1.The development and characteristics of general notice in Chinese Pharmacopoeia 2025 Edition
WANG Fei ; SONG Zonghua ; MA Shuangcheng ; SHU Rong
Drug Standards of China 2025;26(1):011-016
Objective: Introduce and briefly describe the status, characteristics, and writing ideas of general notice in the Chinese Pharmacopoeia 2025 edition, providing reference and suggestions for better understanding and implementation of the Chinese Pharmacopoeia 2025 edition.
Methods:This article elaborates on the content and revision of general notice in the Chinese Pharmacopoeia 2025 edition from the perspective of frame structure and main contents.
Results:Compared with other pharmacopoeias of various countries, Chinese Pharmacopoeia includes standards for traditional Chinese medicine, chemical drugs, biological products and excipients, pharmaceutical packaging materials, etc. Each section of Chinese Pharmacopoeia has its own general notice, with 34 to 48 items arranged in 11 to 12 chapters. Depending on the type of products included and the development history, the general notice in each section present differences in format and content. Given the importance and significance of the standards in Chinese Pharmacopoeia, it is necessary for the industry to coordinate and unify the general notice in various parts of Chinese Pharmacopoeia. With the introduction and revision of regulations, changes in the content of pharmacopoeias, and the application of new technologies, methods, and concepts in drug quality control, considering the unique characteristics of various drugs in quality control and supervision, Chinese Pharmacopoeia has comprehensively standardized relevant requirements. While taking into account the characteristics of the first, second, third, and fourth parts of the pharmacopoeia, it retains the characteristics of relative uniformity and the content of each part, achieving the unified standardization of the general rules of each general notice in the Chinese Pharmacopoeia 2025 edition and the coordination and consistency of common content.
Conclusion: The current version of Chinese Pharmacopoeia has undergone significant changes and improvements in both form and content. By introducing the overall situation and revised content of general notice in the Chinese Pharmacopoeia 2025 edition, pharmacopoeia users can have a deeper understanding of Chinese Pharmacopoeia and use it correctly.
2.Changes and Trends in the microbiological-related standards in the Chinese Pharmacopoeia 2025 Edition
FAN Yiling ; ZHU Ran ; YANG Yan ; JIANG Bo ; SONG Minghui ; WANG Jing ; LI Qiongqiong ; LI Gaomin ; WANG Shujuan ; SHAO Hong ; MA Shihong ; CAO Xiaoyun ; HU Changqin ; MA Shuangcheng, ; YANG Meicheng
Drug Standards of China 2025;26(1):093-098
Objective: To systematically analyze the revisions content and technological development trends of microbiological standards in the Chinese Pharmacopoeia (ChP) 2025 Edition, and explore its novel requirements in risk-based pharmaceutical product lifecycle management.
Methods: A comprehensive review was conducted on 26 microbiological-related standards to summarize the revision directions and scientific implications from perspectives including the revision overview, international harmonization of microbiological standards, risk-based quality management system, and novel tools and methods with Chinese characteristics.
Results: The ChP 2025 edition demonstrates three prominent features in microbiological-related standards: enhanced international harmonization, introduced emerging molecular biological technologies, and established a risk-based microbiological quality control system.
Conclusion: The new edition of the Pharmacopoeia has systematically constructed a microbiological standard system, which significantly improves the scientificity, standardization and applicability of the standards, providing a crucial support for advancing the microbiological quality control in pharmaceutical industries of China.
