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A novel Gram-positive strain, B1T, was isolated from uranium-contaminated soil. The strain was aerobic, rod-shaped, spore-forming, and motile. The strain was able to grow at 20-45â°C, at pH 6.0-9.0, and in the presence of 0-3â% (w/v) NaCl. The complete genome size of the novel strain was 3â853â322 bp. The genomic DNA G+C content was 45.5âmol%. Phylogenetic analysis based on the 16S rRNA gene sequence showed that strain B1T has the highest similarity to Aneurinibacillus soli CB4T (96. 71â%). However, the novel strain showed an average nucleotide identity value of 89.02â% and a digital DNA-DNA hybridization value of 37.40â% with strain CB4T based on the genome sequences. The major fatty acids were iso-C15â:â0 and C16â:â0. The predominate respiratory quinone was MK7. Diphosphatidylglycerol, phosphatidylmethylethanolamine, phosphatidylethanolamine, phosphatidylglycerol, unidentified phospholipids, an unidentified aminolipid and an unidentified lipid were identified as the major polar lipids. The phylogenetic, phenotypic, and chemotaxonomic analyses showed that strain B1T represents a novel species of the genus Aneurinibacillus, for which the name Aneurinibacillus uraniidurans sp. nov. is proposed. The type strain is B1T (=GDMCC 1.4080T=JCM 36228T). Experiments have shown that strain B1T demonstrates uranium tolerance.
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Ácidos Grasos , Uranio , Composición de Base , Ácidos Grasos/química , Filogenia , ARN Ribosómico 16S/genética , Análisis de Secuencia de ADN , ADN Bacteriano/genética , Técnicas de Tipificación Bacteriana , Bacterias , SueloRESUMEN
Tibetan medicine is an essential part of Chinese medicine and has unique theoretical experience and therapeutic advantages. According to the development principle of inheriting the essence, sticking to the truth, and keeping innovative, the supervision department should give clear and reasonable guidance considering the characteristics of Tibetan medicine, establish a standard system for quality control, clinical verification and evaluation, and accelerate the research and commercialization of new drugs. In view of the needs of drug supply-side reform and the current situation of Tibetan medicine and new pharmaceutical research, we ponder and provide suggestions on the confusion faced by the current supervision of Tibetan drug registration, hoping to contribute to the supervision strategy of Tibetan drug registration and the high-quality development of Tibetan medicine industry.
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Medicina Tradicional Tibetana , Investigación Farmacéutica , Tibet , Control de Calidad , Industria FarmacéuticaRESUMEN
The development of traditional Chinese medicine(TCM) has always been highly valued and supported since 1949. However, Chinese medicine industry still faces great challenges in view of the current status of the industry and registration and approval of new products in recent years. Related policies also directly influence the development of the industry. The latest version of the Provisions for Drug Registration and Requirement on Registration Classification and Application Information of Traditional Chinese Medicines have been put into practice since 2020. Registration classification is the core content of the Chinese medicine registration management system, as it is closely related to the research, development, and registration of Chinese medicine and the innovative development of the industry. This article aims to systematically review the historical evolution of the category of Chinese medicine registration and analyze the current status and problems, which is expected to provide a reference for the formulation of supporting documents according to related laws and regulations.
