Adult Bovine Serum Defibrinated (ABSD) is obtained from blood taken from cattle deemed fit for human consumption following ante and post mortem veterinary inspection. The blood is collected in slaughter-houses supervised by government veterinarians.
The blood is collected into sanitary buckets and the fibrin is mechanically removed during the clotting process. The liquid component of the blood is pooled and separated using a continuous flow separator before being dispensed into either 5L Bottles or 25L Bladders and immediately frozen.
| SPECIFICATION - Adult Bovine Serum - Defribrinated Raw (ABSD) | |
| Product | Adult Bovine Serum - Defibrinated Raw |
| Catalogue No. | ABSD |
| Source | Bovine blood from healthy animals which have been inspected ante and post mortem by Australian or New Zealand Government veterinarians and passed as fit for human consumption. |
| Collection Method | Blood is collected into sanitary containers, defibrinated and centrifuged under temperature controlled conditions. It is then immediately frozen. |
| Description | Non sterile frozen orange liquid |
| Pack Size | 5L bottles or 25L bladders or to Customer Specifications |
| Storage | - 20 degrees Centigrade |
| Test | Method | Specification |
| Visual Examination | Visual | Satisfactory |
| Haemoglobin | UV/VISSpectrophotometer | As reported |
| Endotoxin | Kinetic Turbidimetric | As reported |
| Aerobic Microbial Count | CFU/ml | As reported |
| Total Protein | Beckman Coulter Synchron Clinical Systems | 6.0 - 9.0 g/dl |
| pH | pH meter | 6.5 - 8.0 |
| Composition | CAE Agarose Gel Plate | Typical |
EP/USP
The European Pharmacopeia consists of a number of general and specific monographs covering various classes of products.
The monographs set out requirements to be met and followed for all products in the class.
Recently the EP has introduced a Monograph for Bovine Serum – Monograph No 04/2006:2262 to be found in E.P. 5.4
This monograph provides a definition of Bovine Serum and sets out details of production, and requirements for viral inactivation parameters, quality control testing, storage conditions and labelling.
Moregate Bovine Serum products meet these requirements and Certificates of Analysis are modeled on the QC test requirements.
The United States Pharmacopeia-National Formulary (USP-NF) contains standards for medicines, dosage forms, drug substances, excipients, medical devices, and dietary supplements.
Within the Pharmacopeia are Monographs and general chapters.
The monographs consist of information such as the ingredient name, definition, packaging and labelling requirements, storage and a specification.
The specifications list tests to be performed along with the procedure to be followed and the acceptable limit.
EDQM
The European Directorate for the Quality of Medicines (EDQM) has originated from the European Pharmacopoeia Secretariat which, with the addition of new responsibilities changed its name to the European Department for the Quality of Medicines (EDQM). The EDQM sits alongside the European Medicines Agency (EMEA).
Amongst other activities, the EDQM is responsible for the European Pharmacopeia and the issuing of Certificates of Suitability (CEP).
Certificates of Suitability (CEP) are recognised by all signatory states of the European Pharmacopoeia Convention and by the European Union. Other countries have also chosen to recognise them. In the case of Fetal Bovine Serum and other Bovine Serum a CEP can be used by the manufacturers of Fetal Bovine Serum and other Bovine Serum which is intended for use in the manufacture of pharmaceutical products to demonstrate compliance with the Bovine Serum monographs of the European Pharmacopoeia and the EDQM requirements for substances concerned by TSE risk.
The discovery of Bovine Spongiform Encephalopathy (BSE), which is one of a group of similar infections now referred to as Transmissible Spongiform Encephalopathies (TSEs), and it’s spread over many countries of the European Union as well as its discovery in Canada, the USA and Japan is well known. The European events provided the impetus for the Council of Europe Public Health Committee (CEPHC) to pass Resolution AP-CSP (99) 5 addressing the TSE concerns and creating a Certificate of Suitability (COS) pursuant to Directive 75/318/EEC.
The granting of a CoS to a manufacturer, for a particular product, certifies that the product in question has been assessed for the level of risk of transmission of TSEs, and that the risk level is considered low enough that the product is certified as suitable for use in the manufacture of medicinal products in the European Union.
The process of approval requires the manufacturer to submit a dossier that covers all relevant aspects of the collection of raw material and further processing that is performed to reach the product that is offered to end users. This dossier is detailed and covers the specific material that is collected, the collection method, process validation, testing, traceability, quality systems and an expert review.
