Poria cocos (Schw.) Wolf is a traditional Chinese medicinal herb with the effects of diuresis and seepage of dampness, invigorating the spleen and stomach, and tranquillising the heart, and is one of the Taoist medicinal herbs in Yunnan Province. Poria cocos has a long history of cultivation in Yunnan, and is of excellent quality, and is known as “Yun ling”. Poria cocos is one of the 86 fungal substances that are both food and medicine announced by the state in 2002. With its unique medicinal and edible values, it has been widely used in the fields of medicine, food and health care products. In this paper, through a systematic search of China Knowledge Network, PubMed database literature and related patent data. The active ingredients were reviewed, industrial research overview and patent research status of Poria cocos, focusing on the analysis of Poria cocos in the development of medicinal food and food products in the current status of patented technology and the direction of innovation. It is found that the patents related to Poria cocos polysaccharide, Poria cocos triterpenes and other active ingredients are mainly concentrated in the development of functional food and pharmaceutical applications, but there is still a vast space for the development of patent layout of high value-added products. The aim of this paper is to promote the high value-added use of Poria cocos resources, improve the core competitiveness of Poria cocos industry, and help the development of traditional Chinese medicine health industry and the construction of healthy China.

Fungal contamination, represented by aflatoxins, is common in Chinese medicinal materials worldwide, involving multiple varieties listed in the Chinese Pharmacopoeia, which has a serious impact on patient medication safety and the development of the Chinese medicine industry. Compared with destructive methods such as fumigation and irradiation, microbiological control exhibits the unique advantages of being environmentally friendly, highly targeted, and able to maintain the activity of medicinal materials through mechanisms such as microbial adsorption degradation, competitive inhibition, and metabolite antagonism. This article systematically analyzes the current situation of mycotoxin contamination in Chinese medicine, summarizes the research of microbiological control methods in mycotoxin prevention and control, and looks forward to future development directions, attempting to provide the theoretical basis for quality control and standard improvement of Chinese medicine.

OBJECTIVE To explore the application of whole slide imaging and fluorescence imaging in microscopic identification of Chinese patent medicines and establish a new quality control method for Zhuangyaojianshen pills. METHODS For the first time, the whole slide imaging technology was integrated with traditional microscopic identification. In light of the characteristics and challenges in microscopic identification of honeyed pill dosage forms, the pretreatment and sample preparation approaches were continuously refined. The microscopic preparations of Zhuangyaojianshen pills from diverse manufacturers were automatically scanned to acquire their full-field images. At the same time, the fluorescence imaging technology is used to record the microscopic characteristics specified in the current standard, and the advantages of this technology in the microscopic identification of Chinese patent medicines are explored. RESULTS The obtained full-field pictures were of high quality, and most of the structures in the picture were clearly visible, which were of identification significance. In fluorescence mode, all microstructures have spontaneous fluorescence reaction, and the colors of different microstructures are quite different. Combined with the experience of professionals, it was found that no Cuscutae Semen were detected in batch 1 of samples. CONCLUSION A whole slide imaging and fluorescence imaging method suitable for honey pill formulations has been established, which is comprehensive, simple, and fast, and can be used for microscopic identification and quality control of Zhuangyaojianshen pills.

OBJECTIVE To explore the mechanism by which the Mongolian medicine Sihong Decoction relieves renal fibrosis in rats and regulates the energy metabolism pathway to restore renal function. METHODS Sihong Decoction was prepared using equal parts of Rubia cordifolia, Lithospermum erythrorhizon, Eriobotrya japonica leaves, and Shellac, Lac. Male SD rats were administered 200 mg·kg^-1·d^-1 of adenine to establish a model of renal fibrosis, followed by intervention with low and high doses of Sihong Decoction, with losartan serving as the positive control. Renal tissue morphology was assessed via hematoxylin and eosin staining (HE) and Masson′s trichrome staining. The concentrations of blood urea nitrogen (BUN), serum creatinine (Scr) in the serum and lactic acid in renal tissues were detected by the enzyme-linked immunosorbent assay (ELISA) method, and the level of adenosine triphosphate (ATP) in renal tissues was detected by the chemiluminescence method. The expression of renal fibrosis markers and carnitine palmitoyltransferase 1 (CPT1) was evaluated using quantitative real-time reverse transcription polymerase chain reaction (qRT-PCR) and Western blot (WB) techniques. RESULTS Compared with the model group, rats treated with Sihong Decoction showed significant improvements in renal tissue structure, with reduced severity of lesions in renal tubules and glomeruli and a marked decrease in collagen deposition. BUN and Scr levels were notably reduced. Additionally, Sihong Decoction significantly downregulated the expression of α-smooth muscle actin (α-SMA) and type Ⅰ collagen (Collagen Ⅰ), while upregulating epithelial-cadherin (E-cadherin). Furthermore, Sihong Decoction significantly increased ATP levels in renal tissues, decreased lactate levels, and upregulated CPT1 expression. CONCLUSION Sihong Decoction can effectively relieve renal fibrosis in rats. At the same time, it can enhance the β-oxidation ability of fatty acids in the kidneys, optimize the energy metabolism pathway, and promote the recovery of renal damage.