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Medicamentos Herbarios Chinos , Medicina Tradicional China , Industria Farmacéutica , PolíticasRESUMEN
AIM: This study aims to explore the effect of integrated traditional Chinese and Western medicine management mode on nursing care of patients with coronavirus disease 2019 (COVID-19). METHODS: The study included 142 COVID-19 patients hospitalized in Huoshenshan Hospital from February to March 2020. Nursing measures in the treatment (n = 111) and control (n = 31) groups included integrated management care and usual care. The integrated management model had eight components: WeChat group management, early Traditional Chinese Medicine (TCM) treatment, emotional nursing, music therapy, observation of tongue coating and pulse, vital Qi strengthening, preventing recurrence after recovery, and an individualized follow-up scheme. The endpoints included clinical outcome, recovery time of clinical symptoms and signs, days of hospital stay, and survival without intensive care unit (ICU) admission. RESULTS: Recovery time from clinical symptoms such as fever, cough, shortness of breath, muscle aches, and fatigue in the treatment group was shorter than that in the control group. Less time was required to show negative chest computed tomography findings in the treatment group than in the control group (13.0 ± 2.8 vs. 16.7 ± 3.9, p < .025). The lengths of hospital stay in the two groups were 16.4 ± 7.3 days (treatment group) and 24.4 ± 4.8 days (control group) (p < .001). Kaplan-Meier curves for survival without ICU transfer showed statistical difference between the two groups (χ2 = 5.427, p = .020). CONCLUSIONS: Our study shows that the integrated management mode can relieve the symptoms of patients faster, shorten hospital stay and disease course, and reduce the rate of ICU transfers.
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There are five kinds of fermented Cordyceps crude drug and their preparations that have been approved as medicine on the market. Since the initial strains of the crude drug were all isolated from natural Cordyceps sinensisï¼ they have similar namesï¼ chemical components and even clinical applications. Howeverï¼ because of the different strain species and fermentation processesï¼ there was significant difference in quality. As a resultï¼ they should be clearly distinguished in clinical use. Most of the products were researched and developed during the 1980s and 1990sï¼ so there was difference in quality standards for different productsï¼ and their quality control levels of some products were not perfect. At presentï¼ some of the products are approved as Chinese medicineï¼ others are approved as chemical drugsï¼ with a confusion in products nameï¼ management and clinical application. In this paperï¼ the approval numbersï¼ quality standards and clinical applicationsï¼ and current problems of these products were summarized and compared; some suggestions were put forwardï¼ such as standardizing the product nameï¼ unifying the management of approval number categoryï¼ and increasing the specific quality control attributesï¼ in order to provide reference for standard implementationï¼ quality control and drug regulation for fermented Cordyceps crude drugs and their preparations.
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Productos Biológicos/normas , Cordyceps/química , Fermentación , Medicina Tradicional China/normas , Control de CalidadRESUMEN
To establish a UPLC-MS/MS method for simultaneous determination of six triterpenoid constituents (pachymic acid, dehydropachymic acid, dehydrotumulosic acid, polyporenic acid C, dehydroeburicoic acid and dehydrotra metenolic acid) in Guizhi Fuling capsules (GFC). Chromatographic analysis was conducted on Agilent Porosheell 120 SB-C18 column (4.6 mm×150 mm, 2.7 µm), with 0.1% formic acid aqueous solution-methanol as the mobile phase for gradient elution at a flow rate of 0.4 mLâ¢min-1. The column temperature was 30 â and the sample size was 5 µL. The samples were analyzed by tandem mass spectrometer with negative electrospray ionization (ESI) source, and monitored under a multiple reaction monitoring (MRM) mode, with the quantitative ion pairs m/z 527.8â465.5 (pachymic acid), m/z 525.6â465.6 (dehydropachymic acid), m/z 483.4â337.3 (dehydrotumulosic acid), m/z 481.5â419.5 (polyporenic acid C), m/z 467.4â337.1 (dehydroeburicoic acid), m/z 453.4â337.0 (dehydrotra metenolic acid). Six triterpenoid acids showed good linear relationships within the investigated concentration ranges (r> 0.996 8), with RSDs of precision less than 6.2%, and all RSDs of repeatability less than 5.9%. The average recovery rate was 97.90%, 100.2%, 99.60%, 101.7%, 102.6% and 103.0% respectively. The method was rapid, accurate, repeatable and could be used as a method for quantitative determination of triterpenoid acids in Chinese medicine prescriptions, providing a reference method for the quality control of Guizhi Fuling capsules and providing a reference for the content determination for Chinese medicine prescriptions containing Poria cocos.
