Traditional Chinese medicine (TCM) is characterized by complex actions involving multiple components, multiple targets, and holistic regulation. Conventional two-dimensional cell models and animal models have obvious limitations in simulating human physiological environments, elucidating pharmacodynamic mechanisms, and evaluating safety. Organoids and organ-on-a-chip, as emerging three-dimensional in vitro model technologies, can recapitulate human tissue structure and function in humanized and dynamic microenvironments, thereby providing a brand-new experimental platform for TCM research. This review systematically outlines the basic principles and technological advances of organoids and organ-on-a-chip, with a focus on their current applications in TCM safety evaluation, screening of active ingredients and herbal formulas, pharmacodynamic mechanism elucidation, and anti-tumor personalized therapy, and further discusses their potential roles in TCM drug development. On this basis, the major challenges currently faced by these technologies are analyzed, including insufficient model maturity, lack of standardization and verification system, as well as poor adaptability to the complex nature of TCM. Future directions integrating multi-omics and artificial intelligence are also discussed. Organoid and organ-on-a-chip technologies hold promise for promoting more systematic and precise TCM research, with significant potential in TCM drug development and quality control, thereby accelerating the modernization and internationalization of TCM.

Objective: To investigate the equivalence of a rapid sterility testing method in cell therapy products with the sterility testing method outlined in the Pharmacopoeia of the People’s Republic of China, providing insights for the validation of alternative sterility testing methods. Methods: :Following the guidelines of the General Principles 9201 Microbial Examination of Drugs in the Chinese Pharmacopoeia and other relevant technical guidance documents, statistical analysis techniques were employed to methodologically validate the rapid sterility testing method based on respiratory signal detection using the seven specified test strains in the Chinese Pharmacopoeia. Parameters such as method applicability, specificity, detection limit, reproducibility, and robustness were evaluated. Results: The rapid testing method utilized direct inoculation with a volume of 5 mL per bottle. The chi-square test for comparison of the rapid testing method with the pharmacopoeial method showed no significant difference in specificity, limit of detection, reproducibility, or robustness between the two methods under corresponding test conditions (P>0.05). The limit of detection of the rapid testing method was determined to be 1-2 cfu · mL^-1. Under reproducibility test conditions, the detection time (to positive result reporting) fell within the range of 90% to 110% of the mean, except for Bacillus cereus with a 10-mL inoculum volume, where the detection time (57 h) did not meet the requirements. Conclusion: The rapid testing method based on automatic instrument monitoring offers advantages in terms of testing cycle, data integrity, and operational processes. It can replace the pharmacopoeial method for sterility testing of cell therapy products. Manufacturers are advised to adhere to the concept of quality by design, considering factors such as process control, production processes, sterility assurance levels, microbial contamination risks, and user benefit risks when formulating product release strategies.

Objective: To comprehensively characterize the adaptively evolved epidemic strains of Bordetella pertussis at gene and protein levels via RNA sequencing and liquid chromatography-tandem mass spectrometry, investigate characteristic variations of the strains under China’s pertussis vaccination background, and analyze the functional impacts of these changes based on in vivo experimental findings. Methods: Two major epidemic strains (BRK197 and BRK202) of Bordetella pertussis were characterized from bacterial growth patterns and antigen expression profiles. Bacterial growth curves were established to observe proliferation characteristics. RNA sequencing was employed to detect expression trends of genes associated with metabolism, toxins, toxin regulation, and toxin secretion during different growth phases, as well as expression differences of key mutated antigen genes. Liquid chromatography-tandem mass spectrometry was employed to quantify key antigenic protein expression levels. Western blotting of strain fermentation liquids was adopted to verify structural integrity of mutated antigenic proteins. Results: The two epidemic strains exhibited distinct growth and antigen expression patterns in vitro. Specifically, the proliferation and toxin expression of BRK197 peaked in the late logarithmic phase, while those of BRK202 peaked in the early logarithmic phase. Adaptive mutations significantly affected antigen expression levels. Under identical culture conditions, the ptxP3-type strain BRK197 showed higher expression level of the pertussis toxin antigen (P≤0.05), and the fha3-type strain BRK202 exhibited reduced expression of filamentous hemagglutinin antigen (P≤0.01). The mutant antigen protein bands were normally expressed in the epidemic strains, and gene mutations did not disrupt the structural integrity of proteins. Conclusion: Under China’s pertussis vaccination pressure, differentially evolved epidemic strains (BRK197 and BRK202) exhibit distinct characteristics. BRK197 demonstrates stronger toxin-producing capacity, while BRK202 displays enhanced host adaptability in vitro. These differences likely contribute to increased infectivity and pathogenicity during in vivo infection. Adaptive mutations directly affect the expression levels of key antigens, and the ptxP3-type strain can highly express pertussis toxin antigen. Notably, the insertion of VAAPA at amino acid position 2 318 in the filamentous hemagglutinin antigen antigen of the fha3-type strain may lead to low detection levels of filamentous hemagglutinin antigen expression.

