1.Interpretation and thoughts on the formulation and revision of the standards for exogenous harmful residues in traditional Chinese medicinal materials in the Chinese Pharmacopoeia 2025 Edition
WANG Ying ; SHEN Mingrui ; LIU Yuanxi ; ZUO Tiantian ; WANG Dandan ; HE Yi ; CHENG Xianlong ; JIN Hongyu ; LIU Yongli ; WEI Feng ; MA Shuangcheng
Drug Standards of China 2025;26(1):083-092
As people’s attention to health continues to increase, the market demand for traditional Chinese medicine (TCM) is growing steadily. The quality and safety of Chinese medicinal materials have attracted unprecedented social attention. In particular, the issue of exogenous harmful residue pollution in TCM has become a hot topic of concern for both regulatory authorities and society. The Chinese Pharmacopoeia 2025 Edition further refines the detection methods and limit standards for exogenous harmful residues in TCM. This not only reflects China’s high-level emphasis on the quality and safety of TCM but also demonstrates the continuous progress made by China in the field of TCM safety supervision. Basis on this study, by systematically reviewing the development history of the detection standards for exogenous harmful residues in TCM and analyzing the revisions and updates of these detection standards in the Chinese Pharmacopoeia 2025 Edition, deeply explores the key points of the changes in the monitoring standards for exogenous harmful residues in TCM in the Chinese Pharmacopoeia 2025 Edition. Moreover, it interprets the future development directions of the detection of exogenous residues in TCM, aiming to provide a reference for the formulation of TCM safety supervision policies.
2.Compound Xishu Granules Inhibit Proliferation of Hepatocellular Carcinoma Cells by Regulating Ferroptosis
Yuan TIAN ; Yuxi WANG ; Zhen LIU ; Yuncheng MA ; Hongyu ZHU ; Xiaozhu WANG ; Qian LI ; Jian GAO ; Weiling WANG ; Wenhui XU ; Ting WANG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(2):37-45
ObjectiveTo study the mechanism of compound Xishu granules (CXG) in inhibiting the proliferation of hepatocellular carcinoma cells by regulating ferroptosis. MethodsThe transplanted tumor model of human Huh7 was established with nude mice and the successfully modeled mice were randomized into model, Fufang Banmao (0.21 g·kg-1), low-dose (1.87 g·kg-1) CXG, medium-dose (3.74 g·kg-1) CXG, and high-dose (7.49 g·kg-1) CXG groups. Mice were administrated with drinking water or CXG for 28 days, and the body weight and tumor volume were measured every 4 days. Hematoxylin-eosin staining was employed to observe the histopathological changes of tumors. The cell-counting kit-8 (CCK-8) was used to examine the survival rate of Huh7 cells treated with different concentrations (0, 31.25, 62.5, 125, 250, 500, 1 000 mg·L-1) of CXG for 24 h and 48 h. CA-AM, DCFH-DA, and C11-BODIPY581/591 fluorescent probes were used to determine the intracellular levels of ferrous ion (Fe2+), reactive oxygen species (ROS), and lipid peroxide (LPO), respectively. The colorimetric method was employed to measure the levels of glutathione (GSH) and superoxide dismutase (SOD). Western blot was employed to determine the protein levels of glutathione peroxidase 4 (GPX4), transferrin receptor 1 (TFR1), and ferritin heavy chain 1 (FTH1), respectively. ResultsIn the animal experiment, compared with the model group, the drug treatment groups showed reductions in the tumor volume from day 12 (P<0.01). After treatment, the Fufang Banmao and low-, medium-, and high-dose CXG groups had lower tumor volume, relative tumor volume, and tumor weight than the model group (P<0.05), with tumor inhibition rates of 48.99%, 79.93%, 91.38%, and 97.36%, respectively. Moreover, the CXG groups had lower tumor volume and relative tumor volume (P<0.05 in all the three dose groups) and lower tumor weight (P<0.05 in medium-dose and high-dose groups) than the Fufang Banmao group. Compared with the model group, the drug treatment groups showed reduced number of tumor cells, necrotic foci with karyopyknosis, nuclear fragmentation, and nucleolysis, and the high-dose CXG group showed an increase in the proportion of interstitial fibroblasts. In the cell experiment, compared with the blank group, CXG reduced the survival rate of Huh7 cells in a dose-dependent manner after incubation for 24 h and 48 h (P<0.05). Compared with the blank group, the RSL3 group and the low-, medium-, and high-dose CXG groups showed a decrease in the relative fluorescence intensity of CA-AM and increases in the fluorescence intensity of DCFH-DA and fluorescence ratio of C11-BODIPY581/591, which indicated elevations in the levels of Fe2+ (P<0.01), ROS (P<0.05), and LPO (P<0.01), respectively. Compared with the blank group, the RSL3 and low-, medium-, and high-dose CXG groups showed lowered levels of GSH and SOD (P<0.05). In addition, the RSL3 group and the medium- and high-dose CXG groups showed down-regulated expression of GPX4 and FTH1 (P<0.05), and the low- and high-dose CXG groups presented up-regulated expression of TFR1 (P<0.05). ConclusionCXG suppresses the proliferation of hepatocellular carcinoma cells by inducing ferroptosis via downregulating the GSH-GPX4 signaling axis and increasing intracellular Fe2+and LPO levels.
