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Objective:To analyze the clinical efficacy of Shufeng Jiedu Capsule (SFJD capsule) combined with western medicine in the treatment of common coronavirus disease-2019 (COVID-19). Method:By the usage propensity score matching, the clinical data of COVID-19 patients with common COVID-19 admitted to Wuhan third hospital from January 27, 2020 (solstice) to March 5, 2020, were screened out. Thirty-four patients with SFJD capsule combined with conventional therapy according to the inclusion and exclusion criteria were enrolled in treatment group, and 34 patients treated with conventional therapy were enrolled in control group. The disappearance rate of main symptoms (fever, cough, expectoration and fatigue), days of syndrome disappearance, effective rate and disappearance rate of other symptoms, laboratory indexes before treatment and after 7 days′ treatment, effective rate of computed tomography (CT) of the lungs, rate of COVID-19 severe transformation and hospitalization time between the two groups were compared. Result:The baseline data between the two groups showed no statistically significant difference, and was comparable. After 7 days of treatment, the symptom disappearance rate of cough, sputum, fatigue, chest tightness and panting in treatment group was significantly higher than that in control group (P<0.05). The average days of disappearance of main symptoms in treatment group was significantly less than that in control group (P<0.05). The effective rate of main symptom was significantly higher than control group (P<0.05). In treatment group, 8.8%（3/34） of the patients were transferred to severe disease, while 26.5%（9/34） of the patients in control group were transferred to severe disease, with statistically significant differences. After treatment for 7 days, lymphocytes in treatment group significantly increased (P<0.05), C-reactive protein significantly decreased (P<0.05), procalcitonin level significantly decreased (P<0.05), and D-dimer level significantly decreased (P<0.05), while lymphocytes in control group significantly increased (P<0.05), and c-reactive protein significantly decreased (P<0.05). The improvement rate of pulmonary CT in treatment group was 91.2%（31/34）, which was significantly higher than 70.6%（24/34） in control group (P<0.05). After treatment, both groups were cured and discharged, the average length of stay in treatment group was (15.53±2.63) d, which was (16.35±4.98) d in control group，with no statistically significant difference. No adverse events occurred in treatment group, but 3 cases occurred in control group. Conclusion:SFJD capsule combined with western medicine can significantly improve the clinical symptoms of normal COVID-19 patients, such as cough, sputum, fatigue, chest distress and shortness of breath, alleviate the main symptoms effectively, regulate the expressions of relevant peripheral inflammation, promote the absorption of lung inflammation, and improve the cure rate, which indicates that SFJD capsule can be effectively in the treatment of patients with common COVID-19.
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Objective: To observe the clinical effect of Shufeng Jiedu Capsule combined with Arbidol Hydrochloride Capsule in the treatment of COVID-19. Methods: From January 31, 2020 to February 11, 2020, 70 patients with COVID-19 diagnosed and treated in Bozhou people's hospital were selected. According to the different treatments, they were divided into two groups: 40 patients in combination group and 30 patients in Arbidol Hydrochloride Capsule group. Patients in both groups were given routine Arbidol Hydrochloride Capsule orally. On this basis, the combination group was given oral Shufeng Jiedu Capsule for 10 d. The antipyretic time and the disappearance time of dry cough, nasal congestion, runny nose, sore throat, fatigue, diarrhea and other symptoms of patients in two groups were compared. The negative conversion ratio and negative conversion time of novel coronavirus (SARS-CoV-2) were also compared between two groups of patients. Results: There were significant differences in antipyretic time, the disappearance time of dry cough, nasal congestion, runny nose, pharyngeal pain, fatigue, diarrhea, and novel coronavirus negative conversion time in the combination treatment group compared with the control group (P < 0.05). The negative conversion time of combination treatment group was significantly shorter than Arbidol Hydrochloride Capsule group (P < 0.05). Conclusion: The combination of Shufeng Jiedu Capsule and Arbidol Hydrochloride Capsule was better than Arbidol Hydrochloride Capsule alone in the treatment of COVID-19, which could significantly shorten the symptoms improvement time and negative conversion time of the clinical patients.
