OBJECTIVE To identify the current status of pediatric traditional Chinese medicine (TCM) new drug development in China using registration and approval data, and to provide references for improving the pediatric drug regulatory system. METHODS A total of 468 pediatric TCM new drug registration applications accepted by the China National Medical Products Administration from 2002 to 2024 were collected. Registration profiles, review timelines, registration categories, and product distribution characteristics were analyzed in conjunction with policy backgrounds and literature. RESULTS The total number of registration applications initially increased and then decreased, peaking during the implementation of the 2002 and 2005 editions of the Drug Registration Regulation, followed by a sharp decline after the 2007 edition. The review timelines were progressively shortened, with a notable improvement in approval efficiency under the 2020 edition. Modified new drugs consistently dominated registration categories, while the proportion of TCM compound formulations gradually increased. Products were concentrated in respiratory and digestive system therapies, primarily formulated as granules and tablets. Development in other disease areas and pediatric-friendly dosage forms remained insufficient. CONCLUSION Pediatric TCM development in China predominantly focuses on modified new drugs, with issues of product homogeneity and limited innovation momentum. Recommendations include optimizing priority review mechanisms, establishing specialized pediatric TCM research and development guidelines, strengthening clinical demand-driven innovation, and promoting high-quality pediatric TCM formulations.

OBJECTIVE To establish the characteristic map and multi-component content determination method of Huangbaiyi Lung Drink, and to study the purification process of the extract by ceramic membrane ultrafiltration technology, and to establish a purification and refining method for the extraction of Huangbaiyi Lung Drinking Water suitable for industrial production. METHODS HPLC was used to establish the characteristic map of Huangbaiyi Lung Drink, combined with chemical pattern recognition to screen the differential components, and the orthogonal design experiment L₉(3⁴) was used to optimize the optimal ultrafiltration process parameters of Huangbaiyi Lung Drinking Water extract with the identification components, the retention rate of total polysaccharides and alcohol extracts and the impurity removal rate were the process evaluation indexes. RESULTS There were 19 common peaks in the characteristic map, 4 components such as chlorogenic acid, and 11 differential components such as verbascoside isoflavone glucoside were screened. The optimal ultrafiltration process conditions were as follows: membrane pore size of 20 nm, operating pressure of 0.12 MPa, feed liquid temperature of 20 ℃, cross-flow velocity of membrane surface of 4.6 m·s^-1, the retention rates of total polysaccharides, ethanol extracts, chlorogenic acid, verbasyl isoflavone glucoside, glycyrrhizin and rutin were 82.86%, 84.23%, 92.97%, 92.54%, 92.92% and 92.29%, respectively, and the impurity removal rate was 11.73%. CONCLUSION The established method for the determination of multi-component content is reliable, and the selected ultrafiltration refining process has low production cost, good safety and high repeatability, and has a good prospect for industrial production, which can provide a reference for the refining of aqueous extract of traditional Chinese medicine compounds.

Diabetic peripheral neuropathy is one of the most common complications of diabetes. Aldose reductase is a key enzyme in the pathogenesis of diabetic complications. This review systematically reviews the efficacy and safety of five kinds of aldose reductase inhibitors in the treatment of diabetic peripheral nerves. Epalrestat is the only aldose reductase inhibitor in clinical application so far. A number of clinical trials have shown that epalrestat has a certain therapeutic effect on diabetic peripheral neuropathy and has sufficient safety, but long-term studies have shown that its therapeutic effect is not better than mecobalamine. Torrestat, zoporestat, ponastat, and fedastat were all withheld from the market or withdrawn from the market due to efficacy or safety concerns, which was inferred to be related to the structural characteristics of the drugs. Development of more effective and safer aldose reductase inhibitors from the perspective of drug structure will become one of the future research focuses on diabetic peripheral neuropathy.

