1.Material Basis and Its Distribution in vivo of Qili Qiangxin Capsules Analyzed by UPLC-Q-Orbitrap-MS
Jianwei ZHANG ; Jiekai HUA ; Rongsheng LI ; Qin WANG ; Xinnan CHANG ; Wei LIU ; Jie SHEN
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(5):185-193
ObjectiveBased on ultra-performance liquid chromatography-quadrupole-electrostatic field orbitrap high resolution mass spectrometry(UPLC-Q-Orbitrap-MS), the chemical constituents of Qili Qiangxin capsules was identified, and their distribution in vivo was analyzed. MethodsUPLC-Q-Orbitrap-MS was used to detect the sample solution of Qili Qiangxin capsules, as well as the serum, brain, heart, lung, spleen, liver and kidney tissues of mice after oral administration. Using the Thermo Xcalibur 2.2 software, the compound information database was constructed, and the molecular formulas of compounds corresponding to the quasi-molecular ions were fitted. Based on the information of retention time, accurate relative molecular mass and fragments, the compounds and their distribution in vivo were analyzed by comparing with the data of reference substances and literature. ResultsA total of 233 compounds, including 70 terpenoids, 60 flavonoids, 23 organic acids, 17 alkaloids, 20 steroids, 7 coumarins and 36 others, were identified or predicted from Qili Qiangxin capsules, 73 of which were identified matching with standard substances. Tissue distribution results showed that 71, 17, 38, 33, 32, 58 and 43 migrating components were detected in blood, brain, heart, lung, spleen, liver and kidney, respectively. Thirty-seven components were absorbed into the blood and heart, including quinic acid, benzoylaconitine benzoylmesaconine and so on. Fourteen components were absorbed into the blood and six tissues, including calycosin, methylnissolin, formononetin, alisol B, alisol A and so on. ConclusionThis study comprehensively analyzes the chemical components of Qili Qiangxin capsules and their distribution in vivo. Among them, astragaloside Ⅳ, salvianolic acid B, ginsenoside Rb1, ginsenoside Rb3, ginsenoside Rd, ginsenoside Rg3, calycosin-7-glucoside, and sinapine may be the important components for the treatment of heart failure, which can provide useful reference for its quality control and research on pharmacodynamic material basis.
2.Establishment of a method for detecting the potency of recombinant human coagulation factor Ⅶa for injection
Rong WU ; Liping WANG ; Jinye LANG ; Yue ZHU ; Jing ZHOU ; Xun LIU ; Jing NI ; Shunbo ZHOU ; Yaling DING
Chinese Journal of Blood Transfusion 2025;38(3):415-420
[Objective] To establish a method for detecting the potency of recombinant human coagulation factor Ⅶa for injection. [Methods] By adding the sample and factor Ⅶ deficient plasma to the sample cup and activating the reaction with prothrombin time assay reagent (PT reagent), the coagulation time of the sample was determined by the change in magnetic bead swing amplitude in the sample cup. The logarithm of coagulation time was inversely proportional to the logarithm of human factor Ⅶa potency. [Results] Under the experimental conditions, the specificity of the methodology was evaluated through spiked recovery, and the recovery rates ranged from 90.0% to 110.0%. Within the range from 0.125 to 1.000 IU/mL, there was a good linear response between the potency and coagulation time of the standard and sample, with correlation coefficients r>0.99. As for the accuracy and repeatability, the recovery rates of various concentrations detected in the stock solution were 101.0%, 100.0% and 112.0%, respectively, with RSD values of 2.6%, 4.0% and 0.0%, respectively. The recovery rates of various concentrations in finished product testing were 104.0%, 94.7% and 112.0%, respectively, with RSD values of 1.9%, 2.4% and 0.0%, respectively. As for the intermediate precision, the RSD were 4.5% and 3.7%, respectively. After treated with sample diluent, the sample was tested at room temperature for 6 hours and still exhibited relatively stable biological activity. [Conclusion] This detection method is accurate, stable, easy to operate and highly automated, and is suitable for detecting the potency of recombinant human coagulation factor Ⅶa for Injection.
