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.Association of menopausal time and menopausal age with nonalcoholic fatty liver disease: An analysis based on a restricted cubic spline model
Chenlu ZHAO ; Suping MA ; Dongfang SHANG ; Sutong LIU ; Xiaoyan LIU ; Yuanyuan ZHENG ; Wenxia ZHAO
Journal of Clinical Hepatology 2025;41(2):247-253
ObjectiveTo investigate the association of menopausal time and menopausal age with the risk of nonalcoholic fatty liver disease (NAFLD), and to provide a basis for the early prevention and treatment of NAFLD in clinical practice. MethodsRelated data were collected from 373 postmenopausal women who attended the outpatient service of Department of Spleen, Stomach, Liver and Gallbladder Diseases, The First Affiliated Hospital of Henan University of Chinese Medicine, from January 2017 to December 2021, including general information, menopausal age, menopausal time, and presence or absence of NAFLD. The chi-square test was used for comparison of categorical data; the independent-samples t test was used for comparison of normally distributed continuous data between groups, and the Wilcoxon rank-sum test was used for comparison of non-normally distributed continuous data between groups. A Logistic regression analysis was used to calculate the association intensity and 95% confidence interval (95%CI) of menopausal time and menopausal age for the risk of NAFLD, and the restricted cubic spline (RCS) method was used to investigate the dose-response relationship between menopausal time/age and the risk of NAFLD. ResultsCompared with the women with normal menopause or late menopause, the women with early menopause had a higher prevalence rate of NAFLD and a higher degree of steatosis and fibrosis (all P<0.05). After adjustment for the confounding factors such as age and age of menarche, the risk of NAFLD in women with a menopausal time of >3 years was 4.80 (95%CI: 1.93 — 11.95, P=0.001) times that in women with a menopausal time of ≤3 years, and the risk of NAFLD in women with early or late menopause was 8.14 times (95%CI: 1.77 — 37.58, P=0.007) and 0.09 times (95%CI: 0.03 — 0.32, P<0.001), respectively, that in those with a normal menopausal age. There is a dose-response relationship between menopausal time/age and the risk of NAFLD. Menopausal time is positively correlated with the association intensity of NAFLD, while menopausal age is negatively correlated with the association intensity of NAFLD. ConclusionThe longer the menopause time and the earlier the menopause age, the ligher the risk of NAFLD.
3.Effect of Guiqi Yiyuan Ointment on Lewis Lung Cancer Mice by Increasing Autophagic Flux and Stabilizing PD-L1 Expression Through Regulation of ERK Signaling Pathway
Nan YANG ; Qiangping MA ; Jianqing LIANG ; Kejun MIAO ; Shang LI ; Jintian LI ; Juan LI
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(8):107-114
ObjectiveTo investigate the antitumor effect and mechanism of Guiqi Yiyuan ointment on Lewis lung cancer mice based on the extracellular regulatory protein kinase (ERK) signaling pathway. MethodsA Lewis lung cancer mouse model was established. Except for the blank group, the model mice were randomly divided into the model group, Guiqi Yiyuan ointment low, medium, and high dose groups, and the extracellular ERK1/2 inhibitor group, with 10 mice per group. The Guiqi Yiyuan ointment was administered by gavage at doses of 1.75, 3.5, 7.0 g·kg-1·d-1 for the low, medium, and high dose groups, respectively. The ERK1/2 inhibitor group was given the ERK1/2 inhibitor LY3214996 (100 mg·kg-1·d-1) by gavage. The treatment was administered for 14 consecutive days, after which samples were collected. Tumor histopathological changes were observed using hematoxylin-eosin (HE) staining. Transmission electron microscopy was used to observe ultrastructural changes in tumor cells. Immunofluorescence was performed to measure the phosphorylation of ERK1/2 (p-ERK1/2) and the expression of programmed cell death ligand-1 (PD-L1) in tumor tissues. Western blot and real-time quantitative polymerase chain reaction (Real-time PCR) were used to detect the expression of p-ERK1/2, PD-L1, the autophagy marker Beclin-1, the autophagic protein p62, and the microtubule-associated protein light chains LC3Ⅰ and LC3Ⅱ at both the protein and gene levels. ResultsCompared with the model group, the average tumor weight was significantly reduced in the low and medium dose groups of Guiqi Yiyuan ointment (P<0.05), and markedly reduced in the high dose and inhibitor groups (P<0.01). Tumor cells in all treatment groups became progressively irregular, with ruptured nuclei and expanded areas of cell disintegration and necrosis. The number of organellar ablations in tumor tissues increased, and the number of autophagic vesicles also increased in all groups. The mean fluorescence intensity of p-ERK1/2 and PD-L1 was reduced in the low and medium dose groups of Guiqi Yiyuan ointment (P<0.05), and significantly reduced in the high