1.Expert consensus on dispensing management of intravenous infusion drugs for clinical trials in PIVAS
Xingchen YANG ; Wenhuan FU ; Donghui LAO ; Jing ZHAO ; Jianzhong ZHANG ; Group PHARMACY ; Committee HOSPITAL ; Association Pharmaceutical SHANGHAI
China Pharmacy 2025;36(1):1-6
OBJECTIVE To further standardize the dispensing management standard of intravenous infusion drugs for clinical trials in pharmacy intravenous admixture services (PIVAS), and provide reference for medical institutions to provide high-quality pharmaceutical services. METHODS Initiated by PIVAS Group, Hospital Pharmacy Professional Committee, Shanghai Pharmaceutical Association, jointly led by Longhua Hospital, Shanghai University of Traditional Chinese Medicine and Shanghai Geriatric Medical Center, a writing group was established by PIVAS experts from multiple medical institutions to discuss the basic requirements and dispensing process of intravenous infusion drugs for clinical trials in PIVAS. The experts from the leading unit sorted out, summarized, analyzed, fed back and revised the opinions, and finally reached Expert Consensus on Dispensing Management of Intravenous Infusion Drugs for Clinical Trials in PIVAS. RESULTS & CONCLUSIONS The main contents of this consensus include information management, operation process, fund management and document management of intravenous infusion drugs for clinical trials in PIVAS. This consensus establishes a more standardized model for dispensing management of intravenous infusion drugs for clinical trials in PIVAS, by standardizing clinical trail drug management operational procedures, accurately recording and preserving drug-related information, with the aim of achieving standardized and meticulous management of PIVAS’s receipt of clinical trial drugs.
2.Guidelines for Establishing Animal Models of Rheumatoid Arthritis with Cold-dampness Obstruction Syndrome and Dampness-heat Obstruction Syndrome
Na LIN ; Yanqiong ZHANG ; Changhong XIAO ; Shenghao TU ; Jianning SUN ; Shijun XU ; Representation Preparation GROUP
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(6):47-54
Rheumatoid arthritis belongs to arthralgia syndrome in the theory of traditional Chinese medicine, and cold-dampness obstruction syndrome and dampness-heat obstruction syndrome are core syndromes and main syndrome differentiation types of this disease. Fine therapeutic effects have been obtained in the long-term clinical practice of many famous traditional Chinese medicine practitioners following the syndrome differentiation and treatment based on the guiding principles of cold and heat. To adapt to the clinical diagnosis practice of combining disease differentiation and syndrome differentiation, and to better carry out basic research on integrated Chinese and Western medicine and preclinical study on new traditional Chinese medicines, Guidelines for Establishing Animal Models of Rheumatoid Arthritis with Cold-Dampness Obstruction Syndrome and Dampness-Heat Obstruction Syndrome (hereinafter referred to as the Guidelines) were compiled by our research group, in cooperation with the renowned experts in research fields including traditional Chinese medicine, clinical medicine, zoology and evidence-based medicine, which provide a meaningful reference for scientific research, teaching and clinical applications. The compilation process of the Guidelines was guided by the theory of disease and syndrome integration and the principles of "evidence takes the main place, consensus plays an auxiliary role, and experience serves as the reference". Based on the comprehensive evaluation of pathogenesis homology, behavioral phenotypic consistency, and drug treatment predictability compared between animal models and human diseases, by the nominal group method, "recommendations" were formed for recommendations supported by evidence, and "consensus recommendations" were formed for recommendations not supported by evidence. Guidelines were formed involving content such as animal types, arthritis modeling methods, external stimulation conditions, and modeling assessment indicators during the establishment of the animal models of rheumatoid arthritis with cold-dampness obstruction syndrome and dampness-heat obstruction syndrome. The Guidelines are applicable for the disease and syndrome research on rheumatoid arthritis, investigation of therapeutic mechanisms, and development of new traditional Chinese medicine. The Guidelines also provide a reference for the establishment of guidelines on other types of diseases and syndromes combined with animal models to further promote the modernization of traditional Chinese medicine research and its integration with international academic development.
