30 April 2026, Volume 46 Issue 4
    

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    Special Column on the R&D Status and Quality Control of Innovative Therapeutic Biologics
  • Quality control methods in quality standards of antibody products
    YU Chuan-fei
    Chinese Journal of Pharmaceutical Analysis. 2026, 46(4): 561-571. https://doi.org/10.16155/j.0254-1793.2026-0133
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    Focusing on the quality control items specified in the quality standards for antibody products, this paper systematically reviews the latest advances in analytical technologies, encompassing the detection of key quality attributes such as size heterogeneity, charge heterogeneity, glycan heterogeneity, biological activity (including binding/functional activity assays and reporter gene-based methods), excipient content, protein content, peptide mapping analysis, and the quantification of host-related residual impurities. The detection principles, key considerations for method development, and applicable scenarios of the aforementioned technologies are detailed. In addition, the technical advantages, core development points, and application progress of multi-attribute monitoring (MAM) technology for the characterization of post-translational modifications are expounded. The quality control methodology system and technical advances of antibody products summarized in this study can provide a valuable reference for the establishment of quality standards, optimization of quality control methods, and stability studies of antibody drugs, and further facilitate the improvement of quality control and regulatory standards in the research, development, and manufacturing of antibody products.
  • Research and consensus on activity evaluation technologies for recombinant enzyme drugs and key enzyme-based raw and auxiliary materials*
    LI Jing
    Chinese Journal of Pharmaceutical Analysis. 2026, 46(4): 572-581. https://doi.org/10.16155/j.0254-1793.2026-0124
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    This paper systematically sorts out the difficulties in the quality control of recombinant enzyme drugs and conducts an in-depth analysis with five categories of representative enzymes as examples. Thrombolytic enzymes (e.g., tenecteplase) have significant disparities in specific activity due to differences in glycosylation and outdated measurement methods, requiring the establishment of standardized methods and clarification of the determinants of activity. The enzymes (e.g., glucocerebrosidase and α-galactosidase A) for enzyme replacement therapy (ERT) of rare diseases exert their pharmacological effects only through receptor-mediated intracellular transport, requiring the establishment of a multi-dimensional evaluation system from biochemical activity to cellular uptake. Recombinant IgG-degrading enzymes with atypical Michaelis-Menten kinetics pose a fundamental challenge to the conventional evaluation system due to their two-step cleavage mechanism. Process enzymes (e.g.,recombinant nuclease) have long faced the dilemma of no pharmacopoeial standards and no national reference materials, requiring gradual advancement from method establishment, reference material development, collaborative calibration to the formation of national standards. Adjuvant enzymes (e.g., recombinant hyaluronidase) are faced with the lack of national reference materials for recombinant products, and some enterprises directly use extracted heterologous standard substances for activity assignment, resulting in the disordered labeling of activity units. In response to the challenges in activity evaluation of the aforementioned recombinant enzyme drugs and key enzyme-based raw and auxiliary materials and through a review of issues identified during the registration testing of representative drugs, findings from systematic research projects, and literature on drug evaluation strategies, this article summarizes key technical points for the development and validation of recombinant enzyme activity assays. These points include optimization of enzyme kinetic parameters, multi-dimensional evaluation strategies for complex mechanisms, precise control of product quantification, and approaches for developing reference materials. The aim is to provide a theoretical basis and technical support for the research, regulatory evaluation, and clinical safe application of innovative recombinant enzyme drugs.
  • Current status in quality research on immune cell-based therapeutic products*
    WU Xue-ling, MENG Shu-fang, ZHANG Ke-hua
    Chinese Journal of Pharmaceutical Analysis. 2026, 46(4): 582-590. https://doi.org/10.16155/j.0254-1793.2026-0129
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    With the rapid iteration of technologies in cell biology and immunology, immune cell-based therapeutic products have entered a stage of rapid development in industrialization and clinical application. Such products possess the dual attributes of both pharmaceuticals and living cells, and their quality research and quality control are significantly more difficult than conventional drugs. This paper systematically sorts out the classification and research progress of immune cell-based therapeutic products. According to the full life cycle management concept specified in ICH Q12 and Q14, the analysis is carried out focusing on three key links: quality research, quality standards, and analytical methods. It summarizes the particularities of such products in terms of quality research and standards compared with conventional drugs, analyzes the deficiencies existing in the current quality research and control system, and puts forward directions for improvement. This paper provides support for the establishment of a standardized quality research and control system for such products and promotes the standardized and high-quality development of China’s immune cell therapy industry.