OBJECTIVE To investigate the proliferation inhibitory effect and mechanism of action of the N-piperazine oxindole derivative 2G(abbreviated as 2G) on gastric cancer cells. METHODS Using gastric cancer cells HGC-27, AGS, MKN-45, and human normal gastric mucosal epithelial cells GES-1 as the study subjects, the MTT assay was employed to evaluate the effects of oxindole(parent nucleus), compound 2G, and cisplatin on cell proliferation. After treating HGC-27 cells with different compounds, reactive oxygen species(ROS), mitochondrial membrane potential(MMP), mitochondrial damage, and the co-localization of mitochondria and lysosomes were detected using specific probes for ROS, mitochondria, and lysosomes. The expression of mitophagy-related pathway proteins microtubule-associated protein 1 light chain 3(LC3)Ⅱ/Ⅰ and sequestosome-1 (P62) was measured by Western blot. RESULTS Compared with cisplatin (DDP), compound 2G exhibited lower half-maximal inhibitory concentrations (IC₅₀)(P<0.01) against gastric cancer cells HGC-27, AGS, and MKN-45. Additionally, the selectivity index (SI) of compound 2G in AGS and MKN-45 cells was higher than that of DDP(P<0.01), while there was no significant difference in the SI between compound 2G and DDP in HGC-27 cells(P＞0.05). Compound 2G significantly increased cellular ROS levels, reduced MMP(mitochondrial membrane potential), induced mitochondrial damage, and promoted co-localization of mitochondria and lysosomes. Western blot results showed that compound 2G markedly decreased the expression of P62 and increased the LC3 Ⅱ/Ⅰ ratio(P<0.01). Furthermore, when combined with the autophagy inhibitor 3-methyladenine(3-MA), compound 2G′s downregulation of P62 and upregulation of the LC3 Ⅱ/Ⅰ ratio were significantly reversed, and its inhibitory effect on the proliferation of HGC-27 cells was reduced. CONCLUSION The compound 2G can significantly inhibit the proliferation of gastric cancer cells. Its mechanism of action may involve damaging mitochondria, downregulating the autophagy-related protein P62, increasing the LC3 Ⅱ/Ⅰ protein ratio, and thereby promoting mitophagy in gastric cancer cells.

OBJECTIVE To investigate the intervention effect of the aqueous extract of Rehmannia glutinosa (RG) on hypoxia-induced pulmonary hypertension (PH) in mice. METHODS A total of 60 mice were randomly divided into control, model, bosentan (Bos), and the low, medium, and high dose RG (RG-L, RG-M, RG-H) groups. Except for the control group, the other groups were continuously established in 10% hypoxia environment for 35 d, and the drug was given on the 21st day. The cardiac function (right ventricular pressure, right ventricular hypertrophy index, right ventricular/left ventricular area ratio) and pulmonary function (respiratory rate, tidal volume, minute volume, peak inspiratory flow, peak expiratory flow, expiratory flow 50%, pulmonary artery blood flow velocity, pulmonary artery acceleration time/right ventricular ejection time ratio) were measured. The levels of oxidative stress (malondialdehyde, superoxide dismutase, glutathione peroxidase and reactive oxygen species), apoptosis and immune cells (macrophages, neutrophils, Treg cells) in lung tissue were measured to evaluate the intervention effect of different doses of RG on PH mice. Western blotting and immunofluorescence were used to detect the protein expression levels of p-ERK and HIF-1α in lung tissue of mice in each group. RESULTS RG significantly improved cardiac and lung function, reduced oxidative stress and apoptosis, regulated the level of immune cells, reduced the protein expression levels of p-ERK and HIF-1α in mice model of PH. CONCLUSION RG can improve cardiopulmonary injury in mice with hypoxia-induced PH through ERK/HIF-1α signaling pathway.

