OBJECTIVE To promote the standardization of the “Indications” section in package inserts for Chinese patent medicines and ensure rational clinical and patient use. METHODS The “Function and Indications” information of package inserts for Chinese patent medicines was retrieved and collected from the 2020 edition of the Chinese Pharmacopoeia （Volume Ⅰ） and various national and regional standards. Identification criteria were established for syndrome， pathogenesis， disease name， and symptom terminology in the “Indications” section. Microsoft Office Access 2021 was utilized to create query tables for manual extraction of terminological elements， followed by the construction of a three-tier classification system for “Indications” descriptions. A standardized template for “Indications” was developed through quantitative analysis. RESULTS & CONCLUSIONS A total of 9 851 valid package inserts for Chinese patent medicines were included. Among these， the majority （7 991） contained symptom terminology， followed by disease names （5 867） and pathogenesis descriptions （5 167）. Within disease name terminology， Western medical disease names predominated （4 446）， followed by traditional Chinese medicine disease names （2 018）. The “Function and Indications” content of 6 962 package inserts complied with existing requirements. Notably， the secondary classifications of “disease name”， as well as the tertiary classification of “disease name+symptoms” and “symptoms”， failed to meet established standards. Two standardized templates for “Indications” were formulated based on pathogenesis and syndrome：“pathogenesis+disease name+symptoms” and “disease name+syndrome+symptoms”. The “Indications”section should provide complete and accurate information， adhere to standardized formatting， and employ appropriate conjunctions and punctuation. For non-prescription patent medicines， package inserts should be categorized into professional and patient versions. These measures will facilitate the standardization of “Indications” descriptions and advance the overall package inserts for Chinese patent medicines documentation.

OBJECTIVE To analyze the characteristics of pediatric medicines with priority review and approval for marketing in China， providing a reference for promoting enterprise R&D and production， as well as improving the supply guarantee mechanism for pediatric medicines. METHODS Based on publicly available data sources such as List of Approved Information for Pediatric Medications Subject to Priority Review and Approval， Pharnexcloud biomedical database， and National Medical Insurance Drug Directory， this study conducted a comprehensive analysis of the main characteristics of pediatric medicines with priority review and approval for marketing. RESULTS As of June 30， 2024， a total of 68 pediatric medicines had been approved through the priority review and approval process， covering 12 therapeutic areas， with oral dosage forms accounting for 64.71%. The median time from application to inclusion in priority review was 35.50 days， with an average of 41.69 days. The median time from inclusion in priority review to market approval was 1.24 years， with an average of 1.42 years. This included 12 domestic new medicines， 21 domestic generic medicines， 35 imported medicines， as well as 29 pediatric-specific medicines and 21 orphan medicines. Additionally， 31 of these medicines had been included in the medical insurance catalog， representing a proportion of 45.59%. CONCLUSIONS Currently， a trend of differentiated competition is emerging between domestic and imported pediatric medicines. The therapeutic areas for pediatric medicines are continuously expanding， and the dosage forms are becoming more tailored to children’s needs. However， there are still issues such as slow progress in new medicine development， insufficient stability in the medicine review and approval process， and a need to increase the proportion of medicines included in medical insurance.

OBJECTIVE To establish a interview outline design process and quality control evaluation method based on grounded theory， providing ideas for qualitative research interview outline design in medical fields. METHODS A literature review was conducted to understand the current research status； a preliminary interview outline was developed around the research content. The triangulation method， group evaluation， expert review and pre-interview were adopted to execute the interview outline and conduct quality control. The evaluation indicators and target values were formulated （an average score for the overall quality evaluation of all indicators ≥4.5， and an average score for individual indicators ≥4.00） to evaluate the effect of the interview outline. Taking the research on the mechanism of physicians’ prescribing behavior under the background of Diagnosis Related Groups （DRGs） payment as an example， the methodological contents of above interview outline were applied in practical research. RESULTS The interview outline included basic information and interview questions. The interview questions were divided into three parts：influencing factors survey， promoting and hindering factors of standardizing physician prescription behavior， and communication， with a total of 12 questions. After being reviewed by members of the research group， experts review and pre- interview， a total of 9 people participated in the quality control evaluation of the interview outline. The overall evaluation score was 4.94 （＞4.50）， and the average score of each indicator was greater than 4.00， indicating that the quality of the outline met the requirements for the interview and could be used for the formal interview. CONCLUSIONS The established interview outline design and quality control method based on grounded theory provides ideas for the qualitative research interview outline design in the medical field， and lays the foundation for further using grounded theory to study the influencing factors and mechanisms of physician prescription behavior under the DRG background.

