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Danofloxacin is a veterinary fluoroquinolone used to treat respiratory and gastrointestinal diseases of birds, pigs and cattle. The literature reviewed shows some analytical methods to quantify this fluoroquinolone, but microbiological and biological safety studies are limited. The analytical methods were validated by the Official Codes. The LC-DAD method was developed and validated using an RP-18 column, mobile phase containing a mixture of 0.3% triethylamine (pH 3.0) and acetonitrile (85:15, v/v). The microbiological assay was performed by agar diffusion method (3 x 3) and Staphylococcus epidermidis as a microorganism test. Forced degradation studies were performed in both methods. The minimum inhibitory concentration (MIC) was performed by test microdilution and toxicity studies were evaluated using in silico study, cell proliferation, cell viability test, micronuclei and comet assay. LC and a microbiological assay proved linear, accurate, precise, and robust to quantify danofloxacin, but only the LC method showed selectivity to quantify the drug in the presence of its degradation products. These results demonstrate that the LC method is suitable for stability studies of danofloxacin, but a microbiological assay cannot be used to quantify the drug due to the biological activity of the photoproducts. Ex-vivo cytotoxicity and theoretical and experimental genotoxicity were also observed.
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Objective:To study the biological safety and biocompatibility of the mixture of Paris polyphylla-chitosan.Methods:According to the GB/T 16886.12-2005 standard,YY/T 0279-1995 standard and GBT16886.5-2003 standard,samples were prepared and tested by oral mucous membrane irritation test,cytotoxicity test and flow cytometry.Results:No local response to the mixture of Paris polyphylla-chitosan was found,and the visual observation and pathological findings of oral mucosa were normal and similar to that of the control group.Therefore,the mixture of Paris polyphylla-chitosan had no irritation response to oral mucosa.The mixture of Paris polyphylla-chitosan showed no cytotoxicity to L929 cells,and did not affect the cycle distribution and apoptosis of L929 cells.Conclusion:The mixture of Paris polyphylla-chitosan has good bio-safety and biocompatibility.
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Objective:To fabricate and to study the surface morphology and biological safety of a novel coating on microarc-oxidized titanium.Methods:The novel functional coating was fabricated by cross-linking the double-layer nanoparticles loading rhBMP-2 and SDF-1 with gelatin on microarc-oxidation coating on titanium implant surface.The surface topography was observed and optimized,and the biological safety of the novel coating was primarily evaluated by cell toxicity test,oral mucosa stimulation test and hemolysis test in vitro.Results:The novel functional coating possesses excellent morphology.The coating showed the cytotoxicity of score 1 and no mucous membrane irritation,the hemolytic rate of the coating was 4.6％.Conclusion:The coating possesses good morphology and biological safety.
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Objective:To evaluate the biological safety of commercial pure Ti (cpTi),Ti alloy Ti6Al4V and stainless steel 316L.Methods:According to the GB/T16886.5-2003 and YY/T0127.2-2009 standards,the extraction of the 3 materials was respectively prepared,cck-8 assay was used to test their cytotoxicity,single cell gel electrophoresis was used to test their genotoxicity,and in vivo test was used to test their acute systemic toxicity.Results:The cytotoxicity of 100％ extractions of 316L,Ti6Al4V and cpTi was graded to 2,1 and 0,the olive tal moment(OTM) 10.79 ±0.39,9.84 ± 1.78 and 0.92 ± 1.43,the percentage of tail DNA (1.22 ±0.06) ％,(0.92 ± 0.43) ％ and (0.43 ± 0.01) ％ respectively.No systemic toxicity and no body weight change was observed in the acute systemic toxicity test in mice.Conclusion:cpTi has better biologic safety than Ti6Al4V and 316L.
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OBJECTIVE:To strengthen quality management of drug microbiology laboratory and provide reference for relevant inspection institutions. METHODS:Taking measures from the laboratory document management,personnel training,quality con-trol,quality supervision,process control and biological safety,the elements of laboratory quality management were analyzed,and effectively measures were put forward to improve the management level. RESULTS & CONCLUSIONS:The laboratory should es-tablish strict,standardized,systematic laboratory management rules and regulations,quality documents,operating procedures, work guide,etc. to achieve documented management;develop various forms of annual training and assessment programs to con-struct a professional team;strengthen internal(developing an annual internal quality monitoring plan,conducting quality control ac-tivities,regularly checking the suitability of the medium) and external (capability testing,inter-laboratory comparison) manage-ment control level,and reasonably formulate the contents and frequency by combing with actual situation. Besides,the laboratory should strengthen inspection process control,attach great importance to the biological safety management to reduce the risk of labo-ratory quality to a minimum.
