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  • Yue HUANG, Fangzhou LIU, Yifei ZHAO, Yuerui LI, Guohui BAI, Huan HU
    Chinese Pharmaceutical Journal. 2025, 60(2): 153-165.

    "Osteoimmunology" is a field that emphasizes the interaction between the immune system and skeletal system cells. Specifically, it explores how dysregulation of the immune system can result in inflammatory stimulation and the release of inflammatory factors, which significantly impact bone metabolism. Periodontitis is an inflammatory destructive disease of periodontal tissue, triggered initially by dental plaque and influenced by host immune inflammatory responses, genetic factors, and environmental factors. Inflammatory response and alveolar bone resorption stand out as prominent features of periodontitis, with immune system imbalance disrupting bone homeostasis, resulting in alveolar bone loss due to the imbalance of bone formation and resorption. Flavonoid natural products exhibit biological activities such as anti-inflammatory, antioxidant, osteogenic promotion, and antimicrobial effects, effectively ameliorating inflammatory damage to periodontal tissues. This paper provides an overview of nine classical inflammatory signaling pathways potentially involved in alveolar bone inflammatory resorption and reviews advancements in the mechanisms of action of 20 flavonoids reported for inhibiting periodontal tissue destruction associated with periodontitis by suppressing inflammatory responses and modulating inflammatory signaling pathways. The aim is to offer theoretical foundations and novel insights to enhance the treatment strategy of periodontitis.

  • Yulong DUAN, Longshan ZHAO
    Chinese Pharmaceutical Journal. 2025, 60(2): 166-171.

    OBJECTIVE To establish a method for determining the entrapment efficiency of alprostadil injection, compare the differences between ultrafiltration centrifugation and microcolumn centrifugation methods for determining the entrapment efficiency of alprostadil injection, and select the optimal method. METHODS High pressure homogenization method was used to prepare alprostadil injection. Ultrafiltration membrane with different molecular weights were used to establish the ultrafiltration centrifugation method by selecting the centrifugation speed and time. The micro column was prepared with Sephadex G-50, and the encapsulated and free drugs were separated by centrifugal elution. The separation effect was evaluated by establishing the elution curve of soybean oil and free alprostadil. At the same time, the difference between different elution solvents was investigated, the optimal elution solvent was screened, and the microcolumn centrifugation method was established. The drug content was determined by high-performance liquid chromatography and post column derivatization device, and the entrapment efficiency was calculated. RESULTS The entrapment efficiency of three batches of alprostadil injection measured by ultrafiltration centrifugation method ranged from 98.6% to 99.5%, while the entrapment efficiency measured by microcolumn centrifugation method ranged from 89.5% to 91.3%. CONCLUSION The results of the ultrafiltration centrifugation method for determining the entrapment efficiency are too high and not suitable for the determination of the entrapment efficiency of this product. The microcolumn centrifugation method using glycerol aqueous solution as the eluting solvent is suitable for the determination of the entrapment efficiency of this product.

  • Yuan LIU, Zhiyuan NING, Chenxi LU, Zhiyong CHEN, Hui REN, Feifei REN, Xia DU
    Chinese Pharmaceutical Journal. 2025, 60(2): 172-179.

    OBJECTIVE To establish a quantitative analysis of multi-components by single marker (QAMS) for the simultaneous determination of hypoxanthine, vanillic acid, magnolithine, demethyleneberberine, Columbamine, Jatrorrhizine hydrochloride, coptisine hydrochloride, palmatine hydrochloride and berberine hydrochloride in Xiaoxianxiong decoction. METHODS The separation was performed on a Spursil C18 column (4.6 mm×250 mm, 5 μm) with acetonitrile and 0.05 mol·L-1 potassium dihydrogen phosphate solution plus phosphoric acid adjusted to pH=4.0 as the mobile phases. Detection wavelength: 0-20 min: 290 nm; 20-45 min: 300 nm, column temperature 30 ℃, injection volume 10 μL. Using berberine hydrochloride as the internal reference material, the relative correction factors of the remaining eight components were calculated and the content of each component was calculated, and the results were compared with those of the external standard method (ESM) and the QAMS method. The differences between the results of the external standard method (ESM) and QAMS method were compared. RESULTS The nine components of Xiaoxianxiong decoction showed a good linear relationship with peak area in a certain concentration range (r>0.998 0), with the average spiked recoveries of 94.36%-105.57% and the RSD was 0.52%-3.48%, and the results of component contents determined by QAMS and ESM were not statistically significant. CONCLUSION The results of the established QAMS for Xiaoxianxiong decoction are accurate and reliable, and the method is simple and easy to be applied to the quality control of Xiaoxianxiong Decoction.

