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将连续生产并已申报人体接种反应观察的三批吸附精制百日咳菌苗、白喉、破伤风类毒素混合制剂，分别于４～８℃、１８～２２℃、３７℃贮存半年、１年、１年半和３０天，然后以小鼠法或豚鼠法对该制剂进行安全稳定性、效力稳定性以及毒性逆转等测试。其毒力安全稳定性试验表明，三批混合制剂中的精制百日咳菌苗在４～８℃贮半年、１年、１年半后、它们的ＢＷＤＵ／ｍｌ、ＬＰＵ／ｍｌ、ＨＳＵ／ｍｌ均无显著性差异（Ｐ＞０．０５）；白喉及破伤风类毒素在４～８℃贮存半年，１年、１年半以及１８～２２℃贮存半年和３７℃贮存３０天后，三批测试组的豚鼠均健存且体重增加。在效力稳定性试验中，４～８℃贮存１年和１年半后精制百日咳菌苗的效力与贮存前（分别为２６．７３ＩＵ／ｍｌ、２１．０２ＩＵ／ｍｌ、１９．１７ＩＵ／ｍｌ）无显著性差异（ｔ＝０．１１４；Ｐ＞０．０５）；白喉及破伤风类毒素４～８℃贮存长达１年半后，效力仍在２～３．２ＩＵ／ｍｌ，动物保护率仍可达８０～１００％。三批混合制剂在３７℃贮存３０天后，通过Ｓｃｈｉｃｋ毒性试验及测定ＢＷＤＵ／ｍｌ、ＬＰＵ／ｍｌ、ＨＳＵ／ｍｌ各指标显示，精制百日咳菌苗、白喉和破伤风类毒素无毒性逆转。说明该吸附精制百、白、破混合
The three batches of purified preparations of pertussis vaccine, diphtheria and tetanus toxoid, which were continuously produced and declared for human inoculation reaction, were stored for half a year, one year, and one year at 37 ° C. for 4 to 8 ° C., 18 to 22 ° C., respectively Half and 30 days, and then tested by the mouse method or guinea pig method for the stability, potency stability and toxicity reversal of the preparation. Its virulence safety and stability test showed that the three doses of the mixture of refined pertussis vaccine at 4 ~ 8 ℃ storage half a year, a year and a year and a half after, their BWDU / ml, LPU / ml, HSU / ml (P> 0.05). Diphtheria and tetanus toxoid were stored for half a year, one year, one year and a half after storage at 4 ~ 8 ℃ and storage for half a year at 18 ~ 22 ℃ and storage for 30 days at 37 ℃. Guinea pigs are healthy and gain weight. In the efficacy stability test, the potency and pre-storage (26.73 IU / ml, 21.02 IU / ml, 19.17 IU / ml, respectively) of refined pertussis vaccine after 1 year and 1 year and a half after storage at 4 ° C to 8 ° C Diphtheria and tetanus toxoid 4 ~ 8 ℃ storage for up to 1 year and a half, the efficacy is still 2 ~ 3.2IU / ml, the rate of animal protection is still Up to 80 ~ 100%. After three batches of mixed preparations were stored at 37 ° C for 30 days, Schiff toxicity test and determination of BWDU / ml, LPU / ml and HSU / ml showed no reversal of the toxicity of the purified pertussis vaccine, diphtheria and tetanus toxoid. Description of the adsorption purification hundred, white, broken mix