Zhongguo Zhongyao Zazhi最新文献

{"title":"[Progress and prospects of safety assessment methods of medicinal and food homologous substances].","authors":"Pei Cao, Meng-Meng Gao, Min Chen, Lei Zhang","doi":"10.19540/j.cnki.cjcmm.20240615.103","DOIUrl":"10.19540/j.cnki.cjcmm.20240615.103","url":null,"abstract":"<p><p>Food and medicinal substances(FAMS) with both edible and medicinal uses have a long history in China, being an important part of China's excellent traditional culture and traditional Chinese medicine(TCM). The legal management of FAMS is in the form of catalogue, which has a history of nearly 40 years. More than 100 substances have been included in the China's FAMS catalogue. According to the Regulation of Food and Medicinal Substances Catalogue, safety assessment is a basis for substances to be included in the catalogue. The safety assessment of FAMS should follow the principles and requirements of food safety risk assessment. However, FAMS is a complex mixture, and the nature and data adequacy of the assessed substance should be comprehensively considered. Different eva-luation models and methods should be selected according to the principle of case analysis. With the development of next-generation technologies such as big data, artificial intelligence, high-throughput and high-content in vitro testing, and computational toxicology and the trend of increasing edible substances with medicinal effects applying for the inclusion in the China's FAMS catalogue, the methods of risk assessment are applied in the management of FAMS, novel food products, and local characteristic food products, playing a scientific role. This paper systematically reviews the methods, challenges, and prospects of safety assessment of FAMS.</p>","PeriodicalId":52437,"journal":{"name":"Zhongguo Zhongyao Zazhi","volume":"49 17","pages":"4562-4566"},"PeriodicalIF":0.0,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142300598","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"[Quality standards of medicinal and food homologous substances based on dual attributes].","authors":"Wen-Xiao Hu, Su-Ping Xiao, Min Chen, Dan Qian","doi":"10.19540/j.cnki.cjcmm.20240518.101","DOIUrl":"https://doi.org/10.19540/j.cnki.cjcmm.20240518.101","url":null,"abstract":"<p><p>Medicine and food homology culture has a long history in China. With the continuous improvement of people's living standards, there has been a growing investment in health care, leading to significant development in the health industry. Medicinal and food homologous substances, receiving increasing attention, have become the breakthrough and mainstay of the health industry, with broad prospects for related industries. However, the medicinal and edible industry currently faces numerous challenges, especially regarding the research on quality standards for medicinal and food homologous substances, where the study of food attributes is still in its infancy. Therefore, this article elaborated on the current research status of quality standards for medicinal and food homologous substances, clarified the confusion surrounding the concept of medicinal and food homologous substances, and analyzed the weaknesses in the research on food attributes in the quality standards of medicinal and food homologous substances, as well as the lack of unified safety indicators. Based on the dual attributes of medicinal and food homologous substances, it is suggested that research on quality stan-dards should encompass authenticity, safety, nutrition, and efficacy. Under the premise of ensuring authenticity, the safety of exogenous toxic substances should be evaluated in combination with their dual attributes. In the formulation of standards, the nutritional aspect of food properties should be strengthened, and different indicators should be selected for comprehensive quality control based on the sources and properties of medicinal and food homologous substances. By employing multiple techniques for holistic control from various perspectives, a set of systematic quality standards applicable to medicinal and food homologous substances can be established. This study is expected to provide references for the quality control, safe use, and regulation of medicinal and food homologous substances, thereby promoting the healthy development of the entire industry.