1.Analysis of factors influencing total corneal surgically induced astigmatism following implantable collamer lens implantation
Wanghua ZHAO ; Shutian HUANG ; Lanhua XU ; Xia CHEN ; Liangyong ZHU
International Eye Science 2026;26(3):540-545
AIM: To analyze the factors influencing total corneal surgically induced astigmatism(SIA)following implantable collamer lens(ICL)implantation.METHODS:This prospective study enrolled 162 patients(162 eyes)who underwent ICL implantation at our hospital between July 2023 and January 2024. Based on preoperative assessment of anticipated postoperative residual astigmatism, different incisions were selected. Superior incision was selected for patients with expected residual astigmatism with the rule in 75 eyes, and temporal incision was selected for patients with expected residual astigmatism againist the rule in 87 eyes. Parameters including total corneal refractive power, incision length, internal ostium-to-visual axis distance, central corneal thickness, preoperative total corneal astigmatism, and corneal diameter were measured using the Pentacam anterior segment analyzer before and at 3 mo after surgery. Postoperative total corneal SIA was calculated based on the changes in total corneal refractive power. Multiple linear regression analysis was performed to assess the influence of the above parameters on postoperative total corneal SIA.RESULTS:A total of 162 cases(162 eyes)that implanted with ICL were included in the analysis, and 8 cases were lost to follow-up, with a loss rate of 4.9%. Eventually 154 cases(154 eyes)completed the research. The superior incision group comprised 72 cases(72 eyes), including 17 males and 55 females, with a mean age of 25.96±6.17 years, while the temporal incision group comprised 82 cases(82 eyes), including 20 males and 62 females, with a mean age of 27.79±6.47 years. No significant difference in postoperative total corneal SIA was observed between the two groups [0.31(0.21, 0.49)D vs. 0.27(0.13, 0.485)D, P=0.159]. Multiple linear regression analysis revealed that internal ostium-to-visual axis distance and preoperative total corneal astigmatism significantly influenced postoperative total corneal SIA in the superior incision group(P=0.001). The regression equation was: postoperative total corneal SIA=0.71-0.381×internal ostium-to-visual axis distance+0.16×preoperative total corneal astigmatism. No significant influencing factors for postoperative total corneal SIA were identified in the temporal incision group.CONCLUSION: During ICL implantation, the magnitude of total corneal SIA is comparable between superior and temporal incisions. For patients receiving a superior incision, the internal ostium-to-visual axis distance and preoperative total corneal astigmatism value can be used to quantitatively predict postoperative total corneal SIA to a certain extent, thereby aiding in the optimization of postoperative visual quality.
2.Mechanism of action of Qingre huatan huoxue decoction against atherosclerosis based on macrophage polarization
Huaping ZHONG ; Qicheng ZHU ; Zhengwei ZOU ; Zhengyi HE ; Heping XIE ; Xu CHEN ; Zhisheng DUAN ; Tian XIAO
China Pharmacy 2026;37(4):438-443
OBJECTIVE To explore the mechanism of action of Qingre huatan huoxue decoction against atherosclerosis (AS)based on macrophage polarization. METHODS Using atorvastatin served as the positive control, the drug-containing serum of the Qingre huatan huoxue decoction was prepared to treat RAW264.7 macrophages. Macrophage viability, apoptosis rate, and the fluorescence intensities of CD86 and CD206 were measured, along with the levels of tumor necrosis factor-α (TNF-α) and interleukin-1β (IL-1β). Apolipoprotei n E-deficient (ApoE -/- ) mice (AS model mice) fed with a high-fat diet were randomly assigned to model group, atorvastatin group (2.6 mg/kg), and low-, medium- and high-dose groups of Qingre huatan huoxue decoction (90, 180, 360 mg/kg), respectively. C57BL/6J mice fed with a standard diet served as the normal control group, with 10 mice per group. The treatment group mice were administered the corresponding drugs intragastrically, once daily, for 8 consecutive weeks. Serum levels of TNF-α and IL-1β were measured in all groups. Lipid deposition in the aorta (assessed by the percentage of plaque in the entire aorta and aortic root) and morphological changes in the aortic root were observed. Expression levels of CD86 and CD206 in aortic tissue, as well as the protein expression levels of inducible nitric oxide synthase (iNOS), arginase-1 (Arg-1), AMP-activated protein kinase (AMPK), phosphorylated AMPK (p-AMPK), and peroxisome proliferator-activated receptor γ (PPAR-γ) in aortic tissues were all