OBJECTIVE To investigate the ameliorative effect and potential mechanism of imperatorin （IMP） on doxorubicin （DOX） resistance in breast cancer. METHODS The effects of maximum non-toxic concentration （100 μg/mL） of IMP combined with different concentrations of DOX （12.5， 25， 50， 75， 100 μg/mL） on the proliferation of MCF-7/DOX cells were determined by MTT method. MCF-7/DOX cells were divided into blank control group （1‰ dimethyl sulfoxide）， DOX group （50 μg/mL）， IMP+DOX group （100 μg/mL IMP+50 μg/mL DOX） and IMP group （100 μg/mL）. mRNA and protein expressions of multidrug resistance protein 1 （MDR1） and multidrug resistance-associated protein 1 in each group were measured. The relevant pathways and targets involved in the improvement of DOX resistance in breast cancer cells by IMP were screened and validated by using transcriptome sequencing technology， along with gene ontology （GO） enrichment analyses and Kyoto Encyclopedia of Genes and Genomes （KEGG） pathway enrichment analyses. RESULTS Compared with DOX alone， the combination of IMP and DOX reduced the half inhibitory concentration of DOX on MCF-7/DOX cells from 81.965 μg/mL to 43.170 μg/mL， the reverse fold was 1.90， and the mRNA expression of MDR1 was significantly down-regulated （P＜0.05）. The results of GO enrichment analyses and KEGG pathway enrichment analyses indicated that the reversal of DOX resistance in breast cancer by IMP was mainly associated with the regulation of biological processes such as detoxification， multiple biological processes， and cell killing. The main pathway involved was the p53 signaling pathway， and the key targets mainly included constitutively photomorphogenic protein 1 （COP1）， cyclin E1 （CCNE1）， growth arrest and DNA damage-inducible protein 45A E-mail：tangxilan1983@163.com （GADD45A） and GADD45B. The results of the verification experiments showed that compared with DOX group， there was a trend of up-regulation of COP1 mRNA， and significant down- regulation of CCNE1， GADD45A， and GADD45B mRNA expression in IMP+DOX group （P＜0.05）. CONCLUSIONS The effect of IMP in ameliorating DOX resistance in breast cancer is related to its regulation of COP1， CCNE1， GADD45A and GADD45B targets in the p53 signaling pathway.

OBJECTIVE To study the improvement effects and potential mechanisms of water extract from Chrysanthemum morifolium on skeletal muscle atrophy in rats after ischemic stroke. METHODS Sprague-Dawley rats were randomly divided into sham operation group， model group， ATP group （10 mg/kg）， C. morifolium water extract high-dose and low-dose groups （1.08， 0.54 g/kg）. Except for sham operation group， ischemic stroke models were induced in rats from the other groups using middle cerebral artery occlusion. Starting from the first day after surgery， rats in each group were given corresponding drug/normal saline intragastrically， once a day， for consecutive 7 days. On the 7th day post-surgery， the rats’ body weights were measured， and their motor functions were evaluated， including Longa scores， exercise distance， grip strength； the electrophysiological signals of the skeletal muscles in rats were measured； the pathological morphology of the soleus muscle in rats was observed； the levels of tumor necrosis factor-α （TNF-α） in serum and soleus muscle were measured； the expressions of proteins related to TNF-α/c-Jun N- terminal kinase （JNK）/mitogen-activated protein kinase （MAPK） signaling pathway in the soleus muscle were determined. RESULTS Compared with sham operation group， the body weight， grip strength and exercise distance of rats were decreased/ shortened significantly （P＜0.01）； additionally， there was a notable reduction in the interpeak value of skeletal muscle electrophysiology （P＜0.05 or P＜0.01）. Longa score， as well as the levels of TNF-α in serum and soleus muscle， and the expression levels of TNF-α， phosphorylated JNK， phosphorylated MAPK， muscle ring-finger protein-1， and muscle atrophy Fbox- 1 protein in the soleus muscle， were all significantly elevated （P＜0.01）. The skeletal muscle cells of the soleus muscle in the model group showed significant atrophy， with a markedly decreased cross-sectional area （P＜0.01）. Compared with the model group， the levels of the aforementioned indicators were significantly reversed in C. morifolium water extract groups （P＜0.05 or P＜ 0.01）， and the skeletal muscle cells of the soleus muscle were markedly enlarged. CONCLUSIONS C. morifolium water extract can improve skeletal muscle atrophy in rats after ischemic stroke， the mechanism of which may be associated with suppressing the activation of the TNF- α/JNK/MAPK E-mail：19932015@cdutcm.edu.cn signaling pathway.

