinical experience accumulates.
3.Expert consensus on the clinical application of long-acting cabotegravir and rilpivirine
Lijun SUN ; Hongxia WEI ; Haibo DING ; Ping MA ; Hui WANG ; Lijing WANG ; Chunmei WANG ; Min WANG ; Qian WANG ; Hai LONG ; Jinchuan SHI ; Wei LYU ; Biao ZHU ; Jun LIU ; An LIU ; Lianguo RUAN ; Zaicun LI ; Linghua LI ; Huiqin LI ; Shenghua HE ; Meiyin ZOU ; Yuxia SONG ; Renfang ZHANG ; Jian ZHANG ; Xinping YANG ; Yahong CHEN ; Yaokai CHEN ; Hongxin ZHAO ; Qingxia ZHAO ; Zhongsi HONG ; Feng QIAN ; Guangyong XU ; Huihuang HUANG ; Wei CAO ; Jianhua YU ; Juan JIN ; Lin CAI ; Fujie ZHANG
Chinese Journal of Clinical Infectious Diseases 2024;17(6):431-439
The long-acting cabotegravir and rilpivirine injection regimen(CAB+RPV regimen)is the first approved long-acting antiretroviral therapy(ART)for HIV in China,administered once every two months. This regimen provides an innovative alternative to daily oral ART,benefiting virologically suppressed patients. Several large clinical-studies have shown that the CAB+RPV regimen achieves comparable virologic suppression and safety to daily oral regimens,while significantly enhancing patient satisfaction. Based on international and domestic HIV/AIDs guidelines and clinical evidence,this consensus offers expert recommendations on patient selection,clinical management,and key communication strategies for healthcare providers to support the effective use of this regimen,aiming to improve quality of life for people living with HIV and accumulate domestic clinical experience with this advanced treatment approach.
4.Expert consensus on the clinical application of long-acting cabotegravir and rilpivirine
Lijun SUN ; Hongxia WEI ; Haibo DING ; Ping MA ; Hui WANG ; Lijing WANG ; Chunmei WANG ; Min WANG ; Qian WANG ; Hai LONG ; Jinchuan SHI ; Wei LYU ; Biao ZHU ; Jun LIU ; An LIU ; Lianguo RUAN ; Zaicun LI ; Linghua LI ; Huiqin LI ; Shenghua HE ; Meiyin ZOU ; Yuxia SONG ; Renfang ZHANG ; Jian ZHANG ; Xinping YANG ; Yahong CHEN ; Yaokai CHEN ; Hongxin ZHAO ; Qingxia ZHAO ; Zhongsi HONG ; Feng QIAN ; Guangyong XU ; Huihuang HUANG ; Wei CAO ; Jianhua YU ; Juan JIN ; Lin CAI ; Fujie ZHANG
Chinese Journal of Clinical Infectious Diseases 2024;17(6):431-439
The long-acting cabotegravir and rilpivirine injection regimen(CAB+RPV regimen)is the first approved long-acting antiretroviral therapy(ART)for HIV in China,administered once every two months. This regimen provides an innovative alternative to daily oral ART,benefiting virologically suppressed patients. Several large clinical-studies have shown that the CAB+RPV regimen achieves comparable virologic suppression and safety to daily oral regimens,while significantly enhancing patient satisfaction. Based on international and domestic HIV/AIDs guidelines and clinical evidence,this consensus offers expert recommendations on patient selection,clinical management,and key communication strategies for healthcare providers to support the effective use of this regimen,aiming to improve quality of life for people living with HIV and accumulate domestic clinical experience with this advanced treatment approach.
5.HbA1c comparison and diagnostic efficacy analysis of multi center different glycosylated hemoglobin detection systems.
