中国药业
中國藥業
중국약업
CHINA PHARMACEUTICALS
2015年
11期
3-5,6
,共4页
注射用醋酸西曲瑞克%安全性试验%过敏反应
註射用醋痠西麯瑞剋%安全性試驗%過敏反應
주사용작산서곡서극%안전성시험%과민반응
cetrorelix acetate for injection%safety test%allergic reaction
目的：观察注射用醋酸西曲瑞克的临床安全性。方法豚鼠全身主动过敏性试验，首次给药后第14日及21日，分别于耳缘静脉注射供试品，观察动物过敏症状；被动皮肤过敏性试验，大鼠皮内注射抗体血清，静脉注射伊文思蓝，观察蓝色反应斑的大小；体外溶血试验，观察供试品在3 h内有无引起家兔溶血和红细胞凝聚现象；刺激性试验，家兔皮下注射供试品48 h后，观察注射部位组织变化并进行病理组织学检查。结果注射用醋酸西曲瑞克豚鼠全身主动和被动过敏性试验均未见过敏反应；在3h内未见溶血发生，部分受试药物和参比药物均有轻微凝聚现象；病理组织学检查未见刺激性反应。结论应进一步探讨注射用醋酸西曲瑞克凝聚反应发生的原因，加强临床过敏反应的监测，保证临床用药安全。
目的：觀察註射用醋痠西麯瑞剋的臨床安全性。方法豚鼠全身主動過敏性試驗，首次給藥後第14日及21日，分彆于耳緣靜脈註射供試品，觀察動物過敏癥狀；被動皮膚過敏性試驗，大鼠皮內註射抗體血清，靜脈註射伊文思藍，觀察藍色反應斑的大小；體外溶血試驗，觀察供試品在3 h內有無引起傢兔溶血和紅細胞凝聚現象；刺激性試驗，傢兔皮下註射供試品48 h後，觀察註射部位組織變化併進行病理組織學檢查。結果註射用醋痠西麯瑞剋豚鼠全身主動和被動過敏性試驗均未見過敏反應；在3h內未見溶血髮生，部分受試藥物和參比藥物均有輕微凝聚現象；病理組織學檢查未見刺激性反應。結論應進一步探討註射用醋痠西麯瑞剋凝聚反應髮生的原因，加彊臨床過敏反應的鑑測，保證臨床用藥安全。
목적：관찰주사용작산서곡서극적림상안전성。방법돈서전신주동과민성시험，수차급약후제14일급21일，분별우이연정맥주사공시품，관찰동물과민증상；피동피부과민성시험，대서피내주사항체혈청，정맥주사이문사람，관찰람색반응반적대소；체외용혈시험，관찰공시품재3 h내유무인기가토용혈화홍세포응취현상；자격성시험，가토피하주사공시품48 h후，관찰주사부위조직변화병진행병리조직학검사。결과주사용작산서곡서극돈서전신주동화피동과민성시험균미견과민반응；재3h내미견용혈발생，부분수시약물화삼비약물균유경미응취현상；병리조직학검사미견자격성반응。결론응진일보탐토주사용작산서곡서극응취반응발생적원인，가강림상과민반응적감측，보증림상용약안전。
Objective To evaluate the clinical safety of Cetrorelix Acetate for Injection. Methods The active systemic anaphylaxis test was conducted by using guinea pigs. Each guinea pig was injected by Cetrorelix Acetate for Injection via ear vein. The anaphylactic re-actions were observed on 14, 21 d after the first injection. The rat passive skin anaphylactic test was intracutaneously injected by anti-body serum and intravenously by Evans blue for observing the size of blue reaction spots;In the in vitro hemolytic test, the rabbit RBC hemolysis and coagulation phenomena caused by the test specimens were observed within 3 h;in the stimulation test, the tissue changes of injection site in 4 rabbits were observed at 48 h after injecting the test specimen and the pathohistological examination was conduct-ed. Results No allergic reactions were found in the active systemic anaphylaxis test and the passive skin anaphylaxis test; in the in vitro hemolysis test, no hemolytic was found within 3 h, partial test drugs and reference drugs all had slight coagulation phenomena;in the stimulation test, the pathohistological examination did not find the stimulation reaction. Conclusion The further study on the causes of Cetrorelix Acetate for Injection developing the coagulation reaction should be conducted and the monitoring of allergic reaction should be strengthened in its clinical application for ensuring the clinical medication safety.