Objective: To investigate the compatibility and stability of betahistine hydrochloride injection with 5 basic infusion solutions [sodium chloride 0.9% (NS), 5% glucose (5% GS), glucose and sodium chloride (GNS), compound sodium chloride (R), and 10% glucose (10% GS) Injections] within 24 h. Methods: Betahistine hydrochloride injection was admixed with these 5 kinds of infusion solutions, respectively. Then, the following changes at room temperature within 24 hours were examined: appearance (color, Tyndall effect), pH value, osmotic pressure, insoluble particles, active ingredient percentage content, and related substances. Results: The appearance, insoluble particles, active ingredient percentage content, and related substances of each compatibility solution met the requirements within 24 hours. For osmolality, the injection with NS and R was in the normal range of plasma osmolality (285-310 mOsmol · kg^-1), the injection with 5% GS was slightly lower than 285 mOsmol · kg^-1, and the injection with 10% GS and GNS was higher than 310 mOsmol · kg^-1, while the osmolality of all the admixtures was in the tolerance of human body (140-830 mOsmol · kg^-1). The pH of the injection with NS, 5% GS, GNS, and R remained within the intravenous infusion control range of 4-9 within 24 h, whereas the pH of the injection with 10% GS was below 4. Conclusion: NS and R are recommended as compatibility solutions for betahistine hydrochloride injection due to the physicochemical compatibility and stability of these compatibilities within 24 h. When admixed with 5% GS, GNS, or 10% GS, vigilance is warranted against potential adverse reactions, including vascular injury, hemolysis, and phlebitis.

Objective: To establish a high-performance liquid chromatography coupled to triple quadrupole mass spectrometry (HPLC-QTRAP-MS/MS) method for determining the contents of 42 main components in Xiao-Er-An-Shen-Bu-Nao granule, clarify their chemical composition, and analyze the consistency of its preparations. Methods: The Thermo Scientific Hypersil GOLD chromatographic column (150 mm×4.6 mm, 3 μm) was employed in HPLC. Gradient elution was performed with the mobile phase of 0.1% formic acid aqueous solution and methanol at a column temperature of 35 ℃ and a flow rate of 0.4 mL · min^-1. The multiple reaction monitoring (MRM) ion scanning mode was operated to detect in the mass spectrometer. Based on the contents of 42 target components, principal component analysis (PCA), hierarchical cluster analysis (HCA), and content fluctuation of target components (P value) were further employed for the consistency analysis of the preparation. Results: Based on the established HPLC-QTRAP-MS/MS method, the simultaneous quantitative analysis of 42 components in Xiao-Er-An-Shen-Bu-Nao granule could be performed, which included the main components of monarch, minister, assistant, and guide herbs of Xiao-Er-An-Shen-Bu-Nao granule in a relatively comprehensive way. The total contents of 42 components in nine batches of Xiao-Er-An-Shen-Bu-Nao granule samples ranged from 4 759.58 to 5 383.30 μg · g^-1. Among them, the contents of flavonoids were the highest, accounting for 68.81%-72.58%, followed by organic acids, iridoid glycosides, and phenylpropanoids, and the contents of alkaloids were lower. PCA and HCA results showed that there were certain differences in different batches of Xiao-Er-An-Shen-Bu-Nao granule. Among the nine batches of Xiao-Er-An-Shen-Bu-Nao granule, the content of α-asarone fluctuated greatly with P value ranging from 27.75% to 235.75%, while the content of the other 41 components, such as hordenine, fluctuated within an acceptable range with P value ranging from 75% to 125%. Conclusion: The analytical method established in this study is rapid, with high sensitivity and reliable results, which could provide scientific methods and a basis for consistency analysis and quality control of Xiao-Er-An-Shen-Bu-Nao granule preparation.

