1.Clinical research report on Chinese patent medicines and classic traditional Chinese medicine prescriptions (2023)
Xiaolei WU ; Haiyin HU ; Yuetong WANG ; Fauci Alice Josephine ; Yazi ZHANG ; Wenting SONG ; Fengwen YANG ; Boli ZHANG ; Junhua ZHANG ; Zhaochen JI
Digital Chinese Medicine 2025;8(2):123-136
		                        		
		                        			Objective:
		                        			Randomized controlled trials (RCTs) of Chinese patent medicines and classic traditional Chinese medicine prescriptions were systematically reviewed from both Chinese and English journals published in 2023. A preliminary summary and evaluation were conducted on the generation and translation of clinical evidence for these treatments. This analysis aims to inform future research on clinical efficacy evaluation and guide the rational application of evidence. 
		                        		
		                        			Methods:
		                        			 RCTs of Chinese patent medicines and classic traditional Chinese prescriptions published in 2023 were comprehensively retrieved from the Artificial Intelligence Clinical Evidence Database for Chinese Patent Medicine (AICED-CPM), with supplementary searches conducted in China National Knowledge Infrastructure (CNKI), Wanfang Data, Chinese Science and Technology Journal Database (VIP), Chinese Biomedical Literature Database (SinoMed), Cochrane Library, PubMed, Embase, and Web of Science. The study characteristics and methodological quality of these RCTs were systematically analyzed and evaluated. 
		                        		
		                        			Results:
		                        			 A total of 1 443 RCTs of Chinese patent medicines were included, comprising 1 399 Chinese articles and 44 English articles. Additionally, 334 RCTs of classic traditional Chinese medicine prescriptions were found, with 331 published in Chinese and 3 in English. 196 567 participants were included, covering 585 types of Chinese patent medicines (487 oral, 61 injectable, and 37 topical) and 179 classic traditional Chinese medicine prescriptions. The involved studies encompassed 22 types of diseases, with research primarily focusing on diseases of the circulatory system, the respiratory system, and the genitourinary system. The sample sizes ranged from 18 to 3 777 participants, and most studies were conducted at a single center. Methodologically, the implementation of allocation concealment and blinding remained insufficiently emphasized.
		                        		
		                        			Conclusion
		                        			 Overall, compared with 2022, both the number of RCT publications and their methodological quality have improved in 2023, with heightened attention to research on diseases of the genitourinary system. However, quality control and standardized management in the design and implementation processes still require enhancement to produce more high-quality clinical evidence and accelerate the translation and application of this evidence. 
		                        		
		                        		
		                        		
		                        	
2.Overview of the Research on Mechanisms and Application of Essential Oil of Aromatic Chinese Medicinals in Prevention of Respiratory Infectious Disease
Wan Ling LI ; Xinxin WU ; Xiaolei LI ; Mingzhao HAO ; Fang ZHANG ; Yue ZHANG ; Haoyue LI ; Jing ZHAO
Journal of Traditional Chinese Medicine 2025;66(6):638-644
		                        		
		                        			
		                        			Aromatic Chinese medicinal essential oils are volatile oils extracted from aromatic Chinese herbs, which can prevent and treat respiratory infectious diseases through multiple synergistic mechanisms including pathogen inhibition, immune regulation, and inflammatory response regulation. Essential oils are primarily used externally on the body to prevent infections and alleviate symptoms through methods like inhalation, smearing, topical application, bathing, gargling or as a suppository. They can also be utilized in the environment for disinfection and air purification, through methods like diffusion, vaporization, or spraying. The external application of essential oils extracted from Chinese aromatic herbs has the advantages of convenience, quick absorption, and simultaneous influence on both the body and mind. However, there are still challenges and deficiencies in aspects such as the positioning of functions, indications, safety, and the research on the mechanism of action. It has been proposed to combine the theory of aromatic Chinese medicinals with the characteristics of essential oils, and formulate prescriptions of Chinese medicinal essential oils under the principles of traditional Chinese medicine syndrome differentiation, and prevent and treat respiratory infectious diseases efficiently, accurately, and safely, thereby expanding the clinical application of aromatic Chinese medicinals and the preventive theory of traditional Chinese medicine. 
		                        		
