The “Special Provisions for the Supervision and Administration of Traditional Chinese Medicine Production” is China’s first regulatory document specifically designed to systematically regulate the oversight of traditional Chinese medicine (TCM) production. It signifies a deepening shift from general requirements to a specialized system that reflects the unique characteristics of TCM manufacturing. This development helps to enhance the standardization of TCM production and the stability of its quality, modernize regulatory approaches, and provide institutional support for building a drug regulation system tailored to TCM’s features, thereby promoting the high-quality development of the TCM industry. Grounded in the inherent characteristics of TCM-such as the natural origin of its raw materials, long quality formation chains, and complex influencing factors-the provisions establish a regulatory framework covering the entire TCM production lifecycle. This framework addresses key areas including source control of Chinese medicinal materials, production process management, testing and release, traceability systems, pharmacovigilance, and regulatory oversight. The institutional design emphasizes adherence to TCM principles, strengthens the subject responsibility of the marketing authorization holder, highlights source control, rigorous process management, and risk-based classification supervision. Furthermore, it provides detailed requirements for critical issues such as raw material homogenization, extract yield management, contract manufacturing, production resumption, and the oversight of TCM injections. By analyzing the background of its issuance, institutional logic, main content, key innovations, and implementation pathways, this paper aims to facilitate a deeper understanding of the significance of implementing these Special Provisions among the industry.

Objective Based on a confined mass transfer mathematical model, this study aims to establish a quantitative analysis method for the existing states of matrine in the complex solution environment of traditional Chinese medicine (TCM), and elucidate the influence pattern of the compatibility ratio of Danshen (Salviae Miltiorrhizae Radix et Rhizoma, SMRR) and Kushen (Sophorae Flavescentis Radix, SFR) on its acid-base complexation reaction. Methods Based on the mass transfer differences of component states during nanofiltration (NF) and ultrafiltration (UF), the mass transfer coefficient of matrine was fitted taking the component transmission rate and membrane flux as evaluation indicators. Using the molecular and ionic monomer components as references, a quantitative calculation model for the existing states was constructed. The existing states of matrine in the SFR extract and the SMRR- SFR co-extract were fitted to analyze the occurrence patterns of acid-base complexation reactions under different solution environments. Results Coupling UF and NF enhanced the separation differences between the ionic and molecular states of matrine, thereby improving the accuracy of the quantitative calculation model for the ionic state. The correlation coefficients of the power function equations for quantitatively calculating the existing states of matrine were all greater than 0.97, indicating that the model was successfully established. The proportion of matrine in the molecular state was approximately 1.21%-1.91% in both the SFR extract and the co-extract. In the SFR extract, matrine existed as 36.90% in the ionic state and 61.98% in the associated state. After compatibility and extraction of SFR and SMRR, the existing form of matrine changed significantly. When the compatibility ratio of SMRR was low, the ionic state was dominant, with the increase in the proportion of SMRR, the ionic proportion of matrine gradually decreased from 66.73% to 45.83%, transforming into a complex-structured composite state, and the corresponding composite state proportion rose from 31.87% to 52.90%. Conclusion A quantitative calculation method for the existing states of matrine in different solution environments was successfully constructed, providing technical support for elucidating the states of components in complex solution environments.

Honey-roasted Huangqi (Astragali Radix) is a widely used processed product of Astragali Radix in clinical practice. After honey-roasting, the effect of tonifying qi and invigorating spleen is significantly enhanced. Its processing technology and quality evaluation system are very important to ensure clinical efficacy and promote modernization process of traditional Chinese medicine processing. Therefore, this paper systematically summarized the historical evolution of processing of honey-roasting Astragali Radix, as well as the differences between national and local processing standards, by consulting the ancient herbal monographs, processing standards at all levels and modern research results at home and abroad. The effects of pretreatment, honey selection and refining, honey content, honey-water ratio and other key process links on quality of finished products and the status of process optimization were described. The changes of polysaccharides, saponins and flavonoids during honey roasting and the potential mechanism of processing synergistic efficiency were discussed. The development of multidimensional quality evaluation indices and analysis technologies is summarized. On this basis, the key problems such as inconsistent process standards, unclear processing mechanisms and imperfect quality evaluation system were analyzed, and the corresponding countermeasures were put forward, aiming to provide a scientific evidence for process standardization and quality evaluation of honey-roasting Astragali Radix.

