1.Overview of the amendments and revisions to the General Technical Requirements adopted by the Volume Ⅳ of the Chinese Pharmacopoeia 2025 Edition
ZHANG Jun ; NING Baoming ; WEI Shifeng ; SHEN Haoyu ; SHANG Yue ; ZHU Ran ; XU Xinyi ; CHEN Lei ; LIU Tingting ; MA Shuangcheng
Drug Standards of China 2025;26(1):034-044
To introduce the general thinking, guidelines, work objectives and elaboration process of the general technical requirements adopted by volume Ⅳ of the Chinese Pharmacopoeia 2025 Edition, and to summarize and figure out the main characteristics on dosage forms, physico-chemical testing, microbial and biological testing, reference standards and guidelines The newly revised general chapters of pharmacopoeia give full play to the normative and guiding role of the Chinese Pharmacopoeia standard, track the frontier dynamics of international drug regulatory science and the elaboration of monographs, expand the application of state-of-the-art technologies, and steadily promote the harmonization and unification with the ICH guidelines; further enhance the overall capacity of TCM quality control, actively implement the 3 R principles on animal experiments, and practice the concept of environmental-friendly; replace and/or reduce the use of toxic and hazardous reagents, strengthen the requirements of drug safety control This paper aims to provide a full-view perspective for the comprehensive, correct understanding and accurate implementation of general technical requirements included in the Chinese Pharmacopoeia 2025 Edition.
2.Interpretation and thoughts on the formulation and revision of the standards for exogenous harmful residues in traditional Chinese medicinal materials in the Chinese Pharmacopoeia 2025 Edition
WANG Ying ; SHEN Mingrui ; LIU Yuanxi ; ZUO Tiantian ; WANG Dandan ; HE Yi ; CHENG Xianlong ; JIN Hongyu ; LIU Yongli ; WEI Feng ; MA Shuangcheng
Drug Standards of China 2025;26(1):083-092
As people’s attention to health continues to increase, the market demand for traditional Chinese medicine (TCM) is growing steadily. The quality and safety of Chinese medicinal materials have attracted unprecedented social attention. In particular, the issue of exogenous harmful residue pollution in TCM has become a hot topic of concern for both regulatory authorities and society. The Chinese Pharmacopoeia 2025 Edition further refines the detection methods and limit standards for exogenous harmful residues in TCM. This not only reflects China’s high-level emphasis on the quality and safety of TCM but also demonstrates the continuous progress made by China in the field of TCM safety supervision. Basis on this study, by systematically reviewing the development history of the detection standards for exogenous harmful residues in TCM and analyzing the revisions and updates of these detection standards in the Chinese Pharmacopoeia 2025 Edition, deeply explores the key points of the changes in the monitoring standards for exogenous harmful residues in TCM in the Chinese Pharmacopoeia 2025 Edition. Moreover, it interprets the future development directions of the detection of exogenous residues in TCM, aiming to provide a reference for the formulation of TCM safety supervision policies.
