Insomnia is a highly prevalent sleep disorder in clinical practice that severely impairs patients' daytime function and quality of life, and there are still unmet medical needs in its clinical treatment. Traditional Chinese medicine (TCM) has unique advantages in the treatment of insomnia, such as holistic regulation, mild adverse reactions, and long-lasting efficacy.In February 2026, the Center for Drug Evaluation of the National Medical Products Administration issued the Guiding Principles for Clinical Trials of Therapeutic Drugs for Chronic Insomnia (for Trial Implementation). However, it lacks targeted and specific regulatory guidance for the clinical trial design of innovative traditional Chinese medicines. Traditional Chinese medicines exert therapeutic effects on insomnia through multiple targets and pathways, which is significantly different from the clinical trial design of chemical drugs. Based on the clinical advantages and characteristics of TCM in the treatment of insomnia, combined with Chinese and Western medicine guidelines for insomnia, technical requirements for TCM clinical trials, and relevant research progress, this paper systematically analyzes key elements including trial background, diagnostic criteria, inclusion and exclusion criteria, run-in period and treatment course design, background therapy and concomitant medication, efficacy and safety indicators, control group selection, statistical analysis, and benefit-risk, and clarifies the design principles, implementation points, and precautions for each key element in the clinical trials of innovative TCM for insomnia, proposes scientific and rational clinical trial design strategies for innovative TCM in the treatment of insomnia, provides a reference for the standardized conduct of such clinical trials, and supports the establishment of high-quality TCM evidence-based evidence and the research, development and promotion of innovative traditional Chinese medicines.

Insomnia, as a common sleep disorder, exhibits a rising incidence rate annually, with its pathogenesis closely linked to gut microbiota dysbiosis. Currently, most of the clinical methods for the treatment of insomnia have limitations and adverse reactions. A review of recent domestic and international literature indicates that Lianzixin (Nelumbinis Plumula) possesses multi-component, multi-pathway, and multi-target characteristics. It exerts sedative and hypnotic effects by regulating the gut microbiota composition, influencing intestinal barrier function, microbial composition, and their metabolites, while also suppressing inflammatory responses and modulating immune homeostasis. However, its specific molecular mechanism network has not yet been fully elucidated. This review elaborates on mechanism of gut microbiota in occurrence and development of insomnia and the regulatory effects of Nelumbinis Plumula, establishes a systematic analysis of “Nelumbinis Plumula-gut microbiota-insomnia” axis, and provides theoretical support and reference for developing Nelumbinis Plumula-based insomnia treatments and microbiota-targeted drugs, advancing the collaborative prevention and treatment of insomnia through traditional Chinese medicine and Western medicine from basic research to precision clinical therapy.

Zingiberaceae plants are important medicinal and edible resources, widely used in traditional diets and medicine. They combine nutritional value with diverse physiological regulatory functions, holding significant potential for future applications. This study focused on seven Zingiberaceae species listed in the National Health Commission’s inventory of traditional food and medicinal materials: Zingiber officinale (ginger, including fresh and dried forms), Alpinia oxyphylla, Amomum tsaoko, Curcuma longa, A. villosum, Kaempferia galanga, and Alpinia officinarum. A systematic literature review and industrial analysis were conducted to summarize their core functional components, pharmacological activities, and industrialization status. The results showed that these plants are generally rich in volatile oils, gingerols, curcumin, flavonoids, and polysaccharides, exhibiting bioactivities such as anti-inflammatory, antioxidant, metabolic regulatory, neuroprotective, and potential antitumor effects. Furthermore, a comprehensive system for extracting and identifying these functional components and evaluating their bioactivities has been established. Analysis of the industrial chain revealed uneven development of Zingiberaceae resources, with common challenges including fragmented cultivation, extensive processing, lack of standardization, weak branding, and insufficient industry-academia-research collaboration. Corresponding recommendations were proposed: promoting whole-chain standardization, advancing deep processing and high-value product development, building collaborative innovation systems, and implementing branding and internationalization strategies. Future research should integrate advanced technologies like multi-omics to elucidate mechanisms of action and provide evidence-based support hrough high-quality clinical studies. Technological innovation will drive the development and layout of high-value products, facilitating the transformation of Zingiberaceae resources from a “resource advantage” into an “industrial advantage”, thereby contributing to the health industry and regional economic development.