Ping LI ; Ying WU ; Yan XIE ; Feng CHEN ; Shao qiang CHEN ; Yun Hao LI ; Qing Qing LU ; Jing LI ; Yong Wei LI ; Dong Xu PEI ; Ya Jun CHEN ; Hui CHEN ; Yan LI ; Wei WANG ; Hai WANG ; He Tao YU ; Zhu BA ; De CHENG ; Le Ping NING ; Chang Liang LUO ; Xiao Song QIN ; Jin ZHANG ; Ning WU ; Hui Jun XIE ; Jina Hua PAN ; Jian SHUI ; Jian WANG ; Jun Ping YANG ; Xing Hui LIU ; Feng Xia XU ; Lei YANG ; Li Yi HU ; Qun ZHANG ; Biao LI ; Qing Lin LIU ; Man ZHANG ; Shou Jun SHEN ; Min Min JIANG ; Yong WU ; Jin Wei HU ; Shuang Quan LIU ; Da Yong GU ; Xiao Bing XIE
Chinese Journal of Preventive Medicine 2023;57(7):1047-1058
Objective: Compare and analyze the results of the domestic Lanyi AH600 glycated hemoglobin analyzer and other different detection systems to understand the comparability of the detection results of different detectors, and establish the best cut point of Lanyi AH600 determination of haemoglobin A1c (HbA1c) in the diagnosis of diabetes. Methods: Multi center cohort study was adopted. The clinical laboratory departments of 18 medical institutions independently collected test samples from their respective hospitals from March to April 2022, and independently completed comparative analysis of the evaluated instrument (Lanyi AH600) and the reference instrument HbA1c. The reference instruments include four different brands of glycosylated hemoglobin meters, including Arkray, Bio-Rad, DOSOH, and Huizhong. Scatter plot was used to calculate the correlation between the results of different detection systems, and the regression equation was calculated. The consistency analysis between the results of different detection systems was evaluated by Bland Altman method. Consistency judgment principles: (1) When the 95% limits of agreement (95% LoA) of the measurement difference was within 0.4% HbA1c and the measurement score was≥80 points, the comparison consistency was good; (2) When the measurement difference of 95% LoA exceeded 0.4% HbA1c, and the measurement score was≥80 points, the comparison consistency was relatively good; (3) The measurement score was less than 80 points, the comparison consistency was poor. The difference between the results of different detection systems was tested by paired sample T test or Wilcoxon paired sign rank sum test; The best cut-off point of diabetes was analyzed by receiver operating characteristic curve (ROC). Results: The correlation coefficient R2 of results between Lanyi AH600 and the reference instrument in 16 hospitals is≥0.99; The Bland Altman consistency analysis showed that the difference of 95% LoA in Nanjing Maternity and Child Health Care Hospital in Jiangsu Province (reference instrument: Arkray HA8180) was -0.486%-0.325%, and the measurement score was 94.6 points (473/500); The difference of 95% LoA in the Tibetan Traditional Medical Hospital of TAR (reference instrument: Bio-Rad Variant II) was -0.727%-0.612%, and the measurement score was 89.8 points; The difference of 95% LoA in the People's Hospital of Chongqing Liang Jiang New Area (reference instrument: Huizhong MQ-2000PT) was -0.231%-0.461%, and the measurement score was 96.6 points; The difference of 95% LoA in the Taihe Hospital of traditional Chinese Medicine in Anhui Province (reference instrument: Huizhong MQ-2000PT) was -0.469%-0.479%, and the measurement score was 91.9 points. The other 14 hospitals, Lanyi AH600, were compared with 4 reference instrument brands, the difference of 95% LoA was less than 0.4% HbA1c, and the scores were all greater than 95 points. The results of paired sample T test or Wilcoxon paired sign rank sum test showed that there was no statistically significant difference between Lanyi AH600 and the reference instrument Arkray HA8180 (Z=1.665,P=0.096), with no statistical difference. The mean difference between the measured values of the two instruments was 0.004%. The comparison data of Lanyi AH600 and the reference instrument of all other institutions had significant differences (all P<0.001), however, it was necessary to consider whether it was within the clinical acceptable range in combination with the results of the Bland-Altman consistency analysis. The ROC curve of HbA1c detected by Lanyi AH600 in 985 patients with diabetes and 3 423 patients with non-diabetes was analyzed, the area under curve (AUC) was 0.877, the standard error was 0.007, and the 95% confidence interval 95%CI was (0.864, 0.891), which was statistically significant (P<0.001). The maximum value of Youden index was 0.634, and the corresponding HbA1c cut point was 6.235%. The sensitivity and specificity of diabetes diagnosis were 76.2% and 87.2%, respectively. Conclusion: Among the hospitals and instruments currently included in this study, among these four hospitals included Nanjing Maternity and Child Health Care Hospital in Jiangsu Province (reference instrument: Arkray HA8180), Tibetan Traditional Medical Hospital of TAR (reference instrument: Bio-Rad Variant Ⅱ), the People's Hospital of Chongqing Liang Jiang New Area (reference instrument: Huizhong MQ-2000PT), and the Taihe Hospital of traditional Chinese Medicine in Anhui Province (reference instrument: Huizhong MQ-2000PT), the comparison between Lanyi AH600 and the reference instruments showed relatively good consistency, while the other 14 hospitals involved four different brands of reference instruments: Arkray, Bio-Rad, DOSOH, and Huizhong, Lanyi AH600 had good consistency with its comparison. The best cut point of the domestic Lanyi AH600 for detecting HbA1c in the diagnosis of diabetes is 6.235%.