OBJECTIVE To identify tortoiseshell glue and antler glue in Qichong zuogui granules， and determine the contents of 12 chemical components. METHODS Identification and content determination were performed by using liquid chromatography- tandem mass spectrometry （LC-MS/MS） method. The identification was performed on Hypersil GOLD column with a mobile phase consisted of acetonitrile-0.1% formic acid solution （gradient elution）； the electrospray ion source was used to scan in the positive ion multi-reaction detection mode. The mass charge ratio （m/z） 631.3→546.4， 631.3→921.4 was the detection ion pair for tortoiseshell glue， and the m/z 765.4→554.0， 765.4→733.0 was the detection ion pair for antler glue. The determination method for 12 chemical components was as follows： Accucore C18 column， methanol-0.1% formic acid as mobile phase （gradient elution）； scanning range of positive and negative ions was m/z 100→1 000 with the electric spray ion source and single ion detection scanning mode. RESULTS Average retention times of the molecular ion peaks for characteristic peptide segments of tortoiseshell glue and antler glue were 6.28 and 6.77 min， respectively； the linear relationship of 12 chemical components was good within their respective concentration ranges， such as astragaloside Ⅳ， calycosin-7-O-β-D-glucoside， calycosin， chlorogenic acid， ferulic acid， betaine， amygdalin， rutin， hydroxysafflor yellow A， hyperoside， loganin， cyasterone （r＞0.999）； RSDs for precision， stability （24 h） and reproducibility tests were all less than 5%. The average sample recovery rates ranged from 98.04% to 101.08%. The average contents of 12 components were 1.83， 25.73， 13.76，56.71， 23.80， 49.82， 807.49， 15.01， 317.02， 60.21， 202.71 and 17.70 μg/g， respectively. CONCLUSIONS In this study， tortoiseshell glue and antler glue in Qixiong zuogui granules are identified， and the contents of 12 chemical components therein are determined. This provides a reference for the quality control of this granule.

