银杏内酯注射液

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1、银杏内酯注射液血管刺激性作用研究张德波,罗洁,邓莎,郑娇娇,贺抒（成都市药品检验所,四川成都610045）[摘要]目的：对银杏内酯注射液血管刺激性进行研究。方法：考查不同固定剂、不同浓度供试液浓度、不同稀释剂对银杏内酯注射液血管刺激性作用的影响；考查察停止给予银杏内酯注射液14d天后血管刺激能否恢复情况。结果：FAA固定液对血管刺激性的判断有一定影响；使用10%福尔马林溶液或10%福尔马林生理盐水溶液作为固定剂较好；银杏内酯注射液稀释成1.0mg▪ml-1浓度对兔血管有刺激作用，0.5mg▪ml-1、0.2mg▪ml-1浓度对血管无未见刺激

2、作用；0.9%氯化钠注射液、5%葡萄糖注射液两种稀释剂配制药物对血管刺激性无影响；停药14d天后血管刺激作用能部分恢复。结论：银杏内酯注射液现行国家标准中的“刺激性试验”检查标准应当修改。关键词：银杏内酯注射液；血管刺激；标本固定剂；供试浓度；稀释剂；恢复期中图分类号：StudyontheVvascularirritationstimulationforofgGinkgolide iInjectionZhangDebo,LuoJie,DengSha,ZhengJiaojiao,HeShu(ChengduiInstituteforDrugCo

3、ntrol,Chengdu610045)AbstractBSTRACT:ObjectiveBJECTIVE:Baseonthenationalstandardtoimprovethevascularstimulationstandardfor英文与中文不对应，因此删掉StudyonthevascularirritationofgGinkgolide iInjection.MethodsETHODS:StudyonthevascularstimulationstandardaboutItwasinvestigatedthatthediffer

4、entspecimenfixingsolutionsingsolution、,concentrationsofthetestsolutionconcentrations、anddiluentshadtheimpactsonthevascularirritationofGinkgolideInjectionandwhetherthevascularfunctioncouldberecoveredyaftertheuseofGinkgoligeInjectionwasstoppedfor14days.situation afterstopmed

5、ication.ResultsESULTS:FAAThefixingedsolutionofFAAhadcertaininfluenceoninterferedwiththejudgmentofvascularirritationstimulation.The10%fFormaldehyde sSolutionor10%FormaldehydeSodiumChlorideSolutionwerethearebetterfixingsolutions.ThedilutedsolutionofGinkgolideInjection1.0mg▪m

6、l-1hadtheirritationontherabbits’vesselsbutthedilutedsolutionofGinkgolideInjection0.5mg▪ml-1and0.2mg▪ml-1hadnoirritationontherabbits’vessels.testsolutionconcentrationhaseffectonstimulating.TheDdiluentsof0.9%SodiumChloridesolutionand5%Glucosesolutionhadnoeffectimpactonthevas

7、cularirritationstimulation.Thevascularfunctioncouldberecoveredaftertheuseofginkgoligeinjectionwasstoppedfor14days.ConclusionONCLUSION:ThetestofvascularirritationstimulationstandardforinthegGinkgolide iInjectionspecificationshouldbemodified，inordertoevaluatethesecuritymoreo

8、bjectively.KeywordsEYWORDS:gGinkgolide iInjection;vascularirritationstimulation;specimenf