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Medicamentos Herbarios Chinos/química , Fitoquímicos/análisis , Triterpenos/análisis , Wolfiporia/clasificación , Cápsulas , Cromatografía Líquida de Alta Presión , Espectrometría de Masa por Ionización de Electrospray , Espectrometría de Masas en TándemRESUMEN
According to the existing Provisions for Drug Registration (SFDA Order No. 28), applications for new drugs of traditional Chinese medicine are divided into two parts: the applications for drug clinical trial and for drug production (including new drug certificate). It will last for about 10 years from the application for drug clinical trial to get approving, and it also remains many problems and the low probability to succeed. From the sight of pharmaceutical review, there are mainly two aspects of regulatory compliance and technical issues, mainly for changes without approval of the competent authorities of the country. For example, sample preparation and approval of clinical trial process are significant changes. Technical problems are reporting incomplete data or information submitted does not comply with the technical requirements for review, such as: production process validation does not provide information, the preparation of samples for clinical trials and field inspection, production information, or the information provided does not meet the technical requirements. This paper summarizes the frequently asked questions and to make recommendations to advise applicants concerned, timely detection of problems, avoid risk, improving the quality and efficiency of the application for registration.
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Aprobación de Drogas/legislación & jurisprudencia , Evaluación de Medicamentos/legislación & jurisprudencia , Legislación de Medicamentos , Medicina Tradicional China , China , HumanosRESUMEN
In 1999, the nomenclature and case definitions for neuropsychiatric lupus syndromes were published by American College of Rheumatology (ACR), and the cognition of neuropsychiatric damage of systemic lupus erythematosus (SLE) was gradually unified and standardized. Lupus headache is an intractable problem in SLE, especially in SLE patients complicated with multiple organ injury. In general, vascular headache is common in most SLE patients, and a small number of SLE patients complicated with nervous headache are found in clinic. Moreover, its pathophysiological mechanism is far from being understood. Although early diagnosis is essential for good outcomes, the diagnosis method is rather confused in the world. There still exist some limitations in the proposal of clinical classification of headache from ACR and International Headache Society (IHS), and the proposal does not mention the classification of headache related to psychiatric damage. Current therapeutic regimens are almost exclusively based on empirical evidence. Treatment approaches include symptomatic treatment, immunosuppressive, anticoagulant and anti-aggregant therapies. It provides enormous and hopeful space in research of combined therapy strategy, especially in the field of traditional Chinese medicine. The authors discussed the relationship between lupus headache and headache due to internal injury in the view of integrated traditional Chinese and Western medicine, and suggested that the treatment strategy for lupus headache should be made in argument with the headache due to internal injury. Syndrome differentiation treatment according to deficiency in the root and excess in the branch and the therapy for activating blood to dredge collaterals maybe have great advantages in treatment of the headache in SLE.
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Cefalea/diagnóstico , Lupus Eritematoso Sistémico/complicaciones , Medicina Tradicional China , Cefalalgias Vasculares/etiología , Diagnóstico Diferencial , Medicamentos Herbarios Chinos/uso terapéutico , Cefalea/etiología , Humanos , Medicina Tradicional China/métodos , Fitoterapia , Cefalalgias Vasculares/diagnóstico , Cefalalgias Vasculares/tratamiento farmacológicoRESUMEN
The chemical nature, the mode of action, and the in vitro and in vivo anti-HSV activities of the polysaccharide from Prunella vulgaris were characterized. The polysaccharide was isolated by ethanol precipitation, dialysis, CTAB precipitation, and gel exclusion chromatography. The isolated compound (PPS-2b) was a lignin-carbohydrate complex with a molecular weight of 8500. The carbohydrate moiety was composed of glucose, galactose, mannose, galacturonic acid, rhamnose, xylose, and arabinose with glucose as the major sugar. In plaque reduction assay, PPS-2b showed activities against HSV-1 and HSV-2. The anti-HSV activity could be abolished by periodate oxidation. Mechanism studies showed that PPS-2b inactivated HSV-1 directly, blocked HSV-1 binding to Vero cells, and inhibited HSV-1 penetration into Vero cells. A similar inhibition was observed with a gC-deficient strain of HSV-1. The in vivo activities of a Prunella cream formulated with a semi-purified fraction was assessed in a HSV-1 skin lesion model in guinea pigs and a HSV-2 genital infection model in BALB/c mice. Guinea pigs that received the Prunella cream treatment showed a significant reduction (P<0.01) in skin lesions. Mice that received the Prunella cream treatment showed a significant reduction (P<0.01) in mortality. In conclusion, the anti-HSV compound from P. vulgaris is a lignin-polysaccharide complex with potent activity against HSV-1 and HSV-2. Its mode of action appears to be inhibiting viral binding and penetration into host cells.