3.Adrenocortical carcinoma with rhabdoid features: a case report and literature review
Mingchuan CHU ; Huimin SUN ; Hao WANG ; Jian SONG ; Yongshun GUO
Journal of Modern Urology 2025;30(1):64-68
[Objective] To investigate and summarize the clinicopathological features, diagnosis, treatment and prognosis of adrenocortical carcinoma with rhabdoid features. [Methods] The clinical diagnosis and treatment of a case of adrenocortical carcinoma with rhabdoid features admitled to Department of Urology, Weifang People's Hospital were reported.The clinical manifestations, pathological features, diagnosis and prognosis of the disease were analyzed in combination with relevant literature. [Results] A 34-year-old male patient was admitted due to scrotal distension and pain that had persisted for 6 months.Imaging examination showed a huge soft tissue tumor in the left adrenal region of the retroperitoneum with compression displacement of the left kidney, leading to obstruction of venous return in the left spermatic vein, which in turn caused varicose veins.The levels of serum renin, angiotensin, aldosterone, cortisol, and catecholamine were within normal ranges.Surgical resection of the tumor was performed, and postoperative pathological examination revealed that the tumor tissue was predominantly composed of rhabdoid cells, exhibiting positive immunohistochemical staining for INI 1, Syn, Calretinin and Vimentin.Genetic testing did not identify any deletion of SMARCB1 and SMARCA4 mutations.Therefore, the diagnosis was adrenocortical carcinoma with rhabdoid features.At the current 20-month follow-up, no recurrence or metastasis was observed.A review of the literature found that only 7 cases of this disease had been reported. [Conclusion] Adrenocortical carcinoma with rhabdoid features is a rare disease, and a definitive diagnosis is dependent upon pathological examination.Surgical resection remains the primary treatment.Long-term follow-up is essential, and further research is needed to evaluate the impact of adjuvant therapy.
4.Mechanism of Buyang Huanwutang in Inhibiting Ferroptosis and Enhancing Neurological Function Recovery After Spinal Cord Injury via GPX4-ACSL4 Axis
Luchun XU ; Guozheng JIANG ; Yukun MA ; Jiawei SONG ; Yushan GAO ; Guanlong WANG ; Jiaojiao FAN ; Yongdong YANG ; Xing YU ; Xiangsheng TANG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(5):20-30
ObjectiveTo explore the mechanism by which Buyang Huanwutang regulates the glutathione peroxidase 4 (GPX4)-acyl-CoA synthetase long-chain family member 4 (ACSL4) axis to inhibit ferroptosis and promote neurological functional recovery after spinal cord injury (SCI). MethodsNinety rats were randomly divided into five groups: sham operation group, model group, low-dose Buyang Huanwutang group (12.5 g·kg-1), high-dose Buyang Huanwutang group (25 g·kg-1), and Buyang Huanwutang + inhibitor group (25 g·kg-1 + 5 g·kg-1 RSL3). The SCI model was established by using the allen method. Tissue was collected on the 7th and 28th days after operation. Motor function was assessed by using the Basso-Beattie-Bresnahan (BBB) scale. Hematoxylin-eosin (HE), Nissl, and Luxol fast blue (LFB) staining were performed to observe spinal cord histopathology. Transmission electron microscopy was used to examine mitochondrial ultrastructure. Immunofluorescence staining was used to detect the number of NeuN-positive cells and the fluorescence intensity of myelin basic protein (MBP), GPX4, and ACSL4. Real-time fluorescent quantitative polymerase chain reaction (Real-time PCR) was used to analyze the mRNA expression of GPX4 and ACSL4. Enzyme linked immunosorbent assay (ELISA) was performed to measure the levels of reactive oxygen species (ROS), malondialdehyde (MDA), glutathione (GSH), and superoxide dismutase (SOD). Colorimetric assays were used to determine the iron content in spinal cord tissue. ResultsCompared to the sham operation group, the model group exhibited significantly reduced BBB scores (P<0.01), severe pathological damage in spinal cord tissue, and marked mitochondrial ultrastructural disruption. In addition, the model group showed a decrease in the number of NeuN-positive cells (P<0.01), reduced fluorescence intensity of MBP and GPX4 (P<0.01), lower levels of GSH and SOD (P<0.01), and downregulated mRNA expression of GPX4 (P<0.01). Moreover, compared to the sham operation group, the model group had elevated levels of ROS, MDA, and tissue iron content (P<0.01), along with increased fluorescence intensity and mRNA expression of ACSL4 (P<0.01). Compared with the model group and Buyang Huanwutang + inhibitor group, the Buyang Huanwutang group showed significantly improved BBB scores (P<0.05, P<0.01) and exhibited less severe spinal cord tissue damage, reduced edema and inflammatory cell infiltration, increased neuronal survival, and more intact myelin structures. Additionally, mitochondrial ultrastructure was significantly improved in the Buyang Huanwutang group. Compared to the model group and Buyang Huanwutang + inhibitor group, the Buyang Huanwutang group significantly increased the number of NeuN-positive cells and the fluorescence intensity of MBP (P<0.05, P<0.01). Furthermore, Buyang Huanwutang significantly increased the fluorescence intensity and mRNA expression of GPX4 (P<0.01) and decreased the fluorescence intensity and mRNA expression of ACSL4 (P<0.01) compared to the model group and Buyang Huanwutang + inhibitor group. Finally, the Buyang Huanwutang group significantly decreased ROS, MDA, and tissue iron content (P<0.01) and significantly increased GSH and SOD levels (P<0.01) compared to the model group and Buyang Huanwutang + inhibitor group. ConclusionBuyang Huanwutang inhibits ferroptosis through the GPX4/ACSL4 axis, reduces secondary neuronal and myelin injury and oxidative stress, and ultimately promotes the recovery of neurological function.