  • Advances in the research, development and quality control of stem cell-based medicinal products*
    ZHANG Ke-hua, MENG Shu-fang
    Chinese Journal of Pharmaceutical Analysis. 2026, 46(4): 591-601. https://doi.org/10.16155/j.0254-1793.2026-0131
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    Stem cell therapies are currently transitioning from basic research towards industrial translation. Globally, the industrialization of therapies employing induced pluripotent stem cells (iPSC) and gene-edited stem cells is accelerating, with China ranking among the world leaders in terms of the number of registered clinical trial pipelines. However, due to the inherent biological complexity of stem cell-based medicinal products, their quality control is confronted with multidimensional risks, including unintended differentiation, tumorigenicity, and genomic variation. This review systematically outlines the current developmental landscape and risk profiles of stem cell-based medicinal products. Adopting the quality by design principle, this review further elaborates on methodological advances pertaining to pivotal quality control attributes, including cell identity determination, purity assessment, potency evaluation, and safety testing. As the regulatory framework becomes increasingly refined, the integration of quality control measures throughout the entire research and development lifecycle is critical to fostering the high-quality advancement of stem cell-medicinal products.
  • Research and development status and quality control of gene therapy products*
    LIANG Cheng-gang
    Chinese Journal of Pharmaceutical Analysis. 2026, 46(4): 602-613. https://doi.org/10.16155/j.0254-1793.2026-0134
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    In recent years, with the successive approval and market launch of multiple gene therapy products, this field has entered a phase of rapid development. This paper systematically reviews the research and development status as well as quality control of gene therapy products. Through an overview of the current development of gene therapy products and the progress in regulatory frameworks both domestically and internationally, this paper outlines the classification system and discusses the characteristics and clinical advancements of various types of products, including viral vectors, nucleic acid-based drugs, and oncolytic microorganisms. Regarding quality control, this paper expounds layer by layer from raw materials, in-process control, to lot release tests, summarizing common testing indicators and specific quality control considerations for different product types. Taking rAAV-based products as an example, it illustrates the framework of quality standards for viral vectors. Additionally, in light of clinical safety events related to critical quality attributes in recent years, this paper discusses the importance of enhancing quality control for clinical-stage investigational products, aiming to provide a systematic reference for the development and quality evaluation of gene therapy products.
    • Review & Monography
  • Application of palatability evaluation of oral dissolving film (ODF) in process research*
    DU Xin-yi, ZHANG Na, ZHENG Yu-qi, LIU Yang, CHEN Hua, XU Hui, YU Li-ju
    Chinese Journal of Pharmaceutical Analysis. 2026, 46(4): 614-625. https://doi.org/10.16155/j.0254-1793.2025-0370
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    Oral dissolving film (ODF), a novel immediate-release oral dosage form, is characterized by portability and rapid absorption, significantly improving patient medication adherence. Consequently, ODF has attracted widespread attention in the pharmaceutical field in recent years. This review focuses on palatability evaluation methods for ODF and their applications in process research, providing a systematic summary of the relevant progress. In terms of palatability evaluation, this review presents the commonly used methods and research status, including physical indicators (thickness, mechanical properties, disintegration time, dissolution, and adhesion) and sensory indicators (artificial taste testing, electronic tongue, and emerging intelligent sensing technologies), with a comparison of the advantages, disadvantages, and applicable scenarios of various methods. In process research, this review emphasizes the effects of film-forming materials, formulation composition, and preparation processes on the mechanical properties and taste of products, and analyzes how to feed back the palatability evaluation results to process optimization, especially the selection and application of taste-masking technology. Finally, to address the limitations of the current evaluation system, it is proposed that a standardized and multi-dimensional integrated palatability evaluation strategy should be constructed in the future. Therefore, process development can be guided more effectively to promote the clinical transformation and application of ODF technology.