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Objective:There are many different kinds of biological safety cabinets, it make some difficulties in the allocation. Scientific selection which based experimental requirements choose the right equipment match experiments, it can effectively prevent the spread of pathogenic microorganisms of operation personnel damage and environmental pollution.Methods: According to its working characteristics, different laboratory levels, detection items and actual operation of dangerous levels of pathogenic microorganisms, to determine the matched biological safety cabinet.Results: According to the different experiments correctly, choose the appropriate biological safety cabinet, bio-safety has been obviously improved, the incidence of adverse events decreased from 12% to 3%; the experimenter's security has improved.Conclusion: Through the use of biological safety cabinet clear and selection method, can not only improve biological testing of safety consciousness, but also strengthen the biological safety standardization, institutionalization and standardization of the management mechanism, avoid the use of biological safety, improve the quality of the efficiency of laboratory work and experiment, laboratory personnel biological safety.
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Objective:In order to explore the maximum and the optimal velocity of front window air in biological safety cabinets and provide a scientific evidence for relevant test. Methods: As classⅡ biological safety cabinet an testing sample, computational fluid dynamics method is adopted to establish numerical model, then made the simulation of front window airflow. Results: The velocity relationship between front window airflow and the internal air has been confirmed. Conclusion:The maximum velocity of the front window flow is 1.4 m/s and the optimal velocity is 1.0 m/s. The tested data and conclusion can give some suggestions and reference for biological safety cabinets detection.
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Objective:To evaluate the toxicity of NaHCO3 coagulated silica gel for coating on the zirconia bonding surface in vivo. Methods:The silica gel was subjected to short term systemic toxicity test by delayed-type hypersensitivity test by oral route and oral mucosa irritation test according to the YY/T 0244-1 996 standards,T1 6886.1 0-2005 /ISO 1 0993-1 0:2002 standards and YY/T 01 27. 1 3-2009 standards respectively.Results:In the short term systemic acute toxicity tested mice there was no significant difference in the weekly food utilization rate and relative body weight growth rate between the experimental and control groups.No abnormality and path-ological change were observed.The delayed-type hypersensitivity test showed that no erythema and edema reaction presented in all the test cavies after 24 and 48 h of stimulation contact,and the sensitization rate was 0.There was no local or systemic pathological change in all the oral mucosa irritation test animals.Conclusion:NaHCO3 procoagulant silica gel has no in vivo toxicity.
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BACKGROUND: The purpose of this study was to compare the concentration of total airborne bacteria (TAB) in biosafety cabinets (BSCs) at universities and hospital microbial laboratories to assess the performance of BSCs. METHODS: TAB was determined by using the single-stage Anderson sampler (BioStage Viable Cascade Impactor). The samples were obtained three times (with the BSC turned off and the shield open; with the BSC turned off and the shield closed; and with the BSC tuned on and operating) from the areas in front of 11 BSCs. RESULTS: TAB concentrations of accredited and nonaccredited BSCs were determined. No significant differences were observed in the TAB concentrations of the accredited BSCs and the nonaccredited BSCs for the areas outside the BSCs in the laboratories (p > 0.05). TAB concentrations for the BSCs sampled with the shield open and the instrument turned off showed differences based on the sampling site outside the BSC in each laboratory. CONCLUSION: These results imply that TAB concentration is not altered by the performance of the BSCs or TAB itself and/or concentration of TAB outside the BSC is not a good index of BSC performance.
