1.The introduction on the new standards of pharmaceutical excipients in the Chinese Pharmacopoeia 2025 Edition
CHEN Lei ; CHEN Ying ; TU Jiasheng ; LIU Yanming ; ZHENG Luxia ; ZHANG Jun ; MA Shuangcheng
Drug Standards of China 2025;26(1):058-066
According to the work goals and tasks determined by edition outline of the Chinese Pharmacopoeia 2025 Edition, the Chinese Pharmacopoeia 2025 Edition has been completed. Among them, 52 new pharmaceutical excipients monographs have been added, an increase of 15.5% compared with the 2020 Edition, and the total number has reached 387. This article focuses on the general framework and the main characteristics of the standards of pharmaceutical excipients in the Chinese Pharmacopoeia 2025 Edition, which can contribute to accurately understand and utilize the standards in Chinese Pharmacopoeia.
2.Effects of Electroacupuncture at "Fengchi" (GB 20), "Waiguan" (TE 5), and "Yanglingquan" (GB 34) on Nociceptive Sensitization and PKC/TRPV1 Pathway in the Trigeminal Ganglion of Chronic Migraine Model Rats
Yixiang ZENG ; Runze TU ; Shucong ZHAO ; Yang YANG ; Haojia WEN ; Zhuozhong HE ; Shengli ZHOU ; Lei TAN ; Ke HE ; Lei FU
Journal of Traditional Chinese Medicine 2025;66(3):283-289
ObjectiveTo explore the possible mechanisms of electroacupuncture at Fengchi (GB 20), Waiguan (TE 5), and Yanglingquan (GB 34) in treating chronic migraine from the perspective of nociceptive sensitization. MethodsForty SPF-grade SD rats were randomly divided into blank group, model group, electroacupuncture group, electroacupuncture + agonist group, and inhibitor group, with 8 rats in each group. Except for the blank group, rats were injected intraperitoneally with nitroglycerin to establish a chronic migraine rat model. After successful modeling, the electroacupuncture group received electroacupuncture at bilateral "Fengchi" (GB 20), "Waiguan" (TE 5), and "Yanglingquan" (GB 34) for 30 minutes each session. The electroacupuncture + agonist group received the same electroacupuncture treatment and additional injection of protein kinase C (PKC) agonist Phorbol 12-myristate 13-acetate (1.0 ng/μl, 25 μl) via the infraorbital foramen. The inhibitor group received PKC inhibitor Chelerythrine Chloride (1.0 ng/μl, 10 μl) via the infraorbital foramen. The blank group, model group, and inhibitor group underwent restraint for 30 minutes without other interventions. All groups were continuously intervened for 5 days. After the intervention, the nociceptive thresholds (mechanical and thermal pain) of the periorbital area and hind paw were measured. The expression levels of transient receptor potential vanillic acid subtype 1 (TRPV1), phosphorylated TRPV1 (p-TRPV1), PKC proteins, Trpv1, Pkc mRNA, and the average fluorescence intensity of transient receptor potential vanillic acid subtype 1 (TRPV1) and PKC in the trigeminal ganglion were detected using Western Blot, real-time fluorescence quantitative PCR, and immunofluorescence methods. ResultsCompared with the blank group, the mechanical and thermal pain thresholds of the periorbital area and hind paw were reduced in the model group, and the protein levels of TRPV1, PKC, p-TRPV1, as well as the mRNA expression of Trpv1 and Pkc, and the average fluorescence intensity of TRPV1 and PKC in the trigeminal ganglion significantly increased (P<0.05 or P<0.01). Compared with the model group, the electroacupuncture group exhibited increased mechanical and thermal pain thresholds in the periorbital and hind paw areas, and decreased protein levels of TRPV1, PKC, p-TRPV1, mRNA expression of Trpv1 and Pkc, and average fluorescence intensity of TRPV1. In the electroacupuncture + agonist group, the average fluorescence intensity of TRPV1 in the trigeminal ganglion decreased. The inhibitor group exhibited increased mechanical pain thresholds in the periorbital area and thermal pain thresholds in the hind paw, along with decreased protein levels of TRPV1, PKC, p-TRPV1, and the average fluorescence intensity of TRPV1 and PKC (P<0.05 or P<0.01). Compared with the electroacupuncture group, the electroacupuncture + agonist group showed an increase in the protein levels of TRPV1, PKC, p-TRPV1, and the mRNA expression of Trpv1 (P<0.05 or P<0.01). ConclusionElectroacupuncture at the "Fengchi" (GB 20), "Waiguan" (TE 5), and "Yanglingquan" (GB 34) acupoints can increase the mechanical and thermal pain thresholds in chronic migraine rats and alleviate nociceptive sensitization. The mechanism may be related to the inhibition of PKC/TRPV1 pathway.