3.External review of the recommendations of the Guidelines for Evidence-based Use of Biological Agents for the Clinical Treatment of Osteoporosis: a cross-sectional survey
Lingling YU ; Shuang LIU ; Zaiwei SONG ; Qiusha YI ; Yu ZHANG ; Liyan MIAO ; Zhenlin ZHANG ; Chunli SONG ; Yaolong CHEN ; Lingli ZHANG ; Rongsheng ZHAO
China Pharmacy 2025;36(9):1025-1029
OBJECTIVE To assess the scientific rigor, clarity and feasibility of the recommendations of the Guidelines for Evidence-based Use of Biological Agents for the Clinical Treatment of Osteoporosis (hereinafter referred to as the Guideline) through external review, in order to further revise and improve the Guideline recommendations. METHODS This study employed a cross-sectional survey research design, a convenience sampling method was adopted to select frontline medical workers in the field of osteoporosis (including clinical doctors, clinical pharmacists, and nurses) as well as patients or their family members. External review was conducted through a combination of closed-ended and open-ended electronic questionnaires to get feedback from them on the appreciation,clarity and feasibility of the 32 preliminary recommendations in the Guideline. RESULTS A total of 90 external review subjects from 15 hospitals were collected, including 45 clinical doctors, 15 clinical pharmacists, 15 nurses and 15 patients or their family members. The overall appreciation degree of recommendations was 99.38%, the overall clarity degree of recommendations was 98.92%, and the overall feasibility degree of recommendations was 99.65%. At the same time, 111 subjective suggestions were collected, which provided an important reference for the further improvement of the Guideline recommendations. Based on the above feedback, the Guideline steering committee and core expert group revised the wording of 12 draft recommendations without deletion, and finally determined 32 recommendations. CONCLUSIONS The external review provides an important basis for the final formation of the Guideline, further improves the scientific rigor, clarity and feasibility of the recommendations, and ensures the standardization, practicality and implementability of the Guideline.
4.Effects of different storage and transportation devices on the temperatures of “internet plus drug delivery”in hospital under high-temperature conditions in summer
Zheng CAI ; Chen SHANG ; Na HE ; Fang LIU ; Weilong SHI ; Zhe ZHAO ; Rongsheng ZHAO
China Pharmacy 2024;35(6):758-761
OBJECTIVE To explore suitable storage and transportation conditions for “internet plus drug delivery” under high- temperature conditions. METHODS A survey on high-temperature conditions in summer in Beijing was conducted; a retrospective analysis was conducted on “internet plus drug delivery” orders in our hospital from July 2021 to June 2022, summarizing the proportion and delivery range of drugs under different storage and transportation conditions. Additionally, simulation and validation experiments were performed to investigate optimal drug storage and transportation devices for “internet plus drug delivery” in Beijing under high-temperature conditions in summer. RESULTS The monthly average temperature in Beijing from June to August consistently exceeded 25.0 ℃ between 1991 and 2022. From July 2021 to June 2022, a total of 104 drugs were required to be stored below 25.0 ℃, accounting for 31.23% of the 333 drugs listed in our hospital’s “internet plus drug delivery” catalog in Beijing. These drugs were delivered 1 058 times, accounting for 19.63% of the total deliveries. Simulation and validation experiments demonstrated that the average maximum temperature during the next-day delivery process of “carton + foam box + composite aluminum film pearl cotton + 500 g ice bag×2 + gas column bag” was 9.6 ℃, the average minimum temperature was 2.7 ℃, and all the temperatures remained below 15.0 ℃, which could effectively ensure the quality of drugs. CONCLUSIONS Under the high-temperature conditions in summer in Beijing, the storage and transportation device of “carton + foam box + composite aluminum film pearl cotton + 500 g ice bag×2 + gas column bag” can meet the temperature requirements specified in the drug storage instructions for Beijing intra-city drug delivery.
5.Analysis of the working model of pharmacy consultation in medical institutions in China:a scoping review
Pengxiang ZHOU ; Xiaoxia LIU ; Xiaofei LI ; Xiaomin XING ; Sitao TAN ; Rongsheng ZHAO
China Pharmacy 2024;35(16):1946-1950
OBJECTIVE To systematically summarize the working model of pharmacy consultation in medical institutions in China, and to provide reference for the normalization of process, standardization of content and homogenization of services of pharmacy consultation. METHODS A systematic search of Chinese and English literature databases was conducted to incorporate the literature on the working model of pharmacy consultation published by medical institutions in China. Two researchers screened and extracted the key information, and ultimately conducted qualitative summary and descriptive analysis. RESULTS Based on the included 11 articles, the pharmacy consultation working models were explored by clinical pharmacists in China. The contents of consultation mainly involved anti-infection, parenteral nutrition, cancer pain, etc. The general concept of pharmacy consultation should refer to the constructed flowchart, specific consultation problems could refer to the pathway, mind map, or decision tree and other framework guidance to carry out the work. Finally, consultation opinions could be written according to the consultation system or specialty consultation templates, and the adoption of a new working model (such as pharmacist active consultation) could also promote the number and acceptance rate of pharmacy consultation. CONCLUSIONS A series of working models of pharmacy consultation have been initially explored in medical institutions in China. However, it is not yet perfect and lacks a unified quality control and evaluation system for pharmacy consultation, which should be the focus of future research and practice.
