水痘减毒活疫苗豚鼠异常毒性检查方法的探讨  

Investigation on test method for abnormal toxicity of live attenuated varicella vaccine in guinea pigs

作　　者：陈哲文[1] 金于兰[1] 马相虎[1] 张建光[1] 朱玉美[1] 王亮[1] 

机构地区：[1]上海生物制品研究所有限责任公司,上海200052

出　　处：《中国生物制品学杂志》2012年第7期896-900,共5页Chinese Journal of Biologicals

摘　　要：目的探讨水痘减毒活疫苗(以下简称水痘疫苗)的豚鼠异常毒性检查法。方法按照《中国药典》三部(2010版)规定,对本公司生产的41批水痘疫苗进行豚鼠异常毒性检查;分别对本公司生产的水痘疫苗在不同实验室、4个不同厂家的水痘疫苗、本公司生产的不同批号水痘疫苗及不同体重的豚鼠注射本公司生产的水痘疫苗后进行异常毒性检查。注射前每只豚鼠称重,应为250～350 g。每只豚鼠腹腔注射供试品5.0 ml,观察7 d。结果观察期内,豚鼠全部健存,且无异常反应,到期时每只豚鼠体重均增加。其中,同一实验室的豚鼠在注射同一批水痘疫苗后出现体重增加差异;不同实验室的豚鼠体重增加有差异,每天称重影响豚鼠体重的增加;在注射疫苗后的第1、2天,多数豚鼠体重出现略微下降,随后开始逐渐增加。结论本公司生产的水痘疫苗安全性良好,建议采用清洁级以上的豚鼠进行异常毒性检查,同时规定实验动物的性别和注射前的观察期限,并设立阳性、阴性对照,对生物制品的安全性作出更为合理的评价。Objective To investigate the test method for abnormal toxicity of live attenuated varicella vaccine in guinea pigs. Methods Forty-one batches of live attenuated varicella vaccine manufactured by Shanghai Institute of Biological Products Co. Ltd （SIBP） were subjected to abnormal toxicity test in guinea pigs according to the requirements in Chinese Pharmacopoeia （Volume m, 2010 edition）. Abnormal toxicity tests were also performed on the vaccine manufactured by SIBP in various laboratories, the vaccines produced by four other manufacturers, various batches of vaccine manufactured by SIBP, and the vaccine manufactured by SIBP after injection into guinea pigs with various bodyweights. Each guinea pig was weighed before injection, of which the bodyweight should be 250 - 350 g. Each guinea pig was injected i.p. with 0. 5 ml of test sample, and observed for 7 d, Results All the guinea pigs survived without abnormal reactions during the whole observation period, of which the bodyweights increased at the end of observation period. The bodyweight increases of guinea pigs injected with the same batch of vaccine and tested in the same laboratory showed difference. The bodyweight increases of guinea pigs tested in various laboratories showed difference, and weighing every day showed influence on the bodyweight increase. The bodyweights of most of guinea pigs decreased slightly on days 1 and 2 after injection, then increased gradually. Conclusion The live attenuated varicella vaccine manufactured by SIBP showed high safety. The guinea pigs above the clean level are recommended to be used for abnormal toxicity test. Meanwhile, the sex of guinea pig and observation period before injection shall be prescribed, and positive and negative controls shall be set up, so as to evaluate the safety of biologics more rationally.

关 键 词：水痘疫苗 豚鼠 异常毒性 安全性 

分 类 号：R373.12[医药卫生—病原生物学] R392-33[医药卫生—基础医学]