3.Fine setting and effect evaluation of parenteral nutrition refined medication rules
Yu CHEN ; Jie GU ; Lanping DING ; Zhuyue MA ; Hongyu YUAN
China Pharmacy 2025;36(20):2588-2592
OBJECTIVE To establish refined medication rules for parenteral nutrition (PN) and evaluate its effectiveness. METHODS Refined medication rules for PN were constructed based on drug instructions, relevant guidelines, and expert consensus. Through the pre-approval review system of prescription automatic screening system (PASS), PN prescription information for inpatients from January to December 2024 (referred to as “post-intervention”) was collected to analyze the post- intervention prescription review status. PN prescription information for inpatients at our hospital from January to December 2023 and January to December 2024 was collected through the medical order review system to evaluate the rationality rates of PN prescriptions. RESULTS The established refined medication rules for PN included system module rules (including nutrients, drug compatibility, PN concentration and osmotic pressure) and custom review rules (covering off-label drug use, drug compatibility, and other drug use conditions). As of December 2024, the PASS pre-approval review system had established a total of 102 rules, comprising 55 system module rules and 47 custom review rules for PN. After intervention, when comparing with the first quarter of 2024, the number of PN reviewed and intervened by pharmacists decreased, the pharmacist intervention rate dropped, while the rate of physician modifications following pharmacist intervention increased in the fourth quarter. The primary types of irrational prescriptions identified by the system module rules were irrational PN concentration and osmotic pressure. The primary types of irrational prescriptions identified by the custom review rules were off-label drug use (specifically indications for amino acids) and irrational drug incompatibility. In 2024, the number of false-positive tasks and the false-positive rate initially increased and then decreased, while both the number of irrational prescriptions identified through manual review and the false-negative rate showed a declining trend. In 2024, the overall rationality rate after manual review PN refined medication rules for PN medical order review system significantly increased compared to that in 2023 (P<0.01). CONCLUSIONS The refined medication rules for PN in our hospital were established successfully, which can reduce the PN-induced risks and significantly improve the rationality of PN prescriptions.