Objective: To compare the content of four flavones and anti-cough effects of decoction pieces and young fruits of different aging years of Citri Grandis Exocarpium. Methods: :High performance liquid chromatography was employed to measure the content of four flavones in the decoction pieces and young fruits of different aging years of Citri Grandis Exocarpium. Compounds were separated on ELite 31113003 Supersil ODS column (200 mm×4.6 mm, 25 μm), mobile phase was 0.1% formic acid solution (A)-0.1% methyl alcohol solution (B) for gradient elution (0~10 min,30%B→60%B; 10~25 min, 60%B→75%B; 25~32 min, 75%B→100%B; 32~35 min, 100%B→30%B), the column temperature was set at 30 ℃, the flow rate was 1 mL · min^-1,the detected wavelength was 283 nm, the injection volume was 10 μL. Ammonia water was used to induce cough in mice, which were then treated with the decoction pieces and young fruits of different aging years. The cough incubation period and cough frequency in 3 min were recorded. Results: The content of naringin, naringenin, and nobiletin in decoction pieces showed an overall decreasing trend, while that of hesperetin kept increasing with the increase in aging years. As the aging years increased, the content of naringin and naringenin in young fruits showed an overall decreasing trend, while that of hesperetin and nobiletin presented large fluctuations. Compared with the blank group, the decoction pieces aged for 0, 1, and 2 years and young fruits of all aging years prolonged the cough incubation period (P<0.01) and reduced the cough frequency in 3 min (P<0.01). There was no significant difference in cough incubation period or cough frequency among the blank group and decoction pieces aged for 3 and 4 years. Conclusion: All decoction pieces and young fruits tested in this study meet the criteria for total flavone content and naringin content in the Pharmacopoeia of the People’s Republic of China (2020 edition) and local standards (2017 edition) in Guangdong Province. The decoction pieces aged for 0, 1, and 2 years and young fruits of all aging years have good anti-cough effect.

Objective: To establish an HPLC method for the simultaneous determination of several key constituents, namely syringin, echinacoside, verbascoside, epimedin A, epimedin B, epimedin C and icariin in Cistanches Herba formula, aiming to provide experimental evidence for the quality control of the formula and serve as a material basis for research on its anti-fatigue efficacy. Methods: The analysis was performed on a ZORBAX Eclipse Plus C₁₈ column (250 mm×4.6 mm, 5 μm) at 25 ℃, with the mobile phase comprising of acetonitrile-water flowing at 1.0 mL · min^-1 in a gradient elution manner. The detection wavelengths were set at 210 nm, and the injection volume was 10 μL. Results: The content determination method for the signature constituents in the Cistanches Herba formula was established. The linear relationship of the seven constituents was excellent within their respective ranges (r≥0.999 7), and the RSD values of precision, repeatability, and stability were all below 5%. The average recovery rates ranged from 93.5% to 104.0%, with RSD values between 0.11% and 2.5%. The content ranges of the seven constituents in four batches of samples were as follows: syringin (0.12-0.18 mg · g^-1), echinacoside (16.99-18.65 mg · g^-1), verbascoside (1.35-1.76 mg · g^-1), epimedin A (0.18-0.21 mg · g^-1), epimedin B (0.83-0.98 mg · g^-1), epimedin C (0.82-0.98 mg · g^-1), and icariin (0.58-0.83 mg · g^-1). Conclusion: This method demonstrates good sensitivity, strong specificity, and excellent repeatability. It can serve as a reliable basis for the quality evaluation and control of Cistanches Herba formula.