		                        		
		                        		
		                        	
3.Application of Aromatic Inhalation Therapy in Preventing Respiratory Infectious Diseases Based on the Theory of "Aromatics Acting on the Spleen"
Xinxin WU ; Yue ZHANG ; Xiaolei LI ; Haoyue LI ; Fang ZHANG ; Nanjiang YU ; ZHAOJING
Journal of Traditional Chinese Medicine 2025;66(4):432-436
		                        		
		                        			
		                        			Aromatic inhalation therapy is a key traditional Chinese medicine (TCM) approach for preventing respiratory infectious diseases. Its foundational theory, "aromatics acting on the spleen", is deeply rooted in TCM principles and supported by modern medical research. The theory posits that the aromatic properties of medicinals primarily act on the spleen, and the aromatic inhalation therapy achieved its protective effects by modulation of the spleen and spleen channel to enhance the regulation of wei qi, striae and interstices. In TCM, the spleen is considered the mother of the lungs, with the function of nurturing lung; it is also seen as the source of wei qi, responsible for external defense; and the root of healthy qi, forming the foundation of acquired (postnatal) constitution. Thus, preventive strategies for respiratory infectious diseases focus on strengthening the spleen. From a modern medical perspective, the spleen's role in regulating lung immune responses, the shared immune functions of the respiratory and gastrointestinal mucosa, and the spleen's overall immune modulation provide scientific evidence for using aromatic inhalation therapy to prevent respiratory infections. Additionally, aromatic inhalation therapy offers several advantages, including direct action, rapid onset, minimal side effects, controllable risks, convenience, and ease of dissemination, making it a practical and effective preventive measure for respiratory infectious diseases. 
		                        		
		                        		
		                        		
		                        	
4.Mechanism of Tangbikang Dry Paste in Prevention and Treatment of Type 2 Diabetic Peripheral Neuropathy Based on GLO-1/AGE/RAGE Pathway
Lijia WU ; Chengfei ZHANG ; Xiaolei JIA ; Lingling QIN ; Haiyan WANG ; Yukun HUANG ; You WANG ; Xincui BAO ; Jing YANG ; Cuiyan LYU ; Tonghua LIU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(11):60-69
		                        		
		                        			
		                        			ObjectiveTo investigate the mechanism of Tangbikang dry paste in the prevention and treatment of type 2 diabetic peripheral neuropathy (DPN) based on the glyoxalase-1 (GLO-1)/advanced glycation end products (AGE)/receptor for advanced glycation end products (RAGE) pathway. MethodsA total of 56 Sprague-Dawley rats were randomly divided, with eight assigned to the normal group. The remaining 48 rats were fed a high-fat diet combined with intraperitoneal injection of streptozotocin (STZ) to induce a type 2 diabetes mellitus (T2DM) model. Based on blood glucose levels, the rats were randomly assigned to the model group, Tanglin group (13.5 mg·kg-1), metformin group (135 mg·kg-1), and Tangbikang dry paste low-, medium-, and high-dose groups (3, 6, 12 g·kg-1). Successful modeling of DPN was confirmed by a decrease in mechanical pain threshold in the model group at week 4. Fasting blood glucose, body weight, and mechanical pain threshold were measured every 4 weeks. After 16 weeks of intervention, the pathological morphology of the sciatic nerve was observed using hematoxylin-eosin (HE) staining. The expression of RAGE, AGE, protein kinase C (PKC), and collagen (COL) in the sciatic nerve was assessed by immunohistochemistry. The mRNA expression of RAGE, PKC, Toll-like receptor (TLR), COL, and GLO-1 was detected using real-time quantitative PCR (Real-time PCR). Serum levels of aspartate aminotransferase (AST), alanine aminotransferase (ALT), creatinine (CREA), urea (UREA), interleukin-6 (IL-6), and tumor necrosis factor (TNF)-α were measured by enzyme-linked immunosorbent assay (ELISA). ResultsCompared with the normal group, the model group showed significantly increased fasting blood glucose (P<0.01), decreased body weight and mechanical pain threshold (P<0.01), and elevated serum AST, ALT, CREA, UREA, IL-6, and TNF-α levels (P<0.01). The expression of RAGE, AGE, and PKC in the sciatic nerve was significantly increased (P<0.01), while COL expression was decreased (P<0.01). The mRNA expression of TLR, RAGE, and PKC was upregulated (P<0.01), whereas COL and GLO-1 mRNA levels were downregulated (P<0.01). Histological examination showed irregular nerve morphology, axonal alterations, and myelin degeneration. Compared with the model group, fasting blood glucose levels in the Tangbikang dry paste high-dose group at all time points and in the medium-dose group at weeks 4 and 16 were significantly reduced (P<0.05, P<0.01). No significant changes in body weight were observed across all Tangbikang dose groups. The mechanical pain threshold was elevated at different time points after administration in all Tangbikang groups (P<0.05, P<0.01). Serum IL-6 and TNF-α levels were decreased in all dose groups (P<0.05, P<0.01). The expression of RAGE, AGE, and PKC in the sciatic nerve was reduced (P<0.01), while COL expression was increased (P<0.01). The mRNA expression of TLR, RAGE, and PKC was downregulated (P<0.01), whereas GLO-1 mRNA expression was upregulated (P<0.05, P<0.01). Additionally, COL mRNA expression was significantly increased in the low- and high-dose groups (P<0.01). Pathological changes in the sciatic nerve were milder in all Tangbikang groups compared to the model group. ConclusionTangbikang dry paste significantly improves DPN, and its mechanism may be associated with the regulation of the GLO-1/AGE/RAGE signaling pathway. 
		                        		