dose and inhibitor groups (P<0.01). The mRNA expression of ERK1/2, PD-L1, Beclin-1, and p62 was reduced in the medium dose group (P<0.05), while LC3Ⅰ/Ⅱ mRNA expression was elevated (P<0.05). In the high dose and inhibitor groups, mRNA expression of ERK1/2, PD-L1, Beclin-1, and p62 was significantly reduced (P<0.01), while LC3Ⅰ/Ⅱ mRNA expression was significantly increased (P<0.01). Protein expression of p-ERK1/2, PD-L1, Beclin-1, and p62 was reduced in the medium dose group (P<0.05), and LC3Ⅰ/Ⅱ protein expression was elevated (P<0.05). In the high dose and inhibitor groups, protein expression of p-ERK1/2, PD-L1, Beclin-1, and p62 was significantly reduced (P<0.01), while LC3Ⅰ/Ⅱ protein expression was significantly elevated (P<0.01). ConclusionGuiqi Yiyuan ointment may inhibit the activation of the ERK signaling pathway, downregulate the expression of p-ERK1/2, promote autophagic flux in tumor cells, and regulate the expression of PD-L1, thereby exerting an inhibitory effect on tumor growth in Lewis lung cancer mice.
4.Analysis of Current Status and Prospects of Traditional Chinese Medicine in Responding to Public Health Emergencies Under Healthy China Strategy: Taking Major Emerging Epidemics as an Example
Yuqing CAO ; Xinyu JI ; Xiyu SHANG ; Qiujie CAI ; Yipin FAN ; Yanping WANG ; Yan MA
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(20):222-232
Under the background of the Healthy China strategy, the integration of traditional Chinese medicine (TCM) into the public health emergency response system has become an important measure to enhance the capacity for coping with public health emergencies. In recent years, the role of TCM in responding to such emergencies has become increasingly prominent. Taking major emerging epidemics as an example, TCM has developed a rich theoretical system and practical experience in epidemic prevention and treatment over thousands of years, and has played a significant role in successive outbreaks with its unique advantages. Based on the concept of ''preventing disease before its onset'' and the theoretical framework of treatment based on syndrome differentiation, TCM has achieved remarkable results through early intervention and full participation in the integrated model of TCM and Western medicine, from severe acute respiratory syndrome (SARS) to corona virus disease-2019 (COVID-19), in improving clinical symptoms and outcomes, reducing adverse reactions, and promoting recovery. From the perspective of the Healthy China strategy, this paper systematically reviews the historical development of TCM in epidemic prevention and treatment, with particular attention to recent epidemics such as SARS, influenza A (H1N1), and COVID-19. It further examines the similarities and differences between TCM and Western medicine in responding to major emerging epidemics, as well as relevant policies related to TCM in epidemic prevention and control. In addition, it summarizes the existing problems in TCM's role in the prevention and treatment of major emerging epidemics, and explores measures to improve its rapid response capacity under the Healthy China strategy. This study not only provides a ''Chinese solution'' for the prevention and control of newly emerging infectious diseases worldwide, but also offers theoretical and practical references for strengthening the public health emergency response system, carrying strategic significance for promoting the modernization and internationalization of TCM.
5.Determination of urinary perchlorate content and normal reference range of urinary perchlorate in primary school students
Lyu SHANG ; Mengdie SHI ; Hongfei MA ; Siqi ZHAO ; Xiao WANG
Journal of Public Health and Preventive Medicine 2025;36(5):59-62
Objective To explore the normal reference range of perchlorate content in the urine of primary school students, and compare whether there are differences in their urine perchlorate contents among different populations, and to provide reference for the health care of primary school students. Methods A total of 441 primary school students aged 6 to 15 years old in a certain city were selected, and their urine samples were collected. The contents of perchlorate in the urine were determined by ultra-high performance liquid chromatography coupled with mass spectrometry, and the measurement data was statistically analyzed using SPSS software. Results There was no significant gender difference in the content of perchlorate in the urine of primary school students, but there was an age difference. The normal reference range for the content of perchlorate in the urine of primary school students aged 6-9 years old was 0-99.09 μg/L, and the normal reference range for the content of perchlorate in the urine of primary school students aged 10-15 years old was 0-74.56 μg/L. Conclusion Through the measurement and analysis of a large number of samples, a normal reference range for the content of urinary perchlorate in primary school students have been recommended.
