吸附无细胞百白破(DPTa)的稳定性试验  

The Stability Test of Absorbed Acellular Pertussis Vaccine Diphtheria and Tetanus Toxoid(DPTa)

作　　者：傅惠兰[1] 钟泽荣[1] 熊惠玲 沈吉友 黄林 

机构地区：[1]卫生部成都生物制品研究所

出　　处：《微生物学免疫学进展》1998年第1期10-12,共3页Progress In Microbiology and Immunology

摘　　要：采用半综合液体培养基（含０．０５％ＭｅβＣＤ），大罐培养百日咳Ⅰ相ＣＳ菌制备的吸附无细胞百日咳菌苗、白喉、破伤风类毒素混合制剂（ＤＰＴａ）置４－８℃分别保存一年、保存两年，测三种抗原成分的效力及毒性，以及将该制剂于３７℃分别放置三周、三个月，测定有无毒性逆转。结果表明，该制剂质量稳定。This paper reports that pertussiscs phase Ⅰ was cultivated in a 500- liter fermentor using a semisynthetic medium containing 0.05% heptakis (dimethylbcyclodextrin).The protective antigens were purified from the culture supernatant and mixed with diphtheria and tetanus toxoied and absorbed with alumiunum compound to form DPTa.This preparation was stored at 4-8℃ for one year and two years.The potency of three antigens and toxicity of acellular pertussis vaccine were tested.Sinultaneously the preparation was incubated at 37℃ both three weeks and three months.Toxicity reversion of acellular pertussis vaccine was tested too.The tests showed that potency and toxicity of DPTa stored in one year and two years at 4-8℃ were stable,and toxicity revergion of acellular pertussis vaccine incubated at 37℃ both three weeks and three months was not found.

关 键 词：DPTa 效力 毒性 稳定性 百白破 

分 类 号：R392－33[医药卫生—免疫学] R515.601[医药卫生—基础医学]