Objective Huanghuacai (Hemerocallis citrina) is a traditional vegetable with anti-inflammatory and anti-depressant effects. Its leaves are widely used in Taiwan and other regions to promote sleep, however, there are few reports on its chemical composition. This article aims to analyze the characteristic components of H. citrina leaves by fingerprint spectrum and to further determine the content of the index components, including chlorogenic acid, rutin, quercetin-3-O-glucoside, quercitrin, and quercetin, providing a basis for better utilization and quality evaluation of H. citrina leaves. Methods Firstly, the ethanol extraction method was used to prepare H. citrina leaves extract. Chromatographic separation was performed by DIKMA spursil C₁₈ column (250 mm × 4.6 mm, 5 mm) maintained at 30 ℃ and the mobile phase was acetonitrile-0.5% acetic acid water. The injection volume was 10 mL, the detection wavelength was 190—400 nm and the flow rate was 1 mL/min. Based on the principle of maximum absorption wavelength, the wavelengths of 258 nm was selected in two periods of 0—5.5 and 23—48 min, the wavelengths of 300 and 370 nm were selected in two periods of 5.5—23 and 48—80 min respectively, and a three-wavelength switching fingerprint was constructed. Secondly,a quantitative analysis of multi-components by single marker (QAMS) was used to determine the contents of chlorogenic acid, rutin, quercetin-3-O-glucoside, quercetin, and quercetin in ethanol extract of H. citrina leaves. Results The similarity of fingerprint spectrums of 10 batches of H. citrina leaves was above 0.90, and the three-wavelength switching fingerprint spectrums included 42 common peaks (accounting for more than 90% of the total peak area), of which 11, 25, and 26, 32 and 37 were identified as chlorogenic acid, rutin, quercetin-3-O-glucoside, quercitrin, and quercetin. With quercetin (S) as the internal reference, the relative correction factors of chlorogenic acid, rutin, quercetin-3-O-glucoside, and quercitrin were obtained by the QAMS as 1.402, 1.896, 1.268, 1.221. The average contents of the above five components in 10 batches of H. citrina leaves are 0.079, 0.086, 0.374, 0.325, 0.037 mg/g. There was no significant difference between the external standard method and QAMS. Conclusion The three-wavelength switching fingerprint spectrum constructed in this study has significantly increased the number of chromatographic peaks contained in any single wavelength fingerprint spectrum and can be used to characterize the chemical composition of H. citrina leaves. The QAMS further constructed can be used to determine the content of chlorogenic acid, rutin, quercetin-3-O-glucoside, quercitrin, and quercetin at one time. This study provides a methodological basis and reference for the comprehensive evaluation of H. citrina leaves quality.

Objective To clarify the dynamic accumulation pattern of secondary metabolites in the leaves of Acanthopanax senticosus during the growth season, providing theoretical support for precision-guided leaf harvesting tailored to different usage purposes. Methods Colorimetric method and untargeted metabolomics technology were used to analyze the dynamic accumulation characteristics of metabolites such as flavonoids, polyphenols and saponins in the leaves of A. senticosus. Results The growth season was divided into 13 stages (L1—L13) based on leaf morphodevelopmental traits. Total flavonoids, polyphenols, triterpenoids, and saponins exhibited bimodal accumulation peaks at L3 (the peak leaf expansion stage) and L11 (the end of July), with maximum contents at L11, reaching 8.02-, 1.68-, 1.61-, and 1.63-fold increases, respectively, compared to L1. KEGG enrichment analysis revealed that, relative to L3, L11 showed specific upregulation of phenylpropanoid and flavonoid biosynthesis pathways, coupled with synergistic accumulation of light signaling molecules (FAD, lumiflavin) and defense-related compounds (sinapine, quercetin glycosides), while nucleotide synthesis precursors significantly decreased. Additionally, the pharmacopoeial quality control indicator syringin increased by 2.51-fold in L11 relative to L3. Conclusion The secondary metabolism of A. senticosus leaves exhibits significant developmental stage-dependence, among which the L11 stage is a high-enrichment period, this provides metabolomic evidence for the precise utilization of A. senticosus leaves.

