附终端滤器的输液器截留输液微粒效果的实验观察

模拟病房输液环境，检查附终端滤器的一次性输液器的截留效果；结果表明优质的附终端滤器的输液器可有效阻止输液中10～25μm微粒进入机体。     

一次性液器终端滤器对输液中微粒影响的考察

目的:考察一次性输液器终端滤器对输液中不溶性微粒的影响.方法:使用不溶性微粒分析仪针对不同厂家各种输液器以有终端滤器和无终端滤器对各粒径微粒进行测定.结果:终端滤器对25,10,5μm粒径的微粒均有滤过作用,对2μm粒子也有滤过作用.不同厂家生产的输液器质量不同,有的输液器终端滤器几乎不起作用.结论:要加强一次性输液器的质量管理,确保病人输液的安全.     

一次性输液器终端滤器对输液中微粒影响的考察

目的：考察一次性输液器终端滤器对输液中不溶性微粒的影响。方法：使用不溶性微粒分析仪针对不同厂家各种输液器以有终端滤器和无终端滤器对各粒径微粒进行测定。结果：终端滤器对２５，１０，５μｍ粒径的微粒均有滤过作用，对２μｍ粒子也有滤过作用。不同厂家生产的输液器质量不同，有的输液器终端滤器几乎不起作用。结论：要加强一次性输液器的质量管理，确保病人输液的安全     

一次性输液器终端滤器滤除输液中微粒效果的考察

目的：考察3个医院使用的终端滤器除微粒的效果方法：取复方丹参注射液20mL加入5％ GS500mL中，经输液器终端滤器过滤，弃去初滤液约50mL，取续滤液80mL；除去滤器，弃去初溶液约50mL，取续溶液80mL做对照，按中国药典2005年版二部附录微粒检测项下测定过滤液与未过滤液微粒数，并计算滤除率结果：不同厂家的输液器终端滤器对6种微粒的滤除率，经PEMS软件包处理，≥3μm、≥20μm、≥25μm的微粒，其结果无显著性差异（P〉0．05）；≥5μm、≥10μm、≥15μm的微粒，其结果有显著性差异（P〈0．05）、同厂不同批号输液器终端滤器，对微粒的滤除率有2个厂6个批号之间存在显著性差异（P〈0．05）；其余均无显著性差异（P〉0．05）结论：5个厂家的输液器终端滤器对≥20μm和≥25μm 2种微粒的滤除率，均无显著性差异（P〉0．05），均可达80%以上。     

复方毛冬青注射液与3种输液配伍后的微粒及其pH值观察

目的观察复方毛冬青注射液分别与0.9%氯化钠注射液、10%葡萄糖注射液和小儿用葡萄糖氯化钠注射液3种输液配伍时的不溶性微粒及其pH值变化.方法不同剂量(4、6、8和10ml)的复方毛冬青注射液分别与100ml上述输液配伍,混合液的不溶性微粒利用微粒分析仪测定,以及其pH值利用pH/离子计仪测定.结果不同剂量复方毛冬青注射液与各输液混合其4个通道(≥25μm、≥10μm、≥5μm、≥2μm)的不溶性微粒均显著性增多(P＜0.01),且其pH也有明显变化.结论复方毛冬青注射液与3种输液配伍的不溶性微粒不符合中国药典及英国药典的质量标准,应引起重视.建议在临床应用时可在其一次性输液器加装有效的终端滤器.     

ST型终端滤器截留异物效果临床考查

输液中微粒异物的临床危害国内外已大量报道,为了使输液更为安全有效,现已出现了多种输液终端滤器。我们对ST 型输液终端滤器(以下简称ST 滤器)的临床使用效果进行了联合考查。ST 滤器材料选用260目尼龙绢筛网,过滤面积26.74mm~2。按国家标准GB2014—8的规定,260目尼     

如何提高微膜滤器的过滤效率

微膜滤器的过滤介质是微孔滤膜(Micropo-rous Filter Memberanes),简称MFM。它是筛网状精滤介质。国产微膜是由硝化纤维素和醋酸纤维素混合酯所制成。微膜的孔径由0.05到14μm不等。国产微膜用于输液生产的,其孔径有0.65、0.80、1.0、1.2、3.0μm等几种。它们的共同特点是孔径大小十分一致,并均匀地分布在膜上,占全膜面积的80％以上。这些性质使它的滤速比能截留相同大小微粒的其它滤器快40倍。由于它的筛网特性,易被阻塞,必须把欲通过它的药液作     

