Gansu′s native medicinal material, Hedysari Radix(HR), is widely utilized in traditional Chinese medicine. Hedysarum polysaccharides(HPS) are among the primary active ingredients found in HR. By precipitating these polysaccharides with varying concentrations of ethanol, different types can be isolated. Techniques such as infrared spectroscopy and nuclear magnetic resonance have confirmed that these polysaccharides are composed of monosaccharides, including glucose and galactose, and feature various glycosidic bonds and branching structures. The molecular weight distribution falls within a specific range. Furthermore, modern pharmacological studies have demonstrated that HPS exhibit a range of pharmacological effects, including anti-tumor properties and the prevention and treatment of diabetes and its complications. As a result, they have become a focal point of current research. A review of relevant domestic and international literature from recent years provides deeper insights into the benefits and applications of HR. The structure and pharmacological effects of HPS are summarized and analyzed. Additionally, the future development trends of HPS are examined to provide a reference for future research and development in this area.

OBJECTIVE To establish a method for identifying the species of Hirudo nipponica and recognizing the adulteration with blood for weight increase based on characteristic polypeptide technology and chemical markers. METHODS A total of 100 batches of leech samples were collected. Trypsin was selected to enzymatically hydrolyze the samples. Polypeptide information was collected through nano-liquid chromatography-high resolution mass spectrometry (Nano-LC-MS/MS). The PEAKS software was used to analyze the polypeptide sequences and conduct statistical difference analysis to screen out characteristic polypeptides, and their specificity was verified through the multiple reaction monitoring (MRM) mode of liquid chromatography-triple quadrupole mass spectrometry. In view of the phenomenon of adulteration for weight increase, multiple sequence alignments were carried out on the β-globins in the blood of pigs, cows, sheep, horses and donkeys to screen out conserved common characteristic polypeptides, and a detection method based on the ratio of the non-standard quantitative peak areas of characteristic polypeptides was established to determine whether there is a phenomenon of weight increase due to congestion in Hirudo nipponia Whitman. RESULTS Two characteristic polypeptides that can be used for the identification of Hirudo nipponia Whitman and Poecilobdella manillensis Lesson were screened out, which have strong specificity and good durability. The target ion pairs were stably detected in 33 batches of samples of Hirudo nipponia Whitman and Poecilobdella manillensis Lesson. One common characteristic polypeptide was screened out from the blood β-globin. In 23 batches of samples of Hirudo nipponia Whitman, the peak area ratio was between 7 and 18, and there was significant classification difference (P＜0.001), indicating that there is an adulteration behavior of adding livestock blood to increase the weight in some samples. CONCLUSION In this study, a dual technical system for the identification of the species of Hirudo medicinal materials and the recognition of adulteration and weight gain is established. The method has strong specificity and high sensitivity, providing powerful technical support for improving the quality control level of Hirudo medicinal materials.

OBJECTIVE To investigate the effects of mixed activated killer (MAK) immune cells and their combination with interleukin-2 (IL-2) on human hepatocellular carcinoma cells PLC/PRF/5 and related mechanisms. METHODS High, medium, and low concentrations of MAK immune cells (2×10⁸, 1×10⁸, 5×10⁷ mL^-1) and high dose of MAK immune cells (2×10⁸ mL^-1) combined with IL-2 (50 000 IU·mL^-1) were injected into PLC/PRF/5-xengrafted nude mice. The changes of body mass, survival rate, median survival time (MST), and increase in life span (ILS) were detected. MAK immune cells and their combination with IL-2 were cultured alone or acted on PLC/PRF/5 cells. The contents of interferon-γ (IFN-γ), tumor necrosis factor-α (TNF-α), granulocyte-macrophage colony-stimulating factor (GM-CSF), IL-8, and IL-10, the apoptosis rate of PLC/PRF/5 cells, and the activation rate of Caspase 3/7 were detected by flow cytometry. The contents of perforin and granzyme B were detected by ELISA. RESULTS MAK immune cells and their combination with IL-2 could significantly improve the body mass and survival rate of PLC/PRF/5-bearing mice, prolong MST and ILS%, significantly increase IFN-γ, TNF-α, GM-CSF, perforin, granzyme B content, PLC/PRF/5 cell apoptosis rate, and Caspase 3/7 activation rate, reduce IL-8 content, and had no significant effect on IL-10. CONCLUSION Both MAK immune cells and their combination with IL-2 may promote the apoptosis of PLC/PRF/5 cells by increasing the contents of related anti-tumor factors and stimulating the activation of Caspase 3/7 in PLC/PRF/5 cells, and MAK immune cells combined with IL-2 is more effective.