Objective: To establish a size exclusion chromatography-multi-angle laser light scattering-refractive index detection (SEC-MALLS-RI) method for determining the absolute molecular weight of polyethylene glycol 3350 (PEG 3350) in polyethylene glycol electrolyte powder (sodium potassium) and to compare its molecular weight characterization differences with the size exclusion chromatography-charged aerosol detection (SEC-CAD) method. Methods: A Shodex Ohpak SB-803 HQ column (300 mm×8.0 mm, 6 μm) was employed with a mobile phase of 0.2 mol · L^-1 NaCl at a flow rate of 0.5 mL · min^-1 and a column temperature of 30 ℃. The refractive index increment (dn/dc) was set to 0.132 mL · g^-1. Results: The dn/dc of PEG remained relatively stable within the molecular weight range of 1 000-6 000, with a mean value of 0.130 9 mL · g^-1 (RSD=1.6%). Consistent results were obtained across different solvents (RSD=0.44%). The SEC-MALLS-RI method demonstrated precision and repeatability with RSD values of 0.74% and 0.67% respectively. No significant differences in molecular weight determination were observed under varying temperatures or columns (P>0.05), confirming method robustness. The absolute molecular weight determined by SEC-MALLS-RI was lower than the relative molecular weight obtained via SEC-CAD. However, after calibrating the peak molecular weight (M_p) of PEG reference standards using SEC-MALLS-RI for column volume correction, no significant difference was observed between relative and absolute molecular weight results (P>0.05). Conclusion: The SEC-MALLS-RI method eliminates dependence on molecular weight reference standards, simplifies operations, and ensures stability. When using SEC-MALLS-calibrated reference standards in conventional GPC methods, the results of relative molecular weights were closely approximate to the absolute molecular weights.

Dalbergiphenols are a group of characteristic components in plants of Dalbergia, possessing biological activities such as anti-osteoporosis, cardioprotective, antibacterial, antioxidant, and anti-inflammatory properties. This paper analyzes the data from ¹H nuclear magnetic resonance (¹H-NMR) and ¹³C nuclear magnetic resonance (¹³C-NMR) spectra of 19 dalbergiphenols to summarize the patterns of variations between the corresponding chemical shifts and their substituents. This review aims to provide information for the rapid identification of new dalbergiphenols in the future.

Objective: To apply proton Nuclear Magnetic Resonance (¹H-NMR) combined with multivariate statistical analysis for quality assessment of capsular polysaccharides from Neisseria meningitidis serogroups A, C, Y, and W135, providing a scientific foundation for quality assessment and control of meningococcal vaccines. Methods: Capsular polysaccharide samples of meningococcal serogroups A, C, Y, and W135 from multiple batches of different origins were analyzed. Polysaccharide solutions were prepared at a concentration of 3 mg · mL^-1, and the PRESAT pulse sequence was employed to acquire ¹H-NMR data. The NMR spectra in the δ 6-0.6 region were subjected to segment integration at intervals of 0.01, yielding 540 integral bins for discriminant analysis and similarity analysis. For difference analysis, segmented integration was performed at intervals of 0.1, resulting in 55 integral bins. Results: The results confirmed that the capsular polysaccharides of each Neisseria meningitidis serogroup exhibited characteristic ¹H-NMR spectra. The PCA distribution patterns based on ¹H-NMR data were highly consistent with polysaccharide structures, indicating that the ¹H-NMR spectral fingerprints can be used to differentiate serogroups. Furthermore, both PCA and similarity analysis demonstrated high consistency in evaluating batch-to-batch variability and process stability, with highly correlated samples clustering closely in PCA score plots. Difference analysis revealed that key variables contributing to sample variations included O-acetylation sites, O-acetylation levels, and residual process-related impurities. Conclusion: ¹H-NMR can serve as a key technique for quality control in meningococcal vaccine production, including identification of different monovalent polysaccharides and antigen components in vaccine formulations. Additionally, NMR combined with statistical analysis provides precise quantitative indicators for process stability evaluation, supporting product monitoring and release decisions. This approach holds significant value for vaccine quality assurance.

