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 abnormal guinea pig toxicity test for varicella live attenuated vaccine (hereinafter referred to as varicella vaccine). Methods According to the provisions of “Chinese Pharmacopoeia” (2010 edition), 41 batches of varicella vaccine produced by our company were tested for abnormal toxicity in guinea pigs. The chickenpox vaccine produced by our company was tested in different laboratories and 4 chickenpox vaccines of different manufacturers, The production of different batches of varicella vaccine and guinea pigs of different weights after the injection of the company’s chickenpox vaccine for abnormal toxicity check. Each guinea pig weighing before injection should be 250 ~ 350 g. Each guinea pig intraperitoneal injection of test substance 5.0 ml, observed 7 d. Results During the observation period, all guinea pigs survived without any abnormal reaction, and each guinea pig gained weight upon expiration. Among them, the guinea pigs in the same laboratory showed weight gain differences after injecting the same batch of varicella vaccine. The weight gain of different guinea pigs in different laboratories was different, and the weight gain of guinea pigs was weighed daily. On the first and second days after the vaccination, Guinea pigs showed a slight decrease in body weight and then started to increase gradually. Conclusions The chickenpox vaccine produced by our company is safe and it is recommended that guinea pigs above the cleaning grade be tested for abnormal toxicity. The sex of experimental animals and the observation period before injection are also stipulated. Positive and negative controls should be set up to make the safety of biological products More reasonable evaluation.