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Objective: To explore the novel coronavirus disease 2019 (COVID-19) treatment mechanism and active ingredients of Shufeng Jiedu Capsule by network pharmacology and molecular docking. Methods: TCMSP databases were used to search the chemical composition and target of Shufeng Jiedu Capsule, which was composed of Isatidis Radix, Polygonum cuspidatum, Forsythia suspensa, Phragmitis Rhizoma, Patrinia, Verbena officinalis, Bupleurum chinense, and Glycyrrhiza uralensis. The Swiss target prediction database was used to remove the target with possibility of 0. The corresponding targets of the disease were searched in the GeneCards and OMIM databases with the key words of "coronavirus", "pneumonia", "cough", and "fever". Through the UniProt databases to correct the name of the target point, take the intersection of Shufeng Jiedu Capsule and the disease target point, then use the software of Cytoscape 3.7.2 to build the network of traditional Chinese medicine-compound-target for visualization, through DAVID databases to carry out the GO function enrichment analysis and KEGG pathway enrichment analysis, predict the interaction mechanism of the target, and draw the column and bubble chart for visualization. The novel coronavirus (SARS-CoV-2) 3CL hydrolase was then docking with all compounds and the first five compounds with the least binding energy were selected for docking with angiotensin-converting enzyme II (ACE2). Results: The traditional Chinese medicine-compound-target compound target network contains eight kinds of traditional Chinese medicine-compound-target, 157 compounds and 260 corresponding targets. The key targets were PTGS2, ESR1, AR, etc. There were 393 items in GO functional enrichment analysis (P < 0.05), and 139 signaling pathways in KEGG pathway enrichment analysis. Molecular docking results showed that SARS-CoV-2 3CL hydrolase and ACE2 binding energy of the five core compounds, including 6-(3-oxoindolin-2-ylidene) indolo [2,1-b] quinazolin-12-one, bicuculline, physciondiglucoside, dihydroverticillatine, and licoisoflavanone, was smaller than that of recommended chemical drugs, and the binding energy to ACE2 was similar to that of the recommended chemical drug. Conclusion: The compounds in Shufeng Jiedu Capsule can regulate the signaling pathway of human cytomegalovirus infection, Kaposi's sarcoma associated herpesvirus infection, IL-17 signaling pathway, small cell lung cancer, etc. to treat COVID-19 by binding with SARS-CoV-2 3CL hydrolase and ACE2.
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Coronavirus disease 2019 (COVID-19) has become a major global epidemic, and traditional Chinese medicine (TCM) has played an important role in the prevention and control of major epidemics. Taking Shufeng Jiedu Capsule as an example, this paper summarized the ideas and research practice of TCM in early intervention, blocking disease progression, improving symptoms, anti-inflammation and immunoregulation, suppressing "cytokine storm", syndrome differentiation and playing the advantages of compatibility based on the understanding of COVID-19. The idea of establishing a scientific model for the research and development of new drugs of TCM was put forward.
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Objective: In this study, we disassembled the prescription of Shufeng Jiedu Capsule to research the effects of the heat-clearing and detoxifying component, the relieving exterior component and their compatibility on the serum immune system of rats with acute pneumonia respectively, so as to analyze the compatibility rationality of Shufeng Jiedu Capsule. Methods: Shufeng Jiedu Capsule was divided into two components to study the compatibility rationality, which were relieving exterior component and heat-clearing and detoxifying component. The pneumonia model rats induced by Streptococcus pneumoniae was used to observe the effects of Shufeng Jiedu Capsule and its ingredients on peripheral blood lymphocyte classification, serum immunoglobulin level, serum complement protein 3 (C3), vascular bradykinin (BK), monocyte chemoattractant protein 1 (MCP-1), weight of immune organ and lung of pneumonia rats. The relationship between the Shufeng Jiedu Capsule and its decomposing agent was analyzed by Kim’s formula. Results: The whole prescription, the relieving exterior component and the heat clearing and detoxifying component significantly reduced the proportion of B lymphocyte, and increased CD4+/CD8+. The whole prescription and the relieving exterior component significantly increased the proportion of NK cells and decreased the proportion of CD8+. The Q values of rats in the whole prescription group were more than 1 on two indicators, which were the proportion of B lymphocyte and proportion of NK cell. The whole prescription significantly reduced the content of IgM. The whole prescription and relieving exterior component significantly reduced the content of IgG. The content of BK and MCP-1 in the whole prescription and the heat-clearing and detoxifying component was significantly decreased, and the content of MCP-1 in relieving exterior component was significantly decreased. The weight of thymus, spleen, and lung was significantly reduced by the whole prescription and the relieving exterior component. The weight of lung was significantly reduced by the heat clearing and detoxifying component. Relieving exterior component and the heat clearing and detoxifying component had synergistic effect on the weight of the three organs. Conclusion: Shufeng Jiedu Capsule had significant therapeutic effect on Streptococcus pneumoniae infected rats, and significantly regulated immune function by reducing the levels of serum IgM, IgG, BK, and MCP-1. In this model, the relieving exterior component and the heat clearing and detoxifying component have significant synergistic effects, which are mainly reflected in the following indicators: B lymphocyte ratio, NK cell ratio, weight of thymus, spleen, and lung.