OBJECTIVE To screen the active components of Radix Sophorae tonkinensis on liver mitochondria, and to provide a potential pharmacodynamic material basis for the regulation of mitochondria and hepatoprotective effect. METHODS Fresh livers of SPF-grade male SD rats were homogenized and prepared by differential centrifugation, and the structural integrity, purity and biological function of mitochondria were evaluated by transmission electron microscopy, mitochondrial separation purity double enzyme(SDH/AP) assay kit and fluorescence spectrophotometry, respectively. Combined with affinity ultrafiltration and LC-MS, a screening method for hepatocyte mitochondria was constructed, and the feasibility of the screening method was verified by positive control drugs (silybinin, daidzin), negative control drugs (amoxicillin, D-glucurone) and their mixed control solutions. Radix Sophorae tonkinensis was used to investigate the effects of important screening conditions (mitochondrial concentration, sample concentration, incubation time) on the screening results. The established method was used to screen the active components acting on mitochondria in the extract of Radix Sophorae tonkinensis, and the structure of the active compounds was identified by LC-MS and the reference substance. RESULTS A total of 14 active compounds that could bind to mitochondria were screened from Radix Sophorae tonkinensis, mainly alkaloids such as matrine, sophorine, and sophoranol, as well as flavonoids such as genistein, formononetin, calycosin, and sophoranone. CONCLUSIONS In this study, a method is established to screen the potential active components of traditional Chinese medicine using hepatocyte mitochondria as the target, and 14 potential mitochondria-targeting compounds in Radix Sophorae tonkinensis are screened by optimizing the screening method.

OBJECTIVE To establish the accurate and effective identification characteristics between Zanthoxyli Radix and the root and/or rhizome of similar species are also used as Zanthoxyli Radix. METHODS On the basis of field collection and market investigation, the histochemistry and microscopic quantification method have been used to compare different medicinal parts of Zanthoxyli Radix and similar species. RESULTS The existing of pericyclic fibers was the key characteristic to identify the medicinal part of samples; the histochemistry characteristic of lignified tissues and oil cells combined with the area of stone cells can be used to distinguish Zanthoxyli Radix and the similar species. CONCLUSION An objective, measurable microscopic method is established to identify Zanthoxyli Radix and the root and/or rhizome of similar species. It will provide reference for supervision inspection and standard improvement.

