血液制品的现状与展望

血液制品特指血浆蛋白制品和相应的重组制品。根据临床应用的效能,血液制品可以分为白蛋白类、免疫球蛋白类、凝血因子类和微量蛋白制品等不同种类。血浆白蛋白制品是最早应用于战伤救治的血液制品,高纯白蛋白、重组白蛋白以及重组白蛋白融合药物的研发和上市开创了血液制品的新局面。肌肉注射用免疫球蛋白因其制备工艺相对简单,使用方便,价格低廉且不良反应可以接受而一直在临床实践中应用;静脉注射用免疫球蛋白随着新的适应症不断发现,其应用范围越来越广;皮下注射用免疫球蛋白的出现使免疫球蛋白的使用更加方便,已经成为静脉注射用免疫球蛋白安全有效的替代品;针对特定病原体的特异性免疫球蛋白在临床上更具有不可替代的作用。凝血因子和重组凝血因子类制品主要用于相应的先天性遗传性缺陷患者,纤维蛋白原、因子Ⅶ、因子Ⅷ、von Willebrand因子复合物、因子Ⅸ和凝血酶原复合物、因子Ⅺ、因子ⅩⅢ等制品的应用取得了良好的治疗效果。因子Ⅶa和活化凝血酶原复合物对于治疗产生凝血因子抑制物的血友病病人具有十分明显的效果。纤维蛋白原类制品和凝血酶在外科止血方面发挥着重要的作用。多种微量血浆蛋白制品已经上市,如蛋白C、抗凝血酶、α1-抗胰蛋白酶和组织纤溶酶原激活剂等。部分微量血浆蛋白制品也在研发和临床试验过程中,如C1-抑制剂、补体系统Ⅰ因子、α2-巨球蛋白、血清胆碱酯酶、铜蓝蛋白以及纤维结合蛋白等。尽管多种重组血浆蛋白制品已经上市,血浆来源的制品仍将具有其不可替代的特殊地位,血浆蛋白新品种的研发仍是热点。目前,我国血液制品的研发与国外存在着较大的差距,我国血液制品企业面临着机遇与挑战。     

四种动物血浆纤维蛋白原含量的比较

血浆纤维蛋白原是血浆蛋白之一,它是由三对不同的多肽链以二硫键连接而成为纤维状蛋白质。分子量为340.0000,在人体血浆中浓度为200—400mg/100ml血浆。用盐析法可将血浆蛋白分为白蛋白、球蛋白和纤维蛋白三部分。 研究止血、血管内栓塞和溶解栓塞的药物,常以纤维蛋白原含量的变化为指标。因此了解常用实验动物的血浆纤维蛋白原的正常含量,对生理和药理学工作者是有一定参考价值的。据我所查资料,蟾蜍和家鸡的血浆纤维蛋白     

蝮蛇抗栓酶治疗银屑病产生耐受性原因探讨

目的通过治疗银屑病５０例临床观察,探讨部分病例未能治愈与机体对蝮蛇抗栓酶产生耐受性原因分析。方法用蝮蛇杭栓酶０．７５ＩＵ加入生理盐水中静滴,治疗前、后及各疗程间监测血小板计数与血浆纤维蛋白原变化。结果药效消失后,血小板计数与血浆纤维蛋白原增高超过治疗前水平。结论该类药物治疗其他血栓性疾病可将血小板计数与血浆纤维蛋白原增高作为药效消失及耐受性产生的一项指标。     

降纤酶治疗急性脑梗塞的疗效及对血浆纤维蛋白原的影响

目的:研究降纤酶治疗急性脑梗塞的疗效以及对血浆纤维蛋白原的影响。方法:选取2010年4月到2014年6月我院收治的急性脑梗塞患者130例,按照随机数字表法将患者分为研究组和对照组,每组65例,两组均给予常规治疗,对照组在常规治疗的基础上给予安慰剂,研究组给予降纤酶,比较两组临床疗效、神经功能缺损评分、血浆纤维蛋白原水平以及不良反应。结果:研究组总有效率为95.4%,显著高于对照组的76.9%(P0.05);治疗后研究组神经功能缺损评分与治疗前和对照组比较差异具有统计学意义(P0.05);治疗后研究组血浆纤维蛋白原显著低于治疗前和对照组(P0.05);两组不良反应比较差异无统计学意义(P0.05)。结论:降纤酶治疗急性脑梗塞具有较好的临床疗效,改善患者的神经功能,降低血浆纤维蛋白原。     

