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Aim To evaluate the equivalence between micro kinetic chromogenic assay anrl kinetic chromogenic assay in order to provide data support for the use of alternative methods.Methods Detection conditions; micro kinetic chromogenic assay and kinetic chromogenic assay limulus reagent were used, sample amount of each well and limulus reagent was 25 jxL ( kinetic chromogenic assay was 100 jxL) , detection wavelength was 405 nm, ONSET OD value was 0.03, and half- well elisa plate was used for detection ( kinetic chromogenic assay was ordinary ELISA plate).The equivalence of the two methods was evaluated by various statistical methods, such as equivalence test, in collaboration with four laboratories in China.Results The results of one-way an OVA, paired T test and equivalence test were consistent, indicating that there were some differences between the existing kinetic chromogenic assay of different manufacturers, while there was no significant difference between the trace or conventional amount of reagent used by each manufacturer.Conclusions Micro kinetic chromogenic assay is e- quivalent to existing reagents in terms of accuracy and recoverv.J.
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Objective To simplify and optimize the micronucleus test method. Methods The preparation process of micronucleus test was simplified and optimized. In the improved method, the superfine solution was directly absorbed and discarded after cell culture, and then potassium chloride solution was added for hypotonic treatment. Then pre-fixation, centrifugation. Once the centrifugation was completed, the cells which fixed only once were directly dropped to the slide. Results The background of the slides was clear and the cells were slightly darker, but the observation of cells and micronucleus was not affected. There were a lot of binuclear cells, which can meet the counting requirements. With oil and high magnification, the image wais clearer and the background was cleaner. The cytoplasmic integrity rate, cell stain rate and the average number of cells per high magnification field of cells by the improvement method were significantly increased compared with that by the traditional methods, the probability P values were 0.0051 (χ2=7.8375), 0.0140 (χ2=6.0437) and 0.0025 (t=3.0951), respectively. The rate of micronucleus cells and cells group index had no statistical significance compared with the traditional method, the probability P values were 0.7749 (χ2=0.0817) and 0.5152 (U =0.0000), respectively. Conclusion The new method is more simple, easier to control the test quality, more reliable test results, and save time, manpower and material resources.
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Abstract Background: Stress test is used to detect coronary artery disease (CAD). The QTc interval dispersion (dQTc) is an electrocardiographic index of ventricular repolarization heterogeneity. Some researchers have linked transient myocardial ischemia induced by physical exertion with increased heterogeneity of ventricular repolarization measured by dQTc. Objectives: To study the patterns of dQT in patients with and without chronic obstructive CAD and to define a reliable cutoff point for dQT that could become a diagnostic criterion for myocardial ischemia. Methods: We retrospectively analyzed the electrocardiogram in resting and in exercise of 63 patients submitted to exercise test and cardiac catheterization. We divided the patients into three groups: true negative (VN), true positive (VP) and false positive (FP). VN: patients with coronary lesion lower than 70% and exercise test without myocardial ischemia; VP: individuals with stenosis greater than 70% in coronary arteries and a test suggestive of myocardial ischemia; FP: people with stenosis lower than 70% in the coronary arteries and stress test with ischemia criteria. Values of p < 0.05 were considered statistically significant. Results: Resting dQTc was not different among the three groups. However, for the dispersion of the QTc interval in exercise was, respectively, 47 ± 17 ms, 72 ± 42 ms, and 61 ± 31 ms for VN, VP and FP (p = 0.003). Conclusions: Obstructive chronic coronary disease patients have an increase in dQTc during exercise. Measurement of dQTc may be helpful in the diagnosis of myocardial ischemia in the stress test.
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Humans , Male , Female , Adult , Middle Aged , Aged , Coronary Artery Disease/diagnosis , Exercise Test/methods , Coronary Artery Disease/physiopathology , Chronic Disease , Myocardial Ischemia/diagnosis , Electrocardiography/methods , Analytical EpidemiologyABSTRACT
Objective To establish a bacterial endotoxin test method for high concentration vitamin B6 injection. Method The test was taken according to the bacterial endotoxin test in Chinese pharmacopoeia 2015 edition. Result By diluting the sample concentration to 1.04 mg/ml with the buffer of pH6.5-7.5, and using λ=0.06 EU/ml of TAL reagent, the interference could be effectively avoided. Conclusion The method was useful, which could be used to test the bacterial endotoxin in high concentration vitamin B6 injection. The bacterial endotoxin limit was defined as 0.06 EU/mg.