就输液中不溶性微粒的粒径分布谈输液滤器的开发方向

本文就输液中不溶性微粒的粒径分布及输液滤器的开发方向等问题进行了调查及文献复习，并予以讨论。调查结果证明，输液中不溶液微粒的粒径分布状态具有一定规律性，２￣５μｍ的微粒占９８％左右，１０￣２５μｍ的微粒仅占１％￣２％。提示输液滤器的开发需以２￣５μｍ的微粒力依据，使之朝着高效、实用、价廉的方向发展。     

清开灵及黄芪注射液在两种输液中的微粒观察

目的观察清开灵及黄芪注射液溶于不同输液中的微粒情况。方法利用微粒分析仪测定两种中药注射液、两种输液以及两种中药注射液分别溶于两种输液中的微粒。结果混合液中≥10μm、≥5μm、≥2μm的微粒均有显著增加,不同中药注射液溶于不同输液中微粒增加数目不同。结论同种输液比较、复方中药注射液对输液微粒的影响较单方中药注射液显著;同种中药注射液比较,在10%葡萄糖注射液中微粒变化比在0.9%氯化钠注射液中显著。     

终端滤器简介

近年来国内外普遍采用微孔滤膜制备输液,临床输液术也在不断提高。尽管输液中微粒异物数已被控制,由于病区空气不能净化处理以及输液术的管道、器械(橡皮条、接头、注射器等)不能作到无异物、无微粒,因此,输液的终端滤器必将普遍采用。终端滤器国外早有报道,国内也作了大量工     

28种静脉用中药注射剂不溶性微粒的研究

28种静脉用中药注射剂按治疗剂量加入各自溶媒后不溶性微粒的检测表明：每种药物均含有不同粒径及数量的微粒。其中多数符合《中国药典》标准，但有4种药物≥10μm的微粒数在20个以上或≥25μm的微粒多于2个，超过《中国药典》标准。值得注意的是，中药静脉注射剂中小于10μm的微粒个数明显多于西药静脉注射液。提示中药静脉注射剂质控的难度和改善工艺质量的迫切性。本实验对国产精密药液过滤器的滤过作用亦作了考察。     

输液滤器对几种常用静脉注射药物吸附作用的观察

选用部分国产输液滤器对几种临床常用静注药物的吸附作用进行了实验观察。结果表明输液滤器在输注过程中对常用药物均有不同程度的吸附；多数输液滤器的药物吸附量对治疗剂量无明显影响，而对微量及极性药物的吸附作用明显增强，且与输液滤器的大小、材质等因素密切相关。提示微量及极性药物的输注应考虑输液滤器对治疗剂量的影响     

对使用一次性输液器利与弊的研究

本文系统考察了一次性输液器的使用对大输液澄明度的影响。库尔特计数仪和伞棚式澄明度检查仪的检验结果证明,一次性输液器塑料穿刺针的穿刺可使大输液中2μm至5μm的微粒增加至1.6～27.6倍,并使药液出现可见性胶屑。此外,本文还证实了终端过滤器的使用,一方面可以有效地控制输液中10μm至25μm的微粒进入机体,另一方面可能增加2μm至5μm的微粒的污染水平。     

清开灵注射液与4种抗生素配伍前后不溶性微粒的变化

目的探讨清开灵注射液与头孢拉定注射液、头孢哌酮钠注射液、阿米卡星注射液、盐酸环丙沙星注射液配伍后不溶性微粒的变化及解决方法,指导临床合理配伍。方法利用GWF-5J型微粒分析仪分别计数上述配伍后≥5μm、≥10μm、≥12μm、≥20μm、≥25μm、≥50μm的不溶性微粒数,并进行比较。结果4种抗生素与清开灵注射剂配伍后的不溶性微粒超过《中国药典》标准,清开灵注射液与阿米卡星、盐酸环丙沙星注射液配伍后≥5μm、≥10μm、≥12μm、≥20μm、≥25μm、≥50μm的不溶性微粒明显多于配伍前。头孢拉定、头孢哌酮钠这2种注射液与清开灵配伍后的不溶性微粒也比配伍前有所增多,但低于清开灵注射液与阿米卡星、盐酸环丙沙星注射液配伍后的不溶性微粒数。结论临床上清开灵注射液与这些药物联合应用时,应分别放在不同输液瓶中,以避免因不溶性微粒数的增加导致不良反应发生率的上升。     