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Objective: To explore the network regulation mechanism of anti-inflammation and immunoregulation of Shufeng Jiedu Capsule (SJC). Methods: Targets of the 28 compounds in SJC were predicted according to the reverse pharmacophore method. Gene ontology (GO) function enrichment and pathway analysis of the targets were analyzed by MAS 3.0 software and Kyoto Gene and Genome Encyclopedia (KEGG) database. Finally, Cytoscape software was used to construct the network pharmacology map. Results: A total of 28 compounds affected 112 pathways through 127 targets, of which 41 targets and 22 pathways were associated with anti-inflammation and immunoregulation. The network of compound-target-pathway-pathology process was also constructed. Conclusion: SJC interferes with multiple biological processes related to anti-inflammation and immunoregulation by acting on several key proteins such as HRAS, MAP2K1, AKT1, MME, and PTPN1. The mechanism of SJC was preliminarily revealed.
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Objective: To explore the compatibility rationality of Shufeng Jiedu Capsule (SJC) for the treatment of upper respiratory infection (URI). Methods: The potential targets and pathways of 32 compounds selected from ‘heat-clearing and detoxicating group’ (HCDG), ‘relieving exterior syndrome group’ (RESG), and ‘Glycyrrhiza uralensis group (GUG)’ of SJC were predicted by the methods of network pharmacology. The mechanism and compatibility rationality of SJC were analyzed by data integration and analysis. Results: The in silico prediction results showed that 32 compounds of SJC affected 34 related pathways through 94 target proteins which mainly involved with inflammation, lipopolysaccharide and bacterium response, immunoreaction and so on. The three groups of HCDG, RESG, and GUG not only showed common targets and pathways but also had their own emphasis to exert synergistic effects. Conclusion: HCDG plays a therapeutic role by intervening in related physiological process, such as inflammatory response, lipopolysaccharide and bacterium response, defense response and immune response. In addition to providing synergistic effects with HCDG, RESG can also intervene in the process of the sweating and antipyretic through multiple pathways. GUG showed auxiliary therapeutic effect by participating in processes of anti-inflammatory and enhancing the body immunity.
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Objective: In order to investigate the effect of Shufeng Jiedu Capsule (SJC) compatibility on anti-inflammation of pneumonia model rats. SJC whole prescription and its components with effect of heat-clearing and toxin-removing and exterior-releasing were studied. Methods: The pneumonia model of rats induced by Streptococcus pneumoniae was used, divided into control group, model group, cephalexin group, SJC whole prescription group (whole prescription group), SJC exterior-releasing group (exterior-releasing group), and SJC heat-clearing and toxin-removing group (heat clearing and detoxifying group). After administration for 6 d, the colony count of peripheral blood and alveolar lavage fluid (BALF), the number of white blood cell (WBC) and its classification in peripheral blood and alveolar lavage fluid, the contents of nuclear transcription factor-kappa B (NF-κB) and cyclooxygenase (COX-1 and COX-2) were tested to evaluate the compatibility rationality. Results: Compared with model group, the whole prescription group, exterior-releasing group, and heat-clearing and toxin-removing group significantly reduced the colony count of peripheral blood and alveolar lavage fluid, significantly reduced the number of WBC in peripheral blood, significantly increased the proportion of eosinophils and reduced the proportion of basophils. The Q values of rats in the whole prescription group were beyond 1 on two indicators, which were the number of WBC and the proportion of eosinophils. The number of WBC in alveolar lavage fluid and the contents of NF-κB and COX-2 decreased significantly in the whole prescription group, exterior-releasing group and heat-clearing and toxin-removing group. Conclusion: SJC has significant anti-inflammatory effect and therapeutic effect on Streptococcus pneumoniae infection in rats. The exterior-relieving component and the heat-clearing and toxin-removing component have significant synergistic effects.
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The study of secondary development of major Chinese materia medica varieties is the important content of Chinese materia medica (CMM) innovation research, and it is also the important approach of inheriting and developing traditional Chinese medine (TCM) theory and breaking the bottleneck restricting of the development of TCM theory and CMM industry. In this paper, the secondary development of Shufeng Jiedu Capsule (SJC) was systematically studied. The chemical components of SJC were elucidated by the identification and characterization of herbs, SJC and components ingested into the blood. The main effective components were further screened and cleared by integrating UPLC-Q/TOF-MS, NF-κB double luciferase reporter gene system, binding experiments of G protein coupled receptors, network pharmacology analysis, and spectrum-efficiency screening method. Based on the traditional efficacy, the mechanism of SJC was explained in terms of anti-inflammatory immunity, antipyretic effect, pharmacokinetics and tissue distribution of the main components based on the methods of animal model and genomics. The formula features, compatibility regularity were clarified and the action properties, comparative advantages and core clinical value were found and refined by the research of decomposed recipes and the comparison with the similar CMM recipes and chemical drugs. The quality control systems of SJC and related herbs were established by content determination of multi-target ingredients and multi-batch samples, and the establishment of the characteristic mode of HPLC fingerprint. The original quality standards were promoted comprehensively to ensure the uniformity, stability and controllability of product quality. This study not only provided important theoretical and experimental basis for clinical application and guidance of clinical practice, but also provided research ideas and modes for the secondary development of other major CMM varieties.