OBJECTIVE To establish a liquid chromatography-tandem mass spectrometry (LC-MS/MS) method for simultaneous determination of tobramycin and dexamethasone in artificial tears, and detect drug use concentration in human tears and in vitro release. METHODS Zorbax Eclipse plus-C₈ column was used with 2 mmol·L^-1 ammonium acetate aqueous solution as mobile phase A and 90% methanol aqueous solution as mobile phase B for gradient elution. The flow rate was 0.5 mL·min^-1, the column temperature was maintained at 40 ℃, and the injection volume was 2 μL. A mass spectrometer was used with ESI ionization mode, MRM mode, and positive ion mode. RESULTS Tobramycin and dexamethasone showed good linearity in the concentration range of 200-5 000 ng·mL^-1, and the lower limit of quantification was 200 ng·mL^-1. CONCLUSION The established method is rapid, efficient, accurate and sensitive, and can be used for the detection of drug concentration in tears and in vitro release test of tobramycin and dexamethasone eye drops.

OBJECTIVE To establish the UPLC fingerprint of wild Qingqiao from Hebei province, analyze the correlation between fingerprint and antioxidant effect, and preliminarily determine its antioxidant active substances, so as to provide a basis for controlling the quality of wild Qingqiao from Hebei province. METHODS The fingerprints of 29 batches of wild Qingqiao from Hebei province were established by UPLC, and the common peaks were identified by UPLC-Q-TOF-MS. The free radical scavenging rate of 1,1-diphenyl-2-picrylhydrazyl (DPPH) method and 2,2-azino-bis (3-ethylbenzothiazoline-6-sulfonic acid) diammonium salt (ABTS) method was used as the antioxidant index to evaluate the antioxidant activity of wild Qingqiao from Hebei province. The spectrum-effect relationship between common peaks and antioxidant activity of wild Qingqiao from Hebei province was analyzed by grey correlation method and partial least squares regression. RESULTS The UPLC fingerprints of 29 batches of wild Qingqiao from Hebei province were established, and the similarity was between 0.950 and 0.999. A total of 20 common peaks were identified. The common peaks were identified by comparison of standards and UPLC-Q-TOF-MS analysis as citric acid, rengynic acid-1'-O-β-D-glucoside, rengynic acid, rengyol, forsythoside D, adoxosidic acid, forsythide, forsythenside B, 4-hydroxybenzaldehyde, (+)-epipinoresinol-4'-O-β-D-glucoside, forsythoside J, forsythoside A, calcelarioside A, rutin, isoquercetin, rhamnetin, ferulic acid, forsythin, pinoresinol and forsythigenin. By scavenging DPPH and ABTS free radicals, it was found that 29 batches of wild Qingqiao from Hebei province had antioxidant capacity. The results of spectrum-effect analysis showed that 9 components such as citric acid, rengynic acid-1'-O-β-D-glucoside and rengynic acid were positively correlated with antioxidant capacity. Based on the two statistical models, it can be inferred that forsythoside A, rhamnetin and ferulic acid are the main components of the antioxidant activity of wild Qingqiao from Hebei province. CONCLUSION In this study, a quality evaluation model based on chemical composition and antioxidant activity was established, which could provide reference for the antioxidant active ingredients and quality control of wild Forsythiae Fructus from Hebei.