3.Experience in Treating Ischemic Stroke with Triple-Medicinal Combinations
Xueru ZHANG ; Wei SHEN ; Xiao LIANG ; Xiansu CHI ; Yunfan ZHANG ; Liuding WANG ; Yunling ZHANG
Journal of Traditional Chinese Medicine 2025;66(4):407-410
This paper summarized the clinical experience in treating ischemic stroke with jiao (角) medicine (triple-medicinal combinations). Clinically, the combination of Roucongrong (Cistanche deserticola)-Shanyurou (Cornus officinalis)-Guijia (Testudinis Carapax et Plastrum) is used to nourish the kidneys and liver for disease mechanism of liver-kidney depletion, and foundation deficiency due to insufficient essence and blood; the combination of Xixiancao (Sigesbeckia orientalis)-Tianma (Gastrodia elata)-Gouteng (Uncaria rhynchophylla) is used to extinguish wind and eliminate dampness for treating numbness and swelling of limbs caused by ischemic stroke; the combination of Shichangpu (Acorus Tatarinowii)-Yuanzhi (Polygala tenuifolia)-Yujin (Curcumae Radix) is used to improve intelligence, refresh the brain, and clear the mind for treating cognitive impairment, memory loss, or speech difficulties caused by ischemic stroke; the combination of Banxia (Pinellia ternata)-Baizhu (Atractylodes macrocephala)- Tianma (Gastrodiae rhizoma) is used to dissolve phlegm and extinguish wind, unblock meridians and relieve dizziness for treating dizziness or headache caused by ischemic stroke; the combination of Danggui (Angelica sinensis radix)- Chuanxiong (Ligusticum chuanxiong)-Guijianyu (Euonymus alatus) is used to nourish and activate blood circulation, remove blood stasis and unblock meridians for treating weak limbs and activiry difficulty caused by ischemic stroke; the combination of Chaihu (Bupleurum chinense)-Zhiziz (Gardenia jasminoides)-Guanye Jinsitao (Hypericum perforatum) is used to soothe the liver and resolve constraint, cool the blood and calm the mind for treating emotional complications.
4.Differentiation and Treatment of Lipid Turbidity Disease Based on Theory of "Spleen Ascending and Stomach Descending"
Yun HUANG ; Wenyu ZHU ; Wei SONG ; Xiaobo ZHANG ; Xin ZHOU ; Lele YANG ; Tao SHEN
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(3):244-252
Lipid turbidity disease is a metabolic disease featuring lipid metabolism disorders caused by many factors such as social environment, diet, and lifestyle, which is closely related to many diseases in modern medicine, such as hyperlipidemia, obesity, fatty liver, atherosclerosis, metabolic syndrome, and cardiovascular and cerebrovascular diseases, with a wide range of influence and far-reaching harm. According to the Huangdi Neijing, lipid turbidity disease reflects the pathological change of the body's physiologic grease. Grease is the thick part of body fluids, which has the function of nourishing, and it is the initial state and source of important substances in the human body such as brain, marrow, essence, and blood. Once the grease of the human body is abnormal, it can lead to lipid turbidity disease. The Huangdi Neijing also points out the physiological relationship between the transportation and transformation of body fluids and the rise and fall of the spleen and stomach, which can deduce the pathological relationship between the occurrence of lipid turbidity disease and the abnormal rise and fall of the spleen and stomach functions. Lipid turbidity disease is caused by overconsumption of fatty and sweet foods or insufficient spleen and stomach endowments, leading to disorders of the function of promoting clear and reducing turbidity in the spleen and stomach. This leads to the transformation of thick grease in body fluids into lipid turbidity, which accumulates in the body's meridians, blood vessels, skin pores, and organs, forming various forms of metabolic diseases. The research team believed that the pathological basis of lipid turbidity disease was the abnormal rise and fall of the spleen and stomach and the obstruction of the transfer of grease. According to the different locations where lipid turbidity stays, it was divided into four common pathogenesis types: ''inability to distinguish between the clear and turbid, turbid stagnation in the Ying blood'', ''spleen not rising clear, turbid accumulation in the vessels'', ''spleen dysfunction, lipid retention in the pores'', ''spleen failure to transportation and transformation, and grease accumulation in the liver''. According to the pathogenesis, it could be divided into four common syndromes, namely, turbid stagnation in the Ying blood, turbid accumulation in the vessels, lipid retention in the pores, and grease accumulation in the liver, and the corresponding prescriptions were given for syndrome differentiation and treatment, so as to guide clinical differentiation and treatment of the lipid turbidity disease.