</p>","PeriodicalId":52437,"journal":{"name":"Zhongguo Zhongyao Zazhi","volume":"49 17","pages":"4545-4552"},"PeriodicalIF":0.0,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142300601","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"[Mechanism of Panax notoginseng saponins in treating diabetic kidney disease based on network pharmacology and experimental verification].","authors":"Yang-Chen Wang, Ruo-Yu Geng, Jian-Hua Yang, Chong Ma, Wu Dai, Ya-Li Guo, Han-Teng Zhang, Zi-Xuan Xu, Xin-Yue Li, Xin-Xin Ma, Jun-Ping Hu, Li-Mei Wen","doi":"10.19540/j.cnki.cjcmm.20240516.701","DOIUrl":"https://doi.org/10.19540/j.cnki.cjcmm.20240516.701","url":null,"abstract":"<p><p>This study aims to investigate the therapeutic effect and mechanism of Panax notoginseng saponins(PNS) on diabetic kidney disease(DKD) based on network pharmacology, molecular docking, animal experiments. Network pharmacology was employed to screen the potential targets, and STRING was employed to build the protein-protein interaction network. Gene Ontology(GO) and Kyoto Encyclopedia of Genes and Genomes(KEGG) enrichment analyses were carried out for the core targets screened out, and a ″components-targets-pathways″ visualization network was constructed to predict the potential mechanism of PNS in treating DKD. Five active ingredients were screened from PNS, the core targets of which for treating DKD were AKT1, STAT3, ESR1, HSP90AA1, MTOR, et al. The KEGG enrichment analysis showed that the pathways related to PNS for treating DKD included the pathway in cancer, chemical carcinogenesis-receptor activation, and PI3K-AKT signaling pathway. GO analysis revealed that protein binding, homologous protein binding, enzyme binding, and ATP binding were the main biological processes involved in the treatment of DKD with PNS. Male 6-week-old db/db mice were randomized into model, dapagliflozin, and low-dose and high-dose PNS groups, with 10 mice in each group. Ten 6-week-old db/m mice were used as the control group. Mice were administrated with corresponding drugs or distilled water(control and model groups) by gavage once a day for 8 weeks. The body weight, fasting blood glucose, kidney index, microalbuminuria, creatinine, microalbuminuria/creatinine ratio, and urea nitrogen content in the urine of mice were determined. Hematoxylin-eosin(HE) staining, periodic acid-Schiff(PAS) staining, and Masson staining were performed to observe the protective effect of PNS on the renal tissues in db/db mice. The results showed that PNS could significantly reduce the fasting blood glucose level and improve the renal damage in db/db mice. Western blot results showed that PNS down-regulated the protein levels of p-AKT1 and p-STAT3 and decreased the p-AKT1/AKT1 and p-STAT3/STAT3 ratios. In addition, high-dose PNS down-regulated the protein level of PIK3CA. In conclusion, PNS may exert the kidney-protecting effects in DKD by inhibiting STAT3 via the PI3K-AKT signaling pathway.</p>","PeriodicalId":52437,"journal":{"name":"Zhongguo Zhongyao Zazhi","volume":"49 17","pages":"4607-4616"},"PeriodicalIF":0.0,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142300695","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"[Main nutrients content in different specifications of Gastrodiae Rhizoma].","authors":"Xin-Yue Li, Chen-Chen Zhang, Meng Cheng, Min Chen, Dan Qian, Ke Tian, Guang Yang","doi":"10.19540/j.cnki.cjcmm.20240216.104","DOIUrl":"https://doi.org/10.19540/j.cnki.cjcmm.20240216.104","url":null,"abstract":"<p><p>Gastrodiae Rhizoma is a valuable traditional Chinese medicine(TCM) and was newly approved as a catalogue species of medicinal and food homologous substances in 2023. The consumption of Gastrodiae Rhizoma as a food has been increasing year by year, and its nutrients content has become a public concern. However, there is a lack of systematic research on its nutrients content. Gastrodiae Rhizoma is widely distributed and exhibits various specifications. The quality of Gastrodiae Rhizoma varies among different varieties, origins, and grades. In this paper, 76 batches of samples were selected, involving 2 varieties(G. elata f. elata and G. elata f. qlauca), 6 origins(Anhui, Shaanxi, Hubei, Yunnan, Henan and Northeast China) and 5 grades(special grade, first grade, second grade, third grade, and fourth grade). The content of main nutrients of the above samples was determined and analyzed to explore the differences in the content of different specifications of Gastrodiae Rhizoma. The results show that Gastrodiae Rhizoma is rich in a variety of nutrients, including protein, fat, starch, crude fiber, total saponins, moisture, polysaccharides, mineral elements, amino acids, and volatile oils. The total mass of volatile oils reached about 96.00%. The percentages of starch, moisture and polysaccharides werethe highest, accounting for 64.52%, 10.45%, and 8.32%, respectively. There were also differences in nutrient content among different specifications, especially the polysaccharide content of different varieties. Therefore, the research direction of Gastrodiae Rhizoma medicinal and food homologous products can be inclined to the development of meal replacement staple food or polysaccharide functional food. This study provides a reference for the research of Gastrodiae Rhizoma in the field of medicinal and food homologous products.