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Antivirales/uso terapéutico , Herpes Simple/tratamiento farmacológico , Herpesvirus Humano 1/efectos de los fármacos , Herpesvirus Humano 2/efectos de los fármacos , Polisacáridos/uso terapéutico , Prunella , Animales , Antivirales/farmacología , Antivirales/toxicidad , Chlorocebus aethiops , Femenino , Cobayas , Herpes Genital/tratamiento farmacológico , Lignina/farmacología , Lignina/uso terapéutico , Ratones , Ratones Endogámicos BALB C , Fitoterapia , Extractos Vegetales/uso terapéutico , Polisacáridos/química , Polisacáridos/aislamiento & purificación , Polisacáridos/farmacología , Células VeroRESUMEN
OBJECTIVE: To study the antiviral constituents in the stems and leaves of Pithecellibium clypearia. METHOD: The constituents of P. clypearia were systematically separated with various chromatographic techniques in combination with antiviral activity monitoring. Their structures were elucidated by physical and chemical properties and spectral data. RESULT: Six compounds were isolated from P. clypearia and were identified as: tricetiflavan (5, 7, 3', 4', 5'-pentahydroxylflavan) (1), myricitrin (myricetin-3-O-alpha-L-rhamnopyranoside) (2), quercitrin (quercetin-3-O-alpha-L-rhamnopyranoside) (3), quereetin (4), methyl gallate (5) and gallic acid (6). CONCLUSION: Compound 1 approximately 5 were obtained from this plant for the first time. Compound 4 was found to show an obvious anti-respiratory syncytial virus (RSV) activity.
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Antivirales/aislamiento & purificación , Fabaceae/química , Flavonoides/aislamiento & purificación , Plantas Medicinales/química , Quercetina/aislamiento & purificación , Antivirales/química , Antivirales/farmacología , Flavonoides/química , Flavonoides/farmacología , Ácido Gálico/análogos & derivados , Ácido Gálico/química , Ácido Gálico/aislamiento & purificación , Ácido Gálico/farmacología , Concentración 50 Inhibidora , Hojas de la Planta/química , Tallos de la Planta/química , Quercetina/química , Quercetina/farmacología , Virus Sincitiales Respiratorios/efectos de los fármacosRESUMEN
Forty-four medicinal herbs were tested for antiviral activities against respiratory syncytial virus (RSV) by means of the cytopathologic effect (CPE) assay. Twenty-seven of the 44 medicinal herbs showed potent or moderate antiviral activities against RSV with 50% inhibition concentration (IC(50)) ranging from 6.3 to 52.1 microg/ml, and with selectivity index (SI) ranging from 2.0 to 32.1. Further purification of the active extracts from Sophora flavescens Ait. and Scutellaria baicalensis Georgi led to the identification of anagyrine (2), oxymatrine (7), sophoranol (10), wogonin (12), and oroxylin A (13) as the potent anti-RSV components.