OBJECTIVE To prepare polymyxin B sulfate multivesicular liposomes (PMB-MVLs), optimize their formulation, and their quality, stability, release and investigate their antibacterial activity in vitro. METHODS The PMB-MVLs were prepared by the double-emulsion method. The response surface method of Box-Behnken design was used to optimize the initial prescription. High performance liquid chromatography method was established to quantitatively analyze PMB in PMB-MVLs. The physicochemical properties, the in vitro drug release behavior, in vitro antimicrobial activity and formulation safety of PMB-MVLs were investigated. RESULTS The appearance of PMB-MVLs prepared by optimal prescription were non-concentric spherical vesicles with uniform size. The encapsulation efficiency of PMB-MVLs were (69.521±1.531)%. The average particle size was (5.84±1.42) μm, and the average Zeta potential was (-26.77±0.55)mV. The PMB-MVLs showed good stability when stored at 4 ℃ for one month. The results showed that PMB-MVLs were released continuously for 72 h in vitro, and there was no sudden release effect. The in vitro antibacterial activities of PMB-MVLs on E.coli and P.aeruginosa were significantly stronger than those of the free PMB. And PMB-MVLs has no risk of hemolysis within its range of antimicrobial activity. CONCLUSION The slow-release PMB-MVLs are successfully prepared with uniform particle size, high encapsulation efficiency, and enhanced antibacterial activity.

OBJECTIVE To prepare, characterize, and investigate the transdermal behavior of methotrexate phospholipid complex organogel (MTX-PC/OG). METHODS The solubility of MTX-PC in the oil phase, lowest gelling concentration, phase transition temperature, and stability were evaluated as criteria. Preliminary screening of oil phase types, gelling agents, and types and amounts of cogelators for MTX-PC/OG was carried out. The effects of oil phase type, cogelator type and dosage on the transdermal behavior of MTX-PC in vitro were investigated by modified Franz diffusion cell method. The appearance, viscosity, phase transition temperature, content and rheological properties of MTX-PC/OG were characterized. RESULTS Medium chain triglyceride (MCT), isopropyl myristate (IPM) and ethyl oleate (EO) exhibited favorable solubility for MTX-PC. Glycerin monostearate (GMS) demonstrated the most robust gelling capacity as a gelling agent, with optimal gel spreading at a 12.5% concentration. In vitro transdermal permeation results indicated that using MCT as the oil phase and Span 20 as the cogelator significantly enhanced MTX permeation and retention. MTX-PC/OG appeared as a light yellow semisolid state with a uniform texture, viscosity of (85.9±0.5) Pa·s, and a phase transition temperature of (50.4±0.5) ℃. Rheological assessments revealed that MTX-PC/OG is a pseudoplastic fluid with shear-thinning effects, suitable for transdermal drug delivery. Rheological assessments revealed that MTX-PC/OG is a pseudoplastic fluid with shear-thinning effects that facilitate its easy spread. CONCLUSION MTX-PC/OG prescription process is reasonable, with good transdermal and rheological behavior, making it well-suited for skin topical drug delivery.

OBJECTIVE To study the relationship between the spectral effect and the antibacterial effect of Rhizoma macrophylla L. based on grey correlation degree method and partial least square method. METHODS HPLC was used to establish the fingerprint of 13 batches of Moghania macrophylla (Willd.) Kuntze. The antibacterial activity of Moghania macrophylla (Willd.) Kuntze against 4 common pathogenic bacteria (Staphylococcus epidermidis, Escherichia coli, Staphylococcus aureus and Bacillus subtilis) was determined by microdilution method. Using the Similarity Evaluation System of Fingerprint of Traditional Chinese Medicine (TCM), the characteristic maps of 13 batches of Moghania macrophylla (Willd.) Kuntze were established, and the similarity evaluation and characteristic peak identification were carried out. The relative inhibition rate was used as the index of antibacterial activity, and the spectral effect relationship was established by using grey correlation analysis and partial least square method. RESULTS There were 29 common peaks in the fingerprints of 13 batches of samples, and the similarity was no less than 0.906. Peaks 12, 16, 17, 19 and 20 were identified as genistein, ononin, daidzein, genistein and chickpeas A. Staphylococcus epidermidis, Escherichia coli and Staphylococcus aureus had good bacteriostatic effect on 4 kinds of pathogenic bacteria. The results of spectral effect relationship analysis showed that peak 16 (ononin), peak 20 (chickpea A), peak 21 and peak 25 were the main active components of the antibacterial activity. CONCLUSION Through the study of the spectrum effect relationship, it is confirmed that the antibacterial effect of Moghania macrophylla (Willd.) Kuntze is the result of the combined action of many components, which could provide reference for the basic research and quality control of pharmacodynamic substances of Moghania macrophylla (Willd.) Kuntze.