Objective This study aims to clone the LbbHLH94-like gene from Gouqi (Lycium barbarum), analyze its spatiotemporal expression, stress and hormone response patterns, and clarify its regulatory function in carotenoid biosynthesis, so as to provide a theoretical basis for revealing the molecular mechanism of goji berry fruit quality formation. Methods Using Lycium barbarum cv. ‘Ningqi 1’ as material, we employed techniques such as PCR and qRT-PCR to clone and analyze the expression patterns of LbbHLH94-like in different tissues, fruit developmental stages, abiotic stresses and exogenous hormone treatments. The overexpression vector was constructed and transformed into goji plants, and the expression of key genes, enzyme activities and total carotenoid content in carotenoid metabolism were determined. Results The LbbHLH94-like gene was successfully cloned, with an 888 bp open reading frame encoding 296 amino acids, and the sequence was identical to the genome reference sequence. This gene showed obvious spatiotemporal specificity, with the highest expression level at fruit ripening stage. It responded to high and low temperature, salt, drought stresses as well as 6-BA, IBA and GA₃ induction, showing a general pattern of promotion at low concentration and inhibition at high concentration. Overexpression of LbbHLH94-like significantly up-regulated the expression of PDS, enhanced the enzyme activities of PSY and PDS, inhibited the expression and enzyme activity of CCD4, and remarkably increased total carotenoid content in fruits. Conclusion LbbHLH94-like is a key positive regulator of carotenoid biosynthesis in goji berry, and also participates in abiotic stress response and hormone signaling. The results provide important gene resources and theoretical support for quality improvement and precise molecular breeding of Lycium barbarum.

Triple-negative breast cancer (TNBC) is a subtype of breast cancer characterized by the absence of estrogen receptor, progesterone receptor, and human epidermal growth factor receptor 2 expression. It exhibits high invasiveness, elevated rates of recurrence and metastasis, poor prognosis, and currently lacks effective targeted therapeutic approaches. The Coptidis Rhizoma-Euodiae Fructus herb pair is a classic Traditional Chinese Medicine (TCM), its major active components include alkaloid compounds such as berberine, coptisine, evodiamine, and rutaecarpine. In recent years, Coptidis Rhizoma-Euodiae Fructus herb pair has demonstrated tremendous potential in the field of anti-tumor therapy, with increasing research focusing on the pharmacological effects of their alkaloid components in ameliorating TNBC. Accordingly, this review briefly summarizes the alkaloid components of Coptidis Rhizoma and Euodiae Fructus, emphasizing their mechanisms of action in enhancing TNBC treatment, which include inhibiting cell invasion and metastasis, regulating the cell cycle, and inducing apoptosis. This aims to provide references for the further development and utilization of the Coptidis Rhizoma-Euodiae Fructus herb pair and to offer new insights and scientific evidence for the application of TCM in the prevention and treatment of TNBC.

Chinese herbal medicine-derived EV-like particles (CHM-EVLP) constitute a natural nanoscale delivery system sourced from medicinal plants listed in the Chinese Pharmacopoeia. Exhibiting excellent biocompatibility, low immunogenicity, outstanding ability to traverse biological barriers, and synergistic effects from multiple components. They effectively overcome limitations in traditional drug therapies for neurodegenerative diseases (NDDs), such as difficulty in penetrating the blood-brain barrier (BBB) and the limited efficacy of single-target interventions. This paper systematically reviews the biological characteristics and material basis of CHM-EVLP, confirming its core particle size distribution between 30—150 nm and its composite structure comprising lipids, proteins, nucleic acids, and secondary metabolites. It summarises separation and purification techniques—including differential ultracentrifugation, density gradient centrifugation, and ultrafiltration/size exclusion chromatography—alongside multidimensional characterisation methods. It emphasises the core mechanism of CHM-EVLP in preventing and treating NDDs, which involves the synergistic action of four pathways: “inhibiting protein aggregation, regulating neuroinflammation, repairing mitochondria, and protecting neurons”. This approach establishes specific in vivo action pathways for Alzheimer’s disease (AD) and Parkinson’s disease (PD), while analysing suitable scenarios for oral, intranasal, and injectable administration routes. Concurrently, it identifies current limitations in CHM-EVLP research, including the absence of standardised extraction and purification protocols, incomplete quality control systems, and the need for further validation of in vivo delivery efficiency and long-term safety. Future research directions proposed include establishing standardised preparation workflows, constructing a “combined marker system”, and deepening the validation of key bioactive component-target-effect relationships. This work provides theoretical underpinnings and technical references for the engineered development of CHM-EVLPs and the clinical translation of TCM nanomedicines in NDDs prevention and treatment, highlighting their application value in modernising traditional Chinese medicine.

Yupingfeng Powder (玉屏风散) was first recorded in Jiu Yuan Fang of the Southern Song Dynasty. It is composed of three herbs—Huangqi (Astragali Radix), Baizhu (Atractylodis Macrocephalae Rhizoma), and Fangfeng (Saposhnikoviae Radix)—and possesses the therapeutic effects of tonifying qi, consolidating the exterior, and arresting sweating. Existing reviews have primarily focused on its chemical constituents, pharmacological activities, or therapeutic progress in a single disease, whereas a systematic integration of the tripartite relationship among “clinical evidence-mechanism of action-material basis” remains insufficient. From a “multi-component, multi-target, multi-pathway” perspective, this article synthesizes the common regulatory networks of Yupingfeng Powder across different diseases, elucidates the scientific basis of its principle of “treating different diseases with the same method,” and proposes concrete research pathways across four dimensions: evidence-based validation, clinical therapeutic patterns, bioactive substances, and mechanisms of action. By constructing a four-in-one research framework, this review aims to advance the precise clinical application and in-depth development of Yupingfeng Powder.

