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1.
目的:通过考察含糖平衡盐、替硝唑葡萄糖和氧氟沙星葡萄糖注射液对鲎试剂的干扰作用,探讨以细菌内毒素检查法中的凝胶法取代热原检查法检查含糖平衡盐等3种自制注射液细菌内毒素限值的可行性.方法:采用动态浊度法,用EDS-99细菌内毒素测定仪对含糖平衡盐、替硝唑葡萄糖和氧氟沙星葡萄糖注射液进行干扰试验并用凝胶法进行验证.结果:用两个厂家生产的鲎试剂以动态浊度法检测3个不同批号的含糖平衡盐和替硝唑葡萄糖注射液,样品不经稀释,其细菌内毒素回收率均在50%~200%范围内,标准曲线的相关系数绝对值大于0.980,表明含糖平衡盐、替硝唑葡萄糖注射液对鲎试剂反应无干扰作用,3批样品同时用凝胶法检查,其结果均为阴性;氧氟沙星葡萄糖注射液对鲎试剂有干扰,稀释4倍可消除干扰.结论:含糖平衡盐、替硝唑葡萄糖注射液对鲎试剂反应无干扰作用,凝胶法可作为生产含糖平衡盐和替硝唑葡萄糖注射液时日常检查其细菌内毒素限值的方法;氧氟沙星葡萄糖注射液稀释4倍后可用凝胶法检查.  相似文献   

2.
李树馀  梁进 《中国药师》2014,(6):1052-1054
目的:应用微量动态显色法试剂对5%葡萄糖注射液、0.9%氯化钠注射液、替硝唑氯化钠注射液等进行内毒素定量检测,并与凝胶法结果比较.方法:使用微量动态显色法试剂对5%葡萄糖注射液、0.9%氯化钠注射液、替硝唑氯化钠注射液进行干扰初筛试验及干扰试验.使用凝胶法试剂对5%葡萄糖注射液、0.9%氯化钠注射液、替硝唑氯化钠注射液进行细菌内毒素日常检查.结果:使用微量动态显色法试剂对5%葡萄糖注射液、0..9%氯化钠注射液、替硝唑氯化钠注射液在8倍稀释浓度下进行内毒素检测,回收率均在50%~200%之间,检测结果与凝胶法结果一致.结论:微量动态显色法可以应用于大输液及某些药品细菌内毒素检测,尤其是过程监控.  相似文献   

3.
张晔 《中国药业》2006,15(14):24-24
目的建立替硝唑注射液的细菌内毒素检查方法。方法采用不同批号、不同厂家的鲎试剂,按照标准操作规程,对3批替硝唑注射液按有效浓度范围稀释后,进行干扰试验考察。结果替硝唑注射液浓度为3.2mg/mL时对鲎试剂无抑制作用,其细菌内毒素限值为0.625EU/mL。结论可用细菌内毒素检查法(凝胶法)代替家兔热原检查法控制替硝唑注射液的热原。  相似文献   

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目的建立用凝胶法快速检查克林霉素磷酸酯葡萄糖注射液中细菌内毒素的方法,以替代兔法热原检查。方法用不同厂家的鲎试剂对3批不同批号的克林霉素磷酸酯葡萄糖注射液分别进行干扰试验,考察克林霉素磷酸酯葡萄糖注射液中的内毒素。结果克林霉素磷酸酯葡萄糖注射液稀释4倍时可消除对试验的干扰,且不同批号产品的细菌内毒素检查结果均符合规定。结论对克林霉素磷酸酯葡萄糖注射液的热原检查,可以用细菌内毒素检查法替代家兔法。  相似文献   

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目的 想建立替硝唑注射液的细菌内毒素检查法最佳方法,研究以细菌内毒素检查法代替家兔法对替硝唑注射液进行热原检查的可行性.方法 本实验根据鲎试剂在不产生干扰条件下能对样品进行细菌内毒素检查的原理,按照〈中国药典〉2005年版附录XIE细菌内毒素检查法要求进行实验,采用凝胶法鲎试验法,用两个厂家生产的鲎试剂,对连续生产的3批替硝唑注射液按有效浓度范围稀释后,进行干扰实验观察,然后进行细菌内毒素检查,所得结果与家兔法检查热原的结果进行对比.结果 使用灵敏度为0.25 EU/ml的鲎试剂,替硝唑注射液的2倍稀释液对两个厂家的鲎试剂均不产生干扰,3批替硝唑注射液的细菌内毒素检查结果与家兔法所得结果一致.结论 细菌内毒素检查法代替家兔法对替硝唑注射液进行热原检查是可行的.  相似文献   

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鲎试剂能与细菌内毒素发生非常灵敏的特异性反应 ,凡影响凝胶形成的因素 ,对实验结果都会产生影响。我们参照《中国药典》 1 995年版“细菌内毒素检测方法”中干扰试验的基本原理及细菌内毒素检测方法 ,对 0 4 %替硝唑葡萄糖注射液的细菌内毒素检测方法进行了研究 ,现将方法及结果报告如下。1 实验材料 鲎试剂 批号 :980 91 4每支 0 1ml、指示灵敏度 0 5EU/ml (厦门鲎试剂厂 )。细菌内毒素工作标准品 批号 :980 51 0每支 1 0EU (厦门鲎试剂厂 )。鲎试剂溶解液 批号 :970 4 2 5每支 2ml (厦门鲎试剂厂 )。替硝唑葡萄糖注射…  相似文献   