OBJECTIVE To explore the mechanism of fresh Baihe Dihuang Decoction (FBD) against anxiety-like behavior. METHODS Chemical components and anti-anxiety targets of FBD were screened using UHPLC-Q-TOF-MS and network pharmacology. PPI networks and “component-target” networks were constructed, followed by enrichment analyses of KEGG pathways and GO. A mouse model of anxiety disorder was established via 4 consecutive weeks of chronic restraint stress. Anxiety-like behaviors were evaluated using behavioral assays, serum inflammatory factors were detected by ELISA, and neuronal apoptosis, microglial polarization markers, and proteins related to the EGFR axis were determined by Western blot or immunofluorescence in hippocampal tissue. RESULTS A total of 29 components of FBD were identified, with 69 targets for anxiety disorder treatment, including AKT, EGFR, and mTOR. A total of 141 KEGG pathways were enriched, involving the EGFR signaling pathway. The anxiety model was successfully established. FBD significantly improved anxiety-like behaviors in model mice, reduced serum levels of TNF-α, IL-1β, and IL-6, upregulated the expression of NeuN, Bcl-2, BDNF, and CD206, and downregulated Bax, iNOS, and Iba-1. CONCLUSION These findings indicate that FBD prevents anxiety by mediating microglial state transition and inhibiting hippocampal neuronal apoptosis via the EGFR axis.

OBJECTIVE To analyze the impurity profiles in the active pharmaceutical ingredient(API) and preparations of econazole nitrate ointment from different manufacturers,compare the prescriptions, determine the key process conditions during production and storage, and thereby provide support for the quality evaluation of econazole nitrate ointment. METHODS Column switching two-dimensional liquid chromatography-mass spectrometry technology was used to analyze the impurities in the API and preparations of econazole nitrate from different manufacturers, and determine the source of impurities through degradation experiments. RESULTS A total of 10 impurities were detected in the API and preparations of econazole nitrate from different manufacturers, including 3 types of auxiliary impurities, 3 process impurities and 4 degradation impurities. CONCLUSION The sources of impurities in econazole nitrate ointment are complex, and the manufacturing process of API, the prescription of formulation, inner packing, production environment control can all affect product quality. In order to avoid the generation of degradation impurities, enterprises should pay attention to light avoidance operations and oxidizing condition control during the production process while ensuring the quality of raw materials.

OBJECTIVE To explore the particle size distribution and dynamic changes of silicone oil particles in monoclonal antibody injections (mAbs) manufactured by different processes and placed under various storage conditions using micro-flow imaging (MFI) technology, thus to provide a more comprehensive characterization of particles, offering valuable insights for pharmaceutical companies to enhance the stability and safety of monoclonal antibody drugs. METHODS mAbs from company A and company B were subjected to altered storage conditions: static storage at 4 ℃ post-opening and agitation at room temperature. These were compared with untreated controls using MFI to detect insoluble particles. Particle images, size distributions, and counts were analyzed. RESULTS MFI revealed no statistically significant changes in total insoluble particle count or concentration of mAbs from either company under static 4 ℃ or agitated conditions (P>0.05). However, static storage at 4 ℃ increased the average particle size distribution (t=-4.26, P=0.02) and elevated silicone oil droplet content (1.5-2.0 μm) in company B′s mAbs. Agitation reduced ≤1 μm particles (t=5.45, P<0.001) but increased 1-10 μm particles (t=-5.43, P<0.001) and silicone oil content in company B′s mAbs, indicating varying sensitivities to storage conditions across manufacturers. CONCLUSION This study demonstrates the utility of MFI in detecting insoluble particles in mAbs and proposes new approaches for investigating their origins. Under altered storage conditions, company B′s mAbs exhibited notable shifts in particle size distribution and silicone oil content, suggesting a need for product optimization and material selection in primary packaging to enhance stability and safety. Image analysis suggests that increased particle size may stem from protein-silicone oil complex formation, though the exact mechanisms of silicone oil generation require further exploration.