5.Investigation and analysis of drug use and pharmaceutical care in tight medical alliance in Wanzhou District of Chongqing
Suxin WAN ; Qiuyan SUN ; Caibing XU ; Li SHEN ; Hongmei GONG ; Wei FANG
China Pharmacy 2025;36(1):19-23
OBJECTIVE To investigate the use of drugs and the development of pharmaceutical care in the tight medical alliance (shorted for “medical alliance”) of Wanzhou District of Chongqing, and provide reference for the further construction of the medical alliance. METHODS A survey form was designed and distributed to 21 constituent units (5 leading units and 16 member units) of 5 medical alliances in Wanzhou District of Chongqing. The statistical analysis was conducted in aspects of basic drug allocation and use, pharmaceutical personnel team construction, the development of pharmaceutical care, and rational use of antibiotics. RESULTS Among the 21 constituent units, 4 leading units and 14 member units achieved the target for the proportion of essential drug procurement varieties, with a total compliance rate of 85.71%; 4 leading units and 13 member units achieved the target for the proportion of national essential drug allocation and usage amount, with a total compliance rate of 80.95%. The proportions of personnel with doctoral degrees in the 5 leading units and 16 member units were 1.71% and 0 respectively, and the proportions of personnel with senior professional titles were 8.56% and 1.63%, respectively. A total of 5 pharmacy or pharmaceutical combined outpatient clinics were set up in the 21 medical alliance units, and 5 clinical pharmacy information service platforms were established; all 5 leading units were able to regularly carry out clinical pharmacy projects, while only 4 out of 16 member units had conducted medical order review and evaluation. The proportions of irrational use of antibiotics in outpatient prescriptions and inpatient medical records of the 16 member units (4.81%, 5.21%) were significantly higher than those of the 5 leading units (2.80%, 4.00%). CONCLUSIONS The allocation and usage of national essential drugs in 21 constituent units from Wanzhou District of Chongqing are both in good standing. However, the data on the allocation of pharmaceutical professionals and the number, qualifications, and job titles of clinical pharmacists in member units are generally low. Moreover, the pharmaceutical service projects and service quality in member units need to be further improved.
6.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.
7.Expert Consensus on Clinical Application of Pingxuan Capsules
Yuer HU ; Yanming XIE ; Yaming LIN ; Yuanqi ZHAO ; Yihuai ZOU ; Mingquan LI ; Xiaoming SHEN ; Wei PENG ; Changkuan FU ; Yuanyuan LI
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(1):201-210
As a patented characteristic medicine of Yi ethnic minority, Pingxuan capsules have the effects of nourishing the liver and kidney, pacifying the liver, and subduing Yang. With the main indications of dizziness, headache, palpitations, tinnitus, insomnia, dreaminess, waist and knee soreness caused by liver-kidney deficiency and liver Yang upward disturbance, Pingxuan capsules are widely used in the treatment of posterior circulation ischemic vertigo, vestibular migraine, benign paroxysmal positional vertigo. However, the current knowledge is limited regarding the efficacy, syndrome differentiation, and safety of this medicine. On the basis of summarizing the experience of clinicians and the existing evidence, this study invites clinical experts of traditional Chinese and Western medicine, pharmaceutical experts, and methodological experts from relevant fields across China to conduct evidence-based evaluation of Pingxuan capsules. The evaluation follows the Specifications for the Development of Clinical Expert Consensus on Chinese Patent Medicines issued by the Standardization Office of the China Association of Chinese Medicine, and reaches 5 recommendations and 16 consensus suggestions. The consensus clarifies the clinical applications, efficacy, dose, course of treatment, combination of medicines, precautions, and contraindications of Pingxuan capsules in the treatment of vertigo and explains the safety of clinical application. This consensus is applicable to clinicians (traditional Chinese medicine, Western medicine, and integrated traditional Chinese and Western medicine) and pharmacists in tertiary hospitals, secondary hospitals, and community-level medical and health institutions across China, providing a reference for the rational use of Pingxuan capsules in the treatment of vertigo. It is hoped that the promotion of this consensus can facilitate the rational use of drugs in clinical practice, reduce the risk of drug use, and give full play to the advantages of Pingxuan capsules in the treatment of vertigo diseases. This consensus has been reviewed and published by the China Association of Chinese Medicine, with the number GS/CACM330-2023.