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Objective To characterize the oral toxicity of Shufeng Jiedu Capsule (SFJD) in SD rats during peri-weaning period, and provide reference for the clinical application of SFJD in infants. Methods Ten-day-old healthy SD rats were exposed to 0 and 4 g/kg of SFJD once per day for 14 d via intra-gastric administration. Mortality, general physical signs, body weights, spontaneous motor activity, learning and memory functions, hematology (with T and B lymphocyte subgroups included), serum chemistry, serum testosterone, insulin-like growth factor, organ weights, as well as gross pathological findings were evaluated between the control and exposure group. Physical development indicators such as pinna unfolding, coat growth, incisor eruption, and eyes opening time, were also recorded. The body length and tail length of rats under anesthesia were detected. Results After SFJD administration, loose stools and orange colored urine were found in rats, and the color of the urine was related to the color of drugs. The body weight growth rates were decreased compared with the control group. Urine specific gravity was increased in rats. RBC and Ret concentrations were decreased in two of the 16 tested animals. Liver, spleen, and kidney ratios to body and brain weight were increased in rats; The weight of spleen was also increased compared with the control group. Conclusion It was well tolerated to peri-weaning rats after the ig administration of 4 g/kg SFJD. The concerns of diarrhea, mild body weight growth rate, as well as RBC and Ret decrease should be noted for long term and high dose usage in infants and toddlers.
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Objective: To establish the HPLC fingerprint of herbs of Patriniae Herba. Methods: The fingerprints of Patriniae Herba were built using Orca C18 column and acetonitrile-0.05% phosphoric acid as mobile phase. The flow rate was 1.0 mL/min. The detecting wavelength was set at 230 nm. The temperature of column was at 35℃. Results: Under the selected spectrum conditions, HPLC fingerprint of herbs of Patriniae Herba was established, and eight public peaks were shown in the HPLC fingerprint. The methodological study met the required standards. Cluster analysis showed that class I medical BJ1, BJ2, BJ3, BJ4, BJ5, BJ6, BJ7, BJ8, BJ9, both, BJ13, BJ14 each batch Patriniae Herba and control the similarity between fingerprints was 0.987-0.907, Indicating that there are good consistency between batches of medicinal materials; class II medical BJ11, BJ12, and BJ15 group of Patriniae Herba and control fingerprint differences larger. Conclusion: The method is accurate and reliable, simple and efficient, and can be used as the evaluation of Patriniae Herba from different origins and with different varieties.
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Objective: To establish an HPLC fingerprint method of Verbenae officinalis L. and determine the contents of its main components. Methods: Many batches of Verbenae officinalis fingerprint and the contents of main components were determined by HPLC, and the similarity and cluster analysis of the fingerprints of each batch were compared and the contents of the main components were compared. Results: The results showed that the difference of the main content of medicinal materials and fingerprints were between each batch of Verbenae officinalis. Conclusion: The fingerprint and its main components determination method have been established to provide the scientific basis for the quality evaluation of Verbenae officinalis.
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Objective: To study the antipyretic effect of Shufeng Jiedu Capsules (SJC) and its mechanism. Methods: Using the yeast-reduced fever model of rats to study the antipyretic effects of SJC and its mechanism, collecting blood plasma and hypothalamus to measure the indicators related to body temperature such as IL-1α, IL-1β, TNF-α, IFN-γ, PGE2, cAMP, cGMP, Na-K-ATPase, IL-6, and AVP. Results: SJC can significantly decline the contents of TNF-α, IL-6, IL-1α, and IL-1β, and it can also decline the content of pyrogenic medium-cAMP, ratio of cAMP/cGMP, reduce thermogenesis and levels of Na+, K+-ATPase, and significantly enhance the content of endogenous antipyretic medium-AVP. Conclusion: SJC has a significant antipyretic effect which could decline pyrogenic medium and reduce thermogenesis through reducing the content of inflammatory cytokines-PGE2 and cytokines, it also enhances the content of endogenous antipyretic medium-AVP to play its antipyretic effect.