3.Editorial Explanation of Guidelines for Establishing Animal Models of Rheumatoid Arthritis with Cold-dampness Obstruction Syndrome and Dampness-heat Obstruction Syndrome
Na LIN ; Yanqiong ZHANG ; Changhong XIAO ; Shenghao TU ; Jianning SUN ; Shijun XU ; Xia MAO ; Representation Preparation GROUP
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(6):55-59
The Guidelines for Establishing Animal Models of Rheumatoid Arthritis with Cold-dampness Obstruction Syndrome and Dampness-heat Obstruction Syndrome (hereinafter referred to as the Guidelines) (No. T/CACM1567-2024) was published by Chinese Association of Chinese Medicine on January 11, 2024. To assist researchers and medical workers in understanding and applying the Guidelines more accurately, and also to provide reference and assistance for the establishment of guidelines on other types of diseases and syndromes combined with animal models, this paper made a declaration of the workflow, technological links, development references, promotion of its application and after-effect evaluation of the Guidelines that has been made according to the requirements of "Draft Group Standard of the Standardization Office of the Chinese Association of Traditional Chinese Medicine".
4.Expert consensus on perioperative rational use and comprehensive clinical evaluation of NSAIDs in Shandong Province
Association CLINICAL ; Association CLINICAL ; Association COMPREHENSIVE ; Association PAIN ; Province WORKING
China Pharmacy 2025;36(4):385-394
OBJECTIVE To provide a basis for the rational use of nonsteroidal anti-inflammatory drugs (NSAIDs) in the perioperative period, and provide practical methods and technical references for the evaluation and selection of NSAIDs in medical institutions. METHODS Initiated by the Affiliated Hospital of Qingdao University, Clinical Pharmacy Professional Committee of the Shandong Pharmacists Association, Clinical Individualised Drug Testing and Guidance Branch of the Shandong Medical Association, Comprehensive Clinical Medication Evaluation Working Committee of the Shandong Pharmacists Association, Pain Branch of the Shandong Medical Association in conjunction with several medical institutions in Shandong Province organized 22 pharmaceutical experts and medical experts from 17 hospitals in Shandong Province to form a consensus on the rational use and comprehensive clinical evaluation of NSAIDs in the perioperative period through the literature research method, expert interview method and questionnaire survey method based on evidence-based medicine. A comprehensive clinical evaluation was also conducted on a total of 13 specifications of 9 commonly used clinical drug varieties in Shandong Province, including celecoxib, etoricoxib, imrecoxib, ibuprofen (containing reference/original drugs and national/Shandong Province’s centralized volume-based procurement varieties). RESULTS & CONCLUSIONS A consensus opinion was formed on preoperative prophylactic use and postoperative use of NSAIDs, as well as contraindications, digestive tract risk, cardiovascular system risk, bleeding risk and kidney injury risk in the perioperative period. The evaluation and selection criteria of perioperative use of NSAIDs were established, involving 6 dimensions of safety, efficacy, economy, innovation, appropriateness, and accessibility. The results of comprehensive clinical evaluation showed that the top 6 drugs (scores over 70) were Celecoxib capsules (Celebrex) and Celecoxib capsules (Naiqi), Diclofenac sodium sustained-release tablets,Etocoxib tablets (Arcoxia) and Etocoxib tablets (Qimingshu), and Parecoxib sodium for injection. With the progress of clinical research, this consensus will be further updated and adjusted, and medical institutions can combine with the practice to develop a comprehensive clinical evaluation system of NSAIDs suitable for their institutions.