</p>","PeriodicalId":52437,"journal":{"name":"Zhongguo Zhongyao Zazhi","volume":"49 17","pages":"4572-4577"},"PeriodicalIF":0.0,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142300690","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"[Comparison on tissue distribution of five components in Shuganning Injection and Scutellariae Radix extract by UPLC-MS/MS].","authors":"Ting-Ting Lu, Ling Wang, Yan Tian, Ming-Yan Chi, Yong Huang, Zi-Peng Gong, Lin Zheng, Feng He","doi":"10.19540/j.cnki.cjcmm.20240605.201","DOIUrl":"https://doi.org/10.19540/j.cnki.cjcmm.20240605.201","url":null,"abstract":"<p><p>This study established an ultra-high performance liquid chromatography-tandem mass spectrometry(UPLC-MS/MS) method to determine the content of five index components in rat tissues and organs after administration of Shuganning Injection or Scutellariae Radix extract. The dynamic changes and differences of the distribution of the five index components over time between the two groups were studied, and the effects of Scutellariae Radix alone or in combination with other medicines on the tissue distribution of the five components were explored. After Shuganning Injection or Scutellariae Radix extract was injected into the tail vein of rats, the heart, liver, spleen, lung, kidney, stomach, intestine, and brain tissue samples were collected at four time points of 0.17, 0.5, 1, and 2 h, respectively. UPLC-MS/MS was employed to measure the concentrations of the five index components(baicalin, baicalein, oroxylin A, oroxylin A-7-O-β-D-glucuronide, and scutellarin) in the samples of the two groups. The results showed that the established method was simple, fast, and exclusively stable. After the administration of Shuganning Injection and Scutellariae Radix extract, the five index components presented wide distribution and had differences in vivo. The two groups showcased abundant distribution of baicalin, baicalein, and oroxylin A in the kidney and liver, oroxylin A-7-O-β-D-glucuronide in the kidney and brain, and scutellarin in the kidney and heart. The content of baicalin in the heart, liver, kidney, and intestine, baicalein in the liver and kidney, and oroxylin A in the lung after administration of Shuganning Injection(Scutellariae Radix in combination with other medicines) was significantly higher than that after administration of Scutellariae Radix extract. The results of this study suggested that the five components of Shuganning Injection and Scutellariae Radix extract demonstrated wide distribution without accumulation in rats. The combination of Scutellariae Radix with other medicines can increase the distribution of active components in rats, which provided a basis for explaining the rationality of the compatibility of Shuganning Injection from in vivo processes.</p>","PeriodicalId":52437,"journal":{"name":"Zhongguo Zhongyao Zazhi","volume":"49 17","pages":"4768-4776"},"PeriodicalIF":0.0,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142300620","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"[Transepithelial transport in vivo and in vitro and anti-inflammatory activity of cannabidiol].","authors":"Rui Li, Rui Hao, Jue Chen, Li-Yan Lu, Min Li, Wen-Hui Ruan","doi":"10.19540/j.cnki.cjcmm.20240704.202","DOIUrl":"https://doi.org/10.19540/j.cnki.cjcmm.20240704.202","url":null,"abstract":"<p><p>This study used Caco-2 cells and normal rats to investigate the in vitro absorption characteristics and in vivo pharmacokinetic characteristics of cannabidiol(CBD) and explore the anti-inflammatory mechanism of CBD. The safe concentration range of CBD was determined by the CCK-8 assay, and then the effects of time, concentration, temperature, endocytosis inhibitors, and transport inhibitors on the transepithelial absorption and transport of CBD were assessed. The blood drug concentration was measured at different time points after oral administration in rats for pharmacokinetic profiling, and the pharmacokinetic parameters were calculated. The Caco-2 cell model of inflammation injury was established with lipopolysaccharide(LPS). The effects of CBD on lactate dehydrogenase(LDH) activity, transendothelial