3.Hepatitis E virus infection among blood donors in Zhengzhou
Hongna ZHAO ; Yueguang WEI ; Lumin YAN ; Tiantian TU ; Shumin WANG ; Yihui WEI ; Yifang WANG ; Lei ZHAO ; Mingjun CHEN
Chinese Journal of Blood Transfusion 2025;38(1):13-18
[Objective] To analyze the infection status of hepatitis E virus (HEV) among blood donors in Zhengzhou, so as to provide data support for formulating local blood screening strategies. [Methods] Random samples from blood donors from January to December 2022 were tested for HEV RNA using PCR technology. Reactive samples were sequenced for gene analysis, and the donors were followed up. [Results] Among 21 311 samples, 3(0.14‰) were reactive for HEV RNA, all of whom were male. Genetic sequencing results revealed that one strong positive sample was genotype 4, while sequencing failed for the other two due to low viral load. A follow-up of 25 strong positive donors showed that ALT significantly increased on day 7 after donation, anti-HEV IgM and anti-HEV IgG turned positive. On day 21, ALT returned to normal, and on day 35, HEV RNA turned negative. Notably, anti-HEV IgM and anti-HEV IgG persisted until day 482. [Conclusion] There is HEV infection among blood donors in Zhengzhou, and it is necessary to expand the screening scope to comprehensively explore the prevalence and genotype distribution of HEV among blood donors.
4.The technology of fecal microbiota transplantation and its application progress
Shuo YUAN ; Yi-fan ZHANG ; Peng GAO ; Jun LEI ; Ying-yuan LU ; Peng-fei TU ; Yong JIANG
Acta Pharmaceutica Sinica 2025;60(1):82-95
Fecal microbiota transplantation (FMT) technology originated in China during the Eastern Jin Dynasty and has rapidly developed over the past two decades, becoming a primary method for studying the causal relationship between gut microbiota and the occurrence and progression of diseases. At the same time, the therapeutic effects of FMT in the field of gastrointestinal diseases have gained widespread recognition and are gradually expanding into other disease areas. The FMT procedure is relatively complex, and there is currently no standardized method; its success is influenced by various factors, including the donor, recipient, processing of the fecal material, and the method of implantation. Given the increasingly recognized relationship between gut microbiota and various diseases, FMT has become a research hotspot in both scientific studies and clinical applications, achieving a series of significant advancements. To help researchers better understand this technology, this paper will outline the development history of FMT, summarize common operational methods in research and clinical settings, review its application progress, and look forward to future development directions.
5.Two new protoberberine alkaloids from Stephania hernandifolia.