OBJECTIVE To study whether Xiangsha Yiwei Decoction can regulate the nuclear factor-κB(NF-κB)/signal transducer and activator of transcription 3 (STAT3) pathway to improve chronic atrophic gastritis (CAG). rats by targeting the NF-κB/STAT3 pathway. METHODS Rats were stochastically assigned into control group, CAG group, Xiangsha Yiwei Decoction 1.2 g group, Xiangsha Yiwei Decoction 2.4 g group, Xiangsha Yiwei Decoction 2.4 g+ lipopolysaccharide (LPS) group, and Moluo Dan (positive drug) group. The neutral red clearance method was used to detect gastric mucosal blood flow. Enzyme-linked immunosorbent assay (ELISA) was used to detect serum gastrin (GAS), plasma motilin (MTL) levels, and interleukin-10 (IL-10)), interleukin-1β (IL-1β), tumor necrosis factor- alpha (TNF-α), levels in gastric mucosal tissue. Hematoxylin and eosin (HE) staining was used to detect the morphology of gastric mucosa. Terminal-deoxynucleotidyl transferase mediated nick end labeling (TUNEL) staining method was used to detect apoptosis of gastric mucosal tissue cells. The reagent kits were used to detect the levels of superoxide dismutase (SOD), catalase (CAT) and malondialdehyde (MDA). Western blot was used to detect the protein expression of Bcl-2-associated X protein (Bax), B-cell lymphoma-2 (Bcl-2), cleaved cysteine-aspartic acid specific protease-3 (Cleaved caspase-3), and NF-κB/STAT3 pathways. RESULTS Compared with the control group, the gastric mucosa of rats in the CAG group showed obvious damage, the gastric mucosal blood flow (GMBF) level, GAS, MTL and IL-10 levels, SOD and CAT activities, and Bcl-2 protein expression level were lower, while the IL-1β and TNF-α levels, gastric mucosal cell apoptosis rate, MDA content, Bax, Cleaved caspase-3, p-NF-κB/NF-κB, and p-STAT3 protein expression levels were higher (P<0.05). Compared with the CAG group, the degree of gastric mucosal damage in rats in the 1.2 g and 2.4 g Xiangsha Yiwei Decoction groups and the Moluo Dan group was obviously reduced, the GMBF level, GAS, MTL and IL-10 levels, SOD and CAT activities, and Bcl-2 protein expression level were higher, while the IL-1β and TNF-α levels, gastric mucosal cell apoptosis rate, MDA content, Bax, Cleaved caspase-3, p-NF-κB/NF-κB, and p-STAT3 protein expression levels were lower (P<0.05). LPS could reduce the improvement effect of Xiangsha Yiwei Decoction on gastric injury in CAG rats (P<0.05). The levels of the above indicators in the Moluo Dan group were at the same level as those in the high-dose Xiangsha Yiwei Decoction group (P>0.05). CONCLUSION Xiangsha Yiwei Decoction can reduce inflammation, oxidative stress, and gastric mucosal cell apoptosis in CAG rats, alleviate gastric mucosal tissue damage, and may be related to the inhibition of the NF-κB/STAT3 pathway.

OBJECTIVE To explore the mechanism by which the lignan compound podophyllotoxin inhibits T cell proliferation. METHODS Peripheral blood mononuclear cells (PBMCs) were isolated from normal human peripheral blood by lymphocyte separation fluid density gradient centrifugation, and T cells were purified from PBMCs by superparamagnetic nanobeads. T cell activation was promoted by mouse anti-human CD3/CD28 antibodies. The experiment was divided into a control group, a positive drug phosphatidylinositol 3-kinase(PI3K) inhibitor LY294002 (50 μmol·L^-1) group, and low (12.5 nmol·L^-1), medium (25 nmol·L^-1), and high (50 nmol·L^-1) dose podophyllotoxin groups. Flow cytometry was used to detect cell proliferation, cytotoxicity, apoptosis, CD25 expression, and cell cycle. Enzyme-linked immunosorbent assay (ELISA) was used to detect the expression of interleukin (IL)-4 and IL-17A. RESULTS Podophyllotoxin significantly inhibited the proliferation of activated T cells, with a half-maximal inhibitory concentration (IC₅₀) of (20±3) nmol·L^-1. It had no significant cytotoxicity on resting T cells and did not induce apoptosis in activated T cells. Podophyllotoxin could reduce the expression of CD25 and IL-2, and arrest the cell cycle at the G₀/G₁ phase. It could inhibit the expression of IL-17A but did not affect the expression of IL-4. CONCLUSION Podophyllotoxin inhibits T cell proliferation by suppressing T cell activation and blocking the T cell cycle at the G₀/G₁ phase. It effectively reduces the expression of pro-inflammatory factors without affecting the expression of anti-inflammatory factors, suggesting that podophyllotoxin has the potential to serve as a lead compound for the development of new immunosuppressants.

OBJECTIVE To investigate the antitumor activity of the traditional Chinese medicine compound nanoformulation Fujidan (Ganoderma Boletus pill) by establishing eight zebrafish tumor xenograft models of human cancers: A549 (non-small cell lung cancer cell), NCI-H446 (small cell lung cancer cell), HepG2 (hepatocellular carcinoma cell), MIA PaCa-2 (pancreatic cancer cell), MCF-7 (breast cancer cell), MGC-803 (gastric cancer cell), HCT116 (colorectal cancer cell), and KB (oral epidermoid carcinoma cell). METHODS Zebrafish tumor models were established using the CM-DIL-labeled cancer cell microinjection method. The antitumor efficacy of Fujidan was evaluated based on fluorescence intensity as the measurement index. RESULTS Fujidan exhibited significant inhibitory effects on all eight tumor cell types. CONCLUSION This formulation demonstrates broad-spectrum inhibitory activity against multiple tumors, providing a basis for further research into its targeted therapy applications.