Objective: To establish an efficient, accurate, and sensitive method for detecting animal-derived Chinese medicinal materials. Methods: The loop-mediated isothermal amplification (LAMP) primers were designed based on the Cytochrome b gene sequences of Bungarus Parvus, Agkistrodon, and Zaocys. The genes were amplified and connected to the vector pUC57 for the construction of recombinant plasmids, and the visual LAMP detection systems were established. By establishing a temperature gradient ranging from 62 ℃ to 66 ℃, it was determined that 62 ℃ was the optimal temperature for Bungarus Parvus, Agkistrodon, and Zaocys. The sensitivity and specificity of PCR and LAMP methods were compared. The optimal LAMP system for the detection of commercially available snake-derived Chinese medicinal materials was selected. Results: A LAMP system was established for detecting Bungarus Parvus, Agkistrodon, and Zaocys. The system achieved direct visual detection after reaction at 62 ℃ for 40 min. The sensitivity of the LAMP method for detecting Bungarus Parvus, Agkistrodon, and Zaocys was 400 copies · μL^-1, 4 copies · μL^-1, and 4 copies · μL^-1, respectively. Specificity test results indicated that the established LAMP system can specifically detect target snake-derived Chinese medicinal materials and can be used for the detection of commercially available products. Conclusion: The LAMP system established in the experiment has the advantages such as simple operation, high sensitivity, and short time consumption, which can provide a reference for the visual detection of animal-derived Chinese medicinal materials in primary-level medical institutions.

Objective: To address the limitations of trend analysis methods in microbiological monitoring of pharmaceutical manufacturing environment, this study focuses on constructing an in-house library of environmental microorganisms and integrating analytical methods. Methods: Based on the 2022 environmental microbiological identification data from a pharmaceutical enterprise, biological and sampling information of microorganisms was integrated using structured information tables. Python and R were used for data aggregation, calculation of diversity indices, analysis of phenotypic and species-level changes, and construction of an early-warning model, combined with multidimensional analyses such as Sankey diagrams and PCA. Results: A traceable in-house library was successfully established. Sphingomonas was identified as the dominant genus (14.50%), with its detection increasing from January to June and exceeding the alert level in June. Core microbes, persistent microbes (e.g., Ralstonia), and transient microbes were identified, with persistent microbes mainly originating from water systems. Microbial diversity and phenotypic proportions varied over time, and the microbial community structure differed significantly across sampling sources. Conclusion: This in-house library of microbial isolates enables dynamic monitoring and risk early warning of microorganisms, supporting proactive prevention and control in pharmaceutical enterprises and ensuring drug quality.

Objective: To characterize the suspicious structures of several commercially available phosphocholine chloride reagents by nuclear magnetic resonance (NMR). Methods: The suspicious structures of phosphocholine chloride reagents were analyzed by ¹H NMR, ³¹P NMR, ¹³C NMR, ¹H-¹H COSY, ¹H-¹³C HSQC, ¹H-¹³C HMBC, and ¹H-¹⁵N HMBC. Results: The suspicious structures were successfully identified as choline, betaine, and taurine, respectively. The ¹H NMR and ¹³C NMR spectra of the suspicious structures and their corresponding reference standards were compared to further confirm their identity and the peaks were assigned for each compound. Conclusion: This study provides a reliable analytical approach and novel insights for the structural verification and quality control of similar compounds.

Objective: To establish an HPLC method with correction factors and principal component self-control for the determination of related substances in lappaconite hydrobromide and its preparations, and to investigate the impurity profiles of raw materials and preparations produced by different manufacturers. Methods: An Omni Orca-C₁₈ column (250 mm×4.6 mm, 5 μm) was used with a mobile phase consisting of 0.04 mol · L^-1 potassium dihydrogen phosphate solution, methanol, and acetonitrile (68 ∶ 17 ∶ 15) at a flow rate of 1.0 mL · min^-1. The detection wavelength was set at 252 nm, the column temperature at 35 ℃, and the injection volume at 20 μL. Calibration curves for lappaconite hydrobromide and two impurities were established, and relative correction factors were calculated from the slopes. Impurities in the samples were further collected and confirmed using a Waters H-Class UPLC fraction collector. Results: Good separation was achieved between lappaconite hydrobromide and nine other alkaloids. Based on production process information and forced degradation tests, two known impurities and seven unknown impurities in the API and preparations were identified. The relative retention times of N-deacetyllappaconitine and ranaconitine were 1.24 and 1.38, with correction factors of 1.31 and 1.38, respectively. Lappaconite hydrobromide, N-deacetyllappaconitine, and ranaconitine showed good linearity with peak area over the ranges of 1.054-31.62 μg · mL^-1, 1.000-30.00 μg · mL^-1 and 1.031-30.93 μg · mL^-1, respectively (r>0.999 9). Additional determinations for sinomontanine H, isolappaconitine, and 9-deoxylappaconitine were carried out following impurity identification. Related substances in 115 batches of preparations were determined using the established method. The contents of the six impurities (sinomontanine H, isolappaconitine, 9-deoxylappaconitine, ranaconitine, N-demethylated lappaconitine,and impurity 4) were all less than 2.0%. Conclusion: The validated method is simple, rapid, and suitable for accurate determination of related substances in lappaconite hydrobromide preparations. The analysis indicates a wide variety of process-related impurities, with sinomontanine H and N-deacetyllappaconitine being relatively abundant. In addition, the degradation impurity content in injections is too high. In order to reduce the potential safety risks in the quality standard which indicates that revision of the current standards to include related substances testing is necessary.