detected. RESULTS Cell experiment results showed that, at concentrations of 5-100 μg/mL, the drug-containing serum of the Qingre huatan huoxue decoction significantly increased RAW264.7 cell viability ( P <0.05). The drug-containing serum of the Qingre huatan huoxue decoction at concentrations of 10, 50, and 100 μg/mL, along with atorvastatin, significantly reduced apoptosis rates, CD86 fluorescence intensity, and TNF-α and IL-1β levels in RAW264.7 cells, while markedly enhancing CD206 fluorescence intensity ( P <0.05). Animal experiment results showed that, compared with the model group, all dosage groups of Qingre huatan huoxue decoction and the atorvastatin group showed significantly reduced/down-regulated levels of TNF-α and IL-1β in serum, along with decreased aortic total and root plaque percentages, CD86 expression, and iNOS protein expression. CD206 expression and Arg-1, p-AMPK/AMPK, PPAR-γ protein expression were significantly up-regulated ( P <0.05). Pathological morphology of the aorta showed varying degrees of improvement. CONCLUSIONS The formula of Qingre huatan huoxue decoction exerts its anti-AS effects by regulating macrophage polarization, increasing the proportion of M2 macrophages, thereby effectively inhibiting AS plaque formation and reducing inflammatory responses.
3.Research on the preventive and reparative mechanisms of platelet-rich plasma-biodegradable quick setting spray for solar dermatitis
Zhanhong ZHU ; Shaowen LI ; Li CHEN ; Yubing XU ; Mou ZHOU
Chinese Journal of Blood Transfusion 2026;39(2):188-195
Objective: To investigate the preventive and reparative mechanisms of platelet-rich plasma-biodegradable quick setting spray (PRP-BQSS) on solar dermatitis, thereby providing a safe and effective novel therapeutic approach for clinical application. Methods: PRP-BQSS was prepared. A ultraviolet B (UVB)-induced solar dermatitismodel was established in SPF-grade male SD rats. The rats were divided into the prevention experiment (treated with PRP-BQSS, L' Oréal SPF 50+sunscreen, Nature's Hall SPF 50+sunscreen, or saline) and the treatment experiment (treated with PRP-BQSS, Jingwanhong ointment, Green ointment, or saline). The effects were evaluated by measuring epidermal thickness (HE staining) and quantifying the integrated optical density (IOD) of inflammatory cells (CD11b staining). One-way ANOVA and Tukey's HSD test were performed using GraphPad Prism 9.4.0. Results: The PRP-BQSS exhibited significant efficacy in both prevention and repair. In the prevention experiment, the PRP-BQSS prevention group (Group A) showed only mild pale red erythema on the dorsal skin of rats, without significant swelling or desquamation. Histological analysis revealed that epidermal thickness in Group A (36.55±6.58 μm) was comparable to Groups B (L' Oréal, 34.84±6.59 μm) and C (Natural Hall, 34.59±8.20 μm)(P>0.05), but significantly lower than that in Group D (control group, 47.82±11.69 μm). Skin sections from Group A demonstrated intact epidermal structure with clear stratification and no significant inflammatory cell infiltration. The CD11b-positive cell count (24.30±7.43) was significantly lower than that in Group D (33.65±8.47, P<0.05). In the treatment experiment, HE staining of Group A (PRP-BQSS treatment group) showed intact epidermal structure with orderly arrangement of the basal layer, spinous layer, and granular layer, thin and uniform stratum corneum, and regular collagen fiber arrangement. The epidermal thickness of Group A (37.10±6.41 μm) showed no significant difference from Groups B (Jingwanhong ointment group, 38.66±9.07 μm) or C (Green ointment group, 35.72±4.98 μm)(P>0.05), but was significantly lower than that in Group D (control group, 48.35±8.99 μm)(P<0.05). The integral optical density value of CD11b-positive cells in Group A (32.82±11.01) was significantly lower than that in Group D (47.25±13.52, P>0.05). Moreover, the degree of inflammatory infiltration in Group A was relatively lower compared to Group B (37.14±9.20) and Group C (34.32±16.87), suggesting a superior repair capacity. However, the intergroup differences were not statistically significant (P>0.05). Conclusion: PRP-BQSS hydrogel dressing possesses dual preventive and reparative functions. It exerts its effects by reducing CD11b-positive cell infiltration (inflammation suppression) and promoting the orderly arrangement of the basal layer-epidermal layer-granular layer (epidermal reconstruction). This material holds promise as a novel and effective therapeutic approach for the prevention and treatment of solar dermatitis, particularly suitable for high-risk populations such as children, individuals with sensitive skin, and those engaged in outdoor activities.
