The Pharmacopeia of the People′s Republic of China 2025 Edition (referred to as the Chinese Pharmacopoeia 2025, ChP 2025) has been promulgated and implemented. The general idea, compilation principles, and drug standard system of ChP 2025 were analyzed in this article. The sources of drug varieties, changes in general notices, and the core content of revisions were introduced in detail. To facilitate readers′ accurate understanding and effective implementation of this edition of the Pharmacopoeia, the content that may give rise to doubts during the implementation process was further interpreted herein. It was pointed out that the new development concept of “innovation, coordination, green, openness, and sharing” has been fully implemented in ChP 2025 (Volume Ⅱ). In terms of coordination with international standards, the primary responsibility of marketing license holders in the control of residual solvents and elemental impurities was clarified in ChP 2025 (Volume Ⅱ), and the application of risk management concepts and methods for scientific evaluation was encouraged. Additionally, the great significance of the implementation of the “Measures for the Administration of Drug Standards” was emphasized in this article, which has been identified as an important basis for the Pharmacopoeia Committee to continuously improve the standardization and revision requirements for national chemical drug standards.

As a key component of pharmaceutical preparations, the quality control of pharmaceutical excipients is crucial to the safety and efficacy of drugs. The Chinese Pharmacopoeia, as the core of the national drug standard system, sets strict requirements for the quality control of excipients. In recent years, with the rapid development of analytical technologies, an increasing number of advanced analytical techniques have been applied to pharmaceutical excipients. These technologies can accurately determine the composition, purity, and impurities of pharmaceutical excipients, evaluate their safety and functionality, and provide a scientific basis for the quality control of pharmaceutical excipients. In Chinese Pharmacopoeia 2025, the quality control of pharmaceutical excipients not only retains classic spectroscopic and chromatographic methods but also introduces new analytical approaches, thereby improving the precision and systematicness of pharmaceutical excipient quality control. This article provides a comprehensive overview of the application progress of quality control methods for pharmaceutical excipients in Chinese Pharmacopoeia 2025, aiming to offer technical references for pharmaceutical research and development, production, and supervision, and to promote the high-quality development of the pharmaceutical excipient and pharmaceutical industries.

Chinese Pharmacopoeia 2025 has been officially promulgated and put into enforcement from 1^st October 2025. The Chinese Pharmacopoeia, as the core of the national drug standard system, has always played an important role in improving drug quality, ensuring drug safety, and serving drug supervision. The residue of heavy metals and harmful elements in traditional Chinese medicine(TCM) is an important issue of public and industry concern. The heavy metal and harmful element standards formulated in Chinese Pharmacopoeia 2025 have broken through the inclusion mode of heavy metal standards in previous editions, and have significantly increased the number of standards compared with previous editions. This article provides introduction to the drafting and review process of heavy metals and harmful element standards in the previous and new editions of the Chinese Pharmacopoeia. This article also proposes prospects for future research on relevant standards and the development of the TCM industry, to enhance the public and TCM industry understand the relevant standards and promoting the implementation of Chinese Pharmacopoeia 2025.

Articular cartilage injury is a highly prevalent orthopedic condition whose pathogenesis is complex, and involves a variety of factors such as age, obesity and excessive exercise. It has a serious impact on patients’ daily life due to the joint pain, arthritis it causes. Western medicine′s methods for the treating cartilage injuries are expensive and have severe side effects, and there is still a lack of specific drugs to treat cartilage injuries. The theory of traditional Chinese medicine (TCM) provides new ideas for the treatment of cartilage injuries and the development of specific drugs. In the “Yellow Emperor′s Classic of Internal Medicine”, it was first stated that “the kidneys play an important role in the growth of bones, especially bone marrow”. The kidney is the foundation of congenital constitution. It stores essence and generates marrow. When the marrow fills the bones, it can nourish the bones. Based on the basic theory of TCM, TCM and its active ingredients for kidney tonics have been shown to exhibit obvious benefits in the prevention and treatment of articular cartilage and have a wide range of applications. According to the above-mentioned classic theories of TCM, the research progress of kidney tonic TCM and its active ingredients in the treatment of articular cartilage injury is reviewed, to provide new ideas and research directions for the treatment of articular cartilage injury with TCM.