OBJECTIVE To optimize the processing technology of Epimedium koreanum roasted with suet oil and analyze its characteristic chromatogram before and after processing. METHODS The optimal processing technology was optimized by orthogonal experiments with frying power， frying time and medicinal temperature as factors using the comprehensive score of appearance traits （color+odor）， alcohol-soluble extract， the contents of icariin and baohuoside Ⅰ as evaluation index， then proceed with verification. The E. koreanum roasted with suet oil was prepared with the optimal technology. The characteristic chromatograms of 15 batches of E. koreanum were established with the Similarity Evaluation System for Chromatographic Fingerprint of Traditional Chinese Medicine （2012 edition）， and then similarity analysis was also conducted. Clustering analysis， principal component analysis， and orthogonal partial least squares discriminant analysis were used to evaluate the differences in E. koreanum before and after processing. RESULTS The optimal processing technique for E. koreanum roasted with suet oil was as follows： first， heat 4 g of suet oil at a power of 600 W until it melts； next， when the temperature at the bottom of the pan reaches 140 ℃， add 20 g of E. koreanum silk and stir-fry for 6 minutes； finally， remove it and let it cool. Comprehensive score of 3 validation tests was 98.94 points　（RSD＜3%）. The established characteristic chromatogram of E. koreanum and E. koreanum roasted with suet oil were calibrated with 16 and 15 common peaks， respectively. Chromatographic peak 2 was determined to be chlorogenic acid， peak 5 to be chaohuoding A， peak 6 to be chaohuoding B， peak 7 to be chaohuoding C， peak 8 to be icariin， and peak 14 to be baohuoside Ⅰ. The similarities were all greater than 0.9. Results of cluster analysis and principal component analysis showed that E. koreanum and E. koreanum roasted with suet oil were clustered into distinct groups. The results of orthogonal partial least squares discriminant analysis showed that the variable importance projection values for peak 13， peak 15， peak 9， peak 1， peak 8， peak 12， peak 7， and peak 10 were all greater than 1. CONCLUSIONS The study successfully optimized the processing technology of suet oil-roasted E. koreanum. There are significant differences in the characteristic chromatograms of E. koreanum before and after processing. Among them， the chemical components corresponding to peak 13， peak 15， peak 9， peak 1， peak 8， peak 12， peak 7， and peak 10 may be the differential components of E. koreanum before and after processing.

OBJECTIVE To investigate the protective effect and mechanism of saikosaponin C （SSC） on acute liver injury （ALI） in mice induced by carbon tetrachloride （CCl4） based on serum metabolomics. METHODS Forty mice were divided into blank group （water）， model group （water）， positive control drug group （Biphenyl diester drop pills， 150 mg/kg）， and SSC low- and high-dose groups （2.5， 10 mg/kg） using the random number table method， with 8 mice in each group. They were given water/ relevant drugs， once a day， for 7 consecutive days. One hour after the last administration， all mice were intraperitoneally injected with 0.2% CCl4 olive oil to induce ALI model， except for the blank group. After 17 hours of the modeling， the liver index of mice was calculated. The levels of aspartate aminotransferase （AST）， alanine aminotransferase （ALT）， lactate dehydrogenase （LDH）， tumor necrosis factor-α （TNF-α）， interleukin-6 （IL-6）， and IL-1β in serum of mice were detected. The histopathological changes of liver tissue were observed. Meanwhile， the serum metabolomics of mice were analyzed by liquid chromatography-mass spectrometry. RESULTS Compared with the blank group， the levels of liver index， ALT， AST， LDH， TNF-α， IL-6， and IL-1β in the model group were significantly increased （P＜0.01）. Hepatocytes were edema， vacuolar degeneration， more necrosis， and a large number of inflammatory cells were infiltrated. Compared with the model group， liver index and serum index levels of mice were significantly decreased （P＜0.05 or P＜0.01）， accompanied by marked improvement in histopathological damage to the liver tissue. The metabolomics results showed that compared with the model group， there were 63 up-regulated and 256 down-regulated differential metabolites in the serum of mice in the SSC high-dose group， including prostaglandin B2， 20-hydroxy-leukotriene B4， 5- hydroxy-L-tryptophan， 7α -hydroxycholesterol， etc.； these metabolites were primarily involved in metabolic pathways such as arachidonic acid metabolism， 5-hydroxytryptamine synapse， primary bile acid biosynthesis. CONCLUSIONS SSC exerts a protective effect against CCl4-induced ALI by down-regulating the level of key metabolites such as prostaglandin B2 and 20-hydroxy-leukotriene B4， and then ruducing metabolic pathways such as arachidonic acid metabolism， 5- hydroxytryptamine synapse， and primary bile acid biosynthesis.