Wei-Hua DAI ; Xin-Tao CUI ; Yu-Jiao TU ; Lei JIANG ; Lin YUAN
China Journal of Chinese Materia Medica 2025;50(5):1231-1235
The 95% ethanol extract of Stephania hernandifolia was isolated and purified by column chromatography on silica gel and Sephadex LH-20, RP-18 medium-pressure liquid chromatography, and semi-preparative high performance liquid chromatography. The chemical structures of the compounds were identified by NMR and high-resolution mass spectrometry. Four alkaloids were isolated and identified as(-)-8-oxo-2,3,4,10,11-pentamethoxyberberine(1),(-)-8-oxo-11-hydroxy-2,3,4,10-tetramethoxyberberine(2), N-trans-feruloyl tyramine(3), and N-cis-feruloyl tyramine(4). Compounds 1 and 2 were new protoberberine alkaloids, while compounds 3 and 4 were amide alkaloids. All the four compounds were separated from this plant for the first time. The inhibitory activities of compounds 1, 3, and 4 against α-glycosidase were measured by the enzymatic reaction in vitro with 4-nitrophenyl-α-D-glucopyranoside(PNPG) as the substrate. Compounds 3 and 4 showed inhibitory activities against α-glucosidase, with median inhibition concentration(IC_(50)) values of(7.09±0.42) and(31.25±1.14) μmol·L~(-1), respectively.
Berberine Alkaloids/isolation & purification*
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Stephania/chemistry*
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Drugs, Chinese Herbal/isolation & purification*
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Molecular Structure
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alpha-Glucosidases/metabolism*
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Chromatography, High Pressure Liquid
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Alkaloids/isolation & purification*
6.Progress in R&D and key issues in industrial advancement of Cistanches Herba products.
Shuo YUAN ; Yu-Ling XIAO ; Jia-Xu SUN ; Jun LEI ; Jia-Xin HONG ; Peng-Fei TU ; Yong JIANG
China Journal of Chinese Materia Medica 2025;50(13):3815-3840
Cistanches Herba(CH) is a famous tonic traditional Chinese medicine, with the effects of tonifying kidney Yang, nourishing kidney Yin, replenishing essence and blood, and moistening the intestines to relieve constipation. Modern pharmacological studies have shown that CH has anti-aging, anti-fatigue, immunomodulatory, neuroprotective, and anti-aging activities, serving as an ideal raw material for the development of pharmaceuticals and health products. In 2023, CH was added in the catalog of medicinal and food substances, which provided policy support for its application in conventional food products and expanding pathways for industrial diversification. To comprehensively understand current development status of CH products, this review systematically investigated professional databases including Yaozhi(https://db.yaozh.com), Chinese Pharmacopoeia, Compendium of National Standards for Chinese Patent Medicines, and Kezhuang and collected market survey data to thoroughly review the applications of CH as a primary ingredient in domestic and international Chinese patent medicines, health foods, cosmetics, and common food products. Furthermore, this review points out challenges in the current industrial development and future potential market prospects, aiming to provide guidance for the development and industrialization of CH-based pharmaceuticals and health products, thereby promoting the vigorous growth of the CH industry.
Drugs, Chinese Herbal/pharmacology*
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Humans
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Cistanche/chemistry*
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Animals
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Medicine, Chinese Traditional
7.Research progress of new aluminum-containing vaccine adjuvants
Hongmei REN ; Yerong XIONG ; Xiaoying XUN ; Lei JIANG ; Jiasheng TU
Journal of China Pharmaceutical University 2025;56(2):236-243
Aluminum adjuvants are widely used in the field of vaccines due to their ability to induce efficient and long-lasting immune responses and good safety profile. With the development of immunology, the requirements for adjuvants have gradually increased, and traditional aluminum adjuvants can no longer meet all the needs of application. The development of novel aluminum adjuvants has become a hot research topic in order to achieve good immunity-enhancing effects and induce specific types and strengths of immune responses. This review briefly introduces the mechanism of action and safety of aluminum adjuvants, with focus on the research progress of novel aluminum adjuvants in recent years, mainly including nano-aluminum adjuvants and composite aluminum adjuvants (aluminum adjuvants compounded with immunity-stimulating molecules or delivery carriers), and a prospect of their future research direction, aiming to provide some reference for the further development and clinical application of aluminum adjuvants.