Pregnancy
;
Child
;
Humans
;
Female
;
Glycated Hemoglobin
;
Cohort Studies
;
Diabetes Mellitus/diagnosis*
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Sensitivity and Specificity
;
ROC Curve
6.Cannabidiol Promotes Osteogenic Differentiation of Bone Marrow Mesenchymal Stem Cells in the Inflammatory Microenvironment via the CB2-dependent p38 MAPK Signaling Pathway
Lin LI ; Jin FENG ; Lei SUN ; Yao-wei XUAN ; Li WEN ; Yun-xia LI ; Shuo YANG ; Biao ZHU ; Xiao-yu TIAN ; Shuang LI ; Li-sheng ZHAO ; Rui-jie DANG ; Ting JIAO ; Hai-song ZHANG ; Ning WEN
International Journal of Stem Cells 2022;15(4):405-414
Background and Objectives:
Chronic inflammation of bone tissue often results in bone defects and hazards to tissue repair and regeneration. Cannabidiol (CBD) is a natural cannabinoid with multiple biological activities, including anti-inflammatory and osteogenic potential. This study aimed to investigate the efficacy and mechanisms of CBD in the promotion of bone marrow mesenchymal stem cells (BMSCs) osteogenic differentiation in the inflammatory microenvironment.
Methods:
and Results: BMSCs isolated from C57BL/6 mice, expressed stem cell characteristic surface markers and pre-sented multidirectional differentiation potential. The CCK-8 assay was applied to evaluate the effects of CBD on BMSCs’ vitality, and demonstrating the safety of CBD on BMSCs. Then, BMSCs were stimulated with lipopolysaccharide (LPS) to induce inflammatory microenvironment. We found that CBD intervention down-regulated mRNA expression levels of inflammatory cytokines and promoted cells proliferation in LPS-treated BMSCs, also reversed the protein and mRNA levels downregulation of osteogenic markers caused by LPS treatment. Moreover, CBD intervention activated the cannabinoid receptor 2 (CB2) and the p38 mitogen-activated protein kinase (MAPK) signaling pathway. While AM630, a selective CB2 inhibitor, reduced phosphorylated (p)-p38 levels. In addition, AM630 and SB530689, a selective p38 MAPK inhibitor, attenuated the enhancement of osteogenic markers expression levels by CBD in inflammatory microenvironment, respectively.
Conclusions
CBD promoted osteogenic differentiation of BMSCs via the CB2/p38 MAPK signaling pathway in the inflammatory microenvironment.
7.CiteSpace-Based Visualization Analysis of Forensic Research in China from 2010 to 2019.
Hai-Biao ZHU ; Hong-Xia LIU ; Yu-Cong WANG ; Yi-Xun MA ; Dong ZHAO ; Xu WANG ; Tian-Tong YANG
Journal of Forensic Medicine 2022;38(4):478-485
OBJECTIVES:
To analyze the research status of forensic medicine in China from 2010 to 2019, obtain the development trend of forensic medicine and explore the hotspots and research frontiers.
METHODS:
The forensic medical academic papers published on China National Knowledge Infrastructure (CNKI) database from 2010 to 2019 were collected. CiteSpace 5.7.R1, an information visualization analysis software, was used to analyze publication organizations, authors, keywords, and other elements.
RESULTS:
The majority of the research institutions were universities, provincial and ministerial scientific research and forensic institutions. Forensic pathology was still an important branch of forensic medicine and a popular research direction. The "polymorphism" and "Y chromosome" had been the research hotspots in recent years. "Medical damage" and "standard" were the most novel studies.
CONCLUSIONS
In order to provide scientific basis and research direction for forensic research, this paper analyzes the cooperation network, research hotspots and research innovation in forensic research.
