CAJ | 학술논문

目的：评价盐酸阿扎司琼注射液的安全性，为临床用药提供实验依据。方法家兔耳缘静脉给予盐酸阿扎司琼注射液0．5mg·kg -1，每天给药1次，连续给药5d，停药96h后对注射部位进行病理组织学检查；家兔股四头肌给予0．25mg·mL -1盐酸阿扎司琼注射液1mL，给药1次，48h后对注射部位进行病理组织学检查；豚鼠隔日腹腔注射0．5mL盐酸阿扎司琼注射液，连续注射3次，分别于末次致敏后第14天静脉注射1．0 m L盐酸阿扎司琼注射液进行激发，观察豚鼠30 m in内是否出现变态反应；0．1～0．5mL盐酸阿扎司琼注射液在4．5～4．9mL兔红细胞混悬液中放置3h，观察对兔红细胞悬液的溶血及有无红细胞凝聚作用。结果盐酸阿扎司琼注射液无明显血管刺激性；无明显肌肉刺激性；无溶血和凝集反应；豚鼠全身主动过敏性实验为阴性。结论在实验条件下，盐酸阿扎司琼注射液符合注射剂安全要求。
목적：평개염산아찰사경주사액적안전성，위림상용약제공실험의거。방법가토이연정맥급여염산아찰사경주사액0．5mg·kg -1，매천급약1차，련속급약5d，정약96h후대주사부위진행병리조직학검사；가토고사두기급여0．25mg·mL -1염산아찰사경주사액1mL，급약1차，48h후대주사부위진행병리조직학검사；돈서격일복강주사0．5mL염산아찰사경주사액，련속주사3차，분별우말차치민후제14천정맥주사1．0 m L염산아찰사경주사액진행격발，관찰돈서30 m in내시부출현변태반응；0．1～0．5mL염산아찰사경주사액재4．5～4．9mL토홍세포혼현액중방치3h，관찰대토홍세포현액적용혈급유무홍세포응취작용。결과염산아찰사경주사액무명현혈관자격성；무명현기육자격성；무용혈화응집반응；돈서전신주동과민성실험위음성。결론재실험조건하，염산아찰사경주사액부합주사제안전요구。
Objective To valuate the safety of Azastron Hydrochloride Injections and provide evidence for clinical medication .Meth-ods Rabbits were administrated with Azastron Hydrochloride Injections (0 .5 mg · kg -1 ,once daily continuously for 5 d ,iv) ,and histopathlogic examination for the injection site was carried out at 96 h after drug withdrawal .The quadriceps femoris of rabbits were administrated with Azastron Hydrochloride Injection (0 .25 mg · mL -1 ,1 mL for one time ,im) ,and histopathlogic examina-tion of injection site was carried out at 48 h after drug withdrawal .Guinea pigs were ip administrated with Azastron Hydrochloride Injections (0 .5 mL) every other day for three times successively ,and on the day 14 after the last sensitization 1 .0 mL of Azastron Hydrochloride Injections was iv administrated to arouse the reaction ,and hemolyzation and agglutination of rabbit erythrocyte were observed by incubating Azastron Hydrochloride Injections (0 .1-0 .5 mL) placed in rabbit erythrocyte (4 .5-4 .9 mL) in vitro for 3 h .Results Azastron Hydrochloride Injections did not induce obvious vascular and muscle irritative effects and hemolysis reaction , and the active systemic anaphylaxis of Azastron Hydrochloride Injections was negative .Conclusion Azastron Hydrochloride Injec-tions should be safe under the experimental conditions ,and it was complianced with the requirement of injection safety .