Removal of influenza A virus,phage T1, and PP7 from fluids with a nylon 0.04-μM membrane filter

We tested the ability of a 0.04-μm nylon membrane filter to remove viral agents (influenza A virus, 80–120 nm; phage T1, 50–150 nm; and phage PP7, 25 nm) from the following media: ultrapure water (UPW), Dulbecco's modified Eagle minimum essential medium (DMEM), gelatin phosphate (GP), DMEM with 10% (DMEM-10) fetal bovine serum (FBS), and 100% FBS. When challenged with at least 3.0 × 10⁷ plaque-forming units/mL, no influenza A virus was detected downstream of the filter with any of the fluids tested. The titer reduction (Tr) was determined using the equation: . Higher concentrations of phage T1 were removed from UPW (Tr = 1.6 × 10⁶) and DMEM (Tr = 1.1 × 10⁶) than from GP (Tr = 9.3 × 10³), DMEM-10 (Tr = 1.5 × 10²), and 100% FBS (Tr = 2.4 × 10²). Phage PP7 was removed in significant numbers only in ultrapure water (Tr = 8.5 × 10⁴). The results indicate that adsorption enhanced the titer reduction in fluids containing low levels of protein. The titer reduction in DMEM-10 and 100% FBS may reflect the sieving properties of the 0.04-μm filter. As expected, a much smaller Tr was observed in the filtrate of the 0.2-μm filters, compared to the 0.04 μm filters. In contrast to the 0.04-μm filter, no increase in Tr was detected when the 0.2-μm filters were challenged with virus diluted in UPW compared with virus diluted in GP. These results suggest that the 0.04-μm filter has greater adsorptive properties than the 0.2-μm filter. © 1994 by John Wiley & Sons, Inc..     

常用输液溶剂中注射用乌司他丁稳定性研究

目的考察注射用乌司他丁在2种常用输液溶剂中的稳定性。方法按药品说明书规定的用量及浓度,将注射用乌司他丁10万单位分别溶于5%葡萄糖注射液(500 m L)和0.9%氯化钠注射液(500 m L),定时考察配伍溶液的外观、p H、不溶性微粒和含量变化情况。结果注射用乌司他丁与2种溶剂混合配制12 h内,外观和pH均无明显变化,≥10μm不溶性微粒数和≥25μm不溶性微粒数均符合2015年版《中国药典(四部)》规定的限度,且12 h内乌司他丁的含量基本无改变。结论注射用乌司他丁与2种输液溶剂配伍后,室温条件下12 h内可保持相对稳定,临床可采用输液泵持续给药的方法使用。     

Particles shed from syringe filters and their effects on agitation-induced protein aggregation

We tested the hypothesis that foreign particles shed from filters can accelerate the rate of protein aggregation and particle formation during agitation stress. Various types and brands of syringe filters were tested. Particle counts and size distribution (≥1 μm) in buffer alone or in solutions of keratinocyte growth factor 2 (KGF-2) were determined with a micro-flow imaging. Submicron particle populations were characterized by dynamic light scattering. Loss of soluble protein during filtration or postfiltration incubation was determined by ultraviolet spectroscopy and bicinchoninic acid protein assay. There was a wide range (from essentially none to >100,000/mL) in the counts for at least 1 μm particles shed into buffer or KGF-2 solution from the different syringe filters (with or without borosilicate glass microfibers). Filtration of KGF-2 with units containing glass microfibers above the membrane resulted in 20%-80% loss of protein due to adsorption to filter components. Filtration with systems containing a membrane alone resulted in 0%-20% loss of KGF-2. Effects of 24-h postfiltration incubation were tested on KGF-2 solution filtered with polyether sulfone membrane filters. Loss of soluble protein and formation of particles during agitation were much greater than that in control, unfiltered KGF-2 solutions. Similar acceleration of protein aggregation and particle formation was observed when unfiltered KGF-2 solution was mixed with filtered buffer and agitated. Particle shedding from syringe filters--and the resulting acceleration of protein aggregation during agitation--varied greatly among the different syringe filters and individual units of a given filter type. Our results demonstrate that nanoparticles and microparticles shed from the filters can accelerate protein aggregation and particle formation, especially during agitation.     

