OBJECTIVE To investigate the efficacy and safety of different preparations of intravenous immunoglobulin (IVIG) for Kawasaki disease treatment in children. METHODS A retrospective analysis of medical records of pediatric Kawasaki disease patients at our institution in recent three years was conducted. Patients were divided into preparation A group and preparation B group based on the type of IVIG preparations used. Both groups received IVIG (2 g·kg^-1) in conjunction with aspirin therapy following Kawasaki disease diagnosis. Changes in body temperature, white blood cell count, platelet count, C-reactive protein levels, IVIG cost, length of hospital stay, and adverse events were compared. RESULTS According to the drug labeling, there are certain differences between preparation A and preparation B. Preparation B exhibited a significantly shorter duration of fever resolution compared with preparation A (P<0.005), and at the first temperature test after infusion, the body temperature of preparation B group was significantly lower than that of preparation A group (P<0.05). Furthermore, preparation B demonstrated a more significant reduction in white blood cell count following treatment (P=0.010). In terms of hospital stay duration and IVIG monotherapy costs, preparation B had significantly shorter hospital stay (P<0.05) and lower per-unit IVIG expense (P<0.001). No significant differences were observed between the two groups in terms of adverse events, including rashes, infusion interruptions due to high fever, liver injury, and coronary dilation. CONCLUSION There is significant difference in efficacy between different preparations of intravenous immunoglobulin in the treatment of Kawasaki disease in children, but the safety is similar.

OBJECTIVE To screen the commonly used pesticides in Dendrobium officinale to understand their pesticide residues, and explore the establishment of a method for determining the transformation of pesticide residues in Dendrobium officinale and the development of limit standards in accordance with the requirements of GB 2763 Food Safety Standards for Maximum Residue Limits of Pesticides in Food and the Chinese Pharmacopoeia. METHODS LC-MS/MS methods were used to screen and risk assess 6 transformation pesticides in 53 batches of Dendrobium officinale, and the pesticide registration status and the maximum residue limit standards for Dendrobium officinale (dry) in GB 2763 were used to determine the indicators for the transformation of pesticides. RESULTS The pesticides in 53 batches of Dendrobium officinale were analyzed. The transformation pesticide were confirmed in accordance with GB 2763 and the requirements of the Chinese Pharmacopoeia 2020 Edition, and a method for determining the transformation of pesticide residues in Dendrobium officinale was established, along with the development of limit standards. CONCLUSION This study screened 40 commonly used pesticides and 6 transformation in 53 batches of Dendrobium officinale, established a method for determining the transformation of pesticide residues in accordance with GB 2763, and developed limit standards. This study is helpful for understanding the risk of pesticide residues in Dendrobium officinale, regulating the use of pesticides during its cultivation process, and improving its quality standards.

OBJECTIVE To establish a method for simultaneous determination of registered pesticides, prohibited pesticides, and proposed new prohibited pesticide residues in Fritillaria Medicinal Herbs, and propose reference limits. METHODS The detection method for 95 pesticide residues in Fritillaria Medicinal Herbs was established using GC-MS/MS and LC-MS/MS. The prepared samples were extracted with acetonitrile and then purified with the QuEChERs method. A total of 70 batches of samples were detected by the established method. RESULTS According to the GB 2763 conversion guidelines, imidacloprid and avermectin in Fritillaria Medicinal Herbs should be converted to the maximum residue limit (MRL) standards. Additionally, reference limit values are proposed for the 18 prohibited pesticides that were previously suggested for addition. CONCLUSION The study of Fritillaria Medicinal Herbs aims to offer guidance and inspiration for the transformation of traditional Chinese medicine standards and the expansion of the list of banned pesticides. It also provides a reference for the regulatory policies and technological advancements related to pesticide residue management in Fritillaria Medicinal Herbs and other traditional Chinese medicines.

In recent years, in the process of drug research and development, insoluble drugs are faced with the problem of low bioavailability and poor absorption effect. Drug nanocrystals have attracted much attention due to their nano size and unique physical and chemical properties, which can effectively increase drug solubility and permeability, and have advantages such as low dosage of excipients, high drug load and few adverse reactions. However, instability limits their further development. Multieffect stabilizers can significantly improve their stability through steric hindrance, electrostatic repulsion and solvation. The author reviews the main characteristics and limitations of drug nanocrystals, the classification of multi-effect stabilizers and their applications in vivo and in vitro by reviewing and sorting out relevant literature, in order to provide reference for the research and development of drug nanocrystals.

