葛根素注射液细菌内毒素检查方法的研究

目的:考察葛根素注射液细菌内毒素检查方法的可行性.方法:依据<中国药品检验标准操作规程>2000年版细菌内毒素检查法,确定葛根素注射液的有效稀释浓度和细菌内毒素限值.结果:葛根素注射液在最大有效稀释浓度下对鲎试剂无干扰作用,其内毒素限值符合规定.结论:可用细菌内毒素检查法取代<中国药典>2000年版(二部)规定的热原检查法.     

参麦注射液细菌内毒素检查方法的探讨

目的：考察参麦注射液细菌内毒素检查方法的可行性,加强对参麦注射液的质量监控。方法：采用细菌内毒素检查法,考察参麦注射液对鲎试剂的干扰试验,并检测供试品细菌内毒素的限度。结果：对样品进行1∶4稀释,用0.125 EU/mL鲎试剂无干扰,与家兔热源检查法结果一致。结论：与家兔法检查本品热原相比,细菌内毒素法可行性高,此方法避免了家兔热源检查法操作的复杂性,且灵敏度高、方便快捷。     

氨酚比林注射液细菌内毒素检查法的建立

目的：建立氨酚比林注射液细菌内毒素检查法。方法按中国药典2005年版二部附录收载的细菌内毒素检测方法及指导原则进行实验。结果将氨酚比林注射液稀释30倍可消除干扰因素。结论可以用细菌内毒素检查法来控制氨酚比林注射液的质量。     

盐酸赖氨酸葡萄糖注射液细菌内毒素检查法的研究

目的:建立盐酸赖氨酸葡萄糖注射液的细菌内毒素检查法.方法:将盐酸赖氨酸葡萄糖注射液经10倍稀释,用标示灵敏度为0.25Eu·ml-1 的鲎试剂检测其细菌内毒素.结果:盐酸赖氨酸葡萄糖注射液稀释10倍对鲎试剂无干扰作用.结论:可以用细菌内毒素检查法对盐酸赖氨酸葡萄糖注射液进行热原检查.     

血必净注射液细菌内毒素检查法的研究

目的:建立血必净注射液的细菌内毒素检查法.方法:将血必净注射液经12倍稀释,用标示灵敏度为0.25EU·ml-1的鲎试剂检测其细菌内毒素.结果:血必净注射液稀释12倍对鲎试剂无干扰作用.结论:可以用细菌内毒素检查法对血必净注射液进行热原检查.     

鲎试剂用于20%甘露醇注射液细菌内毒素检测

目的:研究甘露醇注射液细菌内毒素的检查方法。方法:按照《中国药典》2000年版(二部)附录方法和指导原则。结果:甘露醇注射液在最大有效稀释浓度下对鲎试剂反应无干扰作用。结论:可用细菌内毒素检查法取代热原检查法。     

转化糖注射液的细菌内毒素检查法探讨

目的探讨转化糖注射液的细菌内毒素检查法的可行性。方法按《中国药典》细菌内毒素检查法及应用指导原则进行实验。结果转化糖注射液原液对0．25EU．ml^-1鲎试剂的凝聚有一定的抑制作用，而1：2稀释液则无干忧作用。结论采用0.25EU．ml^-1或灵敏度更高的鲎试剂对转化糖注射液的细菌内毒素检查是可行的。     

香丹注射液细菌内毒素检查方法的建立及应用

目的为探讨香丹注射液的临床用药安全,我们试图用细菌内毒素检查法(LT)保证香丹注射液的质量. 方法采用细菌内毒素工作标准品与鲎试剂产生凝集反应的机理,判断香丹注射液中细菌内毒素的限量. 结果鲎试剂浓度在0.25EU·ml-1时,香丹注射液经40倍稀释对细菌内毒素测定无干扰. 结论此方法用于香丹注射液细菌内毒素的检查,具有灵敏度高、准确、经济、快捷等优点,对控制香丹注射液的质量、保证临床用药安全有实际意义.     