    • Ingredient Analysis
  • Investigating chemical component changes in Saposhnikoviae Radix before and after carbonization based on UHPLC-Q Exactive Orbitrap MS and chemometrics*
    YANG Xin-yi, WANG Tian-run, WANG Chang-shun, PENG Jiang-ning, FAN Li-lan, ZHANG Xue-hong, ZHAO Zhen-xia, LI Hui
    Chinese Journal of Pharmaceutical Analysis. 2026, 46(4): 626-637. https://doi.org/10.16155/j.0254-1793.2025-0422
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    Objective: To systematically characterize and compare the chemical components of Saposhnikoviae Radix and its carbonized product, thereby clarifying the transformation pattern of the material basis during the processing. Methods: Chemical components in Saposhnikoviae Radix were rapidly identified by ultra-performance liquid chromatography-quadrupole-Exactive Orbitrap-mass spectrometry (UPLC-Q Exactive Orbitrap MS) with a mobile phase composed of 0.1% formic acid in water and 0.1% formic acid in acetonitrile for gradient elution and an electrospray ionization (ESI) source operating in the positive ion mode. Compounds were identified based on relative retention time, multistage fragment ion data, and comparison with reference standards and relevant literature reports. With the peak areas from extracted ion chromatograms of components before and after carbonization as the indicator, principal component analysis (PCA) and orthogonal partial least squares-discriminant analysis (OPLS-DA) were performed on the mass spectrum data with SIMCA 14.1 software. Differential components of Saposhnikoviae Radix before and after carbonization were screened based on variable importance in projection (VIP). Subsequently, a heatmap was generated to visually represent the trends of these differential components. Results: A total of 42 chemical components were identified, including 41 in Saposhnikoviae Radix and 42 in carbonized Saposhnikoviae Radix. Both PCA and OPLS-DA score plots demonstrated significant differences in chemical composition before and after carbonization. Furthermore, 20 components with VIP>1 were screened out by OPLS-DA as the major differential components of Saposhnikoviae Radix before and after carbonization. Among the 20 key differential components, 5-hydroxymethylfurfural (5-HMF) was detected exclusively in carbonized Saposhnikoviae Radix. Noreugenin, norcimifugin, fraxidin, isofraxidin, and isoimperatorin along with four other compounds showed increased levels after carbonization, whereas prim-O-glucosylcimifugin, xanthotoxol, phellopterin, psoralen, and imperatorin along with five other compounds exhibited significant decreases. Conclusion: UPLC-Q Exactive Orbitrap MS enables rapid and accurate identification of chemical components in Saposhnikoviae Radix before and after carbonization. While the chemical components remain largely consistent before and after processing, content differences are observed. Analysis of these differential components may provide a basis for screening novel quality markers (Q-markers) of Saposhnikoviae Radix and its carbonized product, as well as elucidating the mechanism behind carbonizing.
  • HPLC fingerprint and determination of eight components in Jingangteng capsules*
    QIAN Jie, LI Shang-ren, DU Xiong-jun, XU Mei-long, FANG En
    Chinese Journal of Pharmaceutical Analysis. 2026, 46(4): 638-647. https://doi.org/10.16155/j.0254-1793.2024-1260
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    Objective: To establish an HPLC fingerprint and a method for determining the content of 8 components (neochlorogenic acid, chlorogenic acid, cryptochlorogenic acid, polydatin, astilbin, oxyresveratrol, quercitrin, and resveratrol) in Jingangteng capsules. Methods: The HPLC fingerprint of Jingangteng capsules was established, followed by similarity evaluation, principal component analysis (PCA), cluster analysis (CA), and orthogonal partial least squares-discriminant analysis (OPLS-DA). The chromatographic separation was performed on a CAPCELL PAK C18 column (250 mm×4.6 mm, 5 μm) with acetonitrile-0.1% phosphoric acid solution as the mobile phase in gradient elution mode. The detection wavelength was set at 303 nm, the column temperature was maintained at 35 ℃,and the flow rate was 1.0 mL · min-1. The content of neochlorogenic acid, chlorogenic acid, cryptochlorogenic acid, polydatin, astilbin, oxyresveratrol, quercitrin, and resveratrol was determined by HPLC. Results: The established HPLC fingerprints of 15 batches of Jingangteng capsules identified 25 common peaks, of which eight were assigned. The similarity ranged from 0.860 to 0.992. PCA, CA, and OPLS-DA classified the samples into three groups, and 10 components were identified as major contributors to the quality variation among the batches. The average content of neochlorogenic acid, chlorogenic acid, cryptochlorogenic acid, polydatin, astilbin, oxyresveratrol, quercitrin, and resveratrol in the 15 batches was 0.995 9, 2.278 1, 1.846 5, 0.172 3, 0.183 8, 0.824 8, 0.277 5,and 0.525 6 mg · g-1, respectively. Conclusion: This method enables efficient and accurate determination of the eight active components in Jingangteng capsules, providing a reference for the quality control of this preparation.