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The idea and model of quality research on traditional Chinese medicinal materials and compound Chinese materia medica were established and this method was applied to systematical promoting the quality standard of raw herbal materials and preparation of Shufeng Jiedu Capsule (SJC). The chemical components from Polygoni Cuspidati Rhizoma et Radix, Forsythiae Fructus, Isatidis Radix, Bupleuri Radix, Patriniae cum Radice Herba, Verbenae Herba, Phragmitis Rhizoma, and Glycyrrhizae Radix et Rhizoma were identified and 184 compounds were determined. The fingerprints of the eight medicinal materials were established, 10 compounds were identified as the anti-inflammatory substance of SJC by studying the correlation between chemical components and their anti-inflammation effect. The methods of multi-component determination and fingerprint controlling have been established and the quality standard of SJC has been improved comprehensively.
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The pharmacodynamic material basis of Shufeng Jiedu Capsule (SJC) was identified and the mechanism was explained. Ninety-four compounds were identified in SJC and 10 compounds were determined to be the anti-inflammatory ingredients by screening experiments. The mechanism of multi-component, multi-targets, and multi-pathways of SJC which provided a theoretical and experimental basis for the standards of quality control and the clinical application was elucidated by in vivo experiments, network pharmacology, and genomics.
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Objective: To study the protective effects of Shufeng Jiedu Capsule on SD rats with acute liver injury induced by D- galactosamine/lipopolysaccharide (D-GalN/LPS). Methods: Eighty SD rats with average 250 g weight were randomly divided into four groups: the saline control group, LPS-induced model group, Shufeng Jiedu Capsule treatment group, and dexamethasone treatment group with 20 in each group. The rats in the saline group were ip injected with 0.5 mL of saline, other three groups were ip injected with D-GalN 700 mg/kg and LPS 10 μg/kg in order to induce the model of acute liver injury, The rats in dexamethasone treatment group were ip injected with dexamethasone 5 mg/kg, the rats in Shufeng Jiedu Capsule treatment group were ig fed a daily dose 100 mg/kg of Shufeng Jiedu Capsule. At day 1, 3, 5, and 7, five rats from each group were killed and their liver tissues were taken for HE staining to observe pathological manifestations; Enzyme-linked immunosorbent assay (Elisa) was taken for the following tests: the levels of alanine transaminase (ALT) and aspartate aminotransferase (AST), interleukin-1β (IL-1β), tumor necrosis factor alpha (TNF-α), Ornithine carbamoyltransferase (OCT), high-mobility group protein (HMGB-1), and glutathione s-transferase (GST) were determined. Results: Shufeng Jiedu Capsule could significantly alleviate the acute liver injury induced by D-GalN/LPS. Liver tissue of Shufeng Jiedu Capsule treatment group, compared to D-GaIN/LPS-induced model group, had lesser extent lesions. The levels of ALT and AST, IL-1β, TNF-α, OCT, HMGB-1, and GST were significantly lower than those of D-GalN/LPS model group (P 0.05). Conclusion: Shufeng Jiedu Capsule could inhibit the liver cell expression of IL-1β and TNF-α so as to reduce the acute liver injury induced by D-GalN/LPS.
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Objective: To establish a reverse phase high performance liquid chromatographic (RP-HPL) method for the simultaneous determination of the contents of hastatoside, verbenalin, polydatin, ofrsytlloside A, verbascoside, ammonium glycyrrhizinate, and emodin in Shufeng Jiedu Capsule. Methods: RP-HPLC method was applied with the chromatographic condition as follows: the chromatographic column was Unitary C18 column (200 mm × 4.6 mm, 5 μm), acetonitrile-0.1% formic acid as the mobile phrase with gradient elution, the flow rate was 1.0 mL/min, the detection wavelength was 250 nm, the column temperature was 30℃, and the injection volume was 10 μL. Results: Linearity relationships of hastatoside, verbenalin, polydatin, ofrsytlloside A, verbascoside, ammonium glycyrrhizinate, and emodin were 0.096-1.920, 0.089-1.784, 0.119-2.348, 0.059-1.176, 0.021-4.224, 0.206-4.120, and 0.053-1.064 μg, respectively, as well as the average recoveries of 98.43% (RSD 2.13%), 98.30% (RSD 2.68%), 99.31% (RSD 2.76%), 101.64% (RSD 2.37%), 97.47% (RSD 2.05%), 100.89% (RSD 1.98%), and 99.05% (RSD 2.21%). Conclusion: The method is simple, fast, accurate, and can be used to control the quality of Shufeng Jiedu Capsule.