注射用头孢拉定无菌检查试验及方法学验证

目的:确定注射用头孢拉定无菌检查法。方法:取供试品20支,用500ml,0.9%无菌氯化钠溶液稀释,检验量为0.5g/支,采用薄膜过滤法过滤,冲洗液为0.1%蛋白胨溶液800ml,每次冲洗100ml。结果:供试品的该检验量在该检验条件下无抑菌作用或其抑菌作用可以忽略不计。结论:采用薄膜过滤法和此检查条件可进行注射用头孢拉定的无菌检查。     

利福平胶囊的微生物限度检查方法的研究

摘要：目的 建立利福平胶囊的微生物限度检查法，并对方法进行验证。方法 取供试品10g，用100mL十四烷酸异丙酯分散制成油性供试品混悬液，取50mL油性供试品混悬液(相当于利福平胶囊5g)，用pH7.0氯化钠-蛋白胨缓冲液100mL萃取，取水层作为1:20供试液，稀释至1:200供试液，需氧菌按薄膜过滤法，用44℃水浴保温的含0.1%吐温80的pH7.0氯化钠-蛋白胨缓冲液1000mL冲洗，霉菌和酵母菌按常规法计数，控制菌按薄膜过滤法，用pH7.0氯化钠-蛋白胨缓冲液500mL冲洗，可消除利福平胶囊的抑菌活性。结果 采用上述方法进行验证，5种菌的回收比值均达到0.5~2，控制菌生长良好。结论 本方法可用于利福平胶囊的微生物限度的检查。     

注射用头孢曲松钠无菌检查方法研究

目的 完善注射用头孢曲松钠无菌检查方法标准.方法 根据《中国药典》2010年版无菌检查法验证实验的要求,采用薄膜过滤法.将10支供试品,每瓶加8ml的0.9％无菌氯化钠溶液溶解,将其转移至约400 ml的0.9％无菌氯化钠溶液中混匀作为供试品液,供试品按薄膜过滤法,用3只滤筒过滤,400 ml/筒的0.1％蛋白胨水溶液冲洗,每筒加青霉素酶1 ml.阳性对照菌为大肠埃希菌.结果 供试品、空白对照(主要为冲洗液或者青霉素酶)均无菌生长,供试品阳性菌与阳性对照菌比较均生长良好.结论 该方法简单、可行,可作为注射用头孢曲松钠常规无菌检查方法.     

甲氧苄啶注射液无菌检查方法学研究

目的建立甲氧苄啶注射液无菌检查方法。方法按《中国药典》2005年版无菌检查法验证实验的有关要求,取供试品10支.膜-1（批出厂检验量）按薄膜过滤法过滤,再用0.1%无菌蛋白胨水溶液分次冲洗,每膜不少于400mL,阳性对照菌为大肠埃希菌。结果经方法验证,供试品阴性组、阴性对照组均无菌生长,供试品7种阳性菌试验组各滤器中试验菌与阳性菌对照组比较均生长良好,说明供试品的检验量在该检验条件下已消除其抑菌作用或其抑菌作用可以忽略不计。结论本法简便、科学可靠,可作为甲氧苄啶注射液的常规无菌检查方法。     

复方紫草油的无菌检查法

目的:建立复方紫草油的无菌检查法。方法:采用先3 000r.min-1离心20min,弃去上清液后的底部液体加等量无菌聚山梨酯-80,再转移至0.1%的聚山梨酯-80-氯化钠-蛋白胨缓冲液中,然后再采用薄膜过滤法,用0.1%聚山梨酯-80-氯化钠-蛋白胨缓冲液冲洗滤膜。结果:供试品经处理后能通过滤膜,供试品阳性对照管24h内实验菌生长良好。结论:该法能消除复方紫草油的抑菌作用,使无菌检查结果准确可靠。     

冲洗量对含激素类乳膏在微生物限度检查中的影响

《中华人民共和国药典》2005年版二部对含激素类乳膏的微生物限度检查采用薄膜过滤法。即取供试品5g加无菌十四烷酸异丙酯配制成1：10的供试品溶液,过无菌滤膜（ 孔径为0．45μm,直径约为50mm）,再用浓度为0．1％、pH为7．0的无菌氯化钠一蛋白胨缓冲液冲洗过滤。并规定每片滤膜的总过滤量不宜过大,以避免滤膜上的微生物受损伤。本研究对浓度为0．1％、pH为7．0的无菌氯化钠一蛋白胨缓冲液冲洗量进行考察,以便对含激素类乳膏的微生物限度检查得出更准确的判断结果。     

氯霉素水杨酸酊微生物限度检查法的建立

目的:确认所采用的方法是否适用于氯霉素水杨酸酊细菌、霉菌及酵母菌以及控制菌的检查。方法:分别取混合后供试品原液1 m l经薄膜过滤法处理,用pH 7.0无菌氯化钠-蛋白胨缓冲液200 m l分2次冲洗后,取滤膜依法进行细菌、霉菌及酵母菌计数及控制菌检查。结果:基本上可以去除药物成分对微生物限度检查的干扰。对选定方法进行方法学验证,结果符合检查要求。结论:薄膜过滤法用于氯霉素水杨酸酊的微生物限度检查,方法可行、简便。     

复方利多卡因注射液无菌检查方法验证

［摘要］目的对复方利多卡因注射液的无菌检查方法进行验证。方法使用薄膜过滤法进行无菌检查,用pH值7.0无菌氯化钠 蛋白胨缓冲液冲洗,每筒冲洗300 mL。结果6种阳性代表菌均能够正常生长。结论复方利多卡因注射液可采用薄膜过滤法,以金黄色葡萄球菌为阳性对照菌检测。     

注射用头孢匹胺钠的无菌检查方法学研究

目的建立注射用头孢匹胺钠的无菌检测方法。方法用不同量的冲洗液冲洗滤膜的薄膜过滤法。结果采用1 200 ml冲洗液并加入青霉素酶时,阳性对照菌48 h内生长良好,阴性对照及样品无菌生长,试验组有菌生长。结论对注射用头孢匹胺钠可采用薄膜过滤法加青霉素酶进行无菌检查,用pH7.0无菌氯化钠-蛋白胨缓冲液冲洗。冲洗量为1 200 ml(每筒400 ml),每次100 ml。     

注射用单磷酸阿糖腺苷无菌检查方法适用性研究

目的 建立注射用单磷酸阿糖腺苷无菌检查方法标准.方法 按照2015年版《中国药典》规定,采用薄膜过滤法,对14家企业生产的注射用单磷酸阿糖腺苷进行无菌方法适用性研究.结果 确定了规格为0.1g注射用单磷酸阿糖腺苷的无菌检查方法.14家企业(共111批次)无菌检验方法均为:取样品60支,采用薄膜过滤法,用pH 7.0氯化钠-蛋白胨缓冲液冲洗,每次100 mL,共冲洗2次.结论 通过对14家企业生产的注射用单磷酸阿糖腺苷的方法验证资料进行整理、归纳、分析、试验,最终确定严谨统一的无菌检查方法.     

Efficacy of gut lavage,hemodialysis, and hemoperfusion in the therapy of paraquat or diquat intoxication

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.

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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.

     

Aquatic Insects and Trace Metals: Bioavailability,Bioaccumulation, and Toxicity

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.     

In vitro studies on sterically stabilized liposomes (SL) as enzyme carriers in organophosphorus (OP) antagonism

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.     

Alzheimer’s disease – current trends in basic and clinical research. Highlights from the 16th ECNP

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.     

Steroidal sapogenin contents in some domestic plants

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.