  • Quality differences of Aurantii Fructus Immaturus from Jiangxi before and after stir-frying with wheat bran*
    ZHOU Jia-lin, ZHOU Wei, YAO Ying-ping, WU Yu-long
    Chinese Journal of Pharmaceutical Analysis. 2026, 46(4): 648-658. https://doi.org/10.16155/j.0254-1793.2025-0446
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    Objective: To establish a method for controlling the quality difference of Aurantii Fructus Immaturus from Jiangxi before and after stir-frying with wheat bran. Methods: A Hypersil GOLDTM C18 chromatographic column (250 mm×4.6 mm, 5 μm) was used, the column temperature was 30 ℃. The mobile phase was acetonitrile -0.05% phosphoric acid aqueous solution, with a flow rate of 1.0 mL · min-1. The detection wavelengths were set at 283 nm and 320 nm, and the injection volume was 20 μL. The chromatographic fingerprints of Aurantii Fructus Immaturus from Jiangxi before and after bran-frying were established by the traditional Chinese medicine chromatographic fingerprint similarity evaluation system. Chemical pattern recognition analysis was applied to reduce the dimensionality of fingerprint data to screen the marker components responsible for fingerprint differences, so as to analyze the changes in main chemical constituents of Aurantii Fructus Immaturus from Jiangxi before and after processing. This study provides a reference for the processing mechanism and pharmacodynamic research of Aurantii Fructus Immaturus from Jiangxi. The chemical pattern recognition method was employed to perform dimensionality reduction analysis on fingerprint data, on the basis of which the characteristic components that cause differences in fingerprints were explored. Furthermore, the changes in the main chemical components of Aurantii Fructus Immaturus from Jiangxi before and after stir-frying with wheat bran were analyzed. The results were expected to provide a reference for the processing and pharmacological research of Aurantii Fructus Immaturus from Jiangxi. Results: The similarity of HPLC fingerprints of 10 batches of Aurantii Fructus Immaturus from Jiangxi before and after stir-frying with wheat bran was analyzed. The fingerprints of Aurantii Fructus Immaturus from Jiangxi showed 26 common peaks, with the similarity of 0.927-0.996, and those of Aurantii Fructus Immaturus from Jiangxi after stir-frying with wheat bran showed 33 common peaks, with the similarity of 0.969-0.997. The chemometrics analysis classified the 20 samples into two groups and screened out 9 differential components, among which 7 compounds were determined for content. After stir-frying with wheat bran, the content of nobiletin and tangeritin increased (P<0.05), while that of rhoifolin, narirutin, hesperidin, naringin, and neohesperidin decreased (P<0.05). Conclusion: In summary, the established method has good accuracy and reliable stability, which can provide a scientific reference for the quality control of processed Aurantii Fructus Immaturus from Jiangxi.
    • Bioassay·Activity Analysis
  • Purity determination of recombinant elastin by high-performance size-exclusion chromatography
    LI Ran, ZHOU Hao, LU Han-ya, LIU Xin, HOU Zeng-miao, YANG Lu
    Chinese Journal of Pharmaceutical Analysis. 2026, 46(4): 659-664. https://doi.org/10.16155/j.0254-1793.2025-0386
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    Objective: This paper aims to establish a high-performance size-exclusion chromatography method for the purity determination of recombinant elastin. Methods: TSKgel G2000 SWxl (300 mm×7.8 mm, 5 μm) column was used, and the phosphate buffer with 0.05 mol · L-1 was used as the mobile phase at a flow rate of 0.7 mL · min-1.The column temperature was maintained at 25 ℃, and the detection wavelength was 200 nm. The method was validated for system suitability, specificity, precision, linearity, and durability, and the detection limit and quantitation limit were determined, which was applied to the purity determination of raw materials of recombinant elastin. Results: The resolution between the peak of recombinant elastin and the adjacent impurity peak was greater than 1.5, and the peak tailing factor was less than 1.5. The blank solvent did not interfere with the detection of the target protein. The purity RSD of the recombinant elastin peak in the precision verification was less than 5%. The quantification limit was 2.28 μg · mL-1, and the detection limit was 0.68 μg · mL-1. The purity of three batches of raw materials of recombinant elastin was all more than 95%. Conclusion: The method exhibits strong specificity and good precision, which can be used as an analytical method for routine quality control.