5.Meta-analysis of the effects of gene polymorphism on plasma concentration of voriconazole in patients with invasive fungal infection
Yaxuan LI ; Xingde LI ; Guohui WANG ; Panpan MAO ; Xuejiao MA ; Cangsang SONG
China Pharmacy 2025;36(2):225-231
OBJECTIVE To evaluate the influence of gene polymorphism on plasma minimum concentration (cmin) of voriconazole (VRZ) in patients with invasive fungal infection. METHODS The Cochrane Library, Embase, PubMed, Web of Science, China Biomedical Literature Database, CNKI, VIP and Wanfang Data were searched for literature on the correlation between gene polymorphisms and cmin of VRZ from inception to April 2024. After screening the literature, extracting data, and evaluating the quality of the literature, meta-analysis was performed using R 4.3.2 software. RESULTS A total of 21 studies with 2 454 patients were included. The results of meta-analysis showed that the VRZ cmin of CYP2C19 IM and PM types was significantly higher than EM type, and the VRZ cmin of IM type was significantly lower than PM type (P<0.01). The VRZ cmin of CYP2C9 rs1057910 AA type was significantly higher than AC/CC type, and that of CYP3A5 rs776746 CC type was significantly higher than TT type (P<0.01). The VRZ cmin of POR rs10954732 GG type was significantly higher than GA and AA types, and that of POR rs1057868 CT type was significantly lower than TT type (P<0.01). The VRZ cmin of ABCB1 rs1045642 CC type was significantly higher than TT type (P<0.05). The VRZ cmin of NR1I2 rs2472677 CT type was significantly higher than TT type, and rs7643645 AA type was significantly higher than AG type (P<0.05). The VRZ cmin of ABCC2 rs717620 CC type was significantly lower than CT type and TT type, and the CT type was significantly lower than TT type (P<0.01). CONCLUSIONS Mutant alleles in CYP2C19, CYP2C9 rs1057910, CYP3A5 rs776746, POR rs10954732, ABCB1 rs1045642 and NR1I2 rs7643645 can lead to a decrease in VRZ plasma concentration, and mutant allele in ABCC2 rs717620 can lead to an increase in VRZ plasma concentration.
6.Research progress on the interaction between immunosuppressants and intestinal flora after liver transplantation
Saijuan LU ; Cangsang SONG ; Xingde LI ; Guohui WANG ; Panpan MAO
China Pharmacy 2025;36(3):362-366
Immunosuppressants (including cyclosporine, tacrolimus, mycophenolate esters, glucocorticoids, etc.) are the first choice of drugs to prevent organ rejection after liver transplantation, which can effectively reduce the host immune response to the graft, improve the success rate of transplantation, and prolong the survival of patients. Liver transplantation is associated with intestinal flora, while immunosuppressive agents interact with intestinal flora. Immunosuppressive agents change the abundance, composition and metabolites of intestinal flora, while a series of enzymes and metabolites produced by intestinal flora may chemically alter the absorption and metabolism of immunosuppressants. In addition, the incidence of postoperative infection in liver transplantion patients is relatively high, while gut flora affects inflammatory factors, and immunosuppressants interact with inflammatory factors. To some extent, immunosuppressants can be thought of as acting through intestinal flora in patients after liver transplantation.