5.Research progress on extrahepatic targeted delivery of mRNA-LNP
Lei LI ; Cai-li ZHAO ; Ning ZHANG ; Chun-lei LI
Acta Pharmaceutica Sinica 2025;60(2):359-368
Messenger ribonucleic acid (mRNA) is a promising therapeutic drug with great potential in the fields of immunology, oncology, vaccines and inborn metabolic diseases. However, due to its instability and susceptibility to nuclease degradation, efficient delivery vectors are required. Lipid nanoparticles (LNPs) are recognized as the most mature delivery vectors due to their advantages of easy formulation, high stability, efficient cell uptake and endosomal escape. However, the accumulation of LNPs in the liver severely limits the targeting and treatment of mRNA-LNP technology beyond the liver. To overcome this obstacle, researchers have been focusing on various means to achieve precise delivery of extrahepatic tissues and organs. This article mainly expounds the research progress of LNP-specific delivery mRNA from three aspects: endogenous targeting, active targeting and selection of administration route, in order to provide ideas and directions for the design of new mRNA-LNP delivery systems in the future.
6.Research on interview outline design and quality control methods based on grounded theory for physician prescribing behavior
Liyuan TAO ; Li WANG ; Xinli XIANG ; Lu YANG ; Songleng DUAN ; Dechun JIANG
China Pharmacy 2025;36(5):524-528
OBJECTIVE To establish a interview outline design process and quality control evaluation method based on grounded theory, providing ideas for qualitative research interview outline design in medical fields. METHODS A literature review was conducted to understand the current research status; a preliminary interview outline was developed around the research content. The triangulation method, group evaluation, expert review and pre-interview were adopted to execute the interview outline and conduct quality control. The evaluation indicators and target values were formulated (an average score for the overall quality evaluation of all indicators ≥4.5, and an average score for individual indicators ≥4.00) to evaluate the effect of the interview outline. Taking the research on the mechanism of physicians’ prescribing behavior under the background of Diagnosis Related Groups (DRGs) payment as an example, the methodological contents of above interview outline were applied in practical research. RESULTS The interview outline included basic information and interview questions. The interview questions were divided into three parts:influencing factors survey, promoting and hindering factors of standardizing physician prescription behavior, and communication, with a total of 12 questions. After being reviewed by members of the research group, experts review and pre- interview, a total of 9 people participated in the quality control evaluation of the interview outline. The overall evaluation score was 4.94 (>4.50), and the average score of each indicator was greater than 4.00, indicating that the quality of the outline met the requirements for the interview and could be used for the formal interview. CONCLUSIONS The established interview outline design and quality control method based on grounded theory provides ideas for the qualitative research interview outline design in the medical field, and lays the foundation for further using grounded theory to study the influencing factors and mechanisms of physician prescription behavior under the DRG background.
7.Study on Effective Designs for the Identification and Differentiation of Tablets Using KH Coder
Yuka SHONO ; Fumika NAKAGAWA ; Hitomi YAMAMOTO ; Saki GOBARA ; Yuna TOMATSU ; Hiromu MIYAZAKI ; Kenichi OGAWA ; Hidenori SAGARA
Japanese Journal of Drug Informatics 2025;26(4):186-197
Background: This study surveyed pharmacists registered with the Yamaguchi Prefectural Pharmacists Association to determine the key elements of tablet printing design that enhance visibility and distinguishability during dispensing.Objectives: The purpose of this study is to identify suitable design components for tablets that enhance visibility and distinguishability by utilizing text data.Methods: Given the high risk of medication errors due to similar-looking tablets, the study employed KH Coder for text mining analysis of free-text responses.Results: Results indicated that design elements such as "horizontal writing," "straight lines, " and "emphasis on characters" significantly improve visibility and distinguishability, particularly for similar-looking tablets. The findings from this study provide specific guidelines for optimal tablet design, aiming to improve pharmacists' efficiency and enhance medication safety.Conclusions: KH Coder proved to be a valuable tool for analyzing qualitative data in the medical field. While the study focused on pharmacists in Yamaguchi Prefecture, expanding the survey to a national scale is recommended to validate and generalize the findings. This research supports the development of standardized tablet designs that can minimize dispensing errors and ensure patient safety, highlighting the importance of effective tablet printing design in pharmaceutical practice.
