Objective: To establish a method for the determination of veterinary drug residues in Galli Gigerii Endothelium Corneum by ultra high performance liquid chromatography-tandem triple quadrupole mass spectrometry (UPLC-QQQ MS/MS) with solid-phase extraction. Methods: The samples were evenly dispersed,extracted with acetonitrile and acetonitrile containing 0.5% formic acid, and cleaned up with Oasis PRiME HLB solid phase extraction columns. The extracts were separated on Agilent ZORBAX Eclipse Plus C₁₈ (3.0 mm×150 mm, 1.8 μm) using 5 mmol · L^-1 ammonium acetate and acetonitrile (containing 0.1% formic acid) as mobile phase by gradient elution. The detection of veterinary drug residues was detected by tandem mass spectrometry with positive electrospray ion source under multiple reaction monitoring (MRM) mode. The matrix-matched external standard method was used for the quantitation. Results: The method exhibited good linearities within a certain concentration range r≥0.995 8. The limits of detection (LODs) were in the range of 0.1-3 μg · kg^-1. The limits of quantitation (LOQs) were in the range of 0.2-10 μg · kg^-1. The good recovery values (61.9%-121.5%) were achieved for all the 68 veterinary drugs with RSDs ranging from 0.50% to 8.4% for spiking 3 different levels. Out of 50 batches of samples, 5 batches of Galli Gigerii Endothelium Corneum were found to contain veterinary drug residues,including amantadine, doxycycline, enrofloxacin, and florfenicol. Conclusion: This method proves suitable for the rapid determination of multiple veterinary drug residues in Galli Gigerii Endothelium Corneum, with a simple,quick, accurate and procedure.

Objective: To prepare monoclonal antibodies (MAbs) that can specifically recognize genistein(Gen), and to establish a specific and rapid quantitative method for Gen using indirect competitive enzyme-linked immunosorbent assay (ELISA). Methods: Gen was coupled with carrier protein by the Mannich method to synthesize artificial antigens. Femal Balb/c mice aged 6-8 weeks old were immunized by Gen-BSA. After the booster immunization, splenocytes of the mice were collected and fused with SP2/0 myeloma cells under the action of 50% polyethylene glycol (PEG). Subclones were screened by the limiting dilution method to obtain specific MAbs and an indirect competitive ELISA method was established. Results: Two hybridoma cell lines (C1 and C3)were isolated successfully with the titers of 1 ： 32 000, 1 ： 40 000, respectively. Under the optimized conditions,the indirect competitive ELISA based on C3 for Gen showed a half maximum inhibition concentration (IC₅₀) of 16.15 ng · mL^-1 and detection ranges of 3.78-55.85 ng · mL^-1 with cross-reactivity for biochanin A and irisolidone of 4.96% and 2.40%, respectively, negligible cross-reactivity with other Gen analogs including apigenin and 4-oxo-4H-1-benzopyran-2-carboxylic acid. The recovery test showed that the recovery rate was between 85% and 110%, precision tests showed RSD of inter-assay and inter-assay was less than 10%. Conclusion: In this study,Gen-specific MAbs are prepared successfully. An sensitive and accurate indirect competitive ELISA based on MAb for Gen is developed. The developed method can meet the requirements for immunoassay.

Objective: To meet the needs of gadolinium-based contrast agent (GBCA) analysis and testing, and to ensure drug quality and safety, a new strategy for inductively coupled plasma tandem mass spectrometry (ICP-MS/MS) determination of 12 impurity elements (Cr, Fe, Co, Ni, Cu, V, Zn, As, Cd, Ba, Sb, and Pb) in GBCA was proposed. Methods: GBCA was diluted with 2% HNO₃ and directly analyzed by ICP-MS/MS. Spectral interferences from V, Cr, Fe, Co, Ni, and Cu were eliminated using cool plasma/NH₃/He reaction mode. In addition,spectral interferences from Zn, As, Cd, Ba, and Sb were eliminated using hot plasma/O₂/H₂ reaction mode. To evaluate the accuracy and reliability of the method, the standard reference material (NIST SRM 1643f) was analyzed by comparing the method with high-resolution ICP-MS (HR-ICP-MS), and the spiked recovery experiment was conducted. Results: Under optimized conditions, the limits of detection (LOD) of the analytes were 0.014-0.86 ng · L^-1, the spiked recoveries were 96.7%-105.8%, and the RSDs were 1.6%-4.0%. The HR-ICP-MS determination values were consistent with reference values of NIST SRM 1643f. Statistical analysis showed that there was no significant difference between the measured values of the two methods at a 95% confidence level. Conclusion: The analysis method is accurate, reliable, stable and high precision. The combination of ICP-MS/MS and various reaction modes under different plasma conditions has shown promotion value for multi-element analysis in GBCA and can be extended to other fields.