8.Investigation on the current status of pharmaceutical care in medical institutions in China
Tingting ZHENG ; Yuqing ZHANG ; Sitong LIU ; Wei ZHANG ; Jin LU ; Qunhong SHEN ; Jiancun ZHEN
China Pharmacy 2025;36(9):1117-1122
OBJECTIVE To investigate the current status of pharmaceutical care in medical institutions in China, and provide experience and suggestions for better development of pharmaceutical care. METHODS Questionnaire survey was used to investigate the development of pharmaceutical care in medical institutions in 31 provinces (autonomous regions and municipalities directly) in March 2023, and descriptive analysis and binary logistic regression analysis on the influencing factors of pharmaceutical care were conducted. RESULTS A total of 1 368 questionnaires were sent out, and 1 304 valid questionnaires were collected with the effective recovery rate of 95.32%. Pharmaceutical care was carried out in 671 medical institutions (51.46%), and the rates of pharmaceutical care in tertiary, secondary, primary and other medical institutions were 74.79%, 27.97% and 7.35%, respectively. The average number of patients receiving pharmaceutical care was 2 638.96 per year, and there were 8.33 pharmacists in each medical institution to carry out pharmaceutical care, among which 93.68% were clinical pharmacists. The main departments covered by pharmaceutical care services included respiratory and critical care medicine, cardiology, intensive care unit, endocrinology, oncology, gastroenterology, obstetrics and gynecology and other departments. There were only 48 medical institutions (7.15%) with additional compensation for pharmaceutical care services. The main experiences of developing pharmaceutical care were to pay attention to talent cultivation and discipline construction, but the main difficulties were serious shortage of staff and qualified talents, low compensation level and low enthusiasm. Grade of medical institutions, the number of pharmacists engaged in clinical pharmacy, the number of qualified clinical pharmacists and the degree of information in the pharmacy department were the main influencing factors for carrying out pharmaceutical care (P<0.05). CONCLUSIONS In recent years, pharmaceutical care in Chinese medical institutions has made certain progress, while that of primary medical institutions, secondary medical institutions and other medical institutions should be improved. In the future, it is still necessary to further enhance the implementation of pharmaceutical care, promote personnel training, and attach importance to demonstrating the value of pharmaceutical care, thereby promoting the sustainable and high- quality development of pharmaceutical care.
9.Visual Analysis of Literature Research on Compatibility of Bitter and Pungent Medicinals in Traditional Chinese Medicine
Wei SONG ; Lele YANG ; Zhongyi ZHANG ; Tao SHEN
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(13):19-28
ObjectiveTo analyze the research situation, hotspots, and trend of the compatibility of bitter and pungent medicinals in traditional Chinese medicine by knowledge mapping and provide reference for the inheritance and clinical application of this theory. MethodsThe literature on the compatibility of bitter and pungent medicinals was retrieved from 6 databases, including China National Knowledge Infrastructure (CNKI), VIP, Wanfang Data, SinoMed, Web of Science, and PubMed. The literature was searched with the keywords of bitter medicinals, pungent medicinals, compatibility, Banxia Xiexin decoction, Zhuyu pills, and Zuojin pills. The search time ranged from January 1, 1984 to August 10, 2024. NoteExpress 3.7 was used for literature screening, and CiteSpace 6.1.R2 was used to visualize the number of publications, authors, institutional cooperation network, and the co-occurrence, clustering, time line, and burst of keywords. ResultsA total of 628 Chinese articles and 151 English articles related to the compatibility of bitter and pungent medicinals were included, and the annual number of publications rose with fluctuations. WEI Wei was the core author of Chinses articles and SHEN Tao and ZHAO Yanling were the core authors of English articles. China Academy of Chinese Medical Sciences formed a close cooperative network with many research institutions at home and abroad. The high-frequency keywords included pungent dispersing and bitter descending, Coptidis