4.CT signs and AI parameters predict colorectal cancer neoadjuvant chemotherapy efficacy
Guobin LAN ; Chuang LIU ; Hao WANG ; Hongyu MA ; Zeliang LI ; Wen CHEN ; Wenqiang ZHANG
Chinese Journal of Radiological Health 2025;34(5):713-719
Objective To explore the value of CT signs and quantitative parameters of artificial intelligence (AI) in predicting the efficacy of neoadjuvant chemotherapy for colorectal cancer. Methods A total of 349 colorectal cancer patients who received neoadjuvant chemotherapy at Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine in Hebei Province from January 2022 to January 2025 were selected and and divided into the effective group (n = 267) and the ineffective group (n = 82) according to the evaluation criteria for the efficacy of solid tumors. Conduct a CT examination and extract AI quantitative parameters from the CT images based on the lesion. The data were analyzed using SPSS21.0 software, Logistic regression was used to screen the influencing factors of ineffective neoadjuvant chemotherapy in patients with colorectal cancer, and separate and combined models of CT signs and AI quantitative parameters were established. The predictive effect of the model was verified by using the ROC curve, calibration curve and decision curve. Results Compared with the effective group, the proportion of regular tumor morphology and the proportion of non-enlarged lymph nodesin the ineffective group were smaller. The tumor volume, peak value and entropy value were larger (P < 0.05). Multivariable analysis showed that irregular shape (OR= 4.216), presence of lymph node enlargement (OR = 8.998), larger tumor volume (OR = 1.109), higher average CT value (OR = 1.120), elevated peak value (OR = 2.528), and increased entropy value (OR = 1.390) were independent risk factors for ineffective neoadjuvant chemotherapy in colorectal cancer (P < 0.05). The areas under the ROC curves of the individual and combined models of CT signs and AI quantitative parameters were 0.777, 0.818, and 0.877, respectively(P < 0.05). The calibration curve showed a Brier score of 0.091. The decision curve showed that the threshold was between 0.10 and 0.85, and the combined model achieved a relatively high net clinical benefit. Conclusion CT signs combined with AI quantitative parameters has a predictive value for the efficacy of neoadjuvant chemotherapy in colorectal cancer. To provide evidence-based basis for clinical screening of the population benefiting from chemotherapy and optimization of treatment strategies.
5.Effects of decoction of Euphorbia fischeriana Steud.and jujuba against breast cancer of different molecular phenotypes via PI3k/Akt pathway
Liwei MA ; Hongyu YAO ; Zhe CHEN ; Shiyu NI ; Song CHEN ; Jing LI ; Jicheng LIU
Chinese Journal of Comparative Medicine 2024;34(3):27-35
Objective To explore the effect of decoction of Euphorbia fischeriana Steud.and jujuba(DEFSJ)against estrogen receptor(ER)negative(-)and ER positive(+)breast cancer via the PI3k/Akt pathway,and to provide a reference for the targeted treatment of breast cancer.Methods DEFSJ extract was prepared and analyzed using UHPLC-Triple Quad.DEFSJ containing serum(CS)was prepared via a serum pharmacology method.Different concentrations of DEFSJ-CS were applied to(ER-)MDA-MB-453 and(ER+)MCF-7 breast cancer cells in vitro for 48 h.The distribution of cells in different stages of the cellular cycle was evaluated using a Flow cytometer.DNA ladder assay was used to assess the degree of apoptosis,and the expression of PI3k/Akt pathway-related proteins was evaluated by Western blot assay.The expression of FoxO3a,FoxOla,and Bim mRNA was detected by Real-time quantitative PCR.Nuclear transposition of FoxO3a protein was analysed using a confocal laser microscopy.Results Five batches of DEFSJ extract were analyzed using UPLC,and the result showed that the preparation technology was feasible and the quality was controllable,ensuring the accuracy of the pharmacological experiment result.DEFSJ-CS blocked cells in the G2/M phase(P<0.05,P<0.01).Cells treated with DEFSJ-CS displayed the typical apoptotic ladder in the DNA ladder experiment.Compared with the negative control cells,the DEFSJ-CS group cells had decreased protein expression of p-PI3k,p-Akt,p-FoxO3a,and p-FoxO1a(P<0.05,P<0.01);increased protein expression of Bim(P<0.05);decreased mRNA expression of FoxO3a and FoxO1a(P<0.05,P<0.01);increased mRNA expression of Bim(P<0.05,P<0.01);and enhanced nuclear translocation of FoxO3a protein.The data showed that DEFSJ-CS had a stronger effect on(ER-)MDA-MB-453 cells than(ER+)MCF-7 cells.Conclusions The regulatory effect of DEFSJ extract on anti-breast cancer involves the PI3k/Akt pathway,and the effect varies with phenotypic differences.