electrical resistance(TEER), and levels of inflammatory cytokines of the modeled cells were exami-ned, on the basis of which the anti-inflammatory mechanism of CBD was deciphered. The results showed that within the concentration range tested in this study, the CBD uptake by Caco-2 cells reached saturation at the time point of 2 h. Moreover, the CBD uptake was positively correlated with concentration and temperature and CBD could be endocytosed into the cells. CBD could penetrate Caco-2 cells through active transport pathways involving multidrug resistance-associate protein 2(MRP2) and breast cancer resistance protein(BCRP), while the addition of P-gp inhibitors had no effect on CBD transport. Rats exhibited rapid absorption of CBD, with the peak time(t_(max)) of(1.00±0.11) h, and fast elimination of CBD, with a half-life(t_(1/2)) of only(1.86±0.16) h. In addition, CBD significantly ameliorated the increased LDH activity and decreased TEER that were caused by inflammatory response. It maintained the intestinal barrier by down-regulating the expression of pro-inflammatory cytokines interleukin-8(IL-8), interleukin-1 beta(IL-1β) and tumor necrosis factor-α(TNF-α), thus exerting anti-inflammatory effects.</p>","PeriodicalId":52437,"journal":{"name":"Zhongguo Zhongyao Zazhi","volume":"49 17","pages":"4777-4785"},"PeriodicalIF":0.0,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142300636","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"[Daidzein attenuates high glucose-induced inflammatory injury in macrophages by regulating NLRP3 inflammasome signaling pathway].","authors":"Yu-Hui Liu, Shi-Yao Chang, Hong-Yang Zhu, Yu-Ting Li, Yu You","doi":"10.19540/j.cnki.cjcmm.20240516.706","DOIUrl":"10.19540/j.cnki.cjcmm.20240516.706","url":null,"abstract":"<p><p>This study aims to explore the inhibitory effect of daidzein on macrophage inflammation induced by high glucose via regulating the NOD-like receptor protein 3(NLRP3) inflammasome signaling pathway. The cell counting kit-8(CCK-8) assay was employed to detect the effects of daidzein at different concentrations on the viability of RAW264.7 cells. Western blot was employed to determine the protein level of tumor necrosis factor(TNF)-α in macrophages exposed to different concentrations of glucose for different time periods as well as the expression levels of proteins involved in the polarization and Toll-like receptor 4(TLR4)-myeloid differentiation factor(MyD88)-NLRP3 inflammasome pathway of the macrophages exposed to high glucose. Enzyme-linked immunosorbent assay was employed to measure the levels of TNF-α, interleukin(IL)-18, and IL-1β secreted by macrophages. The expression level of nuclear factor-kappa B(NF-κB) p65 in macrophages exposed to high glucose was detected by immunofluorescence, and the level of intracellular reactive oxygen species(ROS) was detected by the DCFH-DA fluorescent probe. The mRNA levels of NLRP3, TNF-α, and IL-18 in macrophages were determined by qRT-PCR. The results showed that treatment with 30 mmol·L~(-1) glucose for 48 h was the best condition for the modeling of macrophage injury. Compared with the blank group, the model group showed improved polarization of macrophages, increased secretion of TNF-α, IL-18, and IL-1β, elevated ROS level, and up-regulated expression of NF-κB p65. In addition, the modeling up-regulated the mRNA levels of NLRP3, TNF-α, and IL-18 and the protein levels of TLR4, MyD88, NLRP3, NF-κB p65, p-NF-κB p65, I-κB, p-I-κB, ASC, pro-caspase-1, pro-IL-1β, cleaved IL-1β, and pro-IL-18. Compared with the model group, daidzein(10, 20, and 40 μmol·L~(-1)) lowered the levels of inflammatory cytokines and down-regulated the mRNA levels of NLRP3, TNF-α, and IL-18 as well as the protein levels of TLR4, MyD88, NLRP3, NF-κB p65, p-NF-κB p65, I-κB, p-I-κB, ASC, pro-caspase-1, pro-IL-1β, cleaved IL-1β, and pro-IL-18. In addition, daidzein reduced intracellular ROS. According to the available reports and the experimental results, high glucose can induce the polarization of macrophages and promote the secretion of inflammatory cytokines. Daidzein can inhibit the expression of ROS in macrophages by regulating the NLRP3 inflammasome signaling pathway, thereby reducing the inflammation of macrophages exposed to high glucose.