| 关于吸附精制百日咳菌苗、白喉、破伤风类毒素混合制剂配方的实验报告 |
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| 引用本文： | 陈平纡,陈爱荣,何长民.关于吸附精制百日咳菌苗、白喉、破伤风类毒素混合制剂配方的实验报告[J].微生物学免疫学进展,1994(2). |
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| 作者姓名： | 陈平纡 陈爱荣 何长民 |
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| 作者单位： | 卫生部兰州生物制品研究所 |
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| 摘 要： | 本文对吸附精制百白破混合制剂的不同配方进行了实验，结果表明，新一代吸附精制百白破混合制剂最佳配方为：精制百日咳菌苗１８μｇＰＮ／ｍｌ、精制白喉类毒素为３０Ｌｆ／ｍｌ、精制破伤风类毒素为１０Ｌｆ／ｍｌ。由该配方组成的吸附精制百白破混合制剂，其中百日咳菌苗的毒性试验ＢＷＤＵ／ｍｌ、ＬＰＵ／ｍｌ、ＨＳＵ／ｍｌ三种指标均符合制检规程要求。其效力单位（ＩＵ／ｍｌ）超过规程要求一倍以上，精制白喉和破伤风类毒素的安全试验均符合规程要求，白类效力试验≥８０－１００％，破类效力试验≥０．５－４．５ＩＵ／ｍｌ。上述结果说明本文提出的配方作为新一代精制百白破混合制剂的配方是适宜和实用的。
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| 关 键 词： | 吸附精制百白破混合制剂，毒性试验，效力试验 |
Experimental Peports on the Formula of Adsorbed Purified Pertussis-Diphtheria-Tetanus Combined Vaccine |
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| Chen Pingyu et al.Experimental Peports on the Formula of Adsorbed Purified Pertussis-Diphtheria-Tetanus Combined Vaccine[J].Progress In Microbiology and Immunology,1994(2). |
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| Authors: | Chen Pingyu |
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| Abstract: | The different formula tests of adsorbed purified pertussis-diphtheria-tetanus combined vaccine were investigated. The results showed that the suitable formula consists of 18μg/ml of purified pertussis vaccine 30Lf/ml diphtheria toxoid and 10Lf/ml of tetanus toxoid. Both of the toxicity test and potency test of 3 lots APDT combined vaccine tested met to the Chinese Requirements for the Biological Products. |
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| Keywords: | Adsorbed purified Pertussis-diphtheria-tetatanus combined vaccine Toxicity test Potency test |
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