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BacteriaABSTRACT
Objective Due to the superior performance,Carbon-Carbon composites,although still at their early stage of development,have gained more and more attention and showed great application potential.Methods According to the National Standard,the biological safety evaluation of carbon-carbon composites were done in the following aspects:cytotoxicity test,acute systemic toxicity test,haemolysis test,pyrogen test,intramuscular implantation test.Results test results showed the biological safety evaluation of carbon-carbon composites well meet the requirement of the national standard with fine biological compatibility.Conclusion The experiment results demonstrate that carbon-carbon composites can be put in clinical application
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Objective To evaluate the biological safety of 125I-filled carbon nanotubes covered with metallic esophageal stent with regard to the normal esophagus before clinical application.Methods 125I-filled carbon nanotubes covered with metallic esophageal stent was prepared.Eighteen of New Zealand rabbits were randomly divided into three groups with 6 rabbits in each group.Three groups of stents,non-radioactive,low radio-activity ( 3.7 - 5.6 MBq),and high activity ( 11.1 - 13.0 MBq ) were placed in the midpiece of esophagus of rabbits.Esophagus opacification and three-diamensions DSA were performed at 0.5 h,7,14 and 30 d after insertion of the stents,respectively.The rabbits were killed at 30d after insertion of the stents,and histologic examinations of the esophageal walls were performed.Results In non-radioactive and low activity groups,1 of 6 rabbits died of wound infection at 1 and 3 d after surgery due to pulmonary infection,respectively.All specimens were obtained from 16 rabbits.Microscopically,in all rabbits of low activity and high activity groups,there were membrana mucosa necrotic and swell and breakage of the muscle fiber in esophageal submucosa and muscularis,submucosal inflammation,which were more severe in high activity group.In low activity group,one esophagus ectal membrane was involved,however,esophageal perforation did not develop.In high activity group,3 of 6rabbits esophageal perforation had developed,in which one esophagus mediastinum fistula developed,without inflammation.In non-radioactive group,it was almost normal in mucosa layer,a small amount of inflammatory cells were found in submucosal layer,and part of muscle fibers was fractured and no pathological changes of necrosis was found.Conclusions Radioactive 125I carbon nanotubes covered metallic stent with low activity(3.7 -5.6 MBq) can be used as intraluminal palliative brachytherapy,which is safe and effective.
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Objective To investigate the biological safety of silicon membrane embedded permanent magnets implanted into canine, so as to evaluate the safety of a micturition alert device designed on the principle of compass. Methods Twelve adult male dogs (weighing 11-12 kg) were divided into experimental group (8 dogs) and control group (4 dogs ). The experimental group was implanted with a silicon membrane embedded NdFeB magnet, which was 10 mm in diameter and 3 mm in thickness and with a magnetic induction intensity of 0. 3 Tesla at the center of the pole face surface. The control group was implanted with a silicon membrane embedded NdFeB alloy with the same dimensions. The grafts were sutured onto the anterior surface of the bladder wall. The dogs were then allowed to live for one year. Both the survival and local pathology around the grafts were observed after implantation. And the pre-operation urine and post-operation urine were compared between the two groups. Results One dog in the experimental group died from operation complications 10 hours after operation, another dog had intestinal obstruction 3 weeks after operation because iron wires in the intestinal tract was caught up by the permanent magnet. The rest 6 dogs in the experimental group and 4 dogs in the control group had no abnormalities in spirit, appetite, urine or stool, and there were no infections. The animals were sacrificed one year after operation. Adhension was found between the epiploon and the bladder wall around permanent magnets in these 10 dogs; the fibrous capsule around the permanent magnets was thin, and the local bladder wall below permanent magnets was thickened, with normal bladder mucosa. Grade 2 inflammatory reaction and fibrous capsule of the local tissue were noted around the grafts. The findings of urine routine were normal before and after operation. Conclusion NdFeB permanent magnets embedded with silicon membrane are biologically safe for clinical application, which warrante further investigations.