Objective: To establish a rapid analytical method for chemical components in complex traditional Chinese medicine (TCM) based on an integrated strategy combining ultra high performance liquid chromatography-quadrupole-time-of-flight mass spectrometry (UHPLC-Q TOF MS/MS) with feature-based molecular networking(FBMN), so as to systematically characterize the chemical components in Sishen pills. Methods: MS data for Sishen pills were acquired using UHPLC-Q TOF MS/MS, with separation performed on on a Waters HSS T3 column(2.1 mm×100 mm, 1.8 µm). The mobile phase was consisted of a gradient elution of 0.1% formic acid in water(A) and acetonitrile (B) at a flow rate of 0.3 mL · min^-1. The electrospray ionization (ESI) source was used for both positive and negative ion modes, with a scan range of m/z 80 to 1 500. The data were uploaded to the Global Natural Product Social Molecular Networking (GNPS) to create a FBMN for Sishen pills. Results: A total of 131 compounds were identified in Sishen pills, by analyzing retention time, accurate molecular mass, MS² fragmentation characteristics, comparison with reference standards and self-established database, as well as utilizing FBMN for predicting structural similarity of compounds. These compounds included 27 alkaloids, 63 flavonoids, 11 phenylpropanoids, 14 phenols, 8 terpenoids, and 8 other compounds. Conclusion: In this study, the chemical components of Sishen pills are quickly and comprehensively characterized, which layes a foundation for the effective materials and quality control research of Sishen pills. The study also provides insights for the rapid analysis of chemical constituents in other TCM formulas.

Objective: To compare the chemical composition changes in Kehuang before and after fermentation using multi-component content determination combined with chemometric analysis. Methods: HPLC was employed using a ZORBAX Eclipse Plus C₁₈ column (4.6 mm×250 mm, 5 μm). The mobile phase consisted of acetonitrile and 0.1% phosphoric acid aqueous solution, applied with gradient elution. The flow rate was set at 1.0 mL · min^-1,the column temperature was maintained at 30 ℃, the detection wavelength was 203 nm, and injection volume was 10 μL. This method was applied to analyze the chemical compositions of Kehuang before and after fermentation and to establish their corresponding chemical fingerprint profiles. Quantitative determination was conducted for 11 chemical constituents, including chlorogenic acid, cimifugin, notoginsenoside R₁, baicalin, berberine, quercetin,baicalein, wogonin, emodin, chrysophanol, and physcion. Furthermore, chemometric methods such as hierarchical cluster analysis (HCA), principal component analysis (PCA), and orthogonal partial least squares discriminant analysis (OPLS-DA) were employed to distinguish and compare the samples before and after fermentation, with the aim of identifying key differential compounds. Results: Chemical fingerprint profiles were established for Kehuang before and after fermentation, with 22 common peaks identified. The fingerprints had good specificity and can be used for quality evaluation of Kehuang. The results of multi-component content determination and chemometrics analysis revealed significant differences in the content of notoginsenoside R₁ (1.023-2.927 mg · g^-1),scutellarein (0.125-0.568 mg · g^-1), and berberine hydrochloride (2.151-3.068 mg · g^-1) among the crude Kehuang powder, fermented Kehuang powder, and the content of Kehuang capsules. Notoginsenoside R₁, scutellarein and berberine were identified as differential markers between pre- and post-fermentation of Kehuang, which could serve as quality indicators for distinguishing and identifying Kehuang before and after fermentation. Conclusion: The chemical composition of Kehuang changes significantly after fermentation, and the differential compounds have been clearly identified, which provides an analytical basis for quality control in the production of Kehuang capsules.

Objective: To explore the growth trend of volatile components in hawthorn fruit at different growth stages. Methods: The volatile components in hawthorn fruits at different growth stages were quantitatively and qualitatively analyzed by gas chromatography-mass spectrometry (GC-MS), and their dynamic changes were investigated and statistically analyzed. The chromatographic column used was HP-5 (30 m×0.32 mm, 0.25 μm),while the column temperature was programmed (initial temperature 60 ℃, increased to 250 ℃ at a rate of 10 ℃ · min^-1,maintained for 33 min), and the inlet temperature was 280 ℃. The ion source was an electron bombardment source(EI), with an ion source temperature of 230 ℃. Results: A total of 57 representative volatile components were detected,of which 16 components disappeared in the later stage of growth, and 12 components were not present in the early stage of growth. The content of 11-decyl-tetracosane was the highest and gradually increased, and the content of hexadecyl acrylate gradually decreased. Conclusion: The investigation of the dynamic changes of volatile components in hawthorn fruit during the growth period provides a reference for further rational development and utilization of hawthorn fruit.