尼可刹米注射液细菌内毒素检查法的研究

目的研究尼可刹米注射液的细菌内毒素检查方法.方法用鲎试剂与细菌内毒素产生凝集反应的机理,来判断供试品中细菌内毒素的限量是否符合规定.结果按中国药典2005年版细菌内毒素检查法附录Ⅺ E检查,每1mg含细菌内毒素的量应小于0.08EU.结论本方法快速、简易、经济且灵敏性高,可用于尼可刹米注射液的细菌内毒素检查.     

盐酸左氧氟沙星注射液细菌内毒素检测方法的研究

目的：探讨用凝胶法检查盐酸左氧氟沙星注射液中的细菌内毒素。方法参照2010版《中国药典》细菌内毒素检查法,用不同厂家的鲎试剂对不同批号的注射用盐酸左氧氟沙星注射液分别进行干扰实验,探讨考察注射用盐酸左氧氟沙星注射液的细菌内毒素检查方法。结果注射用盐酸左氧氟沙星注射液以消除对鲎试剂的干扰,用灵敏度0．25EU/ML的鲎试剂检测内毒素是有效的,与家兔法检测结果应一致。结论初步认为注射用盐酸左氧氟沙星注射液可以用细菌内毒素法取代家兔法的热原检验     

注射用丝裂霉素细菌内毒素检查法的建立

目的：考察注射用丝裂霉素的细菌内毒素检查法的可行性并进行检查。方法：采用《中国药典》2000年版细菌内毒素检查法和细菌内毒素检查法应用指导原则要求进行试验。结果：注射用丝裂霉素可用灵敏度0．25EU／ml的鲎试剂作细菌内毒素检查。结论：细菌内毒素检查法可用于注射用丝裂霉素热原检查。     

乙型脑炎减毒活疫苗细菌内毒素凝胶法的检测

目的建立乙型脑炎减毒活疫苗细菌内毒素检测方法和质量标准,检测样品中的内毒素含量。方法中国药典2010年版三部细菌内毒素检测法(凝胶限度试验、凝胶半定量试验)。结果选用λ为0.5 EU/ml的鲎试剂,采用凝胶限度法对乙型脑炎减毒活疫苗进行细菌内毒素检查,样品经稀释至80倍或以上稀释度后对内毒素检查均无干扰,确定该疫苗的内毒素限度值为40 EU/ml[即20 EU/剂(0.5 ml)]。凝胶限度试验结果显示,疫苗每1 ml中含内毒素的量均小于40EU,即每1次人用剂量(0.5 ml)中含内毒素的量均小于20 EU。凝胶半定量测定结果显示,1人份规格疫苗中含内毒素的量为2.50～10.00 EU/ml(平均5.36 EU/ml);5人份规格疫苗中含内毒素的量为1.50～6.00 EU/ml(平均3.02 EU/ml)。结论凝胶法两种试验均可用于乙型脑炎减毒活疫苗细菌内毒素检测,与凝胶半定量试验相比,凝胶限度试验更为简便、且易于操作;采用凝胶限度法本研究建立了乙型脑炎减毒活疫苗细菌内毒素检测方法和质量标准;凝胶半定量法测定结果用准确数据显示该疫苗的内毒素含量均在人体安全限度以内。     

Exposure–response relationship between endotoxin exposure and lung function impairment in cotton textile workers