  • Revealing the mechanism of blood-absorbed components of Lingzhu Huazhuo formula in ameliorating chronic atrophic gastritis based on UPLC I-Class/Q Exactive-Orbitrap MS and bioinformatics*
    GAO Fan, MO Xiao-xuan, XU Feng-yue, TIAN Jia-ye, ZHAO Xin-meng, LIU Xing-chao, GUO Qiu-hong
    Chinese Journal of Pharmaceutical Analysis. 2026, 46(4): 665-683. https://doi.org/10.16155/j.0254-1793.2025-0402
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    Objective: To predict the core targets and pathways of Lingzhu Huazhuo formula in preventing and treating chronic atrophic gastritis based on UPLC I-Class/Q Exactive-Orbitrap MS and network pharmacology, validate the results through molecular docking and molecular dynamics, and explore the molecular mechanisms of the anti-inflammatory effects of the blood-absorbed components of this formula. Methods: A Waters UPLC HSS T3 column (100 mm×2.1 mm, 1.8 μm) was used at a column temperature of 40 ℃. The mobile phase consisted of solvent A (water containing 0.1% formic acid) and solvent B (methanol) at a flow rate of 0.3 mL · min-1. The gradient elution program was set as follows: 0-1.0 min, 2%B; 1.0-41.0 min, 100%B; 41.0-50.0 min, 100%B; 50.0-50.1 min, 2%B; 50.1-52.0 min, 2%B. The injection volume was 10.0 μL. A quadrupole-Orbitrap mass spectrometer (Q Exactive™) equipped with an electrospray ionization source was employed. The ion source voltages were set at 3.7 kV for the positive ion mode and 3.5 kV for the negative ion mode, with a mass-to-charge (m/z) ratio scanning range of 100-1 500. The chemical components and the blood-absorbed components in Lingzhu Huazhuo formula were identified by comparison of retention time, molecular weights, and MS2 fragment ions with reference standards and literature data. Targets corresponding to these components were screened via databases such as TCMSP. Chronic atrophic gastritis-related targets were obtained from OMIM, TTD, DisGeNET, and other databases. A “Lingzhu Huazhuo formula-active component-target” network was constructed, followed by protein-protein interaction analysis and GO/KEGG enrichment analysis. Molecular docking and molecular dynamics were adopted for validation. Results: UPLC I-Class/Q Exactive-Orbitrap MS identified 45 chemical components and 21 blood-absorbed components. These components synergistically acted on 33 targets, which were involved in 231 biological processes, including collagen decomposition, cellular response to reactive oxygen species, and inflammatory response and participated in 68 signaling pathways such as epidermal growth factor receptor, relaxin, tumor necrosis factor, and IL-17. Core targets included serine/threonine kinase AKT1, PTGS2, matrix metalloproteinase 2, steroid receptor coactivator, matrix metalloproteinase 3, and IL-1β. Molecular docking showed that 6-epi-augustifolin and guidongnin had high binding activity with PTGS2. Molecular dynamics simulation further confirmed that both compounds exhibited good structural stability and binding affinity with PTGS2. Conclusion: Through serum pharmacochemistry, network pharmacology, and molecular dynamics, this study reveals the material basis and mechanism of Lingzhu Huazhuo formula in ameliorating chronic atrophic gastritis, providing a scientific basis for the mechanism research and clinical application of this formula.
    • Safety Monitoring
  • Determination of safrole compounds in Shidishui by GC-HRMS and GC-QQQ*
    ZHANG Li, ZHAO Yi-han, LIU Yi-ning, PANG Qing-lin, ZHANG Yu-lin
    Chinese Journal of Pharmaceutical Analysis. 2026, 46(4): 684-690. https://doi.org/10.16155/j.0254-1793.2024-1145
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    Objective: To establish a precise gas chromatography-mass spectrometry method for the determination of safrole compounds (safrole, isosafrole, and dihydrosafrole) in Shidishui. Methods: The sample was extracted with ethyl acetate on an HP-5MS capillary chromatographic column (30 m×0.25 mm, 0.25 μm) with temperature programming. The injector temperature was 250 ℃, helium was used as the carrier gas at a flow rate of 1.0 mL · min-1,and the injection volume was 1.0 μL in splitless mode. Qualitative analysis was performed by gas chromatography-high resolution mass spectrometry (GC-HRMS) with an EI ion source (70 eV) at 270 ℃, operating in full scan mode over an m/z range of 50-400. Quantitative analysis was performed by gas chromatography-triple quadrupole mass spectrometry (GC-QQQ) with an EI ion source (70 eV) at 230 ℃, using multiple reaction monitoring (MRM) mode. Results: Excellent linearity was achieved for safrole in the concentration range of 2-400 ng · mL-1 and for isosafrole and dihydrosafrole in the range of 0.8-80 ng · mL-1, with correlation coefficients (r) of 0.999 9 for all. The limits of detection (LODs) for safrole, isosafrole, and dihydrosafrole by GC-HRMS were 0.04, 0.4, and 0.5 ng · mL-1,respectively. The LODs by GC-QQQ were 0.02, 0.5, and 0.5 ng · mL-1, and the limits of quantitation for safrole, isosafrole, and dihydrosafrole were 0.06, 1.7, and 1.7 ng · mL-1, respectively. The average recoveries were 100.5%, 80.8%, and 104.0% with relative standard deviations (RSDs, n=6) of 1.1%, 2.0%, and 1.9%, respectively. Sample analysis showed that safrole was detected in all 187 batches of Shidishui at concentrations ranging from 0.03 to 4.4 μg · mL-1. Dihydrosafrole was detected in 135 batches with concentrations ranging from 0.000 6 to 0.5 μg · mL-1. Isosafrole was not detected in any sample. Conclusion: This method is accurate, simple, and highly sensitive, making it suitable for the determination of safrole, isosafrole, and dihydrosafrole in Shidishui, thereby ensuring the safe use of Shidishui.