6.Role of intestinal flora in hypertension complicated with osteoporosis
Mei-Long SI ; Hua JIN ; Min-Ke LIU ; Shuang-Fang LIU ; Bi-Shi LING ; Shang-Wen QI ; Xue-Li MA
The Chinese Journal of Clinical Pharmacology 2024;40(3):449-453
Hypertension and osteoporosis(OP)are common diseases in middle-aged and elderly people,and the number of patients with both diseases has gradually increased in recent years.Because the onset of the disease is hidden,it is easy to cause fractures and serious complications of heart,brain and kidney in the later stage,which not only seriously damages the quality of life of patients,but also increases the difficulty of clinical treatment.Therefore,it is particularly necessary to strengthen the research on this disease.More and more studies have found that the disorder of intestinal flora will lead to the occurrence of OP,while the intestinal flora of patients with hypertension is obviously out of balance.Therefore,this paper thinks that intestinal flora may be the key influencing factor of hypertension complicated with OP,and the imbalance of intestinal flora will lead to the imbalance of short-chain fatty acid metabolism,immune inflammatory reaction and increased sympathetic nerve activity,thus causing the imbalance of bone homeostasis and promoting the occurrence of OP.Therefore,it is suggested that regulating intestinal flora may be a new way to intervene hypertension complicated with OP.
7.Structural design and mechanical property analysis of trabecular scaffold of triply periodic minimal surface with a radial gradient
Yihai ZHANG ; Peng SHANG ; Benyuan MA ; Guanghui HOU ; Lunxu CUI ; Wanzhen SONG ; Dexuan QI ; Yancheng LIU
Chinese Journal of Tissue Engineering Research 2024;28(5):741-746
BACKGROUND:The elastic modulus of traditional bone implants is large and does not match the elastic modulus of human bone,which will cause a stress shielding effect and lead to bone resorption.The trabecular scaffold of the triply periodic minimal surface with radial gradient has elastic modulus matching with human cancellous bone,and its yield strength is greater than that of human cortical bone,which provides a new choice for the design of bone scaffold. OBJECTIVE:Triply periodic minimal surface structure with radial gradient was constructed by the implicit surface method.The sample was manufactured by laser selective melting technology,and the quasi-static compression test was carried out to obtain trabecular scaffolds with mechanical properties matching human bones. METHODS:Four types of the trabecular scaffolds of the triply periodic minimal surface with a radial gradient of G,I,P and D were established by the implicit surface method.Samples were manufactured by laser selective melting technology.We observed the surface morphology of the molded sample,evaluated the molding quality,conducted a quasi-static compression test,and evaluated the mechanical properties of the samples. RESULTS AND CONCLUSION:The quasi-static compression test results showed that compared with the four triply periodic minimal surface scaffolds,the platform stress of the G scaffold had less fluctuation and no failure or fracture,indicating that the G scaffold had the best plasticity.The mechanical properties of the G scaffolds with 45%,55%and 65%porosities were analyzed.It was found that the elastic modulus of G scaffolds with 55%porosity was within the range of elastic modulus of human cancellous bone(0.022-3.7 GPa),and the yield strength was close to the maximum yield strength of human cortical bone(187.7-222.3 MPa).In conclusion,G triply periodic minimal surface scaffold with 55%porosity can reduce the stress shielding effect,bear a higher body load,improve the stability of the implant,and prolong the service life of the implant.