Forensic Medicine
;
China
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Forensic Pathology
;
Software
8.Efficacy and safety of the long-acting fusion inhibitor albuvirtide in antiretroviral-experienced adults with human immunodeficiency virus-1: interim analysis of the randomized, controlled, phase 3, non-inferiority TALENT study.
Bin SU ; Cheng YAO ; Qing-Xia ZHAO ; Wei-Ping CAI ; Min WANG ; Hong-Zhou LU ; Yuan-Yuan CHEN ; Li LIU ; Hui WANG ; Yun HE ; Yu-Huang ZHENG ; Ling-Hua LI ; Jin-Feng CHEN ; Jian-Hua YU ; Biao ZHU ; Min ZHAO ; Yong-Tao SUN ; Wen-Hui LUN ; Wei XIA ; Li-Jun SUN ; Li-Li DAI ; Tai-Yi JIANG ; Mei-Xia WANG ; Qing-Shan ZHENG ; Hai-Yan PENG ; Yao WANG ; Rong-Jian LU ; Jian-Hua HU ; Hui XING ; Yi-Ming SHAO ; Dong XIE ; Tong ZHANG ; Fu-Jie ZHANG ; Hao WU
Chinese Medical Journal 2020;133(24):2919-2927
BACKGROUND:
Albuvirtide is a once-weekly injectable human immunodeficiency virus (HIV)-1 fusion inhibitor. We present interim data for a phase 3 trial assessing the safety and efficacy of albuvirtide plus lopinavir-ritonavir in HIV-1-infected adults already treated with antiretroviral drugs.
METHODS:
We carried out a 48-week, randomized, controlled, open-label non-inferiority trial at 12 sites in China. Adults on the World Health Organization (WHO)-recommended first-line treatment for >6 months with a plasma viral load >1000 copies/mL were enrolled and randomly assigned (1:1) to receive albuvirtide (once weekly) plus ritonavir-boosted lopinavir (ABT group) or the WHO-recommended second-line treatment (NRTI group). The primary endpoint was the proportion of patients with a plasma viral load below 50 copies/mL at 48 weeks. Non-inferiority was prespecified with a margin of 12%.
RESULTS:
At the time of analysis, week 24 data were available for 83 and 92 patients, and week 48 data were available for 46 and 50 patients in the albuvirtide and NRTI groups, respectively. At 48 weeks, 80.4% of patients in the ABT group and 66.0% of those in the NRTI group had HIV-1 RNA levels below 50 copies/mL, meeting the criteria for non-inferiority. For the per-protocol population, the superiority of albuvirtide over NRTI was demonstrated. The frequency of grade 3 to 4 adverse events was similar in the two groups; the most common adverse events were diarrhea, upper respiratory tract infections, and grade 3 to 4 increases in triglyceride concentration. Renal function was significantly more impaired at 12 weeks in the patients of the NRTI group who received tenofovir disoproxil fumarate than in those of the ABT group.
CONCLUSIONS:
The TALENT study is the first phase 3 trial of an injectable long-acting HIV drug. This interim analysis indicates that once-weekly albuvirtide in combination with ritonavir-boosted lopinavir is well tolerated and non-inferior to the WHO-recommended second-line regimen in patients with first-line treatment failure.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT02369965; https://www.clinicaltrials.gov.Chinese Clinical Trial Registry No. ChiCTR-TRC-14004276; http://www.chictr.org.cn/enindex.aspx.
Adult
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Anti-HIV Agents/adverse effects*
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Antiretroviral Therapy, Highly Active
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China
;
Drug Therapy, Combination
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HIV Infections/drug therapy*
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HIV-1
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Humans
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Maleimides
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Peptides
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Ritonavir/therapeutic use*
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Treatment Outcome
;
Viral Load
9.Chinese Trauma Surgeon Association for management guidelines of vacuum sealing drainage application in abdominal surgeries-Update and systematic review.
