2.Study on the Effect of Drug Registration System Adjustment on New Drug Research and Development in China
Ailing FENG ; Fuli GUO ; Hua XING
China Pharmacy 2017;28(22):3025-3029
OBJECTIVE:To provide reference for improving the registration success rate of new drug research and develop-ment(R&D)enterprises after adjusting drug registration system in China. METHODS:The national drug policies,regulations and related documents were comprehensively studied and combed to explore the main contents of drug registration system adjustment and its effects on the R&D forms,drug patent and on-site verification. The suggestions were put forward. RESULTS & CONCLU-SIONS:The adjusted drug management system showed new definitions for new drugs and generic drugs in China,as well as de-tailed requirements and regulations for drug R&D conditions,process and on-site inspection. It enhanced the protection of patents and patentees. The new drugs should be assessed its market value and clinical advantages. Data contents and requirements for drug registration declaration were made the relevant adjustments. New drug R&D enterprises should develop drug listed license manage-ment system as early as possible based on the implementation of listed license management system pilot,improve its efficiency and benefit. The new drug R&D should notice the clinical efficacy and demand of market,focus on the drugs with good clinical effica-cy in common diseases,frequently-occurring diseases and major diseases;and those for treating rare diseases,the elderly and chil-dren disease can use easy access or fast track to accelerate the speed of drug registration. New drug R&D enterprises should im-prove the R&D conditions,and standardize the management of development process to ensure the effective and smooth develop-ment.
3.Confer Effect of Air Disinfection by Using Nanometer Light Catalysis Decontamination Machine in Operating Room
Feng SONG ; Xin DONG ; Caixia YIN ; Hua WEI ; Yubin XING
Chinese Journal of Nosocomiology 2006;0(06):-
OBJECTIVE To analysis the effect of air disinfection by using nanometer light catalysis decontamination machine in operating room. METHODS By compare the effectiveness of air disinfection both by using nanometer light catalysis decontamination machine and ultraviolet rays light. RESULTS The result of tests is 0 CFU/m~2 by nanometer light catalysis decontamination machine and 33.3 CFU/m~2 by ultraviolet rays light in unmanned environment;By different groups: F=220.423,P=0.000,P
4.Antibacterials in Patients Accepted Operation in Grass-roots Hospitals:Their Application and Cost Analysis
Xing-Hua ZHANG ; Hong-Qin SUN ; Feng-Xia XU ; Yan-Hua LV ; Xiao-Qin WANG ;
Chinese Journal of Nosocomiology 1994;0(01):-
OBJECTIVE To investigate the application of antibacterials in patients accepted operation in grass-roots(hospitals),so to standardize the application of antibacterials and cut down the medical cost.METHODS Full-time administrators for nosocomial infection investigated the application of antibacterials in patients who accepted(operation) in Sep 2004,and filled in the questionnaires.RESULTS In 1 383 cases of 11 hospitals the application rate of antibacterials was 98.63%;in which 86.50% were for prophylactic usage and 13.50% for therapeutic usage;(29.90%) for single antibiotics treatment and 50.15% for bigeminy,18.70% were for trigeminy.Time of(application) differentiated(6.90,7.00,6.60d) fromⅠto Ⅲ kinds of operation.Per capita cost of antibacterials was $956.50(47.60%).CONCLUSIONS High cost of antibacterials results from such factors as multiple kinds,long time and(combined) application.
5.Genetic characteristics of hemagglutinin in measles viruses isolated in Henan Province, China.
Da-Xing FENG ; Ming-Hua SENG ; Qian LIU ; Zhen-Ying ZHANG
Chinese Journal of Virology 2014;30(2):134-137
This study aims to investigate the genetic characteristics of hemagglutinin in wild-type measles viruses in Henan Province, China and to provide a basis for measles control and elimination. Specimens were collected from suspected measles cases in Henan during 2008-2012. Cell culture was performed for virus isolation, and RT-PCR was used to amplify hemagglutinin gene. The PCR products were sequenced and analyzed, including construction of phylogenetic tree and analysis of the distance between the isolated virus and the reference virus; then, the variations in predicted amino acids were analyzed. The results showed that 12 measles viruses were isolated in Henan Province and identified as H1a genotype; the nucleotide and amino acid homologies were 98.0%-100% and 97.2%-99.8%, respectively. One glycosylation site changed in all the 12 sequences because of the amino acid mutation from serine to asparagine at the 240th site, as compared with Edmonston-wt. USA/54/A. Overall, the wild-type measles virus genotype circulating in Henan Province from 2008 to 2012 was H1a, with high homology between strains; there were some variations in amino acid sequences, resulting in glycosylation site deletion.