OBJECTIVE To establish a method for the transformation of some commonly used pesticide limit standards in Chrysanthemi Flos based on ‘GB 2763 National Food Safety Standard-Maximum Residue Limits for Pesticides in Food’. METHODS The indexes of Chrysanthemi Flos (dry) in GB 2763 were sorted out, and the quasi-transformation pesticides were determined as pymetrozine, imidacloprid, boscalid and fluazinam according to the transformation principle. The UPLC-MS/MS method was used to establish the transformation method of Chrysanthemi Flos, and the methodological verification was carried out. RESULTS The four pesticides had good linear relationship in the range of 1-50 ng·mL^-1, the correlation coefficients were 0.999 9, the average recovery was 77.9%-95.5%, and the RSD was 1.7%-6.8%. The overall detection rate of the samples was 60%, and the pesticide with the highest detection rate was imidacloprid. The maximum detectable amount was 1 mg·kg^-1 (imidacloprid), and the results did not exceed the maximum residue limit specified in GB 2763. The risk assessment system of pesticide residues in traditional Chinese medicine was used to evaluate the chronic risk of the four pesticide limit values to be transformed. The results showed that the chronic risk of fluazinam was greater than 1, and the chronic risk quotients of the other three pesticides were less than 1. Therefore, fluazinam is not converted temporarily, and only pymetrozine, imidacloprid and boscalid are converted. CONCLUSION The three limit standards of pymetrozine, imidacloprid and boscalid in Chrysanthemi Flos were transformed. The established limit standard transformation method is simple and accurate, which is of great significance for standardizing the use of pesticides and medicinal safety in the process of chrysanthemum planting.

OBJECTIVE To develop and validate a peptide mapping method of an anti-CD33 monoclonal antibody. METHODS Different types of chromatographs (HPLC, UPLC) and different mobile phase systems (formic acid, trifluoroacetic acid) were used for peptide map detection of anti-CD33 antibody. The signature peptide segments were localized using synthetic CDR peptide of the antibody and the localization results were confirmed by mass spectrometry. Based on the relative retention time (RRT), the specificity, precision, and robustness of the method were validated according to the Pharmacopoeia of the People's Republic of China (ChP, 2020). RESULTS The separation time of the peptides by UPLC was shorter than that by HPLC, and the degrees of separation with trifluoroacetic acid in the mobile phase were higher than that with formic acid. The identification results of the signature peptide segment using the maps of synthetic peptide segments were consistent with the results of mass spectrometry. The specificity validation demonstrated that the formulation blank and sample solution blank did not interfere with the detection of signature peptide segments, and there were significant differences between peptide mapping results of different antibodies. The repeatability validation showed that the RSDs (RRT) of signature peptide segments between six parallel samples were 0.01%-0.05%; the intermediate precision validation proved that the RSDs (RRT) of signature peptide segments for different analysts were 0.04%-0.32%; the robustness validation exhibited that the RSDs (RRT) of signature peptide segments were 0.02%-0.09% under different enzyme treatment conditions and 0.36%-1.43% under different chromatographic conditions. Within 25 h in detection, the RSDs (RRT) of the signature peptide segments were 0.01%-0.04%. CONCLUSION This study uses synthetic peptide segments for peptide localization in peptide mapping detection and uses relative retention time to determine the results, which provide a new approach for biopharmaceutical peptide mapping detection.

OBJECTIVE To investigate the feasibility of performing identification of Citri Sarcodactylis Fructus (CSF) and Citri Fructus (CF) based on high performance liquid chromatography (HPLC) fingerprint coupled with multivariate data analysis. METHODS HPLC method was applied to establish the fingerprints of CSF and CF. Similarity evaluation of 12 batches of CSF samples and 10 batches of CF samples was performed by Traditional Chinese Medicine Chromatographic Fingerprint Similarity Evaluation System (2004A edition). Hierarchical cluster analysis (HCA), principal component analysis (PCA) and orthogonal partial least squares-discriminant analysis (OPLS-DA) were used for data analysis. RESULTS HPLC fingerprints of CSF and CF were established, respectively. The fingerprint similarities of CSF samples, as well as the fingerprint similarities of CF samples, were all greater than 0.9. The similarities between the fingerprints of CSF samples and the control fingerprint of CF, as well as the similarities between the fingerprints of CF samples and the control fingerprint of CSF, were all less than 0.9, which indicated significant differences in chemical composition between CSF and CF. The total 22 samples were divided into two groups by HCA, PCA and OPLS-DA, which was consistent with the two varieties. Three differential markers were screened by OPLS-DA and two of them were identified as 5, 7-dimethoxycoumarin and hesperidin by reference substances. The statistical analysis indicated that the ratio of absolute peak area (APA) of hesperidin and 5, 7-dimethoxycoumarin can distinguish CSF and CF from each other simply and accurately. CONCLUSION HPLC fingerprint coupled with multivariate data analysis can be used to identify CSF and CF.