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OBJETIVOS: Verificar evidências da formação de aerossóis durante a manipulação de cepas de micobactérias para teste de sensibilidade às drogas (ANT) e identificação (TIP) e o efeito da descontaminação com solução de álcool 70 por cento e luz ultravioleta (UV) na cabine de segurança biológica (CSB), após os procedimentos laboratoriais. MÉTODOS: Uma placa foi exposta na CSB durante os procedimentos de ANT e TIP. Ao término, a CSB foi limpa e descontaminada com álcool 70 por cento e exposta à luz UV por 15 minutos. Após esse tempo outra placa foi exposta por duas horas, somente com a ventilação da CSB ligada. As placas foram incubadas a 37ºC e observadas por 30 dias. Os esfregaços das colônias isoladas foram corados pelas técnicas de Ziehl Neelsen e Gram, e as colônias de bacilo álcool-ácido-resistente (BAAR) foram identificadas pelos métodos tradicionais. RESULTADOS: Nas 38 placas expostas durante o ANT, cresceram micobactérias em 10 placas (26,3 por cento), fungos em uma (2,6 por cento) e outros bacilos em duas (5,3 por cento). Das placas com micobactérias, oito (80 por cento) foram identificadas como M. tuberculosis e duas (20 por cento) tiveram identificação inconclusiva. Mesmo após a descontaminação com álcool 70 por cento e uso de UV, cresceram fungos em duas placas (5,3 por cento) e cocos em outras duas (5,3 por cento). Nas 30 placas colocadas nas CSB durante a TIP, cresceram micobactérias em 10 placas (33,3 por cento), fungos em duas (6,6 por cento), cocos em uma (3,4 por cento) e uma mistura de micobactérias e outro bacilo em uma (3,4 por cento). Não houve crescimento nas placas expostas após descontaminação das CSB com álcool a 70 por cento e uso de UV ao término da TIP. CONCLUSÃO: Durante os procedimentos houve formação de aerossóis contendo micobactérias, fato que ficou comprovado pelo crescimento de colônias de micobactérias nas placas expostas. Técnicas laboratoriais adequadas devem ser respeitadas para minimizar a formação de aerossóis...
OBJECTIVES: To verify the evidence of aerosol formation during the manipulation of mycobacteria strains for susceptibility (ST) and identification tests (IT) as well as the decontamination effect of alcohol solution 70 percent and ultraviolet (UV) radiation in biological safety cabinets (BSC) after laboratory procedures. METHODS: One plate was exposed in a BSC during ST and IT procedures. Afterwards, the BSC was cleaned and decontaminated with alcohol solution 70 percent and exposed to UV radiation for 15 minutes. After that, another plate was exposed for two hours, only with the BSC ventilation on. Both plates were incubated at 37ºC and observed for 30 days. The smears from the isolated colonies were stained with Ziehl Neelsen and Gram techniques, and acid fast bacilli (AFB) were identified by conventional methods. RESULTS: In 38 plates exposed during ST, there was mycobacteria growth in 10 plates (26.3 percent), fungi in one (2.6 percent) and bacilli in two (5.3 percent). Among those plates that presented mycobacteria growth, eight (80 percent) were identified as M. tuberculosis and two (20 percent) had inconclusive identification. Even after decontamination with alcohol solution 70 percent and UV radiation, two plates presented fungi growth (5.3 percent) and other two presented cocci growth (5.3 percent). Among 30 plates exposed during IT procedures, there was mycobacteria growth in 10 of them (33.3 percent), fungi in two (6.6 percent), cocci in one (3.4 percent) and one (3.4 percent) mixed mycobacteria and another bacillus. No growth was observed when alcohol solution 70 percent and UV radiation were used for decontamination after IT procedures. CONCLUSION: During the procedures there was aerosol formation with mycobacteria, which was proved by mycobacteria growth on the exposed plates. Not only should adequate laboratory techniques be respected to minimize aerosol formation, but professional expertise, the continuity of capacity...
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Containment of Biohazards , Decontamination/methods , Laboratory Equipment , Aerosols , /prevention & control , Mycobacterium , Ultraviolet RaysABSTRACT
Clinical laboratory biological safety is one of whole society safety. This paper introduced briefly the current situation of clinical medical laboratory biosafty in the hospital. and set forth common biological hazards specifically for whose characteristics. Combining the biosafety administration measures from abroad, the issue of laboratory biological safety administration was considered, and put forward some suggestions according to related law and regulation of national laboratory safety administration in order to strengthen clinical laboratory biosafety administration.