		                        		
		                        		
		                        	
5.Mechanism of Tangbikang Dry Paste in Prevention and Treatment of Type 2 Diabetic Peripheral Neuropathy Based on GLO-1/AGE/RAGE Pathway
Lijia WU ; Chengfei ZHANG ; Xiaolei JIA ; Lingling QIN ; Haiyan WANG ; Yukun HUANG ; You WANG ; Xincui BAO ; Jing YANG ; Cuiyan LYU ; Tonghua LIU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(11):60-69
		                        		
		                        			
		                        			ObjectiveTo investigate the mechanism of Tangbikang dry paste in the prevention and treatment of type 2 diabetic peripheral neuropathy (DPN) based on the glyoxalase-1 (GLO-1)/advanced glycation end products (AGE)/receptor for advanced glycation end products (RAGE) pathway. MethodsA total of 56 Sprague-Dawley rats were randomly divided, with eight assigned to the normal group. The remaining 48 rats were fed a high-fat diet combined with intraperitoneal injection of streptozotocin (STZ) to induce a type 2 diabetes mellitus (T2DM) model. Based on blood glucose levels, the rats were randomly assigned to the model group, Tanglin group (13.5 mg·kg-1), metformin group (135 mg·kg-1), and Tangbikang dry paste low-, medium-, and high-dose groups (3, 6, 12 g·kg-1). Successful modeling of DPN was confirmed by a decrease in mechanical pain threshold in the model group at week 4. Fasting blood glucose, body weight, and mechanical pain threshold were measured every 4 weeks. After 16 weeks of intervention, the pathological morphology of the sciatic nerve was observed using hematoxylin-eosin (HE) staining. The expression of RAGE, AGE, protein kinase C (PKC), and collagen (COL) in the sciatic nerve was assessed by immunohistochemistry. The mRNA expression of RAGE, PKC, Toll-like receptor (TLR), COL, and GLO-1 was detected using real-time quantitative PCR (Real-time PCR). Serum levels of aspartate aminotransferase (AST), alanine aminotransferase (ALT), creatinine (CREA), urea (UREA), interleukin-6 (IL-6), and tumor necrosis factor (TNF)-α were measured by enzyme-linked immunosorbent assay (ELISA). ResultsCompared with the normal group, the model group showed significantly increased fasting blood glucose (P<0.01), decreased body weight and mechanical pain threshold (P<0.01), and elevated serum AST, ALT, CREA, UREA, IL-6, and TNF-α levels (P<0.01). The expression of RAGE, AGE, and PKC in the sciatic nerve was significantly increased (P<0.01), while COL expression was decreased (P<0.01). The mRNA expression of TLR, RAGE, and PKC was upregulated (P<0.01), whereas COL and GLO-1 mRNA levels were downregulated (P<0.01). Histological examination showed irregular nerve morphology, axonal alterations, and myelin degeneration. Compared with the model group, fasting blood glucose levels in the Tangbikang dry paste high-dose group at all time points and in the medium-dose group at weeks 4 and 16 were significantly reduced (P<0.05, P<0.01). No significant changes in body weight were observed across all Tangbikang dose groups. The mechanical pain threshold was elevated at different time points after administration in all Tangbikang groups (P<0.05, P<0.01). Serum IL-6 and TNF-α levels were decreased in all dose groups (P<0.05, P<0.01). The expression of RAGE, AGE, and PKC in the sciatic nerve was reduced (P<0.01), while COL expression was increased (P<0.01). The mRNA expression of TLR, RAGE, and PKC was downregulated (P<0.01), whereas GLO-1 mRNA expression was upregulated (P<0.05, P<0.01). Additionally, COL mRNA expression was significantly increased in the low- and high-dose groups (P<0.01). Pathological changes in the sciatic nerve were milder in all Tangbikang groups compared to the model group. ConclusionTangbikang dry paste significantly improves DPN, and its mechanism may be associated with the regulation of the GLO-1/AGE/RAGE signaling pathway. 
		                        		