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RESUMO A concentração de óleos e graxas em amostras de águas contaminadas com resíduos oleosos pode ser determinada pelos procedimentos estabelecidos no Standard Methods for the Examination of Water and Wastewater. No entanto, sua aplicação nem sempre resulta em valores adequados ou níveis de precisão satisfatórios para atendimento de padrões normativos. Nesse sentido, este artigo apresenta uma proposta de ensaio para determinação da concentração de óleos minerais em águas provenientes de áreas pavimentadas, sujeitas ao derramamento de óleos e graxas. Tal método tem por base o método de partição gravimétrica (5520 B), estabelecido pelo Standard Methods. No novo procedimento, a etapa de separação entre o solvente de extração contendo os resíduos e o restante da fase aquosa foi substituída pela evaporação de toda a água da amostra, em estufa a 85ºC. Para avaliar a eficiência do método, foram preparadas amostras com concentrações conhecidas de óleo de 200, 100, 50, 25 e 15 mg.L-1 em água destilada e realizados ensaios de laboratório para determinação do teor de óleo, conforme tal procedimento. Os valores obtidos para as concentrações de óleo são bastante satisfatórios, apresentando comportamento linear em relação às concentrações de referência. Esse fato evidencia a confiabilidade do método proposto e sua aplicabilidade na determinação da concentração de óleos em amostras de águas contaminadas provenientes do escoamento superficial em pavimentos.
ABSTRACT Oil and grease concentration in water samples contaminated by oily residues can be determined by the procedures established in the Standard Methods for the Examination of Water and Wastewater. However, its application does not always result in adequate values or satisfactory accuracy levels in order to meet regulatory standards. In this sense, this paper presents a test-method proposal for determining mineral oil concentration in water samples from runoff of paved areas subject to oil and grease spillages. This method is based on the partition-gravimetric method (5520 B) established by the Standard Methods. In the new procedure, the separation between the extraction solvent containing residues and the aqueous phase remainder was replaced by the whole water sample evaporation in an oven at 85ºC. In order to assess the proposed method's efficiency, samples were prepared with known oil concentrations of 200, 100, 50, 25 and 15 mg.L-1, in distilled water and laboratory tests were performed to determine the oil content, according to the new procedure. The values obtained for the oil concentrations through the proposed procedure are quite satisfactory, presenting linear behavior in relation to the reference concentrations. This fact evidences the reliability of the new method and its applicability in determining the oil concentration in contaminated water samples from runoff in pavement surfaces.
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There are many problems in the use of Bupleurum medicinal materials such as confusion in variety, unclearness in origin and quality problems, e.g., adulteration of authentic Bupleurum and mixing of non-medicinal parts. Therefore, the quality of Chinese patent medicines containing Bupleurum chinense is variable, and it is necessary to establish targeted quality control methods. Based on the quality control methods of Bupleurum and its Chinese patent medicines, combined with the example of Xiaochaihu granules, this paper discussed the quality standard improvement and supplementary test methods of Bupleurum and its Chinese patent medicines, aiming to provide reference for the quality control, quality supervision and standardized production of Chinese patent medicines containing Bupleurum and promote the improvement of its intrinsic quality.
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OBJECTIVE： To provide reference for the formulation of regulatory policies, revision and improvement of standards with the research and summary of Chinese medicine glues in recent years. METHODS： The quality problems of Chinese medicine glues found in national drug sampling inspection since 2012 were summarized, and based on this, the screening of 41 Chinese medicine glues with large production batches and large market share was carried out, and relevant supplementary inspection methods were established. RESULTS AND CONCLUSION： By summarizing the drug quality notices issued by the state and provincial and municipal drug administrations, from 2012 to 2015, it was found that the cowhide feeding in donkey-hide gelatin was serious. From 2015 to 2017, no cowhide feeding problems were found, but the feeding problems of mule and horse skins were extremely prominent. In view of the market problems, seven units completed the screening of 41 Chinese medicine glues, and established 15 supplementary inspection methods, which effectively strengthened the quality control and standardized the industrial order of Chinese medicine glues.