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.

Objective: To conduct an in vitro permeation test (IVPT) of indometacin cataplasms via Franz diffusion cells, which was combined with the in vitro release test (IVRT) and rheological analysis to compare the consistency between imported and domestic products. Methods: IVPT was performed with Franz diffusion cells for the skin of miniature Bama pigs. LC-MS/MS was employed to determine the permeation amount, and HPLC was adopted to measure the skin surface residue and intradermal retention. IVRT was carried out with Franz diffusion cells and HPLC. Rheological properties, including storage modulus (G'), loss modulus (G''), and glass transition temperature (Tg), were evaluated by a rotational rheometer. Results: The maximum flux (126.66±10.11 ng · cm^-2 · h^-1) and cumulative permeation amount (4 322.96±718.41 ng · cm^-2) of the imported product AA01 were significantly higher than those (62.98±11.37 ng · cm^-2 · h^-1 and 1 674.63±162.87 ng · cm^-2) of the domestic product BB02. The IVRT results showed that the release rates were 29.50±0.84 μg · cm^-2 · h^-1/2 and 16.50±0.61 μg · cm^-2 · h^-1/2 for AA01 and BB02, respectively. Rheological analysis results showed that both G' and G'' of AA01 were higher than those of BB02. Conclusion: Significant differences exist in transdermal performance, release rate, and rheological properties between imported and domestic indometacin cataplasms. This study provides a reference for in vitro quality evaluation of such preparations.

Objective: To explore the efficacy and practicality of the short tandem repeat (STR) method, the DNA barcoding method, and the species-specific polymerase chain reaction (PCR) method based on molecular techniques in the species identification of human stem cells and detection of cell line cross-contamination, for the quality control of corresponding cell products. Methods: The STR typing was used to identify human stem cells and detect cross-contamination by extracting the genomic DNA of samples and amplifying 20 STR loci and 1 sex-determining locus. The DNA barcoding method was used to identify the species of human stem cells and cross-contamination between species by amplifying the mitochondrial CO Ⅰ gene sequence and conducting sequence alignment analysis. The species-specific PCR method was used to identify the species of human stem cells and cross-contamination between species by specifically amplifying the conserved mitochondrial CO Ⅰ gene and cytochrome B gene. This study also compared the advantages and disadvantages of the three methods. Results: STR typing, DNA barcoding, and species-specific PCR, all based on molecular technologies, were able to accurately identify the species of human stem cells. When applied to the detection of human cell lines such as human umbilical cord-derived mesenchymal stem cells and human primary adipose-derived mesenchymal stem cells, the STR method was shown to generate distinct allele peaks and establish unique STR profiles. In terms of cell cross-contamination detection, the STR method was effective in detecting intra-species contamination among human stem cells, but could not detect inter-species contamination between human stem cells and other species, such as contamination with mouse cells or hamster cells. When used for detecting human cell lines including human umbilical cord-derived mesenchymal stem cells and human primary adipose-derived mesenchymal stem cells, the BOLD system identification engine enabled the identification of their corresponding species. In cell cross-contamination detection, the DNA barcoding method was able to detect contamination between human stem cells and cell lines of other species, but its sensitivity was contingent upon the species category. The detection sensitivity for cross-contamination between certain species was relatively low, and it could not detect intra-species contamination between human stem cells and other human cells. In the detection of human primary adipose-derived mesenchymal stem cells, the species-specific PCR method was found to yield the expected specific band size of 391 bp. In cell cross-contamination detection, the species-specific PCR method demonstrated efficiency in detecting contamination between human stem cells and cells of other species, exhibiting higher detection sensitivity compared to the DNA barcoding method. However, the range of detectable species was limited by the experimental throughput. Conclusion: All three methods can be used to identify the species of human stem cells. However, when it comes to detecting contamination within or between species of human stem cells, a comprehensive application of multiple detection methods should be considered. This approach ensures the identification of cross-species contamination between cell lines, providing an important guarantee for the quality and safety of human stem cells.

