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人二倍体细胞狂犬病疫苗:实验动物毒理学研究

Rabies vaccine HDC: toxicological studies in laboratory animals.

作者信息

Ronneberger H, Gruschkau H, Majer M

出版信息

Dev Biol Stand. 1978;40:215-20.

PMID:680395
Abstract

A purified rabies vaccine prepared in human diploid cell cultures (Wistar 38 adapted Pitman-Moore strain) was tested in several animal species with single and repeated administration. Acute toxicity studies were performed in mice, rats, and guinea pigs with s.c. or i.m. injections of at least 1 human dose/animal. The results gave no evidence of toxic effects. Studies on local compatibility were carried out in white rabbits (i.c. and s.c.) and albino guinea pigs (i.m.). During the observation period of 1 or 2 weeks after inoculation no adverse reactions were seen. Pyrogen tests in rabbits with 6 lots of vaccines showed that rabies vaccine is pyrogenfree. Long-term studies with 4 injections into rats and dogs and observation over a 4-month period gave no alterations of hematological parameters and of the urinalysis. The behaviour of the animals was not altered. Short- and long-term experiments in animals showed the innocuity of this type of rabies vaccine.

摘要

一种在人二倍体细胞培养物中制备的纯化狂犬病疫苗(Wistar 38适应的皮特曼-摩尔株)在几种动物物种中进行了单次和重复给药测试。对小鼠、大鼠和豚鼠进行了急性毒性研究,通过皮下或肌肉注射,每只动物至少注射1个人用剂量。结果未显示出毒性作用的证据。对白兔(颅内和皮下)和白化豚鼠(肌肉内)进行了局部相容性研究。在接种后1或2周的观察期内未观察到不良反应。对6批疫苗进行的家兔热原试验表明,狂犬病疫苗无热原。对大鼠和狗进行4次注射并观察4个月的长期研究未发现血液学参数和尿液分析有变化。动物的行为未改变。动物的短期和长期实验表明这种类型的狂犬病疫苗是无害的。

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