Only after this dossier has been examined and approved by two rapporteurs and, if necessary, by a panel of experts appointed by the European Directorate for the Quality of Medicines (EDQM) is the manufacturer granted a COS.
Moregate Biotech has been granted a COS for:
- Fetal Bovine Serum – Australian Origin – CEP2000-187
- Fetal Bovine Serum – New Zealand Origin – CEP2000-188
- Adult Bovine Serum - New Zealand Origin – CEP2001-093
- Adult Bovine Serum (Defibrinated) - New Zealand Origin – CEP2000-174
- Bovine Plasma – New Zealand Origin – CEP2003-199
- Bovine Serum Albumin – manufactured in Australia from New Zealand origin Bovine Plasma – CEP2003-205
- Bovine Plasma – Australian Origin - CEP 2005-192
- Bovine Serum Albumin – manufactured in Australia from Australian origin Bovine Plasma - CEP 2005-191
Copies of the Certificates of Suitability are available upon request
Hazards Identification
- Not hazardous
- Get Medical attention immediately
First Aid Measures
Get Medical attention immediately.
Ingestion
If swallowed, give several glasses of water to drink to dilute.
Skin Contact
Wash skin with soap and copious amounts of water.
Eye Contact
Flush with water for at least 15 minutes, lifting upper and lower eyelids occasionally.
Accidental Release
Procedures for Personal Precaution
Exercise appropriate precautions to minimize direct contact with skin or eyes.
Methods for Cleaning Up
Mop up
Ventilate area and wash spill site after material pickup is complete
Handling and Storage
Handling
Normal measures for preventive fire protection
Storage
Keep tightly closed under correct storage conditions
Exposure Controls / Personal Protection
- Wash thoroughly after handling.
- Protective gloves
Disposal Considerations
Contact a licensed professional waste disposal service to dispose of this material.
Transport Information
- Non-hazardous for road transport
- Non-hazardous for sea transport
- Non-hazardous for air transport
Note: The above information is believed to be correct, but shall be used as a guide only.
Disclaimer: For pharmaceutical use only.
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Nutrients.2017May10;9(5).
ClinicalSignificanceandPrognosticEffectofSerum25-hydroxyvitaminDConcentrationsinCriticalandSevereHand,FootandMouthDisease.
手足口病危重儿血清25-羟维生素D浓度的临床意义与预后影响
作者党红星，刘成军，李静，程时骄，许峰
摘要
Abstract
目的：探讨血清25羟维生素D[25（OH)D]浓度与手足口病危重症的关系及评估手足口病危重儿血清25-羟维生素D浓度的临床意义与预后影响。
OBJECTIVE:
Toexaminetheassociationofserum25-hydroxyvitaminD[25(OH)D]concentrationswithcriticalandseverehand,footandmouthdisease(HFMD)andassesstheclinicalsignificanceandprognosticeffectof25(OH)DconcentrationsinchildrenwithHFMD.
方法：本研究为前瞻性观察研究。
METHODS:
ThisisaProspectiveobservationalstudy.
将138例手足口病患儿分为普通组（49例）、重症组（52例）和危重组（37例）。另选取同期门诊体检的59例健康儿童作为对照组。
The138childrenwithHFMDweredividedintocommon(49cases),severe(52cases),andcritical(37cases)HFMDgroups.Another59healthychildrenundergoingoutpatientmedicalexaminationsduringthesameperiodwerechosenasthecontrolgroup.
测定所有对象的血清25（OH）D浓度，每组再分为血清25（OH）D正常组（≥30ng/mL）；不足组（20-29.9ng/mL）；缺乏组（低于20ng/mL）。
Serum25(OH)Dconcentrationsweremeasuredinallthesubjects,andeachgroupwassuBDividedbyserum25(OH)Dconcentrationinto25(OH)Dnormal(≥30ng/mL);insufficiency(20-29.9ng/mL),anddeficiency(<20ng/mL)groups.
手足口病危急重症组在入住儿科ICU（PICU）时记录小儿危重病例评分（PCIS）。
Thepediatriccriticalillnessscore(PCIS)wasrecordedforthecriticalandsevereHFMDgroupuponadmissiontothepediatricintensivecareunit(PICU).