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.

Objective: To investigate the anti-atherosclerosis mechanism and improve the quality control standards of Naoluotong capsules. Methods: The anti-atherosclerosis mechanism of Naoluotong capsules was explored by integrating network pharmacology and cell experiments. On the basis of key pharmacodynamical compounds, a high-performance liquid chromatography (HPLC) method was established to determine the content of salvianolic acid B, tolperisone hydrochloride, methyl hesperidin, and vitamin B₆. Results: Network pharmacology, molecular docking, and cell experiments confirmed that salvianolic acid B and tolperisone hydrochloride in Naoluotong capsules significantly inhibited macrophage foam cell formation. The developed HPLC method demonstrated excellent linearity for the four components (r≥0.999 8), with recovery rates ranging from 99.3% to 102.1% (relative standard deviation≤2.6%). In 53 batches of samples, the content of salvianolic acid B, tolperisone hydrochloride, methyl hesperidin, and vitamin B₆ varied within the ranges of 0.001-1.92 mg per capsule, 35-54 mg per capsule, 3.8-11.0 mg per capsule, and 1.0-2.3 mg per capsule, respectively. Conclusion: Naoluotong capsules exert anti-atherosclerosis effects by multi-target regulation of inflammatory and lipid metabolism pathways. The established activity-guided multi-component quality control method for the in vitro model enables precise quantification of key bioactive components, providing a scientific basis for enhancing the quality standards and ensuring consistency in clinical efficacy of this compound formulation.

Objective: To identify the chemical constituents in the leaves of in Perilla Folium with both surfaces purple, Perilla Folium with upper surface green and the lower surface purple, and Perilla Folium with both surfaces green and to investigate their correlation with leaf color by ultra-performance liquid chromatography-quadrupole-electrostatic field Orbitrap mass spectrometry (UHPLC-Q Exactive Orbitrap MS/MS). Methods: UHPLC was performed on a Waters Atlantis^TM Premier BEH C₁₈ column (100 mm×2.1 mm, 1.7 μm), with the mobile phase of 0.05% formic acid aqueous solution-0.05% formic acid acetonitrile solution in a gradient elution at a column temperature of 40 ℃, the flow rate of 0.3 mL · min^-1; the mass spectrometry was performed in the mode of electrospray ionization with the positive and negative ion detection. Data acquisition was carried out in the scanning range of m/z 100-1 000, and the detected components were comprehensively identified by analyzing the mass spectrometry data in combination with the fragmentation cleavage mode and comparing the results with the existing databases, relevant literature and standard controls. Differences in Perilla Folium of different leaf colors were analyzed by partial least squares-discriminant analysis (PLS-DA). Pearson correlation analysis was conducted to examine the relationship between the chemical composition and the color values of the leaves. Results: A total of 39 chemical constituents were identified from Perilla Folium with different leaf colors. A total of 19 key differential components with VIP values>1 were screened by PLS-DA modeling, including coumarin, vanillic acid, and luteloin-7-O-diglucuronide. The mean values (R-values) of the red image element components were strongly and positively correlated with coumarin, wild scutellarein-7-O-diglucuronide, and luteloin-7-O-diglucuronide. Conclusion: The study screened the index components of Perilla Folium with different leaf colors, revealed the correlation between chemical components and leaf colors, and can provide scientific basis for the quality control and evaluation of medicinal Perilla Folium.