		                        		
		                        		
		                        	
6.Baihe Wuyaotang Ameliorates NAFLD by Enhancing mTOR-mediated Liver Autophagy
Rui WANG ; Tiantian BAN ; Lihui XUE ; Xinyi FENG ; Jiyuan GUO ; Jiaqi LI ; Shenghe JIANG ; Xiaolei HAN ; Baofeng HU ; Wenli ZHANG ; Naijun WU ; Shuang LI ; Yajuan QI
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(7):66-77
		                        		
		                        			
		                        			ObjectiveTo investigate the therapeutic effect of Baihe Wuyaotang (BWT) on non-alcoholic fatty liver disease (NAFLD) and elucidate its underlying mechanism. MethodC57BL/6J mice were randomly assigned to six groups: normal control, model, positive drug (pioglitazone hydrochloride 1.95×10-3 g·kg-1), and low-, medium-, and high-dose BWT (1.3,2.5 and 5.1 g·kg-1). Following a 12-week high-fat diet (HFD) inducement, the mice underwent six weeks of therapeutic intervention with twice-daily drug administration. Body weight was monitored weekly throughout the treatment period. At the fifth week, glucose tolerance (GTT) and insulin tolerance (ITT) tests were conducted. Subsequently, the mice were euthanized for the collection of liver tissue and serum, and the subcutaneous adipose tissue (iWAT) and epididymal adipose tissue (eWAT) were weighed. Serum levels of total triglycerides (TG) and liver function indicators,such as alanine aminotransferase (ALT) and aspartate aminotransferase (AST), were determined. Histological examinations, including oil red O staining, hematoxylin-eosin (HE) staining, Masson staining, and transmission electron microscopy, were performed to evaluate hepatic lipid deposition, pathological morphology, and ultrastructural changes, respectively. Meanwhile, Western blot and real-time quantitative polymerase chain reaction (Real-time PCR) were employed to analyze alterations, at both gene and protein levels, the insulin signaling pathway molecules, including insulin receptor substrate 1/2/protein kinase B/forkhead box gene O1 (IRS1/2/Akt/FoxO1), glycogen synthesis enzymes phosphoenolpyruvate carboxy kinase (Pepck) and glucose-6-phosphatase (G6Pase), lipid metabolism-related genes stearoyl-coA desaturase-1 (SCD-1) and carnitine palmitoyltransferase-1 (CPT-1), fibrosis-associated molecules α-smooth muscle actin (α-SMA), type Ⅰ collagen (CollagenⅠ), and the fibrosis canonical signaling pathway transforming growth factor-β1/drosophila mothers against decapentaplegic protein2/3(TGF-β1/p-Smad/Smad2/3), inflammatory factors such as interleukin(IL)-6, IL-8, IL-11, and IL-1β, autophagy markers LC3B Ⅱ/Ⅰ and p62/SQSTM1, and the expression of mammalian target of rapamycin (mTOR). ResultCompared with the model group, BWT reduced the body weight and liver weight of NAFLD mice(P<0.05, P<0.01), inhibited liver lipid accumulation, and reduced the weight of white fat: it reduced the weight of eWAT and iWAT(P<0.05, P<0.01) as well as the serum TG content(P<0.05, P<0.01). BWT improved the liver function as reflected by the reduced ALT and AST content(P<0.05, P<0.01). It improved liver insulin resistance by upregulating IRS2, p-Akt/Akt, p-FoxO1/FoxO1 expressions(P<0.05). Besides, it improved glucose and lipid metabolism disorders: it reduced fasting blood glucose and postprandial blood glucose(P<0.05, P<0.01), improved GTT and ITT(P<0.05, P<0.01), reduced the expression of Pepck, G6Pase, and SCD-1(P<0.01), and increased the expression of CPT-1(P<0.01). The expressions of α-SMA, Collagen1, and TGF-β1 proteins were down-regulated(P<0.05, P<0.01), while the expression of p-Smad/Smad2/3 was downregulated(P<0.05), suggesting BWT reduced liver fibrosis. BWT inhibited inflammation-related factors as it reduced the gene expression of IL-6, IL-8, IL-11 and IL-1β(P<0.01) and it enhanced autophagy by upregulating LC3B Ⅱ/Ⅰ expression(P<0.05)while downregulating the expression of p62/SQSTM1 and mTOR(P<0.05). ConclusionBWT ameliorates NAFLD by multifaceted improvements, including improving IR and glucose and lipid metabolism, anti-inflammation, anti-fibrosis, and enhancing autophagy. In particular, BWT may enhance liver autophagy by inhibiting the mTOR-mediated signaling pathway. 
		                        		