4.Volatile Component Differences in Xihuangwan Prepared with Natural and Artificial Musk Based on Non-targeted and Targeted Metabolomics
Jing WANG ; Fangzhu XU ; Li MENG ; Qizhen ZHU ; Huanjun ZHAO ; Caina YU ; Xuelian CHEN ; Hui GAO ; Zimin YUAN
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):194-201
ObjectiveHeadspace solid-phase microextraction-gas chromatography-mass spectrometry(HS-SPME-GC-MS) and GC-triple quadrupole MS(GC-QqQ-MS) in combination with non-targeted and targeted metabolomics were employed to systematically analyze the chemical composition differences of Xihuangwan prepared with natural musk and artificial musk, and establish an identification system for them. MethodsThe volatile components of 9 batches of Xihuangwan samples from 8 manufacturers were analyzed by HS-SPME-GC-MS non-targeted metabolomics, and identified by comparing their MS data with the National Institute of Standards and Technology(NIST) spectral library. Orthogonal partial least squares-discriminant analysis(OPLS-DA) was used to identify differential volatile components of Xihuangwan prepared with natural musk and artificial musk. Additionally, GC-QqQ-MS targeted metabolomics was applied to quantify the levels of α-pinene, β-elemene, muscone, dehydroepiandrosterone, bornyl acetate, and octyl acetate in 27 batches of samples from 9 manufacturers. Cluster analysis, principal component analysis(PCA), and partial least squares-discriminant analysis(PLS-DA) were conducted to further explore the differences in volatile components between Xihuangwan samples prepared with natural musk and artificial musk. ResultsNon-targeted metabolomics identified 291 volatile compounds in Xihuangwan, including alkanes, esters, alkanes, alcohols, ketones, naphthalenes and others. OPLS-DA analysis revealed distinct separation between Xihuangwan samples containing artificial musk(A1, C1, D1, E1, F1, G1, I1) and those containing natural musk(H1, H3). A total of 30 differential metabolites were identified. The relative contents of these 30 differential metabolites were visualized using a radar chart, revealing significant differences in the levels of octanol, borneol acetate and muscone. Cluster analysis and PCA results from targeted metabolomics indicated that Xihuangwan could be classified into two distinct groups:one composed of natural musk(H1, H3) and the other of artificial musk, sample H2. PLS-DA identified muscone, octyl acetate, and dehydroepiandrosterone as key differential volatile components. Although no significant difference was observed in the content of octyl acetate between the two groups, statistically significant differences were found for muscone and dehydroepiandrosterone(P<0.05). ConclusionMuscone and dehydroepiandrosterone can be used for the differentiation of Xihuangwan samples containing natural musk from those containing artificial musk. This study systematically and comprehensively analyzed the differences in the types and contents of major volatile components in Xihuangwan prepared with natural musk and artificial musk, providing a scientific basis for quality evaluation and control of Xihuangwan.