Objective: To establish an ultra-high performance liquid chromatography tandem mass spectrometry（UPLC-MS/MS）method for the simultaneous determination of 22 components of Bimin capsules, including benzoylaconine, benzoylmesaconine, benzoylhypacoitine, hypaconitine, mesaconitine, fuziline, aconitine, aconine,mesaconine, isoliquiritigenin, echinatin, protocatechuic acid, liquiritigenin, isoliquiritoside, glycycoumarin,naringenin, schaftoside, licochalcone B, glycyrrhizic acid ammonium salt, liquiritin, liquiritin apioside and isoliquiritin apioside. Methods: The Acclaim^TM RSLC 120C₁₈ column (2.1 mm×100 mm, 2.2 μm) was used with 0.05% formic acid water (A) and acetonitrile (B) as the mobile phase at a flow rate of 0.4 mL · min^-1. Electrospray ionization (ESI) source and multiple reaction monitoring (MRM) mode in both positive and negative were used for ion detections. Resulets:The 22 components displayed a good linear relationship (R²>0.990) in their respective ranges, and the precision, repeatability, stability, and sample recovery rate all met the requirements. It was found that all 22 components were detected in the nasal sensitivity capsules, with significant differences in the content of some components. Conclusion: This method is fast, simple, sensitive and reliable, and can provide scientific basis for the quality control of the Bimin capsules.

Objective: To investigate the improvement in bitter taste of ambroxol hydrochloride by the corrective materials and weight gain of the taste-masking layer, and to establish an objective and scientific taste evaluation method. Methods: The taste-masking effects of corrective materials and taste-masking layer weighting were evaluated using electronic tongue technology, and the palatability between ambroxol hydrochloride direct oral granules and 15 marketed preparations of ambroxol hydrochloride were compared. The electronic tongue datas were subjected to principal component analysis and loadings analysis. Results: The corrective materials were able to mask the bitter taste of ambroxol hydrochloride. The bitter value of the sample solution of ambroxol hydrochloride direct oral granules decreased as the masking layer gained weight. In terms of bitterness and sweetness, ambroxol hydrochloride oral direct granules had a clear advantage over 15 marketed formulations. Conclusion: Using the electronic tongue technology, the taste correction effect and the taste difference between different samples can be accurately assessed,and an evaluation method for the bitter taste masking effect of ambroxol hydrochloride direct oral granules has been established, which provides new ideas and methods for the taste masking study of oral preparations for children.

Oligosaccharides are a class of bioactive components abundantly found in Chinese herbal medicine. They have clinical effects such as antidepressant and anti-Alzheimer’s disease activities, as well as pharmacological activities such as hypoglycemic, laxative, and immune-enhancing effects. The bioactivity of oligosaccharides is closely related to their structure. However, due to the diversity of glycosidic bond configurations, monosaccharide compositions and linkage patterns, it is difficult to accurately determine their structures by conventional analytical methods. Establishing rapid and reliable analytical methods remains a key challenge in carbohydrate research.Although studies on oligosaccharides are increasing, there is a lack of comprehensive reviews on the structure and analytical methods of oligosaccharides in Chinese herbal medicine. This paper systematically reviewed the research progress over the past decade on extraction, separation, structure identification and analytical methods of oligosaccharides in Chinese herbal medicine by consulting domestic and foreign literatures. This review aims to contribute to the development of evaluation method of traditional Chinese medicine based on oligosaccharide components, and provide reference for their application in the quality control of traditional Chinese medicine.

Objective: To establish a method for determining the fingerprint of Yankening tablets and evaluate their quality combined with multivariate statistical analysis and multi-component quantification. Methods: The seperation was performed on a 30 ℃ thermostatic InertSustain C₁₈(250 mm×4.6 mm, 5 μm) column,with the mobile phase comprising of methanol-acetonitrile-0.2% phosphoric acid flowing at 1.0 mL · min^-1 in a gradient elution manner, and the detection wavelength was set at 254 nm to establish HPLC fingerprint of Yankening tablets,contents of 10 components (berberine hydrochloride, baicalin, wogonoside, baicalein, aloe emodin, wogonin, rhein,emodin, chrysophanol, emodin methyl ether) in 17 batches of Yankening tablets were determined, and similarity evaluation, cluster analysis, entropy weight TOPSIS method, and entropy weight grey correlation analysis were used to comprehensively evaluate the quality of Yankening tablets. Results: There were significant differences in the quality of Yankening tablets of the current market. 33 common peaks were obtained by matching in the fingerprints of 17 batches of samples, and the similarity evaluation and cluster analysis results showed differences among different samples. The comprehensive quality ranking and multi-component content determination revealed that the important factors affecting drug quality were the quality and process control level of the three medicinal herbs,Phellodendri Chinensis Cortex, Coptidis Rhizoma and Scutellariae Radix. Conclusion: The fingerprint established by this method, combined with a multivariate statistical model, can provide reference for the quality evaluation research and products quality improvement of Yankening tablets.