清开灵注射液细菌内毒素检查研究

目的：建立清开灵注射液细菌内毒素检查法。方法：采用《中国药典》2005年版附录细菌内毒素检查法。结果：清开灵注射液经30倍稀释后，用灵敏度为0．25EU／mL的鲎试剂检查细菌内毒素无干扰因素的影响。结论：清开灵注射液可应用鲎试剂进行细菌内毒素检查。     

氟康唑氯化钠注射液中细菌内毒素的检测

目的:探讨凝胶法进行氟康唑氯化钠注射液中细菌内毒素检测的方法。方法:用不同厂家的鲎试剂对不同批号的氟康唑氯化钠注射液分别进行干扰实验,考察确立氟康唑氯化钠注射液中细菌内毒素检测法。结果:氟康唑氯化钠注射液样品浓度在1.0g.L-1以下时可消除干扰,结果准确可靠。结论:氟康唑氯化钠注射液可用内毒素检查取代热原检查法。     

注射用阿奇霉素的细菌内毒素检查法

目的建立注射用阿奇霉素细菌内毒素检查方法。方法按2005年版《中国药典（二部）》中细菌内毒素检查法要求进行试验。结果注射用阿奇霉素（2．0mg／mL）稀释2．8倍时不干扰鲎试剂与细菌内毒素的凝胶反应。结论细菌内毒素检查法适用于检测注射用阿奇霉素中的内毒素。     

Anti-inflammatory effects of dimemorfan on inflammatory cells and LPS-induced endotoxin shock in mice

BACKGROUND AND PURPOSE: Dimemorfan (a sigma1 receptor agonist) showed neuroprotective properties in animal models of inflammation-mediated neurodegenerative conditions, but its effects on inflammatory cells and systemic inflammation remain unclear. EXPERIMENTAL APPROACH: The effects of dimemorfan on phorbol-12-myristate-13-acetate (PMA)- and N-formyl-methionyl-leucyl-phenylalanine (fMLP)- induced neutrophils and lipopolysaccharide (LPS)-activated microglial cells, as well as LPS-induced endotoxin shock in mice were elucidated. KEY RESULTS :Dimemorfan decreased PMA- and fMLP-induced production of reactive oxygen species (ROS) and CD11b expression in neutrophils, through mechanisms independent of sigma1 receptors, possibly by blocking ROS production and G-protein-mediated intracellular calcium increase. Dimemorfan also inhibited LPS-induced ROS and nitric oxide (NO) production, as well as that of monocyte chemoattractant protein-1 and tumour necrosis factor-alpha (TNF-alpha), by inhibition of NADPH oxidase (NOX) activity and suppression of iNOS up-regulation through interfering with nuclear factor kappa-B (NF-kappaB) signalling in microglial cells. Treatment in vivo with dimemorfan (1 and 5 mg kg(-1), i.p., at three successive times after LPS) decreased plasma TNF-alpha, and neutrophil infiltration and oxidative stress in the lung and liver. CONCLUSIONS AND IMPLICATIONS: Our results suggest that dimemorfan acts via sigma1 receptor-independent mechanisms to modulate intracellular calcium increase, NOX activity, and NF-kappaB signalling, resulting in inhibition of iNOS expression and NO production, and production of pro-inflammatory cytokines. These effects may contribute its anti-inflammatory action and protective effects against endotoxin shock in mice.     

复方甘草甜素氯化钠注射液的细菌内毒素检查

目的探讨复方甘草甜素氯化钠注射液中细菌内毒素的检查方法。方法选择一定灵敏度的鲎试剂考察复方甘草甜素氯化钠注射液对细菌内毒素检查的干扰作用。结果复方甘草甜素氯化钠注射液对细菌内毒素反应有干扰,将其稀释成1∶8的浓度可消除其干扰作用。结论在1∶8的稀释度下,可用灵敏度为0.25EU.mL-1的鲎试剂进行细菌内毒素检查,从而控制细菌内毒素的限量。     

顺铂原料药细菌内毒素检查方法的研究

建立顺铂原料药的细菌内毒素的检查方法.方法参照《中国药典》2005年版二部附录进行.本方法选用灵敏度为0.25EU·mL-1的鲎试剂,供试品浓度在0.25 mg·mL-1 ～1.0 mg·mL-1之间,通过鲎试剂灵敏度复核、预试验、干扰试验和供试品的细菌内毒素检查,结果证明此方法检查顺铂原料药的细菌内毒素可行.     

动态浊度法测定注射用还原型谷胱甘肽的细菌内毒素含量

目的应用动态浊度法定量测定注射用还原型谷胱甘肽中细菌内毒素的含量。方法通过干扰试验确定样品检测浓度，建立标准曲线并对样品进行细菌内毒素的定量检测。结果注射用还原型谷胱甘肽稀释至质量浓度为1mg／mL时，对鲎试剂检查无干扰作用，细菌内毒素的回收率均在50％～200％范围内。结论用动态浊度法测定注射用还原型谷胱甘肽中的细菌内毒素含量，方法可行。     

特异性鲎试剂检测人参多糖注射液中的细菌内毒素

 目的：建立快速的人参多糖注射液细菌内毒素检查法。方法：用特异性鲎试剂对不同批号的人参多糖注射液分别进行干扰试验,考察确立人参多糖注射液内毒素检查法。结果：将人参多糖注射液稀释25倍利用特异性鲎试剂检测可消除干扰作用,结果准确可靠。结论：选用特异性鲎试剂,细菌内毒素检查法代替人参多糖注射液热原检查是可行的。     

特异性鲎试剂检测人参多糖注射液中的细菌内毒素

目的：建立快速的人参多糖注射液细菌内毒素检查法，方法：用特异性鲎试剂对不同批号的人参多糖注射液分别进行干扰试验，考察确立人参多糖注射液内毒素检查法。结果：将人参多糖注射液稀释25倍利用特异性鲎试剂检测可消除干扰作用，结果准确可靠，结论；选用特异性鲎试剂，细菌内毒素检查法代替人参多糖注射热原检查是可行的。     

凝胶法鲎试验检测金纳多注射液中的细菌内毒素

目的　应用凝胶法鲎试验检测金纳多注射液中的细菌内毒素含量。方法　经干扰试验验证样品在若干稀释倍数下 ,对鲎试验无干扰作用。结果　将样品进行 1 6稀释可以有效地消除其对鲎试验的干扰。结论　凝胶法鲎试验可以检测金纳多注射液中的细菌内毒素含量