Protein and peptide-based therapeutics have demonstrated tremendous potential in the treatment of tumors, autoimmune diseases, and metabolic disorders, owing to their high target specificity and low toxicity. Nevertheless, their inherent characteristics—such as large molecular weight, strong hydrophilicity, and susceptibility to enzymatic degradation—limit their administration primarily to injections, thereby negatively impacting patient compliance and quality of life. In recent years, transdermal delivery has emerged as a promising alternative, offering a non-invasive, convenient, and patient-friendly route for the administration of protein and peptide drugs. Physical enhancement techniques, including microneedles, ultrasound, and iontophoresis, as well as chemical permeation strategies such as cell-penetrating peptides and ionic liquids, have significantly improved transdermal efficiency and local drug concentrations. Concurrently, the integration of targeted ligand modification, intelligent carriers, and stability-enhancing strategies has further facilitated the clinical translation of these delivery systems. Despite ongoing challenges related to safety, standardization, and long-term application, transdermal delivery is anticipated to provide innovative solutions for the long-term and personalized administration of protein and peptide therapeutics.

Deuterated drugs are an emerging class of pharmaceuticals created by replacing specific hydrogen atoms in drug molecules with deuterium atoms. Since the CD bond is more stable than the CH bond, deuteration can significantly alter a drug′s metabolism, efficacy, and safety profile. The deuterium kinetic isotope effect (DKIE) endows deuterated drugs with unique advantages in pharmacokinetics, toxic metabolite regulation, drug-drug interaction mitigation, and chiral structure stabilization. This article systematically reviews five currently marketed deuterated drugs and two under regulatory review, analyzing their structural modification strategies and pharmacological advantages. It also examines 24 deuterated drug candidates in clinical trials in global, spanning therapeutic areas including oncology, antivirals, psychiatric disorders, and gastrointestinal diseases. By comparing the structural features, efficacy, and safety profiles of prototype drugs with their deuterated counterparts, the paper summarizes recent advances in deuterated drug development. The aim is to provide a comprehensive perspective on deuterated drug design and inspire innovative approaches for this novel class of therapeutics.

OBJECTIVE To investigate the types and differences of volatile components in different parts (rhizome, leaf, fruit and flower) of Polygonati Rhizoma produced in Shaanxi. METHODS Volatile components in different parts of Polygonati Rhizoma were detected and analyzed using headspace-gas chromatography-ion mobility spectrometry (HS-GC-IMS). Then, combined with chemical pattern recognition such as principal component analysis (PCA), orthogonal partial least squares-discriminant analysis (OPLS-DA) and cluster analysis, the differences of volatile components of different parts of Polygonati Rhizoma in the form of visualized data were resolved. RESULTS A total of 103 characteristic signals were obtained from different parts of Polygonati Rhizoma using HS-GC-IMS, and 79 species were qualitatively identified, including 26 aldehydes, 17 alcohols, 17 ketones, 11 esters, 2 thioethers, 2 furans, 2 acids, 1 monoterpene and 1 pinenes. PCA, OPLS-DA and cluster analysis could distinguish the different parts of Polygonati Rhizoma effectively. The clustering heatmap results revealed that the 26 characteristic volatile components screened, such as acetic acid Dimer, dimethyl sulfide Monomer, 1-hexanal Dimer could be used as potential markers to distinguish different parts of Polygonati Rhizoma. CONCLUSION The HS-GC-IMS combined with chemical pattern recognition is able to visualize the volatile components and identify their differences in different parts of Polygonati Rhizoma, it will provide theoretical foundation for the identification of different parts of Polygonati Rhizoma produced in Shaanxi and the rational utilization of Polygonati Rhizoma resources from a new perspective.

OBJECTIVE To investigate the effect of curcumin on peritoneal fibrosis (PF) and angiogenesis in peritoneal dialysis (PD) rats based on the hypoxia inducible factor-1α (HIF-1α)/vascular endothelial growth factor receptor 2 (VEGFR2)/extracellular signal-regulated kinase 1/2 (ERK1/2) pathway. METHODS Fifty rats were randomly assigned into control group, model group, YC-1 (HIF-1α inhibitor) group (14 mg·kg^-1), curcumin group (40 mg·kg^-1), and curcumin+dimethyloxaloylglycine (DMOG) (HIF-1α agonist) group (40 mg·kg^-1 curcumin+40 mg·kg^-1 DMOG), with 10 rats in each group. Except for the control group, PD-related PF models were established in the remaining rats using the 5/6 nephrectomy method + PD solution + lipopolysaccharide (LPS) method. Peritoneal balance test was used to detect the peritoneal function of the rats. Hematoxylin-eosin (HE) staining was used to observe pathological changes in peritoneal tissue. Masson staining was used to observe the fibrosis of peritoneal tissue. Immunohistochemical staining was used to detect microvascular density in peritoneal tissue. Real-time fluorescence quantitative polymerase chain reaction (qRT-PCR) was used to detect the gene expression of transforming growth factor-β1 (TGF-β1), α-smooth muscle actin (α-SMA), and type Ⅰ collagen (collagen Ⅰ) in peritoneal tissue. Western blot was used to detect the expression of HIF-1α, vascular endothelial growth factor (VEGF), VEGFR2, ERK1/2, and their phosphorylated proteins in peritoneal tissue. RESULTS Compared with the model group, the ultrafiltration volumes of rats in the YC-1 group and curcumin group were higher, while the mass transfer of glucose, peritoneal thickness, ratio of collagen fiber deposition, microvascular density, the levels of TGF-β1, α-SMA, collagen ⅠmRNAs, and the levels of HIF-1α, VEGF, VEGFR2, phosphorylated ERK1/2 (p-ERK1/2)/ERK1/2 proteins in peritoneal tissue were lower (P<0.05). DMOG could weaken the inhibitory effects of curcumin on PF and angiogenesis in PD rats. CONCLUSION Curcumin can inhibit angiogenesis and PF in PD rats, and its mechanism of action may be related to the inhibition of the activation of HIF-1α/VEGFR2/ERK1/2 pathway.