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The antibacterial property of silver nanoparticles has resulted in their widespread application in many fields,so the chance of silver nanoparticles exposure for human increased greatly.Thus,there is urgent need to assess the safety of such particle.So far,most toxicological studies of silver nanoparticles mainly focus on the cytotoxicity using different examination endpoint such as morphology,mitochondrial function,cell proliferation,enzyme activity,and so on.In addition,the in vitro studies on the toxicity of silver nanopoarticles are also reported,few of the study on molecule mechanism of toxicity was reported.This review provided a summary of antibacterial mechanism of silver nanoparticles and the current research situation of the safety.The future research direction of toxicological study of silver nanoparticles is also prospected based on the current knowledge.
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0.05).RGR showed that the toxicity level of magnesium alloys was 0.And there was no significant abnormality found in biochemical indicators and pathological analysis after inplant in vivo.[Conclusion]Magnesium alloys showed good biocompatibility to L929 mouse fibroblasts,and had no cacoethic effect to test animals,so the magnesium alloys is possible to be a new type and potential of bone surgery implant materials.
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PURPOSE: To perform biological safety test of the Seoul-type keratoprosthesis (SKpro) according to the international standards. METHODS: Mouse fibroblasts were used to assess the cellular toxicity, and albino rabbits were used for the irritation test, intradermal test, ocular toxicity test, pyrogenic test and transplantation test. Albino guinea pigs were used for the sensitization test, and rats were used for the acute toxicity test and chronic toxicity test. All tests were performed using the SKpro extracts, which was extracted under 121degrees C for 1 hour using a 0.9% normal saline as the solvent. RESULTS: For the cellular toxicity test, all the rat fibroblasts showed cell proliferation inhibition of less than 29%, which proved to be non-cellular toxic. For the irritation test and the intradermal reaction test, none of the albino rabbits showed skin rash, crust or edema. On the ocular irritation test, there were no conjunctival, corneal or iris abnormalities among the albino rabbits. On the sensitization test, none of the guinea pigs showed skin rash, crust or edema. On the acute systemic toxicity test, there were no signs of lethargy or coma among rats. On the pyrogenic test, no temperature increase was observed in the albino rabbits. On the transplantation test, there was no evidence of graft reaction around the cornea. On the chronic toxicity test, complete blood analysis, urinalysis and histological findings 6 month after exposure showed no signs of abnormalities. CONCLUSIONS: The result of this study shows that SKpro is non-toxic and biologically safe.
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Animals , Mice , Rabbits , Rats , Cell Proliferation , Coma , Cornea , Edema , Exanthema , Fibroblasts , Guinea Pigs , Intradermal Tests , Iris , Lethargy , Toxicity Tests , Toxicity Tests, Acute , Toxicity Tests, Chronic , Transplants , UrinalysisABSTRACT
Objectives To establish an ideal cellular model for the study of infection of porcine endogenous retrovirus in intro and in vivo and to lay the foundation for evaluating the biological safety of xenotransplantation. Methods Porcine skin fibroblasts were cultured by tissue pieces, cold trypsin, and heat trypsin, respectively. The merit and defect of these methods were analyzed. Results Porcine skin fibroblast line was established and the tissue piece method was superior to trypsin methods. Conclusion Culture of porcine skin fibroblasts with tissue pieces is superior to trypsin method, with the characteristics of low cost and easy operation. The established porcine skin fibroblast cell line supplies an ideal cell model for the study of infection of porcine endogenous retrovirus in vitro and in vivo, provides a new method for the evaluation of biological safety of xenotransplantation, and plays an important role in the skin culture model of production of cloned animals.
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Objective To evaluate the biological safety of a Ni-62.9Cr-23 alloy fabricated by laser solid forming technology.Methods According to the requirements of national standards GB/T16886-2003,YY/T0279-1995 and YY/T0244-1996,general cytotoxicity,acute systemic toxicity,hemolysis testing,oral mucous membrane irritation testing were used to evaluate the alloy.Results The alloy was indicated having no cytotoxicity and with a hemolytic rate of 0.385%.The oral mucous membrane irritation testing showed that the alloy had no mucous membrane irritation.The acute systemic toxicity test indicated that the alloy had no acute systemic toxicity.Conclusion The Ni-62.9Cr-23 alloy has good biological safety in a certain extent.
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The source, super-antioxidant activity, biological safety and application in medicine, health food and animal feed industry of natural astaxanthin are reviewed in present paper. The industrialization prospect of astaxanthin in China is also proposed.