		                        		
		                        		
		                        	
7.Hydroxyapatite-polyvinyl alcohol/collagen-chitosan-gelatin composite hydrogel for repairing rabbit osteochondral defect
Wu WANG ; Xiaolei FAN ; Jie XIE ; Yihe HU ; Min ZENG
Chinese Journal of Tissue Engineering Research 2024;28(5):682-689
		                        		
		                        			
		                        			BACKGROUND:Osteochondral defect of the joint is a difficult problem faced by orthopedic surgeons,and traditional repair methods are difficult to obtain satisfactory curative effects.Hydroxyapatite-polyvinyl alcohol-based composite hydrogel material is a direction of current research. OBJECTIVE:To prepare hydroxyapatite-polyvinyl alcohol/collagen-chitosan-gelatin composite hydrogel material and characterize its physical characteristics,to verify its histocompatibility and cell adhesion and proliferation ability after implantation in vivo,and explore its repair effect on rabbit osteochondral defects. METHODS:The cylindrical porous poly(lactic acid)scaffold was prepared by 3D printing technology(the pore sizes were 1.2,1.4,1.6 and 1.8 mm,respectively).The poly(lactic acid)scaffold was injected with polyvinyl alcohol and hydroxyapatite mixed emulsion.After freezing thawing and dichloromethane dissolution,hydroxyapatite-polyvinyl alcohol hydrogel was prepared.Then,the collagen-chitosan-gelatin mixture was injected into the hydroxyapatite-polyvinyl alcohol hydrogel and crosslinked with genipin.Finally,the hydroxyapatite-polyvinyl alcohol/collagen-chitosan-gelatin composite hydrogel was prepared by alcohol cleaning and freeze-drying.The physical characteristics of the four groups of hydrogels were characterized,and the hydrogels with the best performance were screened for follow-up experiments.Hydroxyapatite-polyvinyl alcohol hydrogel and collagen-chitosan-gelatin composite hydrogel were implanted subcutaneously in SD rats.Hematoxylin-eosin staining and Masson staining were used to observe the adhesion growth of cells on the material surface.Osteochondral defect(diameter:5 mm,depth:6 mm)models were made in the femoral trochlea of bilateral knee joints of 15 rabbits.The composite hydrogel was implanted on the left side(experimental group),while no material was implanted on the right side(control group).Micro-CT and histology were used to evaluate the repair effect of osteochondral defects. RESULTS AND CONCLUSION:(1)Based on the results of porosity,water content,mechanical testing and scanning electron microscopy,it was concluded that the hydroxyapatite-polyvinyl alcohol/collagen-chitosan-gelatin composite hydrogel with a pore size of 1.2 mm was more consistent with the general characteristics of natural cartilage,which was used for subsequent experiments.(2)Hematoxylin-eosin staining and Masson staining exhibited that with the extension of subcutaneous implantation time of the materials,the adhesion of cells around the two materials increased significantly,and the proliferation of cells after the implantation of collagen-chitosan-gelatin was better,a large number of cells could be seen growing into the formed network structure,and the network structure was gradually degraded.(3)In the rabbit osteochondral defect experiment,8 weeks after surgery,Micro-CT examination demonstrated that the material implanted in the experimental group had good integration with the surrounding bone-cartilage,with some bone growth on the surface and inside,while the cartilage and subcartilage in the control group still had obvious defects,without effective repair.Hematoxylin-eosin staining and toluidine blue staining displayed that the composite hydrogel in the experimental group integrated with the surrounding articular cartilage 4-8 weeks after implantation.With the extension of time,new cartilage gradually formed on the surface of the material.At 12 weeks,most of the defect was covered by new cartilage,and good bone growth was also observed in the subcartilage.In the control group,the deep bone defects were mostly repaired and the superficial cartilage and subchondral bone defects were also repaired to a certain extent,but they were mainly replaced by fibrous tissue and part of fibrocartilage 12 weeks after surgery.(4)In conclusion,hydroxyapatite-polyvinyl alcohol/collagen-chitosan-gelatin composite hydrogel material can mimic the structure and function of natural cartilage,and can effectively repair osteochondral defects in animal experiments.
		                        		