监测小儿危重手足口病患者血乳酸（LAC）、血清钙离子（Ca2+）、D-二聚体（DD）、乳酸脱氢酶（LDH）、肌酸激酶同工酶（CK-MB）水平；脑干脑炎、神经源性肺水肿、循环衰竭的发生情况；14天病死率。
ChildrenwithcriticalandsevereHFMDwerealsomonitoredforbloodlactate(LAC),serumcalciumions(Ca++),D-dimer(DD),lactatedehydrogenase(LDH),andcreatinekinase-MB(CK-MB)levels;theincidencesofbrainstemencephalitis,neurogenicpulmonaryedema,andcirculatoryfailure;andthe14-daymortalityrate.
结果：
RESULTS：
各组血清25（OH）D浓度普遍较低。
Serum25(OH)Dconcentrationsweregenerallylowinallgroups.
与对照组（28.1±6.6ng/mL,8%）、普通组（29.5±8.1ng/mL,10%）和重症组（31.9±9.7ng/mL,8%）相比，危重组患者血清25（OH）D平均浓度（20.0±8.4ng/mL）明显较低，血清25（OH）D缺乏比例（18％）明显较高(P＜0.05）。
ThecriticalHFMDgroupshowedasignificantlylowerserum25(OH)Dmeanconcentration(20.0±8.4ng/mL)andahigherproportionofdeficiency(18%)comparedwiththecontrolgroup(28.1±6.6ng/mL,8%),common(29.5±8.1ng/mL,10%)andsevere(31.9±9.7ng/mL,8%)HFMDgroups(p<0.05).
在危重组中，25（OH）D缺乏组比25（OH）D正常组及不足组具有更低的PCIS值（P＜0.05）；而比后两组具有更高LAC、LDH、CK-MB和DD；具有（更高的）脑干脑炎、神经源性肺水肿、循环衰竭发生率及病死率（P＜0.05）。
InthecriticalandsevereHFMDgroups,the25(OH)DdeficiencygrouphadlowerPCISsthanthe25(OH)Dnormalandinsufficiencygroups(p<0.05);andhadhighervaluesthanthelattertwogroupsforLAC,LDH,CK-MBandDD;andtheincidencesofbrainstemencephalitis,neurogenicpulmonaryedema,circulatoryfailure,andmortality(p<0.05).
死亡组较存活组具有显著降低的血清25（OH）D浓度和PCIS（P＜0.05），具有较高的LAC、LDH、CK-MB和DD水平；较高的脑干脑炎、神经源性肺水肿、循环衰竭发病率（P＜0.05）。
Thedeathgroupshowedsignificantlylowerserum25(OH)DconcentrationsandPCISsthanthesurvivalgroup(p<0.05)andhadhigherLAC,LDH,CK-MBandDDlevelsandhigherincidencesofbrainstemencephalitis,neurogenicpulmonaryedema,andcirculatoryfailure(p<0.05).
Logistic回归分析显示，血清25（OH）D浓度是影响重症手足口病患儿病死率的独立因素。
Logisticregressionanalysisrevealedthattheserum25(OH)DconcentrationwasanindependentfactorthatinfluencedmortalityinchildrenwithcriticalandsevereHFMD.
CONCLUSIONS:
结论：
在这项研究中，我们发现，血清25（OH）D浓度在手足口病危重患儿中大幅降低，并与手足口病的严重程度相关。
Inthisstudy,wefindtheserum25(OH)DconcentrationsaresubstantiallyreducedinchildrenwithcriticalandsevereHFMDandareassociatedwiththeseverityofHFMD.
血清25（OH）D浓度对判断重症手足口病进展和预测死亡风险具有临床价值。
Theserum25(OH)DconcentrationsmayhaveclinicalvaluefordeterminingtheprogressionofcriticalHFMDandpredictingtheriskofdeath.
在确定25（OH）D浓度在手足口病诊断的临床价值之前，仍需进一步的证据。
Furtherevidenceisneededbeforeitcanbestatedthat25(OH)DconcentrationshaveclinicalvalueinHMFDdiagnosis.
