OBJECTIVE To interpret and analyze 9625 guidelines on metallic materials and containers for pharmaceutical packaging Systems in the Chinese Pharmacopeia (ChP) 2025 Edition, provide a reference for accurate understanding and implementation of the ChP. METHODS The overview of metallic pharmaceutical packaging materials, the background, core framework, and key technical indicators of standard development and future prospects for advancing standardization and international alignment were introduced. RESULTS Guided by the principles of scientificity, operability, and sustainable development, and based on the guiding ideology, objectives, and key tasks outlined in the ChP 2025 edition, the development of the 9625 for pharmaceutical packaging, along with the supporting methodological standards, was completed under the guidance of the Pharmaceutical Packaging Materials Committee of the Chinese Pharmacopoeia Commission. This was achieved through extensive industry research and consultation. CONCLUSION As of now, foreign pharmacopoeias have not officially included standards for metallic pharmaceutical packaging materials . ChP 2025 edition has officially included standards for metallic pharmaceutical packaging materials for the first time, marking a significant milestone. The 9625 clarifies the critical quality attributes and quality control requirements for metallic materials and containers and provides essential support for quality control. Furthermore, it plays a pivotal role in driving the adoption of advanced testing technologies and enhancing the global influence of the ChP, fostering greater harmonization with international regulatory frameworks.

Reference standards for pharmaceutical are important development resources for the national pharmacy, and accelerating the development of the types, quantities, and quality of reference standards is an urgent need to support the high-quality development of various industries. Due to the limitations of difficult preparation, high cost, and high toxicity of some physical reference standards the development of safer and reusable digital reference standards is of great significance and in line with the national digital development strategy. However, the current digital reference standards still have problems such as vague concepts, narrow application scope, and emphasis on qualitative rather than quantitative methods. This article clarifies the concept and significance of digitalization of reference standards, explores the application scenarios of digital reference standards, and combines the latest developments in digital reference standards research at home and abroad to explore feasible ideas and methods for digitalization of reference standards. It is expected to provide reference for researchers.

Zaoren Anshen Priscription(ZAP) is a representative formula of Chinese medicine to tonify the heart, nourish the liver, tranquilize the mind and benefit the intellect. It has many pharmacological effects such as sedation, hypnosis, anti-anxiety, and anti-depression. Clinically, it is mostly used for the treatment of insomnia and neurasthenia, or used in combination to improve the accompanying symptoms of neurological diseases and cardiovascular diseases. In this study, the progress of chemical composition, pharmacological effect, clinical research and quality control of ZAP were summarized in recent years, and conducted predictive analysis on the quality markers (Q-marker) of ZAP from five aspects: quality transfer and traceability, component effectiveness, component specificity, component measurability and compound compatibility. The results show that jujuboside A, spinosin, betulinic acid, schisandrin A, schisandrin B can be used as the Q-markers of ZAP, so as to provide a reference for the establishment of the whole-process Q-traceability system and the quality control of ZAP.

OBJECTIVE To establish a duplex real-time fluorescence PCR method for the identification of Chrysosplenium carnosum Hook. f. et Thoms and its closely related species Chrysosplenium axillare Maxim. METHODS Based on ITS2 sequences, single nucleotide polymorphism (SNP) sites were identified according to the sequence characteristics of Chrysosplenium carnosum Hook. f. et Thoms and Chrysosplenium axillare Maxim. Specific primers and probes for each species were designed. Key parameters, including primer and probe concentrations, annealing temperature, and number of cycles, were optimized to establish the duplex real-time fluorescence PCR conditions. Additionally, the method was evaluated for precision, repeatability, specificity, and sensitivity. RESULTS The established duplex TaqMan probe-based real-time PCR method demonstrated good repeatability. Even at a spiked-in proportion as low as 1%, characteristic fluorescence amplification curves were consistently observed, further confirming the method′s high sensitivity and specificity. CONCLUSION The duplex TaqMan probe-based real-time PCR method developed in this study exhibits high specificity and sensitivity, enabling simultaneous detection of Chrysosplenium carnosum Hook. f. et Thoms and its closely related species Chrysosplenium axillare Maxim. This method provides a more specific technical approach for distinguishing between Chrysosplenium carnosum Hook. f. et Thoms and Chrysosplenium axillare Maxim, offering enhanced reliability for their identification.