		                        		
		                        		
		                        	
8.Overview of in vitro skin models of transdermal drug delivery systems
Yan LIU ; Xiaolei HU ; Kehong XU ; Hairong ZHAO ; Xiumei WU ; Zizhong YANG ; Chenggui ZHANG ; Yu ZHAO ; Pengfei GAO
Chinese Journal of Comparative Medicine 2024;34(2):122-128
		                        		
		                        			
		                        			Skin modeling of transdermal drug delivery system refers to experimental models that mimic the structure and function of human skin to explore and evaluate absorption,penetration,and efficacy of medicines in transdermal drug delivery.It provides an alternative to traditional human skin experiments and reduces the use of human skin in medical research,which is convenient,controllable,and cost effective.For skin models of transdermal drug delivery systems,this article introduces commonly used animal skin models,artificial skin models,and recombinant human skin models from the perspective of the transdermal absorption pathway of medicines,and analyzes their advantages,disadvantages,and applications so provide references the research and development of transdermal formulations and topical therapies.
		                        		
		                        		
		                        		
		                        	
9.Exploration of applying i-PARIHS framework of implementation science to promote epidemic prevention with TCM
Xiaolei LI ; Haoyue LI ; Yue ZHANG ; Xinxin WU ; Weijun ZHANG ; Jing ZHAO
International Journal of Traditional Chinese Medicine 2024;46(6):692-697
		                        		
		                        			
		                        			The application and evidence of TCM in the prevention and control of epidemic such as COVID-19, influenza, etc. are increasing active, and it has received comprehensive attention from the world. At present, international promotion of prevention of epidemic with TCM faces challenges such as the different acceptances of TCM in various countries, different levels of evidence-based evidence and evaluation methods, and unstable fidelity of TCM epidemic prevention promotion and implementation. In order to promote the international application and promotion of TCM epidemic prevention, this study used the i-PARIHS framework and equation with elements to issue the complementary question, analyzed implementation background, proposed and optimized implementation strategies, and with the suggestions according to i-PARIS equation that select better implementation environments according to local traditional medicine policies and regulations at first, proposed different implementation strategies according to the level of evidence-based evidence, and improved the clarity of expressions of TCM epidemic prevention methods, thereby promoting the international application and promotion of TCM for epidemic prevention.
		                        		