8.Comparison of Therapeutic Effect of Different Preparation Processes of Baihe Dihuangtang on Depressed Mice Based on Q-Marker
Yan LIU ; Jiameng LIU ; Jiahui PENG ; Dan LI ; Shengjun MA ; Jingfan YANG ; Yu FU ; Guangwei ZHU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(17):159-167
ObjectiveBased on modern analytical techniques and a depressed mouse model established by chronic unpredictable mild stress(CUMS), to evaluate the quality marker(Q-Marker) and pharmacodynamic difference of Baihe Dihuangtang prepared by different processes. MethodsHigh performance liquid chromatography(HPLC) was used to establish the characteristic profiles of Baihe Dihuangtang, and determine the content of Q-Marker in the samples prepared by ancient and modern processes. Seventy C57BL/6J mice were randomly divided into the normal group, model group, fluoxetine group(3 mg·kg-1), low and high dose groups of ancient process(6.5, 26 g·kg-1), and low and high dose groups of modern process(6.5, 26 g·kg-1), with 10 mice in each group. Except for the normal group, CUMS was used to induce depression in mice from the other groups for 28 d. After successful modeling, administration groups were given the corresponding drugs by gavage every day, and the normal and model groups were given an equal volume of pure water by gavage for 21 consecutive days. Change in body mass of mice was recorded, tail suspension test and open field test were used to evaluate the depressive behavior of mice, and enzyme-linked immunosorbent assay(ELISA) was employed to determine the contents of tumor necrosis factor-α(TNF-α), interleukin(IL)-1β and IL-6 in serum. ResultsCharacteristic profiles of Baihe Dihuangtang prepared by the two processes were established, the similarity between the two was 0.951, and 8 characteristic peaks were recognized with the reference peak of regaloside A. The results of quantitative analysis showed that the Q-Marker content was similar in Baihe Dihuangtang prepared by ancient and modern processes. The results of pharmacodynamics showed that, compared with the normal group, the model group showed increased immobility time in the tail suspension test, reduced total movement distance in the open field test, and elevated IL-1β, IL-6 and TNF-α levels in the serum(P<0.01). Compared with the model group, the behavioral indicators of mice in the Baihe Dihuangtang treatment group were significantly improved in terms of tail suspension time and open field exercise, and the levels of IL-1β, IL-6 and TNF-α in serum were significantly reduced(P<0.05, P<0.01). Baihe Dihuangtang prepared by the two processes both had antidepressant effects, and the difference between the two was not statistically significant in improving depressive symptoms. ConclusionQ-Marker of Baihe Dihuangtang prepared by modern and ancient methods are equivalent in content, and the pharmacological effects are consistent, indicating that dried Lilii Bulbus can replace fresh products in the preparation of Baihe Dihuangtang. This study provides a scientific basis for the development of new drugs of Baihe Dihuangtang and a reference for its rational application and clinical use.