OBJECTIVE To explore the role and mechanism of irisin in regulating osteogenic differentiation of mouse bone marrow mesenchymal stem cells (BMSCs). METHODS Using different concentrations of irisin (0, 50 and 500 ng·mL -1 ) to intervene in mice BMSCs, the optimal intervention concentration of irisin was determined by CCK-8 and PCR experiments. BMSCs were divided into control, irisin, AMPK inhibitor and irisin+AMPK inhibitor groups. After osteogenic differentiation, each group of cells underwent ALP staining, ALP activity detection, alizarin red S staining, and AMPK, p-AMPK, Runx2 and Osx protein expression by Western blot. RESULTS The optimal intervention concentration for irisin was 100 ng·mL -1 . After osteogenic differentiation, compared with the Control group, the irisin group significantly increased ALP staining, ALP activity, and calcium deposition, as well as the p-AMPK/AMPK protein ratio, Runx2 and Osx protein expression (all P<0.05); the AMPK inhibitor group showed a significant decrease in ALP staining, ALP activity, and calcium deposition, as well as a significant decrease in p-AMPK/AMPK protein ratio, Runx2 and Osx protein expression (all P<0.05). Compared with the irisin group, the irisin+AMPK inhibitor group significantly reduced ALP staining, ALP activity, and calcium deposition, as well as the p-AMPK/AMPK protein ratio, Runx2 and Osx protein expression (all P<0.05). Compared with the AMPK inhibitor group, the irisin+AMPK inhibitor group significantly increased ALP staining, ALP activity, and calcium deposition, as well as the p-AMPK/AMPK protein ratio, Runx2 and Osx protein expression (all P<0.05). CONCLUSION Irisin may promote osteogenic differentiation of BMSCs through the AMPK/Runx2 pathway.

OBJECTIVE To investigate the regulatory ability of puerarin (PUE) on bone density and bone metabolism in osteoporotic (OP) rats and its impact on the miR-21-5p/transforming growth factor-β1 (TGF-β1)/Smads signaling pathway. METHODS An OP rat model was constructed and randomly assigned into model group, low-dose puerarin group (PUE-L), high-dose puerarin group (PUE-H group), and high-dose puerarin+TGF-β1/Smads pathway inhibitor group (PUE-H+Disitertide group), with 20 rats in each group. Another 20 healthy rats were used as the control group. In all rats, bone mineral density was assessed by calculating the bone ash-to-dry weight ratio,serum bone metabolism markers were measured using ELISA kits,microstructural changes in femoral tissue were evaluated via micro-computed tomography (Micro-CT) scanning,osteoclast numbers were quantified through TRAP staining, while histopathological alterations in femoral tissue were examined using HE staining,the relative expression of miR-21-5p and the mRNA levels of TGF-β1, Smad2, Smad3, and Smad7 in bone tissue were quantified by RT-qPCR.Additionally, the relative protein expression levels of TGF-β1, p-Smad2, Smad3, and Smad7 were analyzed by Western blotting. RESULTS With the increase of PUE dosage, the pathological damage of rat femoral tissue was improved, bone density and strength increased, and bone loss decreased. The relative expression levels of TGF-β1 and p-Smad 2/3 protein increased, while the relative expression levels of miR-21-5p and Smad7 mRNA decreased (P<0.05). Disitertide can reverse the improvement effect of PUE on bone injury and bone metabolism in OP rats (P<0.05). CONCLUSION PUE can improve the pathological damage of femoral tissue and regulate bone metabolism in OP rats, which may be related to the miR-21-5p/TGF-β1/Smads signaling pathway.