		                        		
		                        		
		                        	
10.Comparative Study on the Pharmacodynamics of Xiangzhu Fanggan Formula (香术防感方) by Sniffing and Nasal Drops for Prevention of Influenza A H1N1 Virus Infection in Mice
Yue ZHANG ; Yizhi DONG ; Haoyue LI ; Xinxin WU ; Xiaolei LI ; Jing ZHAO
Journal of Traditional Chinese Medicine 2024;65(12):1279-1286
		                        		
		                        			
		                        			ObjectiveTo compare the effectiveness and mechanism of Xiangzhu Fanggan Formula (香术防感方) by sniffing and nasal drops for preventing influenza A H1N1flu. MethodsFifty-six BALB/c mice were randomly divided into normal group, model group, zanamivir group, high-concentration sachet group, low-concentration sachet group, high-concentration nasal drops group, and low-concentration nasal drops group, with 8 mice in each group. In the low- and high-concentration sachet groups, 15 g and 30 g of Xiangzhu Fanggan Formula sachet were used for sniffing for 24 h per day; while in the low- and high-concentration nasal drops groups, nasal drops of Xiangzhu Fanggan Formula were given at a concentration of 0.11 and 0.22 g/ml, 20 μl each time, twice a day; in the zanamivir group, zanamivir was given at a concentration of 1.025 mg/ml of 20 μl each time, twice a day; in the normal group and the model group, nasal drops of normal saline were given at 20 μl each time, twice a day. Each group was given prophylactic intervention for 5 days. On day 5, 1 h after the administration of the drug, the mice in all groups except the normal group received 35 μl of 50 LD50 A/PR/8/34/H1N1 viral solution as nasal drops to prepare influenza A H1N1 model mice. The body mass of the mice was recorded and the rate of change of body mass was calculated daily from day 5 to day 9 of the experiment, and the general status was observed. The mice were sampled on day 9, and the lung index and the inhibition rate of lung index were calculated; HE staining was used to detect pathological changes in lung tissues and to score lung tissue lesions; RT-qPCR was used to detect viral load in lung tissues; and ELISA was used to detect secretory immunoglobulin A (sIgA) and serum tumour necrosis factor α (TNF-α) and interleukin 2 (IL-2), interleukin 6 (IL-6), and interferon γ (IFN-γ) in the lavage fluid of the upper respiratory tract. ResultsOn days 7, 8 and 9 of the experiment, the rate of change in body mass of mice in the model group significantly lower than that in the normal group at the same time points (P<0.05 or P<0.01). On days 8 and 9 of the experiment, the rate of change in body mass of mice in the zanamivir group and the high-concentration nasal drops group increased when compared with the model group (P<0.05 or P<0.01). Compared with the normal group, mice in the model group had significantly higher lung index, lung tissue lesion score, lung tissue viral load, significantly higher serum TNF-α, IL-6, IL-2, IFN-γ levels, and significantly lower sIgA levels in the upper respiratory lavage fluid (P<0.01). Compared with the model group, the lung index and lung tissue viral load reduced, serum IFN-γ, TNF-α, IL-2, IL-6 levels reduced, and sIgA levels increased in the zanamivir group and the high-concentration nosal drops group (P<0.05 or P<0.01); except for low-concentration sachet group, lung tissue lesion scores of the drug intervention groups reduced compared with those of the model group (P<0.01). Compared with the zanamivir group, the lung index increased in the low-concentration sachet group and the low- and high-concentration nasal drops groups, and the serum TNF-α and IL-2 levels increased in all Xiangzhu Fanggan Formula intervention groups (P<0.05 or P<0.01). Compared with high-concentration nasal drops group, serum TNF-α and IFN-γ levels elevated in the high-concentration increased group, and lung tissue viral load elevated in the low-concentration nasal drops group (P<0.05 or P<0.01). The lung index inhibition rate was 80.84% in the zanamivir group, 41.61% and 17.90% in the high- and low-concentration sachet groups, and 35.40% and 25.40% in the high- and low-concentration nasal drops groups, respectively. HE staining showed that the lung tissues of the model group showed thickening of alveolar septa, alveolar collapse, and infiltration of inflammatory cells; whereas, in each drug intervention group, the inflammation of the lung tissues of the mice and the damage reduced, and the most obvious improvement was in the zanamivir group and the high-concentration nasal drops group. ConclusionXiangzhu Fanggan Formula by sniffing and nasal drops could both prevent influenza A H1N1 virus infection, with antiviral and anti-inflammatory effects, also could improve the pathological damage of lung tissue, and improve the immunity of respiratory mucosa. The nasal drops may be better than sachets in inhibiting inflammatory response, especially the high-concentration nasal drops showed more effective. 
		                        		
		                        		
		                        		
		                        	
            
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