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Objective To evaluate the accuracy of VITEK 2 Compact in the detection of the drug susceptibility of carbapenemresistant Klebsiella pneumoniae (CRKP) to Amikacin.Methods The susceptibility for 147 isolates of SRKP to Amikacin were detected by VITEK 2 Compact,disk diffusion method (K-B method) and E-test method,respectively.Results Among the 147 strains of Klebsiella pneumoniae,the drug susceptibility results were consistent between K B and E-test method.Among the 5 strains,the results were totally consistent by VITEK 2 Compact,K-B method and E test method,of which 4 strains were sensitive,1 strains were resistant.There were 142 strains being not consistent between VITEK 2 Compact and E-test method.The results of VITEK 2 Compact were sensitive or intermediate,while E test were drug resistance.Conclusion VITEK 2 Compact is not reliable for the detection of CRKP to Amikacin,which requires that K B method or other methods should be used for the susceptibility of CRKP to Amikacin.
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Objective:To establish the quality control method of electrosurgical unit(ESU) through the safety performance test and data analysis for electrotome.Methods: According to the testing standard of ESU, Fluke ESA612 electrical safety analyzer and QA-ES II electrosurgery unit analyzer were applied to test the properties of ESU were using during 2015 and 2016, and the testing results were analyzed.Results:In 2015 and 2016, the qualified rate of quality control results were 79% and 81%, respectively; the problems of unqualified ESU were resolved and their hidden risks in clinical applications were eliminated.Conclusion: By testing the properties of ESU, we can master the performance of the machine; find and deal with the risk of machine in time, and avoid the hidden danger and enhance the risk management for ESU, so that the machine can be safely and effectively applied in clinical surgery.
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OBJECTIVE:To establish a method for the determination of antibacterial effect of Ofloxacin eye drop. METH-ODS:According to the requirements in Chinese Pharmacopoeia(2015 edition)antibacterial effect test,using Staphylococcus au-reus,Pseudomonas aeruginosa,Escherichia coli,Aspergillus niger and Candida albicans as test bacteria,colonycount method suit-ability test was conducted for Ofloxacin eye drop samples,the verified method was used to determine the number of viable bacteria at each time point,calculate the bacteria number of 1 mL in the sample and the number of bacteria at each time point and convert to lg value. RESULTS:Ofloxacin eye drop sample can reach the standard of antibacterial effectiveness of theB. CONCLU-SIONS:The method can effectively determine whether the antibacterial effect of Ofloxacin eye drop fits the standard.
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Blending uniformity is essential to ensure the homogeneity of Chinese medicine formula particles within each batch. This study was based on the blending process of ebony spray dried powder and dextrin(the proportion of dextrin was 10%),in which the analysis of near infrared (NIR) diffuse reflectance spectra was collected from six different sampling points in combination with moving window F test method in order to assess the blending uniformity of the blending process.The method was validated by the changes of citric acid content determined by the HPLC. The results of moving window F test method showed that the ebony spray dried powder and dextrin was homogeneous during 200-300 r and was segregated during 300-400 r. An advantage of this method is that the threshold value is defined statistically, not empirically and thus does not suffer from threshold ambiguities in common with the moving block standard deviatiun (MBSD). And this method could be employed to monitor other blending process of Chinese medicine powders on line.
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With the enforcement of YY 0505-2012 standard,more attention has been paid to the electromagnetic compatibility test of medical electrical equipment.In all the test items involved in YY 0505-2012,the radiation emission test is the most complicated and the hardest to be passed,so it is very important to master the test method.Microwave therapy equipment is a kind of equipment using microwave radiation energy to treat diseases,and is supervised as class Ⅲ medical equipment.According to the requirements of the relevant standards,all the electromagnetic compatibility testing items of microwave equipment are listed,and the test difficulty and the test focus of the equipment are studied.In the frequency band of the radiation emission experiment,microwave treatment equipment is divided into different categories according to the purpose and environment of the application.By comparing the data of the tests,the differences of different classes of microwave treatment equipment in the radiation emission tests are summarized.
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Objective To evaluate the activity of antibiotics against pan-drug-resistant (PDR) Acinetobacter baumannii by combination antimicrobial susceptibility test in viro with epsilometric methods (Etest method) and microdilution checkerboard (CB method),and to detect a good correlation between timekill curve with the above mentioned two assays.Methods Thirty-one clinical isolates of PDR Acinetobacter baumannii were selected for mono and combination antimicrobial susceptibility test in vitro by E-test and CB method,then a comparison was conducted between the test results and the time-kill curve.Mono drugs involved tigecycline,colistin,imipenem and amikacin,and combinations involved two of drugs above,and three drugs involved imipenem/tigecycline,plus amikacin combination.Results Synergistic effect was detected in imipenem plus colistin and tigecycline plus imipenem combination.A high comparability was revealed between the E-test method with antimicrobial drugs added into the culture medium and the time-kill curves.Synergy in the combination of imipenem/tigecycline,plus amikacin was detected by the CB method and time-kill curves.Conclusion The results showed that the effect of specific combination of antibiotics against PDR Acinetobacter baumannii could be predicted by testing their synergistic effect with combination antimicrobial susceptibility test.