6.Differential expression and bioinformatics analysis of microRNAs in exosomes of sheep poxvirus-infected cells
Xiaoqin MA ; Beibei ZHANG ; Hongyu WANG ; Yun GAO ; Lan WANG ; Mingyu HE ; Zhongzheng ZHU ; Xiaoshan CHAO ; Ying WANG ; Juntao DING
Korean Journal of Veterinary Research 2024;64(4):e23-
Sheep pox is widespread worldwide and is the most severe animal pox virus infection. This study aimed to identify the key microRNAs (miRNAs) differentially expressed in the exosomes of sheep poxvirus-infected cells and their target genes and related pathways and provide a theoretical basis for an in-depth understanding of the molecular mechanisms of sheep poxvirus-infected cells. In this study, the differentially expressed miRNAs were verified by quantitative polymerase chain reaction (qPCR), and the target genes of miRNAs were predicted and analyzed by bioinformatics. The qPCR results showed that the expression trends of oar-miR-21, oar-miR-10b, oar-let-7f, oar-let-7b, and oar-miR-221 were consistent with the sequencing results. The Gene Ontology and Kyoto Encyclopedia of Genes and Genomes results showed that differentially expressed miRNAs were mainly involved in the immune system processes of the Arf6 downstream pathway. The target genes Reactome pathways were mainly enriched in the RAC1 GTPase cycle, CDC42 GTPase cycle, RHO GTPase cycle, RHOV GTPase cycle, and post-transcriptional silencing of small RNAs. The transcription factors SP4, NKX6-1, MEF2A, SP1, EGR1, and POU2F1 that may be connected to sheep pox virus (SPPV)-infected cells were discovered by transcription factor annotation screening. In conclusion, this study screened for differentially expressed miRNAs in SPPV-infected cells and performed a series of bioinformatic analyses of their target genes to provide a theoretical basis for the molecular mechanism of sheep pox virus infections of cells. The data can be used as basic information in future studies on the defense mechanisms against poxvirus infections.
7.Differential expression and bioinformatics analysis of microRNAs in exosomes of sheep poxvirus-infected cells
Xiaoqin MA ; Beibei ZHANG ; Hongyu WANG ; Yun GAO ; Lan WANG ; Mingyu HE ; Zhongzheng ZHU ; Xiaoshan CHAO ; Ying WANG ; Juntao DING
Korean Journal of Veterinary Research 2024;64(4):e23-
Sheep pox is widespread worldwide and is the most severe animal pox virus infection. This study aimed to identify the key microRNAs (miRNAs) differentially expressed in the exosomes of sheep poxvirus-infected cells and their target genes and related pathways and provide a theoretical basis for an in-depth understanding of the molecular mechanisms of sheep poxvirus-infected cells. In this study, the differentially expressed miRNAs were verified by quantitative polymerase chain reaction (qPCR), and the target genes of miRNAs were predicted and analyzed by bioinformatics. The qPCR results showed that the expression trends of oar-miR-21, oar-miR-10b, oar-let-7f, oar-let-7b, and oar-miR-221 were consistent with the sequencing results. The Gene Ontology and Kyoto Encyclopedia of Genes and Genomes results showed that differentially expressed miRNAs were mainly involved in the immune system processes of the Arf6 downstream pathway. The target genes Reactome pathways were mainly enriched in the RAC1 GTPase cycle, CDC42 GTPase cycle, RHO GTPase cycle, RHOV GTPase cycle, and post-transcriptional silencing of small RNAs. The transcription factors SP4, NKX6-1, MEF2A, SP1, EGR1, and POU2F1 that may be connected to sheep pox virus (SPPV)-infected cells were discovered by transcription factor annotation screening. In conclusion, this study screened for differentially expressed miRNAs in SPPV-infected cells and performed a series of bioinformatic analyses of their target genes to provide a theoretical basis for the molecular mechanism of sheep pox virus infections of cells. The data can be used as basic information in future studies on the defense mechanisms against poxvirus infections.