Rhizoma, Euodiae Fructus, Banxia Xiexin decoction, Zuojin pills, compatibility, spleen and stomach diseases, and gut microbiota, which mainly involved common prescriptions, diseases responding specifically to traditional Chinese medicine, mechanism research and so on. The keyword bursts concentrated in famous doctors' experience, network Meta-analysis, inflammatory bowel disease, diabetes mellitus, intestinal microbiota, etc. The compatibility of bitter medicinals and pungent medicinals was widely used in clinical practice. Based on pungent dispersing and bitter descending, the middle energizer was regulated for treating spleen and stomach diseases and inflammatory bowel disease. Bitter and pungent medicinals descending the turbid were used to treat diabetes mellitus and hyperlipidemia by lowering blood glucose and lipid levels. The mild bitter and slightly pungent medicinals were used as supplements to treat depression and COVID-19 by regulating Qi movement. ConclusionIn the past 40 years, the number of publications on the compatibility of bitter and pungent medicinals has been increasing, and the research team has begun to take form. Clinically, the compatibility of bitter and pungent medicinals is the main treatment for spleen and stomach diseases and glycolipid metabolic diseases. At present, the modern scientific essence of the compatibility of bitter and pungent medicinals is mainly explained based on famous doctors' experience inheritance, network meta-analysis, and intestinal flora.
10.Clinical Efficacy of Zhuyuwan in Treatment of Hyperlipidemia with Syndrome of Phlegm Turbidity and Obstruction
Lele YANG ; Danmei LUO ; Jiao CHEN ; Xiaobo ZHANG ; Wei SONG ; Wenyu ZHU ; Xin ZHOU ; Xueping LI ; Tao SHEN
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(13):29-37
ObjectiveTo observe the clinical efficacy and safety of Zhuyuwan in the treatment of hyperlipidemia. MethodsIn this study, hyperlipidemia patients treated in the Hospital of Chengdu University of Traditional Chinese Medicine (TCM) from September 2022 to December 2023 were randomly assigned into a control group and an observation group. Finally, 162 valid cases were included, encompassing 74 cases in the control group and 88 cases in the observation group. The control group was treated with atorvastatin calcium tablets, and the observation group with atorvastatin calcium tablets + Zhuyuwan extract granules. Both groups were treated for 8 weeks. The efficacy in terms of blood lipid level recovery, blood lipid levels, TCM syndrome distribution, efficacy in terms of TCM syndrome, and TCM symptom scores were compared between the two groups as well as between before and after treatment. Liver and kidney functions were monitored for safety assessment. ResultsIn terms of blood lipid level recovery, the total response rate in the observation group was 86.36% (76/88) and that in the control group was 86.49% (64/74), with no statistically significant difference between the two groups. After treatment, both groups showed declines in levels of triglyceride (TG), total cholesterol (TC), and low-density lipoprotein cholesterol (LDL-C) (P<0.05) and elevations in the level of high-density lipoprotein cholesterol (HDL-C) (P<0.05). Moreover, the observation group outperformed the control group in recovering the levels of TG, LDL-C, and HDL-C (P<0.05, P<0.01). In terms of TCM syndrome, hyperlipidemia was mostly caused by phlegm turbidity and obstruction. The total response rate in terms of TCM syndrome in the observation group was 87.30% (55/63), which was higher than that (63.46%, 33/52) in the control group (χ2=9.102, P<0.01). After treatment, the scores of total TCM symptoms, primary symptoms, and secondary symptoms decreased in both groups (P<0.05), and the observation group had lower scores than the control group (P<0.01). The observation group was superior to the control group in alleviating obesity, chest tightness, and low food intake (P<0.05). In terms of safety, the level of aminotransferase was slightly elevated in the control group, and no obvious adverse reaction was observed in the observation group, with no statistical significance in the incidence of adverse reactions. ConclusionZhuyuwan combined with atorvastatin can not only recover blood lipid levels and alleviate TCM symptoms but also reduce the occurrence of adverse reactions.

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