7.
目的:建立盐酸氨溴索葡萄糖注射液的细菌内毒素检查方法.方法:用两个生产厂家的鲎试剂对盐酸氨溴索葡萄糖注射液进行干扰试验研究.结果:盐酸氨溴索葡萄糖注射液对细菌内毒素检查无干扰.结论:可以用细菌内毒素检查法(凝胶法)代替家兔热原检查法控制盐酸氨溴索葡萄糖注射液的热原.  相似文献   

8.
替硝唑葡萄糖注射液的细菌内毒素检查   总被引:1,自引:1,他引:0  
本试验来用鲎试剂检测替硝唑葡萄糖注射液的细菌内毒素,经干扰实验表明.样品1:3倍稀释液,灵敏度为0.5Eu/ml的鲎试剂,可用于替硝唑葡萄糖注射液的细菌内毒素检查.  相似文献   

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目的:建立复方乳酸钠葡萄糖注射液的细菌内毒素检查方法.方法:用两个生产厂的鲎试剂对复方乳酸钠葡萄糖注射液进行干扰试验研究.结果:复方乳酸钠葡萄糖注射液对细菌内毒素检查有干扰作用,但通过稀释可消除其干扰.结论:可以用细菌内毒素检查法(凝胶法)代替家兔热原检查法控制其热原.  相似文献   

10.
动态比浊法测定替硝唑葡萄糖注射液中细菌内毒素含量   总被引:1,自引:0,他引:1  
邓颖  李军 《中国药师》2002,5(4):214-215
目的:建立替硝唑葡萄糖注射液中细菌内毒素含量测定方法。方法:将4批不同厂家生产的替硝唑葡萄糖注射液稀释到0.5mg·ml~(-1),采用动态比浊法,通过干扰实验和验证实验,测定替硝唑葡萄糖注射液中细菌内毒素含量。结果:细菌内毒素含量测定的回收率分别为102.6%,101.7%,98.7%和97.6%;细菌内毒素含量测定结果与热原检查结果一致。结论:替硝唑葡萄糖注射液稀释到0.5mg·ml~(1)即可消除其对鲎试剂的干扰,可用于常规检验。  相似文献   

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Clinical and in vitro investigations were carried out to test the efficacy of gut lavage, hemodialysis, and hemoperfusion in the treatment of poisoning with paraquat or diquat. In a patient suffering from diquat intoxication 130 times more diquat was removed by gut lavage 30 h after ingestion than was removed by complete aspiration of the gastric contents.Determination of in vitro clearances for paraquat and diquat by hemodialysis showed that, at serum concentrations of 1–2 ppm, such as are frequently encountered in poisoning in man, toxicologically relevant quantities of herbicide cannot be removed from the body. At a concentration of 20 ppm, on the other hand, hemodialysis proved to be effective, the clearance being 70 ml/min at a blood flow rate of 100 ml/min. The efficacy of hemoperfusion with coated activated charcoal was on the whole better. Especially at concentrations around 1–2 ppm, the clearance values for hemoperfusion were some 5–7 times higher than those for hemodialysis.In a patient suffering from paraquat poisoning, both hemodialysis as well as hemoperfusion were carried out. The in vitro results could be confirmed: At serum concentrations of paraquat less than 1 ppm no clearance could be obtained by hemodialysis while by hemoperfusion with activated charcoal quite high clearance values were measured and the serum level dropped down to zero.
Zusammenfassung Klinische Untersuchungen und Laboratoriumsversuche wurden durchgeführt, um die Wirksamkeit von Darmspülung, Hämodialyse und Hämoperfusion bei Paraquat- und Deiquat-Vergiftungen zu prüfen.Bei einem Patienten wurde 30 Std nach Deiquat-Aufnahme durch Darmspülung 130mal mehr Deiquat entfernt als durch vollständige Aspiration des Mageninhaltes. In vitro-Versuche ergaben, daß bei Blutserumkonzentrationen von 1–2 ppm, die bei Vergiftungen oft gemessen werden, durch Hämodialyse keine toxikologisch relevanten Paraquat- oder Deiquat-Mengen entfernt werden können. Dagegen erwies sich die Hämodialyse bei 20 ppm und einer Blutumlaufgeschwindigkeit von 100 ml/min mit einer Clearance von 70 ml/min als wirksam. Die Hämoperfusion mit beschicheter Aktivkohle war in diesen Versuchen aber eindeutig überlegen, denn insbesondere bei Konzentrationen um 1–2 ppm waren die Clearance-Werte 5–7mal höher als bei der Hämodialyse.Die in vitro-Ergebnisse wurden bei einem Patienten mit einer Paraquat-Vergiftung bestätigt: Bei Konzentrationen unter 1 ppm war die Hämodialyse wirkungslos, während durch Hämoperfusion relativ hohe Clearance-Werte erreicht wurden, so daß der Serumspiegel rasch unter die Nachweisgrenze abfiel.
  相似文献   