8.Differential expression and bioinformatics analysis of microRNAs in exosomes of sheep poxvirus-infected cells
Xiaoqin MA ; Beibei ZHANG ; Hongyu WANG ; Yun GAO ; Lan WANG ; Mingyu HE ; Zhongzheng ZHU ; Xiaoshan CHAO ; Ying WANG ; Juntao DING
Korean Journal of Veterinary Research 2024;64(4):e23-
Sheep pox is widespread worldwide and is the most severe animal pox virus infection. This study aimed to identify the key microRNAs (miRNAs) differentially expressed in the exosomes of sheep poxvirus-infected cells and their target genes and related pathways and provide a theoretical basis for an in-depth understanding of the molecular mechanisms of sheep poxvirus-infected cells. In this study, the differentially expressed miRNAs were verified by quantitative polymerase chain reaction (qPCR), and the target genes of miRNAs were predicted and analyzed by bioinformatics. The qPCR results showed that the expression trends of oar-miR-21, oar-miR-10b, oar-let-7f, oar-let-7b, and oar-miR-221 were consistent with the sequencing results. The Gene Ontology and Kyoto Encyclopedia of Genes and Genomes results showed that differentially expressed miRNAs were mainly involved in the immune system processes of the Arf6 downstream pathway. The target genes Reactome pathways were mainly enriched in the RAC1 GTPase cycle, CDC42 GTPase cycle, RHO GTPase cycle, RHOV GTPase cycle, and post-transcriptional silencing of small RNAs. The transcription factors SP4, NKX6-1, MEF2A, SP1, EGR1, and POU2F1 that may be connected to sheep pox virus (SPPV)-infected cells were discovered by transcription factor annotation screening. In conclusion, this study screened for differentially expressed miRNAs in SPPV-infected cells and performed a series of bioinformatic analyses of their target genes to provide a theoretical basis for the molecular mechanism of sheep pox virus infections of cells. The data can be used as basic information in future studies on the defense mechanisms against poxvirus infections.
9.Study on Tongue Image Characteristics of TCM Symptoms in Patients with Different Fatigue Degree
Fangfang XIE ; Chaoqun XIE ; Jianwen MA ; Hongyu YUE ; Ruiqi XU ; Xiaojuan HU ; Fei YAO ; Jiatuo XU
Chinese Journal of Information on Traditional Chinese Medicine 2024;31(11):158-165
Objective To investigate the characteristics and rules of tongue image in patients with chronic fatigue syndrome(CFS)with different fatigue degree.Methods Totally 917 patients with severe chronic fatigue syndrome(severe CFS group),351 patients with mild chronic fatigue syndrome(mild CFS group)and 1216 healthy controls(healthy control group)were enrolled in the physical examination center of Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine.The tongue image data of subjects in the three groups were collected using TFDA-1 digital tongue and face diagnostic instrument,and the color space indexes of RGB,HSI,Lab and YCrCb were used to analyze the tongue image differences of CFS people with different fatigue degrees and the tongue image features of CFS patients with liver-qi stagnation syndrome,damp-heat stasis syndrome and spleen deficiency syndrome.Results Compared with the healthy control group,the tongue image indexes TB-R,TB-G,TB-B,TB-I,TB-L,TB-Y,TC-H,TC-I,TC-L and TC-Y increased in the severe CFS group;TB-S,TB-a,TC-S,TC-a,TC-Cr decreased(P<0.05).TB-R,TB-G,TB-B,TB-I,TB-L,TB-Y,TC-R,TC-G,TC-B,TC-I,TC-L and TC-Y increased in severe CFS group compared with mild CFS group.TB-H and TB-b increased in mild CFS group compared with healthy control group.The comparison of syndromes in severe CFS group showed that TB-a,TB-Cr,TC-S,TC-a,TC-Cr and TB-S increased in liver-qi stagnation syndrome compared to damp-heat stasis syndrome;TB-G,TB-B,TB-I,TB-L,TB-Y,TB-b,TB-Cb,TC-G,TC-B,TC-H,TC-I,TC-L,TC-Y and perAll decreased(P<0.05).Compared with spleen deficiency syndrome,TB-a,TB-Cr,TB-CON,TB-ENT,TB-MEAN,TC-a,TC-Cr,TC-CON,TC-ENT,TC-MEAN increased in liver-qi stagnation syndrome;TB-ASM,TC-S and TC-ASM