烙铁头蛇毒纤维蛋白原溶酶研究——Ⅱ.对纤维蛋白原及凝血酶的作用

烙铁头(T.mucrosquamatus)蛇毒纤维蛋白原溶酶TMVFg能水解三肽底物Bz-Phe-Val-Arg-PNA,但对凝血酶的良好底物Cbz-Gly-Pro-Arg-PNA却活性甚低。TMVFS显著延长血浆凝血酶时间。血浆复钙时间及纤维蛋白原溶液凝血酶时间。同时,TMVFg体外也能延长全血凝固时间,表明具有抗凝作用。纤维蛋白原-纤维蛋白转换实验表明:TMVFg水解纤维蛋白原产生的纤维蛋白原断片(FDP)除具有抗凝血酶,抑制纤维蛋白聚合活性外,还能促进纤维蛋白的聚合。 进一步用FPLC分离TMVFg水解人纤维蛋白原混合液,得两个FDP断片功能峰,FDP组分Ⅰ和FDP组分Ⅱ。其中FDP组分Ⅰ能抑制纤维蛋白凝块形成;FDP组分Ⅱ能促进纤维蛋白凝块形成,抑制TMVA(烙铁头蛇毒血小板活化素,它可不通过ADP、花生四烯酸途径而诱导血小板聚集),但对ADP诱导的家兔血小板聚集无影响。TMVFg对凝血酶水解三肽底物Cbz-Gly-Pro-Arg-PNA及凝固纤维蛋白原的活性也有一定抑制作用。 实验证明,TMVFg抗凝的主要作用机理是其水解纤维蛋白原产生的断片对纤维蛋白原凝固的抑制作用、FDP断片抗凝血酶作用及TMVFg本身对凝血酶活性的抑制所引起的,但在二者之间,前者是主要的。 从研究结果发现:TMVFg水解纤维蛋白原所产生的断片有一类能加速凝血酶凝固纤维蛋白原的过程,这就发现了FDP断片的     

肉毒A、B、E、F型抗毒素血浆的试生产与检定

按照《中国生物制品规程》(2000版)的规定,在肉毒A、B、E、F型抗毒素血浆试生产前,制定了肉毒A、B、E、F型类毒素马匹免疫计划及相应抗毒素血浆效价测定方法,免疫结果显示：肉毒A、B、E、F型类毒素免疫马匹成功率分别为75%、75%、60%、100%。     

马免疫血浆的稳定性研究

目的了解不同温度条件对马免疫血浆外观和效价的稳定性影响,为马免疫血浆的采集、分离、贮存、运输及抗毒素生产提供数据支持。方法将破伤风类毒素及肉毒A、B、E、F型类毒素制备的马免疫血浆,分别放置于2~8℃、20℃、37℃3种温度下,并分别于0、1、3、6、12个月取样,依据《中国药典》三部(2010版)的检测方法和标准,对样品进行外观检查及效价检测。结果破伤风及肉毒A、B、E、F型马免疫血浆在2~8℃条件下,放置12个月稳定性良好,外观及效价均符合《中国药典》三部(2010版)规定要求。20℃与37℃下放置的马免疫血浆随着时间的延长,外观会发生不同程度的浑浊,效价也均有不同程度的降低,低效价组比中、高效价组的效价下降明显,且温度越高效价降低幅度越大。结论马免疫血浆在2~8℃条件下质量稳定。     

脑血管疾病患者血尿酸和纤维蛋白原的测定与分析

目的:为了解脑血管疾病患者血尿酸、血浆纤维蛋白原水平及相互关系。方法:对81例脑梗死患者、77例脑出血患者和55例时照者采血测定血尿酸、血浆纤维蛋白原,并分析二者的相关性。结果:脑梗死疾病组和脑出血疾病组UA和Fib水平均高于时照组(P＜0．05);脑血管疾病组组间无差异(P□0．05);血尿酸和血浆纤维蛋白原二者间无相关性。结论:血尿酸、血浆纤维蛋白原作为脑血管疾病的危险因素可能是独立存在的。     