OBJECTIVE To screen the effective components and potent substances of Bletilla striata and to preliminarily predict its mechanism of action. METHODS Oxford cup and microdilution methods were used to evaluate the inhibition of Propionibacterium acnes, Staphylococcus epidermidis and Staphylococcus aureus in different extracted parts of Bletilla striata. Subsequently, a mouse model of acne vulgaris was established to assess the effects of the different extracted components of Bletilla striata on auricular tissue lesions, histopathology, and inflammatory factors. Furthermore, the chemical compositions of the three extracts were analyzed using ultra high performance liquid chromatography-tandem quadrupole mass spectrometry (UPLC-Q-TOF-MS). Network pharmacology was utilized to predict the relevant targets, pharmacodynamic components, and related pathways of Bletilla Striata in the treatment of acne. Additionally, molecular docking was performed on the key pharmacodynamic components and targets to further validate these pharmacodynamic substances. RESULTS The ethyl acetate extract of Bletilla striata could effectively inhibit three kinds of acne-causing bacteria, and its MIC was 2.34, 2.34, 4.59 mg·mL^-1, respectively, the ethyl acetate extract of Bletilla striata significantly improved the auricular tissue lesions in mice, while the remaining two extracts exhibited no anti-acne effect. A total of 51 components of Bletilla striata were identified, including 48 components in the ethyl acetate extract, 13 components in the butanol extract, and 15 components in the water extract, stilbenes were most enriched in the ethyl acetate extract. The results of network pharmacology and molecular docking validation indicated that constituents such as batatasin Ⅲ, 3-(4-hydroxybenzyl)-4-methoxy-2, 7-dihydroxy-9, 10-dihydrophenanthreneand, 3-O-methylbatatasin Ⅲ may serve as key active constituents of Bletilla striata in the treatment of acne. Additionally, MAPK1 and TNF among others may represent potential targets of Bletilla striata in anti-acne therapy. CONCLUSION This study shows that the ethyl acetate extracted parts of Bletilla striata have good anti-acne effects, in which the Stilbenes represented by batatasin Ⅲ may be the main medicinal components, which may provide important references for the in-depth study of the mechanism of Bletilla striata in treating acne.

OBJECTIVE To explore the development of maximum residue limit standards for pesticides in Atractylodis Macrocephalae Rhizoma that conform to the characteristics of traditional Chinese medicine use. METHODS The samples were processed by QuEChERS method, and a combination of GC-MS/MS and LC-MS/MS was used to screen and determine 99 pesticide indicators in Atractylodis Macrocephalae Rhizoma. At the same time, the sensitivity, recovery rate, reproducibility, and precision of the method were verified. A risk assessment model and transformation principle that conforms to the characteristics of traditional Chinese medicine were adopted to determine the indicators and limits of the pesticide limit standards for Atractylodis Macrocephalae Rhizoma. RESULTS The established method for determining 99 pesticides in Atractylodis Macrocephalae Rhizoma meets the methodological requirements. A total of 12 pesticides were detected in 53 batches of Atractylodis Macrocephalae Rhizoma samples, including: tebuconazole, benzofenapyr, cypermethrin and S-cypermethrin, pyraclostrobin, thiamethoxam, enoxymorpholine, diazinon, propiconazole, fipronil, and methoxam. According to the GB2763 conversion guidelines, the limit standard for diazinon in Atractylodis Macrocephalae Rhizoma was converted into a drug standard. CONCLUSION This study helps to understand the risk of pesticide residues in Atractylodis Macrocephalae Rhizoma and provides ideas for the formulation of pesticide residue limit standards for traditional Chinese medicine.