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[一种国家黄热病疫苗的质量标准化]

[The quality standardization of a national vaccine against yellow fever].

作者信息

Rasshchepkina M N, Levina V D, Vorob'eva M S, Kozlov V G

出版信息

Zh Mikrobiol Epidemiol Immunobiol. 1990 Jul(7):47-50.

PMID:2251891
Abstract

One of the commercial lots of yellow fever vaccine has been attested as the National Branch Standard (NBS) of yellow fever vaccine. This NBS has been studied in all tests required by the regulations for standard vaccines. The NBS has been found to meet the necessary requirements in all its characteristics. The study of the thermostability of the NBS at temperatures of 4-10 degrees C, 20-22 degrees C, 37 degrees C during storage for 24 hours to 1 year has revealed the rapid loss of the infectious capacity of the virus at the above temperatures and its high stability during storage at -20 degrees C. Thus, the NBS has been found to retain the required level of immunizing potency for 3 months at a temperature of 4-10 degrees C, for 1 month at 20-22 degrees C and for 2 weeks (the term of observation) at 37 degrees C. The heat resistance of the NBS of yellow fever vaccine corresponds to the WHO requirements. The newly developed NBS has been used as the standard preparation for controlling 27 lots of commercial yellow fever vaccine.

摘要

一批黄热病疫苗商业批次已被认证为黄热病疫苗的国家分支标准(NBS)。该NBS已按照标准疫苗法规要求的所有测试进行了研究。已发现该NBS在其所有特性方面均符合必要要求。对NBS在4至10摄氏度、20至22摄氏度、37摄氏度温度下储存24小时至1年期间的热稳定性研究表明,病毒在上述温度下感染力迅速丧失,而在-20摄氏度储存期间具有高稳定性。因此,已发现该NBS在4至10摄氏度温度下可保持所需免疫效力水平3个月,在20至22摄氏度下可保持1个月,在37摄氏度下可保持2周(观察期)。黄热病疫苗NBS的耐热性符合世界卫生组织要求。新开发的NBS已被用作控制27批商业黄热病疫苗的标准制剂。

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