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This study describes a new approach for organophosphorous (OP) antidotal treatment by encapsulating an OP hydrolyzing enzyme, OPA anhydrolase (OPAA), within sterically stabilized liposomes. The recombinant OPAA enzyme was derived from Alteromonas strain JD6. It has broad substrate specificity to a wide range of OP compounds: DFP and the nerve agents, soman and sarin. Liposomes encapsulating OPAA (SL)* were made by mechanical dispersion method. Hydrolysis of DFP by (SL)* was measured by following an increase of fluoride ion concentration using a fluoride ion selective electrode. OPAA entrapped in the carrier liposomes rapidly hydrolyze DFP, with the rate of DFP hydrolysis directly proportional to the amount of (SL)* added to the solution. Liposomal carriers containing no enzyme did not hydrolyze DFP. The reaction was linear and the rate of hydrolysis was first order in the substrate. This enzyme carrier system serves as a biodegradable protective environment for the recombinant OP-metabolizing enzyme, OPAA, resulting in prolongation of enzymatic concentration in the body. These studies suggest that the protection of OP intoxication can be strikingly enhanced by adding OPAA encapsulated within (SL)* to pralidoxime and atropine.  相似文献   

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Abstract

The uptake of metals from food and water sources by insects is thought to be additive. For a given metal, the proportions taken up from water and food will depend both on the bioavailable concentration of the metal associated with each source and the mechanism and rate by which the metal enters the insect. Attempts to correlate insect trace metal concentrations with the trophic level of insects should be made with a knowledge of the feeding relationships of the individual taxa concerned. Pathways for the uptake of essential metals, such as copper and zinc, exist at the cellular level, and other nonessential metals, such as cadmium, also appear to enter via these routes. Within cells, trace metals can be bound to proteins or stored in granules. The internal distribution of metals among body tissues is very heterogeneous, and distribution patterns tend to be both metal and taxon specific. Trace metals associated with insects can be both bound on the surface of their chitinous exoskeleton and incorporated into body tissues. The quantities of trace meals accumulated by an individual reflect the net balance between the rate of metal influx from both dissolved and particulate sources and the rate of metal efflux from the organism. The toxicity of metals has been demonstrated at all levels of biological organization: cell, tissue, individual, population, and community. Much of the literature pertaining to the toxic effects of metals on aquatic insects is based on laboratory observations and, as such, it is difficult to extrapolate the data to insects in nature. The few experimental studies in nature suggest that trace metal contaminants can affect both the distribution and the abundance of aquatic insects. Insects have a largely unexploited potential as biomonitors of metal contamination in nature. A better understanding of the physico-chemical and biological mechanisms mediating trace metal bioavailability and exchange will facilitate the development of general predictive models relating trace metal concentrations in insects to those in their environment. Such models will facilitate the use of insects as contaminant biomonitors.  相似文献   

17.
Advances in the molecular biological knowledge of neuronal nicotinic acetylcholine receptors (nAChRs) have led to a growing interest by the pharmaceutical industry in the development of novel compounds that selectively modulate nAChR function. The ability of (-)-nicotine, an activator of nAChRs, to enhance attentional aspects of cognition in animals and humans, to exert neuroprotective and anxiolytic-like effects, and presumably to mediate the negative correlation between smoking and Alzheimer's (and Parkinson's) Disease, has focused interest on the potential therapeutic utility of modulators of nAChR function for treatment of some of the deficits associated with these progressive, neurodegenerative conditions. Numerous compounds are known which activate nAChRs and which might serve as lead compounds toward the development of such agents. The pharmacologic diversity of neuronal nAChR subtypes suggests the possibility of developing selective compounds which would have more favourable side-effect profiles than existing agents. This broader class of agents, collectively called cholinergic channel modulators (ChCMs), is anticipated to encompass compounds which would have more favourable side-effect profiles than existing agents, which generally exhibit low selectivity. This selectivity may be achieved by preferentially activating some subtypes of nAChRs (i.e., Cholinergic Channel Activators, ChCAs) or inhibiting the function of other subtypes (Cholinergic Channel Inhibitors, ChCIs). An overview of the biology of nAChRs and the rationale for the use of ChCMs for the treatment of dementia related to neurodegenerative diseases are presented, followed by a discussion of lead compounds and compounds under consideration for clinical evaluation.  相似文献   

18.
In order to find out the values of the steroid resources for the future use. the compositions and contents of steroidal sapogenins from 13 domestic plants have been investigated. As a result,Dioscorea nipponica, D. quinqueloba andSmilax china were found to have large amount of diosgenin. And pennogenin inTrillium kamtschaticum andParis verticillata, yuccagenin inAllium fistulosum, hecogenin inAgave americana and neochlorogenin inSolanum nigum were appeared to be major steroidal sapogenins.  相似文献   

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