OBJECTIVE To investigate the effect of verbascoside (AC) on lung injury and inositol requiring enzyme 1α/thioredoxin-interacting protein/nucleotide binding oligomerization domain-like receptor protein 3 (IRE1α/TXNIP/NLRP3) signaling pathway in Streptococcus pneumoniae (SP) pneumonia rats. METHODS SP pneumonia model rats were constructed, and successfully modeled rats were randomly assigned into Model group, low and high dose verbascoside groups (AC-L, AC-H groups), high dose verbascoside+empty vector group (AC-H+pAdEEasyTM group), and high dose verbascoside+IRE1α overexpression adenovirus vector group (AC-H+Ad-IRE1α group), with 18 rats in each group. Another 18 healthy normal rats were as the Control group. The oxygenation index of rats in each group was measured. Enzyme-linked immunosorbent assay (ELISA) was used to detect the levels of inflammatory factors in bronchoalveolar lavage fluid. The wet/dry ratio (W/D) and oxidative stress level of lung tissue of rats in each group were detected. Hematoxyl-eosin (HE) staining was used to observe the pathological condition of lung tissue. Tdt mediated dutp nick end labeling (TUNEL) staining was used to detect apoptosis in lung tissue cells. Western blot was used to detect the expression of proteins related to the IRE1α/TXNIP/NLRP3 signaling pathway. RESULTS The lung tissue injury in the Model group was more significant than that in the Control group, with swollen and disordered alveolar epithelial cells, dilated alveolar wall capillaries, thickened alveolar septa, and significant infiltration of inflammatory cells, the PaCO₂, levels of TNFα, IL-1β, IL-6, W/D, MDA, apoptosis rate, and the expression of Bax, p-IRE1α/IRE1α, TXNIP, and NLRP3 were higher, and the PaO₂, OI, level of SOD, and the expression of Bcl-2 were lower (P<0.05). The lung tissue morphology of the AC-L and AC-H groups improved compared with the Model group, with slight thickening of the alveolar septa and infiltration of inflammatory cells, the PaCO₂, levels of TNFα, IL-1β, IL-6, W/D, MDA, apoptosis rate, and the expression of Bax, p-IRE1α/IRE1α, TXNIP, and NLRP3 were lower, and the PaO₂, OI, level of SOD, and the expression of Bcl-2 were higher (P<0.05). The PaCO₂, levels of TNFα, IL-1β, IL-6, W/D, MDA, apoptosis rate, and the expression of Bax, p-IRE1α/IRE1α, TXNIP, and NLRP3 in the AC-H+Ad-IRE1α group were higher than those in AC-H+pAdEasyTM group, and the PaO₂, OI, level of SOD, and the expression of Bcl-2 were lower (P<0.05). CONCLUSION Verbascoside can improve lung injury in SP pneumonia rats, and its related to the inhibition of the IRE1α/TXNIP/NLRP3 signaling pathway.

OBJECTIVE To prepare clove oil-loaded nanofibrous membranes, characterize the fibrous membranes, and conduct content determination and in vitro release studies. METHODS Different sizes of clove oil-loaded nanofibrous membranes were prepared by electrostatic spinning using poly(L-lactic acid) and gelatin as the substrates with different contents of clove oil. The morphology, structure and thermal stability of the fibrous membranes were characterized by scanning electron microscopy, Fourier infrared spectroscopy and differential scanning calorimetry, and the content of the fibrous membranes was determined by gas chromatography, and the in vitro release pattern was explored. RESULTS The clove oil-loaded nanofibrous membrane fibers were uniform and smooth with homogeneous structure and good thermal stability. The content of clove oil in the fibrous membranes was determined, and the established in vitro release assay method has certain durability, sensitivity, and selectivity, which can be used for the determination of the in vitro release rate of different clove oil-loaded nanofibrous membranes. The release pattern of clove oil was investigated using zero-order, one-order, Higuchi and Ritger-Peppas equations, respectively, and the release curves of all the fiber membranes showed the best fit to the one- level equation, and the release of clove oil was consistent with Fick diffusion. CONCLUSION For the first time, clove oil is loaded into the nanofiber membrane prepared from poly(L-lactic acid) and gelatin by electrostatic spinning, and the evaluation method of in vitro release of the fiber membrane is established, and its fiber membrane has certain slow release effect, which can improve the bioavailability of clove oil, and it provides a new idea for the future construction of a new type of controlled-release system for traditional Chinese medicine.