OBJECTIVE To study the effective components of Asparagus cochinchinensis peel, a waste product of Asparagus cochinchinensis harvesting and processing, and to provide a reference for the comprehensive reuse of the waste produced in the processing of Asparagus cochinchinensis. METHODS Total saponins were extracted ultrasonically from Asparagus cochinchinensis peel, the extraction process was optimized by one-way and orthogonal tests, and the in vitro antioxidant activity was explored by DPPH free radical and ABTS⁺· free radical methods, and the effects on nematode lifespan, locomotor ability, lipofuscin, oxidative and thermal stress were determined to evaluate the antioxidant effects using the Hidradenitis occidentalis nematode as a model. RESULTS The optimal extraction process involves a methanol volume fraction 60%, a temperature of 50 ℃, a material-to-liquid ratio of 1∶30 (g·mL^-1), and ultrasound treatment conducted three times, each lasting 30 minutes. Under these conditions, the average total saponin content of Asparagus cochinchinensis peel(TSAC-P) is 0.46%, with a relative standard deviation (RSD) of 0.104%. In vitro experiments demonstrate that TSAC-P can reduce free radical content. In studies on aging in Caenorhabditis elegans, these saponins are capable of extending the natural lifespan of the nematodes and also prolonging their lifespan under oxidative and thermal stress conditions. Additionally, TSAC-P can decrease the lipofuscin content in nematodes and increase their body movement frequency. CONCLUSION TSAC-P extract exhibits significant antioxidant properties, which can extend the lifespan of Caenorhabditis elegans and promote healthy aging in these nematodes. The impact of TSAC-P from two different sources on the lifespan of the nematodes showed no significant difference, with the optimal effect observed at a concentration of 0.8 mg·mL^-1. This study is the first to reveal the anti-aging activity of saponin components found in Asparagus peel waste from Neijiang, providing a theoretical basis for their development as functional food additives and pharmaceutical raw materials. Additionally, it plays a positive role in advancing the construction of a “whole plant utilization-circular economy” model for Asparagus resources.

OBJECTIVE To address the shortcomings of the current standard in the Chinese Pharmacopoeia, which only detects two components of Sarcandrae Herba, and establish a multi index component analysis method to analyze the chemical characteristics of medicinal materials from different origins and the transfer patterns of substances in formulations. METHODS UPLC-Q-Exactive Orbitrap-MS/MS was used to identify 41 components in Sarcandrae Herba and its preparations based on retention time, precise mass number (error ≤5×10^-6), and fragment ion characteristics, including organic acids (chlorogenic acid, rosmarinic acid), coumarins (isoxazidine), flavonoids (quercetin glucuronide), and terpenes (atractylodes macrocephala Ⅲ). For quantitative analysis, UPLC-QQQ-MS/MS method was established, using acetonitrile 0.1% formic acid gradient elution and negative ion MRM mode to determine the content of 13 components in 20 batches of samples from eight production areas (chromatographic column: Waters CORTECS T3, flow rate 0.3 mL·min^-1). For chemical pattern recognition, CA, PCA, and OPLS-DA were combined to analyze differences in origin and screen for quality markers. RESULTS The linear relationship of 13 components was good (r²≥0.997 8), and the precision (RSD≤3.83%), repeatability (RSD≤3.56%), and recovery rate (95%-105%) all met the requirements of the pharmacopoeia. CA divided 20 batches of samples into three categories (Yunnan/Guizhou high rosmarinic acid, Fujian high flavonoids, other balanced types). OPLS-DA identified seven differential biomarkers including quercetin 3-O-β-D-glucuronide (VIP>1, Q²=0.977). The transfer rate of phenolic acids in the formulation is greater than 80%, and terpenoids (such as atractylodes macrocephala Ⅲ) are significantly enriched in alcohol extraction. CONCLUSION For the first time, a multi index quantitative method is established for 13 components of Sarcandrae Herba, covering organic acids, flavonoids, and terpenes. Chemical pattern recognition is used to classify Sarcandrae Herba from different origins. Samples of high rosmarinic acid from Yunnan and high flavonoids from Fujian can be used as a basis for harvesting high-quality medicinal materials. The analysis of terpenoid components provides a new direction for the development of anti-inflammatory topical preparations (such as medicinal wine).