  • Zhengyuan SHI, Jie XIE, Ziying LI, You JIANG, Xiqiao XU, Chunjing YANG, Yanwei FU, Dan YAN
    Chinese Pharmaceutical Journal. 2025, 60(2): 180-183.

    OBJECTIVE To analyze the consistency and correlation between UHPLC-MS/MS and chemiluminescence microparticle immune assay (CMIA) in measuring vancomycin concentration in serum.METHODS The concentration of vancomycin was measured by UHPLC-MS/MS and CMIA methods respectively in 95 serum samples of patients receiving vancomycin treatment. A correlation analysis and an agreement analysis were conducted for the two methods used linear regression and Bland-Altman method. RESULTS Based on the results of UHPLC-MS/MS(x) and CMIA(y), the linear regression equation was determined as follows: y=1.088x+0.174. Spearmen correlation analysis indicated a significant correlation between the results by the two methods (P<0.05), and the Spearmen correlation coefficient was 0.969 1. There was statistical difference between vancomycin serum concentrations measured by these two methods. The result was higher by CMIA compared with UHPLC-MS/MS. CONCLUSION The results of the two methods can be calculated to one another by equation, which provides reference for the formulation of clinical individualized medication plan.

  • Yawen WANG, Xuefan CHEN
    Chinese Pharmaceutical Journal. 2025, 60(2): 184-188.

    OBJECTIVE To develop a quantitative proton nuclear magnetic resonance (qHNMR) method for the determination of 1,2-dioleoyl-sn-glycero-3-phosphocholine (DOPC). METHODS A Bruker AVANCE Ⅱ 600 MHz NMR resonance spectra was utilized to acquire the NMR spectra of DOPC. The compound 1,3,5-trimethoxybenzene served as the internal standard, deuterated chloroform as the solvent, with 30° pulses, 16 scans, a test temperature of 25 ℃, and an acquisition time (AQ) of 5 s. The relaxation delay time (D1) was set at 35 s for quantitative analysis of DOPC. RESULTS The sample's 1H-NMR spectra displayed a methyl proton signal at chemical shift δ 0.87; the quantitative peak signals of DOPC and internal standard were well resolved on the 1H-NMR spectra with good linear relationship for DOPC (r>0.9996). The method demonstrated accuracy and repeatability with DOPC content ranging from 96.7% to 98.7%, consistent with results obtained from phosphomolybdic acid colorimetry. CONCLUSION The established qHNMR method accurately quantifies DOPC, is faster than the classical phosphomolybdate colometry method, requires no complex pretreatment operations.

  • Yan CHEN, Yana HU
    Chinese Pharmaceutical Journal. 2025, 60(2): 189-193.

    OBJECTIVE To investigate the effects of DL-3-n-butylphthalide (NBP) soft capsules combined with levodopa and benserazide (LB) on the motor function and serum homocysteine (Hcy) and insulin-like growth factor 1 (IGF-1) levels in elderly patients with Parkinson's disease (PD). METHODS One hundred elderly patients with mid to late-stage PD admitted to our hospital from March 2021 to March 2023 were included in this retrospective study and divided into control group (n=50) and observation group (n=50) based on different treatment methods. The control group received treatment with LB, while the observation group received treatment with LB and NBP soft capsules for a duration of 1 year. The clinical efficacy, Unified Parkinson's Disease Rating Scale (UPDRS) scores, Hoehn-Yahr stage, UPDRS-Ⅲ scores, serum Hcy levels, and IGF-1 levels before and after treatment were compared. RESULTS The clinical effect of the observation group was dramatically better than that of the control group (P<0.05). After 1 year of treatment, both groups showed significant reduction in UPDRS scores, Hoehn-Yahr stage, and UPDRS-Ⅲ scores compared to baseline. Furthermore, the observation group had dramatically lower UPDRS scores, Hoehn-Yahr stage, and UPDRS-Ⅲ scores compared to the control group (P<0.05). After 1 year of treatment, serum Hcy levels were dramatically lower in the observation group compared to the control group, while serum IGF-1 levels were dramatically higher (P<0.05). CONCLUSION In elderly patients with mid to late-stage PD, NBP soft capsules combined with LB can significantly reduce serum Hcy levels, increase IGF-1 levels, and improve motor function in patients with PD.