6.Investigation of patients’preferences regarding therapeutic drug monitoring of mycophenolic acid in solid organ transplantation
Shuang LIU ; Hongsheng CHEN ; Qi GUO ; Yinchu CHENG ; Rongsheng ZHAO ; Xiaofei HOU
China Pharmacy 2024;35(1):90-94
OBJECTIVE To investigate the preferences of patients who underwent solid organ transplantation regarding therapeutic drug monitoring (TDM) of mycophenolic acid (MPA) and explore the factors influencing patients’ decision-making process, so as to provide support for the development of individualized medication guidelines for MPA and improvement of clinical decision-making. METHODS The cross-sectional study was used to design the questionnaire on the patients’ preferences to accept MPA TDM, and involved patients who underwent solid organ transplantation and received MPA treatment at two tertiary hospitals in Beijing from April 14, 2022, to June 27, 2022. The Likert 5-level scoring method was used to score the patients’ preferences to accept MPA TDM, the influencing factors and their correlation of the patients’ preferences to accept MPA TDM were analyzed by Pearson correlation analysis and binary Logistic regression analysis, and the nonparametric test and chi-square test were used to rank and analyze the consistency of the factors affecting patients’ preference decision. RESULTS A total of 140 questionnaires were collected, and the effective recovery rate was 77.35%. The average preference score of 140 patients to receive MPA TDM was (4.01±0.65), and the overall preference value was high. There were 116 (82.86%) patients agreed or strongly agreed with MPA TDM. Significant differences were observed in preference scores between patients who had previously undergone MPA TDM and those who had never undergone it ([ 4.30±0.53) scores vs. (3.80±0.65) scores, P<0.001]. Additionally, patients’ preference scores were significantly influenced by their understanding level and attention level (P<0.001). The ranking of factors contributing to decision-making exhibited consistency (P<0.001). The factors were ranked in descending order of clinical efficacy, safety, comfortability, economy and time cost. CONCLUSIONS The patients who underwent solid organ transplantation hold high preferences towards MPA TDM. The primary factors influencing their decisions are their prior experience, understanding level, and attention level.
7.Projecting the Dynamic Trends of Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome:Modeling the Epidemic in Sichuan Province,China
Li YUAN ; Liu QINXI ; Luan RONGSHENG ; Yang YI ; Wu TAO ; Yang BIHUI
Biomedical and Environmental Sciences 2024;37(9):1003-1014
Objective Our study aimed to provide a comprehensive overview of the current status and dynamic trends of the human immunodeficiency virus (HIV) prevalence in Sichuan,the second most heavily affected province in China,and to explore future interventions. Methods The epidemiological,behavioral,and population census data from multiple sources were analyzed to extract inputs for an acquired immunodeficiency syndrome (AIDS) epidemic model (AEM). Baseline curves,derived from historical trends in HIV prevalence,were used,and the AEM was employed to examine future intervention scenarios. Results In 2015,the modeled data suggested an adult HIV prevalence of 0.191% in Sichuan,with an estimated 128,766 people living with HIV/AIDS and 16,983 individuals with newly diagnosed infections. Considering current high-risk behaviors,the model predicts an increase in the adult prevalence to 0.306% by 2025,projecting an estimated 212,168 people living with HIV/AIDS and 16,555 individuals with newly diagnosed infections. Conclusion Heterosexual transmission will likely emerge as the primary mode of AIDS transmission in Sichuan. Furthermore,we anticipate a stabilization in the incidence of AIDS with a concurrent increase in prevalence. Implementing comprehensive intervention measures aimed at high-risk groups could effectively alleviate the spread of AIDS in Sichuan.
8.Formulation and Analysis on the Standard of Automation and Information Technology
Xun YU ; Jiancun ZHEN ; Liyan MIAO ; Zongqi CHENG ; Wei ZHANG ; Rongsheng ZHAO ; Lan ZHANG ; Xiaoyang LU ; Jian ZHANG ; Dong LIU ; Aizong SHEN ; Weihua LAI ; Jingcheng HE
Herald of Medicine 2024;43(7):1074-1078
To improve patient-centered pharmaceutical management and pharmaceutical service capabilities in the pharmaceutical department of medical institutions,automation and information technology are indispensable.The Pharmacy Administration-Automation and Information Technology is one of the social organization standards of the Chinese Hospital Association as part 4-4 of Pharmaceutical Administration and Pharmaceutical Practice in Healthcare,which standardizes 32 key elements in four aspects:basic requirements for automation construction in medical institutions,construction of automation hardware equipment,construction of intelligent information platform,and quality management and continuous improvement.It can be used to guide medical institutions at all levels to select and optimize pharmacy automation equipment and information platforms.This article introduced the construction methods and contents of the pharmacy automation and information technology standards,to deepen the understanding of peers on this standard and promote its implementation.This article aimed to promote the modernization,informatization,and intelligence of pharmaceutical services in medical institutions,and improve the quality and efficiency of overall medical pharmaceutical administration and service.