5.Volatile Component Differences in Xihuangwan Prepared with Natural and Artificial Musk Based on Non-targeted and Targeted Metabolomics
Jing WANG ; Fangzhu XU ; Li MENG ; Qizhen ZHU ; Huanjun ZHAO ; Caina YU ; Xuelian CHEN ; Hui GAO ; Zimin YUAN
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):194-201
ObjectiveHeadspace solid-phase microextraction-gas chromatography-mass spectrometry(HS-SPME-GC-MS) and GC-triple quadrupole MS(GC-QqQ-MS) in combination with non-targeted and targeted metabolomics were employed to systematically analyze the chemical composition differences of Xihuangwan prepared with natural musk and artificial musk, and establish an identification system for them. MethodsThe volatile components of 9 batches of Xihuangwan samples from 8 manufacturers were analyzed by HS-SPME-GC-MS non-targeted metabolomics, and identified by comparing their MS data with the National Institute of Standards and Technology(NIST) spectral library. Orthogonal partial least squares-discriminant analysis(OPLS-DA) was used to identify differential volatile components of Xihuangwan prepared with natural musk and artificial musk. Additionally, GC-QqQ-MS targeted metabolomics was applied to quantify the levels of α-pinene, β-elemene, muscone, dehydroepiandrosterone, bornyl acetate, and octyl acetate in 27 batches of samples from 9 manufacturers. Cluster analysis, principal component analysis(PCA), and partial least squares-discriminant analysis(PLS-DA) were conducted to further explore the differences in volatile components between Xihuangwan samples prepared with natural musk and artificial musk. ResultsNon-targeted metabolomics identified 291 volatile compounds in Xihuangwan, including alkanes, esters, alkanes, alcohols, ketones, naphthalenes and others. OPLS-DA analysis revealed distinct separation between Xihuangwan samples containing artificial musk(A1, C1, D1, E1, F1, G1, I1) and those containing natural musk(H1, H3). A total of 30 differential metabolites were identified. The relative contents of these 30 differential metabolites were visualized using a radar chart, revealing significant differences in the levels of octanol, borneol acetate and muscone. Cluster analysis and PCA results from targeted metabolomics indicated that Xihuangwan could be classified into two distinct groups:one composed of natural musk(H1, H3) and the other of artificial musk, sample H2. PLS-DA identified muscone, octyl acetate, and dehydroepiandrosterone as key differential volatile components. Although no significant difference was observed in the content of octyl acetate between the two groups, statistically significant differences were found for muscone and dehydroepiandrosterone(P<0.05). ConclusionMuscone and dehydroepiandrosterone can be used for the differentiation of Xihuangwan samples containing natural musk from those containing artificial musk. This study systematically and comprehensively analyzed the differences in the types and contents of major volatile components in Xihuangwan prepared with natural musk and artificial musk, providing a scientific basis for quality evaluation and control of Xihuangwan.
6.Impact of number of positive regional lymph nodes in N1 stage on the prognosis of patients with non-small cell lung cancer: A propensity score matching study
Dandan LIU ; Jiachen WANG ; Lidan CHANG ; Jia CHEN ; Ranran KONG ; Shiyuan LIU ; Minxia ZHU ; Jiantao JIANG ; Shaomin LI ; Zhengshui XU
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2026;33(01):63-71
Objective To explore the impact of number of positive regional lymph nodes (nPRLN) in N1 stage on the prognosis of non-small cell lung cancer (NSCLC) patients. Methods Patients with TxN1M0 stage NSCLC who underwent lobectomy and mediastinal lymph node dissection from 2010 to 2015 were screened from SEER database (17 Regs, 2022nov sub). The optimal cutoff value of nPRLN was determined using X-tile software, and patients were divided into 2 groups according to the cutoff value: a nPRLN≤optimal cutoff group and a nPRLN>optimal cutoff group. The influence of confounding factors was minimized by propensity score matching (PSM) at a ratio of 1 : 1. Kaplan-Meier curves and Cox proportional hazards models were used to evaluate overall survival (OS) and lung cancer-specific survival (LCSS) of patients. Results A total of 1316 patients with TxN1M0 stage NSCLC were included, including 662 males and 654 females, with a median age of 67 (60, 73) years. The optimal cutoff value of nPRLN was 3, with 1165 patients in the nPRLN≤3 group and 151 patients in the nPRLN>3 group. After PSM, there were 138 patients in each group. Regardless of before or after PSM, OS and LCSS of patients in the nPRLN≤3 group were superior to those in the nPRLN>3 group (P<0.001). N1 stage nPRLN>3 was an independent prognostic risk factor for OS [HR=1.52, 95%CI (1.22, 1.89), P<0.001] and LCSS [HR=1.72, 95%CI (1.36, 2.18), P<0.001]. Conclusion N1 stage nPRLN>3 is an independent prognostic risk factor for NSCLC patients in TxN1M0 stage, which may provide new evidence for future revision of TNM staging N1 stage subclassification.