  • Determination of the droplet size distribution of midazolam nasal spray by laser diffraction*
    KONG Yin-di, WANG Gui-tao, CHEN Zhen, JIANG Xiao-long, XU Xiang-yang, DONG Da-wen
    Chinese Journal of Pharmaceutical Analysis. 2026, 46(4): 691-698. https://doi.org/10.16155/j.0254-1793.2025-0222
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    Objective: To establish a laser diffraction method for determining the droplet size distribution of midazolam nasal spray, perform method validation, and apply the validated method for comparative analysis between the in-house preparation and the reference listed drug. Methods: Parameters including the linear velocity, hold time, contact force, retract force of the automatic press trigger, as well as the acquisition frequency, lens, measurement duration, measurement trigger, transmission, optical model, orientation, spray distance, spray angle, nozzle-to-lens distance, and analysis window of the spray particle size analyzer were configured. The droplet size distribution of midazolam nasal spray was measured at spray distances of 30 mm and 60 mm from the actuator orifice. The established method was validated for repeatability, intermediate precision, and robustness. Results: At spray distances of 30 and 60 mm, the relative standard deviations (RSDs) for the droplet size distribution parameters (Dv10, Dv50, Dv90, and Span) from six replicate measurements ranged from 1.6% to 9.5%, all below 50%. The ratios of the mean values obtained from intermediate precision experiments to those from repeatability experiments ranged from 97.60% to 107.15%, all within 60% to 140%. Robustness testing, conducted by varying parameters such as actuation speed, transmission, spray angle, and nozzle-to-lens distance, yielded droplet size distribution results with ratios to those obtained under standard conditions ranging from 86.91% and 139.19%, all within 60% to 140%. The validated method was successfully applied to formulation screening and device selection of the in-house preparation. The final in-house preparation exhibited droplet size distribution profiles similar to those of the reference listed drug. At spray distances of 30 mm and 60 mm, the mean results complied with the specified acceptance criteria (Dv10≥10 μm, 40 μm≤Dv50≤250 μm, Dv90≤450 μm, Span≤3). Conclusion: The established method demonstrates satisfactory repeatability, intermediate precision and robustness in accordance with the test objectives. It provides a reference for quality consistency control of nasal sprays based on droplet size distribution and can be applied to formulation and device screening.