</p>","PeriodicalId":52437,"journal":{"name":"Zhongguo Zhongyao Zazhi","volume":"49 17","pages":"4734-4743"},"PeriodicalIF":0.0,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142300621","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"[Network Meta-analysis of oral Chinese patent medicine combined with conventional western medicine in treatment of gastro-esophageal reflux disease].","authors":"Jia-Xu Zhu, Bin-Yang Yu, Xian Li, Rui Gao","doi":"10.19540/j.cnki.cjcmm.20240523.501","DOIUrl":"10.19540/j.cnki.cjcmm.20240523.501","url":null,"abstract":"<p><p>The effectiveness and safety of various oral Chinese patent medicines combined with conventional western medicine in treatment of gastro-esophageal reflux disease(GERD) were evaluated using network Meta-analysis. CNKI, Wanfang, VIP, SinoMed, PubMed, Cochrane Library, EMbase, and Web of Science were searched for randomized controlled trial(RCT) of oral Chinese patent medicines combined with conventional western medicine in treatment of GERD from inception to September 2023. The quality of the included studies was assessed using the Cochrane risk-of-bias tool, and data analysis was conducted using RevMan 5.4 and Stata 16 software. Forty-seven RCTs were included, involving 10 oral Chinese patent medicines, including Jianwei Yuyang Tablets, Qizhi Weitong Granules, Dalitong Granules, Liuwei Anxiao Capsules, Kangfuxin Liquid, Weisu Granules, Zhizhu Kuanzhong Capsules, Xiaochaihu Granules, Xiaoyao Pills, and Danweikang Capsules. Network Meta-analysis showed that:(1)in terms of effective rate of clinical symptoms, intervention measure ranked first by SUCRA was Dalitong Granules + conventional western medicine.(2)In terms of endoscopic effective rate, intervention measure ranked first by SUCRA was Liuwei Anxiao Capsules + conventional western medicine.(3)In terms of increasing serum gastrin levels, intervention measure ranked first by SUCRA was Weisu Granules + conventional western medicine.(4)In terms of increasing plasma motilin level, intervention measure ranked first by SUCRA was Xiaoyao Pills + conventional western medicine. In terms of symptom scores, quality of life and recurrence rate, only descriptive analyses were performed due to the heterogeneity of the studies, but all studies reported that oral Chinese patent medicines combined with conventional western medicine improved the outcome indicators better than conventional western medicine alone, and the differences were statistically significant. In terms of adverse reactions, there was no significant difference between oral Chinese patent medicine combined with conventional western medicine and conventional western medicine alone. Through cluster analysis, it was found that the comprehensive efficacy of Dalitong Granules + conventional western medicine, Danweikang Capsules + conventional western medicine, Qizhi Weitong Granules + conventional western medicine, Kangfuxin Liquid + conventional western medicine, and Liuwei Anxiao Capsules + conventional western medicine were more prominent, and could improve clinical symptoms and endoscopic inflammation at the same time. The results indicated that oral Chinese patent medicines combined with conventional western medicine in treatment of GERD could improve comprehensive efficacy, alleviate clinical symptoms, and regulate gastrointestinal motility. However, due to limitations such as sample size and quality of the included literature, the conclusions need to be further verified by more large-sample, high-quality studies.</p>","PeriodicalId":52437,"journal":{"name":"Zhongguo Zhongyao Zazhi","volume":"49 17","pages":"4786-4800"},"PeriodicalIF":0.0,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142300696","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"[Guidelines for quality control of human use experience study on traditional Chinese medicine].","authors":"Ya-Qin Tang, Zhong-Qi Yang, Zhao-An Tang, Wei-An Yuan, Jian-Yuan Tang, Chong Zou","doi":"10.19540/j.cnki.cjcmm.20240529.501","DOIUrl":"https://doi.org/10.19540/j.cnki.cjcmm.20240529.501","url":null,"abstract":"<p><p>National Medical Products Administration released the Special provisions on the administration of registration of traditio-nal Chinese medicine(TCM) in February 2023, encouraging high-quality human use experience(HUE) study in TCM clinical practice to obtain sufficient evidence for TCM registration support. The provisions suggested that the HUE study should meet the relevant requirements and accept the drug registration verification. This paper aims to standardize the HUE study, obtain high-quality HUE data to support registration applications, and promote the standardization of research. In accordance with the relevant laws and regulations of the state and the requirements of the technical guidelines for the HUE study in the drug review center of the National Medical Products Administration, the clinical characteristics of