关键词：
KEYWORDS:
25-hydroxyvitaminD;criticalillness;footandmouthdisease;hand
25羟维生素D；危重病；手足口病
1)提供基本营养物质：氨基酸、维生素、无机物、脂类物质、核酸衍生物等，是细胞生长必须的物质。
2)提供结合蛋白：结合蛋白作用是携带重要地低分子量物质，如白蛋白携带维生素、脂肪、以及激素等，转铁蛋白携带铁。结合蛋白在细胞代谢过程中起重要作用。
3)提供激素和各种生长因子：胰岛素、肾上腺皮质激素(氢化可的松、地塞米松)、类固醇激素(雌二醇、睾酮、孕酮)等。生长因子如成纤维细胞生长因子、表皮生长因子、血小板生长因子等。
4)对培养中的细胞起到某些保护作用：有一些细胞，如内皮细胞、骨髓样细胞可以释放蛋白酶，血清中含有抗蛋白酶成分，起到中和作用。这种作用是偶然发现的，现在则有目的的使用血清来终止胰蛋白酶的消化作用。因为胰蛋白酶已经被广泛用于贴壁细胞的消化传代。血清蛋白形成了血清的粘度，可以保护细胞免受机械损伤，特别是在悬浮培养搅拌时，粘度起到重要作用。血清还含有一些微量元素和离子，他们在代谢解毒中起重要作用，如SeO3,硒等
5)提供促接触和伸展因子使细胞贴壁免受机械损伤。
6)血清中有抗体，这是被称作免疫球蛋白的蛋白质，血清可以抗病毒,增强抵抗力血清属于生物制剂。
各位大神，本人实验室小白一枚，现在要保存乙肝病人的血清，以后用来做实验感染细胞。为了最大限度保持病毒的感染活力，应该怎么保存呢？直接-80度冷冻可以吗？需要加甘油吗？
血清蛋白是血浆里最丰富的蛋白质。每一个蛋白分子能携带七个脂肪酸分子。这些脂肪酸分子结合在蛋白的缝隙中，它们富含碳的尾部埋藏在里面安全地避开周围的水分子。血清蛋白同样能够携带许多其它的不溶于水的分子。尤其是血清蛋白，能够携带着许多药物分子，比如布洛芬。
正因为血清蛋白是如此普遍地存在于血液中并且如此容易地被提纯，所以它成为科学家最早研究的蛋白质之一。今天，当需要一种蛋白质时，一种来源于牛体内的类似的蛋白在研究中被广泛地使用，这种蛋白叫做牛族血清蛋白或者称作BSA。许多酶在稀溶液中不稳定，解决的办法是加入一些牛族血清蛋白。在试验中它能使酶稳定，且相对地中性,不会影响酶的性质。
血清的基本成分是水，水中溶有蛋白质、脂肪、糖、无机盐、维生素等营养成分，也溶有人体代谢产物。血清中有抗体，这是被称作免疫球蛋白的蛋白质。
你说的应该称抗毒血清。
因制作时是将蛇毒、病原菌产的毒等小量多次地注射到免子、马血管内，每日慢慢加大注射量，一定时间后，因该动物体内产生抗体，经检测，达到一定效价后，就可以抽血。血液分离血清后再经提纯，就成了抗毒血清。
如蛇、白喉、破伤风、狂犬病抗毒血清等都是如此制备，用来治疗相应毒素反应。
该生物制剂是异种血清，对人会有过敏反应，注射前均要做皮试。阴性可注射，阳性必需作脱敏疗法才行。
热门血清品牌：
1.Gibco
【特点】
已通过ISO9001注册认证
通过最高水平的USP无菌性测试，并经过三重0.1μm过滤
具有ISIA可追溯性认证，血清的生产符合最高的可追溯性标准
澳洲来源特别适用于要求低风险的研究应用
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2.Hyclone
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【特点】
Sciencell的每一批胎牛血清均经过严格的质控和测试，包括近300种人类原代细胞筛选。胎牛血清经无菌过滤，pH值在7左右，内毒素不超过0.625EU/ml，且无病毒成分。
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国产血清推荐：
1.杭州四季青
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2.金源康
【特点】
质控标准：采自健康新生牛，两次0.1um过滤，无支原体；产品质量符合《中国药典》2015版标准。
产品特点：低lgG，低内毒素，促细胞生长优良
应用范围：娇贵细胞培养，种细胞的继代等。
推荐购买：
以下产品限时买二送一
新生牛血清（超级）http://www.biomart.cn/infosupply/20221746.htm
胎牛血清（优极）http://www.biomart.cn/infosupply/20323300.htm
胎牛血清（超级）http://www.biomart.cn/infosupply/25018976.htm
3.CellMax
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限时暑期特惠
优级胎牛血清http://www.biomart.cn/infosupply/14975942.htm
标准胎牛血清http://www.biomart.cn/infosupply/14975944.htm
澳洲特级胎牛血清http://www.biomart.cn/infosupply/14975935.htm
关于一般所说的血清,在这大约要先分清楚什么叫血清,什么叫单抗治疗剂(在大陆医院及一般人也叫血清)
血清,如果正常而言是从病患犬只身上抽取血液而提炼制成的一种抗体,例如从一只患有犬瘟的患犬经过长期治疗痊愈后,将他的血液抽取出来,经过粹取提炼,而这种提炼出来的血清(免疫抗体),是有治疗加预防犬瘟的效果,同样包括其它另5种致命性病毒如细小肠炎,犬勾螺旋病毒,犬肝炎,犬黄胆等也同样是这样提炼,但是患犬经过治疗痊愈性低而且提炼血清需要大量的血液才能提炼(例如500ml的血液才经过筛检提炼为2.8ml的血清,而一只患犬需要注射治疗预防是需要2.5mlX5剂,试问这种高消耗经济成本时间的脆取提炼法,谁愿意去做)
因此早期国外会将犬只的各种致命性病毒,注射入牛,马,羊,猪等足蹄类动物身体内,再藉由这些动物的血液来脆取提炼犬病毒血清(这些病毒会在这些足蹄类动物身上起一些作用,但却不会致命!而这些动物的血液也够多够充沛来做提炼),经过多年试验中以羊只的血液提炼血清是比较有效果的!