Objective To clarify the comprehensive clinical value, advantages, characteristics and therapeutic positioning of Ningmitai Capsules (宁泌泰胶囊) in the treatment of chronic prostatitis (damp-heat accumulation syndrome), and to provide references for decision-making of national medical and health administrative departments and rational clinical drug use. Methods An evaluation system was constructed based on the “6 + 1” dimensions of safety, effectiveness, economy, innovation, suitability, accessibility, and traditional Chinese medicine (TCM) characteristics. Multi-source evidence including questionnaire surveys, official website data, secondary evaluation of literature, and real-world data was integrated. The multi-criteria decision analysis (MCDA) model was used to measure each dimension, and the total value score was calculated based on TCM clinical evidence using software CSCv2.0. Results Ningmitai Capsules were rated Grade A for both safety and effectiveness (no serious adverse reactions, significant effects in anti-infection, relieving pain and alleviating urinary abnormalities); Grade B for economy, innovation, suitability, accessibility, and TCM characteristics (supported by economic evidence, obtained 1 invention patent, high acceptance among target populations, good resource accessibility, and a unique Miao medicine formula); the comprehensive evaluation of clinical value was Grade A. Conclusion Ningmitai Capsules have significant clinical value in the treatment of chronic prostatitis. It is recommended to further conduct pharmacological mechanism research and high-quality evidence-based research, optimize the production process, improve the drug insert, and give full play to its clinical advantages.

This study aimed to characterize the chemical profile of Danggui Buxue Decoction (DBD) and investigate the systemic exposure and tissue distribution of its constituents in mice following oral administration, using UHPLC-Q-Exactive Orbitrap high-resolution mass spectrometry (HRMS). Methods A total of 12 healthy male C57BL/6J mice were randomly divided into a blank control group (n = 3), administered purified water, and a DBD-treated group (n = 9), given a DBD extract at 16 g/kg by gavage. Serum and tissue samples were collected at 0.5, 1.5, and 3 h post-dose, pooled, and processed via protein precipitation. Chromatographic separation was performed on an ACQUITY UPLC BEH C₁₈ column (100 mm × 2.1 mm, 1.7 μm) using a gradient elution with 0.1% formic acid in water and methanol as the mobile phase. Mass spectrometric data were acquired in both positive and negative ion modes via full-scan MS¹/data-dependent MS² scanning. Compound identification was achieved by analyzing relative retention times and MS¹ fragment information using Xcalibur 4.2 software, with confirmation against reference standards, literature data, and databases. Results A total of 158 chemical compounds were identified in DBD, comprising 56 flavonoids, 44 saponins, 24 phthalides, 17 organic acids, 8 coumarins, 2 alkaloids, and 7 other constituents. The number of prototype compounds detected in mice after DBD administration varied over time. The abundance of these migrating components across tissues followed the order: ileum > liver > serum > lung > kidney > spleen > heart > brain. Key constituents identified in the serum and various tissues included 7,3'-dihydroxy-5'-methoxyisoflavone (pterocarpan E), calycosin-7-O-β-D-glucoside, methylnissolin, calycosin, oroxylin A, isomucronulatol, 3-butylidenephthalide, (6αR,11αR)-3,9-dimethoxy-10-hydroxypterocarpan and formononetin. Conclusion This study delineates the comprehensive chemical composition of DBD and in vivo absorption and tissue distribution patterns using HRMS, providing crucial insights for identifying the bioactive constituents of DBD and supporting further tissue pharmacokinetic investigations.

Berberine (BBR) is an isoquinoline alkaloid extracted from traditional medicinal plants such as Coptis chinensis and Phellodendron amurense, with a long history of clinical application. Recent studies have demonstrated that BBR exhibits multifaceted pharmacological activities, including blood glucose lowering, lipid regulation, anti-tumor effects, cardiovascular protection, anti-inflammation, and neuroprotection. However, existing research findings are relatively scattered and lack systematic integration. This article aims to systematically review the main pharmacological effects of BBR and its related molecular mechanisms, intending to elucidate the common regulatory network underlying its multifaceted effects and provide important theoretical support for its clinical translation and the development of innovative drugs. The results indicated that the multifaceted pharmacological effects of BBR are mainly achieved through the coordination of three key pathways: inhibiting the nuclear factor-κB (NF-κB) and mitogen-activated protein kinase (MAPK) signaling pathways to block inflammatory cascade reactions; activating the nuclear factor erythroid 2-related factor 2/antioxidant response element (Nrf2/ARE) pathway to enhance antioxidant defenses; and suppressing the assembly of the NOD-like receptor family, pyrin domain containing protein 3 (NLRP3) inflammasome to reduce cell pyroptosis. This study not only provides a clear molecular map for an in-depth understanding of the systemic pharmacological mechanisms of BBR, but also lays a scientific foundation for the development of drug targets and multi-pathway synergistic treatment strategies for diseases related to inflammation, oxidative stress, and programmed cell death, possessing significant theoretical value and translational prospects.