OBJECTIVE To systematically review the efficacy and safety of tafolecimab on hypercholesterolemia. METHODS Data were collected from Pubmed, Embase, Web of Science, Cochrane Library, CNKI, VIP and Wanfnag database from their eatablishment to Ferbrary 2025. Meanwhile, Meta-analysis of randomized controlled trials(RCTs) was performed by Rev Man 5.4. RESULTS A total of 1 061 patients in three RCTs were included. The effectiveness analysis results showed that tafolecimab 450 mg once every four weeks (Q4W) could significantly reduce the percentage of low-density lipoprotein (LDL-C) (MD=-63.76%,95% CI: -67.17% to -60.53%,P<0.000 01) and improve other relevant indicators compared with placebo, and the difference was statisticaly significant. The safety analysis results showed that there were no significant differences in the main endpoints and secondary endpoints related to the safety of tafolecimab in the treatment of hyperlipidemia compared with the placebo group (P>0.05). CONCLUSION Tafolecimab has good efficacy and safety in Chinese adult patients with hyperlipidemia.

OBJECTIVE To provide a reference for the evaluation of artificial intelligence models in China′s medical products administration. METHODS Through a comprehensive review of websites and literature from the U.S. Food and Drug Administration, the European Medicines Agency, the United Kingdom′s Medicines and Healthcare products Regulatory Agency and the European Union, the evaluation of artificial intelligence in foreign medical products administrations was studied and relevant insights were drawn. RESULTS Foreign medical products administrations take measures to address the challenges of artificial intelligence model assessment, which include establishing regulatory sandbox mechanisms and developing risk-based evaluation frameworks, in order to evaluate models’ performance and safety. Meanwhile, foreign medical products administrations have implemented support measures such as policy issuance, institutional coordination, tool application and personnel training. CONCLUSION Based on foreign practices, this paper proposes implications: strengthening regulatory science research to develop new tools, standards and methods tailored for artificial intelligence; creating a transparent, stable and predictable policy environment to guide the standardized development of the industry; enhancing the construction of technical support capabilities and talent reserves to promote high-quality development of the pharmaceutical industry; and continuously refine data governance and full-lifecycle risk prevention and control systems to fortify the network and data security barrier.

OBJECTIVE To clarify the nomenclature origin, medicinal nature of the traditional Chinese medicine “Zhada”, and its relationship and distinction with “Egui Calculus” (Mabao), thereby providing an evidential basis for its resource utilization and cultural inheritance. METHODS A literature research methodology was employed to systematically review historical herbal classics and modern documents, with a comprehensive analysis conducted on the name, origin, formation site, property and flavor, channel tropism, efficacy, and indications of Zhada. RESULTS Textual research indicates that Zhada originated in ancient Mongolia and was initially introduced to Central China as a “magical stone” for rain-praying and sacrificial rituals. It was first explicitly defined as a calculus formed in various animals in the late Qing dynasty work Quyuan Zazuan. Since then, Zhada has often been used synonymously with Mabao. Although Mabao was not directly recorded in early ancient texts, it has long been associated with Zhada. Mabao was first documented as a medicine in the Compendium of Materia Medica, and the Shenbao in the 12th year of the Tongzhi reign (1873) indicated that Mabao and Zhada were similar substances. It was not until the 1963 edition of the Chinese Pharmacopoeia that Mabao was officially included and distinguished from Zhada. Furthermore, both are primarily formed in the digestive system of source animals, especially in organs such as the gallbladder, stomach, or kidneys, and share medicinal efficacies, including detoxification and calming convulsions. CONCLUSION This study clarifies the historical origin and medicinal properties of Zhada, revealing its historical connection with Mabao and their distinction in modern context. The findings of this study provide historical evidence for the sustainable utilization, cultural inheritance, and clinical application of animal-derived medicinal stones.