OBJECTIVE To establish a gas chromatography (GC) fingerprint for Cuminum cyminum L(CCL) and to quantify the contents of α-pinene, myrcene, α-terpinene, thymol isomer, γ-terpinene, and cuminaldehyde. METHODS An HP-5 capillary column (0.25 μm×0.32 mm×30 m) was utilized. The injector temperature was set at 280 ℃, with a programmed temperature rise. The split ratio was 50∶1. RESULTS Fingerprints for 15 batches of CCL were established, showing a similarity greater than 0.99. A total of 14 common peaks were identified. The contents of six components (α-pinene, myrcene, α-terpinene, P-cymene, γ-terpinene, and cuminaldehyde) were determined. The mass concentrations of each component exhibited a good linear relationship with peak area within the following ranges: 1.25-250, 1.25-250, 1.25-250, 2.5-500, 10-2 000 and 10-2 000 μg·mL^-1, respectively (r≥0.999). The average recoveries (n=3) at high, medium, and low concentrations were 93.1%-95.5%, 98.9%-100.8%, 90.8%-96.8%, 98.6%-100.8%, 97.5%-98.5%, and 96.2%-103.2%, respectively. CONCLUSION The established fingerprint and multi-component content determination methods demonstrate strong specificity, high precision, and stability, providing a comprehensive approach for quality control of Aethusa cynapium L. This study offers a scientific basis for its quality evaluation and standard establishment.

OBJECTIVE To establish a near infrared (NIR) spectral quantitative analysis method of excipient dextrin content in the mixed powder of Paeonia lactiflora and dextrin based on accuracy profile (AP) theory.METHODS The near-infrared diffuse reflection mode was used to collect the near-infrared spectra of mixed powder of dextrin and Paeonia lactiflora with different contents, the NIR quantitative analysis model was built through sample division, spectral pretreatment, and selection of latent variable factors. The AP was built by calculation of β-expectation tolerance interval, and the NIR PLS quantitative analysis results were validated. RESULTS According to the results of AP, when the dextrin content in the mixed powder was low (1%, 3%, 5%), the accuracy of the established near-infrared quantitative analysis method was low. The minimum quantitative limit of dextrin in mixed powder was 5.79%. CONCLUSION AP, as a visual validation tool, can quickly determine the effectiveness of near-infrared quantitative analysis methods at different concentrations and effectively reduce the risk of using NIR quantitative analysis methods.

OBJECTIVE To better implement the requirements of the “Provisions for Drug Registration”, analyze the new situations and problems emerging in recent years in drug registration inspection and explore ways to further improve relevant working mechanisms. METHODS Based on the reform requirements for drug review and approval, and in conjunction with the implementation and revision of the “Drug Registration Inspection Procedures and Technical Requirements Specification”, international drug regulatory practices were referenced. Improvement suggestions are proposed regarding issues identified in drug registration inspections, including the applicability and coordination of specifications submitted by drug registration applicants, the risk-based initiation mechanism for inspections, the representativeness requirements for inspection samples, and the cross-provincial collaborative sampling and inspection mechanism. RESULTS and CONCLUSION While China′s drug registration inspection has achieved remarkable results in practice, it also faces challenges under new circumstances. To further enhance regulatory efficiency and support the high-quality development of the pharmaceutical industry, it is recommended to strengthen the international harmonization of specifications submitted by applicants, refine the risk-based initiation mechanism for inspections, appropriately expand the representativeness requirements for inspection samples, and establish an efficient and collaborative cross-provincial sampling and inspection mechanism.