OBJECTIVE To investigate the effects of triptolide （TP） exposure during pregnancy and lactation on the reproductive system development and function in male offspring of rats， providing a reference for medication safety during pregnancy and lactation. METHODS Pregnant rats were randomly divided into control group （12 rats， normal saline） and T1-T4 groups [12， 13， 14， 17 rats that received TP at 200， 400， 600， and 800 μg/（kg·d） respectively]. They were given relevant medicine/normal saline intragastrically， once a day， until the offspring were born and naturally weaned， the intragastric administration volume of each rat was consistently 2 mL. After 60 days of feeding， reproductive organ weights and coefficients were measured in male offspring， testicular and epididymal histology and sperm morphology were observed. Sperm motility， sperm count， and serum levels of gonadotropin-releasing hormone （GnRH）， follicle stimulating hormone （FSH）， luteinizing hormone （LH）， and testosterone （T） in the epididymides were analyzed. Protein expressions of glycogen synthase kinase 3α （GSK3α）， phosphorylated GSK3α （p-GSK3α）， and phosphatase 1γ2 （PP1γ2） in sperm were also determined. RESULTS Compared with the control group， the testicular and epididymal weights， serum levels of GnRH and T， the relative protein expression of PP1γ2 were significantly decreased in T1-T4 groups. Additionally， in the T2 to T4 groups， there were significant reductions in the weight and coefficient of the seminal vesicle， total number of sperm， sperm concentration， sperm motility as well as relative protein expressions of GSKα， p-GSK3α in the offspring rats. Furthermore， the epididymal coefficient in the T3 and T4 groups， the testicular coefficient， mean sperm track velocity and sperm curvature velocity in the T4 group were significantly decreased （P＜ 0.05）； the number of abnormal sperm， rate of sperm abnormality， and levels of FSH and LH in the offspring rats of the T1 to T4 groups were all significantly increased （P＜0.05）； in the offspring rats of the T1 to T4 groups， there was a decrease in the number of epithelial cells in the seminiferous tubules of the testes. Within the epididymal tissue， degenerative and necrotic changes in the epithelial cells were visible， accompanied by mild infiltration of inflammatory cells in the stroma. CONCLUSIONS TP exposure during pregnancy and lactation disrupts reproductive organ development， impairs spermatogenesis and sperm motility， as well as suppresses androgen synthesis in male offspring，thereby having a negative impact on the development of the reproductive system. These effects may be mechanistically linked to regulation of GSK3α， p-GSK3α and PP1γ2 protein expressions.

OBJECTIVE To design and synthesize mono-carbonyl curcumin analogues（MCACs） and investigate the activities of them against breast cancer. METHODS The analogues F1， F2， and F3 were obtained by aldol condensation reaction， and their antitumor activities（including the activities of human breast cancer cell MCF-7 and human lung cancer cell A549） were detected by MTT assay [evaluated with half inhibitory concentration（IC50）]. The results of MTT assay were compared with those of curcumin. Bioinformatics methods were used to collect the core targets of analogues F1， F2 and F3 acting on breast cancer， and then molecular docking verification was carried out. The cell experiments were conducted to investigate the effects of high， medium and low concentrations （16， 8， 4 μmol/L） of F1， F2 and F3 on the expression of the first core target protein as well as the effects of medium concentration of F1， F2 and F3 on the expression of cleaved-caspase-3. RESULTS Compared with curcumin， IC50 of analogues F1， F2 and F3 to A549 and MCF-7 cells（except for IC50 of analogue F2 to A549 cells） were decreased significantly（P＜ 0.05 or P＜0.01）； among them， IC50 of analogue F2 to MCF-7 cell was the lowest， being（9.67±1.27） μmol/L. Bioinformatics analysis showed that index of affinity of analogues F1， F2 and F3 with the first core target epidermal growth factor receptor （EGFR）， protein kinase B （AKT） and AKT were 5.909 2， 8.402 5 and 6.486 6， respectively； high concentration of F1 could significantly reduce the phosphorylation level of EGFR protein in MCF-7 cells（P＜0.01）， while low， medium， and high concentrations of F2 and high concentration of F3 could significantly reduce the phosphorylation level of AKT protein in MCF-7 cells（P＜0.05 or P＜0.01）. Medium concentration of F1， F2， and F3 could significantly increase the expression level of cleaved- caspase-3 protein in MCF-7 cells（P＜0.01）. CONCLUSIONS Designed and synthesized MCACs F1， F2 and F3 all have good anti- breast cancer activity， and F2 has better anti-breast cancer activity.