Biorelevant in vitro dissolution testing of products containing micronized or nanosized fenofibrate with a view to predicting plasma profiles

The ability of in vitro biorelevant dissolution tests to predict the in vivo performance of nanosized fenofibrate (Lipidil 145 ONE®) and microsized fenofibrate (Lipidil - Ter®) was evaluated in this study. In vitro dissolution was carried out using USP apparatus 2 (paddle method) with updated biorelevant media to simulate the pre- and postprandial states. Membrane filters with different pore sizes were evaluated for their ability to hold back undissolved, nanosized drug particles. It was shown that filters with pore sizes of 0.1 μm and 0.02 μm were able to separate molecularly dissolved drug from colloidal and undissolved particles. In vitro results obtained with a suitable filter were used to generate simulated plasma profiles in combination with two different models using STELLA® software: (a) under the assumption of no permeability restrictions to absorption and (b) under the assumption of a permeability restriction. The simulated plasma profiles were compared to in vivo data for the nanosized and the microsized formulation in the fasted and fed states. The first model approach resulted in good correlation for the microsized fenofibrate formulation, but the plasma profile of the formulation containing nanosized fenofibrate was overpredicted in the fasted state. The second model successfully correlated with in vivo data for both formulations, regardless of prandial state. Comparison of simulations with the two models indicates that in the fasted state, absorption of fenofibrate from the nanosized formulation is at least partly permeability-limited, while for the microsized formulation the dissolution of fenofibrate appears to be rate-determining.     

Crystallization Velocity and UV Performance of Formulations With Oversaturated UV-Filter Content

Cosmetic oils are used to dissolve crystalline lipophilic UV filters; however, little knowledge exists about the effect of other formulation ingredients. This study investigates the influence of emulsifiers on the recrystallization speed of 4 UV filters and the impact of UV-filter crystal formation on delivered performance. The crystallization pattern of studied UV filters was assessed using X-ray diffractometry, whereas their recrystallization speed in formulations with various emulsifiers was monitored microscopically. UV-filter concentration was above the saturation level to promote recrystallization. Furthermore, to understand the kinetics of recrystallization, the conformer number of each UV-filter was calculated. For the impact on performance, the absorbance of a sunscreen was measured before and after recrystallization of the contained UV filter. This study confirmed the crystallinity of tested UV filters. The emulsifier was shown to influence the UV-filter recrystallization speed in emulsions. Continuous oil phase sunscreens were critical; all UV filters recrystallized promptly in oils and water-in-oil emulsions. Large molecule UV filters showed slowest recrystallization speed explained by a higher number of possible conformers. Finally, this work confirmed the negative impact of crystal formation on the delivered photoprotection of a sunscreen.     

中药静脉注射液不溶性微粒研究

目的 :考察复配中药针剂在静脉注射液中的不溶性微粒的变化及解决方法。方法 :将61种中药注射剂按治疗剂量溶配于0 9 %氯化钠注射液中 ,用库尔特仪计数该液中直径大于2 5、5 0、10 0、25 0μm的微粒数 ;对微粒进行理化性质显微鉴别 ;考察精密药液过滤器流速、流量、吸附性和截留作用。结果 :(1)26种中药注射剂微粒数超过《中国药典》 (2000年版 )标准 ,占实验总数42 6 % ;(2)不溶性微粒有玻璃渣、活性炭、橡胶屑、毛屑索条和药物残渣 ;(3)精密药液过滤器的流速、流量符合临床要求 ,截留率为88 5 % ,未见其有吸附作用。结论 :精密药液过滤器可截留中药输液的微粒 ,保证患者用药安全。