TCM were considered, and the Clinical Evaluation Committee of Traditional Chinese Me-dicine of the Chinese Pharmaceutical Association organized and formulated the Guidelines for quality control of human use experience study on traditional Chinese medicine,including the conditions of medical institutions carrying out HUE study, researchers, sponsors, key information and requirements of pharmacy, research programs, key points of ethical review, requirements of the research implementation process, risk management, and subject protection of HUE study. After several rounds of consultation with experts, a guideline document suitable for supporting drug registration and guiding HUE study on TCM was finally formed.</p>","PeriodicalId":52437,"journal":{"name":"Zhongguo Zhongyao Zazhi","volume":"49 17","pages":"4801-4804"},"PeriodicalIF":0.0,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142300626","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"[Protective effect and mechanism of Zuogui Jiangtang Jieyu Formula on damage to hippocampal synaptic microenvironment in rats with diabetes-related depression based on microglia-neuron crosstalk signal CD300f/TLR4].","authors":"Jian Liu, Hui Yang, Hong-Qing Zhao, Wei Li, Zhuo Liu, Yu-Hong Wang","doi":"10.19540/j.cnki.cjcmm.20240611.707","DOIUrl":"10.19540/j.cnki.cjcmm.20240611.707","url":null,"abstract":"&lt;p&gt;&lt;p&gt;This study aims to reveal the protective effect and mechanism of Zuogui Jiangtang Jieyu Formula on the damage to hippo-campal synaptic microenvironment in rats with diabetes-related depression(DD) via regulating microglia immune receptor molecule-like family member f(CD300f)/Toll-like receptor 4(TLR4) signal. Firstly, the model of DD rats was established by a two-week high-fat diet+STZ injection+chronic mild and unpredictable stress plus isolation for 28 days. The rats were randomly divided into normal group, model group, CD300f blocker(CLM1, 2 μg·kg~(-1)) group, CD300f agonist(Fcγ, 5 μg·kg~(-1)) group, positive drug(0.18 g·kg~(-1) metformin+1.8 mg·kg~(-1) fluoxetine) group, and high-dose and low-dose(20.52 and 10.26 g·kg~(-1)) Zuogui Jiangtang Jieyu Formula groups. Depression-like behavior of rats was evaluated by open field and forced swimming experiments. The levels of blood glucose and insulin were detected by biochemical analysis. The levels of tumor necrosis factor α(TNF-α), interleukin-1β(IL-1β), indoleamine 2, 3-dioxygenase(IDO), 5-hydroxytryptamine(5-HT), and dopamine(DA) in the hippocampus were detected by enzyme-linked immunosorbent assay. The changes in the synaptic ultrastructure in hippocampal neurons of rats were observed by transmission electron microscopy. The protein expressions of CD300f, TLR4, synaptophysin(SYN), and postsynaptic density protein 95(PSD-95) in microglial cells of the hippocampus were detected by immunofluorescence and Western blot. The results indicated that compared with that in the normal group, the total movement distance in open field experiments was reduced in the model group, and the immobility time in forced swimming experiments increased, with an elevated insulin level in serum, as well as TNF-α, IL-1β, and IDO levels in the hippocampus. The 5-HT and DA levels in the hippocampus were reduced. In addition, the CD300f expression was down-regulated in microglial cells of the hippocampus, and the TLR4 expression was up-regulated. Moreover, the expression of synapse-related proteins SYN and PSD-95 in hippocampal neurons decreased, and the synaptic ultrastructure of hippocampal neurons was significantly damaged. Compared with the model group, the CD300f blocker and agonist aggravated and alleviated the above abnormal changes, respectively. High-dose and low-dose Zuogui Jiangtang Jieyu Formula could significantly improve the above depression-like beha-vior in rats, inhibit the abnormal increase of TNF-α, IL-1β, and IDO and the decrease of 5-HT and DA, effectively increase the expression of CD300f in microglial cells, and decrease the expression of TLR4. They could up-regulate the protein expression of presyna-ptic membrane SYN and postsynaptic membrane PSD-95 in hippocampal neurons and finally improve the damage to the hippocampal synaptic microenvironment. In conclusion, this research confirmed that Zuogui Jiangtang Jieyu Formula effectively alleviated the depression-like behavior and inhibited inflamma","PeriodicalId":52437,"journal":{"name":"Zhongguo Zhongyao Zazhi","volume":"49 17","pages":"4597-4606"},"PeriodicalIF":0.0,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142300600","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}