8.Preliminary investigation on a method for determining the cumulative dose of low-energy neutrons independently
Lei DENG ; Faming CAO ; Zhe WANG ; Yu TU ; Ning ZHOU
Chinese Journal of Radiological Health 2025;34(4):578-583
Objective To study a method for determining the cumulative dose of low-energy neutrons ( < 100 keV) independently based on a CR-39 detector. Methods According to the theory of track etching kinetics, the differences in the tracks formed by low-energy neutrons or fast neutrons in a BN + CR-39 detector under broad-spectrum neutron irradiation were analyzed. A method was proposed to identify the tracks produced by low-energy neutrons under specific etching conditions while avoiding interference from fast neutron tracks. Results Experimental results demonstrated that the BN + CR-39 detector using TASTRAK PADC CR-39 track-detecting plastic could independently detect the tracks of low-energy neutrons when etched in a 6.25 mol/L NaOH solution for 1 h. The track density showed a good linear relationship with the ambient dose equivalent of low-energy neutrons, and the calibration coefficient was
9.Exploration of Mechanism of Huanglian Zhimutang in Treatment of Type 2 Diabetes Mellitus Based on PI3K/Akt Pathway
Lei WANG ; Yun PAN ; Lihua WAN ; Wenling TU ; Lingyong CAO
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(21):168-177
ObjectiveBased on the phosphoinositide 3-kinase (PI3K)/protein kinase B (Akt) signaling pathway, the effects of Huanglian Zhimutang on glucose and lipid metabolism disorders and hepatic insulin resistance (IR) with type 2 diabetes mellitus (T2DM) were investigated. MethodsGoto-Kakizaki (GK) rats were fed a high-fat diet to induce a T2DM rat model and then randomly divided into four groups: normal control group, model control group, metformin group (0.10 g·kg-1), and Huanglian Zhimutang group (3.60 g·kg-1), with eight rats in each group. Drug intervention was administered continuously for 8 weeks. Serum and liver tissues were collected from each group. Fasting insulin (FINS) levels were measured using enzyme-linked immunosorbent assay (ELISA), and the homeostasis model assessment of insulin resistance (HOMA-IR) index was calculated. Total cholesterol (TC), triglyceride (TG), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C) levels were measured using an automatic biochemical analyzer. Liver tissue pathology was observed via hematoxylin-eosin (HE) staining. Serum interleukin-6 (IL-6) and tumor necrosis factor-α (TNF-α) levels were detected using ELISA. Network pharmacology and transcriptomics sequencing were combined to analyze differentially expressed genes (DEGs) in liver tissue from the normal control group, model control group, and Huanglian Zhimutang group. Kyoto Encyclopedia of Genes and Genomes (KEGG) pathway enrichment analysis was performed to identify pathways affected by Huanglian Zhimutang intervention in T2DM. Real-time quantitative polymerase chain reaction (Real-time PCR) was used to assess the mRNA expression of insulin receptor substrate-1 (IRS-1), PI3K, Akt, and peroxisome proliferator-activated receptor gamma (PPARγ) in liver tissue, while Western blot was used to evaluate corresponding protein expression levels. ResultsAfter 8 weeks of Huanglian Zhimutang intervention, typical symptoms of T2DM rats such as polydipsia, polyphagia, and polyuria were significantly alleviated, along with reductions in fasting blood glucose levels and insulin resistance(P<0.01). Histopathological results revealed that Huanglian Zhimutang effectively improved hepatic steatosis and inflammatory edema and reduced lipid vacuole formation. Biochemical tests demonstrated that Huanglian Zhimutang significantly reduced serum levels of TC, TG, and LDL-C(P<0.01). ELISA results showed that Huanglian Zhimutang effectively decreased serum concentrations of IL-6 and TNF-α(P<0.05,P<0.01). Combined network pharmacology predictions with KEGG pathway analysis of transcriptomics showed that DEGs between the Huanglian Zhimutang and model control groups were significantly enriched in the PI3K/Akt signaling pathway. Real-time PCR and Western blot results confirmed that Huanglian Zhimutang upregulated the expression of PI3K/Akt signaling pathway-related mRNAs and proteins in liver tissue(P<0.05,P<0.01), thereby reducing inflammation, alleviating hepatic lipid accumulation, and enhancing insulin sensitivity. ConclusionHuanglian Zhimutang effectively ameliorates glucose and lipid metabolism disorders in T2DM rats. Its mechanism may be related to the regulation of the PI3K/Akt pathway, which reduces inflammation and hepatic lipid deposition and relieves hepatic insulin resistance.