7.Meta-analysis of the effects of gene polymorphism on plasma concentration of voriconazole in patients with invasive fungal infection
Yaxuan LI ; Xingde LI ; Guohui WANG ; Panpan MAO ; Xuejiao MA ; Cangsang SONG
China Pharmacy 2025;36(2):225-231
OBJECTIVE To evaluate the influence of gene polymorphism on plasma minimum concentration (cmin) of voriconazole (VRZ) in patients with invasive fungal infection. METHODS The Cochrane Library, Embase, PubMed, Web of Science, China Biomedical Literature Database, CNKI, VIP and Wanfang Data were searched for literature on the correlation between gene polymorphisms and cmin of VRZ from inception to April 2024. After screening the literature, extracting data, and evaluating the quality of the literature, meta-analysis was performed using R 4.3.2 software. RESULTS A total of 21 studies with 2 454 patients were included. The results of meta-analysis showed that the VRZ cmin of CYP2C19 IM and PM types was significantly higher than EM type, and the VRZ cmin of IM type was significantly lower than PM type (P<0.01). The VRZ cmin of CYP2C9 rs1057910 AA type was significantly higher than AC/CC type, and that of CYP3A5 rs776746 CC type was significantly higher than TT type (P<0.01). The VRZ cmin of POR rs10954732 GG type was significantly higher than GA and AA types, and that of POR rs1057868 CT type was significantly lower than TT type (P<0.01). The VRZ cmin of ABCB1 rs1045642 CC type was significantly higher than TT type (P<0.05). The VRZ cmin of NR1I2 rs2472677 CT type was significantly higher than TT type, and rs7643645 AA type was significantly higher than AG type (P<0.05). The VRZ cmin of ABCC2 rs717620 CC type was significantly lower than CT type and TT type, and the CT type was significantly lower than TT type (P<0.01). CONCLUSIONS Mutant alleles in CYP2C19, CYP2C9 rs1057910, CYP3A5 rs776746, POR rs10954732, ABCB1 rs1045642 and NR1I2 rs7643645 can lead to a decrease in VRZ plasma concentration, and mutant allele in ABCC2 rs717620 can lead to an increase in VRZ plasma concentration.
8.Research progress on the effects of different myopia prevention and control methods on choroid
Shangzhu ZHANG ; Jiawei WANG ; Ruijie XI ; Song CHAI
International Eye Science 2025;25(1):70-75
In recent years, there has been a significant surge in the prevalence of myopia at younger ages in China. Numerous studies have investigated methods for preventing and controlling myopia, including orthokeratology, low-concentration atropine eye drops, light therapy, posterior scleral reinforcement, and traditional Chinese medicine. These approaches can modulate choroidal thickness, blood flow, and target various molecular mechanisms. Orthokeratology and low-concentration atropine demonstrate a thickening effect on the choroid and regulate choroidal blood flow; the use of multi-point defocus control lenses also shows promise in thickening the choroid; the influence of light and light feeding therapy on myopia prevention and control is also reflected in the choroidal thickness and blood flow; and the traditional Chinese medicine has shown good prospect in influencing the microstructure of the choroid for myopia prevention and control. However, the long-term effects of various prevention and control measures on the choroid still need to be explored with a large sample size. This article provides an overview of various methods used to regulate the choroid and prevent myopia. The mechanisms by which these interventions act on the choroid are described to provide new insights and identity novel clinical strategies for myopia management.