China
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Hemagglutinins
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genetics
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Humans
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Measles
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virology
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Measles virus
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classification
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genetics
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isolation & purification
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Molecular Sequence Data
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Phylogeny
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Viral Proteins
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genetics
6.Optimum harvest study of Gentiana crassicaulis in Ludian.
Yu ZENG ; Xing-Fu CHEN ; Yuan-Feng ZOU ; Jiu-Hua SONG ; Wen-Yu YANG ; Tao CHENG
China Journal of Chinese Materia Medica 2014;39(14):2635-2639
The paper is aimed to study the difference in yield and quality at different harvest time and determine the optimum harvest of planting Gentiana in Ludian traditional harvest period. The authors analyzed the variation in fresh weight, dry weight, dry discount rate, length, diameter, volume and the content of gentiopicroside, loganin acid, alcohol-soluble extract and total ash and made a comprehensive appraisal of yield, appearance quality and intrinsic quality by gray relational distance ideal Comprehensive Evaluation method. The results showed that there is a big difference in yield and quality both 2-year-old and 3-year-old Gentiana harvested in traditional harvest period and the comprehensive evaluation more better when harvested more later. It can be seen, Gentiana harvested the later had a better yield and quality in Ludian traditional harvest period. The harvest of Gentiana can be appropriate delayed depending on the particular circumstances of production.
Agriculture
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methods
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China
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Gentiana
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anatomy & histology
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growth & development
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metabolism
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Iridoid Glucosides
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metabolism
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Organ Size
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Quality Control
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Time Factors
8.Meta-analysis of blood system adverse events of Tripterygium wilfordii.
Zhi-xia LI ; Dong-mei MA ; Xing-hua YANG ; Feng SUN ; Kai YU ; Si-yan ZHAN
China Journal of Chinese Materia Medica 2015;40(2):339-345
A systematic review was undertaken, including studies that evaluated the incidence of the blood system adverse events of Tripterygium wilfordii (TWP). Medline, Embase and the Cochrane library were searched for relevant studies, including RCT, cohort studies and case series, of patients treated with TWP published in English and Chinese from inception up until May 25th, 2013 with the keywords including "Tripterygium wilfordii", "toxicity", "reproductive", "side effect", "adverse", "safety" and "tolerability". Relevant information was extracted and the incidence of the blood system adverse events was pooled with MetaAnalyst software. Besides, subgroup and sensitivity analyses were performed based on age, mode of medicine, observation time and disease system. According to inclusion and exclusion criteria, a total of 49 articles were included in the meta-analysis, they were split into 54 researches incorporated in the analysis. There is a large degree of heterogeneity among the studies, so data was analyzed using random-effects model and the summary estimates of incidence of the blood system adverse events was 6.1%. The weighted combined incidence of three major blood system adverse events were white-blood cells decreasing 5.6% (95% CI, 4.3% - 7.3%), hemoglobin decreasing 1.7% (95% CI, 0.5% - 5.0%) and platelet decreasing 1.8% (95% CI, 1.0% - 3.1%), respectively . Sensitivity analyses based on 45 studies with high quality showed the combined value was close to the summary estimate of total 54 studies. The current evidence indicates that the incidence of the blood system adverse events induced by TWP was high; attentions should be paid on to the prevention and treatment of the blood system adverse events.