OBJECTIVE To study and establish sequence characterized amplifiedregion(SCAR) molecular marker for identifying the original plants and related plants of Rabdosia Herba, and provide a new molecular identification method for the original plants of Rabdosia Herba. METHODS A total of 29 populations of the original plants and related plants of Rabdosia Herba were collected, and inter-simple sequence repeat (ISSR) molecular marker was used to perform PCR amplification on the genomic DNA of the representative population of Rabdosia Herba to obtain ISSR-specific segments. After the ISSR-specific fragments were recovered, purified, cloned and sequenced, SCAR primers were designed based on the sequencing results, which were directly used for the efficient identification of the original plants of Rabdosia Herba. RESULTS Fourteen pairs of ISSR primers were used to perform PCR amplification on 18 representative samples of original plants and related plants of Rabdosia Herba, and 4 specific segments were obtained and successfully transformed into ISSR-SCAR molecular markers. These molecular markers can be used to specifically identify the Rabdosia lophanthoides (Buch. -Ham. ex D. Don) H. Hara, Rabdosia stracheyi (Benth. Ex Hook. f.) Hara, Rabdosia serra (Maxim.) H. Hara, and Rabdosia nervosa (Hemsl.) C. Y. Wu et H. W. Li, respectively. CONCLUSION The established ISSR-SCAR molecular markers produce clear and bright bands with stable results, which can accurately and rapidly identify the original plants and related plants of Rabdosia Herba, providing a new method for the identification of the original plants of Rabdosia Herba.

OBJECTIVE To design and synthesize a series of bifunctional ruthenium complexes containing hydroxamic acid as HDAC6 selective inhibitors by conjugating aromatic hydroxamic acid with bipyridine ruthenium (Ⅱ) complexes, and investigate the in vitro antitumor activity. METHODS Three ruthenium complexes were synthesized with aromatic ring as ‘Linker’ and hydroxamic acid as zinc binding group(ZBG), and their structures were characterized by ¹H-NMR, ¹³C-NMR and HRMS spectrometry. The HDAC inhibitory activity was evaluated by fluorescence analysis. The in vitro antitumor activities against A549, MDA-MB-231, MCF-7, HepG-2 and LO2 cell lines were evaluated by MTT assay. The binding of compounds to the active site of HDAC6 protein was studied by molecular docking. RESULTS All compounds showed selective HDAC6 inhibitory effect, in vitro antitumor activity and tumor-targeting activity, among which representative compound 3 exhibited comparable cytotoxic activity to cisplatin and much higher tumor-targeting activity than cisplatin. CONCLUSION The introduction of a wider “Cap” (surface recognition unit) in the pharmacophore model can improve the specific recognition of the compound against HDAC6, which proved that the design of bifunctional aromatic hydroxamic acid and bipyridine ruthenium complexes is rational.

OBJECTIVE To find new arylaminoquinazoline-based antitumor target compounds with high efficacy and low toxicity. METHODS A series of N-phenyl-4-(trifluoromethyl)quinazoline-2-amine derivatives were synthesized starting from 2-nitrobenzaldehyde or 6-nitroveratraldehyde by a combination of nucleophilic addition, oxidation, reduction, cyclization, chlorination, and coupling reactions. The structures of the target compounds were characterized using NMR and MS. Their antitumor activities in vitro were then evaluated against four human cancer cell lines (PC3, LNCaP, K562, and HeLa) using MTT assay. The target prediction of active compound 8b was performed. RESULTS Compounds 8b and 8c exhibited promising anti-proliferative properties, particularly compound 8b, which exhibited excellent antitumor activity against PC3, LNCaP, and K562 with IC₅₀ values of 5.51, 4.51 and 8.49 μmol·L^-1, respectively. Molecular docking experiment demonstrated that PIM-1 is the potential target of 8b. CONCLUSION The piperazine ring containing compound 8b exhibits the strongest antitumor activity, which is worthy of further study.