Description:
DISCONTINUED–REPLACEMENT:MP0240
Multiplate®RISTOtestisaresearchreagentkitforthequantitativeinvitrodeterminationofvonWillebrandFactor(vWF)-andglycoproteinIb(GpIb)-dependentplateletaggregationstudiesontheMultiplate®analyzer.
RistocetinisanantimicrobialsubstancewhichformscomplexeswithvWF(vonWillebrandfactor).Inthiscomplex,vWFchangesitsconformationinawaythatallowsittobindtoplatelets.Thebindingofristocetin-vWFcomplexesleadstotheaggregationandactivationofplatelets.ThisactivationreliesonthebindingofvWFtotheGPIbreceptoranditisinhibitedbytheactionofAspirin®.ThisexplainstheAspirin®sensitivityofRISTOtest.CompletelackofaggregationintheresearchRISTOhightestcanbecausedbyanabsenceofGPIbreceptorsontheplateletsurface(Bernard-Souliersyndrome)orbyanabsenceofvWFinthesolution(vWDtypeIII).
KitComposition:
Reagents,StorageandStABIlity
- MP0140:Multiplate®RISTOtestReagent,Kit,Ristocetin,1x1.0mL, lyophilized(10mg/ml),with5microtesttubesfor aliquotation.UnopenedvialsoftheRISTOtestreagentmustbestored at2-8°C.Thereagentisstableuntiltheexpirydate printedontheviallabelwhenstoredunderthese conditions.Ifreconstitutedreagentisnotaliquotedinto microtesttubes,theoriginalvialshouldbestoredinan uprightposition. Stable7daysafterreconstitutionwhenstoredat 2-8°C, 4weeks at<-20°Cor24hoursatroomtemperatureafterone timethawing.
AlsoAvailable
- MP0094: Multiplate®RISTOtestAliquotVials,Bag, 100microtubescolorcoded(blue)forfor aliquotation.
- MP0194:Multiplate®RISTOtestReagent,Bag, Ristocetin,1x1.0mL, lyophilized(10mg/ml),withoutmicrotesttubesfor aliquotation.
- MP0240:Multiplate®RISTOtestReagent,Kit,Ristocetin,3x1.0mL, lyophilized(10mg/mL),withoutmicrotesttubesfor aliquotation.
MeasurementPrinciple:
RISTOtestreagentcontainsristocetin.Ristocetinformsa complexwithvWFfromthesample.Thiscomplexbinds totheplateletGpIbreceptorandtriggersplatelet activationandaggregation.RISTOtestcanbeappliedin twoconcentrations:InRISTOhightestahigh concentrationofristocetin(0.77mg/mL)isapplied,which normallyinducesastrongplateletaggregation.Abolished aggregationinRISTOhightestcanbebasedona deficiencyofGpIbreceptorsorvWF.InRISTOlowtesta lowerconcentrationofristocetin(0.2mg/mL)isapplied whichnormallydoesnotinduceastrongaggregation response.Ahigherthanexpectedaggregationin RISTOlowtestmayindicateanenhancedaggregation tendencyofvWF(vWDtypeIIb).
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要是能上传一些真实药厂设备,也许对大家都有帮助。
下面上传《常用制剂设备》的图扫描。
http://www.k65.net/mail/url.php?n=eXpmMzcyMT0v
code:37217613
先说出自己这几天学习注射剂的心得:
关于注射剂仿制,先对照原研处方,处方设计尽量和原研一致,通过考察评价外观、色泽、澄明度、pH、含量、有关物质、细菌内毒素或热原、不溶性微粒和稳定性等,确定一个符合标准的相关标准高于原研药的处方。也就是说注射剂仿制就是通过处方和工艺的筛选找出一个满足标准(pH、含量、有关物质、细菌内毒素或热原等)的处方和工艺,这个是不是仿制的基本思路?
而这其中有还很多问题。只有思路还不进行实际研发。
比如处方设计中,一般常用辅料有哪些?
一般在什么情况下需要加入什么特殊的辅料?比如pH调节剂,抑菌剂等。
做研发的实验步骤是如何。有了一个初步的处方,我们第一步是配溶液?还有灭菌、封口这个步骤是怎样的?每一步都用什么设备,有几种工艺可以选,还一般的操作条件如温度速度时间等。
很多细节问题和思路问题,做注射剂的高手和新手们都来说说哦。这是一个开放的交流大家可以说的更远,说出自己的精华。
另外版主给加个积分呗,很多帖子我看不了!!!
下面是我觉得做注射剂必须了解的基本法规链接,给新手看滴,希望有帮助
http://www.sfda.gov.cn/WS01/CL0058/9348.html
关于印发《可见异物检查法补充规定》的通知
http://www.sfda.gov.cn/WS01/CL0055/27800.html
关于发布化学药品注射剂和多组分生化药注射剂基本技术要求的通知
http://www.sfda.gov.cn/WS01/CL0055/24969_9.html
关于开展注射剂类药品生产工艺和处方核查工作的通知
比较电泳设备.pdf(425.0k)
(y)战友资源。萝卜茄子都是好美味。
常用制药设备1.rar(232.25k)
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