血浆Hcy、FIB及hs-CRP水平与脑梗死严重程度及复发的相关性分析

目的:探讨血浆同型半胱氨酸(Hcy)、血浆纤维蛋白原(FIB)及超敏C反应蛋白(hs-CRP)水平与脑梗死严重程度及复发的关系。方法:回顾性分析本院收治的138例急性脑梗死患者的临床资料,应用神经功能缺损程度量表对患者脑梗死程度进行评定,监测血浆Hcy、FIB、hs-CRP水平,随访1年,分析以上各指标水平与脑梗死严重程度及复发的关系。结果:轻度、中度和重度脑梗死患者Hcy、FIB及hs-CRP水平比较差异均有统计学意义(P0.05);严重程度与Hcy、FIB及hs-CRP水平呈正相关性(r=0.51、0.43、0.39,P0.05);复发者FIB及hs-CRP水平均显著高于未复发者,比较差异有统计学意义(P0.05)。结论:血浆Hcy、FIB及hs-CRP水平越高脑梗死越严重,且脑梗死复发患者FIB及hs-CRP的水平显著上升,临床应紧密检测指标,尽早治疗以防止病情进一步恶化。     

慢性重型肝炎患者血浆D-二聚体和纤维蛋白原水平的变化

目的:分析慢性重型肝炎患者血浆D-二聚体和纤维蛋白原水平的变化及其临床意义.方法:应用乳胶比浊法及凝固法分别测定血浆D-二聚体和纤维蛋白原的水平,其中慢性重型肝炎患者40例,慢性肝炎患者28例作为对照组.结果:慢性重型肝炎患者血浆D-二聚体及纤维蛋白原检测异常率分别为62.5％(25/40)、92.5％(37/40),明显高于慢性肝炎组0％(0/28)、28.6％(8/28).慢性重型肝炎患者血浆D-二聚体及纤维蛋白原检测水平分别为3.45± 1.90 μg/mL、1.36± 0.49 g/L,慢性肝炎组患者血浆D-二聚体及纤维蛋白原检测水平分别0.91± 0.47 μg/mL、2.53± 1.02 g/L,组间比较差异有统计学意义.慢性重型肝炎组患者27例死亡,13例好转出院,死亡组患者血浆D-二聚体异常率74.1％ (20/27),检测水平为3.92± 1.76μg/mL,纤维蛋白原异常率100％(27/27),检测水平为1.17± 0.4 g/L;好转组患者血浆D-二聚体异常率38.5％(5/13),检测水平为2.48± 1.88 μg/mL,纤维蛋白原异常率为76.9％(10/13),检测水平为1.74± 0.44 g/L,差别有统计学意义.结论:慢性重型肝炎患者血浆D-二聚体水平明显增高,纤维蛋白原明显下降,并与患者的病情严重程度及预后相关,检测血浆D-二聚体和纤维蛋白原水平可以作为慢性重型肝炎患者病情轻重及预后判断的临床指标.     

DEVELOPMENT OF A TEXTURE PROFILE PANEL FOR EVALUATING RESTRUCTURED BEEF STEAKS VARYING IN MEAT PARTICLE SIZE

A texture profile panel was developed for measuring textural properties of restructured beef steaks differing in meat particle size. For steaks of different particle sizes, considerable differences existed in the type of sample breakdown and shape of chewed pieces after just two chews. Panelists also found restructured steaks made from large meat particle sizes to be visually more distorted and to contain more gristle than steaks made from small meat particle sizes. Several characteristics (chunkiness after two chews, coarseness of chewed mass at 15 chews) were dropped from the profile over time, while several characteristics (type of sample breakdown and shape of chewed pieces at two chews, size of chewed pieces at 10 chews) not used initially, were added. The texture profile panel approach appears suitable for discerning the textural differences in restructured steaks that can arise from using different meat particle sizes during processing.     