而目前大陆中也是采用相同的方式提炼血清,但是实验对象包括牛马猪羊等足蹄动物,而再粹取血清的过程除了提炼过程严谨也要有相当的保存过程,这两者只要有一个环节有不当,提炼出的血清就会产生极大的不稳定性甚至于无效!!!
这也就是我们常说血清的由来,因为粹取对像非犬只类,加上或许运送或保存或粹取过程(这都是我们无法见到及预期的可変因素)因此血清的作用几乎就大打折扣了,一般使用血清是用于幼中期犬集体长途运输,或是对于一些大犬只因某些原因不能注射疫苗而又需要加强自身免疫时就需要注射(血清是属于一种短暂时提升免疫体的做法),而真正正本清源,是等小狗或大狗身体健康时,注射2-3剂疫苗来确定自身免疫预防!!
也就是说,很多医生或宠物店会因为不完全了解小狗自身情况如何之前,会给狗狗注射血清,希望提高狗狗的免疫抗体,而等狗狗身体和情绪稳定,再开始接种疫苗,但是,前文中也提过,有太多不可预期性会发生,如小狗太早断奶或母乳不足,血清自身因保存或运输不当!这些太多不确定因素造成血清无效外,更容易害了犬只!!
过来我们谈单抗治疗剂,这种疗剂我们称为单抗疫苗(根据犬只患病不同而施以不同的单病毒对抗疗剂,例如犬瘟单抗,细小单抗),这是属于人工合成的活化菌体,其实也很像疫苗指是因为合成为比疫苗更微弱毒性,它是需要一连施打4-5剂,才有作用的针剂,它的作用我大约解释一下,这种抗体是经过人工更弱化的病毒,而注入患犬体内是激发狗狗自身免疫力对这种病毒进行适应力而加以消灭,因此需要施打五剂,等狗狗自身免疫被激发对这种病毒产生抵抗力(排斥性),
狗自生免疫系统就会针对侵入的单种病毒进行围剿消灭,而等自身免疫力能消灭侵入病毒后,狗的身体内这单种病毒病也就会痊愈(当然这只是针对单一种病毒而言,而患病犬只通常并发并非单一种病症,因此要确实诊断使用支持对症诊疗法举个例,如犬瘟并发呼吸道葡萄球链菌引发流鼻涕咳嗽症状,既使犬瘟病毒被消灭但是葡萄球链菌并不会因犬瘟病毒被消灭而停止作怪,医生还是要针对葡萄链球菌作抗生素注射治疗),而痊愈后的狗,自生免疫力会对单一病毒产生终生排斥作用,例如犬只经过细小治愈后,这只狗终身对细小病毒免疫,既使给狗只注射六联疫苗,疫苗内的弱化细小病毒一样被狗狗自身免疫力排斥消灭,而其它五种疫苗却会再犬只身上起作用(既使得犬瘟医治好的狗能终生预防犬瘟,也同样要打疫苗,因为致命性病毒不是只有犬瘟一种,除非你加狗狗天生利害能六种病都得到而又都医治好!这种可能性太低也千万保佑别这么做狗狗和饲主都太辛苦)!
这也就是为什么患病犬只到医院被确诊为细小或犬瘟时,医生又要打血清的原因(其实是单抗),当然单抗不是万灵丹,它只是加强犬只自身激发免疫的一种催化剂,若是犬只本身体质虚弱或是病毒已经大面积侵犯犬只器官,这些治疗方式都只是一种尽人事听天命的方法了!!!