9.Umbrella review of the efficacy and safety of monoclonal antibodies in the treatment of thyroid-associated ophthalmopathy
Shuang LIU ; Hanchun JIANG ; Jingjing WU ; Rongsheng ZHAO
Chinese Journal of Clinical Pharmacology and Therapeutics 2024;29(7):735-743
AIM:To comprehensively evaluate the efficacy and safety of rituximab(RTX),tocilizumab(TCZ),and teprotumumab(TMB)in the treatment of thyroid-associated ophthalmopathy(TAO).METHODS:A systematic search was conducted in PubMed,Embase and Cochrane Library databases for systematic reviews/meta-analyses on TAO treat-ment,with the search time limited to January 2024.The Preferred Reporting Items for Systematic Reviews and Meta-Analyses(PRISMA)2020 state-ment,Assessment of Multiple Systematic Reviews(AMSTAR)2 tool,and Grading of Recommenda-tions,Assessment,Development,and Evaluation(GRADE)were used to assess the reporting quality,methodological quality,and evidence quality of the included studies.RESULTS:The current systematic reviews on the three monoclonal antibodies in TAO treatment exhibited deficiencies in reporting quali-ty,methodological quality,and evidence quality.Di-rect comparative evidence between the three monoclonal antibodies is still lacking.Based on indi-rect comparative evidence,TCZ appears to be the most promising treatment option,followed by TMB and RTX.In terms of efficacy,TCZ and TMB signifi-cantly reduced the Clinical Activity Score(CAS),pro-ptosis,and improved quality of life.TCZ also signifi-cantly reduced the incidence of diplopia.RTX signif-icantly reduced disease response,while RTX and TCZ both significantly improved disease inactiva-tion rates.RTX showed no significant difference in diplopia,lid fissure changes,NOSPECS score and quality of life.The conclusions regarding safety are inconsistent,with TCZ and TMB potentially increas-ing the incidence of adverse events,while RTX showed no significant difference in safety com-pared to glucocorticoids or placebo.CONCLUSION:This study provides evidence-based insights for the selection of three monoclonal antibodies in the treatment of TAO.While TCZ may have advantages in efficacy,considering the limitations of existing evidence,more high-quality studies are needed to further verify and compare the efficacy and safety of different monoclonal antibodies in TAO treat-ment.
10.Clinical comprehensive evaluation of recombinant Mycobacterium tuberculosis fusion protein
Xiaofeng NI ; Sha DIAO ; Siyi HE ; Xuefeng JIAO ; Xiao CHENG ; Zhe CHEN ; Zheng LIU ; Linan ZENG ; Deying KANG ; Bin WU ; Chaomin WAN ; Binwu YING ; Hui ZHANG ; Rongsheng ZHAO ; Liyan MIAO ; Zhuo WANG ; Xiaoyu LI ; Maobai LIU ; Benzhi CAI ; Feng QIU ; Feng SUN ; Naihui CHU ; Minggui LIN ; Wei SHA ; Lingli ZHANG
China Pharmacy 2023;34(4):391-396
OBJECTIVE To evaluate the effectiveness, safety, economy, innovation, suitability and accessibility of recombinant Mycobacterium tuberculosis fusion protein (EC), and to provide evidence for selecting skin detection methods for tuberculosis infection diagnosis and auxiliary diagnosis of tuberculosis. METHODS The effectiveness and safety of EC compared with purified protein derivative of tuberculin (TB-PPD) were analyzed by the method of systematic review. Cost minimization analysis, cost-effectiveness analysis and cost-utility analysis were used to evaluate the short-term economy of EC compared with TB-PPD, and cost-utility analysis was used to evaluate the long-term economy. The evaluation dimensions of innovation, suitability and accessibility were determined by systematic review and improved Delphi expert consultation, and the comprehensive score of EC and TB-PPD in each dimension were calculated by the weight of each indicator. RESULTS The scores of effectiveness, safety, economy, innovation and suitability of EC were all higher than those of TB-PPD. The affordability scores of the two drugs were consistent, while the availability score of EC was lower than those of TB-PPD. After considering dimensions and index weight, the scores of effectiveness, safety, economy, innovation, suitability, accessibility and the comprehensive score of EC were all higher than those of TB-PPD. CONCLUSIONS Compared with TB-PPD, EC performs better in all dimensions of effectiveness, safety, economy, innovation, suitability and accessibility. However, it is worth noting that EC should further improve its availability in the dimension of accessibility.

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