一种新型豆渣面膜

介绍了一种新型豆渣面膜,并对其制备工艺、使用方法进行了研究;再对产品进行了测试、功能性讨论。结果表明,该面膜膏产品均符合中华人民共和国轻工行业标准QB/T2872-2007要求,并具有良好的稳定性、配伍性;该面膜具有生产工艺简单、成本低廉、安全环保,使用功效显著、性能温和、无刺激、无副作用的特点,是一种来源广泛的、实用的、多效的美容护肤品。     

高速逆流色谱法制备灵芝萜烯酮醇

本研究建立一种从灵芝子实体提取物中快速制备灵芝萜烯酮醇的方法。以沪农灵芝1号子实体为原料,经乙醇提取、D101大孔树脂富集后,再经一次正相色谱柱层析,获得富含灵芝萜烯酮醇的流分。采用高速逆流色谱法对该流分进行分离,优化分离条件,获得的最佳条件为：溶剂体系为正己烷-乙酸乙酯-甲醇-水（V/V/V/V,12:24:18:9）,流速2.0mL/min,转速900r/min,上样量500mg,一次上样可得到纯度为90.9%的灵芝萜烯酮醇52.1mg,得率达到10.4%。该方法具有操作简单、污染小、成本低、得率和纯度高的特点,是规模化制备灵芝萜烯酮醇的一种新方法。     

椒莪脂质体的制备及其质量标准的建立

目的:将椒莪油制成脂质体,优选制备工艺,建立质量标准。方法:采用薄膜超声法制备椒莪脂质体,通过正交实验优选处方和制备工艺,HPLC、GC建立其质量标准。结果:最佳处方为卵磷脂:胆固醇7:1,卵磷脂:油3.5:1;HPLC法测定脂质体中莪术油的含量,建立标准曲线,回归方程为Y=14958X+16795,r=0.9996;椒目仁油的测定方法同前文报道。得到的脂质体形态均一,包封率在75%左右。结论:建立的制备工艺简单,便于操作;检测方法的精密度、回收率均符合要求。     

A new validated HPLC-FLD method for detecting ochratoxin A in dry-cured meat and in blue cheese

In the present study, a fast and sensitive method for the quantification of ochratoxin A in two lipidicproteic food matrices has been developed. In particular, the sample preparation procedure has been optimized for dry-cured meat products and blue cheeses and tested for several validation parameters (LOD, LOQ, recovery, repeatability and within-laboratory precision). The procedure has been then applied to several dry-cured meat products and blue cheeses from the market. Ochratoxin A has been occasionally found in dry-cured and smoked ham from the market and the contamination occurred both in the outer and in the inner part of the products. Concerning the blue cheese, the occurrence of ochratoxin A is reported for the first time: OTA was occasionally found at low levels (0.1–3 μg/kg) in commercial samples of Roquefort from France and Gorgonzola from Italy, opening a new issue for risk assessment and quality control. Presented at the 29^th Mykotoxin-Workshop, Fellbach, Germany, May 14–16, 2007 Financial support: This work was partially granted by Emilia-Romagna region (projects: SIQUAL and “Safety and quality of typical pork meat production chain”)     

SMARThivVLmos: a complexity-free and cost effective dynamic model technology for monitoring HIV viral load in resource-poor settings

We design a "simple" and "low cost" model technology for monitoring HIV viral load in resource-poor settings: SMARThivVLmos. Cost and complexity are the major challenges to the developing world, in monitoring HIV patients viral load. We have previously demonstrated in our SMARThivPack model that cost and complexity of laboratory monitoring of HIV patients, may be reduced not only at a first technology development level, but also at a second technology implementation, and at a third global coordination levels. In our SMARThivPack model, the P24 HIV viral load monitoring system passed both the "cost" and the "complexity" tests. However, compared to other alternative viral monitoring systems such as the Cavidi EXAVIR, the sensitivity of the P24 system is too low. Here we describe a dynamic model technology that overcomes the sensitivity barrier of the P24 system while maintaining simplicity and low cost.     

Impact of manufacturing, irradiation and filtration steps to bacterial contamination of autologous fibrin sealant.