8.Expert Consensus on Clinical Diseases Responding Specifically to Traditional Chinese Medicine: Perimenopausal Syndrome
Shiwan HU ; Haiyan LIANG ; Kun MA ; Xiaona MA ; Zihan FANG ; Wenpei BAI ; Xinmin LIU ; Hongtian LI ; Fengmei LIAN ; Wei ZHANG ; Lihua QIN ; Min SHANG ; Ailuan LAI ; Xiuxiang TENG ; Mei MO ; Xiaoxiao ZHANG ; Linhua ZHAO
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(21):234-242
Perimenopausal syndrome (MPS), a common endocrine system disease, is one of the diseases responding specifically to traditional Chinese medicine (TCM). The China Association of Chinese Medicine organized experts in endocrinology, gynecology, and interdisciplinary fields of both Western and Chinese medicine to discuss the advantages and challenges of diagnosing and treating MPS with Western medicine, TCM, and integrative medicine. Experts at the conference believe that MPS is initiated by estrogen decline and rooted in deficiency, with the pathogenesis being imbalance between Yin and Yang in the kidney. The hormone replacement therapy in Western medicine for menopause can rapidly alleviate related symptoms by quickly restoring the estrogen level and timely detect and delay complications of menopause, whereas such a therapy has certain risks, necessitating close monitoring of adverse reactions. Moreover, the various contraindications and precautions limit the clinical application of the hormone replacement therapy. TCM has advantages in synergistically alleviating symptoms such as hot flashes, sweating, sleep disorders, and emotional abnormalities of MPS without causing obvious adverse reactions. However, its efficacy is slower than the hormone replacement therapy, and the TCM evidence for preventing and treating complications of menopause remains unclear. Three suggestions were proposed for the future development of both Western and TCM for ameliorating MPS. First, an integrated diagnosis and treatment system for MPS with both Western and Chinese medicine should be established. Second, high-quality evidence-based interventions for MPS should be developed with TCM alone or in combination with Western medicine. Third, efforts should be made to promote the new TCM drug development and the interdisciplinary cooperation for treating MPS.
9.Establishment and evaluation of a rapid PCR-colloidal gold test strip method for the detection of Fritillaria ussuriensis
Yu-he MA ; Cong-hui SHANG ; Qiu-he MA ; Tao LI ; Yue LIU ; Bei-zhen PAN ; Li-jun GAO ; Ming-cheng LI ; Wei XIA ; Yong-mei QU
Acta Pharmaceutica Sinica 2024;59(6):1773-1778
This study design of specific identification primers for the ITS2 sequence of
10.Cinnamomi Ramulus-Alismatis Rhizoma in Treatment of External-contraction Diseases from Traditional Chinese Medicine and Modern Pharmacy: A Review
Yuqing CAO ; Yang GUO ; Xiyu SHANG ; Zihan JIA ; Yibai XIONG ; Renbo CHEN ; Lei ZHANG ; Lin TONG ; Huamin ZHANG ; Yan MA
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(24):279-288
Cinnamomi Ramulus and Alismatis Rhizoma are commonly used in the treatment of external-contraction diseases. Cinnamomi Ramulus is pungent, sweet, and warm, with the effects of ventilating lung and dispersing cold, warming Yang and transforming Qi, and promoting water and liquid flow from Taiyang meridian to remove dampness. Alismatis Rhizoma is sweet and cold, with the effects of draining dampness and promoting urination, regulating the waterway, removing water retention in lung, and promoting urination to remove dampness and heat. Herbal pairs are extracted from the accumulated experience of medical practitioners over the ages in the use of medicines and have been proved by clinical application to be composed of simple and effective combinations for specific diseases. The herb pair Cinnamomi Ramulus-Alismatis Rhizoma is an important part in ancient classic formulas such as Wulingsan. Both herbs play a role in draining dampness and promoting urination, warming Yang and transforming Qi, being a representative herb pair used for treating external-contraction exterior syndrome and water retention inside. The review of ancient medical publications revealed that there were a large number of compound formulas containing Cinnamomi Ramulus-Alismatis Rhizoma for dispersing cold and removing dampness, which were widely used for thousands of years in clinical practice. Modern pharmacological studies have shown that the active pharmacological components of Cinnamomi Ramulus (cinnamaldehyde and cinnamic acid) and Alismatis Rhizoma (alisol A and 23-acetate alisol B) have anti-inflammatory, antiviral, and immunoregulatory effects and high safety. Qingfei Paidu decoction containing this herbal pair played an important role in fighting against COVID-19. Despite the extensive pharmacological studies on Cinnamomi Ramulus and Alismatis Rhizoma, few studies have been carried out regarding this herb pair. This paper summarizes the traditional Chinese medicine knowledge about Cinnamomi Ramulus and Alismatis Rhizoma in the treatment of external-contraction diseases and summarizes the chemical composition, pharmacological effects, toxicology and other aspects of the two herbs before and after compatibility, aiming to provide a reference for further research and clinical application.


Result Analysis
Print
Save
E-mail