OBJECTIVES: Preventive workplace regulations are so far not based on an ubiquitously accepted threshold for airborne endotoxin in the bioaerosol. METHODS: In a cross-sectional study, 150 employees of a cotton spinning mill underwent lung function testing. Furthermore, in a random subset of 75 textile workers cross-shift lung function test and methacholine challenges were performed. Airborne current endotoxin exposure was classified as "low", "medium", and "high" (100-450 Endotoxin Units (EU)/m(3), respectively) based on endotoxin activity. RESULTS: The exposure-response relationship between current endotoxin exposure and prevalence of an obstructive ventilation pattern was significant (test for linear trend: P = 0.019); the adjusted odds ratio for high endotoxin exposure was 11.22 (95% confidence interval 1.03-121.17). Within individuals, FEV(1)/FVC% was significantly reduced after the shift (paired t test: P = 0.009) but not related to current endotoxin exposure. Twelve workers showed bronchial hyperresponsiveness (8.1% before and 12.2% after the work shift; Fisher's exact test: P = 0.021). CONCLUSION: The study among German cotton textile workers suggests an exposure-dependent effect of current endotoxin exposure on lung function impairment with significant effects above 450 EU/m(3).     

浸提温度对细菌内毒素影响的初步研究

目的:为热原实验和细菌内毒素实验确定合适的浸提温度。方法:采用《中国药典》2010年版(二部)附录检测细菌内毒素的动态浊度法,在不同浸提温度下测定细菌内毒素溶液中细菌内毒素的含量。结果:溶液中的细菌内毒素含量在121°C1h和80°C 1h的浸提条件下会大大减少,在37°C 1h的浸提条件下不会发生明显改变。结论:热原实验和细菌内毒素实验最适合的浸提温度是37°C。     

Endotoxin liberation by strains of N. meningitidis isolated from patients and healthy carriers

The main objective of this study was to assess whether the capacity of Neisseria meningitidis to release endotoxin depends upon the type of strain or upon bacterial mass. Endotoxin release was studied in 32 strains isolated from patients with meningococcal infections and in 49 from asymptomatic carriers, using a quantitative test (limulus test with a chromogenic substrate). The results show that the strains from patients release significantly higher amounts of endotoxin than strains from carriers regardless of serogroup and isolation site. No correlation was found between stage of bacterial growth and the amount of endotoxin liberated. These findings suggest that endotoxin liberation is a characteristic of certain strains of N. meningitidis and is not determined simply by bacterial mass.     

蓝域染色剂的细菌内毒素检测

目的:考察蓝域染色剂的细菌内毒素检查方法的可行性.方法:依据<中华人民共和国药典>2005年版附录XIE细菌内毒素检查法,确定蓝域染色剂的有效稀释浓度和细菌内毒素限值.结果:蓝域染色剂在稀释16倍后对细菌内毒素实验无干扰作用,其细菌内毒素限值符合规定.结论:该产品可以采用细菌内毒素检查法.     

钛镍记忆合金组织吻合器细菌内毒素检测方法的研究

目的：对钛镍记忆合金组织吻合器进行细菌内毒素检查,建立其细菌内毒素检查方法。方法：根据《中国药典》2005版二部附录收载的细菌内毒素检查方法,使用鲎试剂对钛镍记忆合金组织吻合器进行干扰试验。结果：钛镍记忆合金组织吻合器可用标示灵敏度为0.25EU/mL的鲎试剂进行细菌内毒素检查。结论：该方法准确、可靠,具有良好的重复性和灵敏度,可用于钛镍记忆合金组织吻合器细菌内毒素的测定。     

Side-by-side comparison of three sampling methods for aerosolized endotoxin in a wastewater treatment facility

Research studies have established the occurrence of adverse health effects in individuals exposed to organic dusts and water aerosols laden with endotoxin. To determine what exposure levels cause these health effects, it is necessary to quantify airborne endotoxin. Several scientific studies have demonstrated that the quantification of detectable endotoxin is affected by differences in sampling media, analytical method, and aerosol composition. The study reported here performed side-by-side endotoxin sampling using a liquid impinger, a glass fiber filter, and a polycarbonate filter in a wastewater treatment plant. Results show levels of detected endotoxin appear to be highest with the impinger. Coefficients of variation calculated for each sampling method show the glass fiber filter having the least variability when sampling was conducted at the highest endotoxin levels. Lastly, a Spearman rank order correlation test identified an apparent correlation between endotoxin levels obtained with the impinger and the glass fiber filter.