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@#ObjectiveTo study the method of testing abrasion resistance of axillary crutch tips. MethodsA test method based on pressure analysis in normal use of axillary crutches was suggested, which characterized: put 450 N on axis of the tip; the tip or text surface sway 60° for 500000 times in frequency of 40 /min; maximal abrasion thickness after test should be less than 3.3 mm. Experimental facilities were established to carry out fatigue test of wearability. ResultsThe test method suggested can reflect tips abrasion in real context. ConclusionThe text method can be used for tips abrasion and fatigue resistance adjustment.
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OBJECTIVE: To investigate the stability of 0.5% glutaraldehyde solution. METHODS: Classic constant temperature accelerated test method and sample observation method were applied with the content of glutaraldehyde as index. The content of glutaraldehyde was determined by titration which was determined by titration. RESULTS: The content change of 0.5% glutaraldehyde solution was in line with the first order kinetics, and the results of both methods were similar. The validity duration of 0.5% glutaraldehyde solution was 85.7 days at room temperature (25 ℃). CONCLUSION: 0.5% glutaraldehyde solution should be used up as soon as possible and the perfect time is less than 2 week.
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OBJECTIVE:To investigate the stability of Yanhouyan mixture(for pharyngolaryngitis).METHODS: The st-ability of Yanhouyan mixture was investigated by classic constant temperature accelerated test method and sample observation method taking the content of Baicalin as index which was determined by HPLC.RESULTS:The content change of Bacilin in Yanghouyan mixture was in line with the first order kinetics,and the test results for both methods were similar.Under room temperature(25 ℃),the validity duration of Yanhouyan mixture was 1.06 years.CONCLUSION:In establishing the quality standard for Yanhouyan mixture,the advisable storage life of 1 year for which should be considered.
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OBJECTIVE:To validate the test condition and test method of the microbil limit test of the Dental ulcer pellicles of Sunset Abelmoschus Flower.METHODS:The methodological validation was carried out in accordance with the standard for microbil limit test stated in the appendix of China Pharmacopoeia(2005 Edition,VolumeⅠ).RESULTS:By membrane-filter procedure,the recovery rates of different test strains in the samples were all over 70%.CONCLUSION:The membrane-filter procedure can more effectively eliminate the bacteriostatic action of Dental ulcer pellicles of Sunset Abelmoschus Flower so as to result in accurate microbil limit test results.
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OBJECTIVE: To establish a bacterial endotoxin test method for fluorescein sodium injection.METHODS: Based on the bacterial endotoxin test method stated in Chinese Pharmacopoeia 2005 edition(second part),an interference test was conduced on different batches of fluorescein sodium samples using tachypleus amebocyte lysate from different companies.RESULTS: At a concentration of no more than 0.75 mg?mL-1,fluorescein sodium showed no interfere with the bacterial endotoxin test.CONCLUSION: It is feasible for bacterial endotoxin test of fluorescein sodium injection be conducted in a limit value of 0.15 EU?mL-1.
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OBJECTIVE:To prepare gatifloxacin chitosan eye drops and to establish its quality control.METHODS:The eye drops was prepared with chitosan as the base.The content of gatifloxacin was determined by UV spectrophotometry and the stability of the preparation was detected by initial average accelerated method.RESULTS:The linear range for gati?floxacin was5.0～15.0?g/ml(r=0.9990,n=5),the average recovery rate was98.91%(RSD=1.43%).The activation energy for pyrolytic reaction of gatifloxacin chitosan eye drops was25.91kcal/mol,its shelflife at25℃and10℃were93.8days and950days,respectively.CONCLUSION:The preparation technology is feasible and the quality control method is reliable.
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In order to know the general analysis ability of nursing students,the author chose 120 nursing students in grade 2002 and grade 2003 to carry out a pathological test with two kinds of test methods,and compared and analyzed their test performances statistically.The results show that there is obvious difference between the two kinds of test methods.The author is of the opinion that the nursing students are lack of general analysis ability in pathological study and it is necessary to improve the teaching method and test method.