  • Jinsheng GAO, Lei GAN, Ying LIU, Xiaoning HE
    Chinese Pharmaceutical Journal. 2025, 60(2): 194-200.

    OBJECTIVE To evaluate the efficacy and cost-effectiveness of enarodustat in the treatment of renal anemia in non-dialysis patients. METHODS A matched-adjusted indirect comparison of the efficacy of enarodustat and roxadustat was conducted based on their respective phase Ⅲ clinical trials, and the results were used for cost-utility analysis of enarodustat in the treatment of renal anemia in non-dialysis patients. The robustness of the incremental cost-effectiveness ratio was verified through sensitivity analysis and scenario analysis. RESULTS After matching and adjusting the baseline characteristics of the trial population, it was shown that enarodustat was able to significantly increase the proportion of subjects with average hemoglobin ≥10.0 g·dL-1 at weeks 7-9 compared with roxadustat (73.5% vs 61.0%, MD=12.5%, P<0.001); the results of cost-utility analysis showed that compared with roxadustat, enarodustat increased patients' quality-adjusted life years and saved costs, making it an absolutely superior solution.CONCLUSION Compared with roxadustat, enarodustat is more effective and economical in treating renal anemia in patients with non-dialysis chronic kidney disease.

  • Xinyue LI, Jingwen HE, Yi WU, Ruichen MAO, Rong JIANG, Rong SHAO
    Chinese Pharmaceutical Journal. 2025, 60(2): 201-206.

    OBJECTIVE To identify the factors affecting the efficiency of the review and approval process of innovative drugs based on the industrial perspective to provide reference for further strengthening the capacity building and accelerating the review and approval of the marketing of innovative drugs. METHODS Using the grounded theory, this study conducted semi-structured interviews with 15 experts in the field of drug registration from March to May 2023, and Nvivo node coding was used as a traction to construct a model of factors influencing the efficiency of China's innovative drug marketing review and approval. RESULTS We have extracted 14 initial concepts, six initial areas and three main areas, i.e., “review and approval of institutional and team building”“accelerated assessment and approval policies” and “drug technological guidance system”. CONCLUSION The efficiency of review and approval of the marketing of innovative drugs in China is constrained by a variety of factors, and under the industrial perspective, accelerated assessment and approval policies, review and approval team building, and drug technological guidance system still need to be improved and optimized especially.

  • Zhuoran SUN, Yanqiu GU, Dan JIA, Yifeng CHAI, Xiaofei CHEN
    Chinese Pharmaceutical Journal. 2025, 60(1): 1-8.

    Bioaffinity monolithic chromatography is a chromatographic technology developed by combining the latest advances in biology, hylology and chemical analysis. Based on the basic principle of biological affinity, monolithic materials were used to prepare stationary phase, which can simulate intermolecular interactions in vivo to screen and purify active substances. This technology can specifically customize analysis methods for different target active substances and has been widely used in multiple research fields in pharmacy, chemistry and biology. This article focuses on the preparation methods of monolithic columns, systematically reviews the selection for chromatographic columns, as well as the strategies for affinity ligand immobilization such as covalent binding of biomolecules and biological labels. It also summarizes the relevant applications and development directions of bioaffinity monolithic columns in the preparation of active proteins and drug/biological analysis.

  • Chao LI, Huan ZHANG, Chenfeng JI
    Chinese Pharmaceutical Journal. 2025, 60(1): 9-20.

    Platycodonis Radix is a traditional Chinese medicine as homology of medicine and food, and it has the functions of clearing pharynx, moistening throat, regulating immune system, assisting in lowering blood sugar and blood lipid. Platycodonis Radix contains saponins, flavonoids, phenols, polyacetylenes, polysaccharides and other chemical components. Modern pharmacological studies have demonstrated that Platycodonis Radix has anti-tumor, anti-oxidation, anti-obesity, anti-diabetes and other biological activities. In addition, Platycodonis Radix has high value in medicinal and healthcare, so it is of great significance to strengthen the development of Platycodonis Radix healthy products. This paper summarizes the research progress of Platycodonis Radix from three aspects as chemical composition, pharmacological action and modern application, which can provide some valuable references for the comprehensive utilization and development of Platycodonis Radix.