decreased(P<0.05).Compared with spleen deficiency syndrome,TB-a,TB-b,TB-Cr,TB-Cb,TB-CON,TB-ENT,TB-MEAN,TC-G,TC-B,TC-H,TC-I,TC-L,TC-a,TC-Y,TC-Cr,TC-CON,TC-ENT,TC-MEAN,perAll increased;TB-ASM,TC-S and TC-ASM decreased(P<0.05).The comparison of mild CFS syndrome showed that there was no statistical significance between liver-qi stagnation syndrome and spleen deficiency syndrome(P>0.05).TB-Cr,TC-a,TC-Cr and perAll increased and TC-S decreased in damp-heat stasis syndrome compared with spleen deficiency syndrome(P<0.05).TB-S,TB-a,TB-Cr,TC-S,TC-a,TC-Cr increased,and TB-G,TB-B,TB-I,TB-Cb,TB-b,TC-b and TC-Cb decreased(P<0.05)in liver-qi stagnation syndrome compared with damp-heat syndrome.The distribution trend of TC-S was as follows:dampness-heat syndrome
10.Effect of Coptisine on PI3K/Akt/mTOR Signaling Pathway in Chronic Atrophic Gastritis Rats
Jie WANG ; Pengli DU ; Jiaqi DONG ; Yuewei YANG ; Yunxiao GAO ; Hongyu MA ; Xuemei JIA ; Yuxi GUO ; Bolin LI ; Qian YANG
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(18):117-124
ObjectiveTo investigate the therapeutic effect and mechanism of coptisine on chronic atrophic gastritis (CAG) in rats based on the phosphatidylinositol 3-kinase (PI3K)/protein kinase B (Akt)/mammalian target of rapamycin (mTOR) signaling pathway. MethodA CAG rat model was induced by multiple factors, including sodium salicylate, N-methyl-N′-nitro-N-nitrosoguanidine (MNNG), and irregular feeding. The successfully modeled rats were randomly divided into the model group, folic acid group, and high- and low-dose coptisine groups. The high- and low-dose coptisine groups were given coptisine (50, 10 mg·kg-1, respectively), and the folic acid group was given folic acid at 2 mg·kg-1 for 60 days. The pathological changes were detected by hematoxylin-eosin (HE) staining. The ultrastructure of gastric mucosal cells was observed by electron microscopy. Serum pepsinogen Ⅰ (PGⅠ), pepsinogen Ⅱ (PGⅡ), and PGⅠ/PGⅡ ratio (PGR) were detected by immunoturbidimetry. Serum gastrin-17 (G-17) level was detected by radioimmunoassay. The content of interleukin-6 (IL-6), tumor necrosis factor-α (TNF-α) and interleukin-1β (IL-1β) in serum of rats was detected by enzyme-linked immunosorbent assay (ELSIA). Western blot analysis was used to detect the expression levels of TGF-β1, PI3K, phosphorylated-Akt (p-Akt), mTOR, and phosphatase and tensin homolog deleted on chromosome 10 (PTEN) in gastric mucosa. The mRNA levels of TGF-β1, PI3K, Akt, mTOR, PTEN, microtubule-associated protein light chain 3Ⅱ (LC3Ⅱ), and Beclin-1 were detected by real-time quantitative polymerase chain reaction (Real-time PCR). ResultCompared with the normal group, the model group showed atrophy and reduced number of intrinsic glands in the gastric mucosal tissues, as well as inflammatory cell infiltration. The ultrastructure of gastric mucosal cells in the model group displayed nuclear condensation, reduced and swollen mitochondria, and abnormal structure. The serum levels of G-17, PGⅠ, PGR, and the protein and mRNA levels of PTEN in gastric tissues were significantly lower in the model group (P<0.01), while serum levels of IL-6, IL-1β, TNF-α, and the protein and mRNA levels of TGF-β1, PI3K, Akt, and mTOR in gastric tissues were significantly higher (P<0.01). Compared with the model group, various drug intervention groups showed different degrees of improvement in pathological damage and gastric mucosal cell ultrastructure, significantly increased serum levels of G-17, PGⅠ, and PGR (P<0.05,P<0.01), and significantly decreased levels of IL-6, IL-1β, and TNF-α (P<0.05,P<0.01). The high-dose coptisine group significantly downregulated the protein and mRNA levels of TGF-β1, PI3K, Akt, and mTOR (P<0.05,P<0.01). ConclusionBerberine has a therapeutic effect on CAG in rats, possibly exerting a protective effect on gastric mucosa by inhibiting inflammation and blocking the PI3K/Akt/mTOR signaling pathway.

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