  • Identification of Cymini Fructus and its adulterants based on HPLC characteristic chromatogram and QAMS*
    JIN Wan-jun, LIN Rui-li, MA Xiao, ZHANG Ming-tong, CHANG Qi
    Chinese Journal of Pharmaceutical Analysis. 2026, 46(4): 699-708. https://doi.org/10.16155/j.0254-1793.2025-0379
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    Objective: To establish HPLC characteristic chromatogram for differentiating Cymini Fructus from its common adulterants (including Anethi Fructus, Foeniculi Fructus and Carvi Fructus), and to develop a multi-component quantitative determination method for Cymini Fructus based on quantitative analysis of multi-components by single marker (QAMS). Methods: The chromatographic separation was performed on a SVEA C18 column (250 mm×4.6 mm, 5 μm) maintained at 30 ℃. The mobile phase consisted of acetonitrile and 0.5% aqueous acetic acid with gradient elution at a flow rate of 1.0 mL · min-1. The detection wavelength was 334 nm, and the injection volume was 10 μL. A characteristic chromatogram of Cymini Fructus was established to differentiate it from the common adulterants, namely Anethi Fructus, Foeniculi Fructus and Carvi Fructus. Furthermore, using the quantitative analysis of multi-components by single marker (QAMS) technique, bioactive components—chlorogenic acid, luteoloside, luteolin, apigenin, and luteolin-7-O-β-D-glucuronide—were simultaneously quantified, with apigenin-7-O-β-D-glucopyranoside as the internal reference. Results: By comparing the characteristic chromatograms of Cymini Fructus, Anethi Fructus, Carvi Fructus, and Foeniculi Fructus samples, it was found that the eight characteristic peaks were all present in Fructus Cymini, whereas only partial characteristic peaks appeared in the other samples. Consequently, a characteristic HPLC chromatogram for Cymini Fructus was established, designating the apigenin-7-O-β-D-glucopyranoside peak and requiring the detection of eight characteristic peaks. The QAMS method and the external standard method (ESM) were applied to determine the content of apigenin-7-O-β-D-glucopyranoside, chlorogenic acid, luteoloside, luteolin, apigenin, and luteolin-7-O-β-D-glucuronide in 20 batches of Cymini Fructus samples. All six constituents exhibited good linearity within their respective concentration ranges (r≥0.999 0). The average recoveries ranged from 95.9%-101.1%, with relative standard deviations (RSDs) ranging from 0.32% to 1.1%. The content ranges of chlorogenic acid, luteoloside, luteolin, apigenin, luteolin-7-O-β-D-glucuronide, and apigenin-7-O-β-D-glucopyranoside in the 20 batches of samples, as determined by the QAMS method, were 0.373-1.877, 1.971-8.033, 0.356-1.350, 0.187-1.397, 0.111-0.342, and 3.255-14.030 mg · g-1, respectively. These results were in close agreement with those obtained via ESM, showing no statistically significant difference (P>0.05). Conclusion: The established characteristic chromatogram enables unambiguous discrimination of Cymini Fructus from its prevalent adulterants Anethi Fructus, Foeniculi Fructus, and Carvi Fructus. The developed QAMS-based method for Cymini Fructus is stable and reliable, rendering it suitable for the quality control of Cymini Fructus.
    • Quality Control
  • Relationships between ecological factors and quality of Codonopsis Radix*
    WANG Pan, PAN Liang, LIU Sha, LIU Fu-song, CHEN Bi-jun, ZHANG De-lin, PENG Jie, WANG Hua-dong, WU Fa-ming
    Chinese Journal of Pharmaceutical Analysis. 2026, 46(4): 709-719. https://doi.org/10.16155/j.0254-1793.2024-1151
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    Objective: To explore the key ecological factors influencing the variations in the traits and representative component content of Codonopsis Radix (the dried root of Codonopsis pilosula (Franch.) Nannf.), thus providing a scientific basis for high-quality and high-yield cultivation and provide guidance for introduction and domestication of this medicinal herb. Methods: The traits (root length, infraglottal diameter, number of branched roots, fresh weight, dry weight, and drying rate) and the content of representative components (extract, soluble amino acids,polysaccharides, tryptophan, syringin, tangshenoside Ⅰ, lobetyolin, and atractylenolide Ⅲ) in Codonopsis Radix samples of various origins were determined. Additionally, 13 ecological factors covering geography, climate, and soil physicochemistry were also measured. A comprehensive analysis was conducted based on principal component analysis (PCA), grey relational analysis, and stepwise regression analysis to identify the key ecological factors influencing the quality of Codonopsis Radix. Results: Different origins had varying altitudes, climates, and soil physicochemical parameters. The soil samples had pH 3.9-7.9, bring acidic to neutral overall, with some samples being weakly alkaline. PCA results indicated that altitude, mean annual rainfall, mean annual air temperature, soil organic matter, and soil available nitrogen were the primary ecological factors. Grey relational analysis indicated that the dominant ecological factors influencing Codonopsis Radix quality were longitude, latitude, mean annual sunshine duration, mean annual air pressure, mean annual air temperature, mean annual humidity, mean annual rainfall, and soil pH. Multivariate stepwise regression analysis identified altitude, mean annual sunshine duration, mean annual air pressure, mean annual humidity, mean annual rainfall, soil pH, soil organic matter, available phosphorus, and available nitrogen as significantly ecological factors influencing Codonopsis Radix quality. Conclusion: The findings of this study offer recommendations for raising the quality of Codonopsis Radix and introducing, cultivating, and domesticating the medicinal herb.
