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布舍瑞林注射液过敏性、溶血性及刺激性研究
杨雪,王建,刘海余,薛宝君,赵健,崔志刚,汤连升
0
(天津市中升挑战生物科技有限公司)
摘要:
本研究旨在通过过敏性、体外溶血性及肌肉刺激性评价布舍瑞林注射液的安全性。过敏性试验和溶血性试验中设立阴性和阳性对照,而刺激性试验中采用自身对照。试验过程中,对照系统均成立。Hartley豚鼠隔日腹腔连续3次注射给予布舍瑞林注射液(2 μg/只),末次致敏后第14和21天分别静脉注射2倍致敏剂量供试品激发进行主动全身过敏试验,结果为阴性;同样的给药剂量,末次致敏后第10天,皮内注射给予对应的抗体血清,静脉注射激发后未见蓝斑,豚鼠被动皮肤过敏反应结果为阴性。采用2%红细胞悬液进行体外溶血性试验,温育15 min、30 min、45 min、1 h、2 h、3 h各观察1次,布舍瑞林注射液和阴性对照组所有试管未见溶血,终末未见红细胞凝集,而阳性对照组全部溶血。新西兰兔连续肌肉注射给予布舍瑞林注射液(0.5 mL/只),末次给药72 h后,病理组织学检查可见对新西兰兔股四头肌有刺激作用,恢复期结束未见刺激性反应,具有可逆性。研究结果表明,布舍瑞林注射液无过敏性和溶血性,对肌肉有刺激性但停药后可恢复,在应用过程中是安全的。
关键词:  布舍瑞林  皮肤过敏性  体外溶血性  肌肉刺激性
DOI:
投稿时间:2023-03-10修订日期:2023-08-16
基金项目:
Experimental Study of Buserelin Injection on Sensitization, Hemolysis and Irritation
(Tianjin Speerise Challenge Biotechnology Co., Ltd)
Abstract:
The purpose of this study was to evaluate the safety of buserelin injection by sensitization, in vitro hemolysis, and muscle irritation. In the allergy test and hemolysis test, the negative control group, positive control group were set up, while in the irritation test, the self-control method was used. During the test, the control system was established. Hartley guinea pigs were injected with buserelin injection (2 μg/animal) for 3 consecutive times every other day in intraperitoneal, and buserelin injection was administered intravenously at twice the sensitizing dose on days 14 and 21 after the last sensitization for excitation. Allergic reaction was negative. On the 10th day after the last sensitization, the corresponding antibody serum was injected intradermally with the same dose. Locus coeruleus was not observed after intravenous injection excitation .The result of passive cutaneous anaphylaxis was negative in guinea pigs. 2% erythrocyte suspension was used for in vitro test in the hemolysis test, and observed once at 15 min, 30 min, 45 min, 1 h, 2 h and 3 h respectively. No hemolysis was observed in all test tubes of buserelin injection and negative control, and no erythrocyte aggregation was observed at the end. Hemolysis was observed in the all positive control group. New Zealand rabbits were given buserelin injection (0.5 mL/animal) by continuous intramuscular injection. Histopathological examination showed that buserelin injection had obvious irritation to quadriceps femoris of New Zealand rabbits at 72 h after the last administration. No irritation reaction was observed at the end of the recovery period, which was reversible. The results showed that buserelin injection had no allergy and hemolysis, and had irritation to muscle, but it could be recovered after withdrawal, which indicated that buserelin injection was safe in application process.
Key words:  buserelin, skin sensitization, in vitro hemolysis, muscle irritation

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