Yang LI ; Pei-Yuan LI ; Shi-Jing SUN ; Yuan-Zhang YAO ; Zhan-Fei LI ; Tao LIU ; Fan YANG ; Lian-Yang ZHANG ; Xiang-Jun BAI ; Jing-Shan HUO ; Wu-Bing HE ; Jun OUYANG ; Lei PENG ; Ping HU ; Yan-An ZHU ; Ping JIN ; Qi-Feng SHAO ; Yan-Feng WANG ; Rui-Wu DAI ; Pei-Yang HU ; Hai-Ming CHEN ; Ge-Fei WANG ; Yong-Gao WANG ; Hong-Xu JIN ; Chang-Ju ZHU ; Qi-Yong ZHANG ; Biao SHAO ; Xi-Guang SANG ; Chang-Lin YIN
Chinese Journal of Traumatology 2019;22(1):1-11
Vacuum sealing drainage (VSD) is frequently used in abdominal surgeries. However, relevant guidelines are rare. Chinese Trauma Surgeon Association organized a committee composed of 28 experts across China in July 2017, aiming to provide an evidence-based recommendation for the application of VSD in abdominal surgeries. Eleven questions regarding the use of VSD in abdominal surgeries were addressed: (1) which type of materials should be respectively chosen for the intraperitoneal cavity, retroperitoneal cavity and superficial incisions? (2) Can VSD be preventively used for a high-risk abdominal incision with primary suture? (3) Can VSD be used in severely contaminated/infected abdominal surgical sites? (4) Can VSD be used for temporary abdominal cavity closure under some special conditions such as severe abdominal trauma, infection, liver transplantation and intra-abdominal volume increment in abdominal compartment syndrome? (5) Can VSD be used in abdominal organ inflammation, injury, or postoperative drainage? (6) Can VSD be used in the treatment of intestinal fistula and pancreatic fistula? (7) Can VSD be used in the treatment of intra-abdominal and extra-peritoneal abscess? (8) Can VSD be used in the treatment of abdominal wall wounds, wound cavity, and defects? (9) Does VSD increase the risk of bleeding? (10) Does VSD increase the risk of intestinal wall injury? (11) Does VSD increase the risk of peritoneal adhesion? Focusing on these questions, evidence-based recommendations were given accordingly. VSD was strongly recommended regarding the questions 2-4. Weak recommendations were made regarding questions 1 and 5-11. Proper use of VSD in abdominal surgeries can lower the risk of infection in abdominal incisions with primary suture, treat severely contaminated/infected surgical sites and facilitate temporary abdominal cavity closure.
Abdomen
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surgery
;
China
;
Drainage
;
methods
;
Evidence-Based Medicine
;
Humans
;
Practice Guidelines as Topic
;
Societies, Medical
;
organization & administration
;
Surgical Wound Infection
;
prevention & control
;
Traumatology
;
organization & administration
;
Vacuum
10.Simultaneous determination of five anthraquinones in a Chinese traditional preparation by RP-HPLC using an improved extraction procedure.
Yan-bin SHI ; E-mail: YBYYSH@126.COM. ; Hui-li LI ; Hai-qin WANG ; Yan-biao YANG ; Xiao-yun ZHANG ; Hui WANG ; Zong-jie ZHU ; Zhi-Ye ZHANG ; Cheng-an ZHANG
Journal of Integrative Medicine 2014;12(5):455-462
OBJECTIVEThe stable quality of Chinese herbal medicines is a critical factor for their reliable clinical efficiency. An improved liquid-liquid extraction procedure and a liquid chromatographic method were developed to simultaneously analyze five anthraquinones (aloe-emodin, rhein, emodin, chrysophanol and physcion) in a Chinese traditional hospital preparation, Fuyankang mixture, in order to quantitatively control its quality in a more effective way.
METHODSA more economical and repeatable extraction procedure based on conventional liquid-liquid extraction technique was developed and used to extract five marker components in Fuyankang mixture. These anthraquinones were separated in less than 20 min on a C18 column with methanol and 0.1% phosphoric acid (88:12, v/v) as mobile phase. The method was validated for specificity, precision, spiked recovery and stability.
RESULTSCompared to conventional liquid-liquid extraction, the improved liquid-liquid extraction was found to be more effective for simultaneous extraction of anthraquinones from an aqueous Chinese herbal preparation, especially for hydrophobic compounds. The improved extraction method was successfully applied to determine the content of five marker components in Fuyankang mixture by the means of reverse phase high-performance liquid chromatography.
CONCLUSIONThe improved extraction procedure may be suitable for routine quality control of Fuyankang mixture and other traditional preparations at city-level hospitals in China.
Anthraquinones ; analysis ; Chromatography, High Pressure Liquid ; methods ; Chromatography, Reverse-Phase ; methods ; Drugs, Chinese Herbal ; analysis ; Emodin ; analogs & derivatives ; analysis

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