Blood Cells
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drug effects
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Hemoglobins
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analysis
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Humans
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Tripterygium
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adverse effects
9.Biomechanical property changes following rat cornea collagen crosslinking using glyceraldehyde
Ying, WANG ; Feng-mei, HAN ; Yan-hua, CHU ; Quan-hong, HAN ; Kan-xing, ZHAO
Chinese Journal of Experimental Ophthalmology 2012;30(5):414-417
BackgroundSeveral cornea collagen crosslinking methods have been used to treat keratoconus.However,the safety of these methods is dissatisfactory.Glyceraldehyde is a very potent and highly reactive crosslinking agent,with little toxicity,but its effect on corneal biomechanical property is poorly clear.ObjectiveThe aim of this study was to evaluate the biomechanical effects of glyceraldehyde collagen crosslinking on rats cornea.Methods Fifteen clean SD rats were randomly divided into 0.005 mol/L glyceraldhyde group,0.050 mol/L glyceraldhyde group and blank control group.Glyceraldhyde drops was topically administered in the right ryes 2 times per day for consecutive 7 days in the 0.005 mol/L and 0.050 mol/L glyceraldhyde groups,and no any eye drops was used in the blank control group.Seven days later,the rats were sacrificed.Transparency of corneal buttons in these different groups was evaluated.The central corneal strips of 2 mm×6 mm with 2 mm scleral tiasue were obtained for the biomeehanical stress-strain measurement,including ultimate stress ( MPa),ultimate strain (%) and 6% elastic modulus (MPa).Corneal collagen fibril density was assessed by histological examination under a light microscopy.The use of the animals followed the Regulations for the Administration of Affair Concerning Experimental Animals by State Science and Technology Commission.ResultsThe words could be clearly displayed transcorneally in all the three groups.When strain was 6%,the stress was (0.463±0.065 ) MPa in 0.005 mol/L glyceraldehyde group,(0.846±0.240) MPa in 0.050 mol/L glyceraldehyde group,both showing a significant increase in comparison with (0.195±0.103 ) MPa of the blank control group (P=0.029,0.000 ).Following the crosslinking treatment,the ultimate stress was significant elevated in 0.050 mol/L glyceraldehydes group compared with the blank control group ( ( 10.759 ± 3.337 ) MPa vs.(5.295± 1.313 ) MPa,P =0.007 ),but no significant change between the 0.005 mol/L glyceraldehydes group and the blank control group ( ( 6.043 ±2.084) M Pa vs.(5.295 ± 1.313 ) MPa,P =0.660 ).Corneal ultimate strain was lower in the 0.005 mol/L glyceraldehyde group and 0.050 mol/L glyceraldehyde group than the blank control group (36.57% ±3.09% vs.43.87% ± 1.89%,P =0.009;28.53% ±1.89% vs.43.87% ± 1.89%,P =0.000).However,significantly increased 6% elastic modulus were seen in the 0.005 mol/L glyceraldehyde group and 0.050 moL/L glyceraldehyde group compared with the blank control group ( ( 7.718 ± 1.076 ) MPa,( 14.102 ± 4.011 ) MPa vs.( 3.252 ± 1.717 ) M Pa),with statistically significant differences ( P =0.029,0.000).Histological examination showed a increase of collagen fiber density in the 0.050 mol/L glyceraldehyde group.Conclusions Corneal collagen crosslinking induced by glyceraldehyde strengthens biomechanical intensity and increases the density of corneal collagen fiber.But the safety of glyceraldehyde crosslinking for keratoconus needs further study.
10.In vitro proliferation and differentiation characteristics of fibroblast like synovial cells in patients with rheumatoid arthritis
Qiang SHU ; Xing-Fu LI ; Guo-Feng DAI ; Hua-Xiang LIU ;
Chinese Journal of Rheumatology 2000;0(06):-
Objective To investigate the proliferation and differentiation characteristics of fibroblast like synovial cells(FLS)in rheumatoid arthritis(RA)in vitro and the mechanism of the immunosuppressive effect of differentiation inducers, such as all trans retinoid acid(ATRA), ealcitriol [1,25(OH)_2D_3] and dexamethasone(DEX). Methods FLS of knee synovial tissues from RA patients were cultured and identified in vitro in the presence or absence of ATRA, 1,25(OH)_2D_3 and DEX respectively. Synoviocyte proliferation in RA were measured by MTT colorimetrie assay and the survival fraction(SF)of FLS was evaluated. Cell cycle of FLS was observed using fluorescence-activated cell sorting(FCS)method in RA patients. Results The identified synovial cells in patients with RA were FLS(Vimentin and Fibronectin expression was positive), and hadn't been transformed or differentiated to adipocytes and osteoblasts with the three inducers. The SF of all RA-FLS interfered by ATRA, 1,25(OH)_2D_3 and DEX was much lower than that without drugs vehicle group in RA-FLS(P