OBJECTIVE To establish quality standards for mineral-based Chinese herbal formula granules using calcined alumen standard decoction as the primary research subject. METHODS Twelve batches of calcined alumen standard decoctions were prepared by traditional decocting method, and the range of paste yields was measured. The standard decoction was studied by thermogravimetric analysis (TGA), infrared spectroscopy (IR), continuous static extraction, inductively coupled plasma mass spectrometry (ICP-MS), powder X-ray diffraction (PXRD) and ion chromatography (IC). RESULTS Thermogravimetric analysis can be used to determine the content of crystal water and its state. Infrared spectroscopy demonstrates applicability in the qualitative identification of distinct forms of calcined alumen, yet its practical implementation in quality control of formula granules has been constrained by spectral interference from maltodextrin, a routine pharmaceutical excipient. Continuous static extraction method is commonly used for the determination of different ionic species in mineral medicines, and powder X-ray diffraction can be employed to determine the structural characteristics of material phases. However, neither method is suitable for quality control of the standard decoction of calcined alumen. Inductively coupled plasma mass spectrometry can be used for the semi-quantitative analysis of various trace elements in alum. Ion chromatography can be reliably used to determine the potassium ion (K + ) and sulfate ion (SO 2- 4 ) content in calcined alumen standard decoction and to differentiate it from ammonium alum. CONCLUSION The study established the quality inspection method and control method of calcined alumen standard decoction, which can provide reference for the quality standard of mineral Chinese medicine formula granules.

OBJECTIVE To systematically investigate the differences in key quality attributes of commercially available sodium carboxymethyl starch(CMS-Na) produced by different manufacturers using different processes, including physical morphology, particle size and particle size distribution, water swelling capacity, degree of substitution, flowability, compressibility, and the degree of combination with water molecules. METHODS Taking norfloxacin tablets as the model drug, this study delved into the influence of different quality attributes of CMS-Na on the in vitro dissolution rate of tablets. RESULTS Due to the different sources of raw materials, there were significant differences in the physical morphology and water swelling capacity of CMS-Na. In addition, affected by the production processes and their control levels of different manufacturers, there were certain differences in particle size distribution, degree of substitution, flowability, and compressibility of their products. These differences further had varying degrees of influence on the dissolution rate and dissolution uniformity of tablets. CONCLUSION This research reveals that manufacturers could effectively improve the disintegration performance of CMS-Na by controlling the particle size distribution of the product and reducing powder agglomeration.

OBJECTIVE To analyze domestic and international research hotspots and trends in polymyxin drugs, providing references for clinical use. METHODS Original articles related to polymyxin drugs published between January 1, 1995, and December 31, 2024, were retrieved from the Web of Science Core Collection, CNKI, and Wanfang databases. VOSviewer, CiteSpace, and the R package “bibliometrix” were employed for bibliometric visualization analysis. RESULTS A total of 5 479 articles (574 in Chinese, 4 905 in English) from 107 countries were included for analysis. The key findings were as follows: resistance studies accounted for 27% of Chinese and 19% of English publications, while pediatric research was limited (4.35% in Chinese, 2.33% in English). China, the United States, and Australia were the top three countries in terms of publication output, with Monash University as a leading international institution, while domestic institutions included Zhejiang University, Anhui Medical University, Zhejiang University of Technology, and Shandong University. Core research teams domestically and internationally were led by Li Jian, Velkov Tony, Wu Zhaoliang, and Wan Ning, but collaboration was insufficient. Research hotspots analysis revealed that “colistin”, “mcr-1”, and “multidrug-resistant strains” were common keywords, though resistance strain research preferences varied (e.g., global focus on Acinetobacter baumannii, pediatrics on Pseudomonas aeruginosa, and domestic studies on Escherichia coli). Emerging keywords showed that English literature emphasized fundamental research on septic shock, endotoxins, Salmonella Typhimurium, cystic fibrosis, and antimicrobial resistance, while Chinese literature focused more on clinical applications such as wound infections, fermentation engineering, therapeutic efficacy, chronic eczema, multidrug-resistant strain identification, and resistance mechanism/gene detection. CONCLUSION This study presents the first bibliometric analysis of polymyxin drug research both domestically and internationally, offering critical insights for reevaluating future clinical research directions and guiding subsequent studies.