9.Effect of Wulao Qisun Prescription on Proliferation and Osteogenic Differentiation of AS Fibroblasts by Regulating Wnt/β-catenin Signaling Pathway
Juanjuan YANG ; Ping CHEN ; Haidong WANG ; Zhendong WANG ; Haolin LI ; Zhimin ZHANG ; Yuping YANG ; Weigang CHENG ; Jin SU ; Jingjing SONG ; Dongsheng LU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(2):67-73
ObjectiveTo investigate the effect and underlying mechanism of the Wulao Qisun prescription on pathological new bone formation in ankylosing spondylitis (AS). MethodsSynovial fibroblasts were isolated from the hip joints of AS patients and observed under a microscope to assess cell morphology. The cells were identified using immunofluorescence staining. The isolated AS fibroblasts were divided into blank group, low drug-containing serum group, medium drug-containing serum group, high drug-containing serum group, and positive drug group. After drug intervention, cell proliferation was measured using the cell counting kit-8 (CCK-8) assay to observe fibroblast growth and determine the optimal intervention time. Alkaline phosphatase (ALP) activity was measured using the alkaline phosphatase assay. Protein expression of osteocalcin (OCN), osteopontin (OPN), and runt-related transcription factor 2 (Runx2) was detected by Western blot. The mRNA expression levels of Wnt5a, β-catenin, and Dickkopf-1 (DKK-1) were measured by real-time quantitative polymerase chain reaction (Real-time PCR). ResultsCompared with the blank group, each drug-containing serum group of Wulao Qisun prescription and the positive drug group inhibited the proliferation of AS fibroblasts and reduced ALP expression (P<0.01). Compared with the blank group, the low drug-containing serum group of Wulao Qisun prescription downregulated β-catenin mRNA expression (P<0.05). The medium and high drug-containing serum groups and the positive drug group significantly downregulated Wnt5a and β-catenin mRNA expression (P<0.05, P<0.01), with the positive drug group showing the most pronounced effect (P<0.01). The high drug-containing serum group and the positive drug group significantly upregulated DKK-1 mRNA expression (P<0.01). Compared with the blank group, the low drug-containing serum group of Wulao Qisun prescription inhibited the expression of OPN and Runx2 proteins (P<0.05, P<0.01), while the medium and high drug-containing serum groups and the positive drug group inhibited the expression of OCN, OPN, and Runx2 proteins (P<0.05, P<0.01). ConclusionThe Wulao Qisun prescription can inhibit the proliferation and osteogenic differentiation of AS fibroblasts, thereby delaying the formation of pathological new bone in AS. The possible mechanism involves the regulation of Wnt/β-catenin-related gene expression, further inhibiting the transcription of downstream target genes.
10.Active Components of Salviae Miltiorrhizae Radix et Rhizoma and Its Compound in Treatment of Nervous System Diseases: A Review
Weining SONG ; Shuxiang ZHANG ; Fang LU ; Zhize WANG ; Ruyang CHENG ; Shumin LIU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(2):303-313
Nervous system diseases, also known as neuropathies, encompass a wide range of conditions, primarily including Alzheimer's disease (AD), Parkinson's disease (PD), Huntington's disease, and other neurodegenerative disorders, as well as depression, subarachnoid hemorrhage, cerebral ischemia-reperfusion injury, vascular dementia, and other neurological diseases. These diseases pose serious threats to the health and lives of patients, bringing heavy burdens to society and families. The pathogenesis of nervous system diseases is highly complex, involving mechanisms such as neuroinflammation, oxidative stress, apoptosis, endoplasmic reticulum stress, mitochondrial dysfunction, brain-derived neurotrophic factor deficiency, reduced cholinergic activity, axonal injury, and demyelination. In recent years, the incidence and mortality of nervous system diseases have been rising annually. Currently, western medicine primarily focuses on symptomatic treatment, often accompanied by many adverse reactions, including lethargy, excessive sedation, dizziness, headaches, tachycardia, liver function damage, metabolic disorders, and incomplete recovery after surgery. As a traditional Chinese medicine, Salviae Miltiorrhizae Radix et Rhizoma has effects such as promoting blood circulation, removing blood stasis, cooling the blood, clearing the heart, nourishing the blood, and calming the nerves. It can play a role in the treatment and protection against nervous system diseases through multiple targets, pathways, and mechanisms. Studies have found that the water-soluble phenolic acids and fat-soluble diterpenoid quinones in Salviae Miltiorrhizae Radix et Rhizoma are the main active ingredients for the treatment of nervous system diseases. This paper summarized the effects of the active components and compounds of Salviae Miltiorrhizae Radix et Rhizoma on nervous system diseases over the past ten years, aiming to provide a theoretical basis and research ideas for the development and application of active components and compounds of Salviae Miltiorrhizae Radix et Rhizoma in nervous system diseases.

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