OBJECTIVE The development and nonclinical safety evaluation of oligonucleotide drugs still face numerous challenges, and China has yet to establish guiding principles for the nonclinical safety assessment of such drugs. Closely tracking the regulatory trends of major global pharmaceutical authorities on this class of drugs is of great significance for improving China′s drug regulatory standards. METHODS This article introduces the latest draft guidance from the U.S. Food and Drug Administration(FDA), Nonclinical Safety Assessment of Oligonucleotide-Based Therapeutics (Draft Guideline), and compares it with the current international guidelines for oligonucleotide-based therapeutics to explore key considerations in the nonclinical safety evaluation of oligonucleotide-based therapeutics. RESULTS The draft guidance issued by the U.S. FDA provides a relatively scientific, rigorous, and flexible framework for the nonclinical development of oligonucleotide therapies. However, domestic efforts must still accelerate the formulation and revision of regulatory guidelines tailored to China′s unique regulatory practices. CONCLUSION The FDA draft guidance on oligonucleotide-based therapeutics serves as a reference for optimizing and improving the evaluation of oligonucleotide-based therapeutics in China.

OBJECTIVE To provide thoughts and suggestions for vaccine registration management by comparatively analyzing the characteristics of the management systems in this field in China, the United States and Europe, and analyze common problems based on the current situation of vaccine registration in China. METHODS Based on regulatory documents, literature research, and other approaches, a systematic comparison of the similarities and differences in the post-approval vaccine change management systems among China, the United States, and Europe was conducted, and the common problems existing in China's vaccine registration practice were analyzed. RESULTS As our country′s vaccine-related regulations and guiding principles continue to improve, the post-approval vaccine change supervision system has gradually developed from a single approval system to a classified management model including a filing mechanism. However, vaccines have complex production processes and difficult to characterize biological properties. If changes are not strictly evaluated and managed properly, they may directly affect vaccine performance and cause quality risks. Currently, China′s vaccine registration management still faces several common problems during its implementation and needs further optimization. CONCLUSION Post-approval change management of vaccines is a key link to implement “whole-process control” and protect public health. Although our country has established a classified management system, it still needs to learn from international experience, improve risk assessment and supervision mechanisms, and further enhance the scientificity and standardization of vaccine change management.

OBJECTIVE To examine the materia medica records and therapeutic use of stalactite (Zhongru shi), provide textual evidence for its modern clinical use, and, in combination with contemporary studies, explore its current clinical value. METHODS Drawing on classical texts from successive dynasties, Stalactite (Zhongru shi) was investigated from four perspectives-nomenclature, medicinal origin, flavor and channel tropism, and therapeutic indications. And these findings were interpreted in light of modern pharmacological and clinical research to identify potential applications. RESULTS Historical records reveal over twenty different names for the substance, with “Shi zhongru” gaining prominence from the Song dynasty onward, and “Zhongru shi” becoming standardized since Qing dynasty. Early sources distinguished stalactite from two other geologically similar materials-Yinnie and Konggongnie-which were believed to differ in medicinal effects and were not to be used interchangeably. Despite these early distinctions, later texts increasingly conflated the three. The most prized specimens were described as white, translucent, hollow, and as light as goose quills. In contemporary markets, variations in thickness and texture suggest the continued presence of yinnie and konggongnie under the general label of stalactite. Initially classified as sweet, warm, and non-toxic, stalactite came to be associated with “fire toxicity” from the Song period onward. By the Ming and Qing dynasties, it was frequently described as pungent and strongly warming-an evolution likely shaped by its expanded functional applications, mixed sourcing, and calcined preparation. Channel attribution first appeared in Ming texts, linking stalactite primarily to the Yangming channel, with secondary associations to the lung and kidney, reflecting its dual action in warming the upper body and tonifying the lower. Its therapeutic profile gradually shifted from a focus on circulation and unblocking toward a broader tonic role, culminating in Ming-Qing formulations that emphasized its capacity to “warm and nourish the three burners”. In modern clinical contexts, stalactite remains in use for treating yang deficiency syndromes, particularly those involving cold-type cough with phlegm, postpartum hypogalactia, and gastrointestinal ulcers. CONCLUSION Stalactite (Zhongru shi) , characterized by warming and nourishing the three burners and reinforcing combined with unblocking, corresponds well to the therapeutic needs of chronic deficiency disorders such as yang-deficient cough and asthma with cold phlegm, postpartum hypogalactia, and peptic ulcer disease, and needs further exploration and standardized clinical application.