BACKGROUND: Preoperative production of autologous fibrin sealant has become a routine procedure during the last years. As a certain percentage of blood products is contaminated with bacteria, contamination of plasma used for the production of fibrin sealant cannot be excluded. Especially in the orthopaedic setting, application of contaminated fibrin sealant can cause severe infections. MATERIALS AND METHODS: We contaminated plasma with Staphylococcus epidermidis, Corynebacterium striatum, Bacillus subtilis or Escherichia coli and produced fibrin sealant by cryoprecipitation and alcohol precipitation. Additionally, the products were gamma-irradiated at a dose of 30 Gy, frozen at -55 degrees C and filtered through a 0.2 microm filter after thawing. After each preparation step, samples were drawn and numbers of colony forming units were counted after incubation on agar plates. RESULTS: Cryoprecipitation, irradiation, freezing at -55 degrees C, and alcohol precipitation have only little impact on numbers of colony forming units. Filtration through a bacterial filter results in a sterile product. CONCLUSION: Bacteria in plasma as a starting material for production of fibrin sealant survive all routine steps of production, including gamma irradiation and freezing. Filtration of the product through a qualified bacterial filter is the only safe means to provide a sterile product.     

An optimized method for the determination of perfluorooctanoic acid, perfluorooctane sulfonate and other perfluorochemicals in different matrices using liquid chromatography/ion-trap mass spectrometry

Perfluorochemicals (PFC's) are widely spread in the environment and have been detected in blood of wildlife and humans world-wide. Recently, various toxic effects of PFC's in laboratory rats have been demonstrated, resulting in increased government concerns regarding the presence of PFC's in the environment and the implications they have on human health. In the last decade, various analytical methods have been developed for the analysis of PFC's in different matrices whereby the majority of methods have utilised liquid chromatography coupled with mass spectrometry (LC-MS). Here we describe an optimized method for the quantitation of PFC's, including perfluorooctanoic acid (PFOA) and perfluorooctane sulfonate (PFOS), in food packaging, polytetrafluoroethylene (PTFE) sealant tape and drinking water. The method involved PFC's extraction via off-line SPE followed by separation using reversed-phase liquid chromatography on a Phenyl-Hexyl column coupled with ion-trap (IT) mass spectrometric detection. The optimized approach minimized ion-suppression effects commonly seen with conventional elution buffers, improving detection limits down to 25 pg/mL and allowed effective quantitation down to 50 pg/mL for PFOA and PFOS. The optimized LC-MS method detected PFOA and other PFC's in microwave popcorn packaging and PFOA in PTFE sealant tape in the low μg/kg. In all samples, PFOS was not detected.     

A fast method for monitoring the colonization rate of lactobacilli in a meat model system

A random amplified polymorphic DNA (RAPD) assay coupled to a fast and reproducible cell lysis method from Lactobacillus colonies were developed to type lactobacilli of different strains and species, with the aim of precisely enumerating each of the different Lactobacillus strains inoculated in a nutrient-rich environment, such as sausage meat batter. Colonization assays were carried out in an aseptic meat fermentation system for up to 14 d and the inoculated strains were challenged with mixtures of wild lactobacilli. The proportion of inoculated strains remaining at different times was compared with the total number of lactobacilli grown on MRS agar by RAPD. The colonization rate of the different strains tested was very different. The RAPD-fast lysis method developed is simple and, with a low cost per assay, could also be applied to other food fermentations.     

Preparation of the particles of Acanthopanax senticosus

The main objective of this study is to establish the best preparation technology of the particles of Acanthopanax senticosus. First, take the reflux extraction method extract of Acanthopanax senticosus coarse powder, optimized by orthogonal experimental method, to flavonoids flavonoids extraction extraction rate as the indexes to determine the effects of extraction temperature, ethanol concentration, extraction time on flavonoids content. Then by a wet granulation of thorn slender acanthopanax particles, taste with granules, forming rate, melting rate as index to investigate the influences of materials adding amount of granules effect. The results showed that the ethanol water heating reflux extraction method to extract the temperature of 70 deg, the percentage of ethanol 75%, extraction time 2.5 h, the highest content of total flavonoids in the extract. Join the 5 ml and 10 g in the extract of acacia honey, dextrin, starch, sugar ratio for 3:4:8, the best taste of Acanthopanax granules. In the end, the best preparation technology of the granules is established, and the process is simple, which is suitable for the large-scale production of the factory.