7.Application advances, ethical dilemmas, and future directions of large language models in lung cancer diagnosis and treatment
Zhizhen REN ; Yufan XI ; Xu ZHU ; Yijie LUO ; Geting HUANG ; Junqiao SONG ; Xiuyuan XU ; Nan CHEN ; Qiang PU
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2026;33(03):353-362
Lung cancer is a leading cause of cancer-related morbidity and mortality worldwide. Coupled with the substantial workload, the clinical management of lung cancer is challenged by the critical need to efficiently and accurately process increasingly complex medical information. In recent years, large language models (LLMs) technology has undergone explosive development, demonstrating unique advantages in handling complex medical data by leveraging its powerful natural language processing capabilities, and its application value in the field of lung cancer diagnosis and treatment is continuously increasing. The paper systematically analyzes that the exceptional potential of LLMs in lung cancer auxiliary diagnosis, tumor feature extraction, automatic staging, progression/outcome analysis, treatment recommendations, medical documentation generation, and patient education. However, they face critical technical and ethical challenges including inconsistent performance in complex integrated decision-making (e.g., TNM staging, personalized treatment suggestions) and "black box" opacity issues, along with dilemmas such as training data biases, model hallucinations, data privacy concerns, and cross-lingual adaptation challenges ("data colonization"). Future directions should prioritize constructing high-quality multimodal corpora specific to lung cancer, developing interpretable and compliant specialized models, and achieving seamless integration with existing clinical workflows. Through dual drivers of technological innovation and ethical standardization, LLMs should be prudently advanced for holistic lung cancer management processes, ultimately promoting efficient, standardized, and personalized diagnosis and treatment practices.
8.Development and validation of a prognostic nomogram model for patients with the lower third and abdominal oesophageal adenocarcinoma
Zhengshui XU ; Dandan LIU ; Jiantao JIANG ; Ranran KONG ; Jianzhong LI ; Yuefeng MA ; Zhenchuan MA ; Jia CHEN ; Minxia ZHU ; Shaomin LI
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2025;32(02):201-207
Objective To establish an individualized nomogram model and evaluate its efficacy to provide a possible evaluation basis for the prognosis of lower third and abdominal part of oesophageal adenocarcinoma (EAC). Methods Lower third and abdominal part of EAC patients from 2010 to 2015 were chosen from the SEER Research Plus Database (17 Regs, 2022nov sub). The patients were randomly allocated to the training cohort and the internal validation cohort with a ratio of 7∶3 using bootstrap resampling. The Cox proportional hazards regression analysis was used to determine significant contributors to overall survival (OS) in EAC patients, which would be elected to construct the nomogram prediction model. C-index, calibration curve and receiver operating characteristic (ROC) curve were performed to evaluate its efficacy. Finally, the efficacy to evaluate the OS of EAC patients was compared between the nomogram prediction model and TNM staging system. Results In total, 3945 patients with lower third and abdominal part of EAC were enrolled, including 3475 males and 470 females with a median age of 65 (57-72) years. The 2761 patients were allocated to the training cohort and the remaining 1184 patients to the internal validation cohort. In the training and the internal validation cohorts, the C-index of the nomogram model was 0.705 and 0.713, respectively. Meanwhile, the calibration curve also suggested that the nomogram model had a strong capability of predicting 1-, 3-, and 5-year OS rates of EAC patients. The nomogram also had a higher efficacy than the TNM staging system in predicting 1-, 3-, and 5-year OS rates of EAC patients. Conclusion This nomogram prediction model has a high efficiency for predicting OS in the patients with lower third and abdominal part of EAC, which is higher than that of the current TNM staging system.