9.Comparison of Therapeutic Effect of Different Preparation Processes of Baihe Dihuangtang on Depressed Mice Based on Q-Marker
Yan LIU ; Jiameng LIU ; Jiahui PENG ; Dan LI ; Shengjun MA ; Jingfan YANG ; Yu FU ; Guangwei ZHU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(17):159-167
ObjectiveBased on modern analytical techniques and a depressed mouse model established by chronic unpredictable mild stress(CUMS), to evaluate the quality marker(Q-Marker) and pharmacodynamic difference of Baihe Dihuangtang prepared by different processes. MethodsHigh performance liquid chromatography(HPLC) was used to establish the characteristic profiles of Baihe Dihuangtang, and determine the content of Q-Marker in the samples prepared by ancient and modern processes. Seventy C57BL/6J mice were randomly divided into the normal group, model group, fluoxetine group(3 mg·kg-1), low and high dose groups of ancient process(6.5, 26 g·kg-1), and low and high dose groups of modern process(6.5, 26 g·kg-1), with 10 mice in each group. Except for the normal group, CUMS was used to induce depression in mice from the other groups for 28 d. After successful modeling, administration groups were given the corresponding drugs by gavage every day, and the normal and model groups were given an equal volume of pure water by gavage for 21 consecutive days. Change in body mass of mice was recorded, tail suspension test and open field test were used to evaluate the depressive behavior of mice, and enzyme-linked immunosorbent assay(ELISA) was employed to determine the contents of tumor necrosis factor-α(TNF-α), interleukin(IL)-1β and IL-6 in serum. ResultsCharacteristic profiles of Baihe Dihuangtang prepared by the two processes were established, the similarity between the two was 0.951, and 8 characteristic peaks were recognized with the reference peak of regaloside A. The results of quantitative analysis showed that the Q-Marker content was similar in Baihe Dihuangtang prepared by ancient and modern processes. The results of pharmacodynamics showed that, compared with the normal group, the model group showed increased immobility time in the tail suspension test, reduced total movement distance in the open field test, and elevated IL-1β, IL-6 and TNF-α levels in the serum(P<0.01). Compared with the model group, the behavioral indicators of mice in the Baihe Dihuangtang treatment group were significantly improved in terms of tail suspension time and open field exercise, and the levels of IL-1β, IL-6 and TNF-α in serum were significantly reduced(P<0.05, P<0.01). Baihe Dihuangtang prepared by the two processes both had antidepressant effects, and the difference between the two was not statistically significant in improving depressive symptoms. ConclusionQ-Marker of Baihe Dihuangtang prepared by modern and ancient methods are equivalent in content, and the pharmacological effects are consistent, indicating that dried Lilii Bulbus can replace fresh products in the preparation of Baihe Dihuangtang. This study provides a scientific basis for the development of new drugs of Baihe Dihuangtang and a reference for its rational application and clinical use.
10.Quality evaluation of Xintong granules based on HPLC fingerprint and quantitative analysis of multi-components by single-marker method
Xide YE ; Xiaolong FENG ; Mingguo SHAO ; Linchun WAN ; Zhenyu HU ; Chunyu CHEN ; Yu WU ; Junwen BU ; Yuhang QIAN ; Fanqiang MENG
China Pharmacy 2025;36(15):1866-1870
OBJECTIVE To establish the HPLC fingerprint of Xintong granules and the quantitative analysis of multi- components by single-marker method (QAMS) to determine the contents of 7 components, so as to provide a scientific basis for their quality control. METHODS HPLC method was used to establish the fingerprints for 10 batches of Xintong granules (No. S1- S10), and similarity evaluation, cluster analysis (CA) and partial least squares-discriminant analysis (PLS-DA) were performed. At the same time, the contents of seven components, including puerarin, daidzin, calycosin-7-O- β -D-glucoside, stilbene glycoside, naringin, icariin and tanshinone ⅡA, were determined by QAMS method, and were compared with the results of external standard method. RESULTS A total of 18 common peaks were marked and 7 peaks were identified in the HPLC fingerprints for 10 batches of Xintong granules, namely puerarin (peak 4), daidzin (peak 7), calycosin-7-O-β-D-glucoside (peak 9), stilbene glycoside (peak 10), naringin (peak 12), icariin (peak 17), and tanshinone ⅡA (peak 18); the similarities among them were more than 0.990, and CA and PLS-DA results showed that S4-S5,S8-S10,S1-S3 and S6-S7 were clustered into three categories, respectively. Using naringin as the internal standard, the contents of puerarin, daidzin, calycosin-7-O-β-D-glucoside, stilbene glycoside, icariin and tanshinone ⅡA were determined to be 7.868 1-10.181 2, 1.709 2-2.374 1, 0.285 2-0.326 3, 1.024 1- 1.523 9, 0.140 2-0.290 4, and 0.077 1-0.219 4 mg/g, respectively, by the QAMS. These results showed no significant differences compared to those obtained by the external standard method. CONCLUSIONS Established HPLC fingerprint and QAMS method are convenient, stable and accurate, which can provide a basis for the quality evaluation of Xintong granules.


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