OBJECTIVE To develop a supercritical fluid chromatography (SFC) method for the separation and determination of the (S)-enantiomer impurity in sitagliptin phosphate. METHODS The enantiomeric separation was achieved using the Chiralcel OD column (4.6 mm×250 mm, 10 μm) containing cellulose tris(3,5-dimethylphenylcarbamate) as the chiral stationary phase. The mobile phase consisted of supercritical carbon dioxide and methanol containing 0.2% trifluoroacetic acid and 0.2% diethylamine (90∶10). The column temperature was maintained at 35 ℃, with a backpressure of 18.62 MPa. The injection volume was 6 μL, and the flow rate was set at 1.5 mL·min^-1. Detection was performed at 205 nm to separate sitagliptin phosphate and its (S)-enantiomer. RESULTS The (S)-enantiomer and sitagliptin phosphate were eluted within 15 min, with the resolution of 3.2. Both compounds exhibited good linearity in the concentration range of 9-200 μg·mL^-1, with correlation coefficients of 0.999 8 and 0.999 9, respectively. The slope ratio of the linear equation for sitagliptin phosphate and the (S)-enantiomer is 1.0. The peak area normalization method and API external standard method can be used for quantitative determination of the (S)-enantiomer. The limit of quantification (LOQ) was 9 μg·mL^-1 (S/N≥10), and the limit of detection (LOD) was 3 μg·mL^-1 (S/N≥3) for both analytes. CONCLUSION Compared with conventional normal phase liquid chromatography, SFC offers shorter equilibration time and higher separation efficiency. Additionally, it requires fewer alkane solvents, making it an environmentally friendly option. This study provides a reliable approach for the separation, determination, and quality control of sitagliptin phosphate and its (S)-enantiomer.

OBJECTIVE To compare recommendations on levetiracetam (LEV) across different clinical guidelines systematically, to provide a reference for rational drug use in clinical practice. METHODS A review of guidelines on the use of LEV in the field of epilepsy was conducted by searching databases such as CNKI, Wanfang, MEDLINE, and common guideline publication organizations like the National Institute for Health and Care Excellence (NICE) in the UK. The differences in recommendations on LEV use across various countries, regions, and organizations were analyzed. RESULTS The findings indicated that LEV is recommended for focal seizures, generalized seizures, neonatal seizures, status epilepticus, and various epilepsy syndromes in various guidelines. However, there are differences in the recommendations for first-line, second-line, or add-on therapy among these guidelines. CONCLUSION This study systematically compiles guidelines published by various countries and regions, which will assist healthcare professionals in better utilizing these recommendations and provide a reference for the clinical application of LEV.

OBJECTIVE To panoramically analysis the innovative development pathway for pediatric drugs empowered by digital twin, reveal the risks and challenges of digital twin and propose precise governance solutions to alleviate the pediatric clinical medication predicament. METHODS Through literature research method, data analysis method and case analysis method, the status quo and practical dilemma of the development of pediatric drug innovation in China were analyzed, and the breakthrough ideas of applying digital twin technology to promote pediatric drug innovation were explored. RESULTS Digital twin technology can play a powerful enabling role in pediatric drugs research and development project, research and development design, clinical trials, intelligent manufacturing, personalized precision medicine, pharmacovigilance and other links. CONCLUSION It is suggested that digital twin technology be applied to achieve innovative development of pediatric drugs, precisely manage the risks of digital twin technology, vigorously promote the innovative development of the entire chain of the pediatric drug industry, and advance the high-quality development of children′s medical and health services.

OBJECTIVE To explore the regulatory coordination mechanism for traditional Chinese medicine (TCM)/traditional medicines between China and Association of South East Asian Nations(ASEAN). METHODS Based on the regulatory reliance framework, an analysis was conducted from five dimensions: rule reliance, path reliance, quality reliance, resource reliance, and market reliance. RESULTS There exists reliance in the regulation of TCM/traditional medicines between China and ASEAN countries, which provided a theoretical basis for regulatory coordination. CONCLUSION Internationalization involves the two-way integration and coordination of Chinese and foreign rules. Proactively drawing on the regulatory experience of ASEAN countries regarding TCM/traditional medicines, while incorporating China′s solutions into the global governance framework, will lay a foundation for promoting the “going global” of China′s TCM/traditional medicine industry.