  • Comprehensive quality evaluation of propranolol hydrochloride tablets based on multivariate statistical analysis combined with entropy-weight TOPSIS method
    LU Li, SHAO Fang-xian, XU Hui, HUANG Chao-yu, YAN Fei, LI Rui
    Chinese Journal of Pharmaceutical Analysis. 2026, 46(4): 720-729. https://doi.org/10.16155/j.0254-1793.2025-0378
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    Objective: To comprehensively evaluate propranolol hydrochloride tablets manufactured by different generic pharmaceutical enterprises based on the 2024 national drug sampling and inspection program by adopting multivariate statistical analysis and the entropy weight technique for order preference by similarity to an ideal solution (TOPSIS) method, thereby providing a scientific basis for the overall quality improvement of this pharmaceutical variety and offering a methodological reference for the comprehensive quality evaluation of chemical drugs. Methods: The key quality indicators of 178 nationally sampled batches from 6 generic manufacturers were determined, including related substances (total impurity content: 0.092%-0.23%), dissolution rate (96.00%-99.84%), content uniformity (95.97%-99.84%), and content (98.11%-100.4%). Multivariate statistical methods comprising principal component analysis (PCA) and partial least squares-discriminant analysis (PLS-DA) were adopted to screen the critical quality indicators affecting propranolol hydrochloride tablets and cluster analysis was performed on samples from different manufacturers. Furthermore, the entropy weight TOPSIS method was used to analyze the critical quality indicators and rank the overall quality of the samples accordingly. Results: Differences in critical quality indicators could distinguish products from different generic manufacturers. Quality discrepancies existed among samples of various manufacturers, which were mainly attributed to the stability differences in production processes. Conclusion: The combined application of PCA, PLS-DA, and entropy weight TOPSIS yields scientific, reasonable, accurate, and reliable results. This integrated method can objectively reflect the quality differences of propranolol hydrochloride tablets from various manufacturers, and it is of great significance for sample quality control and the overall quality evaluation of this pharmaceutical variety.
    • Standard Deliberation
  • Study on the quality control method of Lingnan geo-authentic medicinal material Pandanus tectorius*
    JIANG Hui-ling, AN Ya-ling, LIU Xiao-kang, XIA Ti-yu, FENG Lin, LI Zhen-wei, ZHANG Dai-di, LAI Min-ling, PENG Li-hua, GUO De-an
    Chinese Journal of Pharmaceutical Analysis. 2026, 46(4): 730-738. https://doi.org/10.16155/j.0254-1793.2025-0431
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    Objective: To improve the quality standard of Pandanus tectorius, a geo-authentic medicinal material, a systematic investigation on its quality control methods was performed in this study. Methods: According to the general principles of the 2025 edition of the Pharmacopoeia of the People’s Republic of China (Part Ⅳ), the moisture and total ash of the medicinal materials were examined, and the content of the water-soluble extract was determined. A TLC-based identification method was established for the authentication of Pandanus tectorius. Based on the HPLC method, the characteristic chromatogram of Pandanus tectorius was established. Using chlorogenic acid as an internal reference, a method for the simultaneous determination of six components in Pandanus tectorius by quantitative analysis of multi-components with a single marker (QAMS) was established. Results: The moisture content, total ash content and water-soluble extract content of 11 batches of Pandanus tectorius were 0.8%-8.6%, 2.4%-6.1% and 10.3%-23.0%, respectively. TLC showed good specificity, and chromatograms from multiple production batches demonstrated spots with matching colors. The similarity of the HPLC characteristic chromatogram of Pandanus tectorius was 0.834-0.990, and 6 common peaks were identified. The RCFs of chlorogenic acid to neochlorogenic acid, cryptochlorogenic acid, isochlorogenic acid B, isochlorogenic acid A, and isochlorogenic acid C were 0.980, 1.035, 0.861, 0.788 and 0.817, respectively. The contents of the six components, as determined by QAMS and the external standard method, were consistent. In this study, the content ranges of the six constituents in 11 batches of Pandanus tectorius were as follows: neochlorogenic acid (0.009%-0.195%), chlorogenic acid (0.008%-0.276%), cryptochlorogenic acid (0.008%-0.174%), isochlorogenic acid B (0.007%-0.073%), isochlorogenic acid A (0.020%-0.101%), and isochlorogenic acid C (0.005%-0.057%). Conclusion: This study systematically establishes a quality control method for Pandanus tectorius, providing an experimental basis for the improvement of its quality standards.
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