hplc法测定血小板贮存袋增塑剂bthc在混合浓缩血小板保存过程中的溶出量

《hplc法测定血小板贮存袋增塑剂bthc在混合浓缩血小板保存过程中的溶出量》由会员上传分享，免费在线阅读，更多相关内容在应用文档-天天文库。

1、HPLC法测定血小板贮存袋增塑剂BTHC在混合浓缩血小板保存过程中的溶出量韩玎玎贺曾李婉晶段炼王红中国医学科学院北京协和医学院输血研宄所目的:建立增塑剂丁酰拧檬酸三正己酉旨(butyryltrihexylcitrate,BTHC)的测定方法，并测定血小板贮存袋所含增塑剂BTHC在混合浓缩血小板保存过程中的溶出量，为该产品的安全性评价提供依据。方法:采用乙腈沉淀血小板悬液中的蛋白等杂质，离心所得上清液用高效液相色谱法(HPLC)测定BTHC的含量，并对测定方法进行方法学研宄。结果:HPLC方法测定BTHC浓度在10502ug•mI

2、；1范围内线性关系良好(r=0.9999),灵敏度为0.04ug，仪器精密度RSD〈5%，回收率为98.6%±8.4%，用该方法测定血小板贮存袋贮存一个治疗剂量的混合浓缩血小板时BTHC的溶出量，贮存第5天溶出量为28.10±2.38mg;贮存第7天溶出量36.63±3.89mg。结论:木法经方法学验证，TT以用于测定BTHC在.血小板悬液中的溶出量。关键词：丁酰拧檬酸三正己酯(BTHC);增塑剂;溶出量;血小板贮存袋;混合浓缩血小板;高效液相色谱法;王红Tel:(028)61648520;E-mail:smile9918@12

3、6.com韩玎玎Tel:(028)61648511;E-mai1:531032212@qq.com基金：四川省科技支撑计划项A“血液净化、透析系统”(设备及耗材)的研制和开发(2014SZ0127)DeterminationoftheamountofBTHCreleasedintopooledplateletconcentratesfromplateletstoragecontainersbyHPLCHANDing-dingHEZengLIWan—jingDUANLianWANGHongInstituteofBloodTrans

4、fusion，ChineseAcademyofMedicalSciences，PekingUnionMedicalCollege;Abstract：Objective:TodevelopamethodforthedeterminationofplasticizerButyryltrihexylcitrate(BTHC)releasedfromplateletstoragecontainersintopooledplateletconcentratesandtoevaluatethesafetyofthisproduct.Meth

5、od:BTI1Cwasobtainedbycentrifugationofpooledplateletconcentratesusingacetonitrileasproteinprecipitationagent,andthequantificationofBTHCwasachievedbyHPLC.Themethodwasvalidatedbymethodologystudy.Results:ThemethodologystudyofHPLCwaspresentedthattheconcentrationofBTHC10-5

6、02ug•mI/1hadagoodlinearrelationship(r=0.9999)，themethodsensitivitywas0.04ug,instrumentalprecisionshowedRSD<5%,andrecoveryratewas98.6%±8.4%.Bythismethod,theamountofBTHCreleasingintoplateletconcentrateswithonetreatmentdosefromplateletstoragebagswas28.10±2.38mgatthe5thd

7、ayofstorageand36.63±3.89mgatthe7'hdayofstorage.Conclusion:Thismethodshowedhighaccuracy，gKowordsinationofBTHCleachingintopooledplateletconcentrates,eoydreliabilityandstabilityforthedetermbutyryltrihexylcitrateBTHCplasticizermigrationplateletstoragebagpooledplateletKey

8、word：butyryltrihexylcitrate(BT11C);plasticizer;migration;plateletstoragebag;pooledplateletconcentrates;highperformanceliquidchromat