10.Exploration of Mechanism of Huanglian Zhimutang in Treatment of Type 2 Diabetes Mellitus Based on PI3K/Akt Pathway
Lei WANG ; Yun PAN ; Lihua WAN ; Wenling TU ; Lingyong CAO
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(21):168-177
ObjectiveBased on the phosphoinositide 3-kinase (PI3K)/protein kinase B (Akt) signaling pathway, the effects of Huanglian Zhimutang on glucose and lipid metabolism disorders and hepatic insulin resistance (IR) with type 2 diabetes mellitus (T2DM) were investigated. MethodsGoto-Kakizaki (GK) rats were fed a high-fat diet to induce a T2DM rat model and then randomly divided into four groups: normal control group, model control group, metformin group (0.10 g·kg-1), and Huanglian Zhimutang group (3.60 g·kg-1), with eight rats in each group. Drug intervention was administered continuously for 8 weeks. Serum and liver tissues were collected from each group. Fasting insulin (FINS) levels were measured using enzyme-linked immunosorbent assay (ELISA), and the homeostasis model assessment of insulin resistance (HOMA-IR) index was calculated. Total cholesterol (TC), triglyceride (TG), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C) levels were measured using an automatic biochemical analyzer. Liver tissue pathology was observed via hematoxylin-eosin (HE) staining. Serum interleukin-6 (IL-6) and tumor necrosis factor-α (TNF-α) levels were detected using ELISA. Network pharmacology and transcriptomics sequencing were combined to analyze differentially expressed genes (DEGs) in liver tissue from the normal control group, model control group, and Huanglian Zhimutang group. Kyoto Encyclopedia of Genes and Genomes (KEGG) pathway enrichment analysis was performed to identify pathways affected by Huanglian Zhimutang intervention in T2DM. Real-time quantitative polymerase chain reaction (Real-time PCR) was used to assess the mRNA expression of insulin receptor substrate-1 (IRS-1), PI3K, Akt, and peroxisome proliferator-activated receptor gamma (PPARγ) in liver tissue, while Western blot was used to evaluate corresponding protein expression levels. ResultsAfter 8 weeks of Huanglian Zhimutang intervention, typical symptoms of T2DM rats such as polydipsia, polyphagia, and polyuria were significantly alleviated, along with reductions in fasting blood glucose levels and insulin resistance(P<0.01). Histopathological results revealed that Huanglian Zhimutang effectively improved hepatic steatosis and inflammatory edema and reduced lipid vacuole formation. Biochemical tests demonstrated that Huanglian Zhimutang significantly reduced serum levels of TC, TG, and LDL-C(P<0.01). ELISA results showed that Huanglian Zhimutang effectively decreased serum concentrations of IL-6 and TNF-α(P<0.05,P<0.01). Combined network pharmacology predictions with KEGG pathway analysis of transcriptomics showed that DEGs between the Huanglian Zhimutang and model control groups were significantly enriched in the PI3K/Akt signaling pathway. Real-time PCR and Western blot results confirmed that Huanglian Zhimutang upregulated the expression of PI3K/Akt signaling pathway-related mRNAs and proteins in liver tissue(P<0.05,P<0.01), thereby reducing inflammation, alleviating hepatic lipid accumulation, and enhancing insulin sensitivity. ConclusionHuanglian Zhimutang effectively ameliorates glucose and lipid metabolism disorders in T2DM rats. Its mechanism may be related to the regulation of the PI3K/Akt pathway, which reduces inflammation and hepatic lipid deposition and relieves hepatic insulin resistance.

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