9.The Effect of Zhiqiao Gancao Decoction (枳壳甘草汤) on Intervertebral Disc Nucleus Pulposus Cell Apoptosis and the Hippo-YAP/TAZ Signaling Pathway in Tail Intervertebral Disc Degeneration Model Rats
Zaishi ZHU ; Zeling HUANG ; Junming CHEN ; Bo XU ; Binjie LU ; Hua CHEN ; Xingxing DUAN ; Yuwei LI ; Xiaofeng SHEN
Journal of Traditional Chinese Medicine 2025;66(5):509-517
ObjectiveTo investigate the possible mechanism by which Zhiqiao Gancao Decoction (枳壳甘草汤, ZGD) delays intervertebral disc degeneration (IDD) based on the Hippo-yes-associated protein (YAP)/transcriptional co-activator with PDZ-binding motif (TAZ) signaling pathway. MethodsA total of 50 SD rats were randomly divided into sham surgery group, model group, low-dose ZGD group, high-dose ZGD group, and high-dose ZGD + inhibitor group, with 10 rats in each group. In the sham surgery group, the rats were pierced in the skin and muscle at the Co6/7/8 segments of the tail with a 21G needle (depth approximately 2 mm) without damaging the intervertebral disc. In the other groups, rats were injected with a 21G needle at the Co6/7/8 segments of the tail to establish an IDD model by piercing the tail intervertebral disc 5 mm. One week after modeling, rats in the low-dose and high-dose ZGD groups were given 6.24 and 12.24 g/(kg·d) of the decoction via gastric gavage, respectively. The high-dose ZGD + inhibitor group was given 12.24 g/(kg·d) of the decoction and an intraperitoneal injection of YAP/TAZ inhibitor Verteporfin 10 mg/kg. The sham surgery and model groups were given 5 ml/(kg·d) of normal saline via gavage. The gavage was given once a day, and the intraperitoneal injection was given every other day. After 4 weeks of continuous intervention, the pathological changes of the tail intervertebral discs were observed using HE staining, Oil Red O-Green staining, and Toluidine Blue staining. Immunohistochemistry was used to detect the expression of aggrecan and MMP3 in the nucleus pulposus. TUNEL fluorescence staining was performed to detect apoptosis in the nucleus pulposus, and the apoptosis rate was calculated. Western blot was used to detect the Hippo-YAP/TAZ signaling pathway, including YAP, phosphorylated YAP (p-YAP), phosphorylated MST1/2 (p-MST1/2), phosphorylated TAZ (p-TAZ) and apoptosis-related proteins, such as Cleaved Caspase 3, P53, Bcl-2 and Bax. ResultsCompared with sham surgery group, the rats in the model group showed significant degenerative changes in the intervertebral disc. The levels of aggrecan, Bcl-2, and YAP proteins in the nucleus pulposus decreased, while the levels of p-MST1/2, p-YAP, p-TAZ, P53, Bax, Cleaved Caspase 3, MMP3 proteins, and the apoptosis rate increased (P < 0.01). Compared with the model group, the drug intervention groups showed partial recovery in intervertebral disc degeneration. The levels of aggrecan, Bcl-2, and YAP proteins increased, while the levels of p-MST1/2, p-YAP, p-TAZ, P53, Bax, Cleaved Caspase 3, MMP3 proteins, and the apoptosis rate decreased (P<0.05 or P<0.01). The high-dose ZGD group showed more significant recovery in intervertebral disc degeneration compared to the low-dose ZGD group, with a decrease in the levels of p-MST1/2, p-YAP, p-TAZ, P53, Bax, Cleaved Caspase 3, MMP3 proteins, and apoptosis rate, and an increase in the levels of aggrecan, Bcl-2, and YAP proteins (P<0.05 or P<0.01). Compared with the high-dose ZGD group, the high-dose ZGD + inhibitor group showed a reduced recovery in intervertebral disc degeneration, with an increase in the levels of p-MST1/2, p-YAP, p-TAZ, P53, Bax, Cleaved Caspase 3, MMP3 proteins, and apoptosis rate, and a decrease in the levels of aggrecan, Bcl-2, and YAP proteins (P<0.05 or P<0.01). ConclusionZGD may delay intervertebral disc degeneration by inhibiting the phosphorylation of YAP in the nucleus pulposus, maintaining the function of the Hippo-YAP/TAZ signaling pathway, and reducing apoptosis of nucleus pulposus cells.
10.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.

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