OBJECTIVE To evaluate the efficacy, safety and economy of serplulimab (SER) as the first-line treatment for extensive-stage small cell lung cancer (ES-SCLC). METHODS A comprehensive search was conducted in PubMed, CNKI and other Chinese and English databases, and related health technology assessment (HTA) websites to collect HTA reports, systematic reviews/meta-analyses, and pharmacoeconomic studies of first-line treatment of ES-SCLC with SER, covering literatures from the establishment of the databases to December 2024. Literature was independently screened; data were extracted and evaluated for quality by two investigators based on inclusion and exclusion criteria. RESULTS A total of 15 papers, including 6 systematic reviews/meta-analyses and 9 economics studies, were included. In terms of efficacy, SER + chemotherapy significantly prolonged patients′ overall survival (OS) and progression-free survival (PFS) and improved the OBJECTIVE remission rate (ORR) compared with conventional chemotherapy alone . Subgroup analysis showed that SER was more effective in patients who were male, smokers, aged <65 years, with normal lactate dehydrogenase(LDH), Eastern Cooperative Oncology Group Performance Status(ECOG PS)0-1, and brain metastases. In terms of safety, SER has a favorable safety profile, with common adverse events including mild-to-moderate anemia, decreased white blood cell and platelet counts, abnormal thyroid function, fatigue, nausea, and decreased appetite. Economically, SER is currently unaffordable in China, necessitating improvements in accessibility through price reductions or assistance programs. CONCLUSION SER is effective and well-tolerated, but is not economically viable under current pricing, and it is recommended that cost-effectiveness should be optimized through health insurance negotiations and tiered pricing strategies.

OBJECTIVE To visualize and analyze the research status and hotspots of Hyssopus cuspidatus Boriss and provide a scientific basis for further research. METHODS By using the bibliometric method and combining the Coocation (COOC) and VOSviewer visualization tools, the literatures related to the Hyssopus cuspidatus Boriss. from 1990 to 2024 were retrieved from databases such as CNKI, Wanfang Data, Sinome, VIP and the Web of Science Core Collection. Annual publications, countries/provinces, institutions, authors, journals, keywords, and collaborative networks were visualized and analyzed. RESULTS Finally, 436 valid papers (173 in Chinese and 263 in English) were included. 1990—2024, the annual number of papers showed a fluctuating upward trend, with phased peaks in 2017 (15) and 2022 (61), respectively. The international research, with Iran as a representative country mainly focuses on volatile oil composition, pharmacological activity mechanism and growth characteristics. Domestic research is dominated by Xinjiang region, with Xinjiang Medical University as the core research institution, which has made significant progress in the analysis of active ingredients, introduction of cultivation technology, quality evaluation system and pharmacological mechanism research. CONCLUSION The research on Hyssopus cuspidatus Boriss. has entered a stable stage, focusing on the active ingredients, mechanism of action, anti-asthma, anti-inflammation and so on. Cooperation between regions and institutions should be strengthened in the future research process, which is conducive to promoting deeper research . The present study reveals the hotspot evolution and cutting-edge direction of Hyssopus cuspidatus Boriss. research through visual knowledge mapping, which provides a systematic theoretical basis and practical reference for its scientific research innovation and industrial development.