Micelles, formed through the self-assembly of amphiphilic molecules, hold significant promise as drug delivery systems for enhancing the solubility, stability, and targeting properties of active components in traditional Chinese medicine (TCM). Within the field of Chinese medicine formulation, numerous active constituents can spontaneously form micelles or be encapsulated within micellar carriers via specific preparation techniques, thereby effectively improving drug performance. This paper reviews the formation mechanisms, preparation techniques, and current applications of TCM micelles. In view of the hybrid nature of micelles within complex TCM systems, it combines structural characterisation techniques with key influencing factors in micelle formation. The study identifies existing issues such as disordered self-assembly and lack of controllability in current research, proposing corresponding suggestions and future directions. This aims to provide theoretical reference for modernisation of TCM and the development of innovative formulations.

Objective This study employed iPBS molecular marker technology to analyze the genetic diversity and genetic differentiation relationships among 32 Dendrobium linawianum germplasm resources from different regions. Methods A “0, 1” matrix was constructed using Excel 2016, and the genetic similarity coefficient (G_s) was calculated using NTSYS-pc 2.10e to construct a UPGMA cluster dendrogram. Additionally, various genetic diversity indices were calculated using Popgene 1.32. Results A total of 84 clear bands were amplified from the six selected iPBS primers, including 76 polymorphic bands, with a polymorphism rate of 90.48% and an average polymorphism information content (PIC) of 0.46, indicating high polymorphism of the iPBS primers. The genetic similarity coefficients ranged from 0.547 6 to 0.965 5, with an average of 0.766 8. At a genetic similarity coefficient of 0.732, the 32 germplasm samples were classified into four populations. The average observed allele number (N_a), average effective allele number (N_e), Nei's genetic diversity index (h), and Shannon diversity information index (I) were 1.631 0, 1.381 6, 0.219 0, and 0.326 7, respectively. Genetic structure analysis revealed that the genetic diversity (H_t), gene differentiation coefficients (H_s) among populations, and genetic differentiation coefficients (G_st) were 0.281 3, 0.219 0, and 0.221 3, respectively. Genetic variation among populations accounted for 22.13% of total variation, while genetic variation within populations accounted for 77.87%, indicating that genetic variation was primarily derived from within populations. Furthermore, DNA fingerprinting of 32 germplasm resources was successfully constructed based on 19 polymorphic loci with six primers, which provided a reference for the classification and identification of D. linawianum. Conclusion The genetic diversity of D. linawianum was significantly lower between populations than within populations, and the genetic variation was mainly within populations. The genetic differentiation characteristics of germplasm resources are significantly correlated with their geographical distribution patterns. This study not only elucidates the genetic relationships among different germplasm of D. linawianum and the characteristics of population genetic diversity, but also provides an important theoretical basis for the subsequent scientific conservation and sustainable utilization of D. linawianum germplasm resources.

Ovarian cancer is often characterized as a “silent killer” due to its insidious onset, difficulty in early diagnosis, and high mortality rate. Furthermore, advanced stages of the disease exhibit high recurrence rates and formidable chemoresistance. In recent years, the synergistic and sensitizing value of traditional Chinese medicine (TCM) in the comprehensive management of ovarian cancer has become increasingly evident. This review systematically summarizes the pivotal mechanisms underlying the intervention of TCM monomers and compound formulas in ovarian cancer. It reveals that TCM constituents not only inhibit tumor invasion and metastasis by inducing cell cycle arrest, promoting apoptosis and ferroptosis, and modulating crucial signaling pathways—including the mitogen-activated protein kinase/extracellular signal-regulated kinase and Janus kinase/signal transducer and activator of transcription pathways—but also demonstrate unique advantages in reversing platinum resistance and alleviating chemotherapy-induced myelosuppression by interfering with glycolipid metabolic reprogramming and remodeling the immune microenvironment. Future research should integrate multi-omics technologies to comprehensively validate these complex molecular networks, thereby providing robust evidence-based medical foundations for clinical precision therapeutics and the development of novel antineoplastic agents.

Objective To compare the levels of multiple components (phenolic acids and luteolin glycoside) in Jinyinhua (Lonicerae Japonicae Flos, LJF), along with changes in “colour, aroma and flavor”, under different drying methods to determine the optimal drying technique. Methods Quality control of phenolic acids and luteoloside in LJF was conducted using HPLC technology. Intelligent sensory technology was employed to study the color, aroma, and taste characteristics of LJF under different drying methods. The quality of LJF processed with various drying techniques was evaluated through correlation analysis of color-aroma-taste and multiple indicator components. Results Steam-blanched drying, freeze-vacuum drying, and microwave-blanched drying resulted in higher total phenolic acid content, while sun-drying, microwave-blanched drying, and steam-blanched drying yielded higher luteoloside levels. The differences in color-aroma-taste profiles of LJF under different drying methods were reflected in brightness (L^*), red-green chromaticity (a^*), and responses from W5S, W1W, W1S, W2S, W2W sensors, along with bitterness and astringency. Correlation analysis revealed that higher total phenolic acids correlated with darker green coloration, elevated W1W sensor responses, intensified astringency, and reduced bitterness. Conversely, increased luteoloside content was associated with higher brightness and diminished responses from W5S and W1W sensors. Freeze-vacuum drying produced optimal color, shade-drying achieved the most pronounced aroma, while steam-blanched and microwave-blanched drying generated distinctive bitter and astringent aftertastes. Conclusion From the perspectives of multi-component retention, chromatic characteristics, and taste profile, steam-blanched drying and microwave-blanched drying have been identified as the optimal drying processing methods for LJF. This study provides a novel methodology for optimizing drying techniques and enabling rapid quality assessment of LJF.

Objective To systematically evaluate the therapeutic effects of Jinzhen Oral Liquid (金振口服液, JZOL) on a pathological model of chronic obstructive pulmonary disease (COPD) complicated with phlegm-heat syndrome, and to elucidate its pharmacological mechanisms from multiple dimensions, including improvement of pulmonary function, suppression of systemic inflammation, regulation of airway mucus secretion, restoration of Th1/Th2 and Th17/Treg immune balance, and modulation of transcriptomic expression profiles. Methods A rat COPD model was established through eight weeks of cigarette smoke exposure combined with intranasal lipopolysaccharide (LPS) instillation. Subsequently, a compound model of COPD with phlegm-heat syndrome was induced by 9 d of wind-heat exposure combined with LPS instillation. Model rats were randomly assigned to model group, dexamethasone (0.2 mg/kg) group and JZOL low-, medium-, high-dose (0.8, 1.6, 3.2 g/kg) groups, and received continuous oral administration for 7 d. Therapeutic efficacy was comprehensively evaluated by assessing pulmonary function parameters, systemic symptoms and signs, inflammatory factors in serum, lung histopathological changes and proportions of lung T cell subsets in lung tissue. Furthermore, transcriptomic sequencing and qRT-PCR were employed to validate the regulatory effects of JZOL on key differentially expressed genes, including lipocalin-2 (Lcn2), indoleamine 2,3-dioxygenase 1 (Ido1), cyclin E1 (Ccne1), homeobox protein B8 (Hoxb8) and G protein-coupled receptor 17 (Gpr17). Results The compound modeling successfully induced severe airflow limitation, fever, constipation, and histopathological and cytopathological alterations in rats. Compared with model group, JZOL significantly improved lung function (P < 0.05, 0.01, 0.001), significantly reduced levels of tumor necrosis factor-α (TNF-α), interleukin-6 (IL-6), C-reactive protein (CRP) and neutrophil elastase (NE) in serum (P < 0.001), significantly reduced bronchial epithelial goblet cell proliferation and acid mucin secretion (P < 0.05, 0.001), and corrected imbalanced Th1/Th2 and Th17/Treg cells ratios (P < 0.05, 0.001). The transcriptome and qRT-PCR validation results showed that JZOL improved COPD through multiple mechanisms, including downregulation of immune microenvironment and protease imbalance related genes, inhibition of abnormal cell cycle and airway remodeling genes, upregulation of key lung regeneration factors and regulation of developmental factors, as well as activation of tissue repair and inflammation resolution pathways. Conclusion JZOL effectively improves lung function and systemic symptoms in COPD rats with